Pain Therapeutics Reports 2013 Financial Results and Provides Guidance for
Conference Call Today at 5:00 p.m. Eastern
AUSTIN, Texas, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc.
(Nasdaq:PTIE) today reported financial results for 2013 and provided guidance
for 2014. Net profit in 2013 was $31.5 million, or $0.70 per diluted share,
compared to a net loss in 2012 of $3.4 million, or $0.08 per share.
"We are excited about what lies ahead for PTIE in 2014," said Remi Barbier,
President & CEO. "We'll be watching the progress of REMOXY carefully over the
next few quarters, as Pfizer has stated an intent to refile an NDA mid-2015.
Any moves towards risk-reduction around this drug candidate may accelerate our
corporate strategy to transition from purely an R&D company to a mix of R&D
and product revenue. Based on the clinical and commercial profiles of REMOXY,
and potential upside of our early-stage assets, I believe 2014 may be a
pivotal year for us."
We expect net cash usage for 2014 may be approximately $12 million, reflecting
increased investment in early-stage assets. At December 31, 2013, cash and
investments were $49.8 million.
Financial Highlights for 2013
oTotal revenue increased to $41.1 million in 2013 from $10.6 million in
2012, reflecting a previously disclosed amendment in our strategic
alliance with Pfizer, Inc. In Q4 2013, we amended our strategic alliance
with Pfizer and, as a result, recognized all remaining non-cash deferred
revenue at the end of Q3 2013 as contract revenue during Q4 2013.
oWe do not expect to have taxable income in 2013 because the related
revenue was recognized for tax purposes in prior years.
oResearch and development expenses decreased to $4.9 million in 2013 from
$7.6 million in 2012, primarily due to lower cash compensation and
non-cash stock-related compensation.Research and development expenses
included non-cash stock-related compensation costs of $1.3 million in 2013
and $3.2 million in 2012.
oGeneral and administrative expenses decreased to $4.8 million in 2013 from
$7.2 million in 2012, primarily due to lower cash compensation and
non-cash stock-related compensation. General and administrative expenses
included non-cash stock-related compensation costs of $1.8 million in 2013
and $3.4 million in 2012.
oAt December 31, 2013, cash and investments were $49.8 million, compared to
$56.3 million at December 31, 2012.We have no debt.
Our lead drug candidate, REMOXY^®, is an extended-release oral formulation of
oxycodone for the management of moderate-to-severe pain when a continuous,
around-the-clock opioid analgesic is needed for an extended period of time.We
designed REMOXY to discourage common methods of tampering and misuse.Pfizer,
Inc. (NYSE:PFE) is our exclusive, worldwide commercial partner for REMOXY
(oxycodone) Extended-Release Capsules CII, except as to Australia and New
REMOXY Deal Economics
*To date, we have received total cash payments of $185 million in program
fees and milestone payments under our strategic alliance with Pfizer.
*We are eligible to receive from Pfizer a $15.0 million payment upon FDA
approval of REMOXY.
*After the commercial launch of REMOXY by Pfizer, we will receive a royalty
of 20% of net sales in the United States, except as to the first $1.0
billion in cumulative net sales, which royalty is set at 15%. Outside the
United States, the royalty rate is 10%.
*We will also receive from Pfizer a supplemental payment of 6.0% to 11.5%
of net sales, depending on the range of total dollar sales in each year,
covered by the strategic alliance. This supplemental payment is tied to
the full amount of our financial obligations to Durect Corporation, our
exclusive supplier of certain excipients in REMOXY.
*In October 2013, Pfizer returned to us all rights with respect to
abuse-resistant formulations of three opioid drugs: hydrocodone,
hydromorphone and oxymorphone.These drug assets now vest exclusively in
us without any royalty or other obligation to Pfizer.We are free to
develop and commercialize these assets on our own or with a licensee of
our choice, and may do so without notice or approval from Pfizer.
Investigational New Drug (IND) applications for all three drug assets are
in place with FDA. We have not yet made a decision to develop or to
out-license these three drug assets.
*All development and commercialization expenses around REMOXY are
reimbursed or paid for by Pfizer.
*We retain commercial rights to REMOXY in Australia/New Zealand.We have
not yet announced a market entry strategy for these territories.
Pain Therapeutics will host a conference call today at 5:00 p.m. Eastern time
to discuss 2013 financial results, provide guidance for 2014 and to respond to
To participate in the conference call, please dial 1-877-407-9039 (within the
U.S.) or 1-201-689-8470 (outside the U.S.) prior to the start of the call.
Those interested in listening to the conference call live via the internet
may do so by visiting the Company's website at www.paintrials.com. A playback
of the call will be available for approximately 7 days after the live event.
To access the playback, please dial 1-877-870-5176 (within the U.S.) or
1-858-384-5517 (outside the U.S.) and enter code 13575504.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel
drugs. The FDA has not approved any of our drug candidates for commercial
sale. For more information, please visit www.paintrials.com.
Note Regarding Forward-Looking Statements: This press release contains
forward-looking statements for purposes of the Private Securities Litigation
Reform Act of 1995 (the "Act").Pain Therapeutics disclaims any intent or
obligation to update these forward-looking statements, and claims the
protection of the Safe Harbor for forward-looking statements contained in the
Act.Examples of such statements include, but are not limited to, any
statements relating to the company's projected cash use for 2014; the progress
of REMOXY over the next few quarters, future growth of early stage assets,
expectations related to taxable income for 2013; potential future milestone
payments; reimbursement of development expenses for REMOXY and supplemental
payments and royalties based on revenue from REMOXY.Such statements are based
on management's current expectations, but actual results may differ materially
due to various factors. Such statements involve risks and uncertainties,
including, but not limited to, those risks and uncertainties relating to
difficulties or delays in obtaining regulatory approval of REMOXY and in
development, testing and pursuit of regulatory approval of our other drug
candidates; unexpected adverse side effects or inadequate therapeutic efficacy
of our drug candidates; difficulties or delays in commercialization efforts
with respect to our products, if any are approved for marketing, or failure of
such products to gain market acceptance; the uncertainty of patent protection
for our intellectual property or trade secrets; unanticipated additional
research and development, litigation and other costs; the timing and receipt
of funds from Pfizer; potential diversion of resources from the pursuit of
development and commercialization of REMOXY; and the potential for
abuse-resistant pain medications or other competing products or therapies to
be developed by competitors and potential competitors or others.For further
information regarding these and other risks related to the Company's business,
investors should consult the Company's filings with the Securities and
– Financial Tables Follow –
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
Three Months Ended Years Ended
December 31, December 31,
2013 2012^(1) 2013 2012^(1)
Program fee revenue $ 35,244 $ 2,468 $ 41,119 $ 10,641
Collaboration revenue — — — 249
Total revenue 35,244 2,468 41,119 10,890
Research and development 1,151 2,101 4,917 7,605
General and 1,190 2,209 4,837 7,182
Total operating expenses 2,341 4,310 9,754 14,787
Operating income (loss) 32,903 (1,842) 31,365 (3,897)
Interest and other 39 46 106 451
Income (loss) before
provision for (benefit 32,942 (1,796) 31,471 (3,446)
from) income taxes
Provision for (benefit (73) — (73) —
from) income taxes
Net income (loss) $33,015 $(1,796) $ 31,544 $ (3,446)
Net income (loss) per
Basic $ 0.73 $ (0.04) $ 0.70 $ (0.08)
Diluted $ 0.72 $ (0.04) $ 0.70 $ (0.08)
used in computing net
income (loss) per share
Basic $ 45,059 $ 44,903 $ 45,007 $ 44,753
Diluted $ 45,862 $ 44,903 $ 45,208 $ 44,753
CONDENSED BALANCE SHEETS
Cash, cash equivalents $ 49,838 $ 56,254
and marketable securities
Other current assets 265 253
Total current assets 50,103 56,507
Other non-current assets — 352
Total assets $ 50,103 $ 56,859
Accounts payable and
accrued development $ 1,086 $ 1,290
Deferred program fee — 7,832
revenue - current portion
Other accrued 715 877
Total current 1,801 9,999
Deferred program fee
revenue - non-current — 33,287
Other liabilities — 437
Total liabilities 1,801 43,723
Common stock 45 45
Additional 152,363 148,738
Accumulated other 1 4
Accumulated deficit (104,107) (135,651)
Total stockholders' 48,302 13,136
Total liabilities and $ 50,103 $ 56,859
(1) Derived from the Company's annual financial statements as of December 31,
2012, included in the Company's Annual Report on Form 10-K filed with the
Securities and Exchange Commission.
CONTACT: For More Information Contact:
Peter S. Roddy
Vice President and Chief Financial Officer
Pain Therapeutics, Inc.
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