Alimera Sciences Reports Fourth Quarter 2012 Financial Results

        Alimera Sciences Reports Fourth Quarter 2012 Financial Results

Company to Begin Generating Revenue in Second Quarter of 2013

Alimera Will Host a Conference Call at 4:30 PM ET Today

PR Newswire

ATLANTA, March 21, 2013

ATLANTA, March 21, 2013 /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 fourth quarter ended December 31,
2012.

"We are about to begin the commercial launch of ILUVIEN®. Product is in our
European warehouse, and our distribution channels and commercial
infrastructure are well positioned," said Dan Myers, president and chief
executive officer of Alimera Sciences. "The training of our sales force has
been completed and our teams are currently on the ground in Germany and the UK
driving demand for ILUVIEN. We will begin shipping as soon as we receive a
required acceptance from the Medicine and Health products Regulatory Agency,
on the intended commercial batch size. Based on the increasing positive
feedback we continue to receive, we believe that ophthalmologists in Europe
are eager to prescribe ILUVIEN for their chronic DME patients who are
considered insufficiently responsive to available therapies."

Market Access Update

On January 23, 2013, Alimera announced that it had received final published
guidance from the UK's National Institute of Health and Clinical Excellence
(NICE), indicating that ILUVIEN is not a cost-effective treatment for chronic
diabetic macular edema (DME) considered insufficiently responsive to available
therapies. In response to this, Alimera submitted a simple patient access
scheme (PAS) for ILUVIEN to the Patient Access Schemes Liaison Unit. The PAS
has been agreed to by the UK's Department of Health and is now under
consideration by NICE for inclusion in its rapid review facility. Under this
facility, the Appraisal Committee at NICE is expected to assess the impact of
the ILUVIEN PAS on ILUVIEN's cost effectiveness and determine whether an
update to the recently published final guidance is warranted.

"The interaction with NICE is proceeding as we expected and we believe that
the ILUVIEN PAS could result in a change in NICE guidance," said Mr. Myers.
"In both Germany and the UK we have added experienced resources to address
market access challenges that other ophthalmology companies have similarly had
to navigate."

FDA Update

Alimera intends to resubmit its New Drug Application for ILUVIEN to the U.S.
Food and Drug Administration (FDA) by the end of March. Using data from
Alimera's two previously completed pivotal Phase III clinical trials (FAME™
Study), the resubmission will focus on the safety aspects of ILUVIEN and the
population of patients with chronic DME, the same group for which marketing
approval for ILUVIEN has been granted in various EU countries. Alimera will
communicate any new PDUFA date once it is known.

Fourth Quarter 2012 Financial Results

Research and development expenses for the fourth quarter of 2012 increased to
$2.3 million, compared to $1.4million for the fourth quarter of 2011. The
increase was primarily attributable to the preparation of the resubmission of
the NDA for ILUVIEN with the U.S. FDA expected in the first quarter of 2013.

For the full year ended December 31, 2012, research and development expenses
increased to $7.9 million, compared to $7.1 million for the full year 2011.

General and administrative expenses in the fourth quarter of 2012 were
$2.1million, compared to $1.4 million in the fourth quarter of 2011. The
increase was primarily attributable to infrastructure build in Europe in
preparation for the launch of ILUVIEN in 2013.

Marketing expenses in the fourth quarter of 2012 were $3.8 million, compared
to $3.1million for the fourth quarter of 2011. The increase was primarily
attributable to the preparation for the planned launch of ILUVIEN in Europe in
2013.

Net loss for the fourth quarter ended December 31, 2012 was $5.3million, or
$(0.17) per common share, compared with a net loss of $6.1million, or $(0.19)
per common share, for the quarter ended December 31, 2011. Net loss per share
was based on 31,524,004 weighted average shares outstanding for the fourth
quarter of 2012 and 31,421,395 weighted average shares outstanding for the
fourth quarter of 2011.

As of December 31, 2012, Alimera had cash, cash equivalents and investments of
$49.6 million, compared to $33.6million as of December31, 2011. 

Conference Call to be Held Today

Alimera will hold a conference call today at 4:30 PM ET to discuss these
results and provide regulatory and commercial updates. 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 corporate website at
www.alimerasciences.com.

A replay of the conference call will be available beginning March 21, 2013 at
7:30 P.M. ET and ending on March 28, 2013 by dialing (855) 859-2056 (U.S. and
Canada) or (404) 537-3406 (international), Conference ID Number: 19269391. A
replay of the webcast will be available on the corporate website for one week,
through March 28, 2013.

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 September 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 Annual Report on Form 10-K for the year ended December 31, 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 press inquiries:
For investor inquiries:
                        Katie Brazel, Fleishman-Hillard
John Mills, ICR
                        for Alimera Sciences
for Alimera Sciences
310-954-1105            404-739-0150
John.Mills@ICRINC.com
                        Katie.Brazel@fleishman.com



Income Statement
(in thousands, except share and per share data)
                     Three Months Ended December   Years Ended December 31,
                     31,
                     2012           2011           2012           2011
                     (Unaudited)    (Unaudited)    (Unaudited)
RESEARCH AND         $        $        $        $     
DEVELOPMENT            2,299        1,368        7,935         7,100
EXPENSES
GENERAL AND
ADMINISTRATIVE       2,087          1,376          6,575          6,203
EXPENSES
MARKETING EXPENSES   3,825          3,066          7,529          8,104
OPERATING EXPENSES   8,211          5,810          22,039         21,407
INTEREST AND OTHER   2              1              5              16
INCOME
INTEREST EXPENSE     (163)          (262)          (795)          (1,125)
CHANGE IN FAIR
VALUE OF DERIVATIVE  3,083          -              3,083          -
WARRANT LIABILITY
NET LOSS            $        $        $        $     
                      (5,289)       (6,071)      (19,746)        (22,516)
NET LOSS PER SHARE                                                $     
APPLICABLE TO        $        $        $          
COMMON SHAREHOLDERS    (0.17)       (0.19)       (0.63)     (0.72)
- Basic and diluted
WEIGHTED - AVERAGE
SHARES OUTSTANDING   31,524,004     31,421,395     31,462,120     31,362,574
- Basic and diluted



Balance Sheet
(in thousands)
                                          December 31, 2012    December 31,
                                                               2011
                                          (Unaudited)
CURRENT ASSETS:
                                          $           $       
Cash and cash equivalents                    49,564            
                                                               33,108
Investments                               -                    500
Inventory                                 719                  -
Prepaid expenses and other current assets 2,029                692
Deferred financing costs                  95                   201
               Total current assets       52,407               34,501
PROPERTY AND EQUIPMENT, NET               114                  197
                                          $           $       
TOTAL ASSETS                                 52,521            
                                                               34,698
CURRENT LIABILITIES:
Accounts payable                          1,973                1,948
Accrued expenses                          1,179                1,638
Outsourced services payable               2,616                658
Note payable - net of issuance costs      2,273                2,462
Capital lease obligations                 6                    12
Derivative Warrant liability              4,418                -
               Total current liabilities  12,465               6,718
LONG-TERM LIABILITIES:
Note payable - less current portion       703                  2,868
Other long-term liabilities               209                  134
SHAREHOLDERS EQUITY:
PREFERRED STOCK
               Series A Convertible       32,045               -
               Preferred Stock
STOCKHOLDER'S DEFICIT:
               Common stock               315                  314
               Additional paid-in capital 237,485              235,619
               Common stock warrants      415                  415
               Accumulated deficit        (231,116)            (211,370)
TOTAL STOCKHOLDERS EQUITY                 39,144               24,978
                                          $           $       
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY    52,521            
                                                               34,698



SOURCE Alimera Sciences, Inc.

Website: http://www.alimerasciences.com
 
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