IPXL - Sector: Healthcare---Industry: Biotechnology & Drugs

[la-onda]

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.

[agatto2]

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

[la-onda]

updated chart,
first pinksheet days = good perfomance

[la-onda]

I would like to give you an update to IPXL, and I´m looking forward to receive some feedback from TA and fundamental side 

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

[la-onda]

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.

[fous]

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 

-fousc

[la-onda]

updated chart:

[la-onda]

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:

[la-onda]

50 EMA crossed 
daily chart:

[la-onda]

1)
http://www.americanbulls.com/StockPage.asp?CompanyTicker=IPXL&MarketTicker=OTC&TYP=S
2)
Crossed the descending trend line 
3) chart:

[la-onda]

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."

[la-onda]

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.

[la-onda]

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.

[la-onda]

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.

[la-onda]

updated chart; TA is appreciated