Börsen Gymnastikraum Pain Therapeutics
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2012 Annual Report PDF 625.2 KB Add to Briefcase
2011 Proxy Statement HTML file N/A
2008 Annual Report PDF 492.3 KB Add to Briefcase
2007 Annual Report PDF 3.4 MB Add to Briefcase
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2002 Annual Report PDF 328.8 KB Add to Briefcase
http://investor.paintrials.com/annuals.cfm
4§Robertson, Sanford Nov 7, 2013 23.7 KB Add to Briefcase
10-Q§Quarterly Report Nov 1, 2013 397.9 KB Add to Briefcase
8-K§Current Report Oct 31, 2013 42.2 KB Add to Briefcase
8-K§Current Report Oct 23, 2013 21.7 KB Add to Briefcase
10-Q§Quarterly Report Aug 1, 2013 396.3 KB Add to Briefcase
8-K§Current Report Aug 1, 2013 41.6 KB Add to Briefcase
SC 13G/A Amended Statement Of Beneficial Ownership Jul 10, 2013 25.5 KB Add to Briefcase
SC 13G Statement Of Beneficial Ownership Jul 8, 2013 69.5 KB Add to Briefcase
8-A12G/A§Amended Registration Statement Jun 20, 2013 52.2 KB Add to Briefcase
8-K§Current Report Jun 20, 2013 395.5 KB Add to Briefcase
4§Gussin, Robert Z Jun 19, 2013 24.6 KB Add to Briefcase
4§Robertson, Sanford Jun 19, 2013 25.1 KB Add to Briefcase
4§O, Donnell Michael J Jun 19, 2013 23.8 KB Add to Briefcase
4§Scannon, Patrick J Md Phd Jun 19, 2013 24.3 KB Add to Briefcase
4§Ramasastry, Saira Jun 19, 2013 24.9 KB Add to Briefcase
4§Schoenhard, Grant Jun 10, 2013 22.5 KB Add to Briefcase
4§Roddy, Peter S Jun 10, 2013 22.5 KB Add to Briefcase
4§Barbier, Remi Jun 10, 2013 22.6 KB Add to Briefcase
4§Friedmann, Nadav Jun 10, 2013 22.5 KB Add to Briefcase
8-K§Current Report Jun 10, 2013 26.0 KB Add to Briefcase
http://investor.paintrials.com/sec.cfm
— No Change to Program Timelines and No Change to REMOXY Deal Economics —
— Commercial Rights to Three Drug Assets Revert to Pain Therapeutics —
AUSTIN, Texas, Oct. 22, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported Pfizer Inc. (NYSE:PFE) has informed us that, having achieved technical milestones related to manufacturing, they will continue the development program for REMOXY® (oxycodone) Extended-Release Capsules CII.
We also were informed that, following guidance received from the U.S. Food and Drug Administration (FDA) earlier this year, Pfizer will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011. These new clinical studies will include, in part, a pivotal bioequivalence study with the modified REMOXY formulation to bridge to the clinical data related to the original REMOXY formulation, and an abuse-potential study with the modified formulation.
The FDA did not require any further drug efficacy trials. As previously disclosed, the complete response submission is not expected to occur prior to mid-2015.
REMOXY DEAL ECONOMICS ARE UNCHANGED
Pfizer is our exclusive, worldwide partner for REMOXY (except as to Australia/New Zealand). We are eligible to receive from Pfizer a $15.0 million payment upon FDA approval of REMOXY. After commercial launch, we will receive from Pfizer a royalty of 20% of net sales of REMOXY in the United States, except as to the first cumulative $1.0 billion in net sales, which royalty is set at 15%. The royalty rate outside the U.S. is 10%.
In addition, we will also receive from Pfizer a supplemental payment of 6% to 11.5% of net sales, depending on the range of total dollar sales in each year. This supplemental payment is tied to the full amount of our financial obligations to Durect Corporation (Nasdaq:DRRX), our exclusive supplier of certain excipients.
THREE ASSETS REVERT BACK TO US
Pfizer has returned to us all rights with respect to abuse-resistant formulations of hydrocodone, hydromorphone and oxymorphone. These drug assets now vest exclusively in PTI without any royalty or other obligation to Pfizer. We are now 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 the three drug assets.
ABOUT REMOXY
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. We developed REMOXY using technology from DURECT Corporation (Nasdaq:DRRX).
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 our projected timeline, potential future milestone payments and royalties based on revenue from REMOXY, the potential development of other abuse resistant drug candidates, and funding obligations of Pfizer. 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 and other costs, the timing and receipt of funds from Pfizer, potential diversion of resources from the pursuit of development and commercialization of drug candidates subject to our strategic alliance with Pfizer as a result of the acquisition of King by Pfizer, 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 Exchange Commission.
CONTACT: For More Information Contact:
Peter S. Roddy
Vice President and Chief Financial Officer
Pain Therapeutics, Inc.
proddy@paintrials.com
(512) 501-2450
http://investor.paintrials.com/releasedetail.cfm?ReleaseID=798941
AUSTIN, Texas, Oct. 31, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter and nine months ended September 30, 2013. Net loss was $762,000, or $0.02 per share in Q3 2013, compared to a net loss of $1,550,000, or $0.03 per share in Q3 2012. Cash and investments were $51.0 million at September 30, 2013.
"We still expect our net cash usage to be under $10 million in CY2013," said Remi Barbier, Chairman, President & CEO. "Based on recent developments, we also believe Pfizer has a robust plan to resubmit the REMOXY® NDA. Key elements of this plan include doing a bioequivalence study and an abuse-potential study using REMOXY, all of which we believe may result in a stream of technical milestones now through 2015."
Q3 2013 Financial Detail
Program fee revenue reflects the non-cash revenue we recognize from upfront program fees received in prior years.
Research and development expenses decreased to $1.4 million in Q3 2013 from $2.4 million in Q3 2012 and to $3.8 million in the first nine months of 2013 from $5.5 million in the first nine months of 2012, primarily due to lower cash-based compensation and lower non-cash stock related compensation. Non-cash stock related research and development expenses decreased to $1.0 million in the first nine months of 2013 from $2.0 million in the first nine months of 2012.
General and administrative expenses decreased to $1.3 million in Q3 2013 from $2.0 million in Q3 2012, and to $3.7 million in the first nine months of 2013 from $5.0 million in the first nine months of 2012, primarily due to lower cash-based compensation and lower non-cash stock related compensation. Non-cash stock related general and administrative expenses decreased to $1.3 million in the first nine months of 2013 from $2.0 million in the first nine months of 2012.
About REMOXY
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 Zealand.
REMOXY Deal Economics
We are eligible to receive from Pfizer a $15.0 million payment upon FDA approval of REMOXY.
After commercial launch of REMOXY, we will receive from Pfizer 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 (Nasdaq:DRRX), our exclusive supplier of certain excipients in REMOXY.
In October 2013, Pfizer returned to us all rights with respect to abuse-resistant formulations of hydrocodone, hydromorphone and oxymorphone. These drug assets now vest exclusively in PTI 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.
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 usage for 2013; Pfizer's development plan, including expected studies, and the timing of any complete response submission for REMOXY; potential future milestone payments and royalties under the strategic alliance with Pfizer based on milestones and on revenue from REMOXY; the potential development of other abuse-resistant drug candidates; and funding obligations of Pfizer under the strategic alliance. 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 carrying out additional studies relating to, and 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; possible decisions by Pfizer to delay or not continue, or to devote less resources to, the development of REMOXY; 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; 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 Exchange Commission.
— Financial Tables Follow —
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2013 2012 2013 2012
Revenue
Program fee revenue $ 1,958 $ 2,725 $ 5,875 $ 8,173
Collaboration revenue -- -- -- 249
Total revenue 1,958 2,725 5,875 8,422
Operating expenses
Research and development 1,444 2,379 3,766 5,504
General and administrative 1,290 2,001 3,647 4,975
Total operating expenses 2,734 4,380 7,413 10,479
Operating loss (776) (1,655) (1,538) (2,057)
Interest income 14 105 67 405
Net loss $ (762) $ (1,550) $ (1,471) $ (1,652)
Net loss per share, basic and diluted $ (0.02) $ (0.03) $ (0.03) $ (0.04)
Weighted-average shares used in computing net loss per share, basic and diluted 45,037 44,601 44,990 44,703
CONDENSED BALANCE SHEETS
(in thousands)
September 30,
2013§ December 31,
2012(1)
(Unaudited)
Assets
Current assets
Cash, cash equivalents and marketable securities $ 51,027 $ 56,254
Other current assets 389 253
Total current assets 51,416 56,507
Non-current assets
Other assets 340 352
Total assets $ 51,756 $ 56,859
Liabilities and stockholders' equity
Current liabilities
Accounts payable and accrued development expenses $ 1,273 $ 1,290
Deferred program fee revenue - current portion 7,832 7,832
Other accrued liabilities 550 877
Total current liabilities 9,655 9,999
Non-current liabilities
Deferred program fee revenue - non-current portion 27,412 33,287
Other liabilities 437 437
Total liabilities 37,504 43,723
Stockholders' equity
Common Stock and additional paid-in-capital 151,373 148,783
Accumulated other comprehensive income 1 4
Accumulated deficit (137,122) (135,651)
Total stockholders' equity 14,252 13,136
Total liabilities and stockholders' equity $ 51,756 $ 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.
proddy@paintrials.com
(512) 501-2450
http://investor.paintrials.com/releasedetail.cfm?ReleaseID=803057
AUSTIN, Texas, Nov. 26, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced that Remi Barbier, Chairman, President & CEO, will present at the Piper Jaffray 25th Annual Healthcare Conference in New York. The Company will present Tuesday, December 3, 2013 at 12:50 p.m. Eastern Time at the New York Palace Hotel in New York City.
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.
CONTACT: For More Information Contact:
Peter S. Roddy
Vice President and Chief Financial Officer
Pain Therapeutics, Inc.
proddy@paintrials.com
(512) 501-2450
http://investor.paintrials.com/releasedetail.cfm?ReleaseID=809649
14.01.14 3,682 3,682§3,682 3,682 € 1.000 3.682
13.01.14 3,771 3,926§3,771 3,926 € 1.000 3.926
03.01.14 3,369 3,596§3,369 3,596 € 1.000 3.596
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02.01.14 4,86 4,8899§4,59 4,69 $ 265.875 1,24 M
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15.01.14 5,00 5,00§4,19 4,39 $ 2.883.819 12,7 M
14.01.14 5,14 5,2272§4,95 5,12 $ 242.681 1,21 M
13.01.14 5,26 5,29§5,01 5,13 $ 217.423 1,10 M
10.01.14 4,97 5,27§4,9204 5,26 $ 238.939 1,20 M
09.01.14 4,93 5,12§4,83 5,08 $ 208.204 1,00 M
08.01.14 4,93 4,98§4,81 4,92 $ 154.708 0,70 M
07.01.14 4,85 4,93§4,79 4,90 $ 198.417 0,94 M
06.01.14 4,85 4,87§4,70 4,81 $ 151.230 0,71 M
03.01.14 4,79 5,09§4,75 4,83 $ 439.248 2,07 M
02.01.14 4,86 4,8899§4,59 4,69 $ 265.875 1,24 M
GrB
http://www.ariva.de/pain_therapeutics-aktie/...and_sales?boerse_id=40
___________
GRATULATION
In Euro: 3,8579 € | Nasdaq, 21.02.14:::::::::: buran und MfG und danke und Börsen Gymnastikraum Pain Therapeutics
28.02.14 5,67 5,83§5,51 5,65 $ 310.723 1,72 M
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