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POZN

Started by la-onda, June 01, 2006, 04:22:24 AM

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la-onda

Profile:
POZEN, Inc., a development stage company, focuses on the development of products for the treatment of acute and chronic pain, and other pain-related conditions. The company is also exploring the development of product candidates in other pain-related therapeutic areas. Its principal product candidate is Trexima, which is being developed in collaboration with GlaxoSmithKline for the treatment of acute migraine. Trexima is a proprietary single tablet containing sumatriptan succinate and naproxen sodium. The company is also exploring the development of product candidates that combine an acid inhibitor with a non-steroidal anti-inflammatory drug (NSAID). POZEN has two product candidates in development that combine a proton pump inhibitor with an NSAID in a single tablet; which include PN 100, a combination of lansoprazole and naproxen; and PN 200, a combination of omeprazole and naproxen. These product candidates are intended to provide management of pain and inflammation associated with conditions, such as osteoarthritis, with fewer gastrointestinal complications compared to an NSAID taken alone.

36 slides presentation:
http://media.corporate-ir.net/media_files/irol/12/121701/presentations/FirstAlbany03.17.06.pdf

Latest results:

POZEN Reports First Quarter 2006 Results

CHAPEL HILL, N.C.--(BUSINESS WIRE)--April 27, 2006--POZEN Inc. (NASDAQ: POZN), today announced results for the first quarter ended March 31, 2006.

First-Quarter Results

POZEN reported a net loss of $6.4 million, or $0.22 per share on a diluted basis, for the first quarter of 2006, compared to a net loss of $5.4 million, or $0.19 per share on a diluted basis, for the first quarter of 2005.

For the first quarter of 2006, POZEN reported revenue of $2.2 million resulting from the amortization of upfront payments received pursuant to collaboration agreements for MT 300(TM) and Trexima(TM). Revenue for the first quarter ended March 31, 2005 was $2.1 million.

Operating expenses for the first quarter of 2006 totaled $9.1 million as compared to $7.7 million for the comparable period in 2005. The increase in operating expenses was primarily due to a $1.9 million charge for non-cash stock-based compensation expenses, related to stock options and other stock-based awards, associated with the adoption of Statement of Financial Accounting Standard No. 123(R) on January 1, 2006. Of this amount, $1.2 million was charged to general and administrative expense and $0.7 million was charged to research and development expense.

At March 31, 2006, cash, cash equivalents and short-term investments totaled $39.6 million compared to $45.8 million at December 31, 2005.

Corporate Highlights

New data from the Trexima Phase III pivotal trials was presented at the American Academy of Neurology scientific meeting in San Diego on April 4-5, 2006. The data presented included poster presentations on satisfaction, productivity and long-term safety, and a podium presentation on the superior clinical benefits of Trexima.

POZEN reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the pivotal Phase III clinical trial for its product candidate PN 200, the combination of omeprazole and naproxen, for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk for developing NSAID-associated gastric ulcers.

POZEN announced the appointment of Donald H. Namm and James J. Mauzey to its Board of Directors in March 2006. Ted G. Wood and James R. Butler have elected to resign from the Board of Directors effective May 16, 2006, the date of the annual meeting of shareholders.

Financial Guidance

For the second quarter of 2006, POZEN expects total revenues to be approximately $2.2 million, and total operating expenses to be in the range of $9.2 million to $11.2 million. The amount of operating expenses reflects estimated non-cash stock-based compensation expenses of approximately $1.7 million, associated with the adoption of Statement of Financial Accounting Standard No. 123(R) on January 1, 2006.
For the 2006 year, POZEN expects total revenue to be in the range of $26 million to $30 million, which includes two anticipated $10 million milestone payments from GSK in connection with the Trexima collaboration. Total operating expenses for the 2006 year are expected to be in the range of $39 million to $43 million and will vary depending upon the timing and pace of our development programs, particularly the PPI/NSAID Phase III programs. The expected total operating expenses reflects estimated non-cash stock-based compensation expenses in the range of $7.0 million to $7.2 million, associated with the adoption of Statement of Financial Accounting Standard No. 123(R) on January 1, 2006.

Shorts:
POZN: Short Interest UP 13.1% to 2.8M in May 2006
Wednesday, May 24, 2006 16:22 ET

According to new short interest data from NASDAQ, short interest for Pozen Incorporated (NasdaqNM: POZN) INCREASED 13.1% to 2,750,890 shares for the month ended mid-May, 2006.

SYMBOL             APRIL             MAY          CHANGE       %CHANGE    DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
POZN           2,432,538       2,750,890        +318,352       +13.09%           8

Based on POZN's 20-day average daily share volume of 387,940, it would require approximately 8 day(s) of buying to cover this short interest.





Upgrade:
POZN: HSBC Ups to Overweight from Neutral
Monday , May 15, 2006 14:45 ET
Issuer: Pozen Incorporated (NasdaqNM: POZN)
Analyst Firm:  HSBC Holdings PLC
Ratings Action: UPGRADE
Current Rating: Overweight (from Neutral)


la-onda

over reaction by the market???
feedback is appreciated:

Pozen shares plunge on Trexima news
Friday , June 09, 2006 15:11 ET

By Staff Reporter

NEW YORK, Jun 10, 2006 (XFN-ASIA via COMTEX) -- Shares of drug developer Pozen Inc. plunged Friday after the Food and Drug Administration said it would not approve migraine treatment Trexima until it provides additional safety information, which may require new studies.

Pozen and development partner GlaxoSmithKline PLC said in a statement that the agency issued an approvable letter on the drug, but also requested the added data. An approvable letter is an official notification which contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.

Shares of Pozen plunged $8.27 on the news, or nearly 59 percent, to a 52-week low of $5.84 on the Nasdaq. Over the past 12 months, shares had traded between $7.25 and $18.62.

Pozen and GlaxoSmithKline plan to request a meeting with the agency as quickly as possible to determine the appropriate next steps to gain full approval.

The treatment, which is Pozen's lead product candidate, combines GlaxoSmithKline's Imitrex, which uses Pozen's RT Technology, with naproxen sodium, a nonsteroidal anti-inflammatory drug. RT Technology allows drugs to quickly dissolve and disperse in the stomach, especially when stomach movement is slowed down, a common occurrence during a migraine.

The companies, which submitted the application in August, had expected to have the treatment approved and on the market by the second half of 2006.

American depositary shares of London-based GlaxoSmithKline shed 72 cents to $54.68 on the New York Stock Exchange.

basonista

Maybe this will help get a bounce today.  Up 10% premarket.

UPDATE 1-RESEARCH ALERT-HSBC raises Pozen to "overweight"
Mon Jun 12, 2006 8:05am ET

June 12 (Reuters) -

POZEN INC. (POZN.O: Quote, Profile, Research)

Current Prior Rating Overweight Neutral Price target $11.50 $15.50

--HSBC said that in light of the U.S. Food and Drug Administration's approvable letter for Trexima, a migraine headache medicine developed by Pozen and GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research), it changed its expectations for the drug's launch to mid-2008 from October 2006.

--HSBC also reduced its 2011 sales projection for Trexima to $530 million from $581 million. Pozen is a high risk opportunity with wide ranging outcomes, it added. (Reporting by Dhanya Ann Thoppil in Bangalore)


la-onda

bellwetherreport.com: The Bellwether Report Becomes very Excited about the Potential Surrounding POZEN Inc
Tuesday , June 13, 2006 09:11 ET

Jun 13, 2006 (M2 PRESSWIRE via COMTEX) -- POZEN Inc (NASDAQ:POZN), is a company that our research team will be tracking over the ensuing weeks. They recently came out with a significant corporate development, causing a market stir. The BWR Research Team will continue to bring its subscribers cutting edge research tools, and second to none customer service.

POZEN Inc development stage company, focuses on the development of products for the treatment of acute and chronic pain, and other pain-related conditions, on Friday announced along with GlaxoSmithKline that the U.S. Food and Drug Administration has issued an approvable letter for Trexima.

An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.

The FDA has determined that Trexima is effective as an acute treatment for migraine headaches. The Agency has requested additional safety information on Trexima, which may require new studies. POZEN and GSK intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps to gain full approval.

Trexima, the proposed brand name for the product candidate combining sumatriptan 85 mg, as the succinate salt, formulated with RT Technology(TM) and naproxen sodium 500 mg in a single tablet, is the first product designed to treat multiple mechanisms of migraine: inflammation and vasodilation.

Shares of Pozen plunged $8.27 on the news, or nearly 59 percent, to a 52-week low of $5.84 on the Nasdaq. Over the past 12 months, shares had traded between $7.25 and $18.62.

Pozen and GlaxoSmithKline plan to request a meeting with the agency as quickly as possible to determine the appropriate next steps to gain full approval.

However announcements over the weekend of positive news from analysts, has sent shares climbing higher in trading this morning, a welcome recovery after Friday's plunge.

On Friday, the Food and Drug Administration said it would not approve migraine treatment Trexima until Pozen provides additional safety information, which may require new studies. Pozen and development partner GlaxoSmithKline PLC said in a statement that the agency issued an approvable letter on the drug, but also requested the added data.

Kevin Scotcher, an analyst with HSBC Global Research, upgraded the stock to "Overweight" from "Neutral." However, he reduced his target price to $11.50 from $15.50 to reflect a newly expected delay in FDA approval for the drug.

Analyst Eun K. Yang with Jefferies and Company Inc. wrote in a Monday note to clients that the stock is oversold. Yang predicts the drug will not cause any serious safety issues because its main ingredients are two already marketed pain relieving drugs, though he noted that the exact nature of the FDA's inquiry is unknown.

Yang rated the stock at "Buy" and also lowered his price target to $15 from $20. He predicts Trexima, which is Pozen's lead product candidate, will be on the market in early 2008, about 15 months later than previously anticipated.

Shares of POZEN Inc have continued to rebound as shares currently trade at $6.27, traded back up over 10% from where it traded yestereday. This company could be a huge opportunity for any investors willing to take a risk for a big payout, should look into. This company will need to get the requested information to the FDA as soon as possible as to turn this company back around. The BWR Research Team will continue to follow the market sentiment on this company and numerous others.

la-onda

wow, up again on no news

traderjbr

Nice bottom fishing there la-onda !

gri64

Applaud la-onda! Thank you for this pick.

I'm in @6.01 and still holding, but I don't like at all today action - we see a real tail...  :(
I expect consolidation on current level (near $7) and next run on any positive news.
Sure, after 3 white candles we can get a decline, but I hope for consolidation.

Any other thought?

la-onda

POZN: BMO Capital Starts @ Market Perform; Sets Tgt @ $8; Analyst Notes
Tuesday , July 11, 2006 07:41 ET

Issuer: Pozen Incorporated (NasdaqNM: POZN)
Analyst Firm:  BMO Capital Markets
Ratings Action: INITIATE
Current Rating: Market Perform
Target Price Action: INITIATE
Target Price: $8.00
Analyst Comments: The firm thinks POZN's main product, Trexima, can exceed $1B in peak sales.

basonista

This could be a good gap fade play for today for anyone interested.  POZN spikes with news and then falls back.  The news out today is nothing special, it basically just says that POZN is still working on having the FDA review their drug again.

la-onda

any comments on POZN ?

la-onda

#10
POZEN Announces Receipt of $40 Million Upfront Payment from AstraZeneca
Thursday September 21, 8:00 am ET
Company Provides Revised 2006 Guidance

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Sept. 21, 2006--POZEN Inc. (NASDAQ:POZN - News), announced today the receipt of the $40 million initial upfront payment from AstraZeneca in connection with the exclusive global collaboration agreement between the two companies. The previously announced collaboration with AstraZeneca has cleared the waiting period required under the Hart-Scott-Rodino Anti-trust Improvements Act making the agreement effective.

POZEN entered into the collaboration agreement with AstraZeneca on August 1, 2006 for the co-development and commercialization of proprietary fixed dose combinations of the proton pump inhibitor (PPI) esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet. The products will be indicated for the management of pain and inflammation associated with conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers.

In addition to the $40 million upfront payment, POZEN is eligible to receive up to $160 million for certain development and regulatory milestones; and $175 million in potential sales performance milestones, if certain thresholds are achieved. In addition, royalties will be paid on net sales on a tiered royalty structure that ranges from mid-single digits to mid-teens.

Financial Guidance

As a result of having more detailed information regarding the timing of activities under the collaboration agreement with AstraZeneca, POZEN is revising its financial guidance for the third quarter and the 2006 year. POZEN expects total revenue to be in the range of $3 to $4 million in the third quarter of 2006, including revenue of $1 to $2 million for work performed under the AstraZeneca agreement. Total operating expenses for the third quarter of 2006 are expected to be in the range of $7.5 to $8.5 million, including $1.5 million of estimated non-cash stock-based compensation expense.

POZEN expects total revenue for the 2006 year to be in the range of $14 to $16 million, including revenue of $5 to $7 million for work performed under the AstraZeneca agreement. Total operating expenses for the 2006 year are expected to be in the range of $36 to $38 million, which includes $6.5 million of estimated non-cash stock-based compensation expense. POZEN anticipates its cash balance will be approximately $60 million at the end of 2006.


&

Pozen "outperform"

Tuesday, September 19, 2006 9:19:29 AM ET
RBC Capital Markets

NEW YORK, September 19 (newratings.com) - Analyst Ken Trbovich of RBC Capital Markets maintains his "outperform" rating on Pozen Inc (POZN.NAS). The target price is set to $15.

In a research note published this morning, the analyst mentions that the Journal of the American Medical Association indicates that naproxen does not increase cardiovascular risk. The analyst expects Pozen to gain FDA approval for Trexima and its other drug candidates that contain naproxen as their active ingredient since naproxen has been proven as the safest option in the non-steroidal anti-inflammatory drugs (NSAID) category.

sebfr

Hi la-onda and great find...Applaud :)

But, in this stock, i am bearish...You can see on the chart my entry price at 12.4
My stop-loss at 13.45. A 8.4% risk.

Why ?
1. Resistance at 13.40
2. Triangle breakout
3. Very low volume on the uptrend
4. Negative divergence

But market is stoped on the trendline when an hammer appeared. Yesterday a doji is formed. A lot of indecision on market. We will see in the newt days if i am wrong...

If resistance is broken, i take my loss AND i will be bullish on this stock...

la-onda

resistance is broken  ;)

la-onda

again nice chart action, why didnĀ“t I bought at the dip around 6$  :'(


cheers
O.

la-onda

1)
Pozen "buy," target price raised
Wednesday, November 01, 2006 2:22:45 AM ET
First Albany
NEW YORK, November 1 (newratings.com) - In a research note published yesterday, analysts at First Albany reiterate their "buy" rating on Pozen Inc (POZN.NAS). The target price has been raised from $16 to $21.

2)
Pozen "outperform," target price raised
Wednesday, November 01, 2006 9:48:13 AM ET
RBC Capital Markets
NEW YORK, November 1 (newratings.com) - Analysts at RBC Capital Markets reiterate their "outperform" rating on Pozen Inc (POZN.NAS). The target price has been raised from $15 to $20.

3)
Pozen cuts 3Q loss; shares nudge higher
Tuesday October 31, 5:09 pm ET

Pozen Inc. narrowed its losses in the 2006 third quarter, posting stronger revenue figures and topping Wall Street projections.

The Chapel Hill drug maker reported a net loss in the 2006 third quarter of nearly $4.1 million, or 14 cents per diluted share, compared to a loss of about $4.7 million, or 16 cents per diluted share, in the same period a year earlier.

Pozen reported third quarter revenue of $3.4 million in 2006, up more than 40 percent from the $2.4 million it posted in the 2005 third quarter.

Analysts polled by Thomson Financial projected, on average, a net loss of 18 cents per share on revenue of $3.08 million.

Pozen said it expects 2006 full-year revenue of between $13.5 million and $14.5 million, including between $4.7 million and $5.7 million for work performed under a contract with AstraZeneca announced earlier this year.