Full Press Release Details
ALIMERA SCIENCES REPORTS FIRST QUARTER 2011 FINANCIAL RESULTS AND
REVIEWS NEW 36 MONTH SAFETY AND EFFICACY DATA
FROM THE PHASE 3 FAME STUDY OF ILUVIEN
Company Expects to Submit New Data by May 13, 2011 Addressing All Aspects of the FDA s
Complete Response Letter
Alimera will host a conference call and slide show presentation at 4:30 PM ET today to discuss
financial results and recently presented data from the FAME Study
Cash, Cash Equivalents and Investments at March 31, 2011 Totaled $50 Million
ATLANTA, May 5, 2011 (GLOBE NEWSWIRE) 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 first quarter
ended March 31, 2011. Alimera will be hosting a conference call at 4:30 p.m. eastern today to
discuss these results and review new data from the identifiable subgroup population that was
presented at the 2011 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in
Fort Lauderdale, Florida on Tuesday, May 3, 2011 and released that same day.
Submission of Response to the FDA s Complete Response Letter (CRL)
In December 2010, the U.S. Food and Drug Administration (FDA) issued a CRL to Alimera relating to
data through month 24 of the FAME Study in its New Drug Application (NDA) for ILUVIEN in the
treatment of diabetic macular edema (DME). Although no new clinical studies were requested, the FDA
asked for analyses of the safety and efficacy data through month 36 of the FAME Study to further
assess the relative benefits and risks of ILUVIEN. Alimera has completed these analyses of the
data through month 36, including this new identifiable subgroup population as further support of
the safety and efficacy of ILUVIEN. Alimera expects to submit the new safety and efficacy data to
the FDA by May 13, 2011.
The FDA was also seeking additional information regarding controls and specifications regarding the
manufacturing, packaging and sterilization of ILUVIEN because the FDA had observed deficiencies in
current good manufacturing practices (cGMP) during its facility inspections of two of Alimera s
third-party manufacturers. The FDA has issued letters to both of these third-party manufacturers
indicating that the inspections are now closed. Alimera believes
that no further action is required and expects to include this information in the response it plans
to file with the FDA by May 13, 2011.
We are pleased that this identifiable subgroup population from the FAME Study provides further
support to our upcoming submission to the FDA. Throughout the FAME Study, ILUVIEN has shown
significant potential for patients suffering with DME and this new data complements the full
population data, said Dan Myers, Alimera s president and CEO. We believe the additional data we
recently released will help the FDA further evaluate the safety and efficacy of ILUVIEN. In
addition, the third-party manufacturing deficiencies identified in the CRL have been resolved and
this information, along with the new safety and efficacy data, will be included in our response to
the FDA s CRL, which we expect to submit by May 13, 2011.
First Quarter 2011 Financial Results
Net loss for the quarter ended March 31, 2011 was $4.7 million, or $0.15 per common share, compared
to net income of $0.2 million or $0.12 per common share, for the quarter ended March 31, 2010. The
reported net income during the first quarter of 2010 included income from discontinued operations
of $4.0 million related to the exercise by Bausch Lomb of its option to extend by two years the
period during which it may continue to develop an allergy product acquired from Alimera in 2006.
Net loss per share was based on 31,277,697 weighted average shares outstanding for the first
quarter of 2011 and 1,619,011 weighted average shares outstanding for the first quarter of 2010.
Research and development expenses for the first quarter of 2011 decreased to $1.8 million, compared
to $3.1 million for the first quarter of 2010, primarily due to the completion of the FAME Study
patient follow-up in September 2010. Offsetting this decrease was an increase in costs associated
with contracting medical science liaisons to engage with retina specialists in the study of
General and administrative expenses in the first quarter of 2011 were $1.5 million, compared to
$0.9 million for the first quarter of 2010. This increase was primarily due to costs associated
with operating as a public company. Sequentially, general and administrative expenses declined by
$0.2 million compared to the fourth quarter of 2010.
Marketing expenses in the first quarter of 2011 were $1.1 million, compared to $0.2 million for the
first quarter of 2010. The increase was primarily due to pre-marketing expenditures related to the
commercial launch of ILUVIEN, which was previously expected in the first half of 2011, and the
hiring of additional key personnel in the second half of 2010.
As of December 31, 2010, Alimera had cash, cash equivalents and investments of $50.0 million,
compared to $54.8 million as of December 31, 2010. In October 2010, Alimera obtained a $32.5
million senior secured credit facility comprised of a $12.5 million term loan and a $20.0 million
working capital revolver. Alimera borrowed $6.25 million of the term loan upon the closing of the
facility. The remaining $6.25 million would be available only following FDA approval of ILUVIEN,
but no later than July 31, 2011. Given the status of the FDA s review of the NDA, it is unlikely
that FDA approval would occur prior to July 31, 2011. However, management is in discussions with
the lenders regarding an extension of the availability of the credit facility, but there are no
assurances that the credit facility will be amended.
Mr. Myers concluded, From a financial perspective we believe our current cash, cash equivalents,
investments and credit facility are sufficient to fund operations through the projected
commercialization of ILUVIEN in late 2011.
Conference Call and Presentation to be Held Today
Alimera will hold a conference call to discuss these results and data today at 4:30 P.M. ET. The
conference call will be hosted by Dan Myers, President and Chief Executive Officer, Rick Eiswirth,
Chief Operating Officer and Chief Financial Officer, and Ken Green Ph.D., Chief Scientific 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 Alimera s
corporate website at http://www.alimerasciences.com.
Slides from the conference call containing more detailed information with respect to the new data
presented by Dr. Antoszyk at the 2011 ARVO Annual Meeting on May 3, 2011 are being furnished by
Alimera to the Securities and Exchange Commission in a Current Report on Form 8-K.
A replay of the conference call will be available beginning May 5, 2011 at 7:30 P.M. ET and ending
on May 19, 2011 by dialing (800) 642-1687 (U.S. and Canada) or (706) 645-9291 (international),
Conference ID Number: 62334484. A replay of the webcast will be available on the corporate website
for two weeks, through May 19, 2011.
ILUVIEN is an investigational, extended release intravitreal insert that Alimera is developing for
the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36
months by delivering sustained sub-microgram levels of corticosteroid 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 insertion device employs a 25-gauge needle, which allows for a
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 advanced product candidate, ILUVIEN, is an investigational intravitreal insert
containing FAc, a non-proprietary corticosteroid with demonstrated efficacy in the treatment of
ocular disease. ILUVIEN is in development for the treatment of DME, a disease of the retina that
affects individuals with diabetes and can lead to severe vision loss and blindness.
Forward Looking Statements