Optimer Pharmaceuticals Reports Third Quarter 2012 Financial Results
Webcast and Conference Call Today at 5:00 p.m. Eastern Time
JERSEY CITY, N.J., Nov. 1, 2012
JERSEY CITY, N.J., Nov. 1, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc.
(NASDAQ: OPTR) today announced the Company's financial results for the quarter
ended September 30, 2012.
Third Quarter 2012 Financial Highlights:
oDIFICID® gross sales in the U.S. and Canada of $18.7 million and net sales
of $16.0 million, represent increases of 3.9% and 4.9% over the second
oEstimated DIFICID ex-wholesaler and ex-specialty pharmacy treatments
shipped in the third quarter to U.S. and Canadian purchasing customers,
including hospitals, retail pharmacies and long-term care facilities,
increased by approximately 7.2% compared to the second quarter
oContract revenues from collaborations, which include royalties and bulk
pharmaceutical sales, were $1.9 million
oTotal revenues were $17.9 million
oCash, cash equivalents and short-term investments at September 30 totaled
oNet loss for the third quarter was $26.8 million, or $0.56 per share
Total revenues for the three months ended September 30, 2012 and 2011 were
$17.9 million and $11.1 million, respectively, an increase of $6.8 million.
In the three months ended September 30, 2012, we recognized $16.0 million of
net product sales of DIFICID in the U.S. and Canada. We recognize product
sales of DIFICID upon delivery of product to our wholesalers and specialty
pharmacies. In addition, we recognized $1.9 million in contract revenue under
our collaborations with Astellas Pharmaceuticals Europe Ltd., Astellas Pharma,
Inc. and Specialized Therapeutics Australia, Pty. Ltd.
We reported a net loss for the third quarter of 2012 of $26.8 million, or
$0.56 per share on both a basic and diluted basis, as compared to a net loss
for the third quarter 2011 of $26.4 million, or $0.57 per share on both a
basic and diluted basis.
Research and development expense for the three months ended September 30, 2012
and 2011 was $10.7 million and $10.4 million, respectively, an increase of
Selling, general and administrative expense for the three months ended
September 30, 2012 and 2011 was $26.4 million and $24.0 million, respectively,
an increase of $2.4 million. The increase was due to higher salary expense and
increased legal and other consulting services.
Co-promotion expenses with Cubist for the three months ended September 30,
2012 and 2011 were $4.4 million and $2.9 million, respectively, an increase of
$1.4 million. The increase represented certain profit-sharing expenses earned
by Cubist under our April 2011 DIFICID co-promotion agreement.
As ofSeptember 30, 2012, we held cash, cash equivalents and short-term
investments of$98.2 million. This does not include proceeds from an
agreement announced October 8, 2012 to sell our stake in Optimer
Biotechnology, Inc. (OBI). The sale is expected to result in net proceeds of
$59.8 million and was structured to close in two tranches. The first closing
took place on October 19, 2012 and the second closing is expected to take
place in the first quarter of 2013.
We had 47.7 million shares outstanding on September 30, 2012.
"Over the last two quarters, we have expanded global availability of
fidaxomicin through the launch of DIFICLIR in Europe with our partner Astellas
Pharma Europe,our own launch of DIFICID in Canada and the continued
negotiation of new agreements," continued Mr. Lichtinger. "As part of our
life-cycle management strategy, we are pursuing new indications to expand the
utility of DIFICID for patients in need. This morning, we announced the dosing
of the first patient in our Phase 3b clinical trial evaluating DIFICID as a
prophylactic in patients undergoing hematopoietic stem cell transplant, a
population with a high prevalence of CDAD and without any FDA-approved
preventative treatments for the disease."
DIFICID net sales of $16.0 million in the third quarter of 2012 reflected a
4.9% increase over the second quarter of 2012 and a 51.5% increase over the
prior year period.
Gross sales to U.S. and Canadian wholesalers and specialty pharmacies of $18.7
million in the third quarter of 2012 represented 6,692 treatments shipped, and
a 3.9% increase over the $18.0 million in gross sales for the second quarter
of 2012 and a 53.7% increase from the prior-year period. Further,
approximately 6,600 DIFICID treatments were shipped from wholesalers and
specialty pharmacies to U.S. and Canadian purchasing customers, including
hospitals, retail pharmacies and long-term care facilities, in the third
quarter, a 7.2% increase over the prior quarter and an increase of 131.7% over
the prior year period.
Additionally, as of September 30, 2012:
oInventory levels at wholesalers remain within the range of 14 to 28 days
oApproximately 2,360 U.S. hospitals had ordered DIFICID
oApproximately 79% of U.S. hospitals covered by Optimer have reordered
oThe number of target hospitals including DIFICID on their formularies was
oApproximately 95% of all commercial lives and 80% of Medicare Part D lives
in the United States had formulary payor access to DIFICID, bringing the
total percent of insured patients with covered access to 88%.
DIFICID Strategic Update
"In October we launched new initiatives to educate the hospital market about
our recently-instituted discount program and on DIFICID RxAssist, and we are
optimistic that these efforts will help facilitate patient access to DIFICID
while in the hospital and upon discharge. We have received positive initial
feedback from hospitals to our initiatives since their introduction last
month," said Pedro Lichtinger, President and CEO of Optimer. "Separately, we
also are engaging in efforts to educate customers about the NTAP program,
which can provide an additional reimbursement to eligible hospitals for
qualifying Medicare Part A in-patient cases where DIFICID is utilized. And,
in addition to our strategic initiatives, we continue educational efforts to
provide information to customers on the burden of CDI, providing data that
help address gaps in evidence regarding readmissions and disease burden."
Conference Call and Webcast
Optimer will host a conference call and webcast to discuss its third quarter
financial results and to 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 and any accompanying slides will be
archived for 30 days following the call.
AboutClostridium difficile-associated Diarrhea (CDAD)
Clostridium difficileinfection (CDI) is a serious illness resulting from
infection of the inner lining of the colon byC. difficilebacteria, which
produce toxins that cause inflammation of the colon, severe diarrhea and, in
the most serious cases, death.Clostridium difficile-associated diarrhea is
the most common symptom of CDI. In recent years,C. difficilehas surpassed
methicillin-resistantStaphylococcus aureus(MRSA) as the leading cause of
healthcare-acquired infections in community hospitals. Patients typically
develop CDAD from the use of broad-spectrum antibiotics that disrupt normal
gastrointestinal (gut) flora, possibly allowingC. difficilebacteria to
About DIFICID® (fidaxomicin) Tablets
DIFICID is the first macrolide antibacterial drug indicated forClostridium
difficile-associated diarrhea (CDAD) to be approved in over 25 years in the
U.S. It is indicated for the treatment of CDAD in adults 18 years of age or
older. DIFICID is administered in 200 mg 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 suspectedC. 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.
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, anFDA-approved macrolide antibacterial drug for the treatment
ofClostridium difficile-associated diarrhea (CDAD) in adults 18 years of age
and older and is commercializing DIFICID in the US and Canada. Optimer also
received marketing authorization for fidaxomicin tablets in theEuropean
Unionwhere 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 whereC. difficilehas
emerged as a serious health problem, includingAsia. Additional information
can be found at http://www.optimerpharma.com.
Statements included in this press release that are not a description of
historical facts are forward-looking statements, including without limitation
statements related to Optimer's initiatives to increase patient access to
DIFICID, the timing of the second closing of Optimer's sale of its remaining
equity in OBI, Optimer's pursuit of new indications for DIFICID and Optimer's
on-going educations efforts regarding its patient access initiatives and the
burden of CDI. Words such as "believes", "would", "anticipates", "plans",
"expects", "may", "intend", "will", 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 releaseand Optimer undertakes
no obligation to update or revise these statements, except as may be required
by law. Actual results may differ materially from those set forth in this
release due to the risks and uncertainties inherent in Optimer's
businessincluding, without limitation, risks relating to:Optimer'sability
to continue driving adoption and use of DIFICID, DIFICID's ability to compete
with cheaper generic alternatives, whether healthcare professionals will
prescribe DIFICID,the extent to which DIFICID will be accepted on additional
hospital formularies and the timing of hospital formulary decisions, whether
Optimer's patient access initiatives will result in additional DIFICID
prescriptions in the hospital or retail markets, whether Rx Assist is utilized
and whether it will facilitate access to DIFICID, whether and when the closing
conditions applicable to the second closing of Optimer's sale of OBI equity
will be satisfied, and other risks detailed inOptimer'sfilings with
theSecurities and Exchange Commission.
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
OPTIMER and DIFICID are trademarks ofOptimer Pharmaceuticals, Inc.All other
trademarks are the property of their respective owners.
Optimer Pharmaceuticals, Inc.
Consolidated Statements of Operations and Comprehensive Loss
Three Months Ended Nine Months Ended
September 30, September 30,
2012 2011 2012 2011
Product sales, net $ $ $ $
15,983,575 10,551,820 45,596,203 10,551,820
Contract revenue 1,891,959 - 36,417,444 69,165,000
Other - 500,264 2,106 645,197
Total revenues 17,875,534 11,052,084 82,015,753 80,362,017
Cost and expenses:
Cost of product 1,421,267 615,955 5,974,858 615,955
Cost of contract 1,213,473 - 2,957,655 4,273,532
Research and 10,710,251 10,405,459 33,335,435 29,074,229
Selling, general and 26,444,831 24,015,928 80,824,042 50,582,925
Co-promotion 4,357,463 2,928,760 19,440,629 2,928,760
expenses with Cubist
Total operating 44,147,285 37,966,102 142,532,619 87,475,401
Loss from operations (26,271,751) (26,914,018) (60,516,866) (7,113,384)
de-consolidation of - - 23,782,229 -
Equity in net loss of (694,433) - (1,849,254) -
Interest income and 195,504 108,431 316,209 227,533
Consolidated net (26,770,680) (26,805,587) (38,267,682) (6,885,851)
Net loss attributable
to non-controlling - 378,916 280,344 1,353,204
Net loss attributable $ $ $ $
to Optimer (26,770,680) (26,426,671) (37,987,338) (5,532,647)
Net loss per share - $ $ $ $
basic and diluted (0.56) (0.57) (0.80) (0.12)
number of shares used
to compute net
loss per share - 47,619,006 46,624,390 47,252,123 45,269,621
basic and diluted
Comprehensive loss $ $ $ $
(27,353,113) (27,976,402) (37,437,798) (7,533,274)
Optimer Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
September 30, December 31,
Cash and cash equivalents $ 86,872,487 $ 31,787,512
Short-term investments 11,339,862 78,791,066
Trade accounts receivable, 6,240,170 6,563,645
Accounts receivable, other 1,675,091 52,289,290
Inventory 13,279,904 3,947,380
Prepaid expenses and other 1,761,757 3,781,830
Total current assets 121,169,271 177,160,723
Equity investment in OBI 28,319,359 -
Property, equipment and other, 3,990,520 2,590,715
Long-term investments 882,000 882,000
Other assets 1,420,841 1,389,734
Total assets $ 155,781,991 $ 182,023,172
LIABILITIES AND STOCKHOLDERS'
Accounts payable $ $
Accrued expenses 19,447,265 21,447,544
Deferred revenue 154,416 -
Total current liabilities 29,203,423 31,308,006
Deferred rent 227,337 151,141
Stockholders' equity 126,351,231 150,564,025
Total liabilities and $ 155,781,991 $ 182,023,172
SOURCE Optimer Pharmaceuticals, Inc.
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