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8-K - FORM 8-K - ALIMERA SCIENCES INC | c12250e8vk.htm |
Exhibit 99.1
ALIMERA SCIENCES REPORTS FOURTH QUARTER 2010 FINANCIAL RESULTS
Reiterates Positive 36-Month Results From the Completed Phase 3 FAME Study of
ILUVIEN® in Patients with Diabetic Macular Edema
ILUVIEN® in Patients with Diabetic Macular Edema
Cash, cash equivalents and investments at December 31, 2010 totaled $54.8 million
ATLANTA, GA February 10, 2011 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
and year ended December 31, 2010.
Our recently released 36-month data showed a consistent response rate of patients whose best
corrected visual acuity improved by 15 or more letters from baseline at month 24 and month 36, with
a peak rate of 31.4% in month 30. We believe these data demonstrate that ILUVIEN® can provide a
long-term option for the treatment of diabetic macular edema (DME), for up to three years, and we
look forward to continuing to work with the FDA toward the approval of ILUVIEN for the treatment of
DME, said Dan Myers, president and chief executive officer of Alimera. During the fourth quarter
of 2010, we increased our pre-marketing budget in preparation for the commercial launch of ILUVIEN
previously expected in the first half of 2011. Our team has many years of experience launching new
pharmaceutical products and we are confident in our go-to-market strategy for a potential
introduction later this year.
Alimera received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA)
in the latter half of December 2010. The FDA issued the CRL to communicate its decision that the
New Drug Application (NDA) for the investigational drug ILUVIEN could not be approved in its
present form.
The NDA included data through month 24 of the study. No new clinical studies were requested by the
FDA in the CRL. However, the FDA asked for analyses of the safety and efficacy data through the end
of the FAME Study to further assess the relative benefits and risks of ILUVIEN. Alimera is
currently preparing the analyses the FDA requested having completed the FAME Study and publicly
released data on February 3, 2011. The FDA is also seeking additional information regarding
controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN,
which Alimera is in the process of compiling.
The FAME Study consisted of two Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the
safety and efficacy of ILUVIEN for the treatment of DME. Both Trial A and Trial B demonstrated
statistical significance in comparison to the control at month 33 individually and on a combined
basis at month 36. The FDA confirmed to Alimera in a recent meeting that there is no requirement to
demonstrate statistical significance in the two trials individually or in the aggregate at month
36. Therefore, Alimera believes these results meet the criteria for replication of efficacy in the
two studies.
We believe the additional 36-month data we recently released will help the FDA evaluate the safety
and efficacy of ILUVIEN and gain further clarity into the benefit to risk ratio. These data will
be included in our submission to the FDA in a follow up to the CRL. Moreover, based on recent
discussions with the FDA we anticipate that the FDA will call an advisory panel subsequent to the
receipt of this submission. We continue to believe that ILUVIEN will be the first ophthalmic drug
approved in the United States for the treatment of DME and have an addressable market that could
reach $1 billion per year, said Mr. Myers.
Financial Highlights
Research and development expenses for the fourth quarter of 2010 decreased to $2.1 million,
compared to $3.1 million for the fourth quarter of 2009, primarily due to the completion of the
FAME Study patient follow up in September of 2010.
General and administrative expenses in the fourth quarter of 2010 were $1.3 million compared to
$1.1 million in the fourth quarter of 2009.
Marketing expenses in the fourth quarter of 2010 were $2.7 million compared to $0.2 million for the
fourth quarter of 2009. 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.
Net loss for the quarter ended December 31, 2010 was $6.3 million, or $0.20 per common share,
compared with a net loss of $24.8 million, or $15.85 per common share, for the quarter ended
December 31, 2009. The primary reason for the decrease in net loss was due to a loss related to an
increase in fair value of the conversion feature of Alimeras previously outstanding preferred
stock in the fourth quarter of 2009. Net loss per share was based on 31,209,551 weighted average
shares outstanding for the fourth quarter of 2010 and 1,564,075 weighted average shares for the
fourth quarter of 2009.
As of December 31, 2010, Alimera had cash, cash equivalents and investments of $54.8 million,
compared to $4.9 million as of December 31, 2009. 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. Borrowings on the revolver may be drawn
subsequent to FDA approval of ILUVIEN up to 85% of eligible accounts receivable.
Financial Outlook
Alimera intends to market and sell ILUVIEN to the approximately 1,600 retinal specialists
practicing in the approximately 900 retina centers across the United States and Canada.
Alimera believes its current cash, cash equivalents, investments and credit facility are sufficient
to fund operations through the projected commercialization of ILUVIEN in late 2011.
Conference Call to be Held Today
Alimera will hold a conference call to discuss these results today at 4:30 P.M. ET. 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 http://www.alimerasciences.com.
A replay of the conference call will be available beginning February 10, 2011 at 7:30 P.M. ET and
ending on February 24, 2011 by dialing (800) 642-1687 (U.S. and Canada) or (706) 645-9291
(international), Conference ID Number: 40881561. A replay of the webcast will be available on the
corporate website for two weeks, through February 24, 2011.
About ILUVIEN
ILUVIEN is an investigative, 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 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 intravitreal insert containing fluocinolone
acetonide (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, predict, project, likely, will, would, could, 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, 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 quarterly reports on Form 10-Q
for the quarters ended March 31, 2010, June 30, 2010, and September 30, 2010, which are on file
with the Securities and Exchange Commission (SEC) and available on the SECs website at
www.sec.gov. Additional factors may also be set forth in those sections of Alimeras annual report
on Form 10-K for the year ended December 31, 2010 to be filed with the SEC.
All forward-looking statements contained in this press release are expressly qualified by the above
paragraph in their entirety. 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.
Income Statement
(in thousands, except share and per share data)
(in thousands, except share and per share data)
Three Months Ended | Years Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||
RESEARCH AND DEVELOPMENT
EXPENSES |
$ | 2,100 | $ | 3,078 | $ | 12,581 | $ | 15,057 | ||||||||
GENERAL AND
ADMINISTRATIVE EXPENSES |
1,272 | 1,056 | 4,610 | 3,407 | ||||||||||||
MARKETING EXPENSES |
2,671 | 211 | 4,880 | 752 | ||||||||||||
OPERATING EXPENSES |
6,043 | 4,345 | 22,071 | 19,216 | ||||||||||||
INTEREST AND OTHER INCOME |
20 | 2 | 73 | 37 | ||||||||||||
INTEREST EXPENSE |
(230 | ) | (474 | ) | (848 | ) | (1,897 | ) | ||||||||
GAIN ON EARLY
EXTINGUISHMENT OF DEBT |
| | 1,343 | | ||||||||||||
DECREASE (INCREASE) IN
FAIR VALUE OF PREFERRED
STOCK CONVERSION FEATURE |
| (17,847 | ) | 3,644 | (23,142 | ) | ||||||||||
LOSS FROM
CONTINUING OPERATIONS |
(6,253 | ) | (22,664 | ) | (17,859 | ) | (44,218 | ) | ||||||||
INCOME FROM DISCONTINUED
OPERATIONS |
| | 4,000 | | ||||||||||||
NET LOSS |
(6,253 | ) | (22,664 | ) | (13,859 | ) | (44,218 | ) | ||||||||
BENEFICIAL CONVERSION
FEATURE OF PREFERRED
STOCK |
| | | (355 | ) | |||||||||||
PREFERRED STOCK ACCRETION |
| (246 | ) | (466 | ) | (623 | ) | |||||||||
PREFERRED STOCK DIVIDENDS |
| (1,885 | ) | (2,638 | ) | (7,225 | ) | |||||||||
NET LOSS APPLICABLE
TO COMMON SHAREHOLDERS |
$ | (6,253 | ) | $ | (24,795 | ) | $ | (16,963 | ) | $ | (52,421 | ) | ||||
NET LOSS PER SHARE
APPLICABLE TO COMMON
SHAREHOLDERS Basic
and diluted |
$ | (0.20 | ) | $ | (15.85 | ) | $ | (0.77 | ) | $ | (34.55 | ) | ||||
WEIGHTED AVERAGE
SHARES OUTSTANDING
Basic and diluted |
31,209,551 | 1,564,075 | 22,167,873 | 1,517,365 | ||||||||||||
Balance Sheets
(in thousands, except share and per share data)
(in thousands, except share and per share data)
December 31, | ||||||||
2010 | 2009 | |||||||
(Unaudited) | ||||||||
CURRENT ASSETS: |
||||||||
Cash and cash equivalents |
$ | 28,514 | $ | 4,858 | ||||
Investments |
26,330 | | ||||||
Prepaid expenses and other current assets |
1,078 | 634 | ||||||
Deferred financing costs |
272 | 815 | ||||||
Total current assets |
56,194 | 6,307 | ||||||
PROPERTY AND EQUIPMENT at cost less
accumulated depreciation |
220 | 254 | ||||||
TOTAL ASSETS |
$ | 56,414 | $ | 6,561 | ||||
CURRENT LIABILITIES: |
||||||||
Accounts payable |
$ | 1,677 | $ | 1,758 | ||||
Accrued expenses |
2,731 | 3,314 | ||||||
Outsourced services payable |
841 | 1,157 | ||||||
Notes payable |
1,157 | 4,500 | ||||||
Capital lease obligations |
11 | 6 | ||||||
Total current liabilities |
6,417 | 10,735 | ||||||
LONG-TERM LIABILITIES: |
||||||||
Notes payable, net of discount less
current portion |
4,767 | 10,500 | ||||||
Fair value of preferred stock conversion
feature |
| 36,701 | ||||||
Other long-term liabilities |
18 | 708 | ||||||
PREFERRED STOCK |
| 113,389 | ||||||
STOCKHOLDERS DEFICIT: |
||||||||
Common stock |
313 | 54 | ||||||
Additional paid-in capital |
233,338 | 4,836 | ||||||
Preferred stock warrants |
| 1,472 | ||||||
Common stock warrants |
415 | 57 | ||||||
Accumulated deficit |
(188,854 | ) | (171,891 | ) | ||||
TOTAL STOCKHOLDERS EQUITY (DEFICIT) |
45,212 | (165,472 | ) | |||||
TOTAL LIABILITIES AND STOCKHOLDERS
EQUITY (DEFICIT) |
$ | 56,414 | $ | 6,561 | ||||