Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global
pharmaceutical company whose mission is to be invaluable to
patients, physicians and partners concerned with retinal health and
maintaining better vision longer, today announced financial results
for the first quarter of 2024. Alimera will host a conference call
today at 9:00 a.m. EDT to discuss these results.
“Our results in this quarter were consistent with our
expectations as we continue to integrate YUTIQ into our U.S.
business and support the acceleration of growth in international
markets, providing further confidence in our ability to achieve
$105 million in revenue and at least 20% EBITDA margins this year,"
said Rick Eiswirth, Alimera’s President and Chief Executive
Officer. "This quarter provided some key clinical milestones with
the completion of enrollment in the Synchronicity Study and the
randomization of the first patient in the DRCR Retina Network study
where ILUVIEN is being studied as a treatment for radiation
retinopathy. We also continue to advance plans for potential
indication expansion opportunities and were pleased that the
National Institute for Health and Care Excellence (NICE)
recommended that chronic DME patients with a natural lens gain
access to ILUVIEN in the United Kingdom."
Key First Quarter Financial Highlights:
- Net revenue of $23.0 million up 70% vs
Q1 2023
- Net loss of $6.3 million compared to a
net loss of $5.0 million in Q1 2023
- Positive adjusted EBITDA of $1.8
million vs. adjusted EBITDA loss of $(2.4) million in Q1 2023
- U.S. net revenue of $14.6 million up
92% vs. Q1 2023
- International net revenue of $8.5
million up 42% vs. Q1 2023
- Global end user demand up 23% over Q1
2023 at 4,028 units for the quarter
- Increased term loan agreement with its
current lenders, investment affiliates managed by SLR Capital
Partners, LLC, by $5.0 million
First Quarter Corporate Highlights:
- First patient randomized in Protocol
AL, a DRCR Retina Network study with ILUVIEN or faricimab
injections versus observation in patients at risk of radiation
retinopathy. Over 40% of radiation retinopathy patients have been
shown to experience the devastating vision loss associated with
radiotherapy within three years of treatment, and currently there
are no FDA approved pharmacotherapies for radiation
retinopathy.
- Received positive final draft guidance
from the National Institute for Health and Care Excellence (NICE)
recommending that chronic diabetic macular edema patients with a
natural lens (phakic patients) be given access to ILUVIEN. Phakic
patients represent up to 75% of the broader DME population in the
United Kingdom.
- Completed enrollment of 110 patient
eyes across 25 sites in the Synchronicity Study, a prospective,
open-label clinical study evaluating the safety and efficacy of
YUTIQ (fluocinolone acetonide intravitreal implant 0.18mg) in the
treatment of chronic non-infectious uveitis and related intraocular
inflammation. The study included a broader retinal physician base
to better understand the way they treat chronic non-infectious
uveitis affecting the posterior segment.
First Quarter 2024 Financial Results
Net Revenue Consolidated global net revenue was up 70% to
approximately $23.0 million for Q1 2024, compared to $13.5 million
for Q1 2023, driven by the addition of YUTIQ in the U.S. segment,
as well as increased unit sales volumes in the International
segment of the business.
U.S. net revenue increased 92% to approximately $14.6 million
for Q1 2024 compared to U.S. net revenue of $7.6 million for Q1
2023. The increase was primarily driven by net revenue from YUTIQ,
which Alimera acquired in May 2023.
International net revenue increased 42% to approximately $8.5
million in Q1 2024, compared to approximately $6.0 million in
Q1 2023. The increase in international net revenue in Q1 2024
was driven both by growth in end user demand and restocking of our
international distributors.
Operating Expenses
Total operating expenses were approximately $22.0
million for Q1 2024, compared to approximately
$14.8 million for Q1 2023. The increase was primarily
attributable to $3.3 million of additional sales and marketing
expenses driven by expansion of our commercial infrastructure to
support selling two products in the U.S., $2.4 million in
additional amortization expense attributable to the YUTIQ
acquisition in May 2023, and a $1.3 million increase in general
administrative expenses relating to $0.7 million of personnel costs
and $0.5 million of stock-based compensation expense.
Cash and Cash Equivalents
As of March 31, 2024, Alimera had cash and cash equivalents of
approximately $14.3 million, compared to $12.1 million at December
31, 2023.
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose
mission is to be invaluable to patients, physicians and partners
concerned with retinal health and maintaining better vision longer.
For more information, please visit www.alimerasciences.com
Non-GAAP Financial Measures
This press release presents Adjusted EBITDA, as defined below,
which is a non-GAAP financial measure. Alimera uses this measure to
supplement the financial information presented on a GAAP basis.
Alimera believes that excluding certain items from its GAAP
financial results allows management to better understand its
ongoing operations and analyze its financial performance from
period to period and provides meaningful supplemental information
to its investors.
Alimera defines “Adjusted EBITDA” as earnings before interest,
taxes, depreciation, amortization, stock-based compensation
expenses, net unrealized gains and losses from foreign currency
exchange transactions, gains on extinguishment of debt, preferred
stock dividends, severance expenses and change in fair value of
warrant asset.
Alimera believes that Adjusted EBITDA, when taken together with
its corresponding GAAP financial measure, provides meaningful
supplemental information to its investors regarding its performance
by excluding certain items that may not be indicative of its
business, results of operations, or outlook. Accordingly, Adjusted
EBITDA for the three months ended March 31, 2024, and 2023,
together with a reconciliation to GAAP net income or loss, its most
directly comparable GAAP financial measure, has been presented in
the table entitled “Reconciliation of GAAP Loss to Non-GAAP
Adjusted EBITDA.”
This non-GAAP financial measure may not be comparable to
similarly titled measures reported by other companies, including
companies in Alimera’s industry, because not all companies
calculate Adjusted EBITDA in an identical manner or may use other
financial measures to evaluate their performance. Therefore, this
non-GAAP financial measure may be limited in usefulness for
comparison between companies.
The presentation of this non-GAAP financial measure is not
intended to be considered in isolation from or as a substitute for
other financial performance measures prepared in accordance with
GAAP and should be read only in conjunction with financial
information presented on a GAAP basis. The principal limitation of
this non-GAAP financial measure is that it excludes significant
elements required by GAAP to be recorded in Alimera’s financial
statements. In addition, this non-GAAP financial measure is subject
to inherent limitations because it reflects the exercise of
judgments by management. Investors are encouraged not to rely on
any single financial measure to evaluate Alimera’s business.
Forward Looking Statements
This press release, includes “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, Alimera’s expectations with respect
to growth opportunities, the commencement, enrollment, timing and
outcome of its and others' clinical studies, the effect of an
expanded label, demand for its product, its business strategy,
future operations, future financial position including the timeline
for achieving positive Adjusted EBITDA, future revenues, projected
costs, prospects, plans and objectives. Words such as “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“contemplates,” “predict,” “project,” “target,” “likely,”
“potential,” “continue,” “ongoing,” “will,” “would,” “should,”
“could,” or the negative of these terms and similar expressions or
words, identify forward-looking statements. Forward-looking
statements are based on current expectations and involve inherent
risks and uncertainties (some of which are beyond Alimera’s
control), including factors that could delay, divert or change any
of them, and could cause actual results to differ materially from
those projected in these forward-looking statements. These risks
and uncertainties include, but are not limited to, those factors
discussed in the “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” sections
of Alimera’s most recently filed Annual Report on Form 10-K, most
recently filed Quarterly Report on Form 10-Q, and any of Alimera’s
subsequent filings with the Securities and Exchange Commission
(SEC) and available on the SEC’s website at www.sec.gov.
All forward-looking statements contained in this press release
are expressly qualified by the cautionary statements contained or
referred to herein. Alimera cautions investors not to rely on the
forward-looking statements Alimera makes or that are made on its
behalf as predictions of future events. These forward-looking
statements speak only as of the date of this press release. Alimera
undertakes no obligation to publicly update or revise any of the
forward-looking statements made in this press release, whether as a
result of new information, future events or otherwise, except as
may be required under applicable securities laws.
For
investor inquiries: |
For
media inquiries: |
Scott Gordon |
Jules Abraham |
for Alimera Sciences |
for Alimera Sciences |
scottg@coreir.com |
julesa@coreir.com |
|
|
ALIMERA SCIENCES, INC. |
CONSOLIDATED BALANCE SHEETS |
(UNAUDITED) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2024 |
|
2023 |
|
(In thousands, except share and per share
data) |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
14,314 |
|
|
$ |
12,058 |
|
Restricted cash |
|
32 |
|
|
|
32 |
|
Accounts receivable, net |
|
34,224 |
|
|
|
34,545 |
|
Prepaid expenses and other current assets |
|
3,693 |
|
|
|
3,909 |
|
Inventory |
|
2,206 |
|
|
|
1,879 |
|
Total current assets |
|
54,469 |
|
|
|
52,423 |
|
Property and equipment,
net |
|
2,377 |
|
|
|
2,466 |
|
Right-of-use assets, net |
|
1,060 |
|
|
|
1,124 |
|
Intangible assets, net |
|
94,471 |
|
|
|
97,355 |
|
Deferred tax asset |
|
102 |
|
|
|
104 |
|
Warrant asset |
|
6 |
|
|
|
52 |
|
Total assets |
$ |
152,485 |
|
|
$ |
153,524 |
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
10,307 |
|
|
$ |
8,252 |
|
Accrued expenses |
|
4,780 |
|
|
|
6,192 |
|
Accrued licensor payment |
|
5,482 |
|
|
|
7,275 |
|
Finance lease obligations |
|
220 |
|
|
|
194 |
|
Total current liabilities |
|
20,789 |
|
|
|
21,913 |
|
Long-term liabilities: |
|
|
|
|
|
Notes payable, net of
discount |
|
69,436 |
|
|
|
64,489 |
|
Accrued licensor payments |
|
15,616 |
|
|
|
15,136 |
|
Other non-current
liabilities |
|
5,991 |
|
|
|
5,816 |
|
Total liabilities |
|
111,832 |
|
|
|
107,354 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $.01 par
value — 10,000,000 shares authorized at March 31, 2024 and December
31, 2023, none issued |
|
— |
|
|
|
— |
|
Common stock, $.01 par value —
150,000,000 shares authorized, 52,374,687 shares issued and
outstanding at March 31, 2024 and 52,354,450 shares issued and
outstanding at December 31, 2023 |
|
524 |
|
|
|
524 |
|
Common stock warrants |
|
4,396 |
|
|
|
4,396 |
|
Additional paid-in
capital |
|
463,328 |
|
|
|
462,446 |
|
Accumulated deficit |
|
(424,741 |
) |
|
|
(418,490 |
) |
Accumulated other
comprehensive loss |
|
(2,854 |
) |
|
|
(2,706 |
) |
Total stockholders’ equity |
|
40,653 |
|
|
|
46,170 |
|
Total liabilities and stockholders’ equity |
$ |
152,485 |
|
|
$ |
153,524 |
|
|
ALIMERA SCIENCES, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(UNAUDITED) |
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2024 |
|
2023 |
|
(In thousands, except share and per share
data) |
|
|
|
|
|
|
Net revenue |
$ |
23,011 |
|
|
$ |
13,546 |
|
Cost of goods sold, excluding
depreciation and amortization |
|
(3,353 |
) |
|
|
(2,028 |
) |
Gross profit |
|
19,658 |
|
|
|
11,518 |
|
Operating expenses: |
|
|
|
|
|
Research, development and medical affairs expenses |
|
4,361 |
|
|
|
4,164 |
|
General and administrative expenses |
|
5,432 |
|
|
|
4,171 |
|
Sales and marketing expenses |
|
9,082 |
|
|
|
5,804 |
|
Depreciation and amortization |
|
3,085 |
|
|
|
681 |
|
Total operating expenses |
|
21,960 |
|
|
|
14,820 |
|
Loss from operations |
|
(2,302 |
) |
|
|
(3,302 |
) |
Interest expense and other, net |
|
(3,739 |
) |
|
|
(1,667 |
) |
Unrealized foreign currency loss, net |
|
(196 |
) |
|
|
(13 |
) |
Change in fair value of warrant asset |
|
(46 |
) |
|
|
14 |
|
Net loss before income
taxes |
|
(6,283 |
) |
|
|
(4,968 |
) |
Income tax benefit |
|
32 |
|
|
|
— |
|
Net loss |
|
(6,251 |
) |
|
|
(4,968 |
) |
Preferred stock dividends |
|
— |
|
|
|
(14 |
) |
Net loss applicable to common
stockholders |
$ |
(6,251 |
) |
|
$ |
(4,982 |
) |
Net loss per share — basic and
diluted |
$ |
(0.12 |
) |
|
$ |
(0.71 |
) |
Weighted average shares
outstanding — basic and diluted |
|
54,356,828 |
|
|
|
7,032,231 |
|
|
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP
ADJUSTED EBITDA |
(UNAUDITED) |
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2024 |
|
2023 |
|
(In thousands) |
U.S. GAAP net loss |
$ |
(6,251 |
) |
|
$ |
(4,968 |
) |
Adjustments to U.S. GAAP net
loss: |
|
|
|
|
|
Interest expense and other, net |
|
3,739 |
|
|
|
1,667 |
|
Income tax benefit |
|
(32 |
) |
|
|
— |
|
Depreciation and amortization |
|
3,085 |
|
|
|
681 |
|
Stock-based compensation |
|
845 |
|
|
|
226 |
|
Foreign currency exchange losses |
|
196 |
|
|
|
13 |
|
Change in fair value of warrant asset |
|
46 |
|
|
|
(14 |
) |
Severance expenses |
|
176 |
|
|
|
— |
|
Non-GAAP adjusted EBITDA |
$ |
1,804 |
|
|
$ |
(2,395 |
) |
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