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28
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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☒ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2024
OR
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☐ |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-38529
Verrica Pharmaceuticals Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
46-3137900 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer
Identification No.) |
44 West Gay Street, Suite 400 West Chester, PA |
19380 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (484) 453-3300
N/A
(Former address of principal executive offices)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, $0.0001 par value |
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VRCA |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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☐ |
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Accelerated filer |
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☐ |
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Non-accelerated filer |
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☒ |
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Smaller reporting company |
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☒ |
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Emerging growth company |
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☐ |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 7, 2024, the registrant had 42,420,053 shares of common stock, $0.0001 par value per share, outstanding.
VERRICA PHARMACEUTICALS INC.
QUARTERLY REPORT ON FORM 10-Q
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Unaudited Financial Statements
VERRICA PHARMACEUTICALS INC.
BALANCE SHEETS
(in thousands, except share and per share amounts)
(unaudited)
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March 31, |
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December 31, |
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2024 |
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2023 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
48,939 |
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$ |
69,547 |
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Accounts receivable |
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7,002 |
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4,248 |
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Unbilled collaboration revenue |
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592 |
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168 |
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Inventory |
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2,499 |
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1,022 |
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Prepaid expenses and other current assets |
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2,344 |
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2,545 |
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Total current assets |
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61,376 |
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77,530 |
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Property and equipment, net |
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937 |
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|
1,052 |
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Operating lease right-of-use asset |
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1,082 |
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|
1,158 |
|
Finance lease right-of-use asset |
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2,460 |
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|
|
1,405 |
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Other non-current assets |
|
|
452 |
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|
|
452 |
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Total assets |
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$ |
66,307 |
|
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$ |
81,597 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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|
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Accounts payable |
|
$ |
2,527 |
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$ |
2,464 |
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Accrued expenses and other current liabilities |
|
|
15,828 |
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13,860 |
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Operating lease liability |
|
|
331 |
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|
|
324 |
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Finance lease liability |
|
|
679 |
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|
|
376 |
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Total current liabilities |
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19,365 |
|
|
|
17,024 |
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Operating lease liability |
|
|
825 |
|
|
|
910 |
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Finance lease liability |
|
|
1,761 |
|
|
|
1,026 |
|
Long term debt |
|
|
42,848 |
|
|
|
42,874 |
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Total liabilities |
|
|
64,799 |
|
|
|
61,834 |
|
Commitments and Contingencies (Note 6) |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares
issued and outstanding as of March 31, 2024 and December 31, 2023 |
|
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 authorized;
42,525,197 shares issued and 42,420,053 shares outstanding as of March 31, 2024 and 42,518,697 shares issued and 42,413,553 shares outstanding as of December 31, 2023 |
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4 |
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4 |
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Treasury stock, at cost, 105,144 shares as of March 31, 2024 and December 31, 2023 |
|
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— |
|
|
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— |
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Additional paid-in capital |
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|
252,287 |
|
|
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250,207 |
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Subscription receivable |
|
|
(4 |
) |
|
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— |
|
Accumulated deficit |
|
|
(250,779 |
) |
|
|
(230,448 |
) |
Total stockholders’ equity |
|
|
1,508 |
|
|
|
19,763 |
|
Total liabilities and stockholders’ equity |
|
$ |
66,307 |
|
|
$ |
81,597 |
|
The accompanying notes are an integral part of these financial statements.
VERRICA PHARMACEUTICALS INC.
STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(Unaudited)
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For the Three Months Ended |
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March 31, |
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2024 |
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2023 |
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|
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Revenue: |
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Product revenue, net |
|
$ |
3,232 |
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|
$ |
— |
|
Collaboration revenue |
|
|
594 |
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|
|
37 |
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Total revenue |
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|
3,826 |
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|
37 |
|
Operating expenses: |
|
|
|
|
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Selling, general and administrative |
|
|
16,339 |
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|
4,319 |
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Research and development |
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4,948 |
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2,739 |
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Cost of product revenue |
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|
546 |
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|
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— |
|
Cost of collaboration revenue |
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|
592 |
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|
68 |
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Total operating expenses |
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|
22,425 |
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|
7,126 |
|
Loss from operations |
|
|
(18,599 |
) |
|
|
(7,089 |
) |
Other (expense) income: |
|
|
|
|
|
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Interest income |
|
|
598 |
|
|
|
500 |
|
Interest expense |
|
|
(2,319 |
) |
|
|
— |
|
Other expense |
|
|
(11 |
) |
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— |
|
Total other (expense) income, net |
|
|
(1,732 |
) |
|
|
500 |
|
Net loss |
|
$ |
(20,331 |
) |
|
$ |
(6,589 |
) |
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Net loss per share, basic and diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.15 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
46,483,669 |
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|
43,023,379 |
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|
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The accompanying notes are an integral part of these financial statements.
VERRICA PHARMACEUTICALS INC.
STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
(Unaudited)
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Total |
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Common Stock |
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Additional |
|
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Subscription |
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Accumulated |
|
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Treasury Stock |
|
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Stockholders’ |
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Shares Issued |
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Amount |
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Paid-in Capital |
|
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Receivable |
|
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Deficit |
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Shares |
|
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Cost |
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Equity |
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|
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January 1, 2024 |
|
|
42,518,697 |
|
|
$ |
4 |
|
|
$ |
250,207 |
|
|
$ |
— |
|
|
$ |
(230,448 |
) |
|
|
105,144 |
|
|
$ |
— |
|
|
$ |
19,763 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
2,072 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,072 |
|
Exercise of stock options |
|
|
6,500 |
|
|
|
— |
|
|
|
8 |
|
|
|
(4 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
4 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(20,331 |
) |
|
|
— |
|
|
|
— |
|
|
|
(20,331 |
) |
March 31, 2024 |
|
|
42,525,197 |
|
|
$ |
4 |
|
|
$ |
252,287 |
|
|
$ |
(4 |
) |
|
$ |
(250,779 |
) |
|
|
105,144 |
|
|
$ |
— |
|
|
$ |
1,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
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|
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|
|
|
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|
|
|
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|
|
|
|
January 1, 2023 |
|
|
41,199,197 |
|
|
$ |
4 |
|
|
$ |
203,482 |
|
|
$ |
— |
|
|
$ |
(163,453 |
) |
|
|
105,144 |
|
|
$ |
— |
|
|
$ |
40,033 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
1,094 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,094 |
|
Issuance of common stock and pre-funded warrants, for the purchase of common stock, net of issuance costs |
|
|
750,000 |
|
|
|
— |
|
|
|
30,301 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
30,301 |
|
Exercise of stock options |
|
|
8,000 |
|
|
|
— |
|
|
|
7 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,589 |
) |
|
|
— |
|
|
|
— |
|
|
|
(6,589 |
) |
March 31, 2023 |
|
|
41,957,197 |
|
|
$ |
4 |
|
|
$ |
234,884 |
|
|
$ |
— |
|
|
$ |
(170,042 |
) |
|
|
105,144 |
|
|
$ |
— |
|
|
$ |
64,846 |
|
The accompanying notes are an integral part of these financial statements.
VERRICA PHARMACEUTICALS INC.
STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Cash flows from operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(20,331 |
) |
|
$ |
(6,589 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Stock-based compensation |
|
|
2,072 |
|
|
|
1,094 |
|
Depreciation expense |
|
|
126 |
|
|
|
131 |
|
Non cash interest expense |
|
|
483 |
|
|
|
— |
|
Amortization of operating lease right-of-use asset |
|
|
76 |
|
|
|
71 |
|
Amortization of finance lease right-of-use asset |
|
|
138 |
|
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(1,275 |
) |
|
|
1,266 |
|
Collaboration revenue receivable, billed and unbilled |
|
|
(424 |
) |
|
|
431 |
|
Accounts payable |
|
|
52 |
|
|
|
14 |
|
Accounts receivable |
|
|
(2,753 |
) |
|
|
— |
|
Accrued expenses and other current liabilities |
|
|
1,968 |
|
|
|
(934 |
) |
Operating lease liability |
|
|
(79 |
) |
|
|
(74 |
) |
Net cash used in operating activities |
|
|
(19,947 |
) |
|
|
(4,590 |
) |
Cash flows from investing activities |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
— |
|
|
|
(11 |
) |
Net cash used in investing activities |
|
|
— |
|
|
|
(11 |
) |
Cash flows from financing activities |
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
4 |
|
|
|
7 |
|
Payment of debt amendment fees |
|
|
(509 |
) |
|
|
— |
|
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs |
|
|
— |
|
|
|
30,301 |
|
Equity issuance costs |
|
|
— |
|
|
|
(28 |
) |
Repayment of finance lease |
|
|
(156 |
) |
|
|
— |
|
Net cash (used in) provided by financing activities |
|
|
(661 |
) |
|
|
30,280 |
|
Net (decrease) increase in cash and cash equivalents |
|
|
(20,608 |
) |
|
|
25,679 |
|
Cash and cash equivalents at the beginning of the period |
|
|
69,547 |
|
|
|
34,273 |
|
Cash and cash equivalents at the end of the period |
|
$ |
48,939 |
|
|
$ |
59,952 |
|
|
|
|
|
|
|
|
Supplemental disclosures |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
1,836 |
|
|
$ |
— |
|
Supplemental disclosure of noncash investing and financing activities: |
|
|
|
|
|
|
Property and equipment purchases in accounts payable or accrued expenses and other current liabilities at period end |
|
$ |
11 |
|
|
$ |
34 |
|
Right-of-use asset obtained in exchange for lease obligation |
|
$ |
1,193 |
|
|
$ |
— |
|
The accompanying notes are an integral part of these financial statements.
VERRICA PHARMACEUTICALS INC.
Notes to Financial Statements
(Unaudited)
Note 1—Organization and Description of Business Operations
Verrica Pharmaceuticals Inc. (the “Company”) was formed on July 3, 2013 and is incorporated in the State of Delaware. The Company is a dermatology therapeutics company developing and selling medications for skin diseases requiring medical intervention. On July 21, 2023, the U.S. Food and Drug Administration (“FDA”) approved YCANTH (VP-102) topical solution for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. The Company launched commercial operations in August 2023.
Liquidity
The Company has incurred substantial operating losses since inception and expects to continue to incur significant losses for the foreseeable future and may never become profitable. As of March 31, 2024, the Company had an accumulated deficit of $250.8 million. The Company believes its cash, and cash equivalents of $48.9 million as of March 31, 2024 will be sufficient to support the Company’s planned operations only into the first quarter of 2025. These factors cause substantial doubt to exist about the Company's ability to continue as a going concern within one year after the date these financial statements are issued. The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.
The Company plans to secure additional capital in the future through equity or debt financings, partnerships, or other sources to carry out the Company’s planned commercial and development activities. If the Company is unable to raise capital when needed or on attractive terms, the Company would be forced to delay, reduce or eliminate its future commercialization efforts or research and development programs.
On July 26, 2023, the Company entered into a Credit Agreement which provides for up to $125.0 million in debt under a Loan Facility (as defined in Note 10). The Company borrowed $50.0 million under the Loan Facility on July 26, 2023, resulting in net proceeds of approximately $44.1 million after payment of certain fees and transaction related expenses. In addition, subject to the Company's achievement of certain revenue targets, up to $25.0 million will be made available on or prior to June 30, 2024, up to $30.0 million will be made available on or prior to December 31, 2024, up to $10.0 million will be made available on or prior to March 31, 2025, and up to $10.0 million will be made available on or prior to June 30, 2025. Amounts borrowed under the Loan Facility will mature on July 26, 2028.
Note 2—Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2023 included in its Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenues and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Collateral Cash
Cash and cash equivalents as of March 31, 2024 includes a cash deposit of $0.5 million with Bank of America as required under the Commercial Credit Card Program with a balance equal to the outstanding credit limit on commercial credit cards.
Fair Value of Financial Instruments and Credit Risk
As of March 31, 2024, the Company’s financial instruments included cash equivalents, accounts receivable, accounts payable, and notes payable. The carrying amount of cash equivalents, accounts receivable and accounts payable approximated fair value, given their short-term nature. The carrying value of the notes payable approximates fair value as the interest rate is reflective of current market rates on debt with similar terms and conditions.
Cash equivalents subject the Company to concentrations of credit risk. However, the Company invests its cash in accordance with a policy objective that seeks to ensure both liquidity and safety of principal. The policy limits investments to instruments issued by the U.S. government, certain SEC registered money market funds that invest only in U.S. government obligations and various other low-risk liquid investment options, and places restrictions on portfolio maturity terms.
Accounts receivable subjects the Company to concentrations of credit risk as all of the Company's revenue is from sales of a single product, YCANTH (VP-102), primarily to one pharmaceutical wholesale/distributor.
Accounts Receivable
Accounts receivable, related to YCANTH (VP-102) sales, was $7.0 million at March 31, 2024. As of March 31, 2024, the Company had no allowance for doubtful accounts. An allowance for doubtful accounts is determined based on the Company's assessment of the creditworthiness and financial condition of its customers, aging of receivables, as well as the general economic environment. Any allowance would reduce the net receivables to the amount that is expected to be collected. Current payment terms for YCANTH (VP-102) are approximately 60 days from the shipment date.
Inventory
The Company values inventory at the lower of cost or net realizable value. Inventory cost is determined using the specific identification method. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of March 31, 2024.
On July 21, 2023, the Company received FDA approval for YCANTH (VP-102) for the treatment of molluscum contagiosum and began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all product purchased from such suppliers was included as a component of research and development expense, as the Company was unable to assert that the inventory had future economic benefit until YCANTH received FDA approval. Pursuant to the supply agreement (Note 6), the Company purchased and included in research and development expenses approximately $4.5 million of raw cantharidin and processed active pharmaceutical ingredient ("API"). The raw cantharidin and processed API is sufficient to produce approximately 14.0 million finished drug product applicators to be used for commercially saleable product and other product candidates. In addition, the Company purchased other components and services related to YCANTH for commercially saleable product and included approximately $1.2 million in research and development expenses prior to FDA approval. As a result, cost of product revenue related to YCANTH will initially reflect a lower average per unit cost of materials over approximately the next nine months as previously expensed inventory is utilized for commercial production and sold to customers. If the Company were to have included those costs previously expensed as a component of cost of product revenue, the Company’s cost of product revenue for the three months ended March 31, 2024 would have been $0.7 million including $0.3 million of obsolete inventory costs.
Product Revenue, Net
The Company recognizes revenue from sales of a single product, YCANTH (VP-102) (the “Product”) in accordance with ASC Topic 606 – Revenue from Contracts with Customers. YCANTH (VP-102) became available for commercial sale and shipment to patients with a prescription in the United States in the third quarter of 2023. The Company sells the Product primarily to one customer, a pharmaceutical wholesaler/distributor (the “Customer”) who in turn sells the Product directly to clinics, hospitals, and federal healthcare programs. Revenue is recognized as the Product is physically delivered to the Customer.
Gross product sales are reduced by corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in the Company’s reported “Product revenue, net” in the accompanying statements of operations. Product revenue, net reflects the amount the Company ultimately expects to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that the Company estimates for the various GTN categories discussed below. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period, in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns,
government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, co-pay assistance and distribution, data, and group purchasing organizations ("GPO") administrative fees may be materially above or below the amount estimated. Variance between actual amounts and estimated amounts may result in prospective adjustments to reported net product revenue.
Each of the GTN estimate categories are discussed below:
Product Returns Allowances: The Customer is contractually permitted to return purchased Product in certain circumstances. The Company estimates expected returns based on the Company’s review of similar products in the industry. As historical data for returns of the Product becomes available over time, the Company will utilize historical return rates of the Product in making its estimates. Returned Product is typically destroyed, since substantially all returns are due to expiry and cannot be resold.
Government Chargebacks: The Product is subject to pricing limits under certain federal government programs, including Medicare and the 340B drug pricing program. Qualifying entities (the “End-Users”) purchase the Product from the Customer at their applicable qualifying discounted price. The chargeback amount the Company incurs represents the difference between the Company’s contractual sales price to the Customer and the end-user’s applicable discounted purchase price under the government program.
Medicaid Rebates: The Product is subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with the Product is covered under Medicaid, resulting in a discounted price for the Product under the applicable Medicaid program. The Medicaid rebate accrual calculations require the Company to project the magnitude of its sales, by state, that will be subject to these rebates.
Patient Assistance: The Company offers a voluntary co-pay patient assistance program intended to provide financial assistance to eligible patients with a prescription drug co-payment required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with YCANTH (VP-102) that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period.
Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of the Company’s products for various commercial services including contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of the Company’s applicable sales.
Cost of Product Revenue
Cost of product revenue includes the cost of inventory sold, which includes direct manufacturing, production and packaging materials for YCANTH (VP-102) sales. Prior to FDA approval of YCANTH (VP-102) in July 2023, the Company expensed approximately $0.1 million in costs associated with the manufacturing of YCANTH (VP-102) as a component of research and development expense. Therefore, these costs are not included in cost of product revenue.
Advertising Expense
Advertising expenses, comprised primarily of print and digital assets, social media and internet advertising as well as search engine marketing, are expensed as incurred and are included in selling, general, and administrative expenses. For the three months ended March 31, 2024, advertising expense was approximately $1.5 million.
Net Loss Per Share
Net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period including pre-funded warrants to purchase shares of common stock that were issued in an underwritten offering in February 2023 (Note 7). The pre-funded warrants to purchase common stock are included in the calculation of basic and diluted net loss per share as the exercise price of $0.0001 per share is non-substantive and is virtually assured. Diluted net loss per share excludes the potential impact of common stock options and unvested shares of restricted stock because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.
The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Shares issuable upon exercise of stock options |
|
|
6,613,615 |
|
|
|
4,722,082 |
|
Non-vested shares under restricted stock grants |
|
|
834,000 |
|
|
|
1,123,000 |
|
Shares issuable upon exercise of warrants pursuant to debt financing |
|
|
518,551 |
|
|
|
— |
|
Total |
|
|
7,966,166 |
|
|
|
5,845,082 |
|
Recently Adopted Accounting Pronouncements
In June 2022, the FASB issued Accounting Standards Update No. 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard became effective for the Company on January 1, 2024, and its adoption did not have an impact on the Company's financial statements and related disclosures.
Note 3 —Inventory
Upon FDA approval of YCANTH (VP-102) for the treatment of molluscum contagiosum on July 21, 2023, the Company began capitalizing the purchases of saleable inventory of YCANTH (VP-102) from suppliers. Inventory consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Raw materials |
|
$ |
1,150 |
|
|
$ |
420 |
|
Work in process |
|
|
668 |
|
|
|
487 |
|
Finished goods |
|
|
681 |
|
|
|
115 |
|
Total inventory |
|
$ |
2,499 |
|
|
$ |
1,022 |
|
Note 4—Property and Equipment
Property and equipment, net consisted of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Machinery and equipment |
|
$ |
1,554 |
|
|
$ |
1,543 |
|
Office equipment |
|
|
326 |
|
|
|
326 |
|
Office furniture and fixtures |
|
|
303 |
|
|
|
303 |
|
Leasehold improvements |
|
|
54 |
|
|
|
54 |
|
|
|
|
2,237 |
|
|
|
2,226 |
|
Accumulated depreciation |
|
|
(1,300 |
) |
|
|
(1,174 |
) |
Total property and equipment, net |
|
$ |
937 |
|
|
$ |
1,052 |
|
Depreciation expense for both of the three months ended March 31, 2024 and 2023 was $0.1 million.
Note 5—Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
2024 |
|
|
December 31,
2023 |
|
Gross to net reserves |
|
$ |
8,502 |
|
|
$ |
5,357 |
|
Clinical trials and drug development |
|
|
3,517 |
|
|
|
2,767 |
|
Compensation and related costs |
|
|
1,393 |
|
|
|
3,438 |
|
Professional fees |
|
|
1,124 |
|
|
|
1,423 |
|
Commercial-related costs |
|
|
878 |
|
|
|
538 |
|
Other current liabilities |
|
|
321 |
|
|
|
244 |
|
Machinery and equipment |
|
|
93 |
|
|
|
93 |
|
Total accrued expenses and other current liabilities |
|
$ |
15,828 |
|
|
$ |
13,860 |
|
Note 6—Commitments and Contingencies
Litigation
On June 6, 2022, plaintiff Kranthi Gorlamari (“Plaintiff”) filed a putative class action complaint captioned Gorlamari v. Verrica Pharmaceuticals Inc., et al., in the U.S. District Court for the Eastern District of Pennsylvania against us and certain of our current and former officers and directors (“Defendants”). On January 12, 2023, the Plaintiff filed an amended complaint alleging that Defendants violated federal securities laws by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the YCANTH (VP-102) drug device and that such deficiencies posed a risk to the prospects for regulatory approval of YCANTH (VP-102) for the treatment of molluscum. The amended complaint seeks unspecified compensatory damages and other relief on behalf of Plaintiff and all other persons and entities which purchased or otherwise acquired our securities between May 19, 2021 and May 24, 2022 (the “Putative Class Period”).
On January 12, 2024, the Court granted in part and denied in part Defendants’ motion to dismiss the amended complaint. The Court held that Plaintiff’s claims relating to statements made in May and June 2021 were sufficiently pled, but dismissed Plaintiff’s claims relating to all other statements made during the Putative Class Period. On January 26, 2024, Plaintiff filed a second amended complaint in an attempt to cure certain of the deficiencies identified in the January 12, 2024 ruling. Defendants’ motion to dismiss the second amended complaint was fully briefed as of April 22, 2024, and is pending before the Court.
The Company is also involved in ordinary, routine legal proceedings that are not considered by management to be material. In the opinion of Company counsel and management, the ultimate liabilities resulting from such legal proceedings will not materially affect the financial position of the Company or its results of operations or cash flows.
Supply Agreement and Purchase Order
On July 16, 2018, the Company entered into a supply agreement with a supplier of crude cantharidin material. All executed purchase orders for crude cantharidin in the ordinary course of business are expected to be covered under the terms of the supply agreement. Pursuant to the supply agreement, the supplier has agreed that it will not supply cantharidin, any beetles or other raw material from which cantharidin is derived to any other customer in North America, subject to specified minimum annual purchase orders and forecasts by the Company. The supply agreement had an initial five-year term, and now renews for successive annual periods absent termination by either party in accordance with the terms of the supply agreement. Each party also has the right to terminate the supply agreement for other customary reasons such as material breach or bankruptcy.
In both 2023 and 2022, the Company executed respective purchase orders pursuant to which the Company agreed to purchase $0.7 million of crude cantharidin material and made prepayments of $0.7 million in each year against the purchase orders. The Company received the shipment for the 2023 purchase during the three months ended March 31, 2024, which was reflected as a prepaid expense of $0.7 million on the balance sheet as of December 31, 2023.
Note 7—Stockholders’ Equity
Common Stock
The Company had authorized 200,000,000 shares of common stock, $0.0001 par value per share, as of March 31, 2024 and December 31, 2023. Each share of common stock is entitled to one vote. Common stock owners are entitled to dividends when funds are legally available and declared by the Board.
Underwritten Public Offering
In February 2023, the Company closed an underwritten offering of 750,000 shares of its common stock and pre-funded warrants to purchase 4,064,814 shares of common stock. The shares of common stock were sold at a price of $6.75 per share and the pre-funded warrants were sold at a price of $6.7499 per pre-funded warrant, resulting in net proceeds of $30.3 million after deducting underwriting discounts and commissions, and offering expense. The pre-funded warrants will not expire and are exercisable in cash or by means of a cashless exercise.
Warrants
The following table summarizes the Company’s outstanding warrants, all of which are exercisable for common stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
Number of warrants |
|
|
Exercise Price |
|
|
Expiration Date |
Pre-funded warrants issued pursuant to 2023 underwritten public offering |
|
|
4,064,814 |
|
|
$ |
0.0001 |
|
|
No expiration |
Warrants issued in connection with OrbiMed debt facility |
|
|
518,551 |
|
|
$ |
6.0264 |
|
|
7/25/2033 |
|
|
|
|
|
|
|
|
|
Note 8—Stock-Based Compensation
Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s statements of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Selling, general and administrative |
|
$ |
1,622 |
|
|
$ |
836 |
|
Research and development |
|
|
450 |
|
|
|
258 |
|
Total stock-based compensation |
|
$ |
2,072 |
|
|
$ |
1,094 |
|
Stock Options
The following table summarizes the Company’s stock option activity for the three months ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
remaining contractual |
|
|
Aggregate intrinsic |
|
|
|
Number of shares |
|
|
exercise price |
|
|
term (in years) |
|
|
value |
|
Outstanding as of December 31, 2023 |
|
|
5,565,615 |
|
|
$ |
8.25 |
|
|
|
7.2 |
|
|
$ |
4,143,150 |
|
Granted |
|
|
1,079,300 |
|
|
|
4.99 |
|
|
|
|
|
|
|
Exercised |
|
|
(6,500 |
) |
|
|
1.24 |
|
|
|
|
|
|
4,755 |
|
Forfeited |
|
|
(24,800 |
) |
|
|
5.24 |
|
|
|
|
|
|
|
Expired |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Outstanding as of March 31, 2024 |
|
|
6,613,615 |
|
|
$ |
7.74 |
|
|
|
7.5 |
|
|
$ |
2,688,929 |
|
Options vested and exercisable as of
March 31, 2024 |
|
|
3,438,271 |
|
|
$ |
9.01 |
|
|
|
5.9 |
|
|
$ |
620,420 |
|
As of March 31, 2024, the total unrecognized compensation related to unvested stock option awards granted was $14.7 million, which the Company expects to recognize over a weighted-average period of 2.84 years.
Stock option compensation expense of $1.5 million and $1.1 million was recognized in the Company's statements of operations during the three months ended March 31, 2024 and 2023, respectively.
Restricted Stock Units
In November 2019 and August 2020 the Company granted 300,000 and 250,000 restricted stock units ("RSUs"), respectively, to its executive officers, of which 125,000 were forfeited. Half of the remaining RSUs vested upon receipt of regulatory approval of the Company’s new drug application for YCANTH (VP-102) for the treatment of molluscum on July 21, 2023 (the “Approval Date”) and the other half will vest on July 21, 2024, subject to the holders’ continuous service through each applicable date.
In March 2023, the Company granted 698,000 RSUs, half of which vested upon the first commercial sale of YCANTH (VP-102) on August 24, 2023 and half of which will vest on August 24, 2024, subject to the holders’ continuous service through each applicable date.
In March 2024, the Company granted 272,500 RSUs to executive officers. These restricted stock units vest 25% annually over four years subject to the holders' continuous service through each applicable date.
Compensation expense of $0.6 million was recognized in the Company’s statements of operations for the three months ended March 31, 2024 related to the vested RSUs based on the fair market value at the date of grant. As of March 31, 2024, the remaining unrecognized compensation expense related to the RSUs was $2.2 million, which the Company expects to recognize over a weighted average service period of 1.6 years now that vesting of these awards is probable.
The following is a summary of changes in the status of non-vested RSUs for the three months ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Grant Date Fair |
|
|
|
Number of Shares |
|
|
Value |
|
Nonvested as of December 31, 2023 |
|
|
561,500 |
|
|
$ |
9.13 |
|
Granted |
|
|
272,500 |
|
|
|
4.80 |
|
Forfeited |
|
|
— |
|
|
|
— |
|
Vested |
|
|
— |
|
|
|
— |
|
Nonvested as of March 31, 2024 |
|
|
834,000 |
|
|
$ |
7.72 |
|
Note 9—Leases
The Company leases 11,201 square feet of office space located in West Chester, Pennsylvania that serves as the Company’s headquarters. The initial term expires on September 1, 2027. Base rent over the initial term is approximately $2.4 million, and the Company is also responsible for its share of the landlord’s operating expense.
The Company leases office space in Scotch Plains, New Jersey under an agreement classified as an operating lease, which commenced on May 1, 2022 and expires on April 30, 2025. Base rent over the initial term is approximately $104,000 per year.
The Company entered into a fleet program to provide vehicles for its sales force. The vehicles are leased for a term of 52 months and classified as finance leases. During the three months ended March 31, 2024, the Company recognized both a right-of-use asset and a lease liability of $1.2 million related to these finance leases.
The components of lease expense are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Finance lease cost: |
|
|
|
|
|
|
Amortization ROU assets |
|
$ |
139 |
|
|
$ |
— |
|
Interest on lease liabilities |
|
|
44 |
|
|
|
— |
|
Total finance lease costs |
|
$ |
183 |
|
|
$ |
— |
|
Operating lease: |
|
|
|
|
|
|
Operating lease costs |
|
$ |
94 |
|
|
$ |
86 |
|
Short-term lease costs |
|
|
— |
|
|
|
— |
|
Total operating lease expense |
|
$ |
94 |
|
|
$ |
86 |
|
Maturities of the Company’s operating and finance leases, excluding short-term leases, as of March 31, 2024 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
Finance |
|
2024 (remaining 9 months) |
|
$ |
293 |
|
|
$ |
648 |
|
2025 |
|
|
372 |
|
|
|
744 |
|
2026 |
|
|
366 |
|
|
|
631 |
|
2027 |
|
|
247 |
|
|
|
592 |
|
Thereafter |
|
|
— |
|
|
|
181 |
|
Total lease payments |
|
|
1,278 |
|
|
|
2,796 |
|
Less imputed interest |
|
|
(122 |
) |
|
|
(356 |
) |
Lease liability |
|
$ |
1,156 |
|
|
$ |
2,440 |
|
The weighted average remaining lease term and discount rates for the Company's leases as of March 31, 2024 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
Finance |
|
Weighted average remaining lease term (years) |
|
|
3.34 |
|
|
|
4.07 |
|
Weighted average discount rate |
|
|
6.25 |
% |
|
|
7.72 |
% |
Note 10—Debt
On July 26, 2023 (the “Closing Date”), the Company entered into a Credit Agreement (the “Credit Agreement”), by and between the Company, as borrower, and OrbiMed Royalty & Credit Opportunities IV, LP, a Delaware limited partnership (the “Initial Lender”), as a lender, and each other lender that may from time to time become a party thereto (each, including the Initial Lender, and together with their affiliates, successors, transferees and assignees, the “Lenders”), and OrbiMed Royalty & Credit Opportunities IV, LP, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”). The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $125.0 million (the “Loan Facility”). The Company borrowed $50.0 million under the Credit Agreement on July 26, 2023, resulting in net proceeds of approximately $44.1 million after payment of certain fees and transaction related expenses. In addition, subject to the Company's achievement of certain revenue targets, up to $25.0 million will be made available on or prior to June 30, 2024, up to $30.0 million will be made available on or prior to December 31, 2024, up to $10.0 million will be made available on or prior to March 31, 2025, and up to $10.0 million will be made available on or prior to June 30, 2025. Amounts borrowed under the Loan Facility will mature on July 26, 2028. During the term of the Loan Facility, interest payable in cash by the Company shall accrue on any outstanding balance due under the Loan Facility at a rate per annum equal to the higher of (x) the SOFR rate (which is the forward-looking term rate for a one-month tenor based on the secured overnight financing rate administered by the CME Group Benchmark Administration Limited) and (y) 4.00% plus, in either case, 8.00%. During an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4.00% in excess
of the otherwise applicable rate of interest. The Company paid or will pay certain fees with respect to the Loan Facility, including an upfront fee, an unused fee on the undrawn portion of the Loan Facility, an administration fee, a prepayment premium and an exit fee, as well as certain other fees and expenses of the Administrative Agent and the Lenders.
The Credit Agreement contains customary events of default, including, but not limited to, nonpayment of principal, interest, fees or other amounts; material inaccuracy of a representation or warranty; failure to perform or observe covenants; cross-defaults with certain other indebtedness; bankruptcy and insolvency events; material monetary judgment defaults; impairment of any material definitive loan documentation; other material adverse effects; key permit and other regulatory events; key person events; and change of control. Upon the occurrence of an event of default (subject to notice and grace periods), additional interest of 4% per annum applies and obligations under the Credit Agreement could be accelerated. As of March 31, 2024, the Company is in compliance with all covenants.
On the Closing Date, the Company also issued the Initial Lender warrants to purchase up to 518,551 shares of the Company’s common stock, at an exercise price of $6.0264 per share, which have a term of 10 years from the issuance date. The warrants were deemed to be classified as equity per the guidance ASC 815 Derivatives and Hedging. The proceeds from the debt transaction were allocated among the two instruments based on their relative fair values. The relative fair value of the warrants was determined to be $2.0 million and the fair value was determined to be $2.4 million based on the Black-Scholes valuation technique and the key assumptions used were as follows: (i) a contracted term of 10 years, (ii) an expected volatility of 94.86%, (iii) a risk free rate of 3.86% and (iv) no estimated dividend yield.
On each of December 20, 2023 and January 31, 2024, the Company entered into an amendment to the Credit Agreement in order to extend a deadline for a specified regulatory milestone. For each amendment, the Company paid an amendment fee of $250,000. The Company accounted for these amendments as modifications and the amendment fees were reflected in the debt discount and amortized over the life of the Credit Agreement using the effective interest method.
The Loan Facility is classified as non-current debt as the Company does not currently intend to repay amounts borrowed under the Loan Facility prior to the maturity date of July 26, 2028 and believes that the probability of any acceleration of the Loan Facility is not probable at March 31, 2024. The Company has incurred debt discount and issuance costs of $10.4 million, that are netted against the carrying value of the Loan Facility. The debt discount and issuance costs consists of $5.9 million paid in cash during the year ended December 31, 2023 and the final payment fee of $2.5 million, classified as a long-term liability and the fair value of the warrants of $2.0 million, classified as equity on the balance sheet.
For the three months ended March 31, 2024, the Company recognized interest expense of $2.3 million of which $1.8 million was interest on the term loan and $0.5 million was non-cash interest expense related to the amortization of deferred debt issuance costs and accrual of the final payment fee.
The following table summarizes the composition of debt as of March 31, 2024 (in thousands):
|
|
|
|
|
Gross proceeds from Loan Facility |
|
$ |
50,000 |
|
Accrued final payment fee |
|
|
2,500 |
|
Unamortized debt discount and issuance costs |
|
|
(9,652 |
) |
Total long-term debt, net |
|
$ |
42,848 |
|
Note 11—License and Collaboration Agreements
Torii Agreements
On March 17, 2021, the Company entered into a collaboration and license agreement (the “Torii Agreement”) with Torii, pursuant to which the Company granted Torii an exclusive license to develop and commercialize the Company’s product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in Japan, including YCANTH (VP-102). Additionally, the Company granted Torii a right of first negotiation with respect to additional indications for the licensed products and certain additional products for use in the licensed field, in each case in Japan.
Pursuant to the Torii Agreement, the Company received milestone payments from Torii in prior periods totaling $20.0 million. Additionally, the Company is entitled to receive from Torii an additional $50.0 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, in addition to tiered transfer price payments for supply of product in the percentage range of the mid-30’s to the mid-40’s of net sales. The transfer payments shall be payable, on a product-by-product basis, beginning on the first commercial sale of such product and ending on the latest of (a) expiration of the last-to-expire valid claim contained in certain licensed patents in Japan that cover such product, (b) expiration of regulatory exclusivity for the first indication for such product in Japan, and, (c) (i) with respect to the first product, ten years after first commercial sale of such product,
and, (ii) with respect to any other product, the later of (x) ten years after first commercial sale of the first product and (y) five years after first commercial sale of such product.
The Torii Agreement expires on a product-by-product basis upon expiration of Torii’s obligation under the agreement to make transfer price payments for such product. Torii has the right to terminate the agreement upon specified prior written notice to us. Additionally, either party may terminate the agreement in the event of an uncured material breach of the agreement by, or insolvency of, the other party. The Company may terminate the agreement in the event that Torii commences a legal action challenging the validity, enforceability or scope of any licensed patents.
On March 7, 2022, the Company executed a Clinical Supply Agreement with Torii, whereby the Company will supply product to Torii for use in clinical trials and other development activities. The Company recognized collaboration revenue of $0.6 million and $37,000 for the three months ended March 31, 2024 and 2023 respectively related to supplies and development activity pursuant to this agreement. The costs of collaboration revenue consists of expenses incurred by the Company for manufacturing supply to support development and testing services pursuant to the Torii Clinical Supply Agreement.
Lytix Agreement
In August 2020, the Company entered into an exclusive license agreement with Lytix Biopharma AS (“Lytix”) for the use of licensed technology, referred to as VP-315, to research, develop, manufacture, have manufactured, use, sell, have sold, offer for sale, import, and otherwise commercialize products for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic Merkel cell carcinoma (the” Lytix Agreement”). As part of the Lytix Agreement, the Company has paid Lytix milestone fees of $3.6 million in previous periods. The Company is also obligated to pay up to $111.0 million contingent on achievement of specified development, regulatory, and sales milestones, as well as tiered royalties based on worldwide annual net sales ranging in the low double digits to the mid-teens, subject to certain customary reductions. The Company’s obligation to pay royalties expires on a country-by-country and product-by-product basis on the later of the expiration or abandonment of the last to expire licensed patent covering VP-315 anywhere in the world and expiration of regulatory exclusivity for VP-315 in such country. Additionally, all upfront fees and milestone-based payments received by the Company from a sublicensee will be treated as net sales and will be subject to the royalty payment obligations under the Lytix Agreement, and all royalties received by the Company from a sublicensee shall be shared with Lytix at a rate that is initially 50% but decreases based on the stage of development of VP-315 at the time such sublicense is granted.
Note 12 – Subsequent Event
Third Amendment to Credit Agreement
On May 6, 2024, the Company entered into an amendment to the Credit Agreement pursuant to which the Lenders waived the going concern requirement under Section 7.1(b) of the Credit Agreement with respect to the financial statements for the quarter ended March 31, 2024 (the “Third Amendment”). In connection with the Third Amendment, the Company paid an amendment fee of $100,000.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with (i) our unaudited interim financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and (ii) our audited financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the years ended December 31, 2022 and 2023 included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024. Our financial statements have been prepared in accordance with U.S. GAAP.
We own various U.S. federal trademark applications and unregistered trademarks, including our company name and YCANTH. All other trademarks or trade names referred to in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this report are referred to without the symbols ® and ™, but such references should not be construed as an indication that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words “expect,” “anticipate,” “intend,” “believe,” “may,” “plan,” “seek” or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties. Our actual results could differ materially from those discussed in these forward-looking statements. In evaluating our business, you should carefully consider the information set forth in this Quarterly Report under Part II - Item 1A “Risk Factors,” and in our other filings with the SEC.
Overview
We are a dermatology therapeutics company developing and selling medications for skin diseases requiring medical intervention. We are primarily focused on developing clinician administered therapies in areas of high unmet need. Our current product portfolio consists of one approved product with several potential follow-on indications, as well as two additional pipeline products. Our commercial product, YCANTH (VP102) (formerly referred to as VP-102), was approved by the U.S. Food and Drug Administration, or FDA, in July 2023 for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. YCANTH (VP-102) is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidin. We are also developing YCANTH (VP-102) for potential follow-on indications for the treatment of common warts and external genital warts. Our two additional product candidates are: (i) VP-315 an oncolytic peptide-based injectable therapy for the potential treatment of dermatology oncologic conditions, including basal cell carcinoma, and (ii) VP-103, a second cantharidin based drug device combination for the potential treatment of plantar warts.
On July 21, 2023, YCANTH (cantharidin) 0.7% topical solution was the first product approved by the FDA for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. We commercially launched YCANTH (VP-102) in August 2023 in the United States for the treatment of molluscum contagiosum. We have built a specialized sales organization consisting of 77 sales representatives in the United States focused on pediatric dermatologists, dermatologists, and select pediatricians. We also plan to advance YCANTH (VP-102) for common warts and external genital warts through a separate regulatory approval process. In the future, we also intend to pursue commercialization for YCANTH (VP-102) for the treatment of molluscum contagiosum, as well as YCANTH (VP-102) for common warts and genital warts if approved, in additional geographic regions, either alone or together with a strategic partner.
We are also developing YCANTH (VP-102) for the treatment of common warts. In June 2019, we announced positive topline results from our COVE-1 Phase 2 open label clinical trial of YCANTH (VP-102) for the treatment of common warts. COVE-1 included two cohorts that evaluated the safety and efficacy of YCANTH (VP-102) in subjects with up to six warts. We held a Type C meeting with FDA on clinical development plan for YCANTH (VP-102) common warts indication on November 6, 2023. The meeting resulted in gaining alignment on the design of a pivotal Phase 3 clinical development plan to evaluate YCANTH (VP-102) for the treatment of common warts. We continue to evaluate the timing and design of a Phase 3 trial of YCANTH (VP-102) for the treatment of common warts, and we plan to seek additional guidance from the FDA in the second quarter of this year.
In addition, we are also developing YCANTH (VP-102) for the treatment of external genital warts. We initiated a Phase 2 clinical trial evaluating the optimal dose regimen, efficacy, safety and tolerability of YCANTH (VP-102) in patients with external genital warts in June 2019. In November 2020, we announced positive topline results from our Phase 2 clinical trial of YCANTH (VP-102) for the treatment of external genital warts. An end of Phase 2 meeting was held with the FDA in May 2021. Based on
results of the Phase 2 trial, we are evaluating the timing and design of a Phase 3 trial of YCANTH (VP-102) for the treatment of external genital warts.
We also intend to develop our product candidate, VP-315, for the treatment of dermatological oncology indications. The FDA accepted our investigational new drug application in November 2021. In April 2022, we dosed the first patient in Part 1 of a three-part Phase 2, multicenter, open-label, dose-escalation proof-of-concept trial with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy in subjects with biopsy proven basal cell carcinoma. In Part 1 of the trial, VP-315 demonstrated a favorable safety and tolerability profile with no reported serious adverse events. We initiated Part 2 of the trial in April 2023. In June 2023, the protocol was amended to remove Part 3 of the trial and to expand Part 2. The last patient in Part 2 of the trial was dosed in December 2023 and we expect top-line results from this trial in the second quarter of 2024.
In addition, we have conducted necessary drug development activities for VP-103, our second cantharidin-based product candidate, and are evaluating when to initiate a Phase 2 clinical trial for the treatment of plantar warts.
Since our inception in 2013, our operations have focused on developing YCANTH (VP-102), organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and conducting clinical trials. We have funded our operations primarily through the sale of equity and equity-linked securities and through borrowings under loan agreements.
On July 26, 2023, we entered into a Credit Agreement with OrbiMed, or the Initial Lender, and each other lender that may from time to time become a party thereto, or the Lenders. The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $125.0 million, or the Loan Facility, of which we borrowed $50.0 million on July 26, 2023, resulting in net proceeds to us of approximately $44.1 million after payment of certain fees and transaction related expenses. In addition, subject to our achievement of certain revenue targets, up to $25.0 million will be made available on or prior to June 30, 2024, up to $30.0 million will be made available on or prior to December 31, 2024, up to $10.0 million will be made available on or prior to March 31, 2025, and up to $10.0 million will be made available on or prior to June 30, 2025. Amounts borrowed under the Loan Facility will mature on July 26, 2028. As part of the Loan Facility, we issued the Initial Lender a warrant to purchase up to 518,551 shares of our common stock, at an exercise price of $6.0264 per share, which have a term of 10 years from the issuance date.
In February 2023, we closed an underwritten offering of 750,000 shares of our common stock and pre-funded warrants to purchase 4,064,814 shares of common stock. The shares of common stock were sold at a price of $6.75 per share and the pre-funded warrants were sold at a price of $6.7499 per pre-funded warrant, resulting in total net proceeds of $30.3 million, after deducting underwriting discounts and commissions, and offering expenses.
Since inception, we have incurred significant operating losses. For the three months ended March 31, 2024 and 2023, our net loss was $20.3 million and $6.6 million, respectively. As of March 31, 2024, we had an accumulated deficit of $250.8 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
•continue commercialization of YCANTH (VP-102) for the treatment of molluscum contagiosum;
•continue our ongoing clinical program evaluating VP-315 for the treatment of basal cell carcinoma and potentially additional dermatological oncology indications;
•continue our ongoing clinical programs evaluating YCANTH (VP-102) for the treatment of common warts and external genital warts, as well as initiate and complete additional clinical trials, as needed;
•initiate clinical trials evaluating VP-103 for the treatment of plantar warts;
•pursue regulatory approvals for YCANTH (VP-102) for the treatment of common warts, external genital warts, or any other indications we may pursue for YCANTH (VP-102), as well as for VP-103 or VP-315;
•seek to discover and develop additional product candidates;
•further establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize YCANTH (VP-102) for the treatment of molluscum contagiosum and any other product candidates for which we may obtain regulatory approval, including YCANTH for external genital warts and common warts,VP-315 and VP-103;
•seek to in-license or acquire additional product candidates for other dermatological conditions;
•adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;
•maintain, expand and protect our intellectual property portfolio;
•hire additional commercial, administrative, clinical, manufacturing and scientific personnel;
•add operational, financial and management information systems and personnel, including personnel to support our product development and planned commercialization efforts; and
•incur additional legal, accounting and other expenses while operating as a public company.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with GAAP, we evaluate our estimates and judgments on an ongoing basis.
A summary of our significant accounting policies are disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. However, we believe that the additional accounting policies disclosed in Note 2 to our financial statement are important to understanding and evaluating our reported financial results.
Components of Results of Operations
Product Revenue, Net
We recognize revenue from sales of YCANTH (VP-102), or the Product, in accordance with ASC Topic 606 – Revenue from Contracts with Customers. YCANTH (VP-102) became available for commercial sale and shipment for the treatment of patients by a healthcare provider in the United States in the year ended December 31, 2023. We sell the Product primarily to one pharmaceutical wholesaler/distributor, or the Customer who in turn sells the Product directly to clinics, hospitals, and federal healthcare programs. Revenue is recognized as the Product is physically delivered to the Customer.
Gross product sales are reduced by corresponding gross-to-net, or GTN, estimates using the expected value method, resulting in our reported “Product revenue, net” in the accompanying statements of operations. Product revenue, net reflects the amount we ultimately expect to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that we estimate for the various GTN categories. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period, in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, co-pay assistance and distribution, data, and group purchasing organizations, or GPOs, administrative fees may be materially above or below the amount estimated. Variance between actual amounts and estimated amounts may result in prospective adjustments to reported net product revenue.
Collaboration Revenue
Collaboration revenue represents revenue from the Torii Agreement pursuant to which we granted Torii an exclusive license to develop and commercialize our product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in Japan, including YCANTH (VP-102).
Operating Expenses
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist principally of salaries and related costs for personnel in sales, executive and administrative functions, including stock-based compensation, travel expenses and recruiting expenses. Other selling, general and administrative expenses include cost of samples, sponsorships, consumer and health care professional marketing and advertising expense, insurance costs, and professional fees for audit, tax and legal services.
We anticipate that our selling, general and administrative expenses, including payroll and related expenses, will increase in the future as we continue to increase our headcount to support the expected growth in our business, expand our operations and organizational capabilities, and continue to commercialize YCANTH (VP-102). We also anticipate increased expenses associated with general operations, including costs related to audit, tax and legal services, director and officer insurance premiums, and investor relations costs.
Research and Development Expenses
Research and development expenses consist of expenses incurred in connection with the discovery and development of YCANTH (VP-102) for the treatment of molluscum contagiosum, potential follow-on indications for YCANTH (VP-102), including
external genital warts and common warts, and our other product candidates. We expense research and development costs as incurred. These expenses include:
•expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials and preclinical studies;
•manufacturing and supply scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial supply and commercial supply, including manufacturing validation batches;
•outsourced professional scientific development services;
•employee-related expenses, which include salaries, benefits and stock-based compensation;
•expenses relating to regulatory activities; and
•laboratory materials and supplies used to support our research activities.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase over the next several years as we increase personnel costs, including stock-based compensation, initiate and conduct clinical trials of YCANTH (VP-102) in patients with common warts, YCANTH (VP-102) in patients with external genital warts, VP-315 for dermatological oncology indications,VP-103 in patients with plantar warts, and conduct other clinical trials and prepare regulatory filings for our product candidates.
The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from YCANTH (VP-102) or our other product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:
•the number of clinical sites included in the trials;
•the length of time required to enroll suitable patients;
•the number of patients that ultimately participate in the trials;
•the number of doses patients receive;
•the duration of patient follow-up; and
•the results of our clinical trials.
Our expenditures are subject to additional uncertainties, including the manufacturing process for our product candidates, the terms and timing of regulatory approvals, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights. We may never succeed in achieving regulatory approval for our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of our product candidates. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
Cost of Product Revenue
Cost of product revenue includes the cost of inventory sold, which includes direct manufacturing and supply chain costs. Prior to FDA approval, all product purchased from such suppliers was included as a component of research and development expense, as we were unable to assert that the inventory had future economic benefit until YCANTH (VP-102) received FDA approval. We purchased and included in research and development expenses approximately $4.5 million of raw cantharidin and processed active pharmaceutical ingredient ("API"). The raw cantharidin and processed API is sufficient to produce approximately 14 million finished drug product applicators to be used for commercially saleable product and other product candidates. In addition, we purchased other components and services related to YCANTH (VP-102) for commercially saleable product and included approximately $1.2 million in research and development expenses prior to FDA approval. As a result, cost of product revenue related to YCANTH (VP-102) will initially reflect a lower average per unit cost of materials over approximately the next nine months as previously expensed inventory is utilized for commercial production and sold to customers. If we included those costs previously expensed as a component of cost of product revenue, our cost of product revenue for three months ended March 31, 2024 would have been $0.7 million.
Cost of Collaboration Revenue
The costs of collaboration revenue consists of payments for manufacturing supply to support development and testing services pursuant to the Torii Clinical Supply Agreement.
Results of Operations for the Three Months Ended March 31, 2024 and 2023
The following table summarizes our results of operations for the three months ended March 31, 2024 and 2023 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
Total revenue |
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
3,232 |
|
|
$ |
— |
|
|
$ |
3,232 |
|
Collaboration revenue |
|
|
594 |
|
|
|
37 |
|
|
|
557 |
|
Total revenue |
|
|
3,826 |
|
|
|
37 |
|
|
|
3,789 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
16,339 |
|
|
|
4,319 |
|
|
|
12,020 |
|
Research and development |
|
|
4,948 |
|
|
|
2,739 |
|
|
|
2,209 |
|
Cost of product revenue |
|
|
546 |
|
|
|
— |
|
|
|
546 |
|
Cost of collaboration revenue |
|
|
592 |
|
|
|
68 |
|
|
|
524 |
|
Total operating expenses |
|
|
22,425 |
|
|
|
7,126 |
|
|
|
15,299 |
|
Loss from operations |
|
|
(18,599 |
) |
|
|
(7,089 |
) |
|
|
(11,510 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
598 |
|
|
|
500 |
|
|
|
98 |
|
Interest expense |
|
|
(2,319 |
) |
|
|
— |
|
|
|
(2,319 |
) |
Other expense |
|
|
(11 |
) |
|
|
— |
|
|
|
(11 |
) |
Total other (expense) income, net |
|
|
(1,732 |
) |
|
|
500 |
|
|
|
(2,232 |
) |
Net loss |
|
$ |
(20,331 |
) |
|
$ |
(6,589 |
) |
|
$ |
(13,742 |
) |
Product Revenue, Net
Product revenue, net was $3.2 million for the three months ended March 31, 2024 and relates to the delivery of YCANTH (VP-102) to FFF, our distribution partner. YCANTH (VP-102), our first FDA approved product, became available for commercial sale in August 2023.
Collaboration Revenue
Collaboration revenue was $0.6 million for the three months ended March 31, 2024, compared to $37,000 for the three months ended March 31, 2023. Both of the three months ended March 31, 2024 and 2023, collaboration revenue consisted of supplies and development activity with Torii.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $16.3 million for the three months ended March 31, 2024, compared to $4.3 million for the three months ended March 31, 2023. The increase of $12.0 million was primarily due to higher expenses related to commercial activities for YCANTH (VP-102), including increased compensation, recruiting fees, benefits and travel due to ramp-up of sales force of $6.2 million, increased marketing and sponsorship costs of $2.3 million, other commercial activity of $1.9 million, and increased legal costs of $0.6 million.
Research and Development Expenses
Research and development expenses were $4.9 million for the three months ended March 31, 2024, compared to $2.7 million for the three months ended March 31, 2023. The increase of $2.2 million was primarily related to additional clinical trial costs for VP-315 of $1.5 million and increased headcount related costs of $0.6 million.
The following table summarizes our research and development expense by product candidate or, for unallocated expenses, by type for the three months ended March 31, 2024 and 2023. We did not incur any research and development expense for VP-103 during the three months ended March 31, 2024 or 2023. Unallocated expenses include compensation and other personnel related costs.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended
March 31, |
|
|
|
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
YCANTH (VP-102) |
|
$ |
579 |
|
|
$ |
805 |
|
|
$ |
(226 |
) |
VP-315 |
|
|
2,390 |
|
|
|
352 |
|
|
|
2,038 |
|
Stock based compensation |
|
|
450 |
|
|
|
258 |
|
|
|
192 |
|
Other unallocated expenses |
|
|
1,529 |
|
|
|
1,324 |
|
|
|
205 |
|
Research and development expense |
|
$ |
4,948 |
|
|
$ |
2,739 |
|
|
$ |
2,209 |
|
|
|
|
|
|
|
|
|
|
|
Cost of Product Revenue
Cost of product revenue of $0.5 million for the three months ended March 31, 2024 consisted of product costs related to the sale of YCANTH (VP-102) and obsolete inventory write-off of $0.3 million.
Cost of Collaboration Revenue
Cost of collaboration revenue was $0.6 million for the three months ended March 31, 2024, compared to $0.1 million for the three months ended March 31, 2023. The increase of $0.5 million was primarily due to increased manufacturing supply required to support development and testing services pursuant to the Torii Clinical Supply Agreement.
Interest Income
Interest income was $0.6 million for the three months ended March 31, 2024 compared to $0.5 million for the three months ended March 31, 2023 primarily due to higher interest rates.
Interest Expense
Interest expense of $2.3 million for the three months ended March 31, 2024 consisted of interest expense on the OrbiMed Credit Agreement as described in Note 10 to our financial statements.
Liquidity and Capital Resources
Since our inception, we have incurred net losses and negative cash flows from our operations. We have financed our operations since inception primarily through sales of our convertible preferred stock, the sale of our common stock, the issuance of debt and $20.0 million from the Torii Agreement. In February 2023, we closed an underwritten offering of 750,000 shares of our common stock and pre-funded warrants to purchase 4,064,814 shares of common stock. The shares of common stock were sold as a price of $6.75 per share and the pre-funded warrants were sold at a price of $6.7499 per pre-funded warrant, resulting in total net proceeds of $30.3 million, after deducting underwriting discounts and commissions and offering expenses.
As of March 31, 2024, we had cash and cash equivalents of $48.9 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
On July 21, 2023, the FDA approved YCANTH (VP-102) topical solution for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. Our first commercial sale of YCANTH (VP-102) occurred in August 2023 to FFF, our primary specialty pharmacy distributor.
On July 26, 2023, we entered into the Credit Agreement which provides for a $125.0 million Loan Facility. We borrowed $50.0 million on July 26, 2023, resulting in net proceeds to us of approximately $44.1 million after payment of certain fees and transaction related expenses. In addition, subject to our achievement of certain revenue targets, up to $25.0 million will be made available on or prior to June 30, 2024, up to $30.0 million will be made available on or prior to December 31, 2024, up to $10.0 million will be made available on or prior to March 31, 2025, and up to $10.0 million will be made available on or prior to June 30, 2025. Amounts borrowed under the Loan Facility will mature on July 26, 2028.
During the term of the Loan Facility, interest payable in cash by us will accrue on any outstanding balance due under the Loan Facility at a rate per annum equal to the higher of (x) the SOFR rate (which is the forward-looking term rate for a one-month tenor based on the secured overnight financing rate administered by the CME Group Benchmark Administration Limited) and (y) 4.00% plus, in either case, 8.00%. During an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4.00% in excess of the otherwise applicable rate of interest. We will pay certain fees with respect to the Loan Facility, including an upfront fee, an unused fee on the undrawn portion of the Loan Facility, an administration fee, a prepayment premium and an exit fee, as well as certain other fees and expenses of the Administrative Agent and the Lenders.
Cash Flows
The following table summarizes our cash flows for the three months ended March 31, 2024 and 2023 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Net cash used in operating activities |
|
$ |
(19,947 |
) |
|
$ |
(4,590 |
) |
Net cash used in investing activities |
|
|
— |
|
|
|
(11 |
) |
Net cash (used in) provided by financing activities |
|
|
(661 |
) |
|
|
30,280 |
|
Net (decrease) increase in cash and cash equivalents |
|
$ |
(20,608 |
) |
|
$ |
25,679 |
|
Operating Activities
During the three months ended March 31, 2024, operating activities used $19.9 million of cash, primarily resulting from a net loss of $20.3 million partially offset by non-cash stock-based compensation of $2.1 million. Net cash used by changes in operating assets and liabilities consisted primarily of increases in accounts receivable of $2.8 million and prepaid expenses and other assets of $1.3 million partially offset by an increase in accrued expenses of $1.7 million.
During the three months ended March 31, 2023, operating activities used $4.6 million of cash, primarily resulting from a net loss of $6.6 million partially offset by non-cash stock-based compensation of $1.1 million. Net cash used by changes in operating assets and liabilities consisted primarily of a decrease in prepaid expenses of $1.3 million partially offset by a decrease in accrued expenses of $0.9 million.
Investing Activities
During the three months ended March 31, 2024, no cash was used in investing activities.
During the three months ended March 31, 2023, net cash used in investing activities of $11,000 for the purchase of property and equipment.
Financing Activities
During the three months ended March 31, 2024, net cash used by financing activities of $0.7 million was primarily due to $0.5 million of debt amendment costs paid related to the Orbimed Credit Agreement.
During the three months ended March 31, 2023, net cash provided by financing activities of $30.3 million was primarily due to the proceeds of $30.3 million, net of issuance costs from the issuance of common stock and pre-funded warrants.
Funding Requirements
Our first commercial sale of YCANTH (VP-102) occurred in August 2023 to FFF, our primary specialty pharmacy distributor. While we expect to generate revenue from the sale of YCANTH (VP-102), we expect our expenses to increase in connection with our ongoing activities, particularly as we initiate commercialization of YCANTH (VP-102) and continue the research and development of, continue or initiate clinical trials of, and seek marketing approval for, our product candidates. Following the approval of YCANTH (VP-102), for the treatment of molluscum contagiosum, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company. We will need substantial additional financing to fund our operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
We believe that our existing cash and cash equivalents as of March 31, 2024 will be sufficient to support our planned operations only into the first quarter of 2025. These factors cause substantial doubt to exist about the Company's ability to continue as a going concern within one year after the date these financial statements are issued. The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.
We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. Our future capital requirements will depend on many factors, including:
•the level of sales achieved, and costs related to the commercialization of YCANTH (VP-102) for the treatment of molluscum contagiosum;
•the costs, timing and outcome of regulatory review of our product candidates;
•the scope, progress, results and costs of our clinical trials;
•the scope, prioritization and number of our research and development programs;
•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•our ability to maintain compliance with covenants under our loan agreements;
•the extent to which we acquire or in-license other product candidates and technologies;
•the impact on the timing of our clinical trials and our business;
•the costs to scale up and secure manufacturing arrangements for commercial production of YCANTH (VP 102) for the treatment of molluscum contagiosum and any product candidate we successfully commercialize; and
•the costs of establishing and maintaining sales and marketing capabilities for YCANTH (VP 102) for the treatment of molluscum contagiosum and any product candidate that obtains regulatory approval.
Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, YCANTH (VP-102), and our other product candidates, if approved, may not achieve commercial success. Our commercial revenues will be derived solely from sales of YCANTH (VP-102) in the near term. We may need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interests of existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Commitments
As of March 31, 2024, there have been no material changes to our contractual obligations and commitments as previously discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Item 3. Quantitative and Qualitative Disclosures About Market Risks
There have been no material changes to our quantitative and qualitative disclosures about market risk as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q to ensure that the information required to be disclosed by us in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2024.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(b) and 15d-15(b) of the Exchange Act that occurred during the quarter ended March 31, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item. 1 Legal Proceedings
On June 6, 2022, plaintiff Kranthi Gorlamari (“Plaintiff”) filed a putative class action complaint captioned Gorlamari v. Verrica Pharmaceuticals Inc., et al., in the U.S. District Court for the Eastern District of Pennsylvania against us and certain of our current and former officers and directors (“Defendants”). On January 12, 2023, the Plaintiff filed an amended complaint alleging that Defendants violated federal securities laws by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the YCANTH (VP-102) drug device and that such deficiencies posed a risk to the prospects for regulatory approval of YCANTH (VP-102) for the treatment of molluscum. The amended complaint seeks unspecified compensatory damages and other relief on behalf of Plaintiff and all other persons and entities which purchased or otherwise acquired our securities between May 19, 2021 and May 24, 2022 (the “Putative Class Period”).
On January 12, 2024, the Court granted in part and denied in part Defendants’ motion to dismiss the amended complaint. The Court held that Plaintiff’s claims relating to statements made in May and June 2021 were sufficiently pled, but dismissed Plaintiff’s claims relating to all other statements made during the Putative Class Period. On January 26, 2024, Plaintiff filed a second amended complaint in an attempt to cure certain of the deficiencies identified in the January 12, 2024 ruling. Defendants’ motion to dismiss the second amended complaint was fully briefed as of April 22, 2024, and is pending before the Court.
We are involved in ordinary, routine legal proceedings that are not considered by management to be material. We believe the ultimate liabilities resulting from such legal proceedings will not materially affect our financial position or our results of operations or cash flows.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on February 29, 2024. Except as set forth below, there have been no material changes to the risk factors described in that report.
Our financial statements have been prepared assuming that we will continue as a going concern.
We have incurred recurring losses from operations since inception and we believe our existing cash and cash equivalents will be sufficient to support our planned operations only into the first quarter of 2025. These factors cause substantial doubt to exist about our ability to continue as a going concern. If we are unable to obtain sufficient funding, our business, prospects, financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or a part of their investment. In addition, if there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, or at all.
Item 5. Other Information
During the quarter ended March 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408 of Regulation S-K).
Item 6. Exhibits
EXHIBIT INDEX
|
|
|
Exhibit
No. |
|
Description |
|
|
|
3.1 (1) |
|
Amended and Restated Certificate of Incorporation. |
|
|
|
3.2 (2) |
|
Amended and Restated Bylaws. |
|
|
|
10.1 (3)# |
|
Second Amendment to Credit Agreement, dated as of January 31, 2024, by and between the Registrant and Orbimed Royalty & Credit Opportunities IV, LP. |
|
|
|
10.2 (4)+ |
|
Second Amended and Restated Non-Employee Director Compensation Policy, adopted by the Board as of February 27, 2024. |
|
|
|
31.1 |
|
Certification of Chief Executive Officer and President (Principal Executive Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith). |
|
|
|
31.2 |
|
Certification of Chief Financial Officer (Principal Financial Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith). |
|
|
|
32.1* |
|
Certifications of Chief Executive Officer and President (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith). |
|
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
|
|
|
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
(1) Previously filed as Exhibit 3.3 to the Company’s Registration Statement on Form S-1 (File No. 333-225104), filed with the Securities and Exchange Commission on May 22, 2018.
(2) Previously filed as Exhibit 3.4 to the Company’s Registration Statement on Form S-1 (File No. 333-225104), filed with the Securities and Exchange Commission on May 22, 2018.
(3) Previously filed as Exhibit 10.28 to the Company’s Annual Report on Form 10-K (File No. 001-38529), filed with the Securities and Exchange Commission on February 29, 2024.
(4) Previously filed as Exhibit 10.21 to the Company’s Annual Report on Form 10-K (File No. 001-38529), filed with the Securities and Exchange Commission on February 29, 2024.
# Certain portions of this exhibit, indicated by asterisks, have been omitted pursuant to Item 601(b)(10) of Regulation S-K because they are not material and would likely cause competitive harm to the registrant if publicly disclosed.
+ Indicates management contract or compensatory plan.
* These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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|
VERRICA PHARMACEUTICALS INC. |
|
|
|
|
May 13, 2024 |
|
|
|
By: |
|
/s/ Ted White |
|
|
|
|
|
|
Ted White |
|
|
|
|
|
|
Chief Executive Officer and President |
|
|
|
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
|
By: |
|
/s/ P. Terence Kohler Jr. |
|
|
|
|
|
|
P. Terence Kohler Jr. |
|
|
|
|
|
|
Chief Financial Officer |
|
|
|
|
|
|
(Principal Financial Officer) |
Exhibit 31.1
VERRICA PHARMACEUTICALS INC.
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Ted White, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2024 of Verrica Pharmaceuticals Inc. (the “registrant”);
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 13, 2024
|
/s/ Ted White |
Ted White |
President and Chief Executive Officer |
(principal executive officer) |
Exhibit 31.2
VERRICA PHARMACEUTICALS INC.
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, P. Terence Kohler Jr., certify that:
1.I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2024 of Verrica Pharmaceuticals Inc. (the “registrant”);
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 13, 2024
|
/s/ P. Terence Kohler Jr. |
P. Terence Kohler Jr. |
Chief Financial Officer |
(principal financial officer) |
Exhibit 32.1
VERRICA PHARMACEUTICALS INC.
PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350),Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals Inc. (the “Company”), and P. Terence Kohler Jr., Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
1.The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2.The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
IN WITNESS WHEREOF , the undersigned have set their hands hereto as of the 13th day of May, 2024.
|
|
|
|
|
/s/ Ted White |
|
|
|
/s/ P. Terence Kohler Jr. |
Ted White |
|
|
|
P. Terence Kohler Jr. |
President and Chief Executive Officer (principal executive officer) |
|
|
|
Chief Financial Officer (principal financial officer) |
* This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
v3.24.1.1.u2
Document and Entity Information - shares
|
3 Months Ended |
|
Mar. 31, 2024 |
May 07, 2024 |
| Document Information [Line Items] |
|
|
| Document Type |
10-Q
|
|
| Amendment Flag |
false
|
|
| Document Period End Date |
Mar. 31, 2024
|
|
| Document Fiscal Year Focus |
2024
|
|
| Document Fiscal Period Focus |
Q1
|
|
| Entity Trading Symbol |
VRCA
|
|
| Entity Interactive Data Current |
Yes
|
|
| Entity Registrant Name |
Verrica Pharmaceuticals Inc.
|
|
| Entity Central Index Key |
0001660334
|
|
| Entity Current Reporting Status |
Yes
|
|
| Current Fiscal Year End Date |
--12-31
|
|
| Entity Filer Category |
Non-accelerated Filer
|
|
| Entity Common Stock, Shares Outstanding |
|
42,420,053
|
| Entity Shell Company |
false
|
|
| Entity Small Business |
true
|
|
| Entity Emerging Growth Company |
false
|
|
| Entity File Number |
001-38529
|
|
| Entity Tax Identification Number |
46-3137900
|
|
| Title of 12(b) Security |
Common Stock, $0.0001 par value
|
|
| Security Exchange Name |
NASDAQ
|
|
| Document Quarterly Report |
true
|
|
| Document Transition Report |
false
|
|
| Entity Incorporation, State or Country Code |
DE
|
|
| Entity Address, Address Line One |
44 West Gay Street
|
|
| Entity Address, Address Line Two |
Suite 400
|
|
| Entity Address, City or Town |
West Chester
|
|
| Entity Address, State or Province |
PA
|
|
| Entity Address, Postal Zip Code |
19380
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| City Area Code |
484
|
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| Local Phone Number |
453-3300
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v3.24.1.1.u2
BALANCE SHEETS (Unaudited) - USD ($)
$ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
| Current assets: |
|
|
| Cash and cash equivalents |
$ 48,939
|
$ 69,547
|
| Accounts receivable, net |
7,002
|
4,248
|
| Unbilled revenue receivable |
592
|
168
|
| Inventory |
2,499
|
1,022
|
| Prepaid expenses and other assets |
2,344
|
2,545
|
| Total current assets |
61,376
|
77,530
|
| Property and equipment, net |
937
|
1,052
|
| Operating lease right-of-use asset |
1,082
|
1,158
|
| Finance lease right-of-use asset |
2,460
|
1,405
|
| Other non-current assets |
452
|
452
|
| Total assets |
66,307
|
81,597
|
| Current liabilities: |
|
|
| Accounts payable |
2,527
|
2,464
|
| Accrued expenses and other current liabilities |
15,828
|
13,860
|
| Operating lease liability |
331
|
324
|
| Financing lease liability |
679
|
376
|
| Total current liabilities |
19,365
|
17,024
|
| Operating lease liability |
825
|
910
|
| Financing lease liability |
1,761
|
1,026
|
| Long term debt |
42,848
|
42,874
|
| Total liabilities |
64,799
|
61,834
|
| Commitments and Contingencies (Note 7) |
|
|
| Stockholders’ equity: |
|
|
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of March 31, 2024 and December 31, 2023 |
0
|
0
|
| Common stock, $0.0001 par value; 200,000,000 authorized; 42,525,197 shares issued and 42,420,053 shares outstanding as of March 31, 2024 and 42,518,697 shares issued and 42,413,553 shares outstanding as of December 31, 2023 |
4
|
4
|
| Treasury stock, at cost, 105,144 shares as of March 31, 2024 and December 31, 2023 |
0
|
0
|
| Additional paid-in capital |
252,287
|
250,207
|
| Subscription receivable |
(4)
|
0
|
| Accumulated deficit |
(250,779)
|
(230,448)
|
| Total stockholders’ equity |
1,508
|
19,763
|
| Total liabilities and stockholders’ equity |
$ 66,307
|
$ 81,597
|
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-Paragraph 2
-Subparagraph (g)(2)(i)
-Publisher FASB
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Section 65
-Paragraph 2
-Subparagraph (h)(2)
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-URI https://asc.fasb.org//1943274/2147480016/944-40-65-2
Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.1.1.u2
BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
| Statement of Financial Position [Abstract] |
|
|
| Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
| Preferred stock, shares authorized |
10,000,000
|
10,000,000
|
| Preferred stock, shares issued |
0
|
0
|
| Preferred stock, shares outstanding |
0
|
0
|
| Common stock, par value |
$ 0.0001
|
$ 0.0001
|
| Common stock, shares authorized |
200,000,000
|
200,000,000
|
| Common stock, shares issued |
42,525,197
|
42,518,697
|
| Common stock, shares outstanding |
42,420,053
|
42,413,553
|
| Treasury Stock, Common, Shares |
105,144
|
105,144
|
| X |
- DefinitionFace amount or stated value per share of common stock. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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v3.24.1.1.u2
STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
$ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
| Revenues [Abstract] |
|
|
| Total revenue |
$ 3,826
|
$ 37
|
| Operating expenses: |
|
|
| Selling, general and administrative |
16,339
|
4,319
|
| Research and development |
4,948
|
2,739
|
| Cost of product revenue |
546
|
0
|
| Cost of collaboration revenue |
592
|
68
|
| Total operating expenses |
22,425
|
7,126
|
| Loss from operations |
(18,599)
|
(7,089)
|
| Other (expense) income: |
|
|
| Interest income |
598
|
500
|
| Interest expense |
(2,319)
|
0
|
| Other expense |
(11)
|
0
|
| Total other (expense) income, net |
(1,732)
|
500
|
| Net loss |
$ (20,331)
|
$ (6,589)
|
| Net loss per share, basic |
$ (0.44)
|
$ (0.15)
|
| Net loss per share, diluted |
$ (0.44)
|
$ (0.15)
|
| Weighted-average common shares outstanding, basic |
46,483,669
|
43,023,379
|
| Weighted-average common shares outstanding, diluted |
46,483,669
|
43,023,379
|
| Product [Member] |
|
|
| Revenues [Abstract] |
|
|
| Total revenue |
$ 3,232
|
$ 0
|
| Collaboration [Member] |
|
|
| Revenues [Abstract] |
|
|
| Total revenue |
$ 594
|
$ 37
|
| X |
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v3.24.1.1.u2
STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($)
$ in Thousands |
Total |
Common Stock [Member] |
Additional Paid-In Capital [Member] |
Subscription Receivable [Member] |
Accumulated Deficit [Member] |
Treasury Stock, Common [Member] |
| Beginning Balance at Dec. 31, 2022 |
$ 40,033
|
$ 4
|
$ 203,482
|
|
$ (163,453)
|
|
| Beginning Balance (shares) at Dec. 31, 2022 |
|
41,199,197
|
|
|
|
105,144
|
| Stock-based compensation |
1,094
|
|
1,094
|
|
|
|
| Issuance of common stock and pre-funded warrants, for the purchase of common stock, net of issuance costs |
30,301
|
|
30,301
|
|
|
|
| Issuance of common stock and pre-funded warrants, for the purchase of common stock, net of issuance costs, Shares |
|
750,000
|
|
|
|
|
| Exercise of stock options |
7
|
|
7
|
|
|
|
| Exercise of stock options (shares) |
|
8,000
|
|
|
|
|
| Net loss |
(6,589)
|
|
|
|
(6,589)
|
|
| Ending Balance at Mar. 31, 2023 |
64,846
|
$ 4
|
234,884
|
|
(170,042)
|
|
| Ending Balance (shares) at Mar. 31, 2023 |
|
41,957,197
|
|
|
|
105,144
|
| Beginning Balance at Dec. 31, 2023 |
19,763
|
$ 4
|
250,207
|
|
(230,448)
|
|
| Beginning Balance (shares) at Dec. 31, 2023 |
|
42,518,697
|
|
|
|
105,144
|
| Stock-based compensation |
2,072
|
|
2,072
|
|
|
|
| Exercise of stock options |
$ 4
|
|
8
|
$ (4)
|
|
|
| Exercise of stock options (shares) |
6,500
|
6,500
|
|
|
|
|
| Net loss |
$ (20,331)
|
|
|
|
(20,331)
|
|
| Ending Balance at Mar. 31, 2024 |
$ 1,508
|
$ 4
|
$ 252,287
|
$ (4)
|
$ (250,779)
|
|
| Ending Balance (shares) at Mar. 31, 2024 |
|
42,525,197
|
|
|
|
105,144
|
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v3.24.1.1.u2
STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
$ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
| Cash flows from operating activities |
|
|
| Net loss |
$ (20,331)
|
$ (6,589)
|
| Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
| Stock-based compensation |
2,072
|
1,094
|
| Depreciation expense |
126
|
131
|
| Non cash interest expense |
483
|
0
|
| Amortization of operating lease right-of-use asset |
76
|
71
|
| Amortization of finance lease right-of-use asset |
138
|
0
|
| Changes in operating assets and liabilities: |
|
|
| Prepaid expenses and other assets |
(1,275)
|
1,266
|
| Collaboration revenue receivable, billed and unbilled |
(424)
|
431
|
| Accounts payable |
52
|
14
|
| Accounts receivable |
(2,753)
|
0
|
| Accrued expenses and other current liabilities |
1,968
|
(934)
|
| Operating lease liability |
(79)
|
(74)
|
| Net cash used in operating activities |
(19,947)
|
(4,590)
|
| Cash flows from investing activities |
|
|
| Purchases of property and equipment |
0
|
(11)
|
| Net cash used in investing activities |
0
|
(11)
|
| Cash flows from financing activities |
|
|
| Proceeds from exercise of stock options |
4
|
7
|
| Payment of debt amendment fees |
(509)
|
0
|
| Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs |
0
|
30,301
|
| Equity issuance costs |
0
|
(28)
|
| Repayment of financing lease |
(156)
|
0
|
| Net cash (used in) provided by financing activities |
(661)
|
30,280
|
| Net (decrease) increase in cash and cash equivalents |
(20,608)
|
25,679
|
| Cash and cash equivalents at the beginning of the period |
69,547
|
34,273
|
| Cash and cash equivalents at the end of the period |
48,939
|
59,952
|
| Supplemental disclosures |
|
|
| Cash paid for interest |
1,836
|
0
|
| Supplemental disclosure of noncash investing and financing activities: |
|
|
| Property and equipment purchases in accounts payable or accrued expenses and other current liabilities at period end |
11
|
34
|
| Right-of-use asset obtained in exchange for lease obligation |
$ 1,193
|
$ 0
|
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-Section 50
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Reference 34: http://www.xbrl.org/2003/role/exampleRef
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-Section 55
-Paragraph 4K
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-Section 45
-Paragraph 1A
-Subparagraph (a)
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-Section 45
-Paragraph 1B
-Subparagraph (a)
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-Section 45
-Paragraph 2
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-Paragraph 1A
-Subparagraph (a)(1)
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v3.24.1.1.u2
Organization and Description of Business Operations
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
| Organization and Description of Business Operations |
Note 1—Organization and Description of Business Operations Verrica Pharmaceuticals Inc. (the “Company”) was formed on July 3, 2013 and is incorporated in the State of Delaware. The Company is a dermatology therapeutics company developing and selling medications for skin diseases requiring medical intervention. On July 21, 2023, the U.S. Food and Drug Administration (“FDA”) approved YCANTH (VP-102) topical solution for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. The Company launched commercial operations in August 2023. Liquidity The Company has incurred substantial operating losses since inception and expects to continue to incur significant losses for the foreseeable future and may never become profitable. As of March 31, 2024, the Company had an accumulated deficit of $250.8 million. The Company believes its cash, and cash equivalents of $48.9 million as of March 31, 2024 will be sufficient to support the Company’s planned operations only into the first quarter of 2025. These factors cause substantial doubt to exist about the Company's ability to continue as a going concern within one year after the date these financial statements are issued. The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern. The Company plans to secure additional capital in the future through equity or debt financings, partnerships, or other sources to carry out the Company’s planned commercial and development activities. If the Company is unable to raise capital when needed or on attractive terms, the Company would be forced to delay, reduce or eliminate its future commercialization efforts or research and development programs. On July 26, 2023, the Company entered into a Credit Agreement which provides for up to $125.0 million in debt under a Loan Facility (as defined in Note 10). The Company borrowed $50.0 million under the Loan Facility on July 26, 2023, resulting in net proceeds of approximately $44.1 million after payment of certain fees and transaction related expenses. In addition, subject to the Company's achievement of certain revenue targets, up to $25.0 million will be made available on or prior to June 30, 2024, up to $30.0 million will be made available on or prior to December 31, 2024, up to $10.0 million will be made available on or prior to March 31, 2025, and up to $10.0 million will be made available on or prior to June 30, 2025. Amounts borrowed under the Loan Facility will mature on July 26, 2028.
|
| X |
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v3.24.1.1.u2
Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Accounting Policies [Abstract] |
|
| Significant Accounting Policies |
Note 2—Significant Accounting Policies Basis of Presentation The accompanying unaudited interim financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2023 included in its Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenues and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Collateral Cash Cash and cash equivalents as of March 31, 2024 includes a cash deposit of $0.5 million with Bank of America as required under the Commercial Credit Card Program with a balance equal to the outstanding credit limit on commercial credit cards. Fair Value of Financial Instruments and Credit Risk As of March 31, 2024, the Company’s financial instruments included cash equivalents, accounts receivable, accounts payable, and notes payable. The carrying amount of cash equivalents, accounts receivable and accounts payable approximated fair value, given their short-term nature. The carrying value of the notes payable approximates fair value as the interest rate is reflective of current market rates on debt with similar terms and conditions. Cash equivalents subject the Company to concentrations of credit risk. However, the Company invests its cash in accordance with a policy objective that seeks to ensure both liquidity and safety of principal. The policy limits investments to instruments issued by the U.S. government, certain SEC registered money market funds that invest only in U.S. government obligations and various other low-risk liquid investment options, and places restrictions on portfolio maturity terms. Accounts receivable subjects the Company to concentrations of credit risk as all of the Company's revenue is from sales of a single product, YCANTH (VP-102), primarily to one pharmaceutical wholesale/distributor. Accounts Receivable Accounts receivable, related to YCANTH (VP-102) sales, was $7.0 million at March 31, 2024. As of March 31, 2024, the Company had no allowance for doubtful accounts. An allowance for doubtful accounts is determined based on the Company's assessment of the creditworthiness and financial condition of its customers, aging of receivables, as well as the general economic environment. Any allowance would reduce the net receivables to the amount that is expected to be collected. Current payment terms for YCANTH (VP-102) are approximately 60 days from the shipment date. Inventory The Company values inventory at the lower of cost or net realizable value. Inventory cost is determined using the specific identification method. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of March 31, 2024. On July 21, 2023, the Company received FDA approval for YCANTH (VP-102) for the treatment of molluscum contagiosum and began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all product purchased from such suppliers was included as a component of research and development expense, as the Company was unable to assert that the inventory had future economic benefit until YCANTH received FDA approval. Pursuant to the supply agreement (Note 6), the Company purchased and included in research and development expenses approximately $4.5 million of raw cantharidin and processed active pharmaceutical ingredient ("API"). The raw cantharidin and processed API is sufficient to produce approximately 14.0 million finished drug product applicators to be used for commercially saleable product and other product candidates. In addition, the Company purchased other components and services related to YCANTH for commercially saleable product and included approximately $1.2 million in research and development expenses prior to FDA approval. As a result, cost of product revenue related to YCANTH will initially reflect a lower average per unit cost of materials over approximately the next nine months as previously expensed inventory is utilized for commercial production and sold to customers. If the Company were to have included those costs previously expensed as a component of cost of product revenue, the Company’s cost of product revenue for the three months ended March 31, 2024 would have been $0.7 million including $0.3 million of obsolete inventory costs. Product Revenue, Net The Company recognizes revenue from sales of a single product, YCANTH (VP-102) (the “Product”) in accordance with ASC Topic 606 – Revenue from Contracts with Customers. YCANTH (VP-102) became available for commercial sale and shipment to patients with a prescription in the United States in the third quarter of 2023. The Company sells the Product primarily to one customer, a pharmaceutical wholesaler/distributor (the “Customer”) who in turn sells the Product directly to clinics, hospitals, and federal healthcare programs. Revenue is recognized as the Product is physically delivered to the Customer. Gross product sales are reduced by corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in the Company’s reported “Product revenue, net” in the accompanying statements of operations. Product revenue, net reflects the amount the Company ultimately expects to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that the Company estimates for the various GTN categories discussed below. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period, in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, co-pay assistance and distribution, data, and group purchasing organizations ("GPO") administrative fees may be materially above or below the amount estimated. Variance between actual amounts and estimated amounts may result in prospective adjustments to reported net product revenue. Each of the GTN estimate categories are discussed below: Product Returns Allowances: The Customer is contractually permitted to return purchased Product in certain circumstances. The Company estimates expected returns based on the Company’s review of similar products in the industry. As historical data for returns of the Product becomes available over time, the Company will utilize historical return rates of the Product in making its estimates. Returned Product is typically destroyed, since substantially all returns are due to expiry and cannot be resold. Government Chargebacks: The Product is subject to pricing limits under certain federal government programs, including Medicare and the 340B drug pricing program. Qualifying entities (the “End-Users”) purchase the Product from the Customer at their applicable qualifying discounted price. The chargeback amount the Company incurs represents the difference between the Company’s contractual sales price to the Customer and the end-user’s applicable discounted purchase price under the government program. Medicaid Rebates: The Product is subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with the Product is covered under Medicaid, resulting in a discounted price for the Product under the applicable Medicaid program. The Medicaid rebate accrual calculations require the Company to project the magnitude of its sales, by state, that will be subject to these rebates. Patient Assistance: The Company offers a voluntary co-pay patient assistance program intended to provide financial assistance to eligible patients with a prescription drug co-payment required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with YCANTH (VP-102) that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of the Company’s products for various commercial services including contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of the Company’s applicable sales. Cost of Product Revenue Cost of product revenue includes the cost of inventory sold, which includes direct manufacturing, production and packaging materials for YCANTH (VP-102) sales. Prior to FDA approval of YCANTH (VP-102) in July 2023, the Company expensed approximately $0.1 million in costs associated with the manufacturing of YCANTH (VP-102) as a component of research and development expense. Therefore, these costs are not included in cost of product revenue. Advertising Expense Advertising expenses, comprised primarily of print and digital assets, social media and internet advertising as well as search engine marketing, are expensed as incurred and are included in selling, general, and administrative expenses. For the three months ended March 31, 2024, advertising expense was approximately $1.5 million. Net Loss Per Share Net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period including pre-funded warrants to purchase shares of common stock that were issued in an underwritten offering in February 2023 (Note 7). The pre-funded warrants to purchase common stock are included in the calculation of basic and diluted net loss per share as the exercise price of $0.0001 per share is non-substantive and is virtually assured. Diluted net loss per share excludes the potential impact of common stock options and unvested shares of restricted stock because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same. The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Shares issuable upon exercise of stock options |
|
|
6,613,615 |
|
|
|
4,722,082 |
|
Non-vested shares under restricted stock grants |
|
|
834,000 |
|
|
|
1,123,000 |
|
Shares issuable upon exercise of warrants pursuant to debt financing |
|
|
518,551 |
|
|
|
— |
|
Total |
|
|
7,966,166 |
|
|
|
5,845,082 |
|
Recently Adopted Accounting Pronouncements In June 2022, the FASB issued Accounting Standards Update No. 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard became effective for the Company on January 1, 2024, and its adoption did not have an impact on the Company's financial statements and related disclosures. |
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- DefinitionThe entire disclosure for the basis of presentation and significant accounting policies concepts. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). Accounting policies describe all significant accounting policies of the reporting entity. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 235
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v3.24.1.1.u2
Inventory
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Inventory Disclosure [Abstract] |
|
| Inventory |
Note 3 —Inventory Upon FDA approval of YCANTH (VP-102) for the treatment of molluscum contagiosum on July 21, 2023, the Company began capitalizing the purchases of saleable inventory of YCANTH (VP-102) from suppliers. Inventory consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Raw materials |
|
$ |
1,150 |
|
|
$ |
420 |
|
Work in process |
|
|
668 |
|
|
|
487 |
|
Finished goods |
|
|
681 |
|
|
|
115 |
|
Total inventory |
|
$ |
2,499 |
|
|
$ |
1,022 |
|
|
| X |
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- DefinitionThe entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.1.1.u2
Property and Equipment
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Property, Plant and Equipment [Abstract] |
|
| Property and Equipment |
Note 4—Property and Equipment Property and equipment, net consisted of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Machinery and equipment |
|
$ |
1,554 |
|
|
$ |
1,543 |
|
Office equipment |
|
|
326 |
|
|
|
326 |
|
Office furniture and fixtures |
|
|
303 |
|
|
|
303 |
|
Leasehold improvements |
|
|
54 |
|
|
|
54 |
|
|
|
|
2,237 |
|
|
|
2,226 |
|
Accumulated depreciation |
|
|
(1,300 |
) |
|
|
(1,174 |
) |
Total property and equipment, net |
|
$ |
937 |
|
|
$ |
1,052 |
|
Depreciation expense for both of the three months ended March 31, 2024 and 2023 was $0.1 million.
|
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 360
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//360/tableOfContent
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-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-SubTopic 360
-Topic 958
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (d)
-SubTopic 360
-Topic 958
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480321/958-360-50-1
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-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-SubTopic 360
-Topic 958
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480321/958-360-50-7
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v3.24.1.1.u2
Accrued Expenses and Other Current Liabilities
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Payables and Accruals [Abstract] |
|
| Accrued Expenses and Other Current Liabilities |
Note 5—Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
2024 |
|
|
December 31,
2023 |
|
Gross to net reserves |
|
$ |
8,502 |
|
|
$ |
5,357 |
|
Clinical trials and drug development |
|
|
3,517 |
|
|
|
2,767 |
|
Compensation and related costs |
|
|
1,393 |
|
|
|
3,438 |
|
Professional fees |
|
|
1,124 |
|
|
|
1,423 |
|
Commercial-related costs |
|
|
878 |
|
|
|
538 |
|
Other current liabilities |
|
|
321 |
|
|
|
244 |
|
Machinery and equipment |
|
|
93 |
|
|
|
93 |
|
Total accrued expenses and other current liabilities |
|
$ |
15,828 |
|
|
$ |
13,860 |
|
|
| X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02.19(a),20,24)
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v3.24.1.1.u2
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Commitments and Contingencies Disclosure [Abstract] |
|
| Commitments and Contingencies |
Note 6—Commitments and Contingencies Litigation On June 6, 2022, plaintiff Kranthi Gorlamari (“Plaintiff”) filed a putative class action complaint captioned Gorlamari v. Verrica Pharmaceuticals Inc., et al., in the U.S. District Court for the Eastern District of Pennsylvania against us and certain of our current and former officers and directors (“Defendants”). On January 12, 2023, the Plaintiff filed an amended complaint alleging that Defendants violated federal securities laws by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the YCANTH (VP-102) drug device and that such deficiencies posed a risk to the prospects for regulatory approval of YCANTH (VP-102) for the treatment of molluscum. The amended complaint seeks unspecified compensatory damages and other relief on behalf of Plaintiff and all other persons and entities which purchased or otherwise acquired our securities between May 19, 2021 and May 24, 2022 (the “Putative Class Period”). On January 12, 2024, the Court granted in part and denied in part Defendants’ motion to dismiss the amended complaint. The Court held that Plaintiff’s claims relating to statements made in May and June 2021 were sufficiently pled, but dismissed Plaintiff’s claims relating to all other statements made during the Putative Class Period. On January 26, 2024, Plaintiff filed a second amended complaint in an attempt to cure certain of the deficiencies identified in the January 12, 2024 ruling. Defendants’ motion to dismiss the second amended complaint was fully briefed as of April 22, 2024, and is pending before the Court. The Company is also involved in ordinary, routine legal proceedings that are not considered by management to be material. In the opinion of Company counsel and management, the ultimate liabilities resulting from such legal proceedings will not materially affect the financial position of the Company or its results of operations or cash flows. Supply Agreement and Purchase Order On July 16, 2018, the Company entered into a supply agreement with a supplier of crude cantharidin material. All executed purchase orders for crude cantharidin in the ordinary course of business are expected to be covered under the terms of the supply agreement. Pursuant to the supply agreement, the supplier has agreed that it will not supply cantharidin, any beetles or other raw material from which cantharidin is derived to any other customer in North America, subject to specified minimum annual purchase orders and forecasts by the Company. The supply agreement had an initial five-year term, and now renews for successive annual periods absent termination by either party in accordance with the terms of the supply agreement. Each party also has the right to terminate the supply agreement for other customary reasons such as material breach or bankruptcy. In both 2023 and 2022, the Company executed respective purchase orders pursuant to which the Company agreed to purchase $0.7 million of crude cantharidin material and made prepayments of $0.7 million in each year against the purchase orders. The Company received the shipment for the 2023 purchase during the three months ended March 31, 2024, which was reflected as a prepaid expense of $0.7 million on the balance sheet as of December 31, 2023.
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- DefinitionThe entire disclosure for commitments and contingencies. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 440
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482648/440-10-50-4
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-Topic 450
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//450/tableOfContent
Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 954
-SubTopic 440
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480327/954-440-50-1
Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 440
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482648/440-10-50-4
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v3.24.1.1.u2
Stockholders' Equity
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Equity [Abstract] |
|
| Stockholders' Equity |
Note 7—Stockholders’ Equity Common Stock The Company had authorized 200,000,000 shares of common stock, $0.0001 par value per share, as of March 31, 2024 and December 31, 2023. Each share of common stock is entitled to one vote. Common stock owners are entitled to dividends when funds are legally available and declared by the Board. Underwritten Public Offering In February 2023, the Company closed an underwritten offering of 750,000 shares of its common stock and pre-funded warrants to purchase 4,064,814 shares of common stock. The shares of common stock were sold at a price of $6.75 per share and the pre-funded warrants were sold at a price of $6.7499 per pre-funded warrant, resulting in net proceeds of $30.3 million after deducting underwriting discounts and commissions, and offering expense. The pre-funded warrants will not expire and are exercisable in cash or by means of a cashless exercise. Warrants The following table summarizes the Company’s outstanding warrants, all of which are exercisable for common stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
Number of warrants |
|
|
Exercise Price |
|
|
Expiration Date |
Pre-funded warrants issued pursuant to 2023 underwritten public offering |
|
|
4,064,814 |
|
|
$ |
0.0001 |
|
|
No expiration |
Warrants issued in connection with OrbiMed debt facility |
|
|
518,551 |
|
|
$ |
6.0264 |
|
|
7/25/2033 |
|
|
|
|
|
|
|
|
|
|
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-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13
Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14
Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2
Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2
Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481004/946-505-50-6
Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480237/815-40-50-6
Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480008/505-10-S99-1
Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13
Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13
Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
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-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14
Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14
Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 16
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-16
Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18
Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18
Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
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v3.24.1.1.u2
Stock-Based Compensation
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Share-Based Payment Arrangement [Abstract] |
|
| Stock-Based Compensation |
Note 8—Stock-Based Compensation Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s statements of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Selling, general and administrative |
|
$ |
1,622 |
|
|
$ |
836 |
|
Research and development |
|
|
450 |
|
|
|
258 |
|
Total stock-based compensation |
|
$ |
2,072 |
|
|
$ |
1,094 |
|
Stock Options The following table summarizes the Company’s stock option activity for the three months ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
remaining contractual |
|
|
Aggregate intrinsic |
|
|
|
Number of shares |
|
|
exercise price |
|
|
term (in years) |
|
|
value |
|
Outstanding as of December 31, 2023 |
|
|
5,565,615 |
|
|
$ |
8.25 |
|
|
|
7.2 |
|
|
$ |
4,143,150 |
|
Granted |
|
|
1,079,300 |
|
|
|
4.99 |
|
|
|
|
|
|
|
Exercised |
|
|
(6,500 |
) |
|
|
1.24 |
|
|
|
|
|
|
4,755 |
|
Forfeited |
|
|
(24,800 |
) |
|
|
5.24 |
|
|
|
|
|
|
|
Expired |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Outstanding as of March 31, 2024 |
|
|
6,613,615 |
|
|
$ |
7.74 |
|
|
|
7.5 |
|
|
$ |
2,688,929 |
|
Options vested and exercisable as of
March 31, 2024 |
|
|
3,438,271 |
|
|
$ |
9.01 |
|
|
|
5.9 |
|
|
$ |
620,420 |
|
As of March 31, 2024, the total unrecognized compensation related to unvested stock option awards granted was $14.7 million, which the Company expects to recognize over a weighted-average period of 2.84 years. Stock option compensation expense of $1.5 million and $1.1 million was recognized in the Company's statements of operations during the three months ended March 31, 2024 and 2023, respectively. Restricted Stock Units In November 2019 and August 2020 the Company granted 300,000 and 250,000 restricted stock units ("RSUs"), respectively, to its executive officers, of which 125,000 were forfeited. Half of the remaining RSUs vested upon receipt of regulatory approval of the Company’s new drug application for YCANTH (VP-102) for the treatment of molluscum on July 21, 2023 (the “Approval Date”) and the other half will vest on July 21, 2024, subject to the holders’ continuous service through each applicable date. In March 2023, the Company granted 698,000 RSUs, half of which vested upon the first commercial sale of YCANTH (VP-102) on August 24, 2023 and half of which will vest on August 24, 2024, subject to the holders’ continuous service through each applicable date. In March 2024, the Company granted 272,500 RSUs to executive officers. These restricted stock units vest 25% annually over four years subject to the holders' continuous service through each applicable date. Compensation expense of $0.6 million was recognized in the Company’s statements of operations for the three months ended March 31, 2024 related to the vested RSUs based on the fair market value at the date of grant. As of March 31, 2024, the remaining unrecognized compensation expense related to the RSUs was $2.2 million, which the Company expects to recognize over a weighted average service period of 1.6 years now that vesting of these awards is probable. The following is a summary of changes in the status of non-vested RSUs for the three months ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Grant Date Fair |
|
|
|
Number of Shares |
|
|
Value |
|
Nonvested as of December 31, 2023 |
|
|
561,500 |
|
|
$ |
9.13 |
|
Granted |
|
|
272,500 |
|
|
|
4.80 |
|
Forfeited |
|
|
— |
|
|
|
— |
|
Vested |
|
|
— |
|
|
|
— |
|
Nonvested as of March 31, 2024 |
|
|
834,000 |
|
|
$ |
7.72 |
|
|
| X |
- DefinitionThe entire disclosure for share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480429/718-10-50-2
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-SubTopic 10
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-Section 50
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-Subparagraph (a)
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-Section 50
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-SubTopic 10
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-Section 50
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-SubTopic 10
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-Section 50
-Paragraph 2
-Subparagraph (l)
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v3.24.1.1.u2
Leases
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Leases [Abstract] |
|
| Leases |
Note 9—Leases The Company leases 11,201 square feet of office space located in West Chester, Pennsylvania that serves as the Company’s headquarters. The initial term expires on September 1, 2027. Base rent over the initial term is approximately $2.4 million, and the Company is also responsible for its share of the landlord’s operating expense. The Company leases office space in Scotch Plains, New Jersey under an agreement classified as an operating lease, which commenced on May 1, 2022 and expires on April 30, 2025. Base rent over the initial term is approximately $104,000 per year. The Company entered into a fleet program to provide vehicles for its sales force. The vehicles are leased for a term of 52 months and classified as finance leases. During the three months ended March 31, 2024, the Company recognized both a right-of-use asset and a lease liability of $1.2 million related to these finance leases. The components of lease expense are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Finance lease cost: |
|
|
|
|
|
|
Amortization ROU assets |
|
$ |
139 |
|
|
$ |
— |
|
Interest on lease liabilities |
|
|
44 |
|
|
|
— |
|
Total finance lease costs |
|
$ |
183 |
|
|
$ |
— |
|
Operating lease: |
|
|
|
|
|
|
Operating lease costs |
|
$ |
94 |
|
|
$ |
86 |
|
Short-term lease costs |
|
|
— |
|
|
|
— |
|
Total operating lease expense |
|
$ |
94 |
|
|
$ |
86 |
|
Maturities of the Company’s operating and finance leases, excluding short-term leases, as of March 31, 2024 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
Finance |
|
2024 (remaining 9 months) |
|
$ |
293 |
|
|
$ |
648 |
|
2025 |
|
|
372 |
|
|
|
744 |
|
2026 |
|
|
366 |
|
|
|
631 |
|
2027 |
|
|
247 |
|
|
|
592 |
|
Thereafter |
|
|
— |
|
|
|
181 |
|
Total lease payments |
|
|
1,278 |
|
|
|
2,796 |
|
Less imputed interest |
|
|
(122 |
) |
|
|
(356 |
) |
Lease liability |
|
$ |
1,156 |
|
|
$ |
2,440 |
|
The weighted average remaining lease term and discount rates for the Company's leases as of March 31, 2024 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
Finance |
|
Weighted average remaining lease term (years) |
|
|
3.34 |
|
|
|
4.07 |
|
Weighted average discount rate |
|
|
6.25 |
% |
|
|
7.72 |
% |
|
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v3.24.1.1.u2
Debt Covenants
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Debt Disclosure [Abstract] |
|
| Debt Covenants |
Note 10—Debt On July 26, 2023 (the “Closing Date”), the Company entered into a Credit Agreement (the “Credit Agreement”), by and between the Company, as borrower, and OrbiMed Royalty & Credit Opportunities IV, LP, a Delaware limited partnership (the “Initial Lender”), as a lender, and each other lender that may from time to time become a party thereto (each, including the Initial Lender, and together with their affiliates, successors, transferees and assignees, the “Lenders”), and OrbiMed Royalty & Credit Opportunities IV, LP, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”). The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $125.0 million (the “Loan Facility”). The Company borrowed $50.0 million under the Credit Agreement on July 26, 2023, resulting in net proceeds of approximately $44.1 million after payment of certain fees and transaction related expenses. In addition, subject to the Company's achievement of certain revenue targets, up to $25.0 million will be made available on or prior to June 30, 2024, up to $30.0 million will be made available on or prior to December 31, 2024, up to $10.0 million will be made available on or prior to March 31, 2025, and up to $10.0 million will be made available on or prior to June 30, 2025. Amounts borrowed under the Loan Facility will mature on July 26, 2028. During the term of the Loan Facility, interest payable in cash by the Company shall accrue on any outstanding balance due under the Loan Facility at a rate per annum equal to the higher of (x) the SOFR rate (which is the forward-looking term rate for a one-month tenor based on the secured overnight financing rate administered by the CME Group Benchmark Administration Limited) and (y) 4.00% plus, in either case, 8.00%. During an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4.00% in excess of the otherwise applicable rate of interest. The Company paid or will pay certain fees with respect to the Loan Facility, including an upfront fee, an unused fee on the undrawn portion of the Loan Facility, an administration fee, a prepayment premium and an exit fee, as well as certain other fees and expenses of the Administrative Agent and the Lenders. The Credit Agreement contains customary events of default, including, but not limited to, nonpayment of principal, interest, fees or other amounts; material inaccuracy of a representation or warranty; failure to perform or observe covenants; cross-defaults with certain other indebtedness; bankruptcy and insolvency events; material monetary judgment defaults; impairment of any material definitive loan documentation; other material adverse effects; key permit and other regulatory events; key person events; and change of control. Upon the occurrence of an event of default (subject to notice and grace periods), additional interest of 4% per annum applies and obligations under the Credit Agreement could be accelerated. As of March 31, 2024, the Company is in compliance with all covenants. On the Closing Date, the Company also issued the Initial Lender warrants to purchase up to 518,551 shares of the Company’s common stock, at an exercise price of $6.0264 per share, which have a term of 10 years from the issuance date. The warrants were deemed to be classified as equity per the guidance ASC 815 Derivatives and Hedging. The proceeds from the debt transaction were allocated among the two instruments based on their relative fair values. The relative fair value of the warrants was determined to be $2.0 million and the fair value was determined to be $2.4 million based on the Black-Scholes valuation technique and the key assumptions used were as follows: (i) a contracted term of 10 years, (ii) an expected volatility of 94.86%, (iii) a risk free rate of 3.86% and (iv) no estimated dividend yield. On each of December 20, 2023 and January 31, 2024, the Company entered into an amendment to the Credit Agreement in order to extend a deadline for a specified regulatory milestone. For each amendment, the Company paid an amendment fee of $250,000. The Company accounted for these amendments as modifications and the amendment fees were reflected in the debt discount and amortized over the life of the Credit Agreement using the effective interest method. The Loan Facility is classified as non-current debt as the Company does not currently intend to repay amounts borrowed under the Loan Facility prior to the maturity date of July 26, 2028 and believes that the probability of any acceleration of the Loan Facility is not probable at March 31, 2024. The Company has incurred debt discount and issuance costs of $10.4 million, that are netted against the carrying value of the Loan Facility. The debt discount and issuance costs consists of $5.9 million paid in cash during the year ended December 31, 2023 and the final payment fee of $2.5 million, classified as a long-term liability and the fair value of the warrants of $2.0 million, classified as equity on the balance sheet. For the three months ended March 31, 2024, the Company recognized interest expense of $2.3 million of which $1.8 million was interest on the term loan and $0.5 million was non-cash interest expense related to the amortization of deferred debt issuance costs and accrual of the final payment fee. The following table summarizes the composition of debt as of March 31, 2024 (in thousands):
|
|
|
|
|
Gross proceeds from Loan Facility |
|
$ |
50,000 |
|
Accrued final payment fee |
|
|
2,500 |
|
Unamortized debt discount and issuance costs |
|
|
(9,652 |
) |
Total long-term debt, net |
|
$ |
42,848 |
|
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v3.24.1.1.u2
License And Collaboration Agreements
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| License And Collaboration Agreements [Abstract] |
|
| License and Collaboration Agreements |
Note 11—License and Collaboration Agreements Torii Agreements On March 17, 2021, the Company entered into a collaboration and license agreement (the “Torii Agreement”) with Torii, pursuant to which the Company granted Torii an exclusive license to develop and commercialize the Company’s product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in Japan, including YCANTH (VP-102). Additionally, the Company granted Torii a right of first negotiation with respect to additional indications for the licensed products and certain additional products for use in the licensed field, in each case in Japan. Pursuant to the Torii Agreement, the Company received milestone payments from Torii in prior periods totaling $20.0 million. Additionally, the Company is entitled to receive from Torii an additional $50.0 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, in addition to tiered transfer price payments for supply of product in the percentage range of the mid-30’s to the mid-40’s of net sales. The transfer payments shall be payable, on a product-by-product basis, beginning on the first commercial sale of such product and ending on the latest of (a) expiration of the last-to-expire valid claim contained in certain licensed patents in Japan that cover such product, (b) expiration of regulatory exclusivity for the first indication for such product in Japan, and, (c) (i) with respect to the first product, ten years after first commercial sale of such product, and, (ii) with respect to any other product, the later of (x) ten years after first commercial sale of the first product and (y) five years after first commercial sale of such product. The Torii Agreement expires on a product-by-product basis upon expiration of Torii’s obligation under the agreement to make transfer price payments for such product. Torii has the right to terminate the agreement upon specified prior written notice to us. Additionally, either party may terminate the agreement in the event of an uncured material breach of the agreement by, or insolvency of, the other party. The Company may terminate the agreement in the event that Torii commences a legal action challenging the validity, enforceability or scope of any licensed patents. On March 7, 2022, the Company executed a Clinical Supply Agreement with Torii, whereby the Company will supply product to Torii for use in clinical trials and other development activities. The Company recognized collaboration revenue of $0.6 million and $37,000 for the three months ended March 31, 2024 and 2023 respectively related to supplies and development activity pursuant to this agreement. The costs of collaboration revenue consists of expenses incurred by the Company for manufacturing supply to support development and testing services pursuant to the Torii Clinical Supply Agreement. Lytix Agreement In August 2020, the Company entered into an exclusive license agreement with Lytix Biopharma AS (“Lytix”) for the use of licensed technology, referred to as VP-315, to research, develop, manufacture, have manufactured, use, sell, have sold, offer for sale, import, and otherwise commercialize products for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic Merkel cell carcinoma (the” Lytix Agreement”). As part of the Lytix Agreement, the Company has paid Lytix milestone fees of $3.6 million in previous periods. The Company is also obligated to pay up to $111.0 million contingent on achievement of specified development, regulatory, and sales milestones, as well as tiered royalties based on worldwide annual net sales ranging in the low double digits to the mid-teens, subject to certain customary reductions. The Company’s obligation to pay royalties expires on a country-by-country and product-by-product basis on the later of the expiration or abandonment of the last to expire licensed patent covering VP-315 anywhere in the world and expiration of regulatory exclusivity for VP-315 in such country. Additionally, all upfront fees and milestone-based payments received by the Company from a sublicensee will be treated as net sales and will be subject to the royalty payment obligations under the Lytix Agreement, and all royalties received by the Company from a sublicensee shall be shared with Lytix at a rate that is initially 50% but decreases based on the stage of development of VP-315 at the time such sublicense is granted.
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v3.24.1.1.u2
Subsequent Event
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Subsequent Events [Abstract] |
|
| Subsequent Event |
Note 12 – Subsequent Event Third Amendment to Credit Agreement On May 6, 2024, the Company entered into an amendment to the Credit Agreement pursuant to which the Lenders waived the going concern requirement under Section 7.1(b) of the Credit Agreement with respect to the financial statements for the quarter ended March 31, 2024 (the “Third Amendment”). In connection with the Third Amendment, the Company paid an amendment fee of $100,000.
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v3.24.1.1.u2
Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Accounting Policies [Abstract] |
|
| Basis of Presentation |
Basis of Presentation The accompanying unaudited interim financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2023 included in its Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.
|
| Use of Estimates |
Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenues and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
|
| Collateral Cash |
Collateral Cash Cash and cash equivalents as of March 31, 2024 includes a cash deposit of $0.5 million with Bank of America as required under the Commercial Credit Card Program with a balance equal to the outstanding credit limit on commercial credit cards.
|
| Fair Value of Financial Instruments and Credit Risk |
Fair Value of Financial Instruments and Credit Risk As of March 31, 2024, the Company’s financial instruments included cash equivalents, accounts receivable, accounts payable, and notes payable. The carrying amount of cash equivalents, accounts receivable and accounts payable approximated fair value, given their short-term nature. The carrying value of the notes payable approximates fair value as the interest rate is reflective of current market rates on debt with similar terms and conditions. Cash equivalents subject the Company to concentrations of credit risk. However, the Company invests its cash in accordance with a policy objective that seeks to ensure both liquidity and safety of principal. The policy limits investments to instruments issued by the U.S. government, certain SEC registered money market funds that invest only in U.S. government obligations and various other low-risk liquid investment options, and places restrictions on portfolio maturity terms. Accounts receivable subjects the Company to concentrations of credit risk as all of the Company's revenue is from sales of a single product, YCANTH (VP-102), primarily to one pharmaceutical wholesale/distributor.
|
| Accounts Receivable, Trade |
Accounts Receivable Accounts receivable, related to YCANTH (VP-102) sales, was $7.0 million at March 31, 2024. As of March 31, 2024, the Company had no allowance for doubtful accounts. An allowance for doubtful accounts is determined based on the Company's assessment of the creditworthiness and financial condition of its customers, aging of receivables, as well as the general economic environment. Any allowance would reduce the net receivables to the amount that is expected to be collected. Current payment terms for YCANTH (VP-102) are approximately 60 days from the shipment date.
|
| Inventory |
Inventory The Company values inventory at the lower of cost or net realizable value. Inventory cost is determined using the specific identification method. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of March 31, 2024. On July 21, 2023, the Company received FDA approval for YCANTH (VP-102) for the treatment of molluscum contagiosum and began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all product purchased from such suppliers was included as a component of research and development expense, as the Company was unable to assert that the inventory had future economic benefit until YCANTH received FDA approval. Pursuant to the supply agreement (Note 6), the Company purchased and included in research and development expenses approximately $4.5 million of raw cantharidin and processed active pharmaceutical ingredient ("API"). The raw cantharidin and processed API is sufficient to produce approximately 14.0 million finished drug product applicators to be used for commercially saleable product and other product candidates. In addition, the Company purchased other components and services related to YCANTH for commercially saleable product and included approximately $1.2 million in research and development expenses prior to FDA approval. As a result, cost of product revenue related to YCANTH will initially reflect a lower average per unit cost of materials over approximately the next nine months as previously expensed inventory is utilized for commercial production and sold to customers. If the Company were to have included those costs previously expensed as a component of cost of product revenue, the Company’s cost of product revenue for the three months ended March 31, 2024 would have been $0.7 million including $0.3 million of obsolete inventory costs.
|
| Product Revenue, Net |
Product Revenue, Net The Company recognizes revenue from sales of a single product, YCANTH (VP-102) (the “Product”) in accordance with ASC Topic 606 – Revenue from Contracts with Customers. YCANTH (VP-102) became available for commercial sale and shipment to patients with a prescription in the United States in the third quarter of 2023. The Company sells the Product primarily to one customer, a pharmaceutical wholesaler/distributor (the “Customer”) who in turn sells the Product directly to clinics, hospitals, and federal healthcare programs. Revenue is recognized as the Product is physically delivered to the Customer. Gross product sales are reduced by corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in the Company’s reported “Product revenue, net” in the accompanying statements of operations. Product revenue, net reflects the amount the Company ultimately expects to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that the Company estimates for the various GTN categories discussed below. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period, in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, co-pay assistance and distribution, data, and group purchasing organizations ("GPO") administrative fees may be materially above or below the amount estimated. Variance between actual amounts and estimated amounts may result in prospective adjustments to reported net product revenue. Each of the GTN estimate categories are discussed below: Product Returns Allowances: The Customer is contractually permitted to return purchased Product in certain circumstances. The Company estimates expected returns based on the Company’s review of similar products in the industry. As historical data for returns of the Product becomes available over time, the Company will utilize historical return rates of the Product in making its estimates. Returned Product is typically destroyed, since substantially all returns are due to expiry and cannot be resold. Government Chargebacks: The Product is subject to pricing limits under certain federal government programs, including Medicare and the 340B drug pricing program. Qualifying entities (the “End-Users”) purchase the Product from the Customer at their applicable qualifying discounted price. The chargeback amount the Company incurs represents the difference between the Company’s contractual sales price to the Customer and the end-user’s applicable discounted purchase price under the government program. Medicaid Rebates: The Product is subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with the Product is covered under Medicaid, resulting in a discounted price for the Product under the applicable Medicaid program. The Medicaid rebate accrual calculations require the Company to project the magnitude of its sales, by state, that will be subject to these rebates. Patient Assistance: The Company offers a voluntary co-pay patient assistance program intended to provide financial assistance to eligible patients with a prescription drug co-payment required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with YCANTH (VP-102) that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of the Company’s products for various commercial services including contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of the Company’s applicable sales.
|
| Cost of Product Revenue |
Cost of Product Revenue Cost of product revenue includes the cost of inventory sold, which includes direct manufacturing, production and packaging materials for YCANTH (VP-102) sales. Prior to FDA approval of YCANTH (VP-102) in July 2023, the Company expensed approximately $0.1 million in costs associated with the manufacturing of YCANTH (VP-102) as a component of research and development expense. Therefore, these costs are not included in cost of product revenue.
|
| Advertising Expense |
Advertising Expense Advertising expenses, comprised primarily of print and digital assets, social media and internet advertising as well as search engine marketing, are expensed as incurred and are included in selling, general, and administrative expenses. For the three months ended March 31, 2024, advertising expense was approximately $1.5 million.
|
| Net Loss Per Share |
Net Loss Per Share Net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period including pre-funded warrants to purchase shares of common stock that were issued in an underwritten offering in February 2023 (Note 7). The pre-funded warrants to purchase common stock are included in the calculation of basic and diluted net loss per share as the exercise price of $0.0001 per share is non-substantive and is virtually assured. Diluted net loss per share excludes the potential impact of common stock options and unvested shares of restricted stock because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same. The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Shares issuable upon exercise of stock options |
|
|
6,613,615 |
|
|
|
4,722,082 |
|
Non-vested shares under restricted stock grants |
|
|
834,000 |
|
|
|
1,123,000 |
|
Shares issuable upon exercise of warrants pursuant to debt financing |
|
|
518,551 |
|
|
|
— |
|
Total |
|
|
7,966,166 |
|
|
|
5,845,082 |
|
|
| Recently Adopted Accounting Pronouncements |
Recently Adopted Accounting Pronouncements In June 2022, the FASB issued Accounting Standards Update No. 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard became effective for the Company on January 1, 2024, and its adoption did not have an impact on the Company's financial statements and related disclosures.
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- DefinitionDisclosure of accounting policy for cash and cash equivalents, including the policy for determining which items are treated as cash equivalents. Other information that may be disclosed includes (1) the nature of any restrictions on the entity's use of its cash and cash equivalents, (2) whether the entity's cash and cash equivalents are insured or expose the entity to credit risk, (3) the classification of any negative balance accounts (overdrafts), and (4) the carrying basis of cash equivalents (for example, at cost) and whether the carrying amount of cash equivalents approximates fair value. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 230
-SubTopic 10
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-Paragraph 1
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-Publisher FASB
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- DefinitionDisclosure of accounting policy for computing basic and diluted earnings or loss per share for each class of common stock and participating security. Addresses all significant policy factors, including any antidilutive items that have been excluded from the computation and takes into account stock dividends, splits and reverse splits that occur after the balance sheet date of the latest reporting period but before the issuance of the financial statements. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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-Subparagraph (c)
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-Name Accounting Standards Codification
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| X |
- DefinitionDisclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
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-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(6)(b))
-Publisher FASB
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-Topic 235
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-Section 50
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-Subparagraph (d)
-Publisher FASB
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-Topic 912
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
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-Section 50
-Paragraph 1
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-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Publisher FASB
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-Name Accounting Standards Codification
-Section 45
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-Name Accounting Standards Codification
-Section 50
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-Subparagraph (d)
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v3.24.1.1.u2
Significant Accounting Policies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Accounting Policies [Abstract] |
|
| Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Common Share |
The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Shares issuable upon exercise of stock options |
|
|
6,613,615 |
|
|
|
4,722,082 |
|
Non-vested shares under restricted stock grants |
|
|
834,000 |
|
|
|
1,123,000 |
|
Shares issuable upon exercise of warrants pursuant to debt financing |
|
|
518,551 |
|
|
|
— |
|
Total |
|
|
7,966,166 |
|
|
|
5,845,082 |
|
|
| X |
- References
+ Details
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| X |
- DefinitionTabular disclosure of securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) in the future that were not included in the computation of diluted EPS because to do so would increase EPS amounts or decrease loss per share amounts for the period presented, by antidilutive securities. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 260
-SubTopic 10
-Section 50
-Paragraph 1
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482662/260-10-50-1
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|
v3.24.1.1.u2
Inventory (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Inventory Disclosure [Abstract] |
|
| Schedule Of Inventory |
Inventory consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Raw materials |
|
$ |
1,150 |
|
|
$ |
420 |
|
Work in process |
|
|
668 |
|
|
|
487 |
|
Finished goods |
|
|
681 |
|
|
|
115 |
|
Total inventory |
|
$ |
2,499 |
|
|
$ |
1,022 |
|
|
| X |
- References
+ Details
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| X |
- DefinitionTabular disclosure of the carrying amount as of the balance sheet date of merchandise, goods, commodities, or supplies held for future sale or to be used in manufacturing, servicing or production process. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(6)(a))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480566/210-10-S99-1
Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(6)(b))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480566/210-10-S99-1
Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(6)(c))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480566/210-10-S99-1
Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section 50
-Paragraph 1
-Publisher FASB
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v3.24.1.1.u2
Property and Equipment (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Property, Plant and Equipment [Abstract] |
|
| Schedule of Property and Equipment, Net |
Property and equipment, net consisted of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Machinery and equipment |
|
$ |
1,554 |
|
|
$ |
1,543 |
|
Office equipment |
|
|
326 |
|
|
|
326 |
|
Office furniture and fixtures |
|
|
303 |
|
|
|
303 |
|
Leasehold improvements |
|
|
54 |
|
|
|
54 |
|
|
|
|
2,237 |
|
|
|
2,226 |
|
Accumulated depreciation |
|
|
(1,300 |
) |
|
|
(1,174 |
) |
Total property and equipment, net |
|
$ |
937 |
|
|
$ |
1,052 |
|
|
| X |
- References
+ Details
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| X |
- DefinitionTabular disclosure of physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, balances by class of assets, depreciation and depletion expense and method used, including composite depreciation, and accumulated deprecation. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-SubTopic 10
-Topic 360
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482099/360-10-50-1
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|
v3.24.1.1.u2
Accrued Expenses and Other Current Liabilities (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Payables and Accruals [Abstract] |
|
| Schedule of Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
2024 |
|
|
December 31,
2023 |
|
Gross to net reserves |
|
$ |
8,502 |
|
|
$ |
5,357 |
|
Clinical trials and drug development |
|
|
3,517 |
|
|
|
2,767 |
|
Compensation and related costs |
|
|
1,393 |
|
|
|
3,438 |
|
Professional fees |
|
|
1,124 |
|
|
|
1,423 |
|
Commercial-related costs |
|
|
878 |
|
|
|
538 |
|
Other current liabilities |
|
|
321 |
|
|
|
244 |
|
Machinery and equipment |
|
|
93 |
|
|
|
93 |
|
Total accrued expenses and other current liabilities |
|
$ |
15,828 |
|
|
$ |
13,860 |
|
|
| X |
- References
+ Details
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|
v3.24.1.1.u2
Stockholders' Equity (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Share-Based Payment Arrangement [Abstract] |
|
| Summary of Company's Outstanding Warrants |
The following table summarizes the Company’s outstanding warrants, all of which are exercisable for common stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
|
Number of warrants |
|
|
Exercise Price |
|
|
Expiration Date |
Pre-funded warrants issued pursuant to 2023 underwritten public offering |
|
|
4,064,814 |
|
|
$ |
0.0001 |
|
|
No expiration |
Warrants issued in connection with OrbiMed debt facility |
|
|
518,551 |
|
|
$ |
6.0264 |
|
|
7/25/2033 |
|
|
|
|
|
|
|
|
|
|
| X |
- DefinitionTabular disclosure of warrants or rights issued. Warrants and rights outstanding are derivative securities that give the holder the right to purchase securities (usually equity) from the issuer at a specific price within a certain time frame. Warrants are often included in a new debt issue to entice investors by a higher return potential. The main difference between warrants and call options is that warrants are issued and guaranteed by the company, whereas options are exchange instruments and are not issued by the company. Also, the lifetime of a warrant is often measured in years, while the lifetime of a typical option is measured in months. Disclose the title of issue of securities called for by warrants and rights outstanding, the aggregate amount of securities called for by warrants and rights outstanding, the date from which the warrants or rights are exercisable, and the price at which the warrant or right is exercisable. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 718
-SubTopic 10
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480429/718-10-50-1
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|
v3.24.1.1.u2
Stock-Based Compensation (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Schedule of Stock Based Compensation Expense |
Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s statements of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Selling, general and administrative |
|
$ |
1,622 |
|
|
$ |
836 |
|
Research and development |
|
|
450 |
|
|
|
258 |
|
Total stock-based compensation |
|
$ |
2,072 |
|
|
$ |
1,094 |
|
|
| Summary of Stock Option Activity |
The following table summarizes the Company’s stock option activity for the three months ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
|
|
|
|
|
|
|
Weighted average |
|
|
remaining contractual |
|
|
Aggregate intrinsic |
|
|
|
Number of shares |
|
|
exercise price |
|
|
term (in years) |
|
|
value |
|
Outstanding as of December 31, 2023 |
|
|
5,565,615 |
|
|
$ |
8.25 |
|
|
|
7.2 |
|
|
$ |
4,143,150 |
|
Granted |
|
|
1,079,300 |
|
|
|
4.99 |
|
|
|
|
|
|
|
Exercised |
|
|
(6,500 |
) |
|
|
1.24 |
|
|
|
|
|
|
4,755 |
|
Forfeited |
|
|
(24,800 |
) |
|
|
5.24 |
|
|
|
|
|
|
|
Expired |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
Outstanding as of March 31, 2024 |
|
|
6,613,615 |
|
|
$ |
7.74 |
|
|
|
7.5 |
|
|
$ |
2,688,929 |
|
Options vested and exercisable as of
March 31, 2024 |
|
|
3,438,271 |
|
|
$ |
9.01 |
|
|
|
5.9 |
|
|
$ |
620,420 |
|
|
| Schedule of Restricted Stock Awards Activities |
The following is a summary of changes in the status of non-vested RSUs for the three months ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Grant Date Fair |
|
|
|
Number of Shares |
|
|
Value |
|
Nonvested as of December 31, 2023 |
|
|
561,500 |
|
|
$ |
9.13 |
|
Granted |
|
|
272,500 |
|
|
|
4.80 |
|
Forfeited |
|
|
— |
|
|
|
— |
|
Vested |
|
|
— |
|
|
|
— |
|
Nonvested as of March 31, 2024 |
|
|
834,000 |
|
|
$ |
7.72 |
|
|
| X |
- DefinitionTabular disclosure of the changes in outstanding nonvested restricted stock shares. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Section 50
-Subparagraph (c)
-Paragraph 2
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-Name Accounting Standards Codification
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v3.24.1.1.u2
Leases (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Leases [Abstract] |
|
| Summary of Components of Lease Expense |
The components of lease expense are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Finance lease cost: |
|
|
|
|
|
|
Amortization ROU assets |
|
$ |
139 |
|
|
$ |
— |
|
Interest on lease liabilities |
|
|
44 |
|
|
|
— |
|
Total finance lease costs |
|
$ |
183 |
|
|
$ |
— |
|
Operating lease: |
|
|
|
|
|
|
Operating lease costs |
|
$ |
94 |
|
|
$ |
86 |
|
Short-term lease costs |
|
|
— |
|
|
|
— |
|
Total operating lease expense |
|
$ |
94 |
|
|
$ |
86 |
|
|
| Schedule of Maturities of Operating and Finance Leases |
Maturities of the Company’s operating and finance leases, excluding short-term leases, as of March 31, 2024 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
Finance |
|
2024 (remaining 9 months) |
|
$ |
293 |
|
|
$ |
648 |
|
2025 |
|
|
372 |
|
|
|
744 |
|
2026 |
|
|
366 |
|
|
|
631 |
|
2027 |
|
|
247 |
|
|
|
592 |
|
Thereafter |
|
|
— |
|
|
|
181 |
|
Total lease payments |
|
|
1,278 |
|
|
|
2,796 |
|
Less imputed interest |
|
|
(122 |
) |
|
|
(356 |
) |
Lease liability |
|
$ |
1,156 |
|
|
$ |
2,440 |
|
|
| Schedule of Weighted Average Remaining Term and Discount Rate |
The weighted average remaining lease term and discount rates for the Company's leases as of March 31, 2024 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
Finance |
|
Weighted average remaining lease term (years) |
|
|
3.34 |
|
|
|
4.07 |
|
Weighted average discount rate |
|
|
6.25 |
% |
|
|
7.72 |
% |
|
| X |
- DefinitionTabular disclosure of lessee's lease cost. Includes, but is not limited to, interest expense for finance lease, amortization of right-of-use asset for finance lease, operating lease cost, short-term lease cost, variable lease cost and sublease income. Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 842
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-Section 50
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v3.24.1.1.u2
Debt Covenants (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
|---|
| Debt Disclosure [Abstract] |
|
| Summary of Composition of Debt |
The following table summarizes the composition of debt as of March 31, 2024 (in thousands):
|
|
|
|
|
Gross proceeds from Loan Facility |
|
$ |
50,000 |
|
Accrued final payment fee |
|
|
2,500 |
|
Unamortized debt discount and issuance costs |
|
|
(9,652 |
) |
Total long-term debt, net |
|
$ |
42,848 |
|
|
| X |
- References
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-Topic 210
-SubTopic 10
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-Paragraph 1
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v3.24.1.1.u2
Organization and Description of Business Operations - Additional Information (Detail) - USD ($)
$ in Thousands |
Jul. 26, 2023 |
Mar. 31, 2024 |
Dec. 31, 2023 |
| Description Of Business [Line Items] |
|
|
|
| Accumulated deficit |
|
$ (250,779)
|
$ (230,448)
|
| Cash and cash equivalents |
|
$ 48,939
|
$ 69,547
|
| Term A Loan [Member] |
|
|
|
| Description Of Business [Line Items] |
|
|
|
| Proceeds from issuance of common stock, net of issuance costs |
$ 44,100
|
|
|
| Maximum borrowing capacity |
125,000
|
|
|
| Line of credit |
$ 50,000
|
|
|
| Loans, maturity date |
Jul. 26, 2028
|
|
|
| Available On Or Prior To June 30, 2024 [Member] |
|
|
|
| Description Of Business [Line Items] |
|
|
|
| Line of Credit Facility, Remaining Borrowing Capacity |
$ 25,000
|
|
|
| Available On Or Prior To December 31, 2024 [Member] |
|
|
|
| Description Of Business [Line Items] |
|
|
|
| Line of Credit Facility, Remaining Borrowing Capacity |
30,000
|
|
|
| Available On Or Prior To March 31, 2025 [Member] |
|
|
|
| Description Of Business [Line Items] |
|
|
|
| Line of Credit Facility, Remaining Borrowing Capacity |
10,000
|
|
|
| Available On Or Prior To June 30, 2025 [Member] |
|
|
|
| Description Of Business [Line Items] |
|
|
|
| Line of Credit Facility, Remaining Borrowing Capacity |
$ 10,000
|
|
|
| X |
- DefinitionAmount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
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-Section S99
-Paragraph 1
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-Subparagraph (a)
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Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
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- DefinitionThe carrying value as of the balance sheet date of the current and noncurrent portions of long-term obligations drawn from a line of credit, which is a bank's commitment to make loans up to a specific amount. Examples of items that might be included in the application of this element may consist of letters of credit, standby letters of credit, and revolving credit arrangements, under which borrowings can be made up to a maximum amount as of any point in time conditional on satisfaction of specified terms before, as of and after the date of drawdowns on the line. Includes short-term obligations that would normally be classified as current liabilities but for which (a) postbalance sheet date issuance of a long term obligation to refinance the short term obligation on a long term basis, or (b) the enterprise has entered into a financing agreement that clearly permits the enterprise to refinance the short-term obligation on a long term basis and the following conditions are met (1) the agreement does not expire within 1 year and is not cancelable by the lender except for violation of an objectively determinable provision, (2) no violation exists at the BS date, and (3) the lender has entered into the financing agreement is expected to be financially capable of honoring the agreement. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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-SubTopic 10
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v3.24.1.1.u2
Significant Accounting Policies - Additional Information (Details) - USD ($)
$ / shares in Units, $ in Thousands |
|
3 Months Ended |
|
Jul. 21, 2023 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
| Significant Accounting Policies [Line Items] |
|
|
|
|
| Banking cash deposits |
|
$ 500
|
|
|
| Accounts receivable |
|
7,002
|
|
$ 4,248
|
| Allowance for doubtful accounts |
|
0
|
|
|
| Finished goods |
|
$ 681
|
|
$ 115
|
| Basic exercise price |
|
$ 0.0001
|
|
|
| Diluted exercise price |
|
$ 0.0001
|
|
|
| Research and development expense |
$ 4,500
|
$ 4,948
|
$ 2,739
|
|
| Cost of product revenue |
|
700
|
|
|
| Advertising expense |
|
1,500
|
|
|
| FDA |
|
|
|
|
| Significant Accounting Policies [Line Items] |
|
|
|
|
| Research and development expense |
100
|
|
|
|
| YCANTH [Member] |
|
|
|
|
| Significant Accounting Policies [Line Items] |
|
|
|
|
| Finished goods |
14,000
|
|
|
|
| Research and development expense |
$ 1,200
|
|
|
|
| Obsolete inventory costs [Member] |
|
|
|
|
| Significant Accounting Policies [Line Items] |
|
|
|
|
| Cost of product revenue |
|
$ 300
|
|
|
| X |
- DefinitionAmount, after allowance for credit loss, of right to consideration from customer for product sold and service rendered in normal course of business, classified as current. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 310
-SubTopic 10
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-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481990/310-10-45-2
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 310
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 9
-Publisher FASB
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-Topic 720
-SubTopic 35
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483406/720-35-50-1
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| X |
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-Topic 944
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-03(a)(5))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479440/944-210-S99-1
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(4))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480566/210-10-S99-1
Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 326
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-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Publisher FASB
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 310
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481962/310-10-50-4
Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 326
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-Paragraph 13
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479319/326-20-50-13
Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 326
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
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-Subparagraph (f)
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-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 323
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481687/323-10-50-3
Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 825
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
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-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482907/825-10-50-28
Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Section S99
-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(4)(i))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480097/470-10-S99-1A
Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 470
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Section S99
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480097/470-10-S99-1A
Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Section S99
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480097/470-10-S99-1A
Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Topic 470
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-Section S99
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-Publisher FASB
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480097/470-10-S99-1B
Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
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-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(B))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480097/470-10-S99-1B
Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
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-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iv))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480097/470-10-S99-1B
Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(5))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480097/470-10-S99-1B
Reference 14: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03.2)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483621/220-10-S99-2
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-Name Accounting Standards Codification
-Topic 942
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-Topic 730
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-Paragraph 1
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Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 912
-SubTopic 730
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-Section 25
-Paragraph 1
-Publisher FASB
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Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 985
-SubTopic 20
-Section 50
-Paragraph 1
-Publisher FASB
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v3.24.1.1.u2
Significant Accounting Policies - Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Common Share (Detail) - shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] |
|
|
| Securities that could potentially dilute basic earnings per share |
7,966,166
|
5,845,082
|
| Shares issuable upon exercise of stock options [Member] |
|
|
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] |
|
|
| Securities that could potentially dilute basic earnings per share |
6,613,615
|
4,722,082
|
| Non-vested shares under restricted stock grants [Member] |
|
|
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] |
|
|
| Securities that could potentially dilute basic earnings per share |
834,000
|
1,123,000
|
| Warrant [Member] |
|
|
| Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] |
|
|
| Securities that could potentially dilute basic earnings per share |
518,551
|
0
|
| X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
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-Paragraph 1
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-Topic 852
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-Section 55
-Paragraph 10
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 210
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-Section 45
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v3.24.1.1.u2
Property and Equipment - Schedule of Property and Equipment, Net (Detail) - USD ($)
$ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
| Property Plant And Equipment [Line Items] |
|
|
| Property and equipment, gross |
$ 2,237
|
$ 2,226
|
| Accumulated depreciation |
(1,300)
|
(1,174)
|
| Total property and equipment, net |
937
|
1,052
|
| Machinery and Equipment [Member] |
|
|
| Property Plant And Equipment [Line Items] |
|
|
| Property and equipment, gross |
1,554
|
1,543
|
| Office Equipment [Member] |
|
|
| Property Plant And Equipment [Line Items] |
|
|
| Property and equipment, gross |
326
|
326
|
| Office Furniture and Fixtures [Member] |
|
|
| Property Plant And Equipment [Line Items] |
|
|
| Property and equipment, gross |
303
|
303
|
| Leasehold Improvements [Member] |
|
|
| Property Plant And Equipment [Line Items] |
|
|
| Property and equipment, gross |
$ 54
|
$ 54
|
| X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
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-Section S99
-Paragraph 1
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-Topic 210
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-Section S99
-Paragraph 1
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-Publisher FASB
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Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 360
-SubTopic 10
-Section 50
-Paragraph 1
-Subparagraph (c)
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-Topic 944
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-Section S99
-Paragraph 1
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v3.24.1.1.u2
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($)
$ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
| Accrued Liabilities, Current [Abstract] |
|
|
| Gross to net reserves |
$ 8,502
|
$ 5,357
|
| Clinical trials and drug development |
3,517
|
2,767
|
| Compensation and related costs |
1,393
|
3,438
|
| Professional fees |
1,124
|
1,423
|
| Commercial-related costs |
878
|
538
|
| Other current liabilities |
321
|
244
|
| Machinery and equipment |
93
|
93
|
| Total accrued expenses and other current liabilities |
$ 15,828
|
$ 13,860
|
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v3.24.1.1.u2
Stockholders' Equity - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Millions |
1 Months Ended |
|
|
Feb. 28, 2023 |
Mar. 31, 2024 |
Dec. 31, 2023 |
| Class of Stock [Line Items] |
|
|
|
| Common stock, shares authorized |
|
200,000,000
|
200,000,000
|
| Common stock, par value |
|
$ 0.0001
|
$ 0.0001
|
| Pre Funded Warrant [Member] |
|
|
|
| Class of Stock [Line Items] |
|
|
|
| Pre-funded warrants to purchase shares of common stock |
|
4,064,814
|
|
| Warrant price (per share) |
$ 6.7499
|
$ 0.0001
|
|
| Underwritten Offering [Member] |
|
|
|
| Class of Stock [Line Items] |
|
|
|
| Number of common shares sold |
750,000
|
|
|
| Shares Issued, Price Per Share |
$ 6.75
|
|
|
| Sale of stock consideration |
$ 30.3
|
|
|
| Underwritten Offering [Member] | Pre Funded Warrant [Member] |
|
|
|
| Class of Stock [Line Items] |
|
|
|
| Pre-funded warrants to purchase shares of common stock |
4,064,814
|
|
|
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v3.24.1.1.u2
Stock-Based Compensation - Schedule of Stock Based Compensation Expense (Detail) - USD ($)
$ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
| Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
| Total stock-based compensation |
$ 2,072
|
$ 1,094
|
| Selling, General and Administrative Expenses [Member] |
|
|
| Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
| Total stock-based compensation |
1,622
|
836
|
| Research and Development [Member] |
|
|
| Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
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| Total stock-based compensation |
$ 450
|
$ 258
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v3.24.1.1.u2
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($)
$ / shares in Units, $ in Thousands |
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Dec. 31, 2023 |
| Share-Based Payment Arrangement, Additional Disclosure [Abstract] |
|
|
| Number of shares, Outstanding Beginning Balance |
5,565,615
|
|
| Number of shares, Granted |
1,079,300
|
|
| Number of shares, Exercised |
(6,500)
|
|
| Number of shares, Forfeited |
(24,800)
|
|
| Number of shares, Expired |
0
|
|
| Number of shares, Outstanding Ending Balance |
6,613,615
|
5,565,615
|
| Number of shares, Options vested and exercisable Ending Balance |
3,438,271
|
|
| Weighted average exercise price, Outstanding Beginning Balance |
$ 8.25
|
|
| Weighted average exercise price, Granted |
4.99
|
|
| Weighted average exercise price, Exercised |
1.24
|
|
| Weighted average exercise price, Forfeited |
5.24
|
|
| Weighted average exercise price, Expired |
0
|
|
| Weighted average exercise price, Outstanding Ending Balance |
7.74
|
$ 8.25
|
| Weighted average exercise price, Options vested and exercisable Ending Balance |
$ 9.01
|
|
| Weighted average remaining contractual life (in years), Outstanding |
7 years 6 months
|
7 years 2 months 12 days
|
| Weighted average remaining contractual life (in years), Options vested and exercisable |
5 years 10 months 24 days
|
|
| Aggregate intrinsic value, Outstanding |
$ 2,688,929
|
$ 4,143,150
|
| Aggregate intrinsic value, Exercised |
4,755
|
|
| Aggregate intrinsic value, Options vested and exercisable Ending Balance |
$ 620,420
|
|
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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| X |
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| X |
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-Topic 505
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-2
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
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-Paragraph 1
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
-Section S99
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-Subparagraph (SX 210.3-04)
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Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
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-Section S99
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v3.24.1.1.u2
Stock-Based Compensation - Additional Information (Detail) - USD ($)
$ in Thousands |
|
|
|
|
1 Months Ended |
3 Months Ended |
Aug. 24, 2024 |
Jul. 21, 2024 |
Aug. 24, 2023 |
Jul. 21, 2023 |
Aug. 31, 2020 |
Nov. 30, 2019 |
Mar. 31, 2024 |
Mar. 31, 2023 |
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
| Total unrecognized compensation |
|
|
|
|
|
|
$ 14,700
|
|
| Weighted-average stock option recognize period |
|
|
|
|
|
|
2 years 10 months 2 days
|
|
| Stock-based compensation |
|
|
|
|
|
|
$ 2,072
|
$ 1,094
|
| Nonvested, Number of Shares, Forfeited |
|
|
|
|
(125,000)
|
|
|
|
| Employee Stock Options [Member] |
|
|
|
|
|
|
|
|
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
| Stock-based compensation |
|
|
|
|
|
|
$ 1,500
|
$ 1,100
|
| Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
| Percentage of stock subject to vesting (as a percent) |
|
|
|
|
|
|
25.00%
|
|
| Weighted-average stock option recognize period |
|
|
|
|
|
|
1 year 7 months 6 days
|
|
| Number of Shares, Granted |
|
|
|
|
|
|
272,500
|
|
| Nonvested, Number of Shares, Forfeited |
|
|
|
|
|
|
0
|
|
| Compensation expense |
|
|
|
|
|
|
$ 600
|
|
| Remaining unrecognized compensation related to nonvested restricted stock units |
|
|
|
|
|
|
$ 2,200
|
|
| Restricted Stock Units (RSUs) [Member] | Executive Officers [Member] |
|
|
|
|
|
|
|
|
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
| Number of Shares, Granted |
|
|
|
|
250,000
|
300,000
|
272,500
|
698,000
|
| Restricted Stock Units (RSUs) [Member] | New Drug Application [Member] |
|
|
|
|
|
|
|
|
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
| Percentage of stock subject to vesting (as a percent) |
|
|
50.00%
|
50.00%
|
|
|
|
|
| Restricted Stock Units (RSUs) [Member] | Forecast [Member] | YCANTH [Member] |
|
|
|
|
|
|
|
|
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
| Percentage of stock subject to vesting (as a percent) |
50.00%
|
|
|
|
|
|
|
|
| Restricted Stock Units (RSUs) [Member] | Forecast [Member] | One Year Anniversary [Member] |
|
|
|
|
|
|
|
|
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
| Percentage of stock subject to vesting (as a percent) |
|
50.00%
|
|
|
|
|
|
|
| X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 14.F)
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Topic 718
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-Section 50
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-Name Accounting Standards Codification
-Section 35
-Paragraph 1D
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.1.1.u2
Stock-Based Compensation - Summary of Non-vested RSUs Activities (Detail) - $ / shares
|
1 Months Ended |
3 Months Ended |
Aug. 31, 2020 |
Mar. 31, 2024 |
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
| Nonvested, Number of Shares, Forfeited |
(125,000)
|
|
| Restricted Stock Units (RSUs) [Member] |
|
|
| Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
| Nonvested, Number of Shares, Beginning Balance |
|
561,500
|
| Nonvested, Number of Shares, Granted |
|
272,500
|
| Nonvested, Number of Shares, Forfeited |
|
0
|
| Non-vested, Number of shares, Vested |
|
0
|
| Nonvested, Number of Shares, Ending Balance |
|
834,000
|
| Nonvested, Weighted Average Grant Date Fair Value, Beginning Balance |
|
$ 9.13
|
| Nonvested, Weighted Average Grant Date Fair Value, Granted |
|
4.8
|
| Nonvested, Weighted Average Grant Date Fair Value, Forfeited |
|
0
|
| Non-vested, Weighted average grant date fair value, Vested |
|
0
|
| Nonvested, Weighted Average Grant Date Fair Value, Ending Balance |
|
$ 7.72
|
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v3.24.1.1.u2
Leases - Additional Information (Detail)
|
3 Months Ended |
|
|
Mar. 31, 2024
USD ($)
ft²
|
Dec. 31, 2023
USD ($)
|
| Lessee Lease Description [Line Items] |
|
|
| Lease expiration date |
Sep. 01, 2027
|
|
| Finance lease right-of-use asset |
$ 2,460,000
|
$ 1,405,000
|
| Operating lease, remaining lease term |
3 years 4 months 2 days
|
|
| Operating lease, discount rate |
6.25%
|
|
| Pennsylvania [Member] |
|
|
| Lessee Lease Description [Line Items] |
|
|
| Area of office space for lease | ft² |
11,201
|
|
| NEW JERSEY |
|
|
| Lessee Lease Description [Line Items] |
|
|
| Lease agreement commencement date |
May 01, 2022
|
|
| Lease expiration date |
Apr. 30, 2025
|
|
| Operating lease, base rent |
$ 104,000
|
|
| Automobile Fleet Lease Program [Member] |
|
|
| Lessee Lease Description [Line Items] |
|
|
| Term of lease |
52 months
|
|
| Finance lease right-of-use asset |
$ 1,200,000
|
|
| Landlord's Operating Expense [Member] |
|
|
| Lessee Lease Description [Line Items] |
|
|
| Operating lease, base rent |
$ 2,400,000
|
|
| X |
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-Topic 842
-SubTopic 20
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
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| X |
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-Topic 842
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-Section 50
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-Topic 842
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-Section 55
-Paragraph 53
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479589/842-20-55-53
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
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-Topic 842
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-Section 55
-Paragraph 53
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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| X |
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| X |
- Details
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v3.24.1.1.u2
| X |
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-Topic 842
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-URI https://asc.fasb.org//1943274/2147479589/842-20-55-53
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-Topic 842
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-URI https://asc.fasb.org//1943274/2147479041/842-20-45-4
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-Topic 842
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-Section 55
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479589/842-20-55-53
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
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|
v3.24.1.1.u2
Leases - Schedule of Maturities of Operating and Finance Leases (Detail)
$ in Thousands |
Mar. 31, 2024
USD ($)
|
| Leases [Abstract] |
|
| Operating Lease, Remainder of Fiscal Year |
$ 293
|
| Operating Lease, Year One |
372
|
| Operating Lease, Year Two |
366
|
| Operating Lease, Year Three |
247
|
| Operating Lease, After Year Three |
0
|
| Operating Lease, Total lease payments |
1,278
|
| Less Operating Lease, imputed interest |
(122)
|
| Operating Lease, Lease liability |
1,156
|
| Finance Lease, Remainder of Fiscal Year |
648
|
| Finance Lease, Year One |
744
|
| Finance Lease, Year Two |
631
|
| Finance Lease, Year Three |
592
|
| Finance Lease, After Year Three |
181
|
| Finance Lease, Total lease payments |
2,796
|
| Less Finance Lease, imputed interest |
(356)
|
| Finance Lease, Lease liability |
$ 2,440
|
| X |
- DefinitionPresent value of lessee's discounted obligation for lease payments from finance lease. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147478964/842-20-50-6
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
-SubTopic 20
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-Section 45
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-Topic 842
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-Section 50
-Paragraph 6
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-Topic 842
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-Topic 842
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-Topic 842
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-Topic 842
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-Topic 842
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-Topic 842
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v3.24.1.1.u2
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-Topic 842
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-Section 55
-Paragraph 53
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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-Paragraph 53
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.1.1.u2
Debt Covenants - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Thousands |
|
|
3 Months Ended |
|
Jan. 31, 2024 |
Jul. 26, 2023 |
Mar. 31, 2024 |
Dec. 31, 2023 |
| Debt Instrument [Line Items] |
|
|
|
|
| Fair value of the warrants |
|
$ 2,400
|
|
|
| Upfront amendment fee |
$ 250,000
|
|
|
|
| Common Stock [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Warrant issued to purchase company's common stock |
|
518,551
|
|
|
| Warrant price (per share) |
|
$ 6.0264
|
|
|
| Warrant term |
|
10 years
|
|
|
| Warrant [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Fair value of the warrants |
|
$ 2,000
|
|
|
| Expected term (years) |
|
10 years
|
|
|
| Expected volatility |
|
94.86%
|
|
|
| Risk free rate |
|
3.86%
|
|
|
| Expected dividend yield |
|
0.00%
|
|
|
| Loan Facility [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Maximum borrowing capacity |
|
$ 125,000
|
|
|
| Initial Commitment Amount |
|
50,000
|
|
|
| Net proceeds after payment of certain fees and transaction related expenses |
|
$ 44,100
|
|
|
| Loans, maturity date |
|
Jul. 26, 2028
|
|
|
| SOFR [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Interest rate (as a percent) |
|
4.00%
|
|
|
| Loans, interest rate |
|
8.00%
|
|
|
| Interest rate (as a percent) |
|
4.00%
|
|
|
| Available On Or Prior To June 30, 2024 [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
$ 25,000
|
|
|
| Available On Or Prior To June 30, 2024 [Member] | Loan Facility [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
25,000
|
|
|
| Available On Or Prior To December 31, 2024 [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
30,000
|
|
|
| Available On Or Prior To December 31, 2024 [Member] | Loan Facility [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
30,000
|
|
|
| Available On Or Prior To March 31, 2025 [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
10,000
|
|
|
| Available On Or Prior To March 31, 2025 [Member] | Loan Facility [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
10,000
|
|
|
| Available On Or Prior To June 30, 2025 [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
10,000
|
|
|
| Available On Or Prior To June 30, 2025 [Member] | Loan Facility [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Remaining Commitment Amount |
|
10,000
|
|
|
| Term A Loan [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Maximum borrowing capacity |
|
$ 125,000
|
|
|
| Loans, maturity date |
|
Jul. 26, 2028
|
|
|
| Line of credit |
|
$ 50,000
|
|
|
| Senior Loan Agreement [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Debt discount and issuance costs |
|
10,400
|
|
$ 5,900
|
| Final payment fee |
|
$ 2,000
|
|
|
| Interest expense |
|
|
$ 2,300
|
|
| Interest on term loan |
|
|
1,800
|
|
| Non-cash interest expense |
|
|
$ 500
|
|
| Senior Loan Agreement [Member] | Contra-Liability [Member] |
|
|
|
|
| Debt Instrument [Line Items] |
|
|
|
|
| Final payment fee |
|
|
|
$ 2,500
|
| X |
- DefinitionAmount of amortization expense attributable to debt issuance costs. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1F
-Subparagraph (b)(2)
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1F
Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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-Section 45
-Paragraph 28
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 45
-Paragraph 3
-Publisher FASB
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
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-Section S99
-Paragraph 2
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-Name Accounting Standards Codification
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Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
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-Publisher FASB
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B
Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 210
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-Topic 835
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Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 5: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
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Reference 6: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
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Reference 8: http://www.xbrl.org/2003/role/exampleRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/exampleRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1F
Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Topic 470
-SubTopic 20
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-Section 50
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B
Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 470
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Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
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-Topic 470
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Reference 2: http://www.xbrl.org/2003/role/exampleRef
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v3.24.1.1.u2
License and Collaboration Agreements - Additional Information (Detail) - USD ($)
$ in Thousands |
|
1 Months Ended |
3 Months Ended |
12 Months Ended |
Mar. 17, 2021 |
Aug. 31, 2020 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2020 |
| Ltyix [Member] |
|
|
|
|
|
| License And Collaboration Agreements [Line Items] |
|
|
|
|
|
| Payments upon achievements of milestone |
|
$ 111,000
|
|
|
|
| One time up front license fee |
|
|
|
|
$ 3,600
|
| Percentage of royalty income shared |
|
50.00%
|
|
|
|
| Torii Agreement [Member] | Torii [Member] |
|
|
|
|
|
| License And Collaboration Agreements [Line Items] |
|
|
|
|
|
| Received payment |
|
|
$ 20,000
|
|
|
| Payments upon achievements of milestone |
|
|
50,000
|
|
|
| Billed collaboration revenue |
|
|
600
|
$ 600
|
|
| Unbilled collaboration revenue |
|
|
$ 37,000
|
$ 37,000
|
|
| Torii Agreement [Member] | Torii [Member] | Minimum [Member] |
|
|
|
|
|
| License And Collaboration Agreements [Line Items] |
|
|
|
|
|
| Mid Percentage of transfer price payments for supply of product net sales |
30.00%
|
|
|
|
|
| Torii Agreement [Member] | Torii [Member] | Maximum [Member] |
|
|
|
|
|
| License And Collaboration Agreements [Line Items] |
|
|
|
|
|
| Mid Percentage of transfer price payments for supply of product net sales |
40.00%
|
|
|
|
|
| X |
- DefinitionAmount of obligation to transfer good or service to customer for which consideration has been received or is receivable. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479837/606-10-45-1
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479806/606-10-50-8
Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479837/606-10-45-2
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| X |
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| X |
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| X |
- Details
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| Namespace Prefix: |
|
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na |
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| Period Type: |
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|
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