Biotech / Medical | Pain Therapeutics, Inc. (PTIE)


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From: Jack@SI1/14/2006 2:09:31 PM
   of 28
 
Thought I should start this board since none existed. PTIE currently has more cash than the MC of some biotechs. Its success will depend on what it does with it.

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From: Doc Bones1/17/2006 9:23:24 AM
   of 28
 
Pain Therapeutics Announces Fourth Quarter and Year-End 2005 Financial Results

Tuesday January 17, 9:15 am ET


SOUTH SAN FRANCISCO, Calif., Jan. 17 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE - News), a biopharmaceutical company, today reported financial results for the fourth quarter and year ended December 31, 2005.

The net loss for the quarter ended December 31, 2005 was $3.1 million, or $0.07 per share, compared to a net loss of $9.3 million, or $0.22 per share for the fourth quarter of 2004. The net loss for the year ended December 31, 2005 was $30.7 million, or $0.70 per share, compared to a net loss of $37.8 million, or $1.01 per share, for the same period of 2004.

At December 31, 2005 Pain Therapeutics' cash, cash equivalents and marketable securities were $212.7 million. This total included the $150.0 million in upfront fees received from King Pharmaceuticals, Inc. in connection with a recently announced strategic alliance.

"In 2005, we made steady progress against our financial objectives, as demonstrated by the closing of the King deal," said Remi Barbier, Pain Therapeutics' president and chief executive officer. "The recent strengthening of our balance sheet allows Pain Therapeutics to move forward rather aggressively with key clinical programs for Remoxy(TM) and Oxytrex(TM) in 2006 while maintaining a relatively low net cash burn. We forecast a net cash burn rate of about $15 million for 2006 against a cash position of $212.7 million. This amount includes a generous allowance to replenish our pipeline with at least one new IND in our core area of expertise with abuse-resistant opioids."

Program fee revenue resulted from the amortization of the $150 million upfront fee received from King from the beginning of the collaboration in November 2005 to the end of 2005. Collaboration revenue reflects reimbursement of Pain Therapeutics' collaboration expenses to the end of 2005 from King.

Research and development expenses decreased to $7.2 million in the fourth quarter of 2005 from $8.9 million in the fourth quarter of 2004. Research and development expenses decreased to $32.9 million for the year 2005 from $35.1 million for the year 2004. The decrease in research and development expenses was primarily related to the completion of the Phase III study with Oxytrex and the termination of the PTI-901 clinical program.

General and administrative expenses increased to $1.6 million in the fourth quarter of 2005 from $1.0 million in the fourth quarter of 2004. General and administrative expenses increased to $4.9 million for the year 2005 from $3.9 million for the year 2004.

Financial Outlook

At December 31, 2005 Pain Therapeutics' cash, cash equivalents and marketable securities were $212.7 million. Pain Therapeutics expects net cash requirements to be approximately $15 million in 2006, plus or minus 10%.

Conference Call and Webcast Information

Pain Therapeutics will host a conference call today at 9:30 a.m. Pacific Time/12:30 p.m. Eastern Time to discuss this announcement. To participate in the conference call, please dial 888-396-2356 (within the U.S.) or 617-847-8709 (outside the U.S.) fifteen minutes prior to the start of the call. The call reference number is 81544426. A playback of the conference call will be available following the call. To access the playback, please dial 888-286-8010 (within the U.S.) or 617-801-6888 (outside the U.S.) and enter reservation number 88878694. A webcast of the conference call will also be available online at www.paintrials.com.

About Pain Therapeutics, Inc.

We are a biopharmaceutical company that develops novel drugs. We have two drug candidates, Remoxy and Oxytrex, in Phase III clinical programs. Both drugs target different segments of the multi-billion dollar market to treat severe chronic pain, such as persistent low-back pain or pain due to advanced stages of osteoarthritis. For more information, please visit our website (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"). PTI 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 timing, scope or expected outcome of the Company's clinical development of its drug candidates, the Company's expected net cash requirements in 2006 and through late-stage development of its drug candidates, the potential benefits of the Company's drug candidates, the Company's plans for filing an IND in 2006 and the size of the potential market for the Company's products. 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 development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary and unanticipated research and development and other costs. 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 Exchange Commission.



PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)

Three Months Ended Year Ended
December 31, December 31,
2005 2004 2005 2004
Revenues:
Program fee revenue $3,712 $-- $3,712 $--
Collaboration revenue 1,368 -- 1,368 --
Total revenues 5,080 -- 5,080 --
Operating expenses (1):
Research and
development 7,154 8,869 32,938 35,093
General and
administrative 1,577 964 4,859 3,868
Total operating
expenses 8,731 9,833 37,707 38,961
Operating loss (3,561) (9,833) (32,717) (38,961)
Other income:
Interest income 519 517 2,047 1,185
Net loss $(3,132) $(9,316) $(30,670) $(37,776)
Basic and diluted loss
per common share $(0.07) $(0.22) $(0.70) $(1.01)
Weighted-average shares
used in computing basic
and diluted loss per
common share 43,916 42,509 43,795 37,267

(1) Included in research and development and general and administrative
expenses are stock based compensation expenses of $90 thousand and $69
thousand for the three months ended December 31, 2005 and 2004,
respectively, and $248 thousand and $401 thousand for the years ended
December 31, 2005 and 2004, respectively.

PAIN THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2005 2004(2)
(Unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable
securities $212,652 $99,397
Collaboration revenue receivable 889 --
Prepaid expenses 623 259
Total current assets 214,164 99,656
Property and equipment, net 1,556 1,461
Other assets 75 75
Total assets $215,795 $101,192
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $998 $877
Accrued development expense 4,461 6,358
Deferred program fee revenue - current portion 26,200 --
Accrued compensation and benefits 501 415
Other accrued liabilities 187 146
Total current liabilities 32,347 7,796
Non-current liabilities:
Deferred program fee revenue - non-current
portion 120,088 --
Total liabilities 152,435 7,796
Stockholders' equity:
Common stock 44 44
Additional paid-in-capital 206,489 205,920
Accumulated other comprehensive loss (479) (544)
Accumulated deficit (142,694) (112,024)
Total stockholders' equity 63,360 93,396
Total liabilities and stockholders' equity $215,795 $101,192

(2) Derived from audited financial statements.

biz.yahoo.com 

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To: Doc Bones who wrote (2)1/17/2006 7:59:14 PM
From: Jack@SI   of 28
 
Thanks Doc. I was in the process of posting the same information but you beat me to it. I did listen to the conference call and Remi was gracious about the King deal. He said it was a win-win for both parties and reflected the value of Remoxy. For PTIE it has already brought in $150 M in cash and could bring in another $150 M in milestone payments plus $100 M in reimbursable expenses plus royalties. Remi confirmed that all DRRX's royalties will be paid by King. His goal is for PTIE to file a new IND each year and expects a new abuse resistent opioid drug IND will be filed 2nd half 2006 as part of the 4 drug King deal. PTIE is negotiating with the FDA over a SPA on a 3rd PIII for Oxytrex (100% owned by PTIE)which was plagued by a high drop rate in a 2nd PIII. Remi said that this problem is common with opioid drugs. He says there are no disagreements with the FDA on the SPA and hopes the paperwork will be completed soon. The CFO confirmed that with King's $150 M payment PTIE is now holding over $200M in cash with no debt and an expected burn rate of $15M this year. This amounts to almost $5.00/share. Really unbelievable for a small biotech. Let's hope it can put this money to some productive use.

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From: LJM2/9/2006 9:01:10 PM
   of 28
 
"Cramer effect on PTIE."

"Sometimes even Cramer can make mistakes," Jim Cramer told viewers of his "Mad Money" TV show Thursday, referring this time to Pain Therapeutics (PTIE:Nasdaq - commentary - research - Cramer's Take).

He said that he shot the company down during the Lightning Round segment of a recent show because he thought it was too risky. But after revisiting the company he found that it's on the cutting edge of modern medicine.

Cramer said the company has plenty of cash and trades at a low price-to-earnings ratio. "They're barely valued above what they have in the bank," he said.

But just as importantly, he said, Pain Therapeutics is close to perfecting the "holy grail" of medical science: the painkiller. He said the company could be a winner if it successfully develops abuse-resistant opiates.

Everybody has pain and everyone wants to kill it, but not everyone wants to end up practically a heroin addict, he said, pointing out that the popular painkiller OxyContin is euphemistically called "hillbilly heroin" because it is highly addictive and sometimes abused.

The company has partnered with King Pharma (KG:NYSE - commentary - research - Cramer's Take) to make abuse-resistant painkillers, and Cramer said such a product may not hook users, but it could hook doctors.

Since OxyContin was introduced in 1995 and generic versions were put on the market, the abuse of painkillers has skyrocketed, Cramer said.

Doctors don't want to prescribe OxyContin or its generics because their addictive properties are so similar to heroin and morphine, he added.

<SNIP>

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To: LJM who wrote (4)2/9/2006 10:30:47 PM
From: tuck   of 28
 
>>"Sometimes even Cramer can make mistakes," Jim Cramer told viewers of his "Mad Money" TV show Thursday, referring this time to Pain Therapeutics (PTIE:Nasdaq - commentary - research - Cramer's Take).

He said that he shot the company down during the Lightning Round segment of a recent show because he thought it was too risky. But after revisiting the company he found that it's on the cutting edge of modern medicine.

Cramer said the company has plenty of cash and trades at a low price-to-earnings ratio.<<

Cramer is still making a mistake; low P/E ratio? Does he mean negative, like that's a good thing?

Whatever, it's up 11% after hours. I used to follow PTIE -- you can find posts on the old "Biotech Lock-Up Expiration Hell" thread -- but now I basically know about as much as Cramer, which ain't sayin' much.

Cheers, Tuck

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To: tuck who wrote (5)2/9/2006 10:41:01 PM
From: rkrw   of 28
 
One thing I can add is the ptie ceo is one of the least impressive bio ceos I've come across. Disingenuous, bad clinical decisions, exaggerating and down talking their remoxy partner (drrx). All in my opinion. drrx is the much better play on remoxy imo because you get similar economics with an actual pipeline and a lower market cap.

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To: rkrw who wrote (6)2/10/2006 10:52:48 AM
From: Jack@SI   of 28
 
The CEO did well putting together the King deal the particulars now well known. Remoxy is now a done deal with King potentially paying another $150 M in milestones and
$100 M of expenses. Once approved King pays DRRX royalties. I like PTIE for Remoxy but the play now is in Oxytrex, an opioid painkiller solely owned by PTIE and with substantially fewer side effects and physical dependency than other opioids. It is true that the last PIII was messed up but PTIE plans to put an SPA in place and said there were no disagreements with the FDA about how that should be done. So what we have is a company with a great deal of cash, small burn rate with achievable milestones and a PIII coming on a $1B drug.
Jack

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From: Jack@SI2/16/2006 7:31:53 PM
   of 28
 
Pain Therapeutics and King Pharmaceuticals Receive Special Protocol Assessment for Remoxy(TM) and Commence Pivotal Phase III
SOUTH SAN FRANCISCO, Calif. and BRISTOL, Tenn., Feb. 16 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE) and King Pharmaceuticals, Inc. (NYSE: KG) today announced that Remoxy has successfully completed a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA). As a result, the companies are commencing a pivotal Phase III trial with Remoxy in 400 patients with severe chronic pain.

Remoxy, an investigational drug, is an abuse-resistant version of long-acting oxycodone, a strong opioid painkiller. Remoxy is intended to meet the needs of physicians who appropriately prescribe oxycodone and who seek to minimize risks of drug diversion, abuse or accidental patient misuse. Pain Therapeutics and King Pharmaceuticals have a strategic alliance in place to develop and commercialize Remoxy and other abuse-resistant opioids.

'We are delighted to have reached agreement with the FDA on a Phase III design for Remoxy,' said Nadav Friedmann, PhD, MD, chief medical and operating officer of Pain Therapeutics. 'We believe this pivotal trial features achievable endpoints, addresses patient drop-out issues and provides a clear path towards product approval.'

Special Protocol Assessment

A Special Protocol Assessment (SPA) from the FDA specifies the Phase III trial objective, design, clinical endpoints and analyses needed to support regulatory approval. These features are considered binding, i.e., the FDA will not later alter its perspective unless public health concerns unrecognized at the time of protocol assessment under this process are evident. For more information please visit the FDA website: www.fda.gov/CbER/gdlns/protocol.pdf .

Phase III Trial Details

Under the terms of the SPA for Remoxy one pivotal Phase III trial is required to file a New Drug Application. The randomized, double-blinded, placebo-controlled, multi-center pivotal trial will enroll 400 patients with moderate-to-severe osteoarthritic pain in multiple U.S. clinical sites. Following a titration period, patients will be randomized to either Remoxy (10-80 mg daily) or placebo for 12 weeks. The primary endpoint is reduction in pain scores over three months compared to baseline. Patient accrual is expected to begin shortly and continue through year end 2006.

About Remoxy

Remoxy is an abuse-resistant version of long-acting oxycodone. Remoxy's sticky, high-viscosity mass resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol releases just a fraction of oxycodone compared to Oxycontin(R) at time points when abusers presumably expect to get high. These physical properties of Remoxy are intended to deter recreational abuse or accidental patient misuse of long-acting oxycodone. The FDA has not yet evaluated the merits, safety or efficacy of Remoxy.
[snip]

Peter considers this a slam dunk.
Message 22173593
An SPA for Oxytrex is next, and maybe not as much a slam dunk, but looks promising from previous phases.

Jack

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From: Doc Bones2/21/2006 9:11:31 AM
   of 28
 
Jim Cramer likes PTIE

Message 22188721

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From: Jack@SI5/4/2006 9:43:30 PM
   of 28
 
Pain Therapeutics' First Quarter 2006 Financial Results Reflect Operating and Financial Strength
Thursday May 4, 4:01 pm ET


SOUTH SAN FRANCISCO, Calif., May 4 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE - News), a biopharmaceutical company, reported first quarter 2006 financial results today. Net income for the quarter ended March 31, 2006 was $0.9 million, or $0.02 per share, compared to a net loss of $8.6 million, or $0.20 per share in the first quarter of 2005.
Cash, cash equivalents and marketable securities were $209.8 million at March 31, 2006.

"We are pleased to report solid operating and financial performance for the first quarter of 2006, with an increasing contribution from our alliance with King Pharmaceuticals, Inc., solid control over our expenses, an on-track clinical campaign with Remoxy(TM), significant regulatory progress with Oxytrex(TM) and good prospects of filing at least one additional IND this year for an undisclosed abuse-resistant drug candidate," said Remi Barbier, president and chief executive officer.

"We are reconfirming our 2006 financial guidance," said Peter S. Roddy, V.P. & Chief Financial Officer. "We continue to expect our net cash requirements for the full year 2006 will be approximately $15 million, plus or minus 10%."


Pipeline of Medicines Continues to Advance
"The first quarter of 2006 marked a strong start of an important year for Pain Therapeutics' pipeline," said Nadav Friedmann, PhD, MD., Chief Operating & Clinical Officer.

During the quarter we commenced a pivotal Phase III program with Remoxy, an abuse-resistant form of twice-daily oxycodone. The Remoxy trial benefits from a Special Protocol Assessment from the FDA. We believe the clinical program that was negotiated with the FDA provides a clear path for product approval. About 20 clinical sites across the U.S. are now initiated for the Remoxy study. In March, we had positive discussions with the FDA regarding a pivotal Phase III program for Oxytrex, a novel opioid painkiller with minimal physical dependence. We plan to advance Oxytrex into a pivotal Phase III program by year-end 2006. Then in April, we announced that we now manufacture a naltrexone dose of 0.0001 mg per tablet. This represents a 10-fold lower dose of naltrexone. We think this remarkable technical achievement may hold favorable clinical or regulatory advantages, such as a more direct comparison of Oxytrex to oxycodone.


First-Quarter Financial Highlights

-- In December 2005, we entered into a definitive strategic alliance with
King Pharmaceuticals, Inc. ("King") to develop Remoxy and three other
abuse-resistant opioid painkillers. Collaboration revenue of $8.8
million reflects reimbursement from King of our collaboration expenses
incurred during the first quarter of 2006.

-- King gave us an upfront payment of $150 million cash in December 2005.
For accounting purposes, each quarter through mid-2011 we plan to
recognize a portion of this cash payment as "Program fee revenue." We
recognized Program fee revenue of $6.6 million this quarter.

-- On January 1, 2006 we adopted Statement No. 123®, Share-Based
Payment, or FAS 123R, as required by the Financial Accounting Standards
Board. In adopting FAS 123R, we began to recognize non-cash equity
related expenses in our financial statements.

-- Research and development expenses increased to $12.9 million from $8.1
million in the first quarter of 2005. The increase was primarily
related to Remoxy, including the initiation of a pivotal Phase III
study, and development activities related to other abuse-resistant
opioid drug candidates.

-- General and administrative expenses increased to $2.0 million from $1.0
million in the first quarter of 2005. This increase was primarily due
to recognition of non-cash equity related expenses following the
adoption of FAS 123R.

-- We have a provision for income taxes of $1.7 million. This amount
consists of the first quarter portion of currently estimated
alternative minimum tax of $2.6 million for the full year 2006. This
provision for income taxes will fluctuate between quarters during 2006.


Conference Call and Webcast Information
Pain Therapeutics will host a conference call today at 1:30 p.m. Pacific Time/4:30 p.m. Eastern Time to discuss this announcement. To participate in the conference call, please dial 866-578-5801 (within the U.S.) or 617-213-8058 (outside the U.S.) fifteen minutes prior to the start of the call. The call reference number is 37288731. A playback of the conference call will also be available. To access the playback, please dial 888-286-8010 (within the U.S.) or 617-801-6888 (outside the U.S.) and enter reservation number 72207618. A webcast of the conference call will be available online at www.paintrials.com.
<snip>

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