3SOF

Public 3SOF Boards => Stock Picking => Topic started by: la-onda on August 09, 2005, 05:24:38 AM

Title: IPXL - Sector: Healthcare---Industry: Biotechnology & Drugs
Post by: la-onda on August 09, 2005, 05:24:38 AM
I would like to introduce IPXL to 3stocksonfire:

Facts:
1)
http://phx.corporate-ir.net/phoenix.zhtml?c=67240&p=irol-presentations
2)
Impax to be delisted by Nasdaq
LOS ANGELES (MarketWatch) - Impax Laboratories Inc. said Friday it will be delisted by Nasdaq for failure to file an annual report for 2004 and a quarterly report earlier this year.
Impax (IPXLE: news, chart, profile) shares tumbled by 27% to $10.28 after the company got word from Nasdaq that the delisting would take effect Monday.
The drugmaker said the notice includes provisions for relisting once it files its 2004 annual and 2005 first-quarter reports. Impax has asked the chief accountant of the Securities and Exchange Commission for advice concerning the filing of those reports.
The company said it expects quotes for its shares will appear on Pink Sheets. The trading symbol will revert to "IPXL" once it moves to Pink Sheets.
"Impax remains committed to regaining compliance with all filing requirements and obtaining relisting of its common stock as soon as possible and continues to work diligently toward completing and filing its delinquent reports," the company said in a press release.
3)
Monday , August 08, 2005 08:05 ET

Issuer: Impax Laboratories Incorporated (NasdaqNM: IPXLE)

Analyst Firm:  Salomon Smith Barney

Ratings Action: UPGRADE

Current Rating: Buy (from Hold)

Target Price Action: MAINTAIN
Target Price: $15.00

Analyst Comments: The firm believes risk/reward is compelling at current levels. They reviewed their forecasts for generic Wellbutrin, Concerta, and Oxycontin to assess Impax's financial performance, and are lowering their forecasts to 30c in 2005 and 97c in 2006 to reflect recent script trends.

4) Wachovias statement:
Based on Wachovias information:
Key Points

• Maintain Outperform rating as current valuation appears to represent an inexpensive call
option on Paragraph IV opportunities. Our analysis suggests that the current share price implies
an option premium of ~$1.50 per share for IPXLE's near-term patent challenge opportunities such
as Allegra-D, Ditropan XL, and Adderall XR, which could deliver $5-$7 in value per share to
IPXLE. Therefore, the risk/reward profile has upside bias, in our view.

• Lowering 2004 EPS estimate to $0.03 from $0.29. Partially reflects the pull-out of gWellbutrin
SR 150mg from FQ4'04 into FQ'05 pursuant to the revised March 2005 strategic alliance
agreement with TEVA. Q4 2004 estimate goes to ($0.08) from $0.18.

• Lowering 2005 EPS estimate to $0.43 from $0.85 on lower revenue and higher SG&A,
partially offset by better gross margin. Lower revenue primarily reflects a more conservative
outlook on gWellbutrin SR 150mg and generic Concerta launch pushed out to FQ4'05. Also
introducing our preliminary FY2006 EPS estimate of $0.65.

• Pending selected patent challenges could provide $0.46 in incremental EPS in 2006. Based on
the company's track record in navigating through both regulatory and legal hurdles, we believe
IPXLE's success in near-term patent cases (i.e. Allegra-D, Ditropan XL, and Adderall XR) is
reasonably good. Our current model excludes positive Paragraph IV outcomes.

Valuation Range: $18 to $20
Our valuation range is based on a P/E multiple of 20x our fully-taxed 2006 EPS estimate of $0.65
($13), plus a 12x multiple on potential incremental EPS contribution of $0.40-$0.60 ($5-$7) from
Paragraph IV opportunities. Risks to the stock trading at our valuation range include significant price
and market share erosion of generic Wellbutrin SR, delay in generic Concerta approval, and inability
to maintain NASDAQ listing. )

chart is not available, try IPXLE (former Nasdaq symbol)

;) comments are appreciated

Cheers
O.


Title: Re: IPXL = strong product pipeline + 7% yesterday
Post by: agatto2 on August 09, 2005, 08:14:11 AM
Heres your chart big guy . By the way nice find, i am studying the effect of the d listing thingy. Earlier in the year cray had the same deal. Stock drops to the toilet then back up when relisted. But this guy is really down. I will wait to see if it fills the gap after a few days of lower volume. And then buy in one way or the other. Im woundering if you can short a d listing stock?? anybody anybody bueller bueller
Title: Re: IPXL = strong product pipeline + 7% yesterday
Post by: la-onda on August 11, 2005, 07:40:18 AM
updated chart,
first pinksheet days = good perfomance
Title: Re: IPXL UPDATE
Post by: la-onda on November 12, 2005, 05:18:41 AM
I would like to give you an update to IPXL, and I´m looking forward to receive some feedback from TA and fundamental side  8)

1.) From the August 26, 2005

Delisted Impax talks to SEC, battles shareholders
Generic drug play for share of $27B market
Susan L. Thomas
When Impax Laboratories Inc. reported its first quarterly profit in May 2004, investors and management were ecstatic. The next quarter Impax hit profitability again.

The excitement, spurred by sales of a generic version of the antidepressant Wellbutrin, dimmed on Nov. 9 when the company restated earnings and its stock plunged.
Although its profits stood, the Hayward generic drug maker has been mired in an accounting mess for nearly 11 months.
This month the Nasdaq delisted Impax stock because the company failed to file its financial reports, a decision that relegated its shares to the Pink Sheets, an over-the-counter trading system most often reserved for penny stocks. The volume of trades has plummeted and nearly a dozen class action lawsuits have been filed alleging the company made false statements about its generic Wellbutrin sales. Impax is fighting the consolidated lawsuit and says the charges are meritless. Its discussions with the Securities and Exchange Commission about how to account for sales of some drugs are ongoing.

Impax has attracted attention this year with a patent strategy that had begun to pay off and speculation that it is a takeover target. By using its controlled-release technology to make difficult-to-develop generic versions of brand-name drugs, Impax claims it does not infringe on patents. All told, the brand-name drugs it aims to undercut represent $27 billion in sales.

Yet, as Impax continues discussions with the SEC, many questions must be answered to lure investors back. Whether the setback will prove temporary or will permanently hinder its prospects remains unclear. At the heart of Impax's woes are questions about when it should book revenue from its wholesale distribution partner, a subsidiary of Teva Pharmaceutical Industries LLC, based in Israel. Impax first ran into trouble with Teva revenues in the second quarter of 2004 when it booked the full value of sales of a generic version of Wellbutrin that had been discounted. Impax CFO Arthur Koch said it was an administrative error on the part of a Teva salesperson who did not report that the sale had been discounted until several months later. Ultimately, the error led to the restatement of two quarters of sales.

mpax has since negotiated a flat discount rate that will apply to all sales to avoid the problem in the future, Koch said. It also reached an agreement with Teva in March 2005 on the net sales and margin amounts from Teva's 2004 sales.
Impax has been unable to file its 2004 financial results because it and the SEC have not determined when Teva sales should be booked. Nor has Impax filed any financial reports for 2005. In March, Impax's auditors sought advice from the SEC's office of the chief accountant.
90 days to get back on Nasdaq
In delisting Impax's stock on Aug. 8, the Nasdaq informed Impax that it could regain its status on the exchange if it filed its financial reports within 90 days. Impax believes the re-listing process would be expedited if that were the case.

"I believe we will be able to do it within the next 90 days," Koch said.
The difficulty in coming to terms on the accounting questions stems from the number of auditing teams involved in the discussions and the breadth of the agreement with Teva, he said. Impax signed a 10-year contract with Teva that covers 12 products, and there are an "unlimited" number of ways for which revenue from those products can be accounted, he added. Teams of auditors from Deloitte and the SEC are involved in the discussions, Koch added. "It's taken a long time to bring them up to speed," he said. "They keep asking more questions. We've gone through it in a great amount of detail."
Koch said the revenue-recognition questions have no impact on the company's liquidity or cash position. When the revenue gets recognized could cause profitability variations by quarter, though. For Impax, the Teva deal represents 40 percent of its entire sales volume, Koch said.
"We have this and we're trying to work our way through this," Koch said. "It's never been a question of integrity or impropriety.
"Once we are finished with this, it will be finished forever," he added. "We are getting every possible level of scrutiny."
UC-Berkeley Assistant Professor Maria Nondorf, who has researched accounting issues and the SEC, said more companies are discussing these issues with the agency as they have become sensitive to the possibility of restating earnings.

"The most unusual thing (in Impax's case) is, it's taken so long," she said.
In this type of situation, a company typically presents its case outlining the reason its revenue should be recognized in a certain way, Nondorf said. It's incumbent upon the company to defend its position to the SEC, which may consult with the Financial Accounting Standards Board. Auditors have to sign off on the plan as well.

"There can be a lot of gray area in these types of contracts," Nondorf said, regarding how partnerships account for sales.
Impax's murky financial picture coupled with its move to the Pink Sheets means some Wall Street observers have quit the stock. Morningstar analyst Shilpa Prakash, for example, dropped coverage of the stock Aug. 10, noting that without accurate financial data she couldn't feel confident in any fair value estimates.
Institutional investors often will not hold delisted stocks. Others remain nervous about liquidity. And once on the Pink Sheets, companies no longer are required to disclose financials.
Winning back investors
Whether its financial travails will ultimately hurt Impax's ability to carry out its generic drug strategy could test the firm. Nondorf said that if Impax provides clear and direct disclosure and gives information that reassures investors about its prospects, it should win back investors.
Impax released unaudited estimates for the first half of this year and 2004 this month that some Wall Street analysts considered disappointing. Competitors with new versions of generic Wellbutrin have entered the market and could squeeze those sales. And many of its generic competitors hold strong market positions.
Impax touts its 16 pending applications with the Food and Drug Administration and five applications that have received tentative approval. It expects to launch additional versions of Wellbutrin this year, and resolved litigation over a generic version of chronic pain drug Oxycontin has paved the way for a more aggressive marketing of that drug later this year too, Koch said. Impax also is awaiting a decision on whether it will receive 180-day exclusivity on a generic version of Concerta, a Johnson & Johnson drug used to treat attention deficit hyperactivity disorder. As part of its strategy to rely less on partners, Impax has four of its own branded drugs in early stages of development, and the company ultimately intends to sell those with its own sales force.

Impax's rise and fall

2004
- May 5 - Impax reports first profitable quarter
- Aug. 4 - Reports second profitable quarter
- Nov. 9 - Restates first and second quarter results
- Dec. 23 - Chief Financial Officer Cornel C. Spiegler announces retirement for personal reasons;  stays on until a successor is named

2005
- Mar. 14 - Files for an extension of time to file annual financial results
- Mar. 31 - Announces delay in filing annual report
- Apr. 1 - Arthur Koch named CFO
- Apr. 6 - Receives notice of possible delisting from Nasdaq
- May 4 - Announces it is seeking guidance from the Securities and ExchangeCommission concerning when to book sales from its Teva partnership
- Jun. 27 - Defaults on a $95 million debenture for failing to file financial reports. Sells new bonds to help pay the debt
- Aug. 5 - Nasdaq delists Impax's stock. IPXL moves to Pink Sheets

link: http://eastbay.bizjournals.com/eastbay/stories/2005/08/29/story4.html?page=1

2)
IMPAX Signs Exclusive Supply and Distribution Agreement with DAVA Pharmaceuticals for Oxycodone Hydrochloride Extended Release Tablets

HAYWARD, Calif., Nov 07, 2005 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) announced today it has entered into a ten year Exclusive Supply and Distribution agreement with DAVA Pharmaceuticals, Inc. (DAVA) for IMPAX's 10mg, 20mg, 40mg and 80mg dosage strengths of Oxycodone Hydrochloride Extended Release Tablets. In exchange for payments of up to $60 million over the next 5 years and sharing of gross profits, DAVA will have exclusive sales and distribution rights in the United States and Puerto Rico. IMPAX will be responsible for all manufacturing and regulatory aspects. The combined branded and generic U.S. sales for the 10mg, 20mg, 40mg and 80mg strengths of Oxycodone Hydrochloride Extended Release Tablets were over $1.8 billion for the twelve-month period ended August 31, 2005 according to NDCHealth.
"We are looking forward to working with DAVA on this important product," said Barry R. Edwards, Chief Executive Officer of IMPAX. "We believe the combination of economic terms and DAVA's strong sales and marketing organization make this a very attractive business opportunity for IMPAX."
IMPAX had been marketing the 80mg dosage strength through its Global Pharmaceutical Division; and will be transitioning sales and marketing responsibilities to DAVA. IMPAX currently has a tentative Abbreviated New Drug Application (ANDA) approval for the 10mg, 20mg and 40mg dosage strengths with final approval subject to the expiration of market exclusivity on December 5th, 2005.

3)
Impax inks $60M distribution deal, misses Nasdaq date
Tuesday November 8, 3:06 pm ET

Impax Laboratories Inc. signed a five-year, $60 million distribution deal with Dava Pharmaceuticals Inc. to sell its extended release pain tablets.
Separately, Hayward-based Impax said it will miss the deadline for expedited relisting of its shares on the Nasdaq.
Under terms of the distribution deal, Impax (OTCB: IPXL) could get up to $60 million on sales of its 10mg, 20mg, 40mg and 80mg dosages of oxycodone hydrochloride extended release tablets. Impax and Dava also will share gross profits from the sales.
Dava, of Fort Lee, N.J., will have exclusive sales and distribution rights in the United States and Puerto Rico, while Impax will be responsible for all manufacturing and regulatory requirements.
Impax had been selling the 80mg dosage strength through its global pharmaceutical division, but will now transfer that responsibility to Dava. Impax has received tentative marketing approval for its 10mg, 20mg and 40 mg dosage strengths, with final approval subject to the expiration of market exclusivity on Dec. 5.
Impax was delisted by the Nasdaq in August after failing to file financial reports.
The company said it has submitted information sought by the office of the chief accountant of the Securities and Exchange Commission (OCA) related to sales under a partnership with a Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA - News) unit.
Impax had asked the OCA for help about when to recognize revenue from sales under the Teva deal, and the OCA asked for more information.
Impax has not filed its 2004 annual financial report or subsequent quarterly reports.
The company first ran into trouble with Teva sales in the second quarter of 2004 when it booked the full value of sales of a generic version of Wellbutrin that had been discounted. Ultimately, Impax had to restate two quarters of sales.
Impax said its stock will remain on the Pink Sheets and that it will ask to be relisted when its catches up on financial filings.

4)
IPXL: Smith Barney Cuts to Hold from Buy; Analyst Notes
Tuesday , November 08, 2005 09:10 ET
Issuer: Impax Laboratories Incorporated (Pink Sheets: IPXL)
Analyst Firm:  Salomon Smith Barney
Ratings Action: DOWNGRADE
Current Rating: Hold (from Buy)
Analyst Comments: The firm notes that IPXL signed a deal with Dava Pharma to distribute its generic Oxycontin. They believe the deal lowers its earnings forecasts and decreases IPXL's attractiveness as a takeout candidate.

5)
Updated IPXL presentation:
http://library.corporate-ir.net/library/67/672/67240/items/166803/IPXLSep05ver1aFINAL.pdf

Very detailed & useful presentation

6) Fridays price action

My personal opinion:
- IPXL has at least 3 big pipeline products to show up in 3-6 months
- Dava Deal analysis: The Dava deal, according to the customs of the 
  industry, will infuse $20M earlier next year (then $10M each year for 2007-2010) and share
  the profit every quarter for ten years. Dava is a newly established company but the CEO is a
  marketing king for generic products.
- The next 4 weeks will be very interesting in my opinion, I am thinking about reentering IPXL

Please check the charts & sildes carefully

thanks in advance for your feedback

Oliver
Title: Re: IPXL Update
Post by: la-onda on November 12, 2005, 05:56:40 AM


Shire Pharmaceuticals says Impax sues for patent invalidity concerning Adderall
Friday , November 11, 2005 17:26 ET
LONDON, Nov 11, 2005 (AFX News - UK via COMTEX) -- Shire Pharmaceuticals Group plc said Impax Laboratories Inc told its unit Shire Laboratories Inc that it has filed a complaint against it in the District Court of Delaware alleging its patent for Adderall is invalid and that Impax is not infringing it.
Adderall is used to treat Attention Deficit Hyperactivity Disorder (ADHD).
The suit involves an ANDA (Abbreviated New Drug Application) filed by Impax seeking US FDA approval to market and sell generic versions of Shire's 5 milligramme, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg Adderall XR products. The patent was issued to Shire on July 5, 2005.
On Oct 20, 2005, Shire announced that it had filed a suit in the US District Court for the Southern District of New York against both Barr Laboratories Inc and Impax for infringement of the same patent.
Shire has separate pending patent litigations against Barr and Impax regarding two other patents, in New York and Delaware respectively.
Title: Re: IPXL UPDATE
Post by: fous on November 12, 2005, 07:56:36 PM
Hey La-Onda,

Personally if i was thinking about filling a position on this one. I would wait for a close above the descending trendline just to be cautious. The general market sentiment towards IPXL appears to be bearish at the moment. As well there management seems to be pretty unorganized not being able to get things done in a timely fashion. A close below 9.65 would be a fairly bearish signal and possibly a good stop loss point if you were to purchase on a upside breakout of the descending trend line.

Good luck on your trade if you decide to fill  :D

-fousc
Title: Re: IPXL UPDATE
Post by: la-onda on November 24, 2005, 07:02:15 AM
updated chart:
Title: Re: IPXL UPDATE
Post by: la-onda on December 28, 2005, 03:09:19 PM
Vadova, IPXL's first brand product, is a new version of oral extended-release carbidopa/levodopa.

The old version is Sinemet CR (Bristol-Myers Squibb). It is the standard of treating parkinson's disease, and IPXL and anthother Co have had generics.

Comparing with Sinemet CR (twice-daily), Vadova has prolonged (once-daily) and stablized (avoiding unpredictable burst or delay) release profile. Vadodo has the potential becoming THE standard of treating Parkinson's disease.

FDA accepted the Vadova NDA on May 3, 2005. According to the PDUFA (Prescription Drug User Fee Act), the latest date for Vadova will be March 2, 2006. However, the history of Sinemet CR weeps off the safety concern. Therefore, the approval of Vadova may come earlier than March 2006.

IPXL will have three years exclusivity on Vadova and may have patent protection if any patent has been applied. The RXs of treating Parkinson's disease usually come from dozens doctors. It is relatively easier for marketing and IPXL has already had the experience.

I expect the peak sales of Vadova to be $50M. For 2006, it may add about $0.10 EPS onto IPXL.

updated chart:
Title: Re: IPXL UPDATE
Post by: la-onda on December 28, 2005, 03:11:56 PM
50 EMA crossed  >:D
daily chart:
Title: Re: IPXL UPDATE
Post by: la-onda on December 29, 2005, 04:39:00 PM
1)
http://www.americanbulls.com/StockPage.asp?CompanyTicker=IPXL&MarketTicker=OTC&TYP=S
2)
Crossed the descending trend line  >:D
3) chart:
Title: Re: IPXL UPDATE
Post by: la-onda on January 19, 2006, 05:46:19 PM
IMPAX Settles Patent Suit and Signs Marketing and Promotion Agreements with Shire
Thursday January 19, 4:08 pm ET

HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 19, 2006--IMPAX Laboratories, Inc. (OTC:IPXL - News) today announced that it has reached a settlement with an affiliate of Britain's Shire Pharmaceuticals Group Plc ("Shire") covering all patent litigation between the parties related to Adderall XR® (mixed amphetamine salts). Under the settlement, IMPAX will be permitted to market generic versions of Adderall XR in the United States no later than January 1, 2010. In certain situations, such as the launch of another generic version of Adderall XR, IMPAX may be permitted to enter the market as Shire's authorized generic. IMPAX will pay Shire a royalty from its generic sales of Adderall XR.
Adderall XR is marketed by Shire for attention deficit hyperactivity disorder (ADHD). According to NDCHealth, U.S. gross sales of Adderall XR tablets were approximately $912 million in the 12 months ended November 30, 2005.
Larry Hsu, Ph.D., IMPAX's President, commented, "This agreement is a win-win for both companies as we are now able to resolve the uncertainty of the outcome of litigation and prevent the suit from becoming an even more costly and time consuming dispute."
In a separate agreement, IMPAX will promote Carbatrol® (carbamazepine extended release capsules), Shire's product for the treatment of epilepsy beginning around July 2006. The general framework of the agreement calls for IMPAX to receive approximately $40 million over three years to detail physicians with the product and related information. IMPAX has agreed to perform a minimum number of such activities over the three year period. Also under the agreement, IMPAX is entitled to certain incentive payments based on prescription growth. Other terms of the agreement are confidential and were not disclosed.

Carbatrol had U.S. gross sales of $78 million for the twelve months ended November 30, 2005, according to NDCHealth.

IMPAX initially plans to recruit and deploy approximately 66 to 70 specialty sales representatives, either directly or through a contract sales arrangement with a third party, or a combination of both. The primary target market for Carbatrol of approximately 8,300 neurologists in the U.S. overlaps with the Company's target market for Vadova(TM) (carbidopa and levodopa). IMPAX's branded product Vadova is actively under review by the U.S. Food and Drug Administration and is expected to be approved this year, thus IMPAX intends to achieve synergies in its overall sales and marketing costs.

Commenting on the agreement, Mr. Barry R. Edwards, IMPAX's CEO, said, "With two important CNS products to market to physicians available at approximately the same time, IMPAX plans to establish a position in the branded products market category from the day we enter the market. We believe this will enhance our reputation in the marketplace, as well as lower our overall sales and marketing costs on a per-product basis. We are very pleased to have earned Shire's confidence and we are looking forward to a mutually rewarding, long-term relationship."
Title: Re: IPXL UPDATE
Post by: la-onda on April 05, 2006, 01:09:12 PM
Here is Lehman Brothers' analysis concerning IPXL's updated presentation. One point that they didn't make, I would point out that only one ANDA filed in 2005 was a Paragraph IV filing. That means, barring anything unusual happening, that IPXL should be getting 10 or more final approvals in 2007; some maybe sooner.

From Lehman Brothers:
SUMMARY: On Friday, 3/31, Impax updated its corporate presentation on its website. We believe the most important information disclosed included the generic pipeline update (7 ANDAs filed in 4Q05) and unaudited cash and debt balances ($56M cash and $80M debt). While the unaudited nature of the balance sheet figures indicate they are not final, we believe Impax's ability to disclose these amounts implies that its advisors and auditors are generally comfortable with these figures, representing a bright spot in the absence of other financial data.

In our opinion, the absence of any controversy (again implied by the disclosure) over the cash balance further reinforces our belief that the long delay in financial reporting is primarily related to timing of revenue recognition and not the actual amount of revenues or cashflow. Impax continues to work with its auditor Deloitte & Touche towards finalizing a revenue recognition policy (related to the Teva alliance) to propose to SEC's Office of Chief Accountant (OCA). We remain optimistic that Impax ultimately can complete this process and make its quarterly/annual SEC filings, though timing remains uncertain.
Title: Re: IPXL UPDATE
Post by: la-onda on April 12, 2006, 06:31:27 AM
update; if missing SEC files will be provided by IPXL, this company should popp up IMO, nice pipeline

IMPAX Comments on Wyeth's Lawsuit Related to Generic Versions of Effexor XR(R)
Friday , April 07, 2006 15:58 ET

HAYWARD, Calif., Apr 07, 2006 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC: IPXL) today announced that Wyeth (NYSE: WYE), has filed a lawsuit against the Company in the United States District Court for the District of Delaware alleging patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for generic versions of Effexor XR(R) 37.5mg, 75mg and 150mg capsules. IMPAX's submission includes a Paragraph IV certification stating the Company believes its product does not infringe upon Wyeth's listed patents.

Wyeth markets Effexor XR for the treatment of depression. According to Wolters Kluwer Health, U.S. sales of Effexor XR Capsules were approximately $2.5 billion in the 12 months ended January 31, 2006.

"We intend to vigorously defend our ANDA," commented Barry R. Edwards, IMPAX's chief executive officer. "This suit is par for the course for branded pharmaceutical manufacturers attempting to keep patients from access to less expensive medications, even though their patents aren't applicable or will have expired."

IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

Title: Re: IPXL UPDATE
Post by: la-onda on April 21, 2006, 02:52:34 AM
Analysts upgrade:
Lehman Brothers seems positive about IPXL making progress on solving the revenue reporting issue. Also, while gWellbutrin is still doing well, the gOxycontin isn't, even with DAVA doing the marketing.


Lehman Brothers from 4/19/06:

Summary Comments: We continue to await news from Impax regarding update on finalizing a revenue recognition policy under the Teva alliance. Although Impax has not provided any timetable, our conversations with management over time suggest that good progress is being made, perhaps moving that much closer to final resolution. We continue to believe that the scope of the issue has not broadened beyond revenue recognition under the Teva alliance, although restatement of 2004 financials is likely.

Financial Results: We officially forecast 1Q06 total revenues of $36M and EPS of $0.09. A key product for Impax continue to include selfmarketed generic Wellbutrin SR 200mg, which averaged 54% TRx share in 1Q (+4 pct pts Q/Q) with TRx volume increasing 11% Q/Q. Also important is Teva-marketed generic Wellbutrin SR 100 & 150mg, which rose 2 pct pts in TRx share to 44% in 1Q and TRx volume increasing 10%. Finally, Dava-marketed generic OxyContin continues to make slow progress with average of 3% average share. Keep in mind that Impax will recognize $6M from amortization of upfront fee, plus gross profit split and a small manufacturing mark-up.

Most of you probably won't be interested in this. But, for those who still read the idiotic ramblings of clcl2002us, this will show once again how wrong he is. When Mylan announced their tentative approval for gAllegra, clcl2002us posted about it and said that this could make Barr launch gAllegra-D. Well, Dr. Reddy's just launched gAllegra, as was expected. The next expected launch of gAllegra is from Sandoz, sometime after June 2006. Notice how Mylan isn't expected to launch yet. Mylan will have nothing to do with Barr's decision on when to launch gAllegra-D. Probably, no launch by any mfgr of gAllegra will influence Barr's decision on gAllegra-D.


Lehman Brothers from 4/19/06:

BARR PHARMACEUTICALS – DR. REDDY'S LAUNCHES GENERIC ALLEGRA, AS EXPECTED: On 4/13, Dr.
Reddy's announced final approval and launch of its generic version of Allegra tabs, 30, 60, 180mg. Dr. Reddy's entry does not come as a surprise, with Barr/Teva's 180-day exclusivity having ended in early March, and Dr. Reddy's 30-month stay having expired during the same month. In our Teva and Barr forecasts, we have assumed Dr. Reddy's entry for the entire June quarter, with expected sales (booked by Teva) of $70M, contributing ~$0.08 EPS to Barr during the quarter and ~$0.01 EPS to Teva. This assumes generic discount of between 50%-60%, Teva/Barr market share between 40-50% (currently has 52.4% for the week of 3/31), and 50/50 split between Teva/Barr. In contrast, our model for the March quarter justed ended, forecasts EPS contribution of ~$0.13 to Barr; forecasted contribution to Teva remains unchanged at about a penny. We do not expect any additional competition until the end of the June quarter, with Sandoz the next 30-month stay to expire in June.


Title: Re: IPXL UPDATE
Post by: la-onda on April 26, 2006, 05:39:15 AM
updated chart; TA is appreciated
Title: Re: IPXL UPDATE
Post by: la-onda on May 17, 2006, 07:14:43 AM
PXL: New 52-Wk Low @ $8.450 dn 3.98%
Tuesday , May 16, 2006 16:55 ET

This is the 1st 52 WEEK LOW alert for IPXL in the past 7 calendar days.
The share price for Impax Laboratories Incorporated (OTC: IPXL) reached a new 52-week low today, trading at $8.450, down $-0.350 (-3.98%) from its previous close of $8.800.
The Company's previous 52-week low of $8.500 was set 162 days ago on December 05, 2005.
One year ago, the Company's shares closed at $16.470. The price has declined more than 48 percent since then.
At the time of this alert, the stock had traded 65,100 shares via 38 trades, 70.20% below it's 20day average of 218,476 shares.
This new 52-week low currently puts the stock:

7.52% below its 20day Moving Average of $9.137
10.51% below its 50day Moving Average of $9.443
15.39% below its 100day Moving Average of $9.987
Title: Re: IPXL UPDATE
Post by: la-onda on May 18, 2006, 06:47:19 AM
time for starting a position ??
Title: Re: IPXL UPDATE
Post by: Richard on May 18, 2006, 08:59:49 AM
Quote from: la-onda on May 18, 2006, 06:47:19 AM
time for starting a position ??


I'm going to have to go with "no" on this one. Chart looks brutal.
Title: Re: IPXL UPDATE new 52 week low
Post by: la-onda on May 30, 2006, 04:42:35 AM
SEC Filling still not in time...  :'(


IPXL presentation:
http://library.corporate-ir.net/library/67/672/67240/items/190148/Investor_Presentation.pdf

chart  ??? :
Title: Re: IPXL UPDATE
Post by: la-onda on June 08, 2006, 03:47:44 AM
little rebound after new 52 week low
Title: Re: IPXL UPDATE
Post by: la-onda on July 05, 2006, 07:02:56 AM
Petitions to FDA Sometimes Delay Generic Drugs
Critics Say Companies Misusing Process

By Marc Kaufman
Washington Post Staff Writer
Monday, July 3, 2006; A01

A procedure designed to alert the Food and Drug Administration to scientific and safety issues is getting a hard look from members of Congress, who say they are concerned that it may be getting subverted by the brand-name drug industry.

Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" -- requests for agency action that any individual, group or company can file -- are being misused by brand-name drugmakers to stave off generic competition.

The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.

Statistics collected by the staff of Sen. Debbie Stabenow (D-Mich.), who has introduced legislation with Sen. Trent Lott (R-Miss.) that would rein in industry-filed citizen petitions, show that 20 of the 21 brand-name petitions settled by the FDA since 2003 were ultimately rejected.

"The brand-name drug industry has found a major new loophole," Stabenow said in an interview. "The way things stand now, even if the FDA finds that a petition was frivolous and rejects it, [the drug companies] can get hundreds of millions of dollars of profits from the delay."

She and others point to the example of Wellbutrin XL, a hot-selling antidepressant that was facing the prospect of competition from cheaper generics late last year.

By the time Biovail Corp., the drug's maker, filed a citizen petition with the FDA, raising concerns about the safety of its potential rivals, Impax Laboratories Inc. and several other companies had already gone through much of the FDA application and review process for their generic versions of the drug. Impax was looking forward to getting a tentative approval that would bring it considerably closer to making and selling its competing drug.

But because of the citizen petition, the FDA has yet to act, and Biovail still has the market for Wellbutrin XL to itself. Impax is fuming, as are many others in the generic drug industry.

In a letter sent last week to FDA Acting Commissioner Andrew von Eschenbach, Stabenow and Lott estimated that the delay in approving a generic version of the antidepressant Wellbutrin XL is costing consumers $37 million a month.

Impax already sells a twice-a-day version of Wellbutrin; the once-a-day XL version was approved by the FDA in 2003 as the patent on the shorter-lasting formulations was running out.

"Biovail's petition is a sham, designed solely to delay the onset of generic competition for its Wellbutrin XL product," Impax told the FDA in a letter. "Biovail has wasted FDA's and Impax's time and resources and has likely cost the American public millions of dollars in taxes and health care expenditures in selfish pursuit of further undeserved windfall profits."

Biovail rejects the view that it is trying to block generic competition, and in its petition made the case that generic versions of its product may not be biologically equivalent and could be dangerous. As a result, the company -- which has also filed patent infringement suits against its prospective rivals -- asked the FDA to require substantial additional testing before any generic version of Wellbutrin XL is approved.

Pharmaceutical Research and Manufacturers of America (PhRMA), which represents brand-name drugmakers, supports the citizen petition process and says the dozens of similar petitions pending with the FDA raise legitimate concerns.

"Most citizen petitions raise important regulatory, legal or scientific issues," said Caroline Loew, the group's senior vice president. "The fact is, the petitions have played a vital role at the FDA since their adoption almost 30 years ago. They have been responsible for important discussions about health and safety, and have been a catalyst for key agency decisions, such as speeding approval of AIDS medicines and implementing rules to protect children from accidental iron poisoning."

Although citizen petitions have raised many important drug policy issues, the Wellbutrin filing is one of several dozen pending that some call "blocking petitions" because they have the effect of delaying approval of a generic alternative. FDA officials said that about 170 citizen petitions are before the agency -- compared with 90 in 1999 -- and that about 30 percent involve industry challenges to generic applications.

FDA Chief Counsel Sheldon Bradshaw told generic drugmakers at a September conference that the agency has been troubled by the number of such petitions. He said they "appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving a drug application, but rather to delay approval by compelling the agency" to review arguments that could have been made months before.

That response caused PhRMA to write to Bradshaw asking for more information. Scott Lassman, PhRMA's assistant general counsel, said the organization found the comments to be "troubling," especially if they could lead to restrictions on how and when citizen petitions could be filed.

More recently, Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said in an interview that the agency has instituted internal changes that will allow for quicker rulings on citizen petitions, especially if they are filed close to the time when a decision on a new generic is expected. But he said that he did not believe there had been an increase in "what a reasonable person would call a blocking petition."

"It's very hard to decide what's a blocking petition and what has value without taking a serious look," Gottlieb said. "I think citizen petitions are very important and have to be preserved. The last thing we want to do is close off an avenue of discourse with the agency."

By regulation, all generic drugs must be "bioequivalent" to the brand-name drugs they copy and must have the same effects and dependability. Industry-sponsored citizen petitions often challenge the process by which bioequivalence was tested.

Because generics generally cost 25 percent to 75 percent less than brand-name products, the sums of money at stake can be enormous -- for the brand-name company, the generic maker, patients, insurance companies and government programs. Wellbutrin XL (a once-a-day formula of bupropion hydrochloride with fewer side effects than the original) costs $1 to $5 a pill and earns about $800 million a year for Biovail and GlaxoSmithKline PLC, which developed the drug. An Impax spokesman said his company planned to sell its generic version, if approved by the FDA, for "a considerable discount
."

Making changes to the citizen petition process is a high priority for the Generic Pharmaceutical Association. Its president, Kathleen Jaeger, said her group considers blocking petitions to be among the greatest obstacles facing the industry.

"Because of the way the system works now, branded companies have every reason to file citizen petitions," she said. "There's a potentially great benefit, and there's no risk. I can't imagine that this is how the originators of the petitions thought they should work."

This is not the first time that the generic industry has complained about citizen petitions that it believed were unfairly blocking generic applications. The Clinton administration responded to those complaints in 1999 with a proposal that would have changed the way the FDA received and handled citizen petitions. PhRMA strongly opposed the rule, and the Bush administration withdrew it in 2003.

Jaeger said the generic industry was working hard with Congress at that time to close other loopholes in the patent system that allowed makers of brand-name drugs to extend their time for exclusive sales. "We were working so hard to get that legislation passed that we didn't really focus on what was happening with the citizen petition rule," she said, "so some of what we won in Congress, we lost to the citizen petitions."

Stabenow and Lott, who are trying, in their bill, to reduce the petitions, said in their letter to von Eschenbach that "the Senate Appropriations Committee recognized the unintended effect citizen petitions were having on the approval of [generic drug applications] and directed the FDA to provide a written report explaining the process and suggesting improvements. . . . It is our understanding the FDA has not moved forward with this request."
link:
http://www.washingtonpost.com/wp-dyn/content/article/2006/07/02/AR2006070200840_pf.html
Title: Re: IPXL UPDATE
Post by: la-onda on July 12, 2006, 03:43:01 AM
Solvay wins settlement from Global and Impax
Tuesday July 11, 1:36 pm ET

Global Pharmaceuticals and Impax Laboratories Inc. will pay Solvay Pharmaceuticals Inc. $23 million to settle a lawsuit that alleged the companies falsely advertised and marketed their products as generic equivalents to and substitutes for Solvay's drugs to treat pancreatic exocrine insufficiency.

Marietta, Ga.-based Solvay Pharmaceuticals Inc. said Global and Impax Laboratories have already paid $12 million of the settlement amount.

Global and Impax also must discontinue marketing that states or implies its products are generic equivalents to Creon brand products and must discontinue current product labeling, distribution and sales of Lipram-CR 5, Lipram-CR 10 and Lipram-CR 20. The terms of the settlement further require the companies to disseminate corrective written advertising to customers, database companies and managed care organizations stating that its products are not generic equivalents to Creon products and should not be substituted for Creon products without physician supervision.

"We believe the outcome of this case validates our long-held assertion that these pseudo-generic products are not true generic equivalents to Creon Minimicrospheres and should not be substituted for our products," said Dr. Laurence Downey, president and CEO of Solvay Pharmaceuticals Inc. "More importantly, this settlement will help to ensure that pancreatic enzyme patients -- including thousands of children with cystic fibrosis -- will receive the life sustaining product they've been prescribed in Creon Minimicrospheres."

Creon is used to treat pancreatic exocrine insufficiency, which is often associated with conditions such as cystic fibrosis and chronic pancreatitis. Pancreatic exocrine insufficiency occurs when enzyme output from the pancreas is inadequate to digest fats, proteins and carbohydrates in food.

Solvay Pharmaceuticals first filed lawsuits in April 2003 in the U.S. District Court of Minnesota against Ethex Corp., KV Pharmaceutical Co., Global Pharmaceuticals and Impax Laboratories Inc. The lawsuit filed against Ethex KV Pharmaceutical is ongoing.

any comments would be appreciated
Title: Re: IPXL UPDATE
Post by: la-onda on August 19, 2006, 01:52:30 AM
something is moving this stock......
Title: Re: IPXL UPDATE
Post by: la-onda on August 22, 2006, 04:41:56 AM
any other opinion  :) ?

yahoo board quotation (thanks clcl):

IPXL history:

With the push of gWSR, IPXL achieved the historical high, $25.74, on 5/5/04.

Massive insiders-selling occurred in June, 2004 and Impax overstated 1Q04 and 2Q04 income.

Aug. 2004, Impax filed 3Q04 10-Q and restated 1Q04 and 2Q04 Financial.

Dec. 2004, CFO resigned.

4/6/05, Impax officially delayed 4Q04 10-Q and 2004 10-K; symbol changed from IPXL to IPXLE at pps=$17.45.

8/5/05 Impax's stock was delisted by NASDAQ; symbol changed from IPXLE to IPXL.PK at pps=$10.28.

The market acted patiently during Aug. 2005 to Mar. 2006: pps ranged $11 +- $2.

Prior to 10/3/05, Greenlight Capital and Mr. Einhorn purchased 3.9765M shares (6.8% of outstanding) from the open market.

Prior to 2/14/06, Wellington (a well known fund) purchased 4.763115M shares (8.14%) from the open market; and Greenlight and Einhorn aggregated the position to 5.8M shares (9.9%). A potential outcome of these purchases would be a proxy fight in the future (2007?).

April 2006, a decision box around $10 was formed. The decision: negative (i.e., a breakdown).

May 2006, a decision box around $9 was formed. The decision: negative.

June 2006, a decision box around $6.5 was formed. The decision: negative.

It was a clear indication of the growing impatience of the market.

July-Mid August 2006, a decision box around $5 was formed (7/7/06 low $4.25). The decision: positive (a breakout) so far.

Aug. 2006, resignation of CEO announced.

After a painfully long period, Impax may submit 2004 10-K in 2006 Fall.

However, Impax may have half a dozen approvals (including tentative approvals) coming out in the next 6 months.

last company presentation:
http://library.corporate-ir.net/library/67/672/67240/items/190148/Investor_Presentation.pdf

latest news:

IMPAX Names Larry Hsu as CEO Effective October 1, 2006

HAYWARD, Calif.--(BUSINESS WIRE)--Aug. 15, 2006--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that its President, Larry Hsu, Ph.D., will assume the additional position of Chief Executive Officer on October 1, 2006. He will replace Barry R. Edwards, the Company's current CEO, who is also resigning as a director of the Company. Mr. Edwards will serve as a special consultant to the Company through October 2008.

Commenting on the change in management, Charles Hsiao, Ph.D., chairman of the board of directors, said, "Since forming IMPAX, we have assembled a strong leadership team, set a clear strategy, focused on development excellence, created new product opportunities and built a solid infrastructure. We are fortunate to have in Larry Hsu a talented executive who is ready and highly capable to take on the responsibilities of chief executive. We are very sorry that Barry will no longer be managing the day to day activities of the Company, but are delighted that he has agreed to remain involved for the next two years. Barry will long be remembered for his inspired leadership during this remarkable period of growth and transformation. "

"I am extremely gratified by the Board's confidence," Dr. Hsu said. "It is an honor to be asked to lead this company, which I co-founded more than 10 years ago. I am grateful to Barry for his stewardship during the past seven years. Thanks to his vision, IMPAX today is a vastly different and more mature company than the one he was asked to lead in 1999."

"The Board of Directors has great confidence in Larry's leadership and in his vision for IMPAX Laboratories," said Mr. Edwards. "He helped create IMPAX's business strategy and he understands, as I do, that the Company's strength lies in the hundreds of employees who have been and continue to be a critical component of our success. The transition is expected to be orderly as several important functions, in particular sales and finance, have been reporting to Larry for some time. Nevertheless, I intend to work closely with Larry to ensure that the transition is seamless."

better chart:
Title: Re: IPXL UPDATE
Post by: la-onda on September 07, 2006, 04:13:50 AM
update:
Impax won the patent case of Ditropan XL based on the US appeals court ruling today. Impax is FTF of the 15 mg stength. Mylan, FTF of the 5 and 10 mg strenths, won as well.
Ditropan XL had $400M market size in 2004.
The last hurdle is the CP JNJ filed on 8/30/2005. Impax can launch 15 mg Ditropan XL immediately following the denial of that CP, and launch 5 and 10 mg 180-day later.

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060906:MTFH60982_2006-09-06_21-03-46_N06460777&type=comktNews&rpc=44

updated chart (nice BO today)

Title: Re: IPXL UPDATE
Post by: la-onda on September 08, 2006, 04:21:07 PM
cup and handle formed ??

TA feedback is appreciated....


cheers
Oliver
Title: Re: IPXL UPDATE
Post by: sebfr on October 02, 2006, 02:49:48 PM
Hi,  :)

Soory but i don't see where "cup and handle" could be...For me it is not a reversal pattern. I prefer to see a "inverted head and shoulders".

Well, the previous gap is filled + volume low on last uptrend and trending range = sell signal
But "Head and shoulders" + "Flag" + high volume on neckline breakout = Buy signal.

Buy strategy :
1. Waiting for a breakout of the flag pattern
2. Waiting for a pullback near neckline (red trendline) at about 6.00

I hope this analysis can help you in your decisions...With penny, the best as the worst can arrive !
Title: Re: IPXL UPDATE
Post by: la-onda on October 26, 2006, 09:07:10 AM
IPXL update:

IMPAX Receives FDA Approval for Generic Version of Colestid(R) Tablets
Company Awarded 180-day Market Exclusivity

HAYWARD, Calif., Oct 26, 2006 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Colestid(R) Tablets (Colestipol Hydrochloride Tablets) 1 gram. The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product under Paragraph IV of the Hatch-Waxman amendments. Pharmacia and Upjohn Company (Pfizer) markets the 1 gram Tablet as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Total brand sales of Colestid(R) Tablets 1 gram in the U.S. were $20 million for the 12 months ended August 31, 2006, according to Wolters Kluwer Health.

"This is our third ANDA approval this year," commented Larry Hsu, Ph.D., IMPAX's President and Chief Executive Officer. "We are looking forward to our Global Pharmaceuticals division marketing our generic Colestid Tablets very shortly."

I didn´t trigger the buy button during the 6$ rest period"

Seems to be that IPXL breakout of the flag pattern was happened  ;D

Sebfr, any comments ?

cheers
O.
Title: Re: IPXL UPDATE
Post by: sebfr on October 28, 2006, 06:01:24 AM
Hi la-onda  :)

You're right. breakout of the flag pattern has happened a few days ago.

We can see a double bottom after market has tested "inverted head and shoulders" neckline. Theorical target at 8.00

Good trades
Title: Re: IPXL UPDATE
Post by: la-onda on November 03, 2006, 05:46:38 PM
FYI:
1)
Impax gets FDA OK for urinary retention drug
Friday November 3, 2:45 pm ET

Impax Laboratories Inc. has been granted U.S. Food and Drug Administration approval for generic versions of Urecholine, which is used for post-operative and post-partum urinary retention.

Hayward-based Impax (OTCBB:IPXL - News) said sales of both the branded and generic versions of Urecholine were about $33 million in the 12 months ended Aug. 31.

The company said the approvals strengthen its strategy to develop niche generic pharmaceuticals.

2)
IPXL Partnership with TEVA, DAVA & Shire

3)
General overview
Title: Re: IPXL UPDATE
Post by: la-onda on November 03, 2006, 05:48:10 PM
4)
2006 details & milestones
Title: Re: IPXL UPDATE
Post by: la-onda on November 03, 2006, 05:55:11 PM
5)
Financial update:
The negative cash flow (due to capital expenditures) is a concern &
IPXL still have the following issue to be solved asap IMO:

IMPAX has been unable to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2004, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. IMPAX's failure to file these periodic reports violated Nasdaq Marketplace Rule 4310(c)(14), compliance with which is required for continued listing on Nasdaq.

If this issue will be solved, IPXL should be traded much higher as now!
more details (29 slides):
http://library.corporate-ir.net/library/67/672/67240/items/219410/IPXLNov062.pdf

Feedback & comments are appreciated
cheers
Oliver
Title: Re: IPXL UPDATE
Post by: la-onda on November 11, 2006, 03:35:06 PM
update:
1)
Investment Conclusion
While we view the appointment of new auditor as
an important milestone in Impax's journey, it by no
means guarantee near-term resolution of the
revenue recognition issue. We remain optimistic
that Impax could be in a position to report its
financials in early 2007.


Summary

This morning, Impax announced the appointment
of Grant Thornton (GT) as its new auditor, who will
take over for Deloitte & Touche (D&T) after
completion of the 2004 audit. Recall, in Nov '05,
Impax announced D&T had decided not to
continue the relationship post 2004 audit.

This is encouraging as we believe GT's
willingness to take Impax on as a client now, prior
to a decision re. revenue recognition, suggests the
auditor believes the revenue recognition issue is
ultimately solvable. Additionally, timing of the
appointment will allow GT to be physically at
Impax facilities to test internal controls for CY06,
an important step under Sarbanes Oxley that must
be completed during the same CY. While GT will
not be involved in the revenue recognition
decision, its understanding of the issues and
knowledge of Impax's business should help to
facilitate the eventual transition from D&T.

2)
MPAX Receives Final FDA Approval and First-to-File Status for Generic Version of Ditropan(R) XL 15 mg
Friday November 10, 10:41 am ET
- Marketing to Begin Immediately -

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL - News) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan® XL, Extended-release Tablets, 15 mg (Oxybutynin Chloride Extended-release Tablets 15 mg). The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of Ditropan XL 15 mg were approximately $58 million in the 12 months ended August 31, 2006, according to Wolters Kluwer Health.

The Company's version of generic Ditropan XL 15 mg is one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA - News). Teva plans to begin marketing the product immediately.

"We are very pleased to now have eight FDA approvals this year and look forward to working with our partner on the launch of our generic version of 15 mg Ditropan XL," said Larry Hsu, President and Chief Executive Officer of IMPAX Laboratories. "We had expected this approval following the September 2006 appeals court ruling in our favor in a patent infringement suit brought against us by Alza," he added.

The Company noted that it continues to have tentative approval for its 5 mg and 10 mg versions of generic Ditropan XL. Conversion of the 5 mg and 10 mg strengths from tentative approval to final approval is contingent upon the expiration of any generic marketing exclusivity by other applicants. Final approval also is dependent upon FDA's evaluation of any new information subsequent to the tentative approval. Wolters Kluwer Health estimates that U.S. sales of all dosage forms of Ditropan XL Extended-release Tablets were approximately $338 million in the 12 months ended August 31, 2006.
Title: Re: IPXL UPDATE
Post by: la-onda on November 24, 2006, 04:19:38 PM
Update on IPXL (clcl2002us quotation)!_

3 major events

1) gWXL approvals (any time).

2) gConcerta approval (any time).

3) Financial Filing (1Q07).

Other significant events:

1) Vadova Full Response (4Q06).

2) Vadova (2007).

3) gOxycodone (settle with Purdue? possible. Otherwise (ENDO withdraw
at 2006 End and TEVA may withdraw in future), if Impax wins the
litigation, this product will become a money cow.

4) gEffexor XR (2008).

5) gAdderall XR (2009).

6) gAllegra-D (2007?).

2005 EPS $0.30.
2006 EPS $0.40 (assuming w/o gWXL, gConcerta).
2007 EPS >$1.00

cheers
O.
Title: Re: IPXL BO !
Post by: la-onda on November 29, 2006, 02:28:21 PM
SAC Capital Advisors, SAC Capital Management has bought 5% of IPXL shares  >:D

http://phx.corporate-ir.net/phoenix.zhtml?c=67240&p=irol-SECText&TEXT=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvZmlsaW5nLnhtbD9yZXBvPXRlbmsmaXBhZ2U9NDUxMTY3MyZhdHRhY2g9T04=
Title: Re: IPXL UPDATE
Post by: la-onda on December 18, 2006, 09:09:27 AM
positive FDA news:
IMPAX Announces FDA Approval of Generic Wellbutrin XL 300 mg
Monday December 18, 8:00 am ET
Product Launched Under Exclusivity Transfer Agreement with Anchen and Teva

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC: IPXL - News; "IMPAX" or "the Company") announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin XL, 300 mg. The product has been launched, pursuant to an Exclusivity Transfer Agreement with Anchen Pharmaceuticals, Inc. and a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA - News).

Anchen obtained approval of its generic Wellbutrin XL product, and in accordance with this agreement, selectively waived its 180-day period of marketing exclusivity in favor of IMPAX Laboratories. Pursuant to the Company's existing strategic alliance agreement with Teva, Teva has U.S. marketing rights to IMPAX's version of this product. Wellbutrin XL 300 mg, marketed by GlaxoSmithKline, had U.S. sales in excess of $1.0 billion for the 12 months ended October 31, 2006, according to Wolters Kluwer Health.

Under the Exclusivity Transfer Agreement, Teva will make certain payments to Anchen in return for a waiver of its exclusivity to IMPAX. In addition, Teva is indemnifying IMPAX against certain losses that might arise from certain legal risks.

"We are very pleased to have received our ninth FDA approval this year, and look forward to offering patients this widely sold anti-depressant as a generic drug beginning immediately," commented Larry Hsu, Ph.D., President and Chief Executive Officer of IMPAX Laboratories.

"In addition, generic Wellbutrin XL is the first of our Tier 3 products to be marketed under the 12-product Strategic Alliance Agreement signed with Teva in July 2001. Under that agreement, upon the first launch date of any Tier 2 or Tier 3 product in the U.S., IMPAX plans to repurchase for $1.00, 16.67% of the IMPAX common stock, or approximately 244,000 shares, sold to Teva during the development phase of the agreement," Dr. Hsu added.

Both the IMPAX and Anchen ANDAs for generic Wellbutrin 300 mg were filed with Paragraph IV certifications with respect to certain patents held by Biovail Laboratories International SRL and listed in the Orange Book. Biovail initiated patent infringement lawsuits against both companies. The IMPAX litigation is ongoing, and IMPAX has filed a motion for summary judgment of noninfringement. Anchen has been granted summary judgment of noninfringement with regard to the Anchen product.
Title: Re: IPXL UPDATE
Post by: la-onda on December 18, 2006, 10:56:50 AM
nice news, nice chart   ;D ;D
Title: Re: IPXL UPDATE
Post by: la-onda on December 21, 2006, 11:57:49 PM
now it´s getting interesting  ;D

1)
Lehman Brothers' Analysis for gWXL   (Not rated)       21-Dec-06 10:47 am   
For anyone who isn't a conspiricy theorist concerning stock analysts, here is LB's analysis for gWXL:


GENERIC WELLBUTRIN XL 300MG PROVIDES SIGNIFICANT OPPORTUNITY FOR IMPAX: Wellbutrin XL 300mg represents a significant market opportunity with meaningful financial contribution expected for Impax for the next several quarters. For Impax, we estimate untaxed EPS contribution of about $0.55 during the 6-month exclusivity (or fully-taxed EPS of approximately $0.35 for the same period). Our forecast makes the following assumptions: (1) $1B brand sales for the 300mg strength and 2-player market for 6 months; (2) generic discount of 45-55% assuming an authorized generic, identity unknown yet; (3) Teva averaging 35-45% market share during the exclusivity period; and (4) pre-split gross margin of 70-80% and Impax's split is 40%. Note that we normally assume that Impax receives 60% of gross profit under the Teva alliance, which has been reduced in this case to account for pay out to Anchen for the FTF status.

Post exclusivity, the profitability from Wellbutrin XL would diminish depending on the number of additional competitors. Other known filers of generic Wellbutrin XL include Abrika (being acquired by Actavis) and Watson Pharmaceuticals. Assuming a 4-player market for a 12-month period post exclusivity, we estimate potential untaxed EPS contribution of about $0.20-$0.30 (or $0.15-$0.20 fully taxed) for Impax, which assumes the 150mg strength is on the market around mid-07. We assume that Anchen does not launch its own generic for the foreseeable future and will continue to receive payout from Impax/Teva.
link:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=23216&tid=8644&mid=8644&tof=4&frt=2

2)
Biovail Sues FDA Over Wellbutrin XL 300mg Generic >BVF

Dec 21, 2006 17:26:00 (ET)

TORONTO (Dow Jones)--Biovail Corp. (BVF) has launched a lawsuit against the U.S. Food and Drug Administration contesting the regulator's approval of a high-dose generic of its key Wellbutrin XL drug.

As reported Dec. 15, privately held Anchen Pharmaceuticals received approval for generic versions of 150mg and 300mg doses of Wellbutrin XL, Biovail's biggest-selling drug. A few days later, Anchen, along with Teva Pharmaceutical Industries Ltd. (TEVA) and Impax Laboratories Inc. (IPXL), announced a three-way agreement allowing for the immediate launch of the 300mg version of the drug.

According to court documents, Biovail, Canada's largest publicly traded pharmaceutical company, says the FDA's approval of Impax Laboratories Inc.'s (IPXL) 300mg generic of Wellbutrin XL "violates the mandatory, statutory 30-month stay to which Biovail is entitled."

It's asking the court to force the FDA to suspend approval of Impax's generic until the expiration of the 30-month stay, or the resolution of the patent suit, whichever comes first.

U.S. law says that, if a patent owner files an action for infringement against an generic applicant within 45 days, approval of the generic is stayed for 30 months. The 30-month stay protects the patent owner from the harm that could otherwise ensue from the FDA granting marketing approval to a potentially infringing product.

But the FDA, in a response filed Wednesday, said it's just following the rules.

"Although Biovail filed a timely patent lawsuit on the 150mg strength, Biovail did not file its patent lawsuit on the 300mg strength Wellbutrin XL within the 45 days required by the (Food and Drug Cosmetic Act), and therefore, is not entitled to a 30-month stay on approval of Impax's generic of that strength," the FDA said in a court filing. "Moreover, Biovail recognized its failure when it amended - 30 days too late - its first patent suit to include the 300mg strength."

The FDA noted that Biovail has benefitted from a monopoly on the antidepressant, and it seeks to "perpetuate" that monopoly through this lawsuit while decreasing the availability of low-cost, reliable and safe drugs for the public.

Officials from Biovail weren't available to comment.

In an interview, Arthur Koch, chief financial officer at Impax, said Biovail's tardiness in filing a patent suit on the 300mg strength was beneficial to Impax, as it would have been subject to the 30-month stay otherwise. He said the 300mg generic has already hit the market.
The 300mg dose of Wellbutrin XL accounted for about $972 million in U.S. sales for the 12 months ended Sept. 30.
"There are many reasons that one would do an arrangement like this," Koch explained. "Teva has very substantial marketing capabillities, we do have substantial marketing and manufacturing capabilities, and Anchen had the contribution it made. The parties each brought something of value to the group, and an arrangement was made."

He also noted that its application for the 150mg version remains active, and it looks forward to the opportunity to launch that as soon as it's able.
Biovail and the FDA have butted heads over this drug before. In August, Biovail launched a lawsuit against the FDA to enforce criteria set forth in its Citizens Petition, which demanded certain criteria be employed by the regulator in determining bioequivalence of Wellbutrin XL generics.
In approving Anchen's generic last week, the FDA dismissed Biovail's petition outright, saying it determined its standards for approval were "appropriate."
Title: Re: IPXL UPDATE
Post by: la-onda on January 03, 2007, 12:26:09 AM
IMPAX Reports SEC Actions
Tuesday January 2, 5:25 pm ET

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL - News; "IMPAX" or the "Company") reported that on Friday December 29, 2006, the Securities and Exchange Commission ("SEC") issued an order instituting an administrative proceeding to determine whether, in light of the Company's failure to file reports since September 2004, the registration of its securities under Section 12 of the Securities Exchange Act of 1934 should be suspended or revoked. An Administrative Law Judge will consider the evidence in this matter and is ordered to issue an initial decision within 120 days. Also on December 29, 2006, the SEC suspended trading in IMPAX shares during the 10-business-day period from December 29, 2006 through January 16, 2007 because of the Company's failure to file reports.

The Company has not filed a periodic report since its report for the period ended September 30, 2004 because, as it announced in May 2005, it has been working to determine the appropriate accounting treatment for transactions under its Strategic Alliance Agreement with an affiliate of Teva Pharmaceutical Industries, Ltd. The Company continues to make significant progress in determining the appropriate accounting treatment and completing its 2004 and 2005 financial statements and is optimistic that its continued progress will enable it to avoid such suspension or revocation of the registration of its securities.

The Company understands that trading in its stock may resume on January 17, 2007 and that dealers will be permitted to publish quotations only on behalf of customers that represent customers' indications of interest and do not involve dealers' solicitation of such interest.

The Company also reported that its available cash and investments at December 31, 2006 was approximately $30.2 million. The Company continues to actively develop, manufacture and ship products and received nine FDA approvals during 2006, including the recent approval of its generic version of Wellbutrin XL 300mg, a product marketed by GlaxoSmithKline that had U.S. sales of $1.0 billion during the 12 months ended October 31, 2006 according to Wolters Kluwer Health.
Title: Re: IPXL UPDATE
Post by: la-onda on January 09, 2007, 04:30:54 PM
ANSWER OF RESPONDENT
IMPAX LABORATORIES, INC.


Respondent Impax Laboratories, Inc. ("Impax" or the "Company") submits this Answer to the allegations relating to the Company contained in the Order dated December 29, 2006.

1. Impax denies that it is located in Bedford Park, Illinois, that it has since 2001 filed reports on forms used by small business issuers, and, upon information and belief, that it has ever had an officer or director who at one time served as an officer or director of respondent Phoenix Waste Services Company, Inc. or has had any affiliation or association of any kind with any of the other respondents herein. Impax admits that it is delinquent in its periodic filings with the Commission, having not filed a periodic financial report since it filed its report on Form 10-Q for the period ended September 30, 2004, and alleges that it has filed 35 current reports on Form 8-K since filing its last Form 10-Q. Impax denies that it is necessary or appropriate for the protection of investors to suspend or revoke the registration of any class of its securities registered pursuant to Section 12 of the Exchange Act and in support thereof alleges as follows.

2. Impax develops, manufactures and distributes generic and selected branded pharmaceutical products. It continues to conduct active operations in all respects. It currently markets 68 generic products, has applications for approximately 20 products pending before the FDA, and has 55 products under development. During 2006 alone it received FDA approvals of nine products, including a recent approval of its generic version of Wellbutrin XL 300mg, a product marketed by GlaxoSmithKline that, according to published industry data, had U.S. sales of $1.0 billion during the 12 months ended October 31, 2006. At December 31, 2006, Impax had available cash and investments of approximately $30.2 million. On December 28, 2006, the day prior to the Commission's suspension of trading in Impax's stock, the stock traded at $9.80 per share and the Company's market capitalization was approximately $600 million.

3. Impax has, upon information and belief, several thousand stockholders, including institutional and other sophisticated investors. Throughout the period since its last Form 10-Q report the Company has continuously apprised investors of developments concerning new product launches and developments in the patent-infringement litigation that necessarily accompanies its business. It has kept reasonably current an investor presentation on its Web site, a copy of which is attached as an Appendix hereto, disclosing the developments in and status of the Company's business, including cash and debt balances and capital expenditures. Throughout the period, industry publications, widely read by investors and analysts who follow the pharmaceutical industry, have published monthly data concerning sales of Impax's products.

4. Impax's failure to file financial reports since its third quarter of 2004 Form 10-Q stems exclusively from a 2001 Strategic Alliance Agreement with a subsidiary of Teva Pharmaceutical Industries, Ltd., a large generic pharmaceutical company. The agreement provided for Impax's development and manufacture of 12 new generic products to be marketed by Teva under exclusive license from Impax, with profits to be shared by the two companies. The agreement also provided (i) for Teva to lend $22 million to Impax and purchase $15 million of its common stock, (ii) for repayment of the loan with shares of Impax common stock at Impax's option, (iii) for loan interest and principal forgiveness to the extent Impax met specified product-development milestones or in exchange for retention of market exclusivity, (iv) for Impax to repurchase a portion of its shares for nominal consideration when a specified milestone had been achieved, and (v) for the parties to share specified regulatory and patent-litigation expenses. Launch of the first product with potential for generating significant revenue under the agreement occurred in February 2004.

5. Under the agreement, Teva is required to reimburse Impax for its cost of manufacturing the products within 30 days following Impax's sale of the products to Teva, to provide Impax with monthly reports of Teva's sales of the products to its customers, and to pay Impax its share of the profits from those sales on a quarterly basis. Impax elected to recognize both the cost-reimbursement and profit components of this revenue at the time title and risk of loss of the products passed from Teva to Teva's customers. It followed this revenue-recognition policy through the third quarter of 2004.

6. During the third quarter of 2004, Impax received sales reports from Teva revealing that Teva had mistakenly omitted certain price adjustments from its product sales reports for the first two quarters of 2004, resulting in its overstatement of Impax's profit share for those two quarters. Impax relied upon Teva's sales reports in preparing its own financial statements and, as a result of these reporting errors, restated its first- and second-quarter results, reducing its previously reported first-quarter revenues from $38.8 million to $34.5 million and net income from $9 million to $5.2 million and reducing second-quarter revenues from $30.8 million to $30.6 million and net income from $0.6 million to $0.3 million.

7. During the course of preparing the Company's 2004 annual report, Impax and its independent auditors, Deloitte & Touche LLP, re-examined the Company's method of recognizing revenue under the Teva agreement and determined that the accounting for Impax's transactions under the agreement is not clearly addressed in the accounting standards and interpretations that comprise GAAP. The Company, on Deloitte's recommendation, decided to seek the advice of the Commission's Office of the Chief Accountant (OCA). To assist it in analyzing the accounting issues presented by the agreement and preparing its submission to OCA, Impax retained the services of a national accounting consulting firm, led by a former Associate Chief Accountant of the Commission, and its regular outside corporate/securities legal team, led by a former member of the Commission's Office of the General Counsel experienced in financial reporting and disclosure.

8. Following extensive consultation with Deloitte, Impax, with the assistance of its accounting and legal advisors, made two submissions to the OCA, the first on May 26, 2005 and, following a June 10 conference call with the OCA staff, a second on November 7, 2005. While both of these submissions proposed new methods of recognizing revenue under the Teva agreement, neither included a statement of the auditors' views concerning such methods. During a January 3, 2006 conference call with the OCA, the staff declined to express its views concerning the Company's proposal until the Company's auditors' views were made known. Since that time Impax, in consultation with Deloitte, has been developing a revised submission to OCA. It has also added to its advisory team a former OCA Chief Counsel.

9. The process of developing a revised submission has included: an in-person meeting with Deloitte on January 10, 2006; delivery of four accounting "white paper" analyses to Deloitte on February 7; in-person meetings on February 27 and March 10 and telephone conferences on May 23 and June 7 with Deloitte to review its comments on the original and several revised versions of the white papers; and, between July 17, 2006 and January 3, 2007, submission to Deloitte of six successive drafts of the revised OCA submission in response to Deloitte's successive written comments and oral comments provided in telephone conferences on August 9 and 11, October 9 and December 7.

10. The length of the process of arriving at a new revenue-recognition method with which its auditors can concur has not been the result of any disagreement between the Company and its auditors. Because of the multiple deliverables under the Teva agreement ( i.e. , research and development, manufacture and delivery of 12 products, and market exclusivity) and various features potentially requiring accounting as derivative financial instruments, the analyses required to determine the appropriate method of recognizing revenue under the agreement have been unusually complex. The current draft of the OCA submission consists of a 31-page single-spaced letter and four separate appendices. The submission addresses some 18 separate provisions of the accounting literature. 1 To date, Impax has incurred approximately $3.1 million of audit and consulting expenses in connection with its 2004 audit.

Title: Re: IPXL UPDATE
Post by: la-onda on January 10, 2007, 04:00:47 AM
WR Hambrecht: Teva underpriced
"If Teva is smart, it will announce the purchase of Impax Labs, Merck KGA by mid-February."

Roee Bergman 7 Jan 07   15:40
WR Hambrecht analyst Andrew Forman recommends Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) as one stock to hold ahead of the JP Morgan Healthcare Conference next week. Forman gives Teva a "Buy" recommendation.

WR Hambrecht says. "This is a global growth story, an overlooked undervalued emerging markets stock, with more accretive US generic acquisitions with Impax Labs Inc. (IPXL.PK) topping the short list with an estimated earnings per share of $0.15 in 2007, or Merck KGA generic business, which could add $0.25 or maybe both complementary to Ivax and easier to integrate, in our view. If Teva is smart, it will announce both of these deals by mid-February and can suspend 2007 guidance until 2008, or at least buy some time."

WR Hambrecht believes that Teva is "trading at historic low multiples... and with all of Wall Street already frightened about a low growth scenario for 2007, explain how a 2006 50%+ earnings growth resulted in Teva losing 28% of its value. At this juncture, it is difficult to image what Teva could say to make the stock go lower, and there seems to be no shortage of incremental buyers for Teva."
Title: Re: IPXL UPDATE
Post by: la-onda on January 17, 2007, 03:17:29 AM
 Citi's Notes on Jan 16   (Not rated)       16-Jan-07 07:16 pm   
➤ Impax shares have not traded since December 28th due to an SEC mandated
trading suspension; trading will begin again tomorrow on an unsolicted basis.
➤ Risk remains: an administrative hearing will proceed within 100 days to
determine whether Impax's registration should be suspended or revoked.
➤ However, in its January 8th response to the SEC, Impax suggested it could file
its revised submission to the OCA within 10 days; we view this submission as
an important first step on the road to becoming current with its financials.
➤ Operationally, Impax has made significant strides of late, launching generic
formulations of both Ditropan XL and the 300mg dose of Wellbutrin XL.
➤ Impax has also continued its development of Vadova; a submission to the
FDA in the near-term suggests a launch before year-end remains possible.
➤ We are more than doubling our 2007 earnings estimate to account for recent
launches, and we are increasing our target price to $11 (from $7) per share; reiterate Hold.
Title: Re: IPXL UPDATE
Post by: la-onda on January 17, 2007, 11:53:02 AM
Impax Labs: Suspension Of Registration Not Necessary
Dow Jones Newswires - January 09, 2007 6:31 PM ET

Impax Laboratories Inc. (IPXL) said Tuesday that it's not necessary for the Securities and Exchange Commission to suspend registration of the company's securities.

The SEC last month instituted an administrative proceeding to decide whether the registration of Impax's securities should be suspended or revoked. Impax filed its response with the SEC on Tuesday, saying a suspension "for the protection of investors" isn't needed.

Impax hasn't filed a quarterly or annual report since 2004. The SEC has already suspended trading in Impax shares during the period from Dec. 29, 2006, through Jan. 16, 2007, because Impax hasn't filed reports.

The Hayward, Calif., company makes and distributes generic and branded pharmaceutical products.
Title: Re: IPXL UPDATE
Post by: SMONYSE on January 19, 2007, 12:41:45 PM
Citi is now at 11 and the other analyst is at 15.  This was a widely followed stock before so I expect more analysts to follow this in the coming months.  Like the fact taht hartford went fro 9% to 14% ownership. ;D
Title: Re: IPXL UPDATE
Post by: la-onda on April 03, 2007, 06:28:58 AM
US FDA approves generic version of King heart drug
Mon Apr 2, 2007 3:48 PM ET

(Recasts with generic maker, updates shares, adds background)

WASHINGTON, April 2 (Reuters) - Impax Laboratories Inc. <IPXL.PK> has won U.S. approval to market the first generic version of King Pharmaceuticals Inc.'s <KG.N> drug Corzide to treat hypertension, the U.S. Food and Drug Administration said on Monday.

After the news, shares of King Pharmaceuticals fell more than 1 percent before trading down 8 cents, or 0.4 percent, at $19.59 on the New York Stock Exchange shortly before the market  close. Corzide, also known as nadolol/bendroflumethiazide, is a type of beta blocker to treat hypertension -- unusually high blood pressure that can damage the heart. The condition can also raise the risk of heart attack, stroke and other complications. King Pharmaceuticals bought rights to the drug from Bristol-Myers Squibb Co. in 2001. It was first approved by the agency in 1983.

In its 2005 annual report, King said it was anticipating a decline in Corzide prescriptions in the face of expected competition. Representatives for the drugmaker could not be immediately reached for comment.

On Monday, the FDA granted Impax approval to market two different doses of the drug, a 40 milligram version and an 80 milligram one, according to agency spokeswoman Kimberly Rawlings.

Impax Chief Financial Officer Arthur Koch had no immediate comment on the approval but said the company would issue a news release soon.
Title: Re: IPXL UPDATE
Post by: la-onda on April 03, 2007, 08:24:58 AM
MPAX Announces FDA Approval of Generic Corzide
Tuesday April 3, 8:00 am ET
Product to Be Launched by Global Pharmaceuticals Division

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL - News; "IMPAX" or "the Company") announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Applications (ANDA) for Nadolol/Bendroflumethiazide 40mg/5mg and 80mg/5mg, generic of Corzide®. The Company will begin marketing the products through its Global Pharmaceuticals division in the near future.

Corzide, marketed by Monarch Pharmaceuticals, a wholly-owned subsidiary of King Pharmaceuticals, Inc., for the treatment of hypertension, had sales of approximately $5.5 million in the 12 months ended February 28, 2007, according to Wolters Kluwer Health.

"This is our first approval in 2007 and we are very pleased to add generic Corzide to the growing portfolio of products our Global Pharmaceuticals division offers to patients," said Larry Hsu, Ph.D., President and Chief Executive Officer of IMPAX Laboratories.
Title: Re: IPXL UPDATE
Post by: la-onda on May 01, 2007, 08:29:21 AM
IMPAX Reports SEC Actions
Tuesday May 1, 8:00 am ET

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC: IPXL - News; "IMPAX" or "the Company") reported that on April 30, 2007, an Administrative Law Judge ("ALJ") of the Securities and Exchange Commission ("Commission") issued an initial decision that, if upheld by the Commission itself, would result in the revocation of the registration of the Company's common stock under section 12 of the Securities Exchange Act of 1934. The Company will file a timely appeal to the Commission and hopes to persuade the Commission, based upon the evidence developed in a two-day hearing in February before the ALJ, that revocation or suspension of such registration is neither necessary nor appropriate for the protection of investors. The ALJ's decision will not be effective during the pendency of the appeal.

The ALJ's initial decision is based upon the Company's failure to file periodic reports since its quarterly report for the period ended September 30, 2004. As previously announced, the reason for this reporting delinquency is that the Company has been working to determine the appropriate accounting treatment for transactions under its Strategic Alliance Agreement with an affiliate of Teva Pharmaceutical Industries, Ltd. The Company has now developed an accounting treatment that it deems appropriate and is awaiting the concurrence of the Commission's Office of the Chief Accountant ("OCA") in its proposed treatment. Although it cannot predict when the OCA will reach a conclusion, the Company currently estimates that it will be in a position to file all of its delinquent reports within two to three months following a favorable determination by the OCA.

The Company also reported that its available cash and investments at March 31, 2007 was approximately $46.6 million, compared with $29.1 million at December 31, 2006. The Company continues to actively develop, manufacture and ship pharmaceutical products and received nine FDA approvals during 2006.


still holding my IPXL shares....  8)
Title: Re: IPXL UPDATE
Post by: la-onda on May 10, 2007, 01:07:37 AM
IPXL update:
IMPAX Receives Final FDA Approval for Generic Ditropan(R) XL 5 mg and 10 mg
Wednesday, May 09, 2007 09:56ET

HAYWARD, Calif., May 09, 2007 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC: IPXL) ("IMPAX" or "the Company") today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Ditropan(R) XL, (Oxybutynin Chloride) 5 mg and 10 mg Extended-release Tablets. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of both the branded and generic 5 mg and 10 mg dosage forms were approximately $233 million in the 12 months ended March 2007, according to Wolters Kluwer Health. The Company's version of generic Ditropan XL is one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA). Teva plans to begin marketing the product immediately.
"This is our second FDA approval this year and we look forward to working with our partner on the launch of our generic version of 5 mg and 10 mg Ditropan XL," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer. "We are pleased to add these dosage forms to our 15 mg version, which received approval and 180-day marketing exclusivity last November," Dr. Hsu added.


Updated May presentation:
http://media.corporate-ir.net/media_files/irol/67/67240/Presentations/IPXLMay07v1.pdf
Title: Re: IPXL UPDATE
Post by: la-onda on August 22, 2007, 09:44:28 AM
August presentation :

http://library.corporate-ir.net/library/67/672/67240/items/257277/IPXLAug07FINAL.pdf

IPXL update (quotation  ;) )
The "Presentation" is the Impax's way to communicate with investors under current unusual circumstances. For me, Presentation + EDGAR + Company's PR make a great deal of transparency -- much better than many many other companies. Notes from LB and Citi are very helpful as well.

First at all, financially Impax is in a good shape. In 1H07, six-month cash increment was $33.0M and the company paid off $2.6M debt. The six-months EPS was no less than $0.60 -- in line with LB and Citi expectation.

How about 2H07? We may see some price erosion with 300mg gWXL by counting on competitions from Watson and potentially from Abrika. Previously, the players were (Teva + Impax + Anchen) and (Biovail + GSK). Seems to me that Teva is in the driver's seat and it is a very smart driver. Based on Citi's notes, the Rx number of gWXL in 1H07 was almost the same as Branded WXL. That indicates that Teva has left plenty of rooms for others to keep a better price. Thus, I don't expect a significant shrinkage in market share for (Teva + Impax + Anchen). (Teva + Impax) launched 5&10mg gDitropan in late May. Impax will have better income from gOxy. Thus, Impax will do well in 2H07.

Therefore, $1.20 EPS for Impax's 2007 book is achieveable.

How about 2008? Citi's target ($11) is based on (17 x $0.68 2008 EPS). But that $0.68 is ridiculous -- with intentional biases (to have a $11 target). For gDitropan, no new players are expected at this time. Even counting no some price erosion in gDitropan and further price erosion in 300mg gWXL, the new income from 150mg gWXL will be spare than enough to fill the hole. Beyond 2008, Impax may have gAllergra-D, gConcerta, gEffexorER, gAdderall, gDapakote, Vadova, etc.

How about buyout by Teva. This is an issue that I am not so sure. Eventually, Teva will own Impax -- nobady has any doubts. But why would Teva buy it now? I cann't get it. However, I will be happy to vote for a buyout of $25 per share.

Surprise!! Surprise?? no gap up as the milestone of OCA conclusion was reached on 7/25 and then the positive earning was "presented" on 8/8. However, everyone should remember that no gap down as the trading suspended by SEC and then the judge ruled an initial decision of revocation. Seems that the pps was down about $1 with "no reason." Let's try again -- perhaps a reason: The market is in a volatile correction -- specifically with the "credit crunch." Some aggressive investors got hurt and need money to cover their losses from other stocks. If they bought IPXL at $5-12, they may rush to sell. In November 2006, Greenlight Capital sold 5.8M shares of IPXL due to their own financial crises. This time, big boys may try to put a lid on "ask" to force selling cheap. On Aug 8, the pps was likely to drop to $8 or $6 at one time, but the positive earning in the presentation pulled pps back. Looking at the trading details these days, the buying volume at "ask" was much greater than the selling volume at "bid." But who knows what's next with such a bad market environment.

IPXL closed at $10.8 on last Friday. Wrt $1.20 EPS, the P/E is exactly at 9.0. How low will it go? And how long will the low P/E stay? Only the market can tell. In 7/30 notes Citi's analyst said: "We note that Impax is not totally out of the woods, as an administrative law judge has recommended that Impax shares be revoked." He also said in the same note: "Additionally, we note that the judge would likely consider Impax's significant progress in its efforts to "get current" when considering the appeal." Well enough, balancedly presented two-side.

&

Some addition to your thoughts:

"The "Presentation" is the Impax's way to communicate with investors under current unusual circumstances. For me, Presentation + EDGAR + Company's PR make a great deal of transparency -- much better than many many other companies. Notes from LB and Citi are very helpful as well."

I dont excatly agree with this statement because I feel it is just their way of showing the SEC that they have been "trying" to provide the public with as much information as possible without giving anything away. It does however, provide the very less the indication that IMPAX is growing and is profitable. Their PRs are nothing more than wild guesses that never ever come true. In cases where it does some true, it is often wrong or far off from their orginial estimates. Thank god for LB and Citi notes. If it werent for them, shareholders will be truely in the dark about everything (if Impax had their way). The only reason I am interested in this stock is because of LB and Citi's notes and not because of Impax's "transparency".

In any case, the presentation on 08/08/07 does provide some clues of IMPAX's profitability and confirms LB and Citi's notes. Beginning of the year Dec 2006 our cash was about $29 million. Fast forward to June 2007, it is now $62 million. This is an increase in ~ $33 milion.

Impax in 2007 is building a manufacturing plant in Taiwan, estimated operational date of 2010. Based on the presentation, this will boost IMPAX's operational capacity by 50%. That is huge. Our earnings will only grow because of this increase in capacity. Their current manufacturing plant must be overwhelmed by the demand of their products. If not, why spend the money to build additional capacity.

I agree with you that a buyout by Teva in my opinon looks very unlikely anytime soon. Why would IMPAX expand into Taiwan and waste money like that. If their intention is for a buyout, they would not expand like that and not consolidate their book value to inflat their worth. But you never know. Teva has a very close partnership with Impax and owns alot of IMPAX's share on the cheap 6-7 years ago.

The market for last couple of weeks has been horrible. The dow reached a high of 14000 and now is at ~13100. Impax's stock has held up fairly well compare to other companies. I believe this stock is poise for some appreciation near the periodic filings.

LB's target price of $15 is based on 17x 2006 EPS estimate of $0.86. Impax's six month EPS is ~$0.60. Therefore, $1.20 EPS is quite achievable for 2007. If we take the 17x multiple (which is a discount multiple compare to other companies), we are looking at a price target of about $21.


Title: Re: IPXL UPDATE
Post by: la-onda on September 06, 2007, 04:21:36 AM
thanks clcl  ;)

Counting on the "8-12 weeks" with the date July 25, the expectation of filing is between September 19 and October 17.

My rough estimates for yearly EPS are
2004, about even;
2005, $0.15;
2006, $0.30;
2007, $1.20;
and it is sustainable beyond 2007.

Earning is the life-source of the stock market, nobody ingor that for any stick. Such that smart traders know the value of IPXL just what discount rate should be apply under filing-delinquent status, and some of they try to take advantages.

In last December, a high EPS was already set. With the support from a buyer (VAM), pps was around 8 x 2007EPS (as high as 10 x), even with the trading suspension and the threat of revocation. Now, the buyer got enough shares and stopped buying. A little withdraw symptom was observed last week and the pps is currently a little below 9 x.

Supply and demand is the primary principle of capitalism. IPXL float is about 58.6M common shares. The majority has being held by Wellington + SAC Capital + VAM + insiders. Quit many individuals know the value and won't sell easily, except some aggressors lost to other stocks and need cash. The convertible is a tricky part. For a declining stock, convertible may sell short. However, IPXL bottomed at aroud $5 one year ago so short selling should not be a strong factor anymore. With the bright EPS and discounted multiplier, the demand of IPXL will exponentially increase along with approaching filing and the supply will be in drought.

Big boys always play but they have to ultimately abbey the principle. Everyday trading is still full of randomness but the foundamental trend will steadily show up.
Title: Re: IPXL UPDATE
Post by: la-onda on January 05, 2008, 06:13:16 AM
Filing Is Coming -- CitiGroup's Predictions      4-Jan-08 04:27 pm   
2008 predictions
Our forecasts for the year ahead in specialty pharma

* Bystolic disappoints - Given the long list of generic alternatives in the
beta blocker market, we predict the launch of Bystolic (nebivolol) will fall
short of expectations, and we are lowering our forecasts for both Mylan and
Forest Labs to reflect a slow sales ramp.
* Allergan exceeds expectations - Allergan is one of our preferred names for
'08, and we predict the company will exceed earnings expectations over the
next two years, as we do not expect either a weak consumer or increased
competition to meaningfully slow the momentum Allergan enjoys across its
aesthetic platform.
* Mylan earnings fall short - With gross margin pressures (as key franchises
face increased competition) and a heavy debt load, we predict Mylan's 2008
earnings will fall short of both management guidance and consensus
expectations.
* The FDA approves Puricase - As potentially the first new gout therapy in 30
years, we believe the FDA will grant Puricase priority review; and given its
efficacy and safety profile, we believe the agency will approve Puricase by
year-end.
* Valeant outlicenses retigabine - We believe retigabine ranks among the most
attractive late-stage small molecule candidates, and we expect Valeant to
sign a deal with a marketing partner in 2008.
* Other predictions - We also predict that Impax will file audited financial
statements and that Copaxone sales will exceed expectations.

Andrew Swanson, Sara C Moreno , Andrew J Finkelstein

latest presentation:
http://media.corporate-ir.net/media_files/irol/67/67240/Presentations/IPXLNov.13.07.pdf
Title: Re: IPXL UPDATE
Post by: la-onda on October 22, 2008, 07:38:40 AM
 >:D

IMPAX Files Form 10 Registration Statement
Friday , October 10, 2008 18:36ET

HAYWARD, Calif., Oct 10, 2008 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. today announced the completion of the audits of the Company's 2004 through 2007 financial results and that it has filed a Form 10 registration statement with the Securities and Exchange Commission pursuant to section 12(g) of the Securities Exchange Act. Section 12(g) provides the registration statements thereunder shall become effective within 60 days after filing. The Company will issue a further announcement when the registration statement becomes effective and trading in the Company's stock resumes.

For the six months ended June 30, 2008, total revenues increased to $128.6 million (up 38%) and income before income taxes increased to $32.0 million (up more than 900%), compared with total revenues of $92.9 million and income before income taxes of $3.0 million for the same period last year. Net income per share on a diluted basis for the six months ended June 30, 2008 was $0.30, compared with tax-benefit aided net income per share on a diluted basis of $1.24 in the prior year period. The results for the first six months of 2007 include a reversal of a deferred tax asset valuation of $1.33 per diluted share ($81.5 million).

Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories, said, "We are obviously pleased that the audit work has been completed and that public trading of our shares is likely soon to resume. Despite this long ordeal, we successfully grew our business by continuing to execute our strategy of applying our formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of brand products. At last count, we had 46 generic pharmaceutical products approved by the U.S. Food and Drug Administration ('FDA'), and a further 76 products pending FDA review or under development to target currently marketed products with more than $34 billion in U.S. brand and generic sales. We are also continuing to invest in our brand business, where we currently have one product in Phase III trials, have filed an IND on another product, and have four additional exploratory stage products."

Dr. Hsu continued, "Our improved first-half results indicate our ongoing commitment to invest in research and development programs which are driving, and should continue to drive, the growth of our business. Our ANDA filing goal in 2008 is eight to ten new applications with at least 25% of these having the potential to be first-to-file product opportunities. Year to date, we have filed five ANDAs and believe we will be able to achieve our goal in the fourth quarter."

Six Months Ended June 30, 2008 Results

Revenues

Total net revenues for the six months ended June 30, 2008 increased 38% to $128.6 million, compared to $92.9 million in the prior year period driven by increases at the Company's RX Partner, Global and OTC Partner segments.

Global product net revenues for the six months ended June 30, 2008 increased 25% to $50.1 million, compared to $40.1 million in the prior year period primarily due to the Company's generic versions of Lofibra(R) capsules, a cholesterol-lowering drug of which the Company's product was the only generic version in a market experiencing increasing demand for drugs of this type, and Colestid(R) tablets due to the increasing demand for the tablet form of this drug.

Rx Partner revenues for the six months ended June 30, 2008 increased 51% to $62.7 million, compared to $41.6 million in the prior year period primarily attributable to sales of generic OxyContin(R) and generic Wellbutrin(R) XL 300 mg of which the Company's customers' inventories were relatively full during the first quarter of 2007 as a result of the product's launch in December 2006, and generic OxyContin. Under a litigation settlement agreement, the Company's product was one of only two generic versions of OxyContin(R) in the marketplace in January 2008, when we ceased further sales of this product.

OTC Partner revenues for the six months ended June 30, 2008 increased 98% to $9.3 million, compared to $4.7 million in the prior year period primarily attributable to higher demand for seasonal allergy products

Promotional Partner revenues for the six months ended June 30, 2008 were $6.5 million with nominal change to the same period in 2007.

Margins


Gross profit for the six months ended June 30, 2008 increased 90% to $84.5 million, compared to $44.6 million in the prior year period. Gross profit margin for the six months ended June 30, 2008 increased 18 percentage points to approximately 66% of total revenues, as compared to 48% of total revenue in the prior year period. The increase in profit margin was due almost entirely to sales of generic OxyContin(R) during the first quarter of 2008.

Expenses

Total research and development expenses for the six months ended June 30, 2008 were $27.6 million, compared to $16.5 million in the prior year period. Generic project activity increased $7.1 million to $20.0 million primarily due to increased spending on bioequivalent studies related to five new and 23 pending ANDA filings, higher patent prosecution an opinion expenses and investment in additional human resources. Brand product activity relating to the Company's pipeline increased $4.0 million to $7.6 million due to expenses associated with 36 additional research personnel added during the period representing 65% of the total increase in brand R & D spending and higher spending on clinical trials.

Patent litigation expenses for the six months ended June 30, 2008 were $3.0 million, down $3.4 million over the prior year period due to lower costs resulting from a lower number of open patent litigations as a result of two settlements during the first half of 2008.

Selling, general and administrative expenses for the six months ended June 30, 2008 were $22.0 million, up $3.3 million over the prior year period primarily attributable to additional marketing and sales promotional spending.

Other income and expense

Interest income and other expenses was $1.5 million higher for the six months ended June 30, 2008, primarily due to higher cash balances as a result of the increase in net sales.

Tax Rate

The provision for income taxes for the six months ended June 30, 2008 was a charge of $14.2 million, compared to a benefit of $76.0 million in 2007 related to the release of a valuation allowance of a deferred tax asset. The effective tax rate for the first six months of 2008 was 43%.

Balance Sheet Information


The Company had cash, cash equivalents and short-term marketable securities of $154.8 and total debt of $83.7 million as of June 30, 2008.

In August and September 2008, the Company repurchased in the aggregate $62.3 million principal amount of their 3.5% debentures.

Non-GAAP Results for the Six Months Ended June 30, 2008

A substantial portion of the Company's revenue is derived from alliance agreements with marketing partners and, in accordance with generally accepted accounting principles (GAAP), is deferred and recognized over the estimated remaining life of the related agreement. The Company believes it is useful to present supplemental information showing what results of operations would have been had such revenue not been deferred and instead recognized at the time marketing partners reported the revenue to the Company. The Company utilizes this information in the management of its business, including in defining performance goals for executives, and believe it may be useful to investors, drug wholesalers and others in understanding changes in the Company's cash position and in evaluating customer acceptance of the Company's products in comparison with its competitors that do not defer significant portions of their revenue. However, this non-GAAP financial information should not be considered by investors as an alternative to operating income or net income as an indicator of the Company's performance. We derive the non-GAAP results by adding the deferred revenues to our revenues determined in accordance with GAAP and deducting the amortized portion of previously deferred revenues. The following tables presents the Company's results as reported in accordance with GAAP and in accordance with this non-GAAP method.

   
Full Year 2007 Results

For the year ended December 31, 2007, the Company earned tax-benefit aided earnings per diluted share of $2.06, compared to a net less of $0.20 per diluted share in the prior year period. The results for 2007 include a tax credit of $0.80 per diluted share ($48.8 million) related to the release of a valuation allowance of a deferred tax asset. Excluding the tax-credit, adjusted diluted earnings per share were $1.26 for the year ended December 31, 2007, compared to a loss per share of $0.20 in the prior year period.

Revenues

Total net revenues for 2007 increased 102% to $273.8 million, compared to $135.2 million in the prior year period driven by an increase in the Company's Rx Partner, Global and Promotional Partner segments.

Global product net revenues for 2007 increased 13% to $88.0 million, compared to $78.2 million in the prior year period primarily due to the launch of the Company's generic version of Colestid(R) tablets and increased sales of its generic version of Lofibra(R) capsules, as it was the only generic version in the market. These increases were partially offset by lower sales of the generic versions of Brethine(R) and Minocin(R) due to increasing price competition.

Rx Partner revenues for 2007 increased to more than 300% to $161.1 million, compared to $36.8 million in the prior year period primarily attributable to sales of the Company's generic version of OxyContin(R). Under a litigation settlement agreement, the Company's product was one of only two generic versions of OxyContin(R) in the marketplace during the second and fourth quarters of 2007. Higher sales of new generic versions of Ditropan(R) XL 5 mg, 10 mg and 15 mg tablets and Wellbutrin(R) XL 300 mg were partially offset by a decline in sales of generic Wellbutrin(R) SR 100 mg & 150 mg tablets, and generic Prilosec(R) 10 mg and 20 mg capsules due to a declining market which contributed to both lower volume and pricing as competitors sought to maintain or grow market share.

OTC Partner revenues for 2007 declined 14% to $11.9 million, compared to $13.8 million in the prior year period due to lower demand.

Promotional Partner revenues for 2007 nearly doubled to $12.8 million, compared to $6.4 million in 2006 due to the fact that the Company did not begin providing promotional services until mid-2006.

Margins

Gross profit for 2007 increased 164% to $166.1 million, compared to $63.0 million in 2006. Gross margin for 2007 increased 14 percentage points to approximately 61% of total revenues, compared to 47% of total revenue in 2006. Of the total 2007 increase of 14 percentage points, nine percentage points resulted from the relatively high margins associated with sales of generic OxyContin(R) and the balance resulted from operational efficiencies.

Expenses

Total research and development expenses for 2007 were $40.0 million, compared to $29.6 million for 2006. Generic project activity increased $6.8 million to $31.2 million, primarily due to increased spending on bioequivalent studies related to submission of 13 new ANDA filings in 2007 as compared to seven filings in 2006. Brand product activity relating to the Company's pipeline increased $3.5 million to $8.8 million due to higher spending on clinical trials.

Patent litigation expenses for 2007 were $10.0 million, up $0.3 million due to higher expenses related to our generic Effexor XR(R) litigation.

Selling, general and administrative expenses for 2007 were $39.6 million, up $7.2 million primarily attributable to $1.7 million in professional fees related to legal, accounting, and audit services and $3.9 million in incentive compensation.

There were no material litigation settlement expenses in 2007, as compared with $2.6 million for interest expense and legal fees related to a litigation settlement in 2006 of a suit brought against the Company in 2003 by Solvay Pharmaceuticals, Inc.

Other income and expense

Interest income and other expenses was $2.2 million higher in 2007, primarily due to higher cash balances as a result of the increase in net sales

Tax Rate

Income tax benefit for 2007 was $48.8 million with an effective tax rate of 35% before the change in valuation allowance. There was a nominal income tax expense in 2006 as we reported a loss from operations.

Balance Sheet Information

The Company had cash, cash equivalents and short-term marketable securities of $143.5 and total debt of $89.7 million as of December 31, 2007.

           
Title: Re: IPXL UPDATE
Post by: la-onda on January 28, 2009, 07:18:39 AM
IMPAX Resolves Remaining SEC Comments on Form 10 Registration Statement
Tuesday , January 27, 2009 09:26ET

HAYWARD, Calif., Jan 27, 2009 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL.PK) today announced that all comments from the U.S. Securities and Exchange Commission's review of the Company's Form 10 Registration Statement have been resolved. Additionally, the Financial Industry Regulatory Authority (FINRA) has approved the application of several market makers to resume quotations of the Company's common stock (symbol IPXL.PK) on the Pink Sheets.

Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories, said: "We are pleased to have completed the process of re-registering our shares and that market-making activities in the stock have resumed. We expect shortly to submit an application for relisting of our shares on The NASDAQ Stock Market."

&

Impax wins final FDA approval for generic ulcer drug
Tuesday , January 27, 2009 09:57ET

Jan 27, 2009 (Datamonitor via COMTEX) -- Impax Laboratories, a technology based specialty pharmaceutical company, through its generic drug division Global Pharmaceuticals, has announced that the FDA has granted final approval of its abbreviated new drug application for a generic version of Prilosec 40mg delayed-release capsules.

AstraZeneca markets Prilosec for the treatment of duodenal/gastric ulcers and gastro-esophageal reflux disease.

The company's versions of generic Prilosec (including previously approved and marketed 10mg and 20mg capsules) are one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries. Teva began marketing the 40mg product immediately.
Title: Re: IPXL
Post by: la-onda on April 09, 2010, 07:09:30 AM
update (one of my long term holdings)  ;):

Five Small-Cap Giants for Earnings Season
By Louis Navellier  04/07/10 - 11:35 AM EDT


Stock quotes in this article: IGLD , IPXL , NVMI , IMAX , CREE 

Small Cap Stock No. 2: Impax Laboratories(IPXL)

*

Impax Laboratories is an innovative drugmaker that is constantly seeking a cheaper way to bring specialty generic pharmaceuticals to patients around the world. The company concentrates on controlled-release versions of drugs and niche pharmaceuticals that require difficult-to-obtain raw materials or specialized expertise.

In the fourth quarter, the company sales soared almost fourfold to $176.1 million compared with the same quarter a year earlier. During the same period, Impax Laboratories' earnings rose an incredible 306.7%, to $38.1 million, or 61 cents per share, compared with $9 million, or 15 cents per share. The company's operating earnings were 69 cents per share. The analyst community was expecting operating earning of 14 cents per share on sales of $91.4 million, so Impax Laboratories posted a whopping 392.9% earnings surprise and a stunning 92.7% sales surprise. Analysts have raised their earnings consensus estimates upward 254.3% just in the past month, so I am definitely expecting a great surprise from IPXL when it reports earnings.


http://www.thestreet.com/story/10719911/3/five-small-cap-giants-for-earnings-season.html
http://finviz.com/quote.ashx?t=ipxl&ty=c&ta=1&p=d
Title: Re: IPXL
Post by: la-onda on May 13, 2010, 08:14:38 PM
fyi :)

Impax Labratories (IPXL) is a generic drug maker. The company focuses on controlled-release generic substitutes for brand-name drugs that have gone off-patent, or have insufficient patent protections. Currently, the company has 57 approved generic drugs, including substitutes for Claritin, Wellbutrin, Prilosec, and Flomax. The bulk of Impax's sales are directly to wholesalers like Cardinal Health (CAH) or McKesson (MCK). The firm also has joint ventures with several larger generics companies to sell their drugs, including a fairly large one with generic powerhouse Teva (TEVA). Impax is also developing a couple of branded drugs, although this is not really material to results yet.

Generics are a much different business than branded pharmaceuticals. In branded drugs, companies like Pfizer (PFE) spend billions on large R&D pipelines to develop proprietary drugs. The success rate is low, but the winners are incredibly lucrative with a decade of patent protection and huge profit margins.

Success in generics is much different. There are two keys here. One is consistently getting short (8 week) exclusivity periods on generic compounds by being the first to file applications (ANDAs) with the FDA. Impax's recent success and, in fact, its appearance in MFI is solely due to the company winning this period for generic Flomax in Q1. Having this uncontested period allowed Impax to book $176 million of incremental revenue over Q1 of 2009. That gain alone triples the total of $59 million booked last Q1! This higher revenue of course led to much higher profits - operating income was up 4,726%! As a result, the Magic Formula earnings yield is measured against a one-time revenue event and is unsustainably high at 29%.

While generic Flomax will continue to produce very good results for the first month of Q2, exclusivity ended at the end of April. For the remainder of the year, it will be a modest contributor to revenue. If we look out to 2011 expectations, earnings yield is around 10.8%. That is still pretty cheap but not exceptional.

The other key to success in generics is scale. Price is *the* competitive advantage, and being the low cost producer is paramount. Unfortunately for Impax, it pales in size to the big generics makers like Teva and Sandoz, the generics division of Novartis (NVS). Due to this fact, Impax's success will be lumpy and largely dependent on how well it invests its windfalls like Flomax.

MagicDiligence believes that generic drugs is a good industry to be in right now, and Impax has a lot of interesting qualities. For one, the company is very sound financially. The balance sheet has over $130 million in cash and no debt. Second, management has a pretty strong record of getting ANDAs passed and winning exclusivity. In addition to Flomax, Impax has been early to market with versions of OxyContin and Wellbutrin. Finally, there is a landslide of big-name drugs coming off patent in the 2011-2015 period, presenting a massive opportunity for generics makers. Impax has 32 generic drug applications pending with the FDA, and another 50+ in development.

Also intriguing is Impax's history with Teva. The two companies have had agreements for a decade, and Teva has even invested in Impax in the past. Currently, Teva distributes several of Impax's products, including generic Prilosec and Claritin. Teva has been very aggressive about expanding its already dominant scale, swallowing large competitor Barr in 2008. Impax could be a very attractive acquisition to further this cause.

And Teva isn't the only potential acquirer. As mentioned, scale is key in generics. A lot of traditional drug makers, including Pfizer, have been looking to expand their generics business. Impax also has alliance agreements with Wyeth, now a part of... Pfizer. While the potential to be acquired should never be a prime reason to invest, it is nevertheless an interesting potential catalyst for these shares.

Overall, Impax has a good track record, excellent financial health, and operates in a growth industry with both organic expansion and the potential to be bought. MagicDiligence believes it makes a nice Magic Formula purchase at current prices - and a potential future Top Buy.
Title: Re: IPXL
Post by: la-onda on June 06, 2010, 02:34:47 AM
 ;D
Title: Re: IPXL
Post by: la-onda on December 08, 2010, 08:26:13 AM
latest IR presentation:

http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NzA1MTZ8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1

consolidation in the 18-19 $ area  :o
Title: Re: IPXL - Sector: Healthcare---Industry: Biotechnology & Drugs
Post by: setravis on March 15, 2011, 03:37:34 AM
Impax (IPXL) says Parkinson's drug meets study goal
AP - Mon Mar 14, 9:09PM CDT

HAYWARD, Calif. (AP) — Impax Laboratories Inc. said Monday that its potential Parkinson's disease drug met key goals in a late-stage study.

The company said the drug candidate IPX066 met key treatment goals when compared with immediate-release carbidopa-levodopa. IPX066 is an extended-release version of carbidopa-levodopa. The study focused on patients with fluctuations in motor function.

The study involved 471 subjects. Impax plans on presenting full study results at an upcoming scientific meeting.

Shares of Impax surged $2.93, or 13.3 percent, to $25 in afterhours trading after closing unchanged at $22.07 during the regular trading session.

Title: Re: IPXL - Sector: Healthcare---Industry: Biotechnology & Drugs
Post by: la-onda on April 15, 2011, 10:34:38 PM
strong chart action:


Impax Laboratories Schedules Conference Call and Webcast for First Quarter 2011 Financial Results
Thursday , April 14, 2011 13:00ET

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that its first quarter 2011 financial results will be released before the market opens on Tuesday, May 3, 2011 and will be available on Impax's Web site at www.impaxlabs.com. The Company will host a conference call and live webcast with financial analysts at 11:00 a.m., Eastern Time.