Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a global
pharmaceutical company that specializes in the commercialization
and development of prescription ophthalmic pharmaceuticals, today
announced top-line financial results for the three months ended
June 30, 2017.
“We are very pleased that in the second quarter of 2017 we
achieved positive adjusted EBITDA for the first time in the history
of the Company”, said Dan Myers, Alimera's Chief Executive Officer.
“We accomplished this through revenue growth of 8% compared to the
same period in 2016 while establishing an appropriate level of
operating expenses following the U.S. launch. Additionally, we
amended our agreement with pSivida in July to allow for the
potential expansion of ILUVIEN’s indication to include posterior
uveitis in Europe, the Middle East and Africa. We continue to
present new real world data on ILUVIEN in Europe and the U.S. data
that we believe will resonate well with physicians. Importantly,
due to our anticipated growth and level of operating expenses, we
believe we will be able to achieve positive operating cash flow
late this year.”
Second Quarter Financial Results
Consolidated net revenue increased by approximately $800,000, or
8%, to approximately $10.4 million for the three months ended June
30, 2017, compared to net revenue of approximately $9.6 million for
the three months ended June 30, 2016. The increase was primarily
attributable to increased sales volume in the U.S.
U.S. net revenue increased by approximately $900,000, or 13%, to
approximately $8.1 million for the three months ended June 30,
2017, compared to U.S. net revenue of approximately $7.2 million
for the three months ended June 30, 2016. The increase was driven
by increased sales of ILUVIEN in the U.S., primarily attributable
to an increase in end user unit demand of 9%.
International net revenue was approximately $2.3 million for the
three months ended June 30, 2017 and 2016. International segment
demand, primarily in Germany, the UK and Portugal, was flat,
suppressed in the second quarter of 2017 due to an out of stock
situation in Germany as a result of increasing demand in the first
quarter of 2017.
Consolidated gross profit increased by $600,000, or 7%, to $9.6
million for three months ended June 30, 2017, compared to $9.0
million for the three months ended June 30, 2016. Gross margin was
93% and 94% for the three months ended June 30, 2017 and 2016,
respectively.
Consolidated operating expenses decreased by approximately $4.5
million, or 29%, to approximately $11.0 million for the three
months ended June 30, 2017, compared to $15.5 million for the three
months ended June 30, 2016.
Consolidated research, development and medical affairs expenses
for the three months ended June 30, 2017 decreased by approximately
$1.0 million, or 31%, to approximately $2.2 million, compared to
$3.2 million for the three months ended June 30, 2016. The
reduction was primarily attributable to a reduction in Alimera’s
international scientific study costs and decreases in personnel
costs.
Consolidated general and administrative expenses for the three
months ended June 30, 2017 decreased by approximately $1.0 million,
or 25%, to approximately $3.0 million, compared to approximately
$4.0 million for the three months ended June 30, 2016. The
reduction was primarily attributable to a reduction in personnel
costs and due to a payment we made to pSivida in 2016 as part of a
dispute that was later settled in 2017.
Consolidated sales and marketing expenses decreased by $2.4
million, or 32%, to $5.1 million for the three months ended June
30, 2017, compared to $7.5 million reported for the three months
ended June 30, 2016. The decrease was primarily attributable to
cost saving plans implemented by Alimera in late 2016 and early
2017.
Alimera's reported GAAP net loss was approximately $2.8 million
for the three months ended June 30, 2017, compared to approximately
$6.9 million loss reported for the three months ended June 30,
2016.
Non-GAAP Financial Results
Adjusted EBITDA, as defined below, was approximately positive
$0.5 million for the three months ended June 30, 2017, compared to
approximately negative $4.4 million for the three months ended June
30, 2016. This was due to the increase in revenue globally and the
decrease in operating expenses due to the cost savings plans
Alimera implemented in late 2016 and early 2017.
For purpose of this press release, “Adjusted EBITDA” is adjusted
earnings before interest, taxes, depreciation, amortization,
non-cash stock-based compensation expenses, and to the extent they
are included in the calculation of earnings, net unrealized gains
and losses from foreign currency exchange transactions and gains
and losses from the change in the fair value of derivative warrant
liability.
Alimera provides non-GAAP financial information, which it
believes can enhance an overall understanding of its financial
performance when considered together with GAAP figures. Refer to
the sections of this press release entitled “Non-GAAP Financial
Information” and “Reconciliation of GAAP Measures to Non-GAAP
Adjusted Measures,” which includes Adjusted EBITDA and Adjusted
Operating Expenses.
Conference Call
An accompanying conference call will be hosted by Dan Myers,
Chief Executive Officer and Rick Eiswirth, President and Chief
Financial Officer. The call will be held at 9:00 AM ET, on August
3, 2017. Please refer to the information below for conference call
dial-in information and webcast registration.
Conference date: August 3, 2017, 9:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Alimera Sciences Second
Quarter 2017 Results Call Webcast Registration:
Click Here
Following the live call, a replay will be available on the
Company's website, www.alimerasciences.com, under "Investor
Relations".
Non-GAAP Financial Information
This press release contains a discussion of a non-GAAP financial
measure, as defined in Regulation G of 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 and Adjusted Operating Expenses will be a more
relevant measure of Alimera’s operating performance. Alimera uses
Adjusted EBITDA and Adjusted Operating Expenses in the management
of its business and Alimera’s lender uses Adjusted EBITDA as a
financial covenant measurement. Accordingly, Adjusted EBITDA and
Adjusted Operating Expenses for the second quarter of 2017 have
been presented in certain instances excluding items identified in
the reconciliations provided. For a reconciliation of these
non-GAAP financial measures to their most directly comparable GAAP
financial measure, see the table below.
This non-GAAP financial measure, as presented, may not be
comparable to similarly titled measures reported by other companies
since not all companies may calculate this measure in an identical
manner and, therefore, it is not necessarily an accurate measure 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 this non-GAAP financial measure is that it excludes significant
elements that are required by GAAP to be recorded in Alimera’s
financial statements. In addition, it is subject to inherent
limitations as they reflect the exercise of judgments by management
in determining this non-GAAP financial measure. In order to
compensate for these limitations, Alimera presents its non-GAAP
financial results in connection with its GAAP results. Investors
are encouraged to review the reconciliation of our non-GAAP
financial measures to their most directly comparable GAAP financial
measure.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, 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 will affect millions of people in aging populations. Alimera's
commitment to retina specialists and their patients is manifest in
its product and in its development portfolio designed to treat
early- and late-stage diseases. For more information, please visit
www.alimerasciences.com.
Forward-Looking Statements
This press release contains "forward-looking statements," within
the meaning of the Private Securities Litigation Reform Act of
1995, regarding, among other things, the opportunity for further
growth in 2017 for ILUVIEN and the ability of Alimera to achieve
positive operating cash flow. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual results to differ materially
from those projected in its forward-looking statements. Meaningful
factors which could cause actual results to differ include, but are
not limited to, continued market acceptance of ILUVIEN in the U.S.
and Europe, including physicians' ability to obtain reimbursement,
as well as 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, 2016 and Quarterly Report on
Form 10-Q for the quarter ended March 31, 2017, which are on file
with the Securities and Exchange Commission (the SEC) and available
on the SEC's website at http://www.sec.gov. Additional factors may
be set forth in those sections of Alimera's Quarterly Report on
Form 10-Q for the quarter ended June 30, 2017, to be filed with the
SEC in the third quarter of 2017. In addition to the risks
described above and in Alimera's Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the SEC, other unknown or unpredictable factors
also could affect Alimera's results. There can be no assurance that
the actual results or developments anticipated by Alimera will be
realized or, even if substantially realized, that they will have
the expected consequences to, or effects on, Alimera. Therefore, no
assurance can be given that the outcomes stated in such
forward-looking statements and estimates will be achieved. 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 too
heavily on the forward-looking statements Alimera makes or that are
made on its behalf. These forward-looking statements 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.
|
|
ALIMERA SCIENCES, INC. |
CONSOLIDATED BALANCE SHEETS |
|
|
June 30,2017 |
|
December 31,2016 |
|
(In thousands, except share and per
share data) |
CURRENT ASSETS: |
|
|
|
Cash and
cash equivalents |
$ |
26,882 |
|
|
$ |
30,979 |
|
Restricted cash |
33 |
|
|
31 |
|
Accounts
receivable, net |
13,648 |
|
|
13,839 |
|
Prepaid
expenses and other current assets |
2,574 |
|
|
2,107 |
|
Inventory, net |
1,143 |
|
|
446 |
|
Total current assets |
44,280 |
|
|
47,402 |
|
NON-CURRENT
ASSETS: |
|
|
|
Property
and equipment, net |
1,477 |
|
|
1,787 |
|
Intangible asset, net |
19,642 |
|
|
20,604 |
|
Deferred
tax asset |
474 |
|
|
436 |
|
TOTAL ASSETS |
$ |
65,873 |
|
|
$ |
70,229 |
|
CURRENT
LIABILITIES: |
|
|
|
Accounts
payable |
$ |
5,711 |
|
|
$ |
4,986 |
|
Accrued
expenses |
3,729 |
|
|
3,758 |
|
Derivative warrant liability |
— |
|
|
188 |
|
Capital
lease obligations |
137 |
|
|
191 |
|
Total current liabilities |
9,577 |
|
|
9,123 |
|
NON-CURRENT
LIABILITIES: |
|
|
|
Note
payable |
33,689 |
|
|
33,084 |
|
Capital
lease obligations — less current portion |
132 |
|
|
274 |
|
Other
non-current liabilities |
773 |
|
|
2,162 |
|
COMMITMENTS AND
CONTINGENCIES |
|
|
|
STOCKHOLDERS’
EQUITY: |
|
|
|
Preferred
stock, |
|
|
|
Series A Convertible Preferred Stock |
19,227 |
|
|
19,227 |
|
Series B Convertible Preferred Stock |
49,568 |
|
|
49,568 |
|
Common
stock |
670 |
|
|
649 |
|
Additional paid-in capital |
336,093 |
|
|
330,781 |
|
Common
stock warrants |
3,707 |
|
|
3,707 |
|
Accumulated deficit |
(386,566 |
) |
|
(377,074 |
) |
Accumulated other comprehensive loss |
(997 |
) |
|
(1,272 |
) |
TOTAL STOCKHOLDERS’
EQUITY |
21,702 |
|
|
25,586 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
65,873 |
|
|
$ |
70,229 |
|
|
|
ALIMERA SCIENCES, INC. |
CONSOLIDATED STATEMENTS OF
OPERATIONS |
FOR THE THREE AND SIX MONTHS ENDED
JUNE 30, 2017 AND 2016 |
|
|
Three Months EndedJune
30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
(In thousands, except share and per share
data) |
NET REVENUE |
$ |
10,368 |
|
|
$ |
9,557 |
|
|
$ |
16,986 |
|
|
$ |
15,358 |
|
COST OF GOODS SOLD,
EXCLUDING DEPRECIATION AND AMORTIZATION |
(769 |
) |
|
(556 |
) |
|
(1,356 |
) |
|
(934 |
) |
GROSS PROFIT |
9,599 |
|
|
9,001 |
|
|
15,630 |
|
|
14,424 |
|
|
|
|
|
|
|
|
|
RESEARCH, DEVELOPMENT
AND MEDICAL AFFAIRS EXPENSES |
2,238 |
|
|
3,205 |
|
|
4,348 |
|
|
6,225 |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
3,012 |
|
|
4,039 |
|
|
6,276 |
|
|
7,434 |
|
SALES AND MARKETING
EXPENSES |
5,060 |
|
|
7,510 |
|
|
10,562 |
|
|
14,619 |
|
DEPRECIATION AND
AMORTIZATION |
667 |
|
|
696 |
|
|
1,333 |
|
|
1,385 |
|
OPERATING EXPENSES |
10,977 |
|
|
15,450 |
|
|
22,519 |
|
|
29,663 |
|
NET LOSS FROM
OPERATIONS |
(1,378 |
) |
|
(6,449 |
) |
|
(6,889 |
) |
|
(15,239 |
) |
|
|
|
|
|
|
|
|
INTEREST EXPENSE, NET
AND OTHER |
(1,384 |
) |
|
(1,177 |
) |
|
(2,721 |
) |
|
(2,512 |
) |
UNREALIZED FOREIGN
CURRENCY GAIN (LOSS), NET |
28 |
|
|
(14 |
) |
|
— |
|
|
20 |
|
CHANGE IN FAIR VALUE OF
DERIVATIVE WARRANT LIABILITY |
21 |
|
|
824 |
|
|
188 |
|
|
2,343 |
|
LOSS ON EARLY
EXTINGUISHMENT OF DEBT |
— |
|
|
— |
|
|
— |
|
|
(2,564 |
) |
NET LOSS BEFORE
TAXES |
(2,713 |
) |
|
(6,816 |
) |
|
(9,422 |
) |
|
(17,952 |
) |
PROVISION FOR
TAXES |
(44 |
) |
|
(42 |
) |
|
(70 |
) |
|
(51 |
) |
NET LOSS |
$ |
(2,757 |
) |
|
$ |
(6,858 |
) |
|
$ |
(9,492 |
) |
|
$ |
(18,003 |
) |
NET LOSS PER SHARE —
Basic and diluted |
$ |
(0.04 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.40 |
) |
WEIGHTED AVERAGE SHARES
OUTSTANDING — Basic and diluted |
65,485,106 |
|
|
45,088,072 |
|
|
65,175,724 |
|
|
45,046,952 |
|
|
|
RECONCILIATION OF GAAP MEASURES TO NON-GAAP
ADJUSTED MEASURES |
GAAP NET LOSS TO NON-GAAP ADJUSTED
EBITDA |
|
|
Three Months EndedJune
30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
(In thousands, unaudited) |
GAAP Net Loss |
$ |
(2,757 |
) |
|
$ |
(6,858 |
) |
|
$ |
(9,492 |
) |
|
$ |
(18,003 |
) |
Adjustments to Net Loss: |
|
|
|
|
|
|
|
|
|
|
|
Interest
Expense, Net and Other |
1,384 |
|
|
1,177 |
|
|
2,721 |
|
|
2,512 |
|
Depreciation and Amortization |
667 |
|
|
696 |
|
|
1,333 |
|
|
1,385 |
|
Provision
for Taxes |
44 |
|
|
42 |
|
|
70 |
|
|
51 |
|
Stock-Based Compensation |
1,233 |
|
|
1,323 |
|
|
2,400 |
|
|
2,620 |
|
Unrealized Foreign Currency Exchange (Gains) Losses
|
(28 |
) |
|
14 |
|
|
— |
|
|
(20 |
) |
Change in
the Fair Value of Derivative Warrant Liability |
(21 |
) |
|
(824 |
) |
|
(188 |
) |
|
(2,343 |
) |
NON-GAAP Adjusted
EBITDA |
$ |
522 |
|
|
$ |
(4,430 |
) |
|
$ |
(3,156 |
) |
|
$ |
(13,798 |
) |
|
|
GAAP OPERATING EXPENSES TO NON-GAAP ADJUSTED
OPERATING EXPENSES |
|
|
Three Months EndedJune
30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
(In thousands, unaudited) |
GAAP Operating
Expenses |
$ |
10,977 |
|
|
$ |
15,450 |
|
|
$ |
22,519 |
|
|
$ |
29,663 |
|
Adjustments to Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and Amortization |
(667 |
) |
|
(696 |
) |
|
(1,333 |
) |
|
(1,385 |
) |
Stock-Based Compensation |
(1,233 |
) |
|
(1,323 |
) |
|
(2,400 |
) |
|
(2,620 |
) |
NON-GAAP Adjusted
Operating Expenses |
$ |
9,077 |
|
|
$ |
13,431 |
|
|
$ |
18,786 |
|
|
$ |
25,658 |
|
|
For press inquiries:
Katie Brazel
for Alimera Sciences
404-317-8361
kbrazel@bellsouth.net
For investor inquiries:
CG Capital
for Alimera Sciences
877-889-1972
investorrelations@cg.capital
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