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8-K - FORM 8-K - ALIMERA SCIENCES INC | c24117e8vk.htm |
Exhibit
99.1
![(ALIMERA LOGO)](c24117c2411701.gif)
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 THIRD QUARTER 2011 FINANCIAL RESULTS
Alimera will host a Conference Call at 4:30 PM ET Today to discuss Financial Results
Cash,
Cash Equivalents and Investments in Marketable Securities at September 30, 2011 Totaled
$38.6 Million
ATLANTA, November 3, 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 third quarter
ended September 30, 2011. Alimera will host a conference call at 4:30 p.m. ET today to discuss
these results.
In December 2010, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter
(CRL) to Alimera relating to its New Drug Application (NDA) for ILUVIEN in the treatment of
diabetic macular edema (DME), which included data through month 24 of the FAME Study. Alimera
submitted a response to the FDA on May 12, 2011, which addressed the issues raised in the CRL. The
FDA classified Alimeras response as a Class 2 resubmission, resulting in a six month review period
and a Prescription Drug User Fee Act or PDUFA date of November 12, 2011.
In September 2011, the Company enrolled its first patient in a physician utilization study of its
intended commercial inserter for ILUVIEN. The study was initiated in response to a request from
the FDA to ensure physicians have a proper understanding of the instructions for inserting the
ILUVIEN micro insert into patient eyes. The Company has enrolled 54 patient eyes to date in this
study, evaluating the safety and utility of the commercial version of the inserter for ILUVIEN, and
is targeting to enroll 100 patient eyes before commercial launch.
After supportive clinical presentations regarding our 36 month FAME study data of ILUVIEN were
made at the American Academy of Ophthalmology last week, we remain confident that ILUVIEN has the
potential to be a very useful treatment to address DME, a blinding disease with limited
pharmacological options, said Dan Myers, Alimeras president and CEO.
Third Quarter 2011 Financial Results
Net loss for the quarter ended September 30, 2011 was $6.5 million, or $0.21 per common share,
compared to net loss of $6.1 million, or $0.20 per common share, for the third quarter ended
September 30, 2010. Net loss per share was based on 31,396,517 weighted average shares outstanding
for the third quarter of 2011 and 31,145,856 weighted average shares outstanding for the third
quarter of 2010.
Research and development expenses for the third quarter of 2011 decreased to $2.2 million, compared
to $3.3 million for the third quarter of 2010. The decrease was primarily attributable to the cost
savings associated with the completion of the FAME Study in 2010 and EU registration costs for
ILUVIEN incurred in the third quarter of 2010. This was offset by an increase of expenses related
to the initiation of the physician utilization study of the ILUVIEN commercial inserter in the
third quarter of 2011. The Company will owe an additional milestone payment of $25.0 million to
pSivida in the event that the FDA approves the Companys NDA for ILUVIEN.
General and administrative expenses in the third quarter of 2011 were $1.4 million, compared to
$1.3 million for the third quarter of 2010.
Marketing expenses in the third quarter of 2011 were $2.6 million, compared to $1.6 million for the
third quarter of 2010. The increase was primarily due to the continued expenditures related to
developing market awareness of and launch plans for ILUVIEN. The Company expects further increases
in marketing commercial expenses as the Company hires additional personnel and further establishes
sales and marketing capabilities. The Company intends to focus its sales and marketing efforts on
the approximately 1,600 retina specialists practicing in the approximately 900 retina centers
across the U.S.
As of September 30, 2011, Alimera had cash, cash equivalents and investments in marketable
securities of $38.6 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 was available only following FDA
approval of ILUVIEN, but no later than July 31, 2011. In May 2011, Alimera and the lenders agreed
to amend the terms of the credit facility given that the FDAs review of the NDA was expected to
extend beyond the July 31, 2011 deadline. The amended terms extend the FDA approval deadline for
the second advance under the term loan to December 31, 2011, and increase the amount available
under the second advance, from $6.25 million to $11.0 million. In addition, the term loan was
extended from October 31, 2013 to April 30, 2014.
We believe we have sufficient funds available to finance our operations through the projected
launch of ILUVIEN, and we expect to begin generating revenue in the first quarter of 2012, said
Mr. Myers.
Conference Call to be Held Today
Alimera will hold a conference call to discuss these third quarter 2011 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 Alimeras
corporate website at http://www.alimerasciences.com.
A replay of the conference call will be available beginning November 3, 2011 at 7:30 P.M. ET and
ending on November 17, 2011 by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406
(international), Conference ID Number: 20075942. A replay of the webcast will be available on the
corporate website for two weeks, through November 17, 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 the 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 fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated
efficacy in the treatment of ocular disease. ILUVIEN is in development for the treatment of
diabetic macular edema (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, and Quarterly Report on
Form 10-Q for the quarter ended June 30, 2011, which are 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
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(Unaudited) | ||||||||||||||||
(In thousands except share and per share data) | ||||||||||||||||
RESEARCH AND
DEVELOPMENT
EXPENSES |
$ | 2,224 | $ | 3,276 | $ | 5,732 | $ | 10,481 | ||||||||
GENERAL AND
ADMINISTRATIVE
EXPENSES |
1,421 | 1,260 | 4,827 | 3,338 | ||||||||||||
MARKETING EXPENSES |
2,612 | 1,583 | 5,038 | 2,209 | ||||||||||||
OPERATING EXPENSES |
6,257 | 6,119 | 15,597 | 16,028 | ||||||||||||
INTEREST INCOME |
1 | 37 | 15 | 53 | ||||||||||||
INTEREST EXPENSE |
(284 | ) | | (863 | ) | (618 | ) | |||||||||
GAIN ON EARLY
EXTINGUISHMENT OF
DEBT |
| | | 1,343 | ||||||||||||
DECREASE IN FAIR
VALUE OF PREFERRED
STOCK CONVERSION
FEATURE |
| | | 3,644 | ||||||||||||
LOSS FROM
CONTINUING
OPERATIONS |
(6,540 | ) | (6,082 | ) | (16,445 | ) | (11,606 | ) | ||||||||
INCOME FROM
DISCONTINUED
OPERATIONS |
| | | 4,000 | ||||||||||||
NET LOSS |
(6,540 | ) | (6,082 | ) | (16,445 | ) | (7,606 | ) | ||||||||
REDEEMABLE
PREFERRED STOCK
ACCRETION |
| | | (466 | ) | |||||||||||
REDEEMABLE
PREFERRED STOCK
DIVIDENDS |
| | | (2,638 | ) | |||||||||||
NET LOSS APPLICABLE
TO COMMON
SHAREHOLDERS |
$ | (6,540 | ) | $ | (6,082 | ) | $ | (16,445 | ) | $ | (10,710 | ) | ||||
NET LOSS PER SHARE
APPLICABLE TO
COMMON SHAREHOLDERS
Basic and
diluted |
$ | (0.21 | ) | $ | (0.20 | ) | $ | (0.52 | ) | $ | (0.56 | ) | ||||
WEIGHTED AVERAGE
SHARES OUTSTANDING
Basic and
diluted |
31,396,517 | 31,145,856 | 31,342,752 | 19,120,860 | ||||||||||||
Balance Sheets
(In thousands)
(In thousands)
September | December | |||||||
30, 2011 | 31, 2010 | |||||||
(Unaudited) | ||||||||
CURRENT ASSETS: |
||||||||
Cash and cash equivalents |
$ | 38,107 | $ | 28,514 | ||||
Investments in marketable securities |
502 | 26,330 | ||||||
Prepaid expenses and other current assets |
1,236 | 1,078 | ||||||
Deferred financing costs |
231 | 272 | ||||||
Total current assets |
40,076 | 56,194 | ||||||
PROPERTY AND EQUIPMENT at cost less accumulated depreciation |
218 | 220 | ||||||
TOTAL ASSETS |
$ | 40,294 | $ | 56,414 | ||||
CURRENT LIABILITIES: |
||||||||
Accounts payable |
$ | 1,950 | $ | 1,677 | ||||
Accrued expenses |
1,459 | 2,731 | ||||||
Outsourced services payable |
393 | 841 | ||||||
Notes payable |
2,386 | 1,157 | ||||||
Capital lease obligations |
11 | 11 | ||||||
Total current liabilities |
6,199 | 6,417 | ||||||
LONG-TERM LIABILITIES: |
||||||||
Notes payable, net of discount less current portion |
3,501 | 4,767 | ||||||
Other long-term liabilities |
9 | 18 | ||||||
STOCKHOLDERS EQUITY: |
||||||||
Common stock |
314 | 313 | ||||||
Additional paid-in capital |
235,155 | 233,338 | ||||||
Common stock warrants |
415 | 415 | ||||||
Accumulated deficit |
(205,299 | ) | (188,854 | ) | ||||
TOTAL STOCKHOLDERS EQUITY |
30,585 | 45,212 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ | 40,294 | $ | 56,414 | ||||