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 third quarter of 2023. Alimera will host a
conference call today at 9:00 a.m. EDT to discuss these results.
“We are pleased to announce record net revenue of $23.4 million,
a significant decrease in our net loss and record Adjusted EBITDA
in our first full quarter selling both ILUVIEN and YUTIQ,” said
Rick Eiswirth, Alimera’s President and Chief Executive Officer. “We
believe we are already seeing an impact of the expanded sales team
selling both ILUVIEN and YUTIQ and are on track to deliver over
$100 million in net revenue and more than $20 million in Adjusted
EBITDA in 2024. We are excited by the opportunities for sustained
sales growth of both YUTIQ and ILUVIEN and we are actively
evaluating indication expansion opportunities to broaden the number
of patients that either long-acting steroid implant can help treat.
We expect to share more on these possibilities in the coming
months.”
Key Third Quarter Highlights
- Net revenue of $23.4 million up 72% vs. third quarter of
2022
- Net loss decreased by 74% to $1.4 million vs. third quarter of
2022
- Positive adjusted EBITDA of $5.4 million vs. adjusted EBITDA
loss of $(2.5) million in third quarter of 2022
- Global end user demand up 7% vs. third quarter of 2022
- U.S. end user demand up 13.6%
- International direct market end user demand up 20.4%
- Expanded the U.S. sales force from 29 to 35 Retina Account
Managers
Clinical Updates
Alimera’s overenrolled NEW DAY Study evaluating ILUVIEN’s
utility as baseline therapy head-to-head versus the leading
anti-VEGF in the treatment of diabetic macular edema has completed
enrollment with 306 patients and remains on track with top-line
data anticipated in the first quarter of 2025.
Alimera is actively enrolling patients in the SYNCHRONICITY
Study, a prospective, open-label clinical study evaluating the
safety and efficacy of YUTIQ for the treatment of chronic,
non-infectious uveitis affecting the posterior segment and related
intraocular inflammation. This is a two-year follow-up study with
an interim top-line six-month efficacy readout anticipated in the
third quarter of 2024.
Alimera has completed enrollment in the CALM Study with 240
eyes. The CALM Study is a registry study conducted in collaboration
with the Cleveland Clinic collecting real world data to better
understand the variety of conditions treated with YUTIQ for
non-infectious uveitis affecting the posterior segment. Alimera
plans to present efficacy outcome data on individual and combined
patient cohorts during medical conferences in 2024.
Alimera is working with the Jaeb Center for Health Research
Foundation Inc. acting on behalf of the DRCR Retina Network to
provide ILUVIEN and support Protocol AL. Protocol AL is a
randomized clinical trial evaluating intravitreal Faricimab (6.0
mg) injections or Fluocinolone Acetonide (0.19 mg) intravitreal
implants versus observation in the prevention of visual acuity loss
due to radiation retinopathy following plaque brachytherapy.
Third Quarter 2023 Financial Results
Revenue Net revenue was up 72% to approximately $23.4 million
for Q3 2023 compared to $13.6 million for Q3 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 103% to approximately $18.1 million
for Q3 2023 compared to U.S. product revenue of $8.9 million for Q3
2022. U.S end user demand for ILUVIEN in Q3 2023 was 1,145 units,
up 8% compared to Q3 2022. YUTIQ end user demand was 1,046 units in
the third quarter, up 20% compared to Q3 2022. Going forward,
Alimera intends to report end-user demand on a consolidated
basis.
International net revenue increased 13% to approximately
$5.3 million for Q3 2023, compared to approximately
$4.7 million for Q3 2022. Growth was driven primarily by a
significant increase in end user demand in our direct markets of
20.4% compared to Q3 2022. International segment end user demand
overall was down 2% to 1,265 units compared to 1,292 units in Q3
2022 as Alimera’s distributor partners rationed sales during the
quarter because of deferred shipments to these partners in
2023.
Operating ExpensesTotal operating expenses were
approximately $18.8 million for Q3 2023, compared to
approximately $15.0 million for Q3 2022. The increase 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.
Cash and Cash EquivalentsAs of September 30, 2023, Alimera had
cash and cash equivalents of approximately $8.3 million, compared
to $18.8 million on June 30, 2023. Cash utilization during the
quarter was primarily a result of the working capital investments
required to support the addition of YUTIQ to Alimera. The Company
expects to generate positive cash flow in the fourth quarter of
2023 and in 2024.
ALIM Call Details - Q3 2023 Financial Results Conference
Call
Conference Call to Be Held October 26, 2023A
live conference call will be hosted today October 26, at 9:00 a.m.
EDT by Rick Eiswirth, president and chief executive officer, and
Russell Skibsted, 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, October 26, 9:00 a.m. EDTConference
dial-in: 844-839-2190International dial-in: 412-317-9583Conference
Call Name: Alimera Sciences (Nasdaq: ALIM) Third Quarter 2023
Earnings and Business Update
Conference Call Pre-registration: Participants are asked to
pre-register for the call by navigating to:
https://dpregister.com/sreg/10183110/fa99503540Please 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 through the company’s website.Live
Webcast
URL:https://event.choruscall.com/mediaframe/webcast.html?webcastid=8U00zjTj
A replay will be available on Alimera’s
website, www.alimerasciences.com, under “Investor Relations”
one hour following the live call.Conference Call replay: US Toll
Free: 1-877-344-7529International Toll: 1-412-317-0088Canada Toll
Free: 855-669-9658Replay Access Code: 4883323End Date: November 9,
2023Webcast Replay End Date: January 26, 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 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, losses on extinguishment of debt, preferred
stock dividends, severance expenses, change in fair value of common
stock warrants and change in fair value of warrant asset. Alimera
believes that Adjusted EBITDA, when taken together with its most
directly comparable 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 and nine months ended September 30, 2023 and
2022, 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.”
Alimera has relied upon the exception in item 10I(1)(i)(B) of
Regulation S-K and has not reconciled forward-looking Adjusted
EBITDA to its corresponding GAAP financial measure because Alimera
cannot predict with reasonable certainty the ultimate outcome of
certain components of such reconciliations, including
market-related assumptions that are not within Alimera’s control,
or others that may arise, without unreasonable effort. For these
reasons, Alimera is unable to assess the probable significance of
the unavailable information, which could materially impact the
amount of future net loss.
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 its 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 its business strategy, future operations, future financial
position, outlook and guidance, timeline for achieving positive
cash flow, 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. 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.
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 and nine months ended September 30, 2023
are not yet complete. These estimates are not a comprehensive
statement of Alimera’s financial results for the third quarter, 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 unaudited financial statements for the
three and nine months ended September 30, 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.
For
investor inquiries:Scott Gordonfor Alimera
Sciencesscottg@coreir.com |
For
media inquiries:Jules Abrahamfor Alimera
Sciencesjulesa@coreir.com |
ALIMERA SCIENCES, INC.CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
2023 |
|
|
2022 |
|
|
(unaudited) |
|
|
|
(In thousands, except share and per share
data) |
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
8,285 |
|
|
$ |
5,274 |
|
Restricted cash |
|
31 |
|
|
|
30 |
|
Accounts receivable, net |
|
33,943 |
|
|
|
19,612 |
|
Prepaid expenses and other current assets |
|
4,383 |
|
|
|
2,892 |
|
Inventory |
|
1,760 |
|
|
|
1,605 |
|
Total current assets |
|
48,402 |
|
|
|
29,413 |
|
NON-CURRENT ASSETS: |
|
|
|
|
|
Property and equipment, net |
|
2,442 |
|
|
|
2,525 |
|
Right of use assets, net |
|
1,176 |
|
|
|
1,395 |
|
Intangible assets, net |
|
101,975 |
|
|
|
8,957 |
|
Deferred tax asset |
|
127 |
|
|
|
129 |
|
Warrant asset |
|
70 |
|
|
|
183 |
|
TOTAL ASSETS |
$ |
154,192 |
|
|
$ |
42,602 |
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
6,205 |
|
|
$ |
10,088 |
|
Accrued expenses |
|
6,010 |
|
|
|
3,998 |
|
Accrued milestone payment |
|
5,313 |
|
|
|
— |
|
Notes payable |
|
— |
|
|
|
25,313 |
|
Finance lease obligations |
|
193 |
|
|
|
333 |
|
Total current liabilities |
|
17,721 |
|
|
|
39,732 |
|
NON-CURRENT LIABILITIES: |
|
|
|
|
|
Notes payable, net of discount |
|
64,222 |
|
|
|
18,683 |
|
Accrued licensor payments |
|
17,537 |
|
|
|
— |
|
Other non-current liabilities |
|
5,872 |
|
|
|
4,995 |
|
COMMITMENTS AND
CONTINGENCIES |
|
|
|
|
|
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 |
|
461,622 |
|
|
|
378,238 |
|
Accumulated deficit |
|
(414,708 |
) |
|
|
(415,388 |
) |
Accumulated other comprehensive loss |
|
(2,994 |
) |
|
|
(2,955 |
) |
TOTAL STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
48,840 |
|
|
|
(20,808 |
) |
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
$ |
154,192 |
|
|
$ |
42,602 |
|
ALIMERA SCIENCES, INC.CONSOLIDATED
STATEMENTS OF OPERATIONSFOR THE THREE AND NINE
MONTHS ENDED SEPTEMBER 30, 2023 AND 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
(In thousands, except share and per share
data) |
|
(unaudited) |
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
REVENUE, NET |
$ |
23,364 |
|
|
$ |
13,598 |
|
|
$ |
54,448 |
|
|
$ |
40,100 |
|
COST OF GOODS SOLD, EXCLUDING
DEPRECIATION AND AMORTIZATION |
|
(2,758 |
) |
|
|
(2,006 |
) |
|
|
(7,211 |
) |
|
|
(5,852 |
) |
GROSS PROFIT |
|
20,606 |
|
|
|
11,592 |
|
|
|
47,237 |
|
|
|
34,248 |
|
RESEARCH, DEVELOPMENT AND
MEDICAL AFFAIRS EXPENSES |
|
4,045 |
|
|
|
4,483 |
|
|
|
11,857 |
|
|
|
11,998 |
|
GENERAL AND ADMINISTRATIVE
EXPENSES |
|
3,607 |
|
|
|
3,352 |
|
|
|
12,151 |
|
|
|
9,537 |
|
SALES AND MARKETING
EXPENSES |
|
7,940 |
|
|
|
6,504 |
|
|
|
20,178 |
|
|
|
20,222 |
|
DEPRECIATION AND
AMORTIZATION |
|
3,160 |
|
|
|
664 |
|
|
|
5,707 |
|
|
|
2,023 |
|
OPERATING EXPENSES |
|
18,752 |
|
|
|
15,003 |
|
|
|
49,893 |
|
|
|
43,780 |
|
INCOME (LOSS) FROM
OPERATIONS |
|
1,854 |
|
|
|
(3,411 |
) |
|
|
(2,656 |
) |
|
|
(9,532 |
) |
INTEREST EXPENSE AND
OTHER |
|
(2,070 |
) |
|
|
(1,500 |
) |
|
|
(5,431 |
) |
|
|
(4,247 |
) |
UNREALIZED FOREIGN CURRENCY
(LOSS) GAIN, NET |
|
(138 |
) |
|
|
(67 |
) |
|
|
(158 |
) |
|
|
79 |
|
LOSS ON EXTINGUISHMENT OF
DEBT |
|
— |
|
|
|
— |
|
|
|
(1,079 |
) |
|
|
— |
|
CHANGE IN FAIR VALUE OF
WARRANT ASSET |
|
(22 |
) |
|
|
(267 |
) |
|
|
(113 |
) |
|
|
(598 |
) |
CHANGE IN FAIR VALUE OF
WARRANT LIABILITY |
|
(925 |
) |
|
|
— |
|
|
|
(6,836 |
) |
|
|
— |
|
NET LOSS BEFORE TAXES |
|
(1,301 |
) |
|
|
(5,245 |
) |
|
|
(16,273 |
) |
|
|
(14,298 |
) |
INCOME TAX PROVISION |
|
(53 |
) |
|
|
(12 |
) |
|
|
(78 |
) |
|
|
(29 |
) |
NET LOSS |
|
(1,354 |
) |
|
|
(5,257 |
) |
|
|
(16,351 |
) |
|
|
(14,327 |
) |
PREFERRED STOCK DIVIDENDS |
|
(576 |
) |
|
|
— |
|
|
|
(1,259 |
) |
|
|
— |
|
NET LOSS APPLICABLE TO COMMON
STOCKHOLDERS |
$ |
(1,930 |
) |
|
$ |
(5,257 |
) |
|
$ |
(17,610 |
) |
|
$ |
(14,327 |
) |
NET LOSS PER SHARE APPLICABLE
TO COMMON STOCKHOLDERS — Basic and Diluted |
$ |
(0.06 |
) |
|
$ |
(0.75 |
) |
|
$ |
(1.11 |
) |
|
$ |
(2.05 |
) |
WEIGHTED AVERAGE SHARES
OUTSTANDING — Basic and Diluted |
|
32,106,014 |
|
|
|
6,996,575 |
|
|
|
15,835,807 |
|
|
|
6,995,695 |
|
RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED
MEASURESRECONCILIATION OF GAAP
NET LOSS TO NON-GAAP ADJUSTED EBITDA(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
(unaudited) |
GAAP NET LOSS |
$ |
(1,354 |
) |
|
|
$ |
(5,257 |
) |
|
|
$ |
(16,351 |
) |
|
|
$ |
(14,327 |
) |
|
Adjustments to net loss: |
|
|
|
|
|
|
|
Interest expense and
other |
2,070 |
|
|
|
1,500 |
|
|
|
5,431 |
|
|
|
4,247 |
|
|
Provision for taxes |
53 |
|
|
|
12 |
|
|
|
78 |
|
|
|
29 |
|
|
Depreciation and
amortization |
3,160 |
|
|
|
664 |
|
|
|
5,707 |
|
|
|
2,023 |
|
|
Stock-based compensation
expenses |
404 |
|
|
|
143 |
|
|
|
630 |
|
|
|
723 |
|
|
Unrealized foreign currency
exchange losses (gains) |
138 |
|
|
|
67 |
|
|
|
158 |
|
|
|
(79 |
) |
|
Loss on extinguishment of
debt |
— |
|
|
|
— |
|
|
|
1,079 |
|
|
|
— |
|
|
Change in fair value of common
stock warrants |
925 |
|
|
|
— |
|
|
|
6,836 |
|
|
|
— |
|
|
Change in fair value of
warrant asset |
22 |
|
|
|
267 |
|
|
|
113 |
|
|
|
598 |
|
|
Severance expenses |
— |
|
|
|
110 |
|
|
|
— |
|
|
|
147 |
|
|
NON-GAAP ADJUSTED EBITDA |
$ |
5,418 |
|
|
|
$ |
(2,494 |
) |
|
|
$ |
3,681 |
|
|
|
$ |
(6,639 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alimera Sciences (NASDAQ:ALIM)
Historical Stock Chart
From Apr 2024 to May 2024
Alimera Sciences (NASDAQ:ALIM)
Historical Stock Chart
From May 2023 to May 2024