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 fourth quarter and full year 2023. Alimera will host a
conference call today at 9:00 a.m. EDT to discuss these results.
“Our outstanding fourth quarter and full year 2023 net revenue
of $26.3 million and $80.8 million, respectively, mark major
achievements for Alimera and are a testament to the realized vision
and strong execution of our entire team in only our second full
quarter marketing both ILUVIEN and YUTIQ,” said Rick Eiswirth,
Alimera’s President and Chief Executive Officer. “We are proud to
have achieved positive Adjusted EBITDA during the fourth quarter of
2023, while maintaining a consistent net loss compared to the
fourth quarter of 2022, despite facing greater interest and
amortization expenses following the YUTIQ acquisition.
“The success of our expanded sales team in selling both ILUVIEN
and YUTIQ in the U.S. is evident, and we are further encouraged by
the strong demand we continue to see in our international markets,
leading us to be incredibly excited about the opportunities for
sustained sales growth of both YUTIQ and ILUVIEN. As a result, we
are increasing our revenue guidance for 2024 and expect to deliver
over $105 million in net revenue and a greater than 20% Adjusted
EBITDA margin for the full year. Additionally, we are advancing
plans for potential indication expansion opportunities to broaden
the number of patients that either of our long-acting steroid
implants can help treat,” Mr. Eiswirth concluded.
Elliot Maltz, CFO, added, “As a result of our strong revenue
growth in the second half of 2023 and early in 2024, we have
triggered multiple revenue-based milestone payments embedded in our
debt agreements with SLR earlier than expected. To preserve cash
for working capital purposes as we continue to grow ILUVIEN and
YUTIQ, we are pleased to report that SLR has agreed to increase our
loan facility by $5 million. Further, as a result of the full year
adjusted EBITDA, we have met a major milestone to allow for an
additional year of interest only payments on the loan
facility.”
Key Fourth Quarter Financial Highlights:
- Net revenue of $26.3 million up 88% vs. fourth quarter of
2022
- Net loss of $3.8 million consistent with fourth quarter of
2022
- Positive adjusted EBITDA of $5.0 million vs. adjusted EBITDA
loss of $(1.2) million in fourth quarter of 2022
- U.S. net revenue of $19.2 million up 104% vs. fourth quarter of
2022
- International net revenue of $7.1 million up 54% vs. fourth
quarter of 2022
Full Year 2023 Financial Highlights:
- Net revenue of $80.8 million up 49% vs. 2022
- Net loss of $20.1 million vs. $18.1 million in 2022
- Positive adjusted EBITDA of $8.7 million vs. adjusted EBITDA
loss of $(7.9) million in 2022
- U.S. net revenue of $56.7 million up 66% vs. 2022
- International net revenue of $24.0 million up 21% vs. 2022
Corporate Highlights:
- Acquired U.S. commercial rights to YUTIQ (fluocinolone
acetonide intravitreal insert) 0.18mg for the treatment of chronic
non-infectious uveitis affecting the posterior segment of the eye,
leveraging existing commercial infrastructure.
- Completed recruitment in the landmark NEW DAY Study for
ILUVIEN, which is a multicenter, masked, randomized, controlled
trial designed to generate prospective data evaluating ILUVIEN as a
baseline therapy in the treatment of DME and demonstrate its
potential advantages over the current standard of care of repeat
anti-VEGF (aflibercept) injections. If successful, the NEW DAY
Study could support a change to the current paradigm of DME
treatment, offering patients a first-line, baseline treatment
option that can maintain vision longer with fewer injections than
other therapies. The NEW DAY Study currently has enrolled
approximately 300 treatment-naïve, or near naïve, DME patients in
approximately 42 sites around the U.S.
- Completed recruitment in the Synchronicity Study for YUTIQ,
which is a prospective, open-label clinical study evaluating the
safety and efficacy of YUTIQ for the treatment of macular edema
associated with chronic, non-infectious uveitis affecting the
posterior segment of the eye and related intraocular
inflammation.
- Strengthened management team with additions of Jason Werner,
Todd Wood and Elliot Maltz.
- Increased term loan agreement with its current lenders,
investment affiliates managed by SLR Capital Partners, LLC, by $5
million.
- Achieved Adjusted EBITDA-based milestone trigger, extending the
interest-only period of the Company’s term loan agreement to May of
2026 so long as the Company maintains covenant compliance.
Alimera will host a conference call today at 9:00 a.m. ET to
discuss these results. Details for the call can be found below.
Fourth Quarter and Full Year 2023 Financial
Results
Net Revenue for Q4 2023
Consolidated net revenue was up 88% to approximately $26.3
million for Q4 2023, compared to $14.0 million for Q4 2022 driven
by the addition of YUTIQ in the U.S. segment and continuing
growth of ILUVIEN sales in the quarter.
U.S. net revenue increased 104% to approximately $19.2 million
for Q4 2023 compared to U.S. net revenue of $9.4 million for Q4
2022. U.S. end user demand for our fluocinolone implants in Q4 2023
was 2,065 units, up 4.4% compared to Q4 2022.
International net revenue increased 52% to approximately
$7.1 million in Q4 2023, compared to approximately
$4.6 million in Q4 2022. Growth was driven primarily by end
user demand growth of 17% in our direct markets and stocking
shipments to our international distributors that were more than
double that of Q4 2022. Total international segment end user demand
overall was 1,464 units, down 6.5% compared to Q4 2022 due to
limited inventory in our distributor markets of Spain and France
during the quarter. We do not anticipate stocking issues in these
markets moving forward in 2024 as our investments in ensuring
available manufacturing capacity have led to significant shipments
being made to both distributors late in Q4 2023.
Net Revenue for FY 2023
For 2023, consolidated net revenue increased 49% to
approximately $80.8 million, compared to approximately
$54.1 million in 2022. The 2023 increase was primarily
attributable to (a) the acquisition of YUTIQ in the United States
in May and (b) strong growth in our international segment.
For 2023, U.S. net revenue increased 66%, or approximately $22.5
million, to $56.7 million compared to $34.2 million in 2022. The
increase was attributable to the acquisition of YUTIQ in May of
2023 and the continued growth of ILUVIEN.
For 2023, international net revenue increased 21% to
approximately $24.0 million for 2023, compared to approximately
$19.9 million in 2022. The increase in product revenue was
primarily due to increasing growth in the international markets
where we sell ILUVIEN directly and improving demand from our
international distributor partners.
Operating Expenses
Total operating expenses were approximately $22.0
million for Q4 2023, compared to approximately
$14.2 million for Q4 2022. Total operating expenses for 2023
were approximately $71.8 million compared to approximately $57.9
million in 2022. The increase in 2023 was primarily attributable to
the increased operating costs associated with the addition of YUTIQ
in the U.S. segment and depreciation and amortization associated
with the assets acquired.
Net Loss
Net loss for Q4 2023 was $(3.8) million, compared to net loss of
approximately $(3.8) million for Q4 2022. For 2023, net loss
totaled approximately $(20.1) million compared to a net loss of
approximately $(18.1) million in 2022.
Basic and diluted net loss per share for Q4 2023 was
approximately $(0.07) compared to basic and diluted net loss per
share of $(0.54) for Q4 2022.
Basic and diluted net loss per share for 2023 was $(0.79)
compared to basic and diluted net loss per share for 2022 of
$(2.59).
Adjusted EBITDA
Adjusted EBITDA, a non-GAAP financial measure defined below, was
approximately $5.0 million for Q4 2023, compared to negative
adjusted EBITDA of approximately $(1.2) million for Q4 2022.
For 2023, Adjusted EBITDA was approximately $8.7 million compared
to an adjusted EBITDA loss of approximately $(7.9) million for
2022.
Cash and Cash Equivalents
As of December 31, 2023, Alimera had cash and cash equivalents
of approximately $12.1 million, compared to $5.3 million as of
December 31, 2022 and $8.3 million as of September 30, 2023.
Definition of Non-GAAP Financial MeasureFor
purposes of this press release, “Adjusted EBITDA” is defined as
earnings before interest, taxes, depreciation, amortization,
stock-based compensation expenses, net unrealized gains and losses
from foreign currency exchange transactions, losses on
extinguishment of debt, severance expenses and change in fair value
of warrant asset. Please refer to the sections of this press
release entitled “Non-GAAP Financial Measure” and “Reconciliation
of GAAP Measures to Non-GAAP Adjusted Measures –GAAP Net Income or
Loss to Non-GAAP Adjusted EBITDA.”
ALIM Call Details - Fourth Quarter and Full Year 2023
Earnings and Business Update
Conference Call to Be Held March 7, 2024A live
conference call will be hosted today, at 9:00 a.m. EST by Rick
Eiswirth, President and Chief Executive Officer, and Elliot Maltz,
Chief Financial Officer, to discuss Alimera’s financial results and
provide an update on corporate developments. Please refer to the
information below for conference call dial-in information and
webcast registration.
Conference date: Thursday, March 7, 2024, 9:00 a.m.
ESTConference dial-in: 844-839-2190International dial-in:
412-717-9583Conference Call Name: Alimera Sciences (Nasdaq: ALIM)
Fourth Quarter and Full Year 2023 Earnings and Business
UpdateConference Call Pre-registration: Participants are asked to
pre-register for the call by navigating to:
https://dpregister.com/sreg/10186495/fb9ad32c9bPlease note that
registered participants will receive their dial-in number upon
registration and will dial directly into the call without delay.
All callers should dial in approximately 10 minutes prior to the
scheduled start time and ask to be joined into the Alimera Sciences
call.
The conference call will also be available through a live
webcast which is also available via the company’s website.
Live Webcast URL: A replay will be available on Alimera’s
website, www.alimerasciences.com, under “Investor Relations” one
hour following the live call and will remain available until June
7, 2024.
Conference Call replay: US Toll Free:
1-877-344-7529International Toll: 1-412-317-0088Canada Toll Free:
855-669-9658Replay Access Code: 3648198End Date: March 21,
2024Webcast Replay End Date: June 7, 2024
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 Measure
This press release contains a discussion of a non-GAAP financial
measure, as defined in Regulation G promulgated under the
Securities Exchange Act of 1934, as amended. Alimera reports its
financial results in compliance with GAAP but believes that the
non-GAAP measure of Adjusted EBITDA provides useful information to
investors regarding Alimera’s operating performance. Alimera uses
Adjusted EBITDA in the management of its business. Accordingly,
Adjusted EBITDA for the three and twelve months ended December 31,
2023 and 2022 has been presented in certain instances excluding
items identified in the reconciliations provided in the table
entitled “Reconciliation of GAAP Measures to Non-GAAP Adjusted
Measures – GAAP Net Income or Loss to Non-GAAP Adjusted EBITDA.”
GAAP net income or loss is the most directly comparable GAAP
financial measure to Adjusted EBITDA.
Adjusted EBITDA, as presented, may not be comparable to
similarly titled measures reported by other companies because not
all companies may calculate Adjusted EBITDA in an identical manner.
Therefore, Adjusted EBITDA is not necessarily an accurate measure
of comparison between companies.
The presentation of Adjusted EBITDA is not intended to be
considered in isolation or as a substitute for guidance prepared in
accordance with GAAP. 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, Adjusted EBITDA is subject to inherent limitations as it
reflects the exercise of judgments by management in determining
this non-GAAP financial measure.
Forward Looking Statements
This press release contains, and the conference call in which
executives of Alimera will discuss this press release may include
“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 its business
strategy, future operations, future financial position, outlook and
guidance, Alimera’s prospects, plans and objectives, and timing and
outcome of its clinical trials. 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.
Such 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 these expectations, 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, factors discussed in the “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” sections of (i) Alimera’s most recently
filed Annual Report on Form 10-K for the year ended
December 31, 2022, and (ii) Alimera’s most recently filed
Quarterly Reports on Form 10-Q for the quarters ended March 31,
June 30, and September 30, 2023, all of which are on file with the
SEC and are available on the SEC’s website at
http://www.sec.gov.
The expected financial results discussed in this press release
are preliminary and unaudited and represent the most current
information available to Alimera’s management, as financial closing
procedures for the three months and full year ended December 31,
2023 are not yet complete. These estimates are not a comprehensive
statement of Alimera’s financial results for the fourth quarter and
the full year, and actual results may differ materially from these
estimates as a result of the completion of quarter-end financial
reporting process and the subsequent occurrence or identification
of events prior to the formal issuance of the audited financial
statements for the full year ended December 31, 2023.
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. Therefore, you
should not rely on these forward-looking statements as representing
Alimera’s views as of any date after today.
For investor inquiries:Scott Gordonfor Alimera
Sciencesscottg@coreir.com
|
For media inquiries:Jules Abrahamfor Alimera
Sciencesjulesa@coreir.com |
ALIMERA SCIENCES, INC.CONSOLIDATED
BALANCE SHEETS(In thousands,
unaudited) |
|
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
12,058 |
|
|
$ |
5,274 |
|
Restricted cash |
|
|
32 |
|
|
|
30 |
|
Accounts receivable, net |
|
|
34,545 |
|
|
|
19,612 |
|
Prepaid expenses and other current assets |
|
|
3,909 |
|
|
|
2,892 |
|
Inventory |
|
|
1,879 |
|
|
|
1,605 |
|
Total current assets |
|
|
52,423 |
|
|
|
29,413 |
|
Property and equipment, net |
|
|
2,466 |
|
|
|
2,525 |
|
Right of use assets, net |
|
|
1,124 |
|
|
|
1,395 |
|
Intangible asset, net |
|
|
97,355 |
|
|
|
8,957 |
|
Deferred tax asset |
|
|
104 |
|
|
|
129 |
|
Warrant asset |
|
|
52 |
|
|
|
183 |
|
Total assets |
|
$ |
153,524 |
|
|
$ |
42,602 |
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT) |
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
8,253 |
|
|
$ |
10,088 |
|
Accrued expenses |
|
|
6,193 |
|
|
|
3,998 |
|
Accrued licensor payments |
|
|
7,275 |
|
|
|
- |
|
Notes payable |
|
|
- |
|
|
|
25,313 |
|
Finance lease obligations |
|
|
194 |
|
|
|
333 |
|
Total current liabilities |
|
|
21,915 |
|
|
|
39,732 |
|
Notes payable |
|
|
64,489 |
|
|
|
18,683 |
|
Accrued licensor payments |
|
|
15,136 |
|
|
|
- |
|
Other non-current liabilities |
|
|
5,815 |
|
|
|
4,995 |
|
Total liabilities |
|
|
107,355 |
|
|
|
63,410 |
|
Stockholders' equity
(deficit): |
|
|
|
|
Preferred stock: |
|
|
|
|
Series A convertible preferred stock |
|
|
- |
|
|
|
19,227 |
|
Common stock |
|
|
524 |
|
|
|
70 |
|
Common stock warrants |
|
|
4,396 |
|
|
|
- |
|
Additional paid-in capital |
|
|
462,446 |
|
|
|
378,238 |
|
Accumulated deficit |
|
|
(418,491 |
) |
|
|
(415,388 |
) |
Accumulated other comprehensive loss |
|
|
(2,706 |
) |
|
|
(2,955 |
) |
Total stockholders' equity
(deficit) |
|
|
46,169 |
|
|
|
(20,808 |
) |
Total liabilities
stockholders' equity (deficit) |
|
$ |
153,524 |
|
|
$ |
42,602 |
|
|
|
|
|
|
|
|
|
|
|
ALIMERA SCIENCES, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS(In thousands, except
share and per share
data)(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Net revenue |
$ |
26,306 |
|
|
$ |
14,029 |
|
|
$ |
80,754 |
|
|
$ |
54,129 |
|
Cost of goods
sold, excluding depreciation and amortization |
|
(3,626 |
) |
|
|
(2,125 |
) |
|
|
(10,837 |
) |
|
|
(7,977 |
) |
Gross profit |
|
22,680 |
|
|
|
11,904 |
|
|
|
69,917 |
|
|
|
46,152 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research, development and
medical affairs expenses |
|
4,769 |
|
|
|
4,230 |
|
|
|
16,626 |
|
|
|
16,228 |
|
|
General and administrative
expenses |
|
6,379 |
|
|
|
3,491 |
|
|
|
18,530 |
|
|
|
13,028 |
|
|
Sales and marketing
expenses |
|
7,768 |
|
|
|
5,765 |
|
|
|
27,946 |
|
|
|
25,987 |
|
|
Depreciation and
amortization |
|
3,040 |
|
|
|
683 |
|
|
|
8,747 |
|
|
|
2,706 |
|
|
Total operating expenses |
|
21,956 |
|
|
|
14,169 |
|
|
|
71,849 |
|
|
|
57,949 |
|
Income (loss) from
operations |
|
724 |
|
|
|
(2,265 |
) |
|
|
(1,932 |
) |
|
|
(11,797 |
) |
|
Interest expense and other,
net |
|
(4,754 |
) |
|
|
(1,634 |
) |
|
|
(10,185 |
) |
|
|
(5,881 |
) |
|
Unrealized foreign currency
gain, net |
|
274 |
|
|
|
170 |
|
|
|
116 |
|
|
|
249 |
|
|
Loss on extinguishment of
debt |
|
- |
|
|
|
- |
|
|
|
(1,079 |
) |
|
|
- |
|
|
Change in fair value of common
stock warrant |
|
- |
|
|
|
- |
|
|
|
(6,836 |
) |
|
|
- |
|
|
Change in fair value of
warrant asset |
|
(18 |
) |
|
|
(52 |
) |
|
|
(131 |
) |
|
|
(650 |
) |
Net loss before
income taxes |
|
(3,774 |
) |
|
|
(3,781 |
) |
|
|
(20,047 |
) |
|
|
(18,079 |
) |
|
Income tax (provision)
benefit |
|
(7 |
) |
|
|
1 |
|
|
|
(85 |
) |
|
|
(28 |
) |
Net loss |
$ |
(3,781 |
) |
|
$ |
(3,780 |
) |
|
$ |
(20,132 |
) |
|
$ |
(18,107 |
) |
|
Preferred stock dividends |
|
- |
|
|
|
- |
|
|
|
(1,259 |
) |
|
|
- |
|
Net loss
applicable to common shareholders |
$ |
(3,781 |
) |
|
$ |
(3,780 |
) |
|
$ |
(21,391 |
) |
|
$ |
(18,107 |
) |
Net loss per share
- basic and diluted |
$ |
(0.07 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.79 |
) |
|
$ |
(2.59 |
) |
Weighted average
shares outstanding - basic and diluted |
|
54,422,965 |
|
|
|
7,000,279 |
|
|
|
25,561,885 |
|
|
|
6,996,850 |
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED
EBITDA(In thousands, unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
GAAP net loss |
$ |
(3,781 |
) |
|
$ |
(3,780 |
) |
|
$ |
(20,132 |
) |
|
$ |
(18,107 |
) |
Adjustments to net
loss: |
|
|
|
|
|
|
|
|
Interest expense, net and
other |
|
4,754 |
|
|
|
1,634 |
|
|
|
10,185 |
|
|
|
5,881 |
|
|
Income tax provision
(benefit) |
|
7 |
|
|
|
(1 |
) |
|
|
85 |
|
|
|
28 |
|
|
Depreciation and
amortization |
|
3,040 |
|
|
|
683 |
|
|
|
8,747 |
|
|
|
2,706 |
|
|
Stock-based compensation
expense |
|
805 |
|
|
|
187 |
|
|
|
1,435 |
|
|
|
910 |
|
|
Unrealized foreign currency
exchange gain, net |
|
(274 |
) |
|
|
(13 |
) |
|
|
(116 |
) |
|
|
(92 |
) |
|
Loss on extinguishment of
debt |
|
- |
|
|
|
- |
|
|
|
1,079 |
|
|
|
- |
|
|
Change in fair value of common
stock warrants |
|
- |
|
|
|
- |
|
|
|
6,836 |
|
|
|
- |
|
|
Change in fair value of
warrant asset |
|
18 |
|
|
|
52 |
|
|
|
131 |
|
|
|
650 |
|
|
Severance expenses |
|
461 |
|
|
|
- |
|
|
|
461 |
|
|
|
147 |
|
Non-GAAP adjusted
EBITDA |
$ |
5,030 |
|
|
$ |
(1,238 |
) |
|
$ |
8,711 |
|
|
$ |
(7,877 |
) |
|
|
|
|
|
|
|
|
|
Alimera Sciences (NASDAQ:ALIM)
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From Mar 2024 to Apr 2024
Alimera Sciences (NASDAQ:ALIM)
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From Apr 2023 to Apr 2024