Alimera Sciences Reports First Quarter 2014 Financial Results

        Alimera Sciences Reports First Quarter 2014 Financial Results

ILUVIEN® Revenue Up Over 120% Sequentially from Fourth Quarter of 2013

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

PR Newswire

ATLANTA, May 8, 2014

ATLANTA, May 8, 2014 /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, 2014.

"We achieved solid revenue growth from sales of ILUVIEN during this first
quarter of 2014 due to increasing demand for ILUVIEN in Germany and the early
implementation of NICE guidance for the reimbursement of ILUVIEN in the United
Kingdom," said Dan Myers, president and chief executive officer of Alimera
Sciences. "We are continuing our plans for the geographic expansion of ILUVIEN
through our pursuit of a public price in France, our ongoing application for
ten additional European Union country approvals through the Mutual Recognition
Procedure, a recently secured reimbursement in Portugal and our partnership
with Specialised Therapeutics Australia for the distribution of ILUVIEN in
Australia and New Zealand."

In March 2014, Alimera resubmitted its new drug application (NDA) for ILUVIEN
to the Federal Drug Administration (FDA). In the resubmission, Alimera
responded to questions raised in the FDA's complete response letter (CRL)
received in October 2013 and included data from ILUVIEN patients and physician
experience with the applicator in the United Kingdom and Germany, where
ILUVIEN is currently commercially available. In April 2014, Alimera announced
that the resubmission of its NDA for ILUVIEN had been acknowledged by the FDA
as a complete class 2 response and that its Prescription Drug User Fee Act
(PDUFA) goal date of September 26, 2014 had been established.

First Quarter 2014 Financial Results

Revenue for the first quarter of 2014 was $2.1 million compared to total
revenue of $935,000 in the fourth quarter of 2013. GAAP cost of goods sold
were $564,000 for the first quarter of 2014 and GAAP gross profit was $1.5
million. GAAP cost of goods sold and GAAP gross profit during the quarter
were impacted by a reserve of $435,000 for potential German inventory
expiration later in 2014. Excluding these items, Non-GAAP adjusted cost of
goods sold was $129,000 and Non-GAAP adjusted gross margin was $2.0 million
for the first quarter of 2014. Alimera initiated the commercial launch of
ILUVIEN in Germany and the United Kingdom during the second quarter of 2013
and began recognizing cost of goods sold at that time. 

Research and development expenses for the first quarter of 2014 increased 30%
to $2.6 million compared to $2.0million for the first quarter of 2013. The
increase was primarily attributable to increases in costs associated with the
submission of Alimera's response to the CRL from the FDA in March 2014 and to
costs associated with new clinical studies being performed in the European
Union (EU), including costs associated with a five-year, post-authorization,
open label registry study of ILUVIEN.

General and administrative expenses in the first quarter of 2014 increased 10%
to $2.9million compared to $2.7 million in the first quarter of 2013. The
increase was primarily attributable to increases in personnel costs.

Sales and marketing expenses in the first quarter of 2014 decreased 4% to $3.4
million compared to $3.6million for the first quarter of 2013. The decrease
was primarily attributable to non-recurring marketing and market access costs
in preparation for the commercial launch of ILUVIEN in the EU in the second
quarter of 2013, offset by increases in costs associated with contracting with
Quintiles Commercial as the commercial infrastructure in the EU was built out
over the course of 2013.

GAAP net loss attributable to common shareholders for the first quarter of
2014 was $20.8million, or $(0.58) per common share, compared with GAAP net
loss attributable to common shareholders for the first quarter of 2013 of
$14.0million, or $(0.44) per common share. GAAP net loss attributable to
common shareholders for the first quarter ended March 31, 2014 was impacted by
non-cash items, including a change in the fair value of a derivative warrant
liability, an inventory reserve and an unrealized foreign currency loss.
Non-GAAP adjusted net loss attributable to common shareholders was $7.1
million, or $(0.20) per common share for the first quarter of 2014, compared
to a non-GAAP adjusted net loss attributable to common shareholders of $8.4
million or $(0.27) per common share for the first quarter of 2013, which was
impacted by a non-cash change in the fair value of a derivative warrant
liability of $5.6 million. Net loss attributable to common shareholders per
share and non-GAAP adjusted net loss attributable to common shareholders per
share was based on 35,853,869 weighted average shares outstanding for the
first quarter of 2014 and 31,545,569 weighted average shares outstanding for
the first quarter of 2013.

Reconciliations of GAAP cost of goods sold to Non-GAAP adjusted costs of goods
sold, GAAP adjusted gross margin to Non-GAAP adjusted gross margin, GAAP net
loss attributable to common shareholders to Non-GAAP adjusted net loss
attributable to common shareholders and GAAP net loss attributable to common
shareholders per common share to Non-GAAP adjusted net loss attributable to
common shareholders per common share is included below under the heading
"Non-GAAP Financial Measures."

In January 2014, Alimera entered into a securities purchase agreement with
certain investors pursuant to which it sold an aggregate of 6,250,000 shares
of common stock at a purchase price of $6.00 per share. Gross proceeds from
the offering were $37.5 million prior to the payment of approximately $2.4
million of related issuance costs. As of March 31, 2014, Alimera had cash and
cash equivalents of $41.3 million compared to $12.6million as of December 31,
2013. In April 2014, Alimera entered into a Loan Agreement with Hercules
Technology Growth Capital (Hercules) for a term loan in the principal amount
of $35 million. Hercules advanced $10 million to Alimera and will advance the
remaining $25 million in the event that the FDA approves ILUVIEN on or before
October 31, 2014 and certain other conditions are satisfied. The additional
$25 million advance will be used to fund a $25 million milestone payment
obligation that the Company will owe in the event that the FDA approves
ILUVIEN. Alimera used proceeds from the initial funding of $10 million under
the term loan to refinance its 2013 term loan with Silicon Valley Bank which
resulted in net proceeds of $4.7 million.

Conference Call to be Held Today

Alimera will hold a conference call today at 4:30 p.m. 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 May 8, 2014 at
7:30 p.m. ET and ending on May 16, 2014 by dialing (855) 859-2056 (U.S. and
Canada) or (404) 537-3406 (international), Conference ID Number: 41171987. A
replay of the webcast will also be available on the corporate website.

About ILUVIEN^®

ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained
release intravitreal implant used to treat vision impairment associated with
chronic DME considered insufficiently responsive to available therapies. Each
ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering
sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is
injected in the back of the patient's eye to a position that takes advantage
of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle,
which allows for a self-sealing wound. In the FAME™ Study, a phase III
clinical study of ILUVIEN, the most frequently reported adverse drug reactions
included cataract development and increased ocular pressure. ILUVIEN has not
been approved for sale in the United States.

About Alimera Sciences, Inc.

Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company that specializes in the research, development and
commercialization of prescription ophthalmic pharmaceuticals. Alimera's
European operations are conducted from London by its wholly-owned subsidiary,
Alimera Sciences Limited.

Non-GAAP Financial Measures

Alimera believes the metrics Non-GAAP adjusted cost of goods sold, Non-GAAP
adjusted gross margin, Non-GAAP adjusted net loss attributable to common
shareholders and Non-GAAP adjusted net loss attributable to common
shareholders per common share are useful financial measures for investors in
evaluating Alimera's performance for the periods presented. Non-GAAP adjusted
cost of goods sold, Non-GAAP adjusted gross margin, Non-GAAP adjusted net loss
attributable to common shareholders and Non-GAAP adjusted net loss
attributable to common shareholders per common share exclude certain non-cash
items. These Non-GAAP metrics, however, are not measures of financial
performance under accounting principles generally accepted inthe United
States(GAAP) and should not be considered a substitute for cost of goods
sold, gross margin, net loss attributable to common shareholders or net loss
attributable to common shareholders 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 these Non-GAAP metrics are
useful supplements for it and investors to Alimera's GAAP financial
information because these measures exclude non-cash or infrequent adjustments
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
these Non-GAAP financial measures to their most directly comparable GAAP
financial measure, 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 UK and
France and the regulatory status and potential commercialization of ILUVIEN in
the U.S., Australia, New Zealand and the ten additional EU countries for which
Alimera has applied for approval. 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, 2013,
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, 2014 to be filed with the SEC. 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.



CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)
                                                  Three Months EndedMarch 31,
                                                  2014            2013
                                                  (Unaudited)
NET REVENUE                                       $  2,084        $  —
COST OF GOODS SOLD                                (564)           —
GROSS MARGIN                                      1,520           —
RESEARCH AND DEVELOPMENT EXPENSES                 2,626           2,023
GENERAL AND ADMINISTRATIVE EXPENSES               2,927           2,670
SALES AND MARKETING EXPENSES                      3,411           3,563
OPERATING EXPENSES                                8,964           8,256
INTEREST EXPENSE, NET AND OTHER                   (129)           (134)
UNREALIZED FOREIGN CURRENCY LOSS, NET             (56)            —
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT        (13,130)        (5,594)
LIABILITY
NET LOSS                                          $  (20,759)     $  (13,984)
NET LOSS PER SHARE APPLICABLE TO COMMON           $  (0.58)       $  (0.44)
STOCKHOLDERS — Basic and diluted
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and   35,853,869      31,545,569
diluted



CONSOLIDATED BALANCE SHEETS

(in thousands)
                                                     March 31,    December 31,
                                                                  2013
                                                     2014
                                                     (Unaudited)
CURRENT ASSETS:
Cash and cash equivalents                            $   41,326   $   12,628
Accounts receivable, net                             1,278        500
Prepaid expenses and other current assets            2,413        3,474
Inventory, net                                       1,234        1,786
Deferred financing costs                             208          250
Total current assets                                 46,459       18,638
PROPERTY AND EQUIPMENT — at cost less accumulated    959          982
depreciation
TOTAL ASSETS                                         $   47,418   $   19,620
CURRENT LIABILITIES:
Accounts payable                                     $   1,844    $   1,735
Accrued expenses                                     758          934
Outsourced services payable                          183          603
Note payable                                         1,667        1,667
Capital lease obligations                            10           10
Total current liabilities                            4,462        4,949
NON-CURRENT LIABILITIES:
Derivative warrant liability                         29,511       16,381
Note payable — less current portion                  2,778        3,194
Other non-current liabilities                        16           21
STOCKHOLDERS' EQUITY (DEFICIT):
Series A convertible preferred stock                 32,045       32,045
Common stock                                         380          316
Additional paid-in capital                           276,595      240,135
Common stock warrants                                219          412
Accumulated deficit                                  (298,104)    (277,345)
Accumulated other comprehensive loss                 (484)        (488)
TOTAL STOCKHOLDERS' EQUITY (DEFICIT)                 10,651       (4,925)
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) $   47,418   $   19,620

RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES

(in thousands, except share and per share data)
                                                        Three Months Ended

                                                        March 31,
                                                        2014        2013
                                                        (Unaudited)
GAAP COST OF GOODS SOLD                                 $ 564       $ —
Adjustments to costs of goods sold:
Reserve for potential product expiration                (435)       —
NON-GAAP ADJUSTED COST OF GOODS SOLD                    $ 129       $ —
GAAP GROSS MARGIN                                       $ 1,520     $ —
Adjustments to gross margin:
Reserve for potential product expiration                  435         —
NON-GAAP ADJUSTED GROSS MARGIN                          $ 1,955     $ —
GAAP NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS       $ (20,759)  $ (13,984)
Adjustments to net loss:
Unrealized foreign currency loss, net                   56          —
Change in fair value of derivative warrant liability    13,130      5,594
Reserve for potential product expiration                435         —
NON-GAAP ADJUSTED NET LOSS ATTRIBUTABLE TO COMMON       $ (7,138)   $ (8,390)
SHAREHOLDERS
GAAP NET LOSS PER SHARE — Basic and diluted             $ (0.58)    $ (0.44)
Adjustments to net loss:
Unrealized foreign currency loss, net                     0.00        —
Change in fair value of derivative warrant liability      0.37        0.17
Reserve for potential product expiration                  0.01        —
NON-GAAP ADJUSTED NET LOSS PER SHARE — Basic and        $ (0.20)    $ (0.27)
diluted
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted 35,853,869  31,545,569





                        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

SOURCE Alimera Sciences, Inc.

Website: http://www.alimerasciences.com
 
Press spacebar to pause and continue. Press esc to stop.