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8-K - FORM 8-K - ALIMERA SCIENCES INC | c21000e8vk.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 SECOND QUARTER 2011 FINANCIAL RESULTS
Alimera will host a Conference Call at 4:30 PM ET Today to discuss Financial Results and provide an Update on Regulatory Developments
Cash, Cash Equivalents and Investments in Marketable Securities at June 30, 2011 Totaled $44.4 Million
ATLANTA, August 4, 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 second quarter
ended June 30, 2011. Alimera will host a conference call at 4:30 p.m. ET today to discuss these
results and provide a regulatory update.
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 July 2011, the FDA
notified the Company that an advisory committee will not be called during this review.
We believe that we have met all clinical endpoints for ILUVIEN and that our data supports the
FDAs efficacy and safety requirements, said Dan Myers, Alimeras president and CEO, and we look
forward to continuing to work with the FDA toward the approval of Iluvien.
Second Quarter 2011 Financial Results
Net loss for the quarter ended June 30, 2011 was $5.2 million, or $0.17 per common share, compared
to net loss of $4.8 million, or $0.20 per common share, for the second quarter ended June 30, 2010.
Net loss per share was based on 31,354,243 weighted average shares outstanding for the second
quarter of 2011 and 24,293,458 weighted average shares outstanding for the second quarter of 2010.
Research and development expenses for the second quarter of 2011 decreased to $1.8 million,
compared to $4.1 million for the second quarter of 2010, primarily due to approximately $1.6
million in costs to file the Companys NDA in the United States with the FDA in May of 2010 and
$1.2 million in costs associated with its FAME Study. Offsetting this decrease was an increase in
costs associated with contracting with medical science liaisons on behalf of Alimera.
General and administrative expenses in the second quarter of 2011 were $1.9 million, compared to
$1.2 million for the second quarter of 2010. This increase was primarily due to costs associated
with operating as a public company.
Marketing expenses in the second quarter of 2011 were $1.3 million, compared to $0.4 million for
the second quarter of 2010. The increase was primarily due to continued 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. Alimera expects
continued increases in marketing expenses starting in late 2011 in anticipation of the
commercialization of ILUVIEN.
As of June 30, 2011, Alimera had cash, cash equivalents and investments in marketable securities of
$44.4 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.
We continue to believe that our cash, cash equivalents, investments in marketable securities and
credit facility are sufficient to fund our operations through the projected launch of ILUVIEN and
the expected generation of revenue after approval, said Mr. Myers.
Conference Call to be Held Today
Alimera will hold a conference call to discuss these second 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 August 4, 2011 at 7:30 P.M. ET and
ending on August 18, 2011 by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406
(international), Conference ID Number: 84946031. A replay of the webcast will be available on the
corporate website for two weeks, through August 18, 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 March 31, 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 | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(Unaudited) | ||||||||||||||||
(in thousands except share and per share data) | ||||||||||||||||
RESEARCH AND
DEVELOPMENT
EXPENSES |
$ | 1,751 | $ | 4,140 | $ | 3,508 | $ | 7,205 | ||||||||
GENERAL AND
ADMINISTRATIVE
EXPENSES |
1,866 | 1,174 | 3,406 | 2,078 | ||||||||||||
MARKETING EXPENSES |
1,309 | 379 | 2,426 | 626 | ||||||||||||
OPERATING EXPENSES |
4,926 | 5,693 | 9,340 | 9,909 | ||||||||||||
INTEREST INCOME |
2 | 14 | 14 | 16 | ||||||||||||
INTEREST EXPENSE |
(284 | ) | (144 | ) | (579 | ) | (618 | ) | ||||||||
GAIN ON EARLY
EXTINGUISHMENT OF
DEBT |
| 1,343 | | 1,343 | ||||||||||||
DECREASE IN FAIR
VALUE OF PREFERRED
STOCK CONVERSION
FEATURE |
| 379 | | 3,644 | ||||||||||||
LOSS FROM
CONTINUING
OPERATIONS |
(5,208 | ) | (4,101 | ) | (9,905 | ) | (5,524 | ) | ||||||||
INCOME FROM
DISCONTINUED
OPERATIONS |
| | | 4,000 | ||||||||||||
NET LOSS |
(5,208 | ) | (4,101 | ) | (9,905 | ) | (1,524 | ) | ||||||||
REDEEMABLE
PREFERRED STOCK
ACCRETION |
| (107 | ) | | (466 | ) | ||||||||||
REDEEMABLE
PREFERRED STOCK
DIVIDENDS |
| (613 | ) | | (2,638 | ) | ||||||||||
NET LOSS APPLICABLE
TO COMMON
SHAREHOLDERS |
$ | (5,208 | ) | $ | (4,821 | ) | $ | (9,905 | ) | $ | (4,628 | ) | ||||
NET LOSS PER SHARE
APPLICABLE TO
COMMON SHAREHOLDERS
Basic and
diluted |
$ | (0.17 | ) | $ | (0.20 | ) | $ | (0.32 | ) | $ | (0.36 | ) | ||||
WEIGHTED AVERAGE
SHARES OUTSTANDING
Basic and
diluted |
31,354,243 | 24,293,458 | 31,316,181 | 13,008,707 | ||||||||||||
Balance Sheets
(in thousands)
(in thousands)
June 30, 2011 |
December 31, 2010 |
|||||||
(Unaudited) | ||||||||
CURRENT ASSETS: |
||||||||
Cash and cash equivalents |
$ | 43,932 | $ | 28,514 | ||||
Investments in marketable securities |
502 | 26,330 | ||||||
Prepaid expenses and other current assets |
954 | 1,078 | ||||||
Deferred financing costs |
265 | 272 | ||||||
Total current assets |
45,653 | 56,194 | ||||||
PROPERTY AND EQUIPMENT at cost less accumulated depreciation |
221 | 220 | ||||||
TOTAL ASSETS |
$ | 45,874 | $ | 56,414 | ||||
CURRENT LIABILITIES: |
||||||||
Accounts payable |
$ | 1,431 | $ | 1,677 | ||||
Accrued expenses |
1,352 | 2,731 | ||||||
Outsourced services payable |
335 | 841 | ||||||
Notes payable |
2,083 | 1,157 | ||||||
Capital lease obligations |
11 | 11 | ||||||
Total current liabilities |
5,212 | 6,417 | ||||||
LONG-TERM LIABILITIES: |
||||||||
Notes payable, net of discount less current portion |
4,000 | 4,767 | ||||||
Other long-term liabilities |
12 | 18 | ||||||
STOCKHOLDERS EQUITY: |
||||||||
Common stock |
314 | 313 | ||||||
Additional paid-in capital |
234,680 | 233,338 | ||||||
Common stock warrants |
415 | 415 | ||||||
Accumulated deficit |
(198,759 | ) | (188,854 | ) | ||||
TOTAL STOCKHOLDERS EQUITY |
36,650 | 45,212 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ | 45,874 | $ | 56,414 | ||||