Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a global
pharmaceutical company that specializes in the commercialization,
research and development of prescription ophthalmic
pharmaceuticals, today announced top-line financial results for the
three months ended March 31, 2017.
“We are very pleased with the significant increase in end user
unit demand seen in the first quarter of 2017. Additionally, our
distribution partners made strides to put us in an excellent
position for expansion of ILUVIEN availability in our international
business,” said Dan Myers, Alimera's Chief Executive Officer.
“The presentation of real world data on ILUVIEN this week at
the ARVO conference, data that we believe better demonstrates
ILUVIEN’s safety and effectiveness than our pivotal FAME Trial,
will resonate well with physicians and will have a positive impact
on our business. Due to the increase in end user unit demand,
anticipated growth and our reduction in operating expenses, we
believe we should be able to achieve positive cash flows from
operations.”
First Quarter Financial Results
Consolidated net revenue increased by approximately $800,000, or
14%, to approximately $6.6 million for the three months ended March
31, 2017, compared to net revenue of approximately $5.8 million for
the three months ended March 31, 2016. The increase was
primarily attributable to increased sales volume in the U.S. and
our international segment.
U.S. net revenue increased by approximately $300,000, or 7%, to
approximately $4.4 million for the three months ended March 31,
2017, compared to U.S. net revenue of approximately $4.1 million
for the three months ended March 31, 2016. This increase was
driven by increased sales of ILUVIEN in the U.S., attributable to
an increase in end user unit demand, offset by fluctuations in the
timing of orders by our two U.S. distributors.
International net revenue increased approximately $500,000, or
29%, to approximately $2.2 million for the three months ended March
31, 2017, compared to approximately $1.7 million for the three
months ended March 31, 2016. The increase was primarily
attributable to higher sales volume in the United Kingdom, Germany
and Portugal compared to the first quarter of 2016, offset by
decreases in the value of the British pound sterling and the Euro
which impacted reported revenue.
Consolidated gross profit increased by $600,000, or 11%, to $6.0
million for three months ended March 31, 2017, compared with $5.4
million for the three months ended March 31, 2016. Gross margin was
91% and 93% for the three months ended March 31, 2017 and 2016,
respectively.
Consolidated operating expenses decreased by approximately $2.7
million, or 19%, to approximately $11.5 million for the three
months ended March 31, 2017, compared to $14.2 million for the
three months ended March 31, 2016.
Consolidated research, development and medical affairs expenses
for the three months ended March 31, 2017 decreased by
approximately $900,000, or 30%, to approximately $2.1 million,
compared to $3.0 million for the three months ended March 31, 2016.
The reduction was primarily attributable to a reduction in ongoing
clinical study and regulatory maintenance costs.
Consolidated general and administrative expenses for the three
months ended March 31, 2017 decreased by approximately $100,000, or
3%, to approximately $3.3 million, compared to approximately $3.4
million for the three months ended March 31, 2016.
Consolidated sales and marketing expenses decreased by $1.6
million, or 23%, to $5.5 million for the three months ended March
31, 2017, compared to $7.1 million reported for the three months
ended March 31, 2016. The decrease was primarily attributable to
cost saving plans put in place in late 2016 and early 2017.
Alimera's reported GAAP net loss for the three months ended
March 31, 2017 was approximately $6.7 million, compared to
approximately $11.1 million loss reported for the three months
ended March 31, 2016.
Non-GAAP Financial Results
Adjusted EBITDA, as defined below, for the three months ended
March 31, 2017 was approximately negative $3.7 million, compared to
approximately negative $9.4 million for the three months ended
March 31, 2016. This was due to the increase in revenue
globally and the decrease in operating expenses due to the cost
savings plans Alimera put in place 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 expense, and to the extent they
are included in the calculation of earnings, net unrealized gain
(loss) from foreign currency exchange transactions and gains
(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, Rick Eiswirth, President and Chief
Financial Officer and Dr. Christopher Reimann of Cincinnati Eye to
discuss the results and ILUVIEN real world experience. The call
will be held at 8:00 AM ET, on May 9, 2017. Please refer to the
information below for conference call dial-in information and
webcast registration.
Conference date: May 9, 2017, 8:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Alimera Sciences First
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 certain non-GAAP
financial measures, 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
measures of Adjusted EBITDA and Adjusted Operating Expenses will be
more relevant measures 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 first 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.
These non-GAAP financial measures, as presented, may not be
comparable to similarly titled measures reported by other companies
since not all companies may calculate these measures in an
identical manner and, therefore, they 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 that are required by GAAP to be recorded in
Alimera’s financial statements. In addition, they are subject to
inherent limitations as they reflect the exercise of judgments by
management in determining these non-GAAP financial measures. 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, research 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. 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, which is 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 March 31, 2017, to be filed in the
second quarter of 2017 with the SEC. 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 |
(in thousands) |
|
|
|
|
|
March 31,2017 |
|
December 31,2016 |
|
(unaudited) |
|
|
CURRENT ASSETS: |
|
|
|
Cash and
cash equivalents |
$ |
26,737 |
|
|
$ |
30,979 |
|
Restricted cash |
31 |
|
|
31 |
|
Accounts
receivable, net |
10,768 |
|
|
13,839 |
|
Prepaid
expenses and other current assets |
2,112 |
|
|
2,107 |
|
Inventory, net |
802 |
|
|
446 |
|
Total
current assets |
40,450 |
|
|
47,402 |
|
NON-CURRENT
ASSETS: |
|
|
|
Property
and equipment, net |
1,572 |
|
|
1,787 |
|
Intangible asset, net |
20,125 |
|
|
20,604 |
|
Deferred
tax asset |
443 |
|
|
436 |
|
TOTAL ASSETS |
$ |
62,590 |
|
|
$ |
70,229 |
|
CURRENT
LIABILITIES: |
|
|
|
Accounts
payable |
$ |
3,963 |
|
|
$ |
4,986 |
|
Accrued
expenses |
2,636 |
|
|
3,758 |
|
Derivative warrant liability |
21 |
|
|
188 |
|
Capital
lease obligations |
157 |
|
|
191 |
|
Total
current liabilities |
6,777 |
|
|
9,123 |
|
NON-CURRENT
LIABILITIES: |
|
|
|
Note
payable |
33,409 |
|
|
33,084 |
|
Capital
lease obligations — less current portion |
184 |
|
|
274 |
|
Other
non-current liabilities |
2,154 |
|
|
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 |
649 |
|
|
649 |
|
Additional paid-in capital |
331,947 |
|
|
330,781 |
|
Common
stock warrants |
3,707 |
|
|
3,707 |
|
Accumulated deficit |
(383,809 |
) |
|
(377,074 |
) |
Accumulated other comprehensive loss |
(1,223 |
) |
|
(1,272 |
) |
TOTAL STOCKHOLDERS’
EQUITY |
20,066 |
|
|
25,586 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
62,590 |
|
|
$ |
70,229 |
|
|
|
|
|
|
|
|
|
ALIMERA SCIENCES, INC. |
CONSOLIDATED STATEMENTS OF
OPERATIONS |
FOR THE THREE MONTHS ENDED MARCH 31, 2017
AND 2016 |
(unaudited) |
|
|
|
Three Months EndedMarch
31, |
|
2017 |
|
2016 |
|
(In thousands, except share and per share
data) |
NET REVENUE |
$ |
6,618 |
|
|
$ |
5,801 |
|
COST OF GOODS SOLD,
EXCLUDING DEPRECIATION AND AMORTIZATION |
(587 |
) |
|
(378 |
) |
GROSS PROFIT |
6,031 |
|
|
5,423 |
|
|
|
|
|
RESEARCH, DEVELOPMENT
AND MEDICAL AFFAIRS EXPENSES |
2,110 |
|
|
3,020 |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
3,264 |
|
|
3,395 |
|
SALES AND MARKETING
EXPENSES |
5,502 |
|
|
7,109 |
|
DEPRECIATION AND
AMORTIZATION |
666 |
|
|
689 |
|
OPERATING EXPENSES |
11,542 |
|
|
14,213 |
|
NET LOSS FROM
OPERATIONS |
(5,511 |
) |
|
(8,790 |
) |
|
|
|
|
INTEREST EXPENSE, NET
AND OTHER |
(1,337 |
) |
|
(1,335 |
) |
UNREALIZED FOREIGN
CURRENCY (LOSS) GAIN, NET |
(28 |
) |
|
34 |
|
CHANGE IN FAIR VALUE OF
DERIVATIVE WARRANT LIABILITY |
167 |
|
|
1,519 |
|
LOSS ON EARLY
EXTINGUISHMENT OF DEBT |
— |
|
|
(2,564 |
) |
NET LOSS BEFORE
TAXES |
(6,709 |
) |
|
(11,136 |
) |
PROVISION FOR
TAXES |
(26 |
) |
|
(9 |
) |
NET LOSS |
$ |
(6,735 |
) |
|
$ |
(11,145 |
) |
NET LOSS PER SHARE —
Basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.25 |
) |
WEIGHTED AVERAGE SHARES
OUTSTANDING — Basic and diluted |
64,862,904 |
|
|
45,005,833 |
|
|
|
|
|
|
|
RECONCILIATION OF GAAP MEASURES TO NON-GAAP
ADJUSTED MEASURES |
|
|
|
|
ADJUSTED EBITDA |
(in thousands, unaudited) |
|
Three Months Ended March
31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
GAAP Net
Loss |
$ |
(6,735 |
) |
|
$ |
(11,145 |
) |
Adjustments to Net Loss: |
|
|
|
Interest
Expense |
|
1,338 |
|
|
|
1,338 |
|
Depreciation and Amortization |
|
666 |
|
|
|
689 |
|
Provision
for Taxes |
|
26 |
|
|
|
9 |
|
Stock-Based Compensation |
|
1,166 |
|
|
|
1,296 |
|
Unrealized Foreign Currency Exchange Losses (Gains) |
|
28 |
|
|
|
(34 |
) |
Change in
the Fair Value of Derivative Warrant Liability |
|
(167 |
) |
|
|
(1,519 |
) |
NON-GAAP
Adjusted EBITDA |
$ |
(3,678 |
) |
|
$ |
(9,366 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
ADJUSTED OPERATING EXPENSES |
(in thousands, unaudited) |
|
Three Months Ended March
31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
GAAP
Total Operating Expenses |
$ |
11,542 |
|
|
$ |
14,213 |
|
Adjustments to Operating Expenses: |
|
|
|
Depreciation and Amortization |
|
(666 |
) |
|
|
(689 |
) |
Stock-Based Compensation |
|
(1,166 |
) |
|
|
(1,296 |
) |
NON-GAAP
Total Adjusted Operating Expenses |
$ |
9,710 |
|
|
$ |
12,228 |
|
|
|
|
|
Contact:
CG Capital
877.889.1972
investorrelations@cg.capital
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