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8-K - FORM 8-K - ALIMERA SCIENCES INC | c16574e8vk.htm |
EX-99.2 - EX-99.2 - ALIMERA SCIENCES INC | c16574exv99w2.htm |
Exhibit 99.1 |
FOR IMMEDIATE RELEASE
INVESTOR CONTACT:
ICR, LLC
John Mills
310-954-1105
John.Mills@icrinc.com
ICR, LLC
John Mills
310-954-1105
John.Mills@icrinc.com
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®
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 FDAs
Complete Response Letter
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
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 FDAs 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 Alimeras
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, Alimeras 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 FDAs 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
ILUVIEN.
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 FDAs 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 Alimeras
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.
About ILUVIEN®
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 patients eye to a position that takes advantage of the
eyes natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a
self-sealing wound.
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
This press release contains forward-looking statements, within the meaning of the Private
Securities Litigation Reform Act of 1995, regarding, among other things, Alimeras future results
of operations and financial position, business strategy and plans and objectives of management for
Alimeras 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 Alimeras
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
Alimeras product candidates, uncertainty as to Alimeras ability to commercialize, and market
acceptance of, its product candidates, the extent of government regulations, uncertainty as to
relationship between the benefits of Alimeras product candidates and the risks of their
side-effect profiles, dependence on third-party manufacturers to manufacture Alimeras product
candidates in sufficient quantities and quality, uncertainty of clinical trial results, limited
sales and marketing infrastructure, inability of Alimeras outside sales force to successfully sell
and market ILUVIEN in the U.S. following regulatory approval and Alimeras 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 Managements Discussion and
Analysis of Financial Condition and Results of Operations sections of Alimeras annual report on
Form 10-K for the year ended December 31, 2010, which is on file with the Securities and Exchange
Commission (SEC) and available on the SECs website at www.sec.gov. In addition to the risks
described above and in Alimeras 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 Alimeras 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.
STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(in thousands, except share and per share data)
Three Months Ended March 31, | ||||||||
2011 | 2010 | |||||||
(Unaudited) | ||||||||
(In thousands, except share | ||||||||
and per share data) | ||||||||
RESEARCH AND DEVELOPMENT EXPENSES |
$ | 1,757 | $ | 3,065 | ||||
GENERAL AND ADMINISTRATIVE EXPENSES |
1,540 | 904 | ||||||
MARKETING EXPENSES |
1,117 | 247 | ||||||
OPERATING EXPENSES |
4,414 | 4,216 | ||||||
INTEREST INCOME |
12 | 2 | ||||||
INTEREST EXPENSE |
(295 | ) | (474 | ) | ||||
DECREASE IN FAIR VALUE OF PREFERRED STOCK CONVERSION FEATURE |
| 3,265 | ||||||
LOSS FROM CONTINUING OPERATIONS |
(4,697 | ) | (1,423 | ) | ||||
INCOME FROM DISCONTINUED OPERATIONS |
| 4,000 | ||||||
NET (LOSS) INCOME |
(4,697 | ) | 2,577 | |||||
PREFERRED STOCK ACCRETION |
| (359 | ) | |||||
PREFERRED STOCK DIVIDENDS |
| (2,025 | ) | |||||
NET (LOSS) INCOME APPLICABLE TO COMMON STOCKHOLDERS |
$ | (4,697 | ) | $ | 193 | |||
NET (LOSS) INCOME PER SHARE APPLICABLE TO COMMON
STOCKHOLDERS Basic and diluted |
$ | (0.15 | ) | $ | 0.12 | |||
WEIGHTED AVERAGE SHARES OUTSTANDING Basic and diluted |
31,277,697 | 1,619,011 | ||||||
BALANCE SHEETS
(in thousands)
(in thousands)
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
(Unaudited) | ||||||||
CURRENT ASSETS: |
||||||||
Cash and cash equivalents |
$ | 49,457 | $ | 28,514 | ||||
Investments |
503 | 26,330 | ||||||
Prepaid expenses and other current assets |
846 | 1,078 | ||||||
Deferred financing costs |
247 | 272 | ||||||
Total current assets |
51,053 | 56,194 | ||||||
PROPERTY AND EQUIPMENT at cost less accumulated depreciation |
180 | 220 | ||||||
TOTAL ASSETS |
$ | 51,233 | $ | 56,414 | ||||
CURRENT LIABILITIES: |
||||||||
Accounts payable |
$ | 2,013 | $ | 1,677 | ||||
Accrued expenses |
1,434 | 2,731 | ||||||
Outsourced services payable |
681 | 841 | ||||||
Notes payable |
1,852 | 1,157 | ||||||
Capital lease obligations |
11 | 11 | ||||||
Total current liabilities |
5,991 | 6,417 | ||||||
LONG-TERM LIABILITIES: |
||||||||
Notes payable, net of discount less current portion |
4,162 | 4,767 | ||||||
Other long-term liabilities |
15 | 18 | ||||||
STOCKHOLDERS DEFICIT: |
||||||||
Common stock |
313 | 313 | ||||||
Additional paid-in capital |
233,888 | 233,338 | ||||||
Common stock warrants |
415 | 415 | ||||||
Accumulated deficit |
(193,551 | ) | (188,854 | ) | ||||
TOTAL STOCKHOLDERS EQUITY |
41,065 | 45,212 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ | 51,233 | $ | 56,414 | ||||