Alimera Sciences Reports First Quarter 2013 Financial Results

        Alimera Sciences Reports First Quarter 2013 Financial Results

Company Begins Selling ILUVIEN in the United Kingdom and Germany During Second
Quarter of 2013

FDA PDUFA Goal Date of October 17, 2013 Set for ILUVIEN

Alimera Will Host a Conference Call at 4:30 PM ET Today

PR Newswire

ATLANTA, May 9, 2013

ATLANTA, May 9, 2013 /PRNewswire/ --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, 2013.

"During the first quarter of 2013 we significantly expanded our marketing
efforts and sales reach with physicians to prepare for the European market
launch of ILUVIEN. We recently announced the launch of ILUVIEN in both the
United Kingdom and in Germany and are confident in our ability to address the
expected demand for our product. On May 7, 2013, Albert J. Augustin, M.D.,
professor and chairman of the Department of Ophthalmology, Klinikum Karlsruhe,
Karlsruhe, Germany, treated the world's first patient with the implant
injection since the product became commercially available," said Dan Myers,
Alimera's president and chief executive officer. "This is a significant
milestone for not only our Company but also for the patients suffering from
the debilitating effects of chronic diabetic macular edema in these regions
and their physicians."

Market Access Update

On April 29, 2013, Alimera announced that ILUVIEN had become commercially
available in the United Kingdom. In addition, Alimera recently submitted a
simple Patient Access Scheme (PAS), which has been agreed to by the United
Kingdom's Department of Health, to the United Kingdom's National Institute for
Health and Care Excellence (NICE) for consideration under its rapid review
facility. The NICE Appraisal Committee will assess the likely impact of the
ILUVIEN PAS and determine whether an update to NICE's previously issued final
guidance is warranted. If the PAS is accepted by NICE, it is anticipated that
ILUVIEN would be funded for chronic diabetic macular edema (DME) patients in
England and Wales through the National Health Service. The NICE Appraisal
Committee is scheduled to meet on May 15, 2013 to discuss the ILUVIEN PAS and
will communicate its decision at a later date.

FDA Update

Alimera recently announced that its resubmission of the New Drug Application
(NDA) for ILUVIEN has been acknowledged as received by the U.S. Food and Drug
Administration (FDA) as a complete class 2 response to the FDA's November 2011
letter and that a new Prescription Drug User Fee Act (PDUFA) goal date of
October 17, 2013 has been established. In the resubmission, Alimera responded
to questions raised in the FDA's letter and provided additional analyses as
well as new information to support that ILUVIEN is safe and effective in the
treatment of patients with chronic DME. The resubmission focused on the safety
aspects of ILUVIEN and the subgroup population of patients with chronic DME,
the same subgroup for which marketing approval for ILUVIEN has been granted in
six countries in the European Union. Alimera used existing data from two
previously completed pivotal Phase 3 clinical trials (collectively called the
FAME™ Study).

"We are pleased to have recently learned of the PDUFA goal date for our NDA
for ILUVIEN in the fall and look forward to the FDA's response," said Mr.
Myers.

First Quarter 2013 Financial Results

Research and development expenses for the first quarter of 2013 increased to
$2.0 million, compared to $1.6million for the first quarter of 2012. The
increase was primarily attributable to preparation of the resubmission of the
NDA for ILUVIEN. In the event the FDA approves Alimera's NDA for ILUVIEN,
Alimera will owe an additional milestone payment of $25.0 million to pSivida
Corp.

General and administrative expenses in the first quarter of 2013 were
$2.7million, compared to $1.4 million in the first quarter of 2012. The
increase was primarily due to infrastructure build and financial and
operational planning for Alimera's European operations.

Sales and Marketing expenses in the first quarter of 2013 were $3.6 million,
compared to $1.1million for the first quarter of 2012. The increase was
primarily attributable to the expansion of Alimera's sales and marketing team,
directly and in conjunction with Quintiles Commercial, and the development of
market awareness in preparation for the launch of ILUVIEN in Europe.

Net loss for the quarter ended March 31, 2013 was $14.0million, or $(0.44)
per common share, compared with a net loss of $4.4million, or $(0.14) per
common share, for the quarter ended March 31, 2012. Net loss for the quarter
ended March 31, 2013 was impacted by a non-cash warrant valuation adjustment
of $5.6 million resulting from the increase in Alimera's common stock price.
Adjusted net loss excluding the non-cash warrant valuation adjustment for the
quarter ended March 31, 2013 was $8.4 million, or $(0.27) per common share.
Net loss and adjusted net loss per share were based on 31,545,569 weighted
average shares outstanding for the first quarter of 2013 and 31,427,355
weighted average shares outstanding for the first quarter of 2012. A
reconciliation of net loss to adjusted net loss and net loss per common share
to adjusted net loss per common share is included below under the heading
"Non-GAAP Financial Measures."

As of March 31, 2013, Alimera had cash, cash equivalents and investments of
$39.3 million, compared to $49.6million as of December 31, 2012.

$20 Million Debt Facility

Alimera announced on May 8, 2013, that its United Kingdom subsidiary, Alimera
Sciences Limited, had entered into a Loan and Security Agreement with Silicon
Valley Bank (SVB) providing for a term loan in the principal amount of $5
million and up to an additional $15 million under a working capital line of
credit.

The proceeds of the term loan will provide Alimera Sciences Limited with
additional working capital for general corporate purposes. The line of credit
will be utilized to finance eligible accounts receivable in the United
Kingdom, Germany and France, and replaces the $20 million line of credit
previously provided by SVB to finance accounts receivable in the United
States. Alimera believes this debt facility strengthens its financial
position for the commercialization of ILUVIEN® in the United Kingdom, Germany
and France and provides additional resources as management evaluates its
expansion plans in Europe.

Conference Call to be Held Today

Alimera will hold a conference call today at 4:30 PM ET to discuss these
results and provide regulatory and commercial updates. 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
www.alimerasciences.com.

A replay of the conference call will be available beginning May 9, 2013 at
7:30 p.m. ET and ending on May 15, 2013 by dialing (855) 859-2056 (U.S. and
Canada) or (404) 537-3406 (international), Conference ID Number: 64145879. A
replay of the webcast will be available on the corporate website for one week,
through May 15, 2013.

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 primary product,
ILUVIEN, is an intravitreal implant containing fluocinolone acetonide (FAc), a
non-proprietary corticosteroid with demonstrated efficacy in the treatment of
ocular disease.



For investor inquiries: For press inquiries:
John Mills, ICR         Katie Brazel, Fleishman-Hillard
for Alimera Sciences    for Alimera Sciences
310-954-1105            404-739-0150
John.Mills@ICRINC.com   Katie.Brazel@fleishman.com



Non-GAAP Financial Measures

Alimera believes the metric "adjusted net loss" and "adjusted net loss per
common share" are useful financial measures for investors in evaluating
Alimera's performance for the periods presented. Adjusted net loss and
adjusted net loss per common share exclude changes in fair value of derivative
warrant liability, a non-cash expense. These metrics, however, are not
measures of financial performance under accounting principles generally
accepted in the United States (GAAP) and should not be considered a substitute
for net loss or net loss per common share in accordance with GAAP and may not
be comparable to similarly titled measures reported by other companies.
Alimera's management believes that adjusted net loss and adjusted net loss per
common share are useful supplements for it and investors to Alimera's GAAP
financial information because these measures exclude a non-cash expense which
management believes is not reflective of Alimera's operating results due its
dependence on the price of Alimera's common stock. These non-GAAP financial
measures also facilitates management's internal comparison to Alimera's
historical financial performance and the financial performance of other
companies. However, non-GAAP financial measures should only be read in
conjunction with financial information reported under GAAP when understanding
Alimera's operating performance. For a reconciliation of net loss to adjusted
net loss and net loss per common share to adjusted net loss per common share,
see the table below.

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, Alimera's commercial plans for ILUVIEN in Germany, the United
Kingdom and France and the regulatory status of ILUVIEN in the United States.
Such forward-looking statements are based on current expectations and involve
inherent risks and uncertainties, including factors that could delay, divert
or change any of them, and could cause actual results to 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,
uncertainty as to Alimera's ability to commercialize, and market acceptance
of, ILUVIEN in the EU, as well as other factors discussed in the "Risk
Factors" and "Management's Discussion and Analysis of Financial Condition and
Results of Operations" sections of Alimera's Annual Report on Form 10-K for
the year ended December 31, 2012, which is on file with the Securities and
Exchange Commission (SEC) and available on the SEC's website at www.sec.gov.
Additional factors may also be set forth in those sections of Alimera's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 to be filed
with the SEC in the second quarter of 2013. In addition to the risks described
above and in Alimera's 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 Alimera's 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.



Income Statement

(in thousands, except share and per share data)
                                                  Three Months Ended March31,
                                                  2013             2012
                                                  (Unaudited)
RESEARCH AND DEVELOPMENT EXPENSES                 $  2,023         $  1,581
GENERAL AND ADMINISTRATIVE EXPENSES               2,670            1,434
SALES AND MARKETING EXPENSES                      3,563            1,113
OPERATING EXPENSES                                8,256            4,128
INTEREST INCOME                                   1                1
INTEREST EXPENSE                                  (135)            (234)
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT        (5,594)          —
LIABILITY
NET LOSS                                          $  (13,984)      $  (4,361)
NET LOSS PER SHARE APPLICABLE TO COMMON
                                                  $  (0.44)        $  (0.14)
SHAREHOLDERS — Basic and diluted
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and   31,545,569       31,427,355
diluted





Reconciliation of GAAP Net Loss to Adjusted Net Loss

(in thousands, except share and per share data)


                                                  Three Months Ended March31,
                                                  2013           2012
                                                  (Unaudited)
GAAP NET LOSS                                     $ (13,984)     $ (4,361)
Adjustments to net loss:
Change in fair value of derivative warrant          (5,594)        —
liability
NON-GAAP ADJUSTED NET LOSS                        $ (8,390)      $ (4,361)
GAAP NET LOSS PER SHARE — Basic and diluted       $ (0.44)       $ (0.14)
Adjustments to net loss:
Change in fair value of derivative warrant          (0.17)         —
liability
NON-GAAP ADJUSTED NET LOSS PER SHARE— Basic and   $ (0.27)       $ (0.14)
diluted
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and     31,545,569     31,427,355
diluted



Balance Sheet

(in thousands)
                                                     March31,    December31,
                                                     2013         2012
                                                     (Unaudited)
CURRENT ASSETS:
Cash and cash equivalents                            $   39,307   $   49,564
Prepaid expenses and other current assets            2,640        2,029
Inventory                                            1,058        719
Deferred financing costs                             74           95
Total current assets                                 43,079       52,407
PROPERTY AND EQUIPMENT — at cost less accumulated    115          114
depreciation
TOTAL ASSETS                                         $   43,194   $   52,521
CURRENT LIABILITIES:
Accounts payable                                     $   2,340    $   1,973
Accrued expenses                                     1,272        1,179
Outsourced services payable                          1,096        2,616
Notes payable                                        2,348        2,273
Capital lease obligations                            3            6
Derivative warrant liability                         10,011       4,418
Total current liabilities                            17,070       12,465
LONG-TERM LIABILITIES:
Notes payable, net of discount — less current        153          703
portion
Other long-term liabilities                          235          209
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Preferred stock:
Series A Convertible Preferred Stock                 32,045       32,045
Common stock                                         316          315
Additional paid-in capital                           238,052      237,485
Common stock warrants                                415          415
Accumulated deficit                                  (245,100)    (231,116)
Accumulated other comprehensive income               8            —
TOTAL STOCKHOLDERS' EQUITY                           25,736       39,144
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY           $   43,194   $   52,521



SOURCE Alimera Sciences, Inc.

Website: http://www.alimerasciences.com
 
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