Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the
commercialization and development of prescription ophthalmology
treatments for the management of retinal diseases, announces
financial results for the three months ended March 31, 2020.
Alimera will host a conference call on Thursday, April 30, 2020 at
9:00 AM ET to review these financial results and provide an update
on corporate developments.
“I want to recognize both our employees who have addressed the
challenges of COVID-19 with great energy and dedication and the
retina physicians and their staffs around the world who are serving
patients during this difficult time. As for the first quarter
results, we are pleased to report consolidated revenue of $14.5
million, a 12% gain over the first quarter of last year. We also
narrowed our GAAP net loss by 57% while achieving $1.3 million in
positive adjusted EBITDA despite the advent of the coronavirus
pandemic in the quarter,” said Rick Eiswirth, Alimera’s President
and Chief Executive Officer. Mr. Eiswirth continued: “With
the onset of COVID-19 in the regions where we operate, our access
to physicians, and patients’ willingness to visit physicians, has
become limited, especially for diabetic patients who have been
advised they are at higher risk for severe illness from COVID-19.
With very little in-person access to physicians and hospitals, it
has been challenging or impossible for our sales representatives to
meet with retina specialists and their staff to educate them about
the benefits of ILUVIEN©. These limitations and other effects of
COVID-19 had a material adverse impact on our revenues late in the
first quarter and in the month of April. We expect these factors to
continue to adversely impact our revenue, but the extent and
duration of that impact is uncertain at this time. Therefore,
we are aggressively managing our non-payroll expenses to mitigate
this loss of revenue and retain our personnel to serve physicians
when access is restored.”
Mr. Eiswirth further observed, regarding ILUVIEN: “We believe
that the COVID-19 experience highlights the benefits of ILUVIEN as
a non-acute therapy treating diabetic macular edema and uveitis
consistently and continuously for up to three years while reducing
the recurrence of these diseases. As more patients begin to return
to physician clinics, we expect physicians will need to manage
through a significant backlog of patients and will consider
reducing the risk of COVID-19 exposure to patients by adopting a
therapy like ILUVIEN that requires fewer office visits than
short-acting treatments.”
First Quarter 2020 Financial Results
Consolidated Net RevenueConsolidated net revenue for Q1 2020 grew
12% to $14.5 million, compared to $12.9 million for Q1 2019.
U.S. net revenue was $7.1 million for Q1 2020, up 4% from $6.8
million during the same period in 2019. End user demand, which
represents units purchased by physicians and pharmacies from
Alimera’s U.S. distributors, decreased in Q1 2020 to 855 units
compared to 973 units in Q1 2019 due to the impact from the
COVID-19 virus pandemic late in the first quarter, as well as a
temporary shortage in stock in the U.S. in the first quarter. There
was no material increase in the stock levels held by the company’s
U.S. distributors during the quarter, as sales to distributors only
differed from end user demand by approximately 3%.
International net revenue increased 23% to approximately $7.5
million in Q1 2020, compared to approximately $6.1 million for the
same period during 2019, driven primarily by growth in our DME
business in Alimera’s direct markets as well as the launches of
ILUVIEN’s uveitis indication in Germany and the U.K. in the second
half of 2019.
Operating Expenses Total operating expenses for Q1 2020
decreased by $0.3 million or 2% to $12.4 million, compared to
$12.7 million during Q1 2019.
Net Loss and Non-GAAP Adjusted EBITDAFor Q1 2020, Alimera
reported a net loss of approximately $1.2 million, compared to
a net loss of $2.8 million for Q1 2019. “Adjusted EBITDA,” a
non-GAAP financial measure defined below, was approximately $1.3
million for Q1 2020, compared to approximately $27,000 for Q1
2019.
Net Loss per ShareBasic and diluted net loss per share for Q1
2020 was $0.24. This compares to basic and diluted net loss per
share for Q1 2019 of $0.59.
Cash and Cash EquivalentsOn February 24, 2020, Alimera announced
that it had drawn down the remaining $2.5 million under the
$45 million term loan agreement with its current lenders,
investment affiliates managed by Solar Capital Partners, LLC. Under
the terms of the agreement, Alimera had the option to draw down an
additional $2.5 million if it achieved $30.0 million in
revenue for any trailing six-month period ending on or before
November 30, 2020. The $2.5 million loan brings the total Alimera
borrowings under the agreement to the maximum $45 million
available.
As of March 31, 2020, Alimera had cash and cash equivalents of
approximately $12.2 million, compared to $9.4 million in cash
and cash equivalents as of December 31, 2019.
On April 23, 2020, Alimera announced that it received on April
22, 2020 approximately $1.8 million in support from the federal
government under the Paycheck Protection Program.
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 and severance expenses. Please refer to the
sections of this press release entitled “Non-GAAP Financial
Measure” and “Reconciliation of GAAP Net Loss to Non-GAAP Adjusted
EBITDA.”
Conference Call to Be Held April 30, 2020A live
conference call will be hosted on April 30, 2020 at 9:00am eastern
time by Rick Eiswirth, President and Chief Executive Officer, and
Phil Jones, Chief Financial Officer, to discuss Alimera’s financial
results. Please refer to the information below for conference call
dial-in information and webcast registration.
Conference date: Thursday April 30, 2020 9:00 AM ET Conference
dial-in: 866-777-2509International dial-in:
412-317-5413Conference Call Name: Alimera Sciences (Nasdaq: ALIM)
First Quarter 2020 Financial Results and Corporate Update
Conference Call Conference Call Pre-registration: Participants
can register for the conference by navigating to
http://dpregister.com/10142450Please note that
registered participants will receive their dial in number upon
registration and will dial directly into the call without
delay.Live Webcast URL:
https://services.choruscall.com/links/alimera200430.html
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:
10142450End Date: May 14, 2020
About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera is a pharmaceutical company that specializes in the
commercialization and development of prescription ophthalmic
pharmaceuticals. Alimera is presently focused on diseases affecting
the back of the eye, or retina, because these diseases are not well
treated with current therapies and affect millions of people
globally. 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 months March 31, 2020
has been presented in certain instances excluding items identified
in the reconciliations provided in the table entitled
“Reconciliation of GAAP Net Loss to non-GAAP Adjusted EBITDA.” GAAP
net 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.
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is
a sustained release intravitreal implant, injected into the back of
the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is
designed to release submicrogram levels of fluocinolone acetonide,
a corticosteroid, for up to 36 months, to reduce the recurrence of
disease, enabling patients to maintain vision longer with fewer
injections. ILUVIEN is approved in the U.S., Canada, Kuwait,
Lebanon and the U.A.E. to treat diabetic macular edema (DME) in
patients who have been previously treated with a course of
corticosteroids and did not have a clinically significant rise in
intraocular pressure. In 17 European countries, ILUVIEN is
indicated for the treatment of vision impairment associated with
chronic DME considered insufficiently responsive to available
therapies and for prevention of relapse in recurrent non-infectious
uveitis affecting the posterior segment of the eye (NIPU). Alimera
does not have the contractual right to pursue approval to treat
uveitis in the U.S., and therefore does not have a regulatory
license in the U.S. to treat NIPU. For important safety information
on ILUVIEN, see https://iluvien.com/#isi
Forward Looking Statements
This press release contains, and the remarks by Alimera’s
officers on the conference call may contain, “forward-looking
statements,” within the meaning of the Private Securities
Litigation Reform Act of 1995, regarding, among other things,
Alimera’s expectations regarding (a) the level of sales in this
quarter, (b) the continuance of the current circumstances for
patient visits with their physicians and the effects of those
circumstances, (c) opportunities for the sale of ILUVIEN when
patient visits resume at a more normal level, (d) Alimera’s
modification of its operational activities and the effect of those
modifications, and (e) Alimera’s intention to retain its personnel
to serve physicians when access is restored. Such forward-looking
statements are based on current expectations and involve inherent
risks and uncertainties, including factors that could delay, divert
or change them, and could cause actual results to differ materially
from those projected in the forward-looking statements. Meaningful
factors that could cause actual results to differ include, but are
not limited to,
- uncertainty about the impact of COVID on Alimera’s revenue, the
duration of the pandemic, Alimera’s ability to manage its expenses
and whether it can manage those expenses sufficiently to mitigate
the loss of revenue;
- other adverse effects of COVID-19 in the regions where Alimera
has customers, employees and distributors;
- the adverse effects of COVID-19 on sales of ILUVIEN resulting
from (a) limitations on in-person access to physicians and (b) the
unwillingness of patients, many of whom suffer from diabetic
macular edema, to visit their physicians in person due to their
fear of contracting COVID-19;
- Alimera’s ability to retain its personnel, given the uncertain
COVID-19 environment and the anticipated lower level of sales of
ILUVIEN or
other unexpected circumstances, and 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, 2019, which are on file with the Securities and Exchange
Commission (SEC) and available on 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
first quarter of 2020, to be filed with the SEC soon.
The forward-looking statements in this press release speak only
as of the date of this press release (unless another date is
indicated). Alimera undertakes no obligation, and specifically
declines any obligation, to publicly update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
For investor
inquiries:
Scott Gordonfor Alimera Sciences
scottg@coreir.com |
For media
inquiries:Jules Abrahamfor Alimera
Sciencesjulesa@coreir.com |
ALIMERA SCIENCES,
INC.CONSOLIDATED BALANCE
SHEETS(in thousands)
|
|
|
|
|
|
|
|
March 31,2020 |
|
December 31,2019 |
|
(unaudited) |
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
$ |
12,242 |
|
|
$ |
9,426 |
|
Restricted cash |
31 |
|
|
33 |
|
Accounts receivable, net |
16,179 |
|
|
19,331 |
|
Prepaid expenses and other
current assets |
2,497 |
|
|
2,565 |
|
Inventory |
1,196 |
|
|
1,390 |
|
Total current assets |
32,145 |
|
|
32,745 |
|
NON-CURRENT ASSETS: |
|
|
|
Property and equipment,
net |
867 |
|
|
940 |
|
Right of use assets, net |
967 |
|
|
1,107 |
|
Intangible asset, net |
14,299 |
|
|
14,783 |
|
Deferred tax asset |
720 |
|
|
734 |
|
TOTAL ASSETS |
$ |
48,998 |
|
|
$ |
50,309 |
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable |
$ |
5,833 |
|
|
$ |
7,077 |
|
Accrued expenses |
3,045 |
|
|
4,716 |
|
Finance lease obligations |
243 |
|
|
255 |
|
Total current liabilities |
9,121 |
|
|
12,048 |
|
NON-CURRENT LIABILITIES: |
|
|
|
Note payable, net of
discount |
41,395 |
|
|
38,658 |
|
Finance lease obligations —
less current portion |
97 |
|
|
94 |
|
Other non-current
liabilities |
3,789 |
|
|
3,954 |
|
COMMITMENTS AND
CONTINGENCIES |
|
|
|
STOCKHOLDERS’ DEFICIT: |
|
|
|
Preferred stock: |
|
|
|
Series A Convertible Preferred
Stock |
19,227 |
|
|
19,227 |
|
Series C Convertible Preferred
Stock |
11,117 |
|
|
11,117 |
|
Common stock |
50 |
|
|
50 |
|
Additional paid-in
capital |
350,442 |
|
|
350,117 |
|
Common stock warrants |
3,707 |
|
|
3,707 |
|
Accumulated deficit |
(388,768 |
) |
|
(387,570 |
) |
Accumulated other
comprehensive loss |
(1,179 |
) |
|
(1,093 |
) |
TOTAL STOCKHOLDERS’
DEFICIT |
(5,404 |
) |
|
(4,445 |
) |
TOTAL LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
$ |
48,998 |
|
|
$ |
50,309 |
|
ALIMERA SCIENCES,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONSFOR THE THREE MONTHS ENDED
MARCH 31, 2020 AND 2019(in thousands, except
share and per share data)
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
2020 |
|
2019 |
|
(Unaudited) |
|
|
NET REVENUE |
$ |
14,535 |
|
|
$ |
12,890 |
|
COST OF GOODS SOLD, EXCLUDING
DEPRECIATION AND AMORTIZATION |
(1,927 |
) |
|
(1,600 |
) |
GROSS PROFIT |
12,608 |
|
|
11,290 |
|
|
|
|
|
RESEARCH, DEVELOPMENT AND
MEDICAL AFFAIRS EXPENSES |
2,883 |
|
|
2,727 |
|
GENERAL AND ADMINISTRATIVE
EXPENSES |
3,181 |
|
|
3,393 |
|
SALES AND MARKETING
EXPENSES |
5,672 |
|
|
5,913 |
|
DEPRECIATION AND
AMORTIZATION |
654 |
|
|
652 |
|
OPERATING EXPENSES |
12,390 |
|
|
12,685 |
|
NET INCOME (LOSS) FROM
OPERATIONS |
218 |
|
|
(1,395 |
) |
|
|
|
|
INTEREST EXPENSE AND
OTHER |
(1,292 |
) |
|
(1,228 |
) |
UNREALIZED FOREIGN CURRENCY
LOSS, NET |
(81 |
) |
|
(69 |
) |
NET LOSS BEFORE TAXES |
(1,155 |
) |
|
(2,692 |
) |
PROVISION FOR TAXES |
(43 |
) |
|
(71 |
) |
NET LOSS |
$ |
(1,198 |
) |
|
$ |
(2,763 |
) |
NET LOSS PER SHARE — Basic and
diluted |
$ |
(0.24 |
) |
|
$ |
(0.59 |
) |
WEIGHTED AVERAGE SHARES
OUTSTANDING — Basic and diluted |
4,980,722 |
|
|
4,716,054 |
|
ALIMERA SCIENCES,
INC.REPORTABLE SEGMENT
INFORMATIONFOR THE THREE MONTHS ENDED MARCH 31,
2020 AND 2019(in thousands)
|
|
|
Three Months EndedMarch 31,
2020 |
|
Three Months EndedMarch 31,
2019 |
|
|
|
U.S. |
|
International |
|
Other |
|
Consolidated |
|
U.S. |
|
International |
|
Other |
|
Consolidated |
|
|
(unaudited) |
|
NET REVENUE |
$ |
7,068 |
|
|
$ |
7,467 |
|
|
$ |
— |
|
|
$ |
14,535 |
|
|
$ |
6,766 |
|
|
$ |
6,124 |
|
|
$ |
— |
|
|
$ |
12,890 |
|
|
COST OF GOODS
SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
(759 |
) |
|
(1,168 |
) |
|
— |
|
|
(1,927 |
) |
|
(685 |
) |
|
(915 |
) |
|
— |
|
|
(1,600 |
) |
|
GROSS PROFIT |
6,309 |
|
|
6,299 |
|
|
— |
|
|
12,608 |
|
|
6,081 |
|
|
5,209 |
|
|
— |
|
|
11,290 |
|
|
|
|
RESEARCH,
DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
1,922 |
|
|
893 |
|
|
68 |
|
|
2,883 |
|
|
1,427 |
|
|
1,170 |
|
|
130 |
|
|
2,727 |
|
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
1,973 |
|
|
936 |
|
|
272 |
|
|
3,181 |
|
|
1,933 |
|
|
988 |
|
|
472 |
|
|
3,393 |
|
|
SALES AND
MARKETING EXPENSES |
4,280 |
|
|
1,292 |
|
|
100 |
|
|
5,672 |
|
|
4,041 |
|
|
1,705 |
|
|
167 |
|
|
5,913 |
|
|
DEPRECIATION AND
AMORTIZATION |
— |
|
|
— |
|
|
654 |
|
|
654 |
|
|
— |
|
|
— |
|
|
652 |
|
|
652 |
|
|
OPERATING
EXPENSES |
8,175 |
|
|
3,121 |
|
|
1,094 |
|
|
12,390 |
|
|
7,401 |
|
|
3,863 |
|
|
1,421 |
|
|
12,685 |
|
|
SEGMENT (LOSS)
INCOME FROM OPERATIONS |
(1,866 |
) |
|
3,178 |
|
|
(1,094 |
) |
|
218 |
|
|
(1,320 |
) |
|
1,346 |
|
|
(1,421 |
) |
|
(1,395 |
) |
|
OTHER INCOME AND
EXPENSES, NET |
— |
|
|
— |
|
|
(1,373 |
) |
|
(1,373 |
) |
|
— |
|
|
— |
|
|
(1,297 |
) |
|
(1,297 |
) |
|
NET LOSS BEFORE
TAXES |
|
|
|
|
|
|
$ |
(1,155 |
) |
|
|
|
|
|
|
|
$ |
(2,692 |
) |
RECONCILIATION OF GAAP MEASURES TO
NON-GAAP ADJUSTED MEASURESGAAP NET LOSS TO
NON-GAAP ADJUSTED EBITDA(in
thousands)
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
2020 |
|
2019 |
|
(Unaudited) |
|
|
|
|
GAAP NET LOSS |
$ |
(1,198 |
) |
|
$ |
(2,763 |
) |
Adjustments to net loss: |
|
|
|
Interest expense and
other |
1,292 |
|
|
1,228 |
|
Provision for taxes |
43 |
|
|
71 |
|
Depreciation and
amortization |
654 |
|
|
652 |
|
Stock-based compensation
expenses |
440 |
|
|
770 |
|
Unrealized foreign currency
exchange losses |
81 |
|
|
69 |
|
NON-GAAP ADJUSTED EBITDA |
$ |
1,312 |
|
|
$ |
27 |
|
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