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Optimer Reports First Quarter 2013 Financial Results



             Optimer Reports First Quarter 2013 Financial Results

$19.4 million in total net revenues for Q1 2013

PR Newswire

JERSEY CITY, N.J., May 9, 2013

JERSEY CITY, N.J., May 9, 2013 /PRNewswire/ -- Optimer Pharmaceuticals,
Inc. (NASDAQ: OPTR) announced today unaudited financial results for the first
quarter ended March 31, 2013.  

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

Financial Highlights

  o First quarter 2013 DIFICID net product sales in the U.S. and Canada of
    $16.8 million, compared to $14.4 million in 2012
  o First quarter 2013 total net revenues of $19.4 million
  o Cash, cash equivalents and short-term investments at March 31,
    2013 totaled $93.3 million
  o 2013 net loss for the first quarter was $31.3 million, or $0.65 per share

"Net product sales in the first quarter of $16.8 million were essentially flat
from the fourth quarter.  We believe net product sales, which are derived from
shipments to wholesalers and specialty pharmacies, were negatively impacted by
an inventory sell-down by wholesalers. We saw a nearly 5% increase in demand
for DIFICID during the quarter, as determined by estimated shipments from
wholesalers to hospitals and retail and long-term care pharmacies, and we see
continuing increased demand through April," said Dr. Henry McKinnell,
Optimer's CEO and Chairman of the Board. "As we move toward mid-year and
beyond, I am confident that if we maintain our focus on establishing DIFICID
as an important treatment option for patients with CDAD, including execution
on the strategic initiatives started in the latter part of 2012, we will
improve adoption of DIFICID."

Financial Overview

Total net revenues for the quarters ended March 31, 2013 and 2012 were $19.4
million and $14.4 million, respectively, an increase of $5.0 million.  The
increase was due to an increase in DIFICID net product sales and an increase
in contract revenue.

DIFICID net product sales in the United States and Canada for the quarters
ended March 31, 2013 and 2012 were $16.8 million and $14.4 million,
respectively, an increase of $2.4 million.  This increase was due to an
increase in the number of customers ordering DIFICID and increased sales to
existing DIFICID customers, as well as the impact of a 5.6% price increase
effective January 3, 2013.  We recognize product sales of DIFICID upon
delivery of product to our wholesalers.

Contract revenue for the quarter ended March 31, 2013 was $2.6 million.  There
was no contract revenue in the quarter ended March 31, 2012.  The $2.6 million
was related to fidaxomicin shipments to Astellas Pharma Europe, Astellas
Japan, AstraZeneca and Specialised Therapeutics Australia, as well as
royalties received from Astellas Pharma Europe.  In addition, we recognized
approximately $0.3 million of revenue on the up-front payments we received
from AstraZeneca and Astellas Japan in the prior year.

Cost of product sales for the three months ended March 31, 2013 and 2012 was
$1.6 million and $1.2 million, respectively.  The increase was due to higher
net product sales in the quarter ended March 31, 2013 as compared to the
year-ago period.

Research and development expense for the quarters ended March 31, 2013 and
2012 was $9.9 million and $11.1 million, respectively, a decrease of $1.2
million. The decrease was primarily due to lower chemistry, manufacturing and
control (or CMC) expenses, as well as lower consulting expenses. The decrease
was offset by higher health economics and outcomes research expenses. We also
incurred higher expenses related to our prophylaxis and pediatric clinical
trials.

Selling, general and administrative expense for quarters ended March 31, 2013
and 2012 was $34.0 million and $25.5 million, respectively, an increase of
$8.5 million. The increase primarily was due to higher legal, professional and
outside service expenses. We also recognized higher stock compensation
expense, primarily related to previously announced management departures.

Co-promotion expenses with Cubist for the quarters ended March 31, 2013 and
2012 were $3.8 million and $10.1 million, respectively, a decrease of $6.3
million. The co-promotion expenses for the quarter ended March 31, 2012
included an accrual of the first-year sales target bonus and an accrual of the
first-year gross profit on sales above the sales target.

Net loss for the first quarter of 2013 was $31.3 million, or $0.65 cents per
share, on a basic and diluted basis, as compared to net loss for the first
quarter of 2012 of $10.9 million, or $0.23 cents per share, on a basic and
diluted basis. The net loss in the year-ago quarter was favorably impacted by
a $23.8 million gain on the deconsolidation of OBI.

At March 31, 2013, Optimer held cash, cash equivalents and short-term
investments of $93.3 million. 

Optimer had 48.0 million shares outstanding on March 31, 2013.

"As we maintain our focus and commitment to establishing DIFICID as an
important first-line treatment option for patients, we are similarly focused
on conducting our review of strategic alternatives so that we can optimize
value for our stockholders," continued Dr. McKinnell.

Conference Call and Webcast
The Company will host a conference call and webcast to discuss its first
quarter 2013 financial results and provide a corporate update today at 5:00
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
at www.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.
DIFICID should not be used for systemic infections. Acute hypersensitivity
reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the
event of a severe reaction, discontinue DIFICID. Only use DIFICID for
infection proven, or strongly suspected, to be caused by C. difficile.
Prescribing DIFICID in the absence of a proven or strongly suspected C.
difficile infection is unlikely to provide benefit to the patient and
increases the risk of the development of drug resistant bacteria. The most
common adverse reactions reported in clinical trials are nausea (11%),
vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia
(2%) and neutropenia (2%).

Please visit www.DIFICID.com or call 855-DIFICID (343-4243) for full
prescribing information for DIFICID.

About Optimer Pharmaceuticals
We are a global biopharmaceutical company currently focused on commercializing
our antibiotic product DIFICID® (fidaxomicin) tablets in the United States and
Canada, and developing other fidaxomicin products in the United States and
worldwide, both by ourselves and with our partners and licensees. DIFICID, a
macrolide antibacterial drug, was approved by the U.S. Food and Drug
Administration on May 27, 2011, for the treatment of Clostridium difficile
-associated diarrhea, or CDAD, in adults 18 years of age and older.
Fidaxomicin has also received marketing authorization in other jurisdictions,
including the European Union, where it is marketed under the trade name
DIFICLIR™ by our licensee, Astellas Pharma Europe. CDAD is the most common
symptom of Clostridium difficile infection, or CDI. 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
(unaudited)
                                  Three Months Ended 
                                  March 31, 
                                 2013                   2012
Revenues:
Product, net                     $   16,813,536         $   14,380,541
Contract revenue                 2,621,958              -
Other                            -                      2,106
Total revenues                   19,435,494             14,382,647
Cost and expenses:
Cost of product sales            1,634,454              1,216,524
Cost of contract revenue         1,656,046              1,067,736
Research and development         9,886,185              11,067,967
Selling, general and             33,999,733             25,522,282
administrative
Co-promotion expenses with       3,750,000              10,081,583
Cubist
Total operating expenses         50,926,418             48,956,092
Loss from operations             (31,490,924)           (34,573,445)
Gain of de-consolidation of OBI  -                      23,782,229
Equity in net loss of OBI        -                      (485,969)
Interest income and other, net   159,225                76,387
Consolidated net loss            $ (31,331,699)         $  (11,200,798)
Net loss attributable to         -                      280,344
non-controlling interest
Net loss attributable to Optimer $ (31,331,699)         $  (10,920,454)
Pharmaceuticals, Inc.
Net income (loss) per share -    $              (0.65)  $               (0.23)
basic and diluted
Weighted average number of
shares used to compute net
  income (loss) per share -      47,884,210             46,722,617
basic and diluted
Optimer Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
                                 March 31,              December 31,
                                 2013                   2012
                                 (unaudited)
ASSETS
Current assets:
    Cash and cash equivalents    $   87,964,542         $ 119,444,586
    Short-term investments       5,385,109              4,556,329
Trade accounts receivable, net   7,062,761              7,119,089
Accounts receivable, other       3,939,220              2,391,071
Inventory                        22,142,846             15,061,771
    Prepaid expenses and other   2,943,388              3,442,717
current assets
Total current assets             129,437,866            152,015,563
Property and equipment, net      4,027,355              4,338,720
Long-term investments            -                      820,000
Deferred tax assets, non-current 890,843                890,843
Other assets                     1,070,388              1,362,196
Total assets                     $ 135,426,452          $ 159,427,322
LIABILITIES  AND STOCKHOLDERS'
EQUITY 
Current liabilities:
Accounts payable                 $     3,728,709        $     7,166,127
Accrued expenses                 24,473,695             19,165,362
Deferred revenue                 128,229                456,250
Total current liabilities        28,330,633             26,787,739
Deferred rent                    1,110,743              938,520
Income taxes payable,            890,843                890,843
non-current
Stockholders' equity             105,094,233            130,810,220
Total liabilities and            $ 135,426,452          $ 159,427,322
stockholders' equity 

SOURCE Optimer Pharmaceuticals, Inc.

Website: http://www.optimerpharma.com
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