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 second quarter of 2023.
“This was a pivotal quarter for Alimera. We completed a
transformational transaction to add YUTIQ to our portfolio,
enabling us to further leverage our extensive commercial
infrastructure in the U.S., adopt learning from our experience
selling behind a uveitis indication in Europe and bring critical
mass to our revenue base. The transaction has provided immediate
results, despite planned costs of combining the two products in our
infrastructure, contributing to the generation of positive Adjusted
EBITDA in the second quarter,” said Rick Eiswirth, Alimera’s
President and Chief Executive Officer. “In addition, we completed
enrollment in the NEW DAY study which we expect will support
consideration of ILUVIEN as a first-line treatment option for DME
that can maintain vision longer with fewer injections while
highlighting the value of long term, consistent drug delivery in
managing the recurrence of retinal disease.”
Key Second Quarter Highlights:
- Acquisition of additional commercialization rights for YUTIQ
(fluocinolone acetonide intravitreal insert) 0.18mg for the
treatment of chronic non-infectious uveitis affecting the posterior
segment of the eye
- Revenue of $17.5 million up 20% vs. second quarter of 2022
- Global ILUVIEN end user demand growth of 13.5% over Q2 2022;
YUTIQ added an additional 440 units of end user demand
- Net loss of $10.7 million versus $3.1 million in Q2 2022 driven
primarily by cost associated with financings this year
- Positive adjusted EBITDA of $900,000 vs. a loss of $1 million
in Q2 2022
- Completion of the NEW DAY Study enrollment with 306 patients;
anticipating data in early 2025
Second Quarter 2023 Financial Results
Revenue Product revenue was up 20% to approximately $17.5
million for Q2 2023, compared to $14.6 million for Q2 2022. The
increase was primarily due to the addition of YUTIQ into the U.S.
portfolio. Global end user demand for ILUVIEN in Q2 2023 was 2,601
units, up 13.5% compared to Q2 2022. In addition, YUTIQ generated
an additional 440 units of end user demand in the second quarter
from the date of acquisition in late May.
U.S. product revenue increased 34% to approximately $11.9
million for Q2 2023 compared to U.S. product revenue of $8.9
million for Q2 2022. U.S. end user demand for ILUVIEN and YUTIQ in
Q2 2023 was 1,500 units, compared to 1,063 of ILUVIEN in Q2
2022.
International net product revenue remained flat at approximately
$5.7 million in Q2 2023, compared to approximately
$5.7 million in Q2 2022 as a result of deferred shipments to
our distributor partners. International segment end user demand was
up 26% to 1,541 units compared to 1,220 units in Q2 2022.
Operating ExpensesTotal operating expenses were
approximately $16.3 million for Q2 2023, compared to
approximately $14.4 million for Q2 2022. The increase was
primarily attributable to approximately $630,000 in bad debt
expense, and approximately $1.2 million in amortization of the new
intangible asset related to the YUTIQ transaction.
Cash and Cash EquivalentsAs of June 30, 2023, Alimera had cash
and cash equivalents of approximately $18.8 million, compared to
$13.1 million at March 31, 2023.
About Alimera Sciences, Inc.
www.alimerasciences.com
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 .
Non-GAAP Financial Measures
This press release presents Adjusted EBITDA and Adjusted net
product revenue, each as defined below, which are non-GAAP
financial measures. Alimera uses these measures 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
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 and six months ended June 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 is subject to variability of its reported U.S. dollar
results due to changes in foreign currency exchange rates. Those
changes have been volatile over the past several years. The
adjustment of the effects of foreign currency exchange in its
international segment as if foreign exchange rates had remained
constant with the same periods of 2022, or what Alimera refers to
as Adjusted net product revenue, is a non-GAAP measure. Alimera
believes that this non-GAAP measure provides additional information
that enables enhanced comparison to prior periods and additional
insight into the underlying performance of its business outside of
the U.S. Accordingly, Adjusted net product revenue for the three
and six months ended June 30, 2023 and 2022, together with a
reconciliation to GAAP net product revenue, its most directly
comparable GAAP financial measure, has been presented in the table
entitled “Reconciliation of GAAP Net Product Revenue to Non-GAAP
Adjusted Net Product Revenue.”
These non-GAAP financial measures 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 or Adjusted net product revenue in an
identical manner or may use other financial measures to evaluate
their performance. Therefore, these non-GAAP financial measures may
be limited in their usefulness for comparison between
companies.
The presentation of these non-GAAP financial measures 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
these non-GAAP financial measures is that they exclude significant
elements required by GAAP to be recorded in Alimera’s financial
statements. In addition, these non-GAAP financial measures are
subject to inherent limitations because they reflect 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, Adjusted EBITDA, future revenues and projected costs,
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.
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 |
|
|
June 30, |
|
December 31, |
|
2023 |
|
2022 |
|
(unaudited) |
|
|
|
(In thousands, except share and per share
data) |
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
18,775 |
|
|
$ |
5,274 |
|
Restricted cash |
|
32 |
|
|
|
30 |
|
Accounts receivable, net |
|
22,589 |
|
|
|
19,612 |
|
Prepaid expenses and other current assets |
|
3,571 |
|
|
|
2,892 |
|
Inventory |
|
1,055 |
|
|
|
1,605 |
|
Total current assets |
|
46,022 |
|
|
|
29,413 |
|
NON-CURRENT ASSETS: |
|
|
|
|
|
Property and equipment, net |
|
2,465 |
|
|
|
2,525 |
|
Right of use assets, net |
|
1,277 |
|
|
|
1,395 |
|
Intangible assets, net |
|
104,935 |
|
|
|
8,957 |
|
Deferred tax asset |
|
131 |
|
|
|
129 |
|
Warrant asset |
|
93 |
|
|
|
183 |
|
TOTAL ASSETS |
$ |
154,923 |
|
|
$ |
42,602 |
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
8,040 |
|
|
$ |
10,088 |
|
Accrued expenses |
|
6,002 |
|
|
|
3,998 |
|
Notes payable |
|
— |
|
|
|
25,313 |
|
Finance lease obligations |
|
203 |
|
|
|
333 |
|
Total current liabilities |
|
14,245 |
|
|
|
39,732 |
|
NON-CURRENT LIABILITIES: |
|
|
|
|
|
Notes payable, net of discount |
|
63,954 |
|
|
|
18,683 |
|
Common stock warrants |
|
3,471 |
|
|
|
— |
|
Accrued licensor payments |
|
21,079 |
|
|
|
— |
|
Other non-current liabilities |
|
5,944 |
|
|
|
4,995 |
|
COMMITMENTS AND
CONTINGENCIES |
|
|
|
|
|
STOCKHOLDERS’ EQUITY
(DEFICIT): |
|
|
|
|
|
Preferred stock: |
|
|
|
|
|
Series A Convertible Preferred Stock |
|
— |
|
|
|
19,227 |
|
Series B Convertible Preferred Stock |
|
74,725 |
|
|
|
— |
|
Common stock |
|
88 |
|
|
|
70 |
|
Additional paid-in capital |
|
386,979 |
|
|
|
378,238 |
|
Accumulated deficit |
|
(412,779 |
) |
|
|
(415,388 |
) |
Accumulated other comprehensive loss |
|
(2,783 |
) |
|
|
(2,955 |
) |
TOTAL STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
46,230 |
|
|
|
(20,808 |
) |
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
$ |
154,923 |
|
|
$ |
42,602 |
|
|
|
|
|
|
|
|
|
ALIMERA SCIENCES, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND
2022 |
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
(In thousands, except share and per share
data) |
|
(unaudited) |
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
PRODUCT REVENUE, NET |
$ |
17,538 |
|
|
$ |
14,604 |
|
|
$ |
31,084 |
|
|
$ |
26,502 |
|
COST OF GOODS SOLD, EXCLUDING
DEPRECIATION AND AMORTIZATION |
|
(2,425 |
) |
|
|
(2,166 |
) |
|
|
(4,453 |
) |
|
|
(3,846 |
) |
GROSS PROFIT |
|
15,113 |
|
|
|
12,438 |
|
|
|
26,631 |
|
|
|
22,656 |
|
RESEARCH, DEVELOPMENT AND
MEDICAL AFFAIRS EXPENSES |
|
3,648 |
|
|
|
3,932 |
|
|
|
7,812 |
|
|
|
7,515 |
|
GENERAL AND ADMINISTRATIVE
EXPENSES |
|
4,373 |
|
|
|
2,945 |
|
|
|
8,544 |
|
|
|
6,185 |
|
SALES AND MARKETING
EXPENSES |
|
6,434 |
|
|
|
6,865 |
|
|
|
12,238 |
|
|
|
13,718 |
|
DEPRECIATION AND
AMORTIZATION |
|
1,866 |
|
|
|
670 |
|
|
|
2,547 |
|
|
|
1,359 |
|
OPERATING EXPENSES |
|
16,321 |
|
|
|
14,412 |
|
|
|
31,141 |
|
|
|
28,777 |
|
LOSS FROM OPERATIONS |
|
(1,208 |
) |
|
|
(1,974 |
) |
|
|
(4,510 |
) |
|
|
(6,121 |
) |
INTEREST EXPENSE AND
OTHER |
|
(1,694 |
) |
|
|
(1,383 |
) |
|
|
(3,361 |
) |
|
|
(2,747 |
) |
UNREALIZED FOREIGN CURRENCY
(LOSS) GAIN, NET |
|
(7 |
) |
|
|
38 |
|
|
|
(20 |
) |
|
|
146 |
|
LOSS ON EXTINGUISHMENT OF
DEBT |
|
(1,079 |
) |
|
|
— |
|
|
|
(1,079 |
) |
|
|
— |
|
CHANGE IN FAIR VALUE OF
WARRANT ASSET |
|
(105 |
) |
|
|
221 |
|
|
|
(91 |
) |
|
|
(331 |
) |
CHANGE IN FAIR VALUE OF
WARRANT LIABILITY |
|
(5,911 |
) |
|
|
— |
|
|
|
(5,911 |
) |
|
|
— |
|
NET LOSS BEFORE TAXES |
|
(10,004 |
) |
|
|
(3,098 |
) |
|
|
(14,972 |
) |
|
|
(9,053 |
) |
INCOME TAX PROVISION |
|
(25 |
) |
|
|
(17 |
) |
|
|
(25 |
) |
|
|
(17 |
) |
NET LOSS |
|
(10,029 |
) |
|
|
(3,115 |
) |
|
|
(14,997 |
) |
|
|
(9,070 |
) |
PREFERRED STOCK DIVIDENDS |
|
(669 |
) |
|
|
— |
|
|
|
(683 |
) |
|
|
|
NET LOSS APPLICABLE TO COMMON
STOCKHOLDERS |
$ |
(10,698 |
) |
|
$ |
(3,115 |
) |
|
$ |
(15,680 |
) |
|
$ |
(9,070 |
) |
NET LOSS PER SHARE APPLICABLE
TO COMMON STOCKHOLDERS — Basic and Diluted |
$ |
(1.32 |
) |
|
$ |
(0.45 |
) |
|
$ |
(2.07 |
) |
|
$ |
(1.30 |
) |
WEIGHTED AVERAGE SHARES
OUTSTANDING — Basic and Diluted |
|
8,093,640 |
|
|
|
6,999,707 |
|
|
|
7,565,868 |
|
|
|
6,995,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED
MEASURES |
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP
ADJUSTED EBITDA |
(in thousands) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
(unaudited) |
GAAP NET LOSS |
$ |
(10,029 |
) |
|
|
$ |
(3,115 |
) |
|
|
$ |
(14,997 |
) |
|
|
$ |
(9,070 |
) |
|
Adjustments to net loss: |
|
|
|
|
|
|
|
Interest expense and
other |
1,694 |
|
|
|
1,383 |
|
|
|
3,361 |
|
|
|
2,747 |
|
|
Provision for taxes |
25 |
|
|
|
17 |
|
|
|
25 |
|
|
|
17 |
|
|
Depreciation and
amortization |
1,866 |
|
|
|
670 |
|
|
|
2,547 |
|
|
|
1,359 |
|
|
Stock-based compensation
expenses |
216 |
|
|
|
268 |
|
|
|
442 |
|
|
|
581 |
|
|
Unrealized foreign currency
exchange losses (gains) |
7 |
|
|
|
(38 |
) |
|
|
20 |
|
|
|
(146 |
) |
|
Loss on extinguishment of
debt |
1,079 |
|
|
|
— |
|
|
|
1,079 |
|
|
|
— |
|
|
Change in fair value of common
stock warrants |
5,911 |
|
|
|
— |
|
|
|
5,911 |
|
|
|
— |
|
|
Change in fair value of
warrant asset |
105 |
|
|
|
(221 |
) |
|
|
91 |
|
|
|
331 |
|
|
Severance expenses |
— |
|
|
|
37 |
|
|
|
— |
|
|
|
37 |
|
|
NON-GAAP ADJUSTED EBITDA |
$ |
874 |
|
|
|
$ |
(999 |
) |
|
|
$ |
(1,521 |
) |
|
|
$ |
(4,144 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP NET PRODUCT REVENUE TO NON-GAAP
ADJUSTED NET PRODUCT REVENUE |
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2023 |
|
2022 |
|
2023 |
|
|
2022 |
|
(In thousands) |
GAAP NET PRODUCT REVENUE |
$ |
17,538 |
|
$ |
14,604 |
|
$ |
31,084 |
|
|
$ |
26,502 |
Adjustment to net product
revenue: |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency fluctuations,
net |
|
136 |
|
|
— |
|
|
(137 |
) |
|
|
— |
NON-GAAP ADJUSTED NET PRODUCT
REVENUE |
$ |
17,674 |
|
$ |
14,604 |
|
$ |
30,947 |
|
|
$ |
26,502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Alimera Sciences (NASDAQ:ALIM)
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Alimera Sciences (NASDAQ:ALIM)
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