Optimer Reports Fourth Quarter and Fiscal Year 2012 Financial Results

    Optimer Reports Fourth Quarter and Fiscal Year 2012 Financial Results

Optimer reports $62.4 million in DIFICID® (fidaxomicin) tablets net product
sales for 2012

PR Newswire

JERSEY CITY, N.J., Feb. 28, 2013

JERSEY CITY, N.J., Feb. 28, 2013 /PRNewswire/ --Optimer Pharmaceuticals,
Inc.(NASDAQ: OPTR) announced today unaudited financial results for the fourth
quarter and fiscal year endedDecember 31, 2012. 

(Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO )

Financial Highlights

  o2012 DIFICID net product sales in the U.S. and Canada of $62.4 million,
    compared to $21.5 million in 2011
  oA 14.3% increase in U.S. and Canadian DIFICID shipments in the fourth
    quarter, resulting in net sales of$16.8 million
  o2012 contract revenue from collaborations, which include up-front
    payments, milestones, royalties and product sales, were$39.1 million
  o2012 total revenues were$101.5 million
  oCash, cash equivalents and short-term investments atDecember 31,
    2012totaled$124.0 million
  o2012 net loss was $37.0 million, or $0.78 per share, and 2012 net income
    for the fourth quarter was $1.0 million, $0.02 per share

"2012 was an exciting year for Optimer. DIFICID is now available in over a
dozen countries," said Dr. Henry McKinnell, Optimer's CEO and Chairman of the
Board. "In the U.S. we will be focusing on improving the formulary status of
DIFICID in the hospital marketplace and on expanding the use of this important
new medicine in all channels."

Financial Overview
Total revenue for the years ended December 31, 2012 and 2011 was$101.5
million and $145.0 million, respectively. Total revenue for the fourth
quarter 2012 and 2011 was$19.5 million and$64.6 million, respectively. The
decreases were due to a reduction in contract revenue, which in 2011 included
$122.7 million from the Astellas Pharma Europe (APEL) agreement, offset by
increases in DIFICID net product sales.

DIFICID net product sales in the U.S. and Canada for the year and quarter
ended December 31, 2012 were$62.4 million and $16.8 million, respectively.
We recognize product sales of DIFICID upon delivery of product to our
wholesalers. The increase in DIFICID net product sales in 2012 reflects
higher demand for DIFICID, as well as a full year of sales. DIFICID was
launched in July 2011.

Contract revenue for the years ended December 31, 2012 and 2011 was $39.1
million and $122.7 million, respectively, a decrease of $83.6 million.
Contract revenue is generated from collaboration partners and includes
up-front and milestone payments, royalties and product sales. In 2011,
contract revenue included a $69.2 million up-front payment from APEL and a
$53.5 million milestone upon EMA approval of DIFICLIR™. Contract revenue in
2012 included a $19.9 million up-front payment from Astellas Japan and a $12.6
million milestone payment from APEL in association with the first commercial
sale of DIFICLIR in an APEL territory. Contract revenues in 2012 also
included inventory shipments to our collaboration partners and royalty income
from APEL.

Research and development expense for the years ended December31, 2012 and
2011 was $45.2 million and $43.1 million, respectively, an increase of $2.1
million. The increase primarily was due to higher health economics and
outcomes research and pharmacovigilance expenses. We also incurred expenses
related to our prophylaxis and pediatric clinical trials, which began in
2012. The increase was partially offset by lower materials costs associated
with DIFICID production prior to FDA approval in 2011. Research and
development expense for the quarters ending December 31, 2012 and 2011
was$11.9 million and$14.0 million, respectively, a decrease of $2.1
million.

Selling, general and administrative expense for years ended December 31, 2012
and 2011 was $112.0 million and $80.6 million, respectively, an increase of
$31.4 million. The increase primarily was due to our commercialization
efforts for DIFICID which included a full year of expense in 2012. We also
incurred higher compensation expense and higher legal and facilities expenses.
SG&A expense for the quarters ending December 31, 2012 and 2011 was$31.2
million and$30.0 respectively, an increase of $1.2 million. In order to
conform to our current period financial statement presentation, we
reclassified two line items on our 2011 Consolidated Statements of Operations
to separately identify co-promotion expenses with Cubist Pharmaceuticals, Inc.
Previously, Cubist co-promotion expenses were included in our SG&A expense.

Co-promotion expenses with Cubist for the years ended December 31, 2012 and
2011 were $23.2 million and $6.6 million, respectively, an increase of $16.6
million. This increase was due to a full year of co-promotion expenses and
included the year-one sales target bonus and gross profit share on sales above
the target. Co-promotion expenses for the quarters ending December 31, 2012
and 2011 were $3.8 million and$3.6 million, respectively, an increase of $0.2
million.

For the year ended December 31, 2012, Optimer reported a net loss of$37.0
million, or$0.78per share, on both a basic and diluted basis, as compared to
net income for the year ended December 31, 2011 of$7.8 million, or$0.17per
share, on both a basic and diluted basis. Net income for the fourth quarter
of 2012 was$1.0 million, or$0.02per share, on a basic and diluted basis, as
compared to net income for the fourth quarter of 2011 of$13.4 million,
or$0.29and$0.28per share, on a basic and diluted basis, respectively. Net
income in the fourth quarter of 2012 includes a gain of $31.5 million from the
sale of our equity interest in Optimer Biotechnology, Inc. (OBI).

AtDecember 31, 2012, Optimer held cash, cash equivalents and short-term
investments of$124.0 million. This includes proceeds from the sale of our
equity interest in OBI, which was completed in the fourth quarter.

Optimer had 47.8 million shares outstanding on December 31, 2012.

"Healthcare policy is shifting to new ways to control healthcare spending,
particularly in hospitals. Many of our recent research initiatives, such as
analyzing the cost burden of Clostridium difficile infection, are designed to
assist hospitals to better understand the disease burden on their patients and
institutions," said Dr. McKinnell.

As ofDecember 31, 2012:

  oInventory levels at wholesalers remain within the range of 14 to 28 days
    of demand
  oApproximately 2,750 hospitals had ordered DIFICID
  oAbout 83% of hospitals covered by Optimer have reordered DIFICID
  oApproximately 1,000 hospitals are estimated to have placed DIFICID on
    formulary

As a result of the management changes announced yesterday and processes and
procedures in connection therewith, we have determined that the filing of our
Form 10-K will be delayed.

Conference Call and Webcast
The Company will host a conference call and webcast to discuss its fourth
quarter and fiscal year 2012 financial results and provide a corporate update
today at5:00 p.m. Eastern Time(2:00 p.m. Pacific Time).

The conference call may be accessed by dialing (877) 280-7280 for domestic
callers and +1 (678) 825-8232 for international callers. Please specify to
the operator that you would like to join "Optimer's Financial Results Call."
The conference call will be webcast live under the Investors section of
Optimer's website atwww.optimerpharma.com, where it will be archived for 30
days following the call. 

About DIFICID® (fidaxomicin) Tablets
DIFICID is the first macrolide antibacterial drug indicated for Clostridium
difficile-associated diarrhea (CDAD) to be approved in over 25 years in the
U.S. It is indicated in the U.S. for the treatment of CDAD in adults 18 years
of age or older. DIFICID is administered in 200 milligram tablets given
orally, twice daily.

Important Safety Information for DIFICID
DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin or
to any of the excipients in the formulation. DIFICID should not be used for
systemic infections. Only use DIFICID for infection proven, or strongly
suspected, to be caused byC. difficile. Prescribing DIFICID in the absence
of a proven, or strongly suspected,C. difficileinfection is unlikely to
provide benefit to the patient and increases the risk of the development of
drug-resistant bacteria. The most common adverse reactions are nausea (11%),
vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia
(2%) and neutropenia (2%).

Please visitwww.DIFICID.comor call 855-DIFICID (343-4243) for full
prescribing information for DIFICID.

AboutOptimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a global biopharmaceutical company focused on
developing and commercializing innovative hospital specialty products that
have a positive impact on society. Optimer developed DIFICID® (fidaxomicin)
tablets, an FDA-approved macrolide antibacterial drug for the treatment of
Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and
older, and is commercializing DIFICID in the U.S. and Canada. Optimer also
received marketing authorization for fidaxomicin tablets in the European Union
where its partner, Astellas Pharma Europe, is commercializing fidaxomicin
under the trade name DIFICLIR™. The Company is exploring marketing
authorization in other parts of the world where C. difficile has emerged as a
serious health problem. Additional information can be found at
http://www.optimerpharma.com.

Forward-looking Statements
Statements included in this press release that are not a description of
historical facts are forward-looking statements, including, without
limitation, statements related to the implementation and impact of Optimer's
commercialization strategy, Optimer's pursuit of new indications for DIFICID,
Optimer's on-going education efforts regarding its patient access initiatives
and the burden of Clostridium difficile infection and expansion of DIFICID
sales or market potential. Words such as "expect," "anticipate," "will,"
"could," "would," "project," "intend," "plan," "believe," "predict,"
"estimate," "should," "may," "potential," "continue," "ongoing" or variations
of such words and similar expressions are intended to identify forward-looking
statements. The inclusion of forward-looking statements should not be regarded
as a representation by Optimer that any of its plans will be achieved. These
forward-looking statements are based on management's expectations on the date
of this release. Actual results may differ materially from those set forth in
this release due to the risks and uncertainties inherent in Optimer's business
including, without limitation, risks relating to: Optimer's ability to
continue to increase adoption and use of DIFICID, the implementation and
success of DIFICID growth initiatives and entry into new markets, whether or
not healthcare professionals will prescribe DIFICID, the extent to which
DIFICID receives reimbursement coverage from healthcare payors and government
agencies, the extent to which DIFICID will be accepted on additional hospital
formularies and the timing of hospital formulary decisions, Optimer's ability
to successfully coordinate commercialization efforts with Cubist under its
co-promotion agreement, whether Optimer will be able to realize expected
benefits under its co-promotion agreement with Cubist and its collaboration
agreements with other partners, the possibility of alternative means of
preventing or treating CDAD impacting adoption and sales of DIFICID, Optimer's
ability, through its third-party manufacturers and logistics providers, to
maintain a sufficient supply of DIFICID to meet demand, the effects of changes
in Optimer's management, the outcome of Optimer's review of strategic
alternatives including a possible sale of the Company, the potential for
lawsuits and enforcement proceedings related to the previously disclosed
investigations by U.S. authorities and other risks detailed in Optimer's
filings with the Securities and Exchange Commission. Forward-looking
statements speak only as of the date of this release, and Optimer undertakes
no obligation to update or revise these statements, except as may be required
by law.

Contacts

Optimer Pharmaceuticals, Inc.
David Walsey, VP of Investor Relations and Corporate Communications
858-964-3418

Canale Communications
Jason I. Spark, Senior Vice President
(619) 849-6005



Optimer Pharmaceuticals, Inc.
Consolidated Statements of Operations and Comprehensive Loss
                      Three Months Ended         Years Ended
                      December 31,               December 31,
                      2012           2011          2012            2011
                      (unaudited)                  (unaudited)
Revenues:
Product sales, net    $         $        $          $     
                      16,820,952     10,959,217    62,417,155     21,511,037
Contract revenue      2,694,724      53,584,000    39,112,168      122,749,000
Other                 -              73,139        2,106           718,336
 Total revenues     19,515,676     64,616,356    101,531,429     144,978,373
Cost and expenses:
Cost of product sales 1,364,656      909,843       5,486,239       1,525,798
Cost of contract      1,652,008      3,310,821     6,462,939       7,584,353
revenue
Research and          11,867,287     14,011,078    45,202,722      43,085,307
development
Selling, general and  31,201,682     29,991,411    112,025,724     80,574,336
administrative
Co-promotion expenses 3,750,000      3,641,161     23,190,629      6,569,921
with Cubist
Total operating       49,835,633     51,864,314    192,368,253     139,339,715
expenses
Gain (loss) from      (30,319,957)   12,752,042    (90,836,824)    5,638,658
operations
Gain on
de-consolidation of   -              -             23,782,229      -
OBI
Gain on sale of OBI   31,500,606     -             31,500,606      -
shares
Equity in net loss of -              -             (1,849,254)     -
OBI
Interest income       (179,940)      63,337        136,269         290,870
(loss) and other, net
Consolidated net gain 1,000,709      12,815,379    (37,266,974)    5,929,528
(loss)
Net loss attributable
to non-controlling    -              538,892       280,344         1,892,096
interest
Net gain (loss)
attributable to       $         $         $            $     
Optimer               1,000,709     13,354,271   (36,986,630)    7,821,624
Pharmaceuticals, Inc.
Net gain (loss) per   $        $        $         $     
share - basic            0.02               (0.78)       
                                     0.29                         0.17
Net gain (loss) per   $        $        $         $     
share - diluted           0.02               (0.78)       
                                     0.28                         0.17
Weighted average
number of shares used
to compute net
 gain (loss) per     47,742,372     46,668,310    47,331,510      45,622,168
share - basic
Weighted average
number of shares used
to compute net
 gain (loss) per     48,244,646     47,527,766    47,331,510      46,369,683
share - diluted
Optimer Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
                      December 31,   December 31,
                      2012           2011
                      (unaudited)
ASSETS
Current assets:
 Cash and cash     $          $     
equivalents           119,444,586    31,787,512
 Short-term        4,556,329      78,791,066
investments
 Trade accounts     7,119,089      6,563,645
receivable, net
 Accounts           2,391,071      52,289,290
receivable, other
 Inventory          15,061,771     3,947,380
 Prepaid expenses
and other current     3,442,717      3,781,830
assets
Total current assets  152,015,563    177,160,723
Property, equipment   4,338,720      2,590,715
and other, net
Long-term investments 820,000        882,000
Deferred tax assets,  890,843        -
non-current
Other assets          1,362,196      1,389,734
Total assets          $          $    
                      159,427,322    182,023,172
LIABILITIES AND
STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable      $        $     
                      7,166,127       9,860,462
Accrued expenses      19,165,362     21,447,544
Deferred revenue      456,250        -
Total current         26,787,739     31,308,006
liabilities
Deferred rent         938,520        151,141
Income taxes payable, 890,843        -
non-current
Stockholders' equity 130,810,220    150,564,025
Total liabilities and $          $    
stockholders' equity 159,427,322    182,023,172



SOURCE Optimer Pharmaceuticals, Inc.

Website: http://www.optimerpharma.com