Alimera Sciences Reports Third Quarter 2012 Financial Results

        Alimera Sciences Reports Third Quarter 2012 Financial Results

Company Expects to Begin Generating Revenue in the First Quarter of 2013

Company Plans to Resubmit NDA for ILUVIEN® to FDA in the First Quarter of 2013

Completed Enrollment for Physician Utilization Study of the ILUVIEN Inserter

Alimera Will Host a Conference Call at 4:30 P.M. ET Today

PR Newswire

ATLANTA, Nov. 7, 2012

ATLANTA, Nov. 7, 2012 /PRNewswire/ --Alimera Sciences, Inc. (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research,
development and commercialization of prescription ophthalmic pharmaceuticals,
today announced financial results for the third quarter ended September 30,
2012.

"Three commercial batches of ILUVIEN® are expected to be shipped this week to
the EU in preparation for the planned commercial launch in three EU countries
during 2013, starting with Germany in the first quarter of 2013," said Dan
Myers, president and chief executive officer of Alimera Sciences. "We expect
to initiate our commercial launch in the United Kingdom during the second
quarter of 2013 and in France during the third quarter of 2013. We have been
working towards our goal of a successful commercial launch in the EU by
focusing our efforts on identifying and hiring our European management team
and by working with our contract sales organization and third party logistics
provider to prepare for the commercial launch."

FDA Resubmission of NDA and Enrollment Update

Alimera met with the U.S. Food and Drug Administration (FDA) in June 2012 to
discuss the FDA's November 2011 Complete Response Letter (CRL) regarding
Alimera's New Drug Application (NDA) for ILUVIEN for the treatment of diabetic
macular edema (DME). Following the meeting, the FDA agreed to an extension of
the deadline to resubmit Alimera's NDA for ILUVIEN. Based on this agreement,
Alimera now intends to resubmit its NDA for ILUVIEN during the first quarter
of 2013. Using data from its two previously completed pivotal Phase III
clinical trials (FAME™ Study), the resubmission will focus on the population
of patients with chronic DME, the same group for which marketing approval for
ILUVIEN has been granted in various European Union countries.

Following the June 2012 meeting with the FDA, Alimera reinitiated its
physician utilization study of the ILUVIEN inserter and has since completed
enrollment with a total of 121 patients.

"As we approach the EU launch of ILUVIEN, we continue to pursue the potential
opportunity in the United States," Mr. Myers continued. "We were very pleased
with the interest by U.S. retinal specialists to quickly complete the
utilization study."

Third Quarter 2012 Financial Results

As of September 30, 2012, Alimera had cash, cash equivalents and investments
of $17.4 million, compared to $33.1million as of December 31, 2011. On
October 2, 2012, Alimera received gross proceeds of $40.0 million from the
closing of its Series A Preferred financing.

Research and development expenses for the third quarter of 2012 remained
consistent at $2.2million, compared to $2.2million for the third quarter of
2011. The majority of Alimera's research and development expenses incurred to
date have been related to the development of ILUVIEN.

General and administrative expenses in the third quarter of 2012 were
$1.5million, compared to $1.4 million in the third quarter of 2011.

Marketing expenses in the third quarter of 2012 decreased to $1.5 million,
compared to $2.6 million for the third quarter of 2011. Marketing expenses in
the third quarter of 2012 were used primarily for developing market awareness
and preparing for the planned launch of ILUVIEN in the EU in 2013.

Net loss for the quarter ended September 30, 2012 was $5.4million, or $0.17
per common share, compared with a net loss of $6.5million, or $0.21 per
common share, for the quarter ended September 30, 2011. 

Conference Call to be Held Today

Alimera will hold a conference call today at 4:30 P.M. ET to discuss these
results and provide an overall business update. The conference call will be
hosted by Dan Myers, president and chief executive officer, and Rick Eiswirth,
chief operating officer and chief financial officer.

To participate in the call, please dial (877) 369-6586 (U.S. and Canada) or
(253) 237-1165 (international). A live webcast will be available on the
Investor Relations section of the company's corporate website at
http://www.alimerasciences.com.

A replay of the conference call will be available beginning November 7, 2012
at 7:30 p.m. ET and ending on November 14, 2012 by dialing (855) 859-2056
(U.S. and Canada) or (404) 537-3406 (international), Conference ID Number:
50093793. A replay of the webcast will be available on the corporate website
for one week, through November 14, 2012.

About Alimera Sciences, Inc.

Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical
company that specializes in the research, development and commercialization of
prescription ophthalmic pharmaceuticals. Presently, Alimera is focused on
diseases affecting the back of the eye, or retina. Its primary product,
ILUVIEN, is an intravitreal implant containing fluocinolone acetonide (FAc), a
non-proprietary corticosteroid with demonstrated efficacy in the treatment of
ocular disease.

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, Alimera's commercial plans for ILUVIEN in Germany, the UK and
France. 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, uncertainty as to Alimera's ability to commercialize, and market
acceptance of, ILUVIEN in the EU, 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, 2011 and Quarterly Report on Form
10-Q for the quarter ended June 30, 2012, which are on file with the
Securities and Exchange Commission (SEC) and available on the SEC's website at
www.sec.gov. Additional factors may also be set forth in those sections of
Alimera's Quarterly Report on Form 10-Q for the quarter ended September 30,
2012 to be filed 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. 

For investor inquiries:
John Mills, ICR
for Alimera Sciences
310-954-1105
John.Mills@ICRINC.com

For press inquiries:
Katie Brazel, Fleishman-Hillard
for Alimera Sciences
404-739-0150
Katie.Brazel@fleishman.com



ALIMERA SCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands)
                                                 September 30,   December 31,
                                                 2012            2011
                                                 (Unaudited)
CURRENT ASSETS:
Cash and cash equivalents                        $  17,355       $ 33,108
Investments in marketable securities                —              500
Prepaid expenses and other current assets           1,549          692
Inventory                                           671            —
Deferred financing costs                            119            201
Total current assets                                19,694         34,501
PROPERTY AND EQUIPMENT — at cost less               132            197
accumulated depreciation
TOTAL ASSETS                                     $  19,826       $ 34,698
CURRENT LIABILITIES:
Accounts payable                                 $  1,702        $ 1,948
Accrued expenses                                    2,252          1,638
Outsourced services payable                         161            658
Notes payable                                       2,462          2,462
Capital lease obligations                           9              12
Total current liabilities                           6,586          6,718
LONG-TERM LIABILITIES:
Notes payable, net of discount — less current       1,250          2,868
portion
Other long-term liabilities                         193            134
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Preferred stock                                     —              —
Common stock                                        315            314
Additional paid-in capital                          236,894        235,619
Common stock warrants                               415            415
Accumulated deficit                                 (225,827)      (211,370)
TOTAL STOCKHOLDERS' EQUITY                          11,797         24,978
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY       $  19,826       $ 34,698



ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
                   Three Months Ended September   Nine Months Ended September
                   30,                            30,
                   2012            2011           2012           2011
                   (Unaudited)
RESEARCH AND
DEVELOPMENT        $  2,199        $ 2,224        $ 5,636        $ 5,732
EXPENSES
GENERAL AND
ADMINISTRATIVE        1,506          1,421          4,488          4,827
EXPENSES
MARKETING             1,503          2,612          3,704          5,038
EXPENSES
OPERATING             5,208          6,257          13,828         15,597
EXPENSES
INTEREST INCOME       1              1              3              15
INTEREST EXPENSE      (187)          (284)          (632)          (863)
NET LOSS           $  (5,394)      $ (6,540)      $ (14,457)     $ (16,445)
NET LOSS PER
SHARE APPLICABLE
TO COMMON          $  (0.17)       $ (0.21)       $ (0.46)       $ (0.52)
SHAREHOLDERS —
Basic and diluted
WEIGHTED-AVERAGE
SHARES                31,465,752     31,396,517     31,443,568     31,342,752
OUTSTANDING —
Basic and diluted





SOURCE Alimera Sciences, Inc.

Website: http://www.alimerasciences.com
 
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