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 2022. Alimera will host a
conference call today at 9:00 a.m. EST to discuss these results.
“The third quarter delivered another strong performance for
ILUVIEN global end user demand with our U.S. Segment and our
International Segment both up 27% over the same period a year ago,”
said Rick Eiswirth, Alimera’s President and Chief Executive
Officer. “2022 has been a record performance for end user demand in
both our U.S. and International Segments for the nine months ended
September 30. This has also been a very productive year for our
geographic expansion strategy, as we obtained reimbursement in six
European countries for our non-infectious uveitis indication,
driving strong performance in our French and Spanish markets
specifically. We are also very excited to have announced our
agreement to work with the DRCR Retina Network in evaluating
ILUVIEN’s potential to reduce the incidence and recurrence of
radiation retinopathy, another unmet need affecting the
retina.”
Third Quarter 2022 Financial Results
Consolidated Net Revenue Consolidated net revenue increased 11%
to approximately $13.6 million for Q3 2022 compared to $12.2
million for Q3 2021. Fluctuations in foreign currency exchange
rates since Q3 2021 have unfavorably impacted our Q3 2022
international revenue by approximately $800,000, due to the
weakened Euro and British Pound Sterling over the past year.
Excluding fluctuations in foreign currency exchange rates, revenue
increased by approximately 18% over Q3 2021. Adjustments in net
product revenue to exclude fluctuations in foreign currency
exchange rates result in a non-GAAP financial measure. Please refer
to the section of this press release entitled “Non-GAAP Financial
Measures” and the table entitled “Reconciliation of GAAP Net
Product Revenue to Non-GAAP Adjusted Net Product Revenue.”
U.S. Net Revenue U.S. net product revenue increased 27% to
approximately $8.9 million for Q3 2022 compared to $7.0 million for
Q3 2021. The increase was primarily due to investment in our sales,
marketing, scientific and medical programs, which drove greater
utilization of ILUVIEN. End user demand, which represents units
purchased by physicians and pharmacies from our distributors,
increased 27% to 1,061 units during Q3 2022, a record third quarter
for our U.S. segment, compared to 837 units during Q3 2021.
International Net Revenue International net product revenue
decreased by approximately $500,000, or approximately 10%, to
approximately $4.7 million for Q3 2022, compared to approximately
$5.2 million for Q3 2021. The decrease in international net product
revenue among our direct and distributor markets in Europe was
primarily the result of deteriorating foreign exchange rates for
the Euro and British Pound Sterling, which had an unfavorable
impact on our international revenue of approximately $800,000 in
Q3 2022. Excluding fluctuations in foreign currency exchange
rates, revenue increased by approximately 6% over Q3 2021. Other
factors contributing to the decrease in international product
revenue were lower sales in certain markets in Europe and the
timing of orders from our international distributors,
notwithstanding a 27% increase in end user demand from 1,018 units
in Q3 2021 to 1,292 units in Q3 2022.
Operating ExpensesTotal operating expenses were
approximately $15.0 million for Q3 2022, compared to
approximately $12.5 million for Q3 2021.
This increase was composed of a) cost increases in research,
development and medical affairs associated with transfer of our
inserter component manufacturing, NEW DAY Study and travel, b)
added sales and marketing expense associated with the direct to
patient marketing campaign and increased personnel costs, and c)
increased general and administrative costs tied to a $560,000
recovery of VAT refunds in 2021 that did not recur in 2022.
Net Loss and Adjusted EBITDANet loss for Q3 2022 was $5.3
million, compared to a net loss of approximately $4.2 million
for Q3 2021.
“Adjusted EBITDA,” a non-GAAP financial measure, was
approximately $(2.5) million for Q3 2022, compared to Adjusted
EBITDA of approximately $(1.1) million for Q3 2021. For
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 section of this press release
entitled “Non-GAAP Financial Measures” and the table entitled
“Reconciliation of GAAP Net Income or Loss to Non-GAAP Adjusted
EBITDA.”
Net Loss per ShareBasic and diluted net loss per share for Q3
2022 was approximately $(0.75) compared to basic and diluted net
loss per share of $(0.60) for Q3 2021.
Cash and Cash EquivalentsOn September 30, 2022, Alimera had cash
and cash equivalents of approximately $5.5 million dollars,
compared to $7.9 million in cash and cash equivalents on June 30,
2022.
ALIM Call Details - Q3 2022 Financial Results Conference
Call
Conference Call to Be Held November 14, 2022A
live conference call will be hosted today November 14, 2022, at
9:00 a.m. EST by Rick Eiswirth, president and chief executive
officer, and Phil Jones, 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: Monday, November 14, 2022, 9;00 a.m.
ESTConference dial-in: 844-839-2190International dial-in:
412-317-9583Conference Call Name: Alimera Sciences (Nasdaq: ALIM)
Third Quarter 2022 Financial Results Conference
Call Conference Call
Pre-registration: Participants are asked to pre-register for
the call by navigating to:
https://dpregister.com/sreg/10172804/f4f6c45000
Please 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=lcASYWZJA
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: 1728884End Date: November 28,
2022Webcast Replay End Date: February 14, 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 contains a discussion of non-GAAP financial
measures, 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 financial measures of Adjusted EBITDA and adjusted net
product revenue to exclude fluctuations in foreign currency
exchange rates provide useful information to investors regarding
Alimera’s operating performance. Alimera uses each of these
non-GAAP financial measures in the management of its business.
Accordingly, Adjusted EBITDA for the three months ended September
30, 2022 and 2021 has been presented in certain instances excluding
items identified in the reconciliations provided in the table
entitled “Reconciliation of 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. Further, net
product revenue has been adjusted to exclude fluctuations in
foreign currency exchange rates for the three months ended
September 30, 2022 and 2021. See the table entitled
“Reconciliation of GAAP Net Product Revenue to Non-GAAP Adjusted
Net Product Revenue.” GAAP net product revenue is the most directly
comparable GAAP financial measure to adjusted net product
revenue.
These non-GAAP financial measures, as presented, may not be
comparable to similarly titled measures reported by other companies
because not all companies calculate Adjusted EBITDA or adjust
revenue for currency fluctuations in an identical manner.
Therefore, these non-GAAP financial measures are not necessarily
accurate measures of comparison between companies.
The presentation of these non-GAAP financial measures is not
intended to be considered in isolation or as a substitute for
guidance prepared in accordance with GAAP. 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 in determining these
non-GAAP financial measures.
Forward Looking Statements
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. Any such forward-looking statements will be based on current
expectations and involve inherent risks and uncertainties,
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.
Meaningful factors that could cause actual results to differ
include, but are not limited to, uncertainties associated with
(a) governmental orders and policies adopted by healthcare
facilities to address the COVID-19 pandemic; (b) the possible
resurgence of the pandemic in certain markets; (c) the effects of
the emergence of COVID-19 variants that increase the
transmissibility of the coronavirus, particularly if those variants
are or become more deadly; (d) the success or failure of the
continued vaccine campaigns in Alimera’s markets; and (e) whether
and when Alimera’s international operations will return to their
prior growth trajectory in certain key markets, particularly
Germany; as well as the other factors discussed in the “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” sections of Alimera’s Annual
Report on Form 10-K for the year ended December 31, 2021 and
Alimera’s Quarterly Reports on Form 10-Q for the quarters ended
March 31, 2022 and June 30, 2022, which are on file with the SEC
and are available on Alimera’s website and the SEC’s website at
http://www.sec.gov. Additional factors will also be described in
those sections of Alimera’s Quarterly Report on Form 10-Q for the
third quarter of 2022 to be filed with the SEC today.
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 required by law. Therefore, you should not rely on these
forward-looking statements as representing Alimera’s views as of
any date after today.
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
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
(In thousands, except share and per share
data) |
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
5,514 |
|
|
$ |
16,510 |
|
Restricted cash |
|
28 |
|
|
|
34 |
|
Accounts receivable, net |
|
19,142 |
|
|
|
19,128 |
|
Prepaid expenses and other current assets |
|
3,290 |
|
|
|
3,809 |
|
Inventory |
|
1,786 |
|
|
|
2,679 |
|
Total current assets |
|
29,760 |
|
|
|
42,160 |
|
NON-CURRENT ASSETS: |
|
|
|
|
|
Property and equipment, net |
|
2,446 |
|
|
|
2,783 |
|
Right of use assets, net |
|
1,424 |
|
|
|
1,710 |
|
Intangible asset, net |
|
9,446 |
|
|
|
10,897 |
|
Deferred tax asset |
|
118 |
|
|
|
137 |
|
Warrant asset |
|
235 |
|
|
|
833 |
|
TOTAL ASSETS |
$ |
43,429 |
|
|
$ |
58,520 |
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
8,706 |
|
|
$ |
8,706 |
|
Accrued expenses |
|
3,661 |
|
|
|
3,617 |
|
Notes payable |
|
21,316 |
|
|
|
— |
|
Finance lease obligations |
|
327 |
|
|
|
269 |
|
Total current liabilities |
|
34,010 |
|
|
|
12,592 |
|
NON-CURRENT LIABILITIES: |
|
|
|
|
|
Notes payable, net of discount |
|
22,492 |
|
|
|
43,080 |
|
Other non-current liabilities |
|
5,005 |
|
|
|
5,453 |
|
COMMITMENTS AND
CONTINGENCIES |
|
|
|
|
|
STOCKHOLDERS’ DEFICIT: |
|
|
|
|
|
Preferred stock: |
|
|
|
|
|
Series A Convertible Preferred Stock |
|
19,227 |
|
|
|
19,227 |
|
Common stock |
|
70 |
|
|
|
69 |
|
Additional paid-in capital |
|
378,005 |
|
|
|
377,229 |
|
Accumulated deficit |
|
(411,608 |
) |
|
|
(397,281 |
) |
Accumulated other comprehensive loss |
|
(3,772 |
) |
|
|
(1,849 |
) |
TOTAL STOCKHOLDERS’
DEFICIT |
|
(18,078 |
) |
|
|
(2,605 |
) |
TOTAL LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
$ |
43,429 |
|
|
$ |
58,520 |
|
ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
FOR THE THREE AND NINE MONTHS ENDED
SEPTEMBER 30, 2022 AND 2021
(In thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
(In thousands, except share and per share
data) |
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
PRODUCT REVENUE, NET |
$ |
13,598 |
|
|
$ |
12,153 |
|
|
$ |
40,100 |
|
|
$ |
34,022 |
|
LICENSE REVENUE |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
11,048 |
|
NET REVENUE |
|
13,598 |
|
|
|
12,153 |
|
|
|
40,100 |
|
|
|
45,070 |
|
COST OF GOODS SOLD, EXCLUDING
DEPRECIATION AND AMORTIZATION |
|
(2,006 |
) |
|
|
(1,689 |
) |
|
|
(5,852 |
) |
|
|
(5,064 |
) |
GROSS PROFIT |
|
11,592 |
|
|
|
10,464 |
|
|
|
34,248 |
|
|
|
40,006 |
|
RESEARCH, DEVELOPMENT AND
MEDICAL AFFAIRS EXPENSES |
|
4,483 |
|
|
|
3,278 |
|
|
|
11,998 |
|
|
|
10,058 |
|
GENERAL AND ADMINISTRATIVE
EXPENSES |
|
3,352 |
|
|
|
2,808 |
|
|
|
9,537 |
|
|
|
9,577 |
|
SALES AND MARKETING
EXPENSES |
|
6,504 |
|
|
|
5,751 |
|
|
|
20,222 |
|
|
|
15,900 |
|
DEPRECIATION AND
AMORTIZATION |
|
664 |
|
|
|
649 |
|
|
|
2,023 |
|
|
|
1,920 |
|
OPERATING EXPENSES |
|
15,003 |
|
|
|
12,486 |
|
|
|
43,780 |
|
|
|
37,455 |
|
LOSS FROM OPERATIONS |
|
(3,411 |
) |
|
|
(2,022 |
) |
|
|
(9,532 |
) |
|
|
2,551 |
|
INTEREST EXPENSE AND
OTHER |
|
(1,500 |
) |
|
|
(1,360 |
) |
|
|
(4,247 |
) |
|
|
(4,050 |
) |
UNREALIZED FOREIGN CURRENCY
(LOSS) GAIN, NET |
|
(67 |
) |
|
|
142 |
|
|
|
79 |
|
|
|
323 |
|
GAIN ON EXTINGUISHMENT OF
DEBT |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,792 |
|
CHANGE IN FAIR VALUE OF
WARRANT ASSET |
|
(267 |
) |
|
|
(1,112 |
) |
|
|
(598 |
) |
|
|
(411 |
) |
NET (LOSS) INCOME BEFORE
TAXES |
|
(5,245 |
) |
|
|
(4,352 |
) |
|
|
(14,298 |
) |
|
|
205 |
|
INCOME TAX (PROVISION)
BENEFIT |
|
(12 |
) |
|
|
169 |
|
|
|
(29 |
) |
|
|
(471 |
) |
NET LOSS |
$ |
(5,257 |
) |
|
$ |
(4,183 |
) |
|
$ |
(14,327 |
) |
|
$ |
(266 |
) |
NET LOSS PER SHARE — Basic and
Diluted |
$ |
(0.75 |
) |
|
$ |
(0.60 |
) |
|
$ |
(2.05 |
) |
|
$ |
(0.04 |
) |
WEIGHTED AVERAGE SHARES
OUTSTANDING — Basic and Diluted |
|
6,996,575 |
|
|
|
6,924,174 |
|
|
|
6,995,695 |
|
|
|
6,480,952 |
|
RECONCILIATION OF GAAP MEASURES TO
NON-GAAP ADJUSTED MEASURES
(in thousands)
RECONCILIATION OF GAAP NET LOSS TO
NON-GAAP ADJUSTED EBITDA
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
(unaudited) |
GAAP NET LOSS |
$ |
(5,257 |
) |
|
$ |
(4,183 |
) |
|
$ |
(14,327 |
) |
|
$ |
(266 |
) |
Adjustments to net loss: |
|
|
|
|
|
|
|
Interest expense and other |
1,500 |
|
|
1,360 |
|
|
4,247 |
|
|
4,050 |
|
Provision (benefit) for taxes |
12 |
|
|
(169 |
) |
|
29 |
|
|
471 |
|
Depreciation and amortization |
664 |
|
|
649 |
|
|
2,023 |
|
|
1,920 |
|
Stock-based compensation expenses |
143 |
|
|
244 |
|
|
723 |
|
|
758 |
|
Unrealized foreign currency exchange loss (gain), net |
67 |
|
|
(142 |
) |
|
(79 |
) |
|
(323 |
) |
Gain on extinguishment of debt |
— |
|
|
— |
|
|
— |
|
|
(1,792 |
) |
Change in fair value of warrant asset |
267 |
|
|
1,112 |
|
|
598 |
|
|
411 |
|
Severance expenses |
110 |
|
|
— |
|
|
147 |
|
|
195 |
|
NON-GAAP ADJUSTED EBITDA |
$ |
(2,494 |
) |
|
$ |
(1,129 |
) |
|
$ |
(6,639 |
) |
|
$ |
5,424 |
|
RECONCILIATION OF GAAP NET PRODUCT REVENUE TO NON-GAAP
ADJUSTED NET PRODUCT REVENUE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
(unaudited) |
GAAP NET PRODUCT REVENUE |
$ |
13,598 |
|
|
$ |
12,153 |
|
|
$ |
40,100 |
|
|
$ |
34,022 |
|
Adjustment to net product
revenue: |
|
|
|
|
|
|
|
Foreign currency fluctuations, net |
809 |
|
|
- |
|
|
1,894 |
|
|
- |
|
NON-GAAP ADJUSTED
NET PRODUCT REVENUE |
$ |
14,407 |
|
|
$ |
12,153 |
|
|
$ |
41,994 |
|
|
$ |
34,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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