CorMedix Inc. Reports Second Quarter and Six Month 2023 Financial Results and Provides Business Update
August 08 2023 - 7:30AM
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused
on developing and commercializing therapeutic products for the
prevention and treatment of life-threatening diseases and
conditions, today announced financial results for the second
quarter and six months ended June 30, 2023 and provided an update
on recent business events.
Recent Corporate Highlights:
- CorMedix’s DefenCath NDA was
accepted for filing by the U.S. Food and Drug Administration (FDA)
and was assigned a Prescription Drug User Fee Act (PDUFA) target
action date of November 15, 2023.
- CorMedix announced a first-of-kind
strategic initiative with Boston Medical Center to enhance patient
safety and reduce health disparities in structurally marginalized
populations at risk for catheter-related bloodstream infections
(CRBSIs) while undergoing dialysis. In the initial stages of the
strategic alliance, the parties will assess the incidence and scope
of CRBSIs, CRBSI-related readmissions, and other information.
- Center for Medicare and Medicaid
Services has finalized its Inpatient Prospective Payment System
2024 rule that included a New Technology Add-On Payment (NTAP) of
up to $17,111 per hospital stay for reimbursement of DefenCath if
approved by FDA.
- CorMedix completed an equity
offering in July 2023 which generated net proceeds of approximately
$43.2 million. This includes a full exercise of the over-allotment
option which yielded gross proceeds of approximately $6.0
million.
- Cash and short-term investments,
excluding restricted cash, at June 30, 2023 amounted to $52.4
million, and including net proceeds from the equity offering that
closed in July 2023, pro forma cash and short-term investments of
approximately $95 million.
Joe Todisco, CorMedix CEO, commented, “we are pleased with the
progress that we have made toward our goal of achieving a potential
FDA approval of DefenCath later this year. With the recent
financing completed, we believe CorMedix is in a strong financial
position and we are heavily focused on operational execution and
commercial preparedness ahead of our target action date in
November. We look forward to providing updates as we aim to deliver
on our commitment to reducing the risk of infections in patients
receiving hemodialysis via central venous catheters.”
Second Quarter and Six Month 2023
Financial Highlights
For the second quarter of 2023, CorMedix
recorded a net loss of $11.3 million, or $0.25 per share, compared
with a net loss of $7.6 million, or $0.19 per share, in the second
quarter of 2022, an increase of $3.7 million or 48%. The higher net
loss recognized in 2023 compared with 2022 included an increase in
both SG&A expenses and R&D expenses versus the second
quarter of 2022.
Operating expenses in the second quarter of 2023
increased approximately 43% to $11.8 million, compared with $8.3
million in the second quarter of 2022. R&D expense increased
approximately 49% to $4.8 million compared with $3.2 million in the
second quarter of 2022, mainly due to an increase in costs related
to the manufacturing of DefenCath prior to its potential marketing
approval. SG&A expense increased approximately 39% to $7.0
million compared with $5.1 million in the second quarter of 2022.
This increase was driven primarily by an increase in costs related
to market research studies and pre-launch activities in preparation
for the potential marketing approval of DefenCath.
For the six months ended June 30, 2023, CorMedix
recorded a net loss of $21.8 million, or $0.49 per share, compared
with a net loss of $14.6 million, or $0.38 per share, in the first
half of 2022. Operating expenses in the first half of 2023 were
$22.8 million, compared to $15.3 million in the first half of 2022,
an increase of approximately 49%. This increase was primarily
due to costs related to market research studies, pre-launch
activities in preparation for the potential marketing approval of
DefenCath and costs for the manufacturing of DefenCath prior to its
potential marketing approval.
The Company reported cash and short-term
investments of $52.4 million at June 30, 2023, excluding restricted
cash. In addition, CorMedix received approximately $43.2 million in
net proceeds from its equity financing that closed in July of 2023.
The Company believes that it has sufficient resources to fund
operations for at least twelve months from the filing of its
Quarterly Report on Form 10-Q for the quarter ended June 30,
2023.
Conference Call Information
The management team of CorMedix will host a
conference call and webcast today, August 8, 2023, at 8:30 AM
Eastern Time, to discuss recent corporate developments and
financial results. Call details and dial-in information are as
follows:
Tuesday, August
8th @ 8:30am ET
Domestic:International:Conference ID:Webcast:
|
1-877-423-98131-201-689-857313740152 Webcast Link |
About CorMedix
CorMedix Inc. is a biopharmaceutical company
focused on developing and commercializing therapeutic products for
the prevention and treatment of life-threatening conditions and
diseases. The Company is focused on developing its lead product
DefenCath™, a novel, non-antibiotic antimicrobial solution designed
to prevent costly and life-threatening bloodstream infections
associated with the use of central venous catheters in patients
undergoing chronic hemodialysis. DefenCath has been designated by
FDA as Fast Track and as a Qualified Infectious Disease Product
(QIDP), and the original New Drug Application (NDA) received
priority review in recognition of its potential to address an unmet
medical need. QIDP provides for an additional five years of
marketing exclusivity, which will be added to the five years
granted to a New Chemical Entity upon approval of the NDA. CorMedix
also committed to conducting a clinical study in pediatric patients
using a central venous catheter for hemodialysis when the NDA is
approved, which will add an additional six months of marketing
exclusivity when the study is completed. CorMedix received a second
Complete Response Letter from the FDA last August related to
deficiencies at both its primary contract manufacturer and its
supplier of heparin API. After receiving guidance from FDA at a
Type A meeting in April of 2023, the NDA for DefenCath was
resubmitted. In June of 2023, the resubmitted NDA was accepted for
filing by the FDA. CorMedix also intends to develop DefenCath as a
catheter lock solution for use in other patient populations, and
the Company is working with top-tier researchers to develop
taurolidine-based therapies for rare pediatric cancers. For more
information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, that are subject to risks and uncertainties. All
statements, other than statements of historical facts, regarding
management’s expectations, beliefs, goals, plans or CorMedix’s
prospects, including, but not limited to, CorMedix’s future
financial position, financing plans, future revenues, projected
costs and the sufficiency of our cash and short-term investments to
fund our operations should be considered forward-looking
statements. Readers are cautioned that actual results may differ
materially from projections or estimates due to a variety of
important factors, including: the risks and uncertainties related
to market conditions; the ability to secure final FDA approval
prior to July 1, 2024; CorMedix’s ability to manage its cash
resources and the impact on current, planned or future research;
the ability to achieve commercial preparedness ahead of the target
action date in November 2023; and that preclinical results are not
indicative of success in clinical trials and might not be
replicated in any subsequent studies or trials. These and other
risks are described in greater detail in CorMedix’s filings with
the SEC, copies of which are available free of charge at the SEC’s
website at www.sec.gov or upon request from CorMedix. CorMedix may
not actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. CorMedix assumes no obligation and
does not intend to update these forward-looking statements, except
as required by law.
Investor Contact:Dan FerryManaging
DirectorLifeSci Advisors(617) 430-7576
CORMEDIX INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)
|
|
For the Three Months Ended June 30, |
|
For the Six Months Ended June
30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
Net sales |
$ |
- |
|
$ |
21,253 |
|
$ |
- |
|
$ |
28,889 |
|
Cost of sales |
|
- |
|
|
(332 |
) |
|
- |
|
|
(1,859 |
) |
Gross profit (loss) |
|
- |
|
|
20,921 |
|
|
- |
|
|
27,030 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
(4,794,758 |
) |
|
(3,209,471 |
) |
|
(8,202,260 |
) |
|
(5,497,058 |
) |
Selling, general and administrative |
|
(7,009,824 |
) |
|
(5,051,895 |
) |
|
(14,619,501 |
) |
|
(9,802,778 |
) |
Total Operating Expenses |
|
(11,804,582 |
) |
|
(8,261,366 |
) |
|
(22,821,761 |
) |
|
(15,299,836 |
) |
Loss From
Operations |
|
(11,804,582 |
) |
|
(8,240,445 |
) |
|
(22,821,761 |
) |
|
(15,272,806 |
) |
Other Income
(Expense): |
|
|
|
|
|
|
|
|
Total Other Income |
|
530,964 |
|
|
49,989 |
|
|
980,917 |
|
|
48,156 |
|
Loss before income taxes |
|
(11,273,618 |
) |
|
(8,190,456 |
) |
|
(21,840,844 |
) |
|
(15,224,650 |
) |
Tax benefit |
|
- |
|
|
585,617 |
|
|
- |
|
|
585,617 |
|
Net Loss |
|
(11,273,618 |
) |
|
(7,604,839 |
) |
|
(21,840,844 |
) |
|
(14,639,033 |
) |
Other Comprehensive
Income (Loss): |
|
|
|
|
|
|
|
|
Total Other Comprehensive Income (Loss) |
|
(10,535 |
) |
|
(10,402 |
) |
|
7,954 |
|
|
(47,611 |
) |
Comprehensive
Loss |
$ |
(11,284,153 |
) |
$ |
(7,615,241 |
) |
$ |
(21,832,890 |
) |
$ |
(14,686,644 |
) |
Net Loss Per Common Share
– Basic and Diluted |
$ |
(0.25 |
) |
$ |
(0.19 |
) |
$ |
(0.49 |
) |
$ |
(0.38 |
) |
Weighted Average Common
Shares Outstanding – Basic and Diluted |
|
45,365,635 |
|
|
39,761,754 |
|
|
44,731,838 |
|
|
39,008,590 |
|
CORMEDIX INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEET
DATA(Unaudited)
|
|
June 30, |
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Cash, cash equivalents and
restricted cash |
$ |
19,888,972 |
|
$ |
43,374,745 |
|
|
Short-term investments |
$ |
32,701,210 |
|
$ |
15,644,062 |
|
|
Total
Assets |
$ |
57,032,780 |
|
$ |
62,038,259 |
|
|
|
|
|
|
|
|
Total
Liabilities |
$ |
7,981,671 |
|
$ |
6,978,523 |
|
|
Accumulated deficit |
$ |
(297,201,630 |
) |
$ |
(275,360,786 |
) |
|
Total Stockholders’
Equity |
$ |
49,051,109 |
|
$ |
55,059,736 |
|
|
CORMEDIX INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS(Unaudited)
|
Six Month Periods Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Cash Flows from
Operating Activities: |
|
|
|
Net loss |
$ |
(21,840,844 |
) |
|
$ |
(14,639,033 |
) |
Net cash used in operating
activities |
|
(18,966,316 |
) |
|
|
(12,206,457 |
) |
Cash Flows from
Investing Activities: |
|
|
|
Net cash used in investing
activities |
|
(17,072,611 |
) |
|
|
(3,593,220 |
) |
|
|
|
|
Cash Flows from
Financing Activities: |
|
|
|
Net cash provided by financing
activities |
|
12,550,623 |
|
|
|
11,415,372 |
|
Net Decrease in Cash
and Cash Equivalents |
|
(23,485,773 |
) |
|
|
(4,397,860 |
) |
Cash and Cash
Equivalents and Restricted Cash - Beginning of Period |
|
43,374,745 |
|
|
|
53,551,277 |
|
Cash and Cash
Equivalents and Restricted Cash - End of Period |
$ |
19,888,972 |
|
|
$ |
49,153,417 |
|
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