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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@fl

Key Takeaway: ALIMERA SCIENCES REPORTS FOURTH QUARTER 2011 FINANCIAL RESULTS ILUVIEN expected to be first sustained release pharmaceutical in the European Union (EU) to treat diabetic macular edema (DME) Alimera believes marketing authorizations for ILUVIEN will be seven EU countries befor

Full Press Release Details

ALIMERA SCIENCES REPORTS FOURTH QUARTER 2011 FINANCIAL RESULTS
ILUVIEN expected to be first sustained release pharmaceutical in the
European Union (EU) to treat diabetic macular edema (DME)
Alimera believes marketing authorizations for ILUVIEN will be
seven EU countries before the end of the First Quarter 2012
Cash, Cash Equivalents and Investments at December 31, 2011
Totaled $33.6 Million
Alimera Will Host a Conference Call at 4:30 P.M. ET Today
March 8, 2012 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, 2011.
Last week we announced the positive outcome of
the Decentralized Procedure for ILUVIEN in Europe, indicating that ILUVIEN is approvable, in the seven European
countries in which we filed, for the treatment of chronic diabetic macular edema, said Dan Myers, Alimera s president and chief executive officer. We now are focused on the national phase of the process, during which labeling in
each country s local language is finalized. We expect to receive marketing authorization in each country by the end of the first quarter.
The International Diabetes Federation estimates that 19.1 million people are currently living with diabetes in the seven countries in which Alimera filed for marketing authorization (Austria, France,
Germany, Italy, Portugal, Spain and the United Kingdom). Of these, Alimera estimates that 1.1 million people suffer from diabetic macular edema (DME).
I would like to reiterate that this is not only a positive achievement for Alimera, but an exciting development for the many patients in Europe suffering from this debilitating disease, said
Mr. Myers. We are now working to ensure that ILUVIEN is made available to patients as soon as possible, which we expect to be by the end of 2012.
Alimera plans to meet with the U.S. Food and Drug Administration (FDA) during the second quarter of 2012 to discuss the complete response letter it received in November 2011 from the FDA in response to
Alimera s New Drug Application for ILUVIEN for the treatment of DME associated with diabetic retinopathy.
Research and development expenses for the fourth quarter of 2011 decreased to $1.4 million,
compared to $2.1 million for the fourth quarter of 2010. The decrease was primarily due to technical development in 2010 of the engineering processes necessary to produce ILUVIEN.
General and administrative expenses in the fourth quarter of 2011 were $1.4 million, compared to $1.3 million in the fourth quarter
Marketing expenses in the fourth quarter of 2011 were $3.1 million, compared to $2.7 million for the fourth
quarter of 2010. The increase was primarily due to increased spending in 2011 in anticipation of the previously expected launch of ILUVIEN in the U.S. during the first quarter of 2012.
Net loss for the quarter ended December 31, 2011 was $6.1 million, or $0.19 per common share, compared with a net loss of
$6.3 million, or $0.20 per common share, for the quarter ended December 31, 2010. Net loss per share was based on 31,421,395 weighted average shares outstanding for the fourth quarter of 2011 and 31,209,551 weighted average shares for the
fourth quarter of 2010.
As of December 31, 2011, Alimera had cash, cash equivalents and investments of $33.6 million,
compared to $54.8 million as of December 31, 2010.
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 a regulatory 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 corporate
A replay of the conference call will be available beginning March 8, 2012 at
7:30 P.M. ET and ending on March 22, 2012 by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international), Conference ID Number: 54201361. A replay of the webcast will be available on the corporate website for two weeks,
through March 22, 2012.
ILUVIEN (190 micrograms fluocinolone
acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat chronic DME. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone
acetonide (FAc). ILUVIEN is inserted in the back of the patient s eye to a position that takes advantage of the eye s natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.
Safety was assessed among those patients treated with ILUVIEN who were in the subgroup of patients with DME for three years or more and were considered to have chronic DME. Intraocular pressure (IOP)
increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 12.7% of these patients by month 36, compared to 18.4% in the full ILUVIEN treated patient population. By month 36, 3.6% of these patients had undergone an
incisional surgical procedure to reduce elevated IOP, compared to 4.8% in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 84.1% at month 36, with 87.3% undergoing
a cataract operation, compared to 81.7% and 80.0%, respectively, in the full patient population.
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina
responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition has progressed to DME. The onset of DME is painless and may go undetected by the patient until it manifests with the
blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. As the population of people with diabetes increases, it is anticipated that the annual incidence of diagnosed DME will
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 future results
of operations and financial position, business strategy and plans and objectives of management for Alimera s future operations. Words such as anticipate, believe, estimate, expect,
intend, may, plan, contemplate, predict, project, target, likely, potential, continue, will, would,
should, could, or the negative of these terms and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The events and
circumstances reflected in Alimera s forward-looking statements may not occur and actual results could 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, delay in or failure to obtain regulatory approval of Alimera s product candidates, uncertainty as to Alimera s ability to commercialize (alone or with others), and market acceptance of, its product
candidates, the extent of government regulations, uncertainty as to relationship between the benefits of Alimera s product candidates and the risks of their side-effect profiles, dependence on third-party manufacturers to manufacture
Alimera s product candidates in sufficient quantities and quality, uncertainty of clinical trial results, limited sales and marketing infrastructure, inability of Alimera s outside sales force to successfully sell and market ILUVIEN in the
U.S. following regulatory approval and Alimera s ability to operate its business in compliance with the covenants and restrictions that it is subject to under its credit facility, 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, 2010, and Quarterly Report on Form
10-Q for the quarter ended September 30, 2011, 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, 2011 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.
(in thousands, except share and per share data)
September 30, September 30, September 30, September 30,
Three Months Ended December 31, Years Ended December 31,
2011 2010 2011 2010
(Unaudited) (Unaudited) (Unaudited)
RESEARCH AND DEVELOPMENT EXPENSES $ 1,368 $ 2,100 $ 7,100 $ 12,581
GENERAL AND ADMINISTRATIVE EXPENSES 1,376 1,272 6,203 4,610
MARKETING EXPENSES 3,066 2,671 8,104 4,880
OPERATING EXPENSES 5,810 6,043 21,407 22,071
INTEREST AND OTHER INCOME 1 20 16 73
INTEREST EXPENSE (262 ) (230 ) (1,125 ) (848 )
GAIN ON EARLY EXTINGUISHMENT OF DEBT 1,343
DECREASE IN FAIR VALUE OF PREFERRED STOCK CONVERSION FEATURE 3,644
LOSS FROM CONTINUING OPERATIONS (6,071 ) (6,253 ) (22,516 ) (17,859 )
INCOME FROM DISCONTINUED OPERATIONS 4,000
NET LOSS (6,071 ) (6,253 ) (22,516 ) (13,859 )
BENEFICIAL CONVERSION FEATURE OF PREFERRED STOCK
PREFERRED STOCK ACCRETION (466 )
PREFERRED STOCK DIVIDENDS (2,638 )
NET LOSS APPLICABLE TO COMMON SHAREHOLDERS $ (6,071 ) $ (6,253 ) $ (22,516 ) $ (16,963 )
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS Basic and diluted $ (0.19 ) $ (0.20 ) $ (0.72 ) $ (0.77 )
WEIGHTED AVERAGE SHARES OUTSTANDING Basic and diluted 31,421,395 31,209,551 31,362,574 22,167,873
September 30, September 30,
December 31,
2011 2010
(Unaudited)
CURRENT ASSETS:
Cash and cash equivalents $ 33,108 $ 28,514
Investments 500 26,330
Prepaid expenses and other current assets 692 1,078
Deferred financing costs 201 272
Total current assets 34,501 56,194
PROPERTY AND EQUIPMENT at cost less accumulated depreciation 197 220
TOTAL ASSETS $ 34,698 $ 56,414
CURRENT LIABILITIES:
Accounts payable $ 1,948 $ 1,677
Accrued expenses 1,638 2,731
Outsourced services payable 658 841
Notes payable 2,462 1,157
Capital lease obligations 12 11
Total current liabilities 6,718 6,417
LONG-TERM LIABILITIES:
Notes payable, net of discount less current portion 2,996 4,767
Other long-term liabilities 6 18
STOCKHOLDERS DEFICIT:
Common stock 314 313
Additional paid-in capital 235,619 233,338
Common stock warrants 415 415
Accumulated deficit (211,370 ) (188,854 )
TOTAL STOCKHOLDERS EQUITY 24,978 45,212
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY $ 34,698 $ 56,414
Last updated: Mar 8, 2012