Alimera Sciences Reports Second Quarter 2013 Financial Results

        Alimera Sciences Reports Second Quarter 2013 Financial Results

Company Generates First Revenue from ILUVIEN®

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

PR Newswire

ATLANTA, Aug. 12, 2013

ATLANTA, Aug. 12, 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 second quarter ended June 30, 2013.

"We began generating revenue from ILUVIEN in the second quarter of 2013 in
Germany and the United Kingdom and continue to make progress in gaining market
access in Germany, the United Kingdom and France," said Dan Myers, Alimera's
president and chief executive officer. "The initial response has been very
positive among early adopting physicians as well as patients, with some ofthe
patients receiving an implant in both eyes."

Market Access Update

ILUVIEN was launched commercially in the United Kingdom and Germany in April
and May 2013, respectively, and Alimera expects to launch ILUVIEN in France in
the first quarter of 2014. In addition to sales activity, Alimera is pursuing
expanded reimbursement in the United Kingdom and Germany and will soon be
engaged in price negotiations in France.

In the United Kingdom, the recent issuance by the Appraisal Committee of the
United Kingdom's National Institute for Health and Care Excellence (NICE) of a
positive Appraisal Consultation Document (ACD) on ILUVIEN is expected to lead
to an Appraisal Committee meeting later in August to produce a Final Appraisal
Determination (FAD). Alimera is optimistic that a FAD will be issued in
September confirming the recommendation of ILUVIEN for the treatment of
chronic DME in a pseudophakic population insufficiently responsive to
available therapies, however there can be no assurance that NICE will accept
the Appraisal Committee's recommendation.

"We are working diligently to increase the availability of ILUVIEN topatients
in these countries. While the expanded reimbursement process is slow, we are
making good progress as evidenced by the broader access through the statutory
insurance funds in Germany and the Appraisal Committee's recommendation, which
we hope will result in a change in published guidance in the United Kingdom,"
added Mr. Myers. "Additionally, we recently announced that the French National
Health Authority's Transparency Commission issued a favorable opinion for the
reimbursement and hospital listing of ILUVIEN by the French National Health
Insurance. This is another important development in the commercialization of
ILUVIEN, and we will use this opinion in our pricing discussions with the
French health authorities."

Second Quarter 2013 Financial Results

Total revenue for the quarter ended June 30, 2013 was $179,000, which was
generated in connection with the commercial launch of ILUVIEN in Germany and
the United Kingdom during the quarter.

Research and development expenses for the second quarter of 2013 increased to
$2.2 million, compared to $1.9million for the second quarter of 2012. The
increase was primarily attributable to an increase of approximately $240,000
in costs associated with contracting medical science liaisons to engage with
retina specialists in Germany, the United Kingdom and France.

General and administrative expenses in the second quarter of 2013 were
$2.4million, compared to $1.5 million in the second quarter of 2012. The
increase was primarily due to an increase in professional fees associated with
the establishment of Alimera's infrastructure and tax planning for expansion
in Europe.

Sales and marketing expenses in the second quarter of 2013 increased to $4.9
million, compared to $1.1million for the second quarter of 2012. The increase
was primarily due to costs associated with Alimera's agreement with Quintiles
Commercial for services related to the launch of ILUVIEN in Germany and the
United Kingdom in the second quarter of 2013.

Alimera expects further increases in sales and marketing expenses as the
commercial launch of ILUVIEN continues in Europe.

Net loss attributable to common shareholders for the quarter ended June 30,
2013 was $(21.3)million, or $(0.67) per common share, compared with a net
loss attributable to common shareholdersof $(4.7)million, or $(0.15) per
common share, for the quarter ended June 30, 2012. Net loss attributable to
common shareholders for the quarter ended June 30, 2013 was impacted by a
non-cash warrant valuation adjustment of $6.7 million resulting from the
increase in Alimera's common stock price, non-cash accretion of a beneficial
conversion feature of $5.0 million associated with a decrease in the
conversion price of our Series A Convertible Preferred Stock and a loss of
$153,000 related to an early extinguishment of debt. Adjusted net loss
attributable to common shareholders excluding the non-cash warrant valuation
adjustment, the non-cashaccretion of the beneficial conversion feature and
theloss on the early extinguishment of debt  for the quarter ended June 30,
2013 was $9.5 million, or $(0.30) per common share. Net loss attributable to
common shareholders per shareand adjusted net loss attributable to common
shareholders per share were based on 31,574,858 weighted average shares
outstanding for the second quarter of 2013 and 31,430,651 weighted average
shares outstanding for the second quarter of 2012. A reconciliation of net
loss attributable to common shareholders to adjusted net loss attributable to
common shareholders 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 June 30, 2013, Alimera had cash, cash equivalents and investments of
$31.9 million, compared to $49.5million as of December 31, 2012.

$20 Million Debt Facility

In May 2013, Alimera Sciences Limited, Alimera's subsidiary in the United
Kingdom, entered into a Loan and Security Agreement with Silicon Valley Bank
(SVB) to provide additional working capital in the amount of $5 million and up
to an additional $15 million under a working capital line of credit. 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. The debt facility provides Alimera with additional resources as
management strengthens its market position and evaluates its expansion plans
for ILUVIEN 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
http://www.alimerasciences.com.

A replay of the conference call will be available beginning August 12, 2013 at
7:30 p.m. ET and ending on August 18, 2013 by dialing (855) 859-2056 (U.S. and
Canada) or (404) 537-3406 (international), Conference ID Number: 24162060. A
replay of the webcast will be available on Alimera's corporate website for one
week, through August 18, 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 the first product to provide a therapeutic effect of up to 36
months for patients with chronic DME considered insufficiently responsive to
available therapies.

Non-GAAP Financial Measures

Alimera believes the metric "adjusted net loss attributable to common
shareholders" 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 attributable to common shareholdersand adjusted
net loss per common share exclude the non-cash warrant valuation adjustment,
the non-cash accretion of the beneficial conversion feature and the loss on
the early extinguishment. 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
attributable to common shareholdersor 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
attributable to common shareholdersand adjusted net loss per common share are
useful supplements for it and investors to Alimera's GAAP financial
information because these measures excludenon-cash or infrequent expenses
which management believes are not reflective of Alimera's operating results.
These non-GAAP financial measures also facilitate 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 attributable to common shareholdersto adjusted net loss attributable
to common shareholdersand 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. 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 and Quarterly Report on Form
10-Q for the quarter ended March 31, 2013, which are 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 June 30, 2013 to
be filed with the SEC in the third 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.

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

Income Statement

(in thousands, except share and per share data)
                        Three Months Ended June30,  Six Months Ended June 30,
                        2013            2012         2013          2012
                        (Unaudited)
REVENUE                 $  179          $  —         $  179        $  —
COST OF GOODS SOLD      (11)            —               (11)          —
GROSS MARGIN            168             —               168           —
RESEARCH AND            2,180           1,856           4,203         3,437
DEVELOPMENT EXPENSES
GENERAL AND             2,429           1,548           5,099         2,982
ADMINISTRATIVE EXPENSES
SALES AND MARKETING     4,898           1,088           8,461         2,201
EXPENSES
OPERATING EXPENSES      9,507           4,492           17,763        8,620
INTEREST EXPENSE        (129)           (210)           (263)         (443)
CHANGE IN FAIR VALUE OF
DERIVATIVE              (6,742)         —               (12,336)      —

WARRANT LIABILITY
LOSS ON EARLY           (153)           —               (153)         —
EXTINGUISHMENT OF DEBT
NET LOSS                $  (16,363)     $  (4,702)   $  (30,347)   $  (9,063)
ACCRETION OF PREFERRED
STOCK
                           (4,950)         —            (4,950)       —
BENEFICIAL CONVERSION
FEATURE
NET LOSS ATTRIBUTABLE
TO COMMON               $  (21,313)     $  (4,702)   $  (35,297)   $  (9,063)

SHAREHOLDERS
NET LOSS PER SHARE —    $  (0.67)       $  (0.15)    $  (1.12)     $  (0.29)
Basic and diluted
WEIGHTED AVERAGE SHARES
OUTSTANDING             31,574,858      31,430,651   31,560,294    31,429,003

— Basic and diluted



Reconciliation of GAAP Net Loss to Adjusted Net Loss

(in thousands, except share and per share data)
                        Three Months Ended June30,  Six Months Ended June 30,
                        2013            2012         2013          2012
                        (Unaudited)
GAAP NET LOSS
ATTRIBUTABLE TO COMMON  $  (21,313)     $  (4,702)   $  (35,297)   $  (9,063)

SHAREHOLDERS
Adjustments to net
loss:
 Change in fair
value of derivative     (6,742)         —               (12,336)      —
warrant liability
 Loss on early       (153)           —               (153)         —
extinguishment of debt
 Accretion of
preferred stock
beneficial conversion   (4,950)         —               (4,950)       —

 feature
NON-GAAP ADJUSTED NET
LOSS
                        $  (9,468)      $  (4,702)   $  (17,858)   $  (9,063)
ATTRIBUTABLE TO COMMON
SHAREHOLDERS
GAAP NET LOSS PER SHARE
— Basic and             $  (0.67)       $  (0.15)    $  (1.12)     $  (0.29)

diluted
Adjustments to net
loss:
 Change in fair
value of derivative        (0.21)          —            (0.39)        —
warrant liability
 Loss on early          (0.00)          —            (0.00)        —
extinguishment of debt
 Accretion of
preferred stock
beneficial conversion      (0.16)          —            (0.16)        —

 feature
NON-GAAP ADJUSTED NET
LOSS PER SHARE — Basic  $  (0.30)       $  (0.15)    $  (0.57)     $  (0.29)
and diluted
WEIGHTED AVERAGE SHARES
OUTSTANDING             31,574,858      31,430,651   31,560,294    31,429,003

— Basic and diluted

Balance Sheet

(in thousands)
                                                     June 30,     December31,
                                                     2013         2012
                                                     (Unaudited)
CURRENT ASSETS:
Cash and cash equivalents                            $   31,925   $   49,564
Accounts receivable, net                             129          —
Prepaid expenses and other current assets            3,206        2,029
Inventory                                            1,813        719
Deferred financing costs                             313          95
 Total current assets                          37,386       52,407
PROPERTY AND EQUIPMENT — at cost less accumulated    469          114
depreciation
TOTAL ASSETS                                         $   37,855   $   52,521
CURRENT LIABILITIES:
Accounts payable                                     $   3,195    $   1,973
Accrued expenses                                     1,601        1,179
Outsourced services payable                          1,292        2,616
Notes payable                                        1,111        2,273
Capital lease obligations                            9            6
  Total current liabilities                     7,208        8,047
NON-CURRENT LIABILITIES:
Derivative warrant liability                         16,754       4,418
Notes payable — less current portion                 3,889        703
Other non-current liabilities                        33           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                           238,567      237,485
Common stock warrants                                461          415
Accumulated deficit                                  (261,463)    (231,116)
Accumulated other comprehensive income               45           —
TOTAL STOCKHOLDERS' EQUITY                           9,971        39,144
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY           $   37,855   $   52,521



SOURCE Alimera Sciences, Inc.

Website: http://www.alimerasciences.com
 
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