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Replies to #71397 on Biotech Values
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DewDiligence

01/16/09 1:52 AM

#71618 RE: DewDiligence #71397

This article on IDIX is so badly written I’m posting it mostly for its entertainment value.

http://www.portfolio.com/news-markets/local-news/boston/2009/01/15/antiviral-work-helps-idenix-buck-biotech-stock-trend

Antiviral Work Helps Idenix Buck Biotech Stock Trend

Jan 15 2009 12:39PM EST
By Julie M. Donnelly

There’s at least one bit of bright biotech news amid all the economic ugliness.

Cambridge-based Idenix Pharmaceuticals (Nasdaq: IDIX) ended the year with its stock price up 114 percent, compared with the biotech industry that overall by one measure—an analysis by the Biotechnology Industry Organization—was down by a median of 61 percent.

CEO Jean-Pierre Sommadossi said the recipe was simple. “We set out our goals for the year, and we met every single one of them,” he said in an interview. [Actually, IDIX missed the stated goal of inking a partnership for IDX899 by year-end, but Sommadossi now says the deal will get done “within weeks.”]

Idenix, which employs 180, plans to have big news in the next few weeks—an agreement to out-license its HIV drug, IDX899, which is in phase 2-clinical trials. The negotiation process began in the spring, and equity analysts say a license agreement is currently being worked out by attorneys. [LOL—the analysts are saying this because it’s what Sommadossi said on the JPM webcast two days ago.]

The company already has one drug on the market—Tyzeka/Sebivo for hepatitis B—that is licensed to Novartis. A report by Standard and Poor’s projects 2009 sales for the company to be $11 million, mostly due to royalties from Tyzeka/Sebivo.

The stock climb came even though the company remains unprofitable and had an operating loss in each of the last four quarters. Standard and Poor’s predicts operating losses for the next few years as the company focuses on expensive research and development activities.

Idenix raised a total $68.5 million in two venture rounds before it went public in 2004. The IPO was worth $140 million and a second offering in 2005 yielded $150 million. The stock closed at $5.70 on Jan. 14, following a high of $10.10 over the last year. Standard and Poor’s projects a 12-month target share price of $7 [LMAO].

The drug candidate up for sale would be part of a cocktail typically taken by HIV patients, and would target drug-resistant forms of the virus. [Not true—the main target for IDX899 is the treatment-naïve setting.]

Up to 15 percent of patients newly diagnosed with HIV are infected with a strain which is resistant to at least one drug currently on the market. Once that deal goes through, the company plans to focus its efforts on developing three drug targets for hepatitis C.

Idenix has just announced it is initiating a proof-of-concept human trial for one of the three, IDX184 [#msg-34763865]. The drug target would focus on patients who have not yet received any treatment.

Idenix competitors include Gilead Sciences of California, Bristol-Myers Squibb in New York and GlaxoSmithKline, all of which have HIV drugs that have been approved by the U.S. Food and Drug Administration. [Wrong again—GSK is a has-been in the HIV market and is not a major competitor, while GILD is more of a potential collaborator with Truvada than a direct competitor.]

Locally, Panacos Pharmaceuticals Inc. (Nasdaq: PANC) in Watertown, a 42-employee startup with research operations in Maryland, wants to be among the first out of the gate with its drug Bevirimat, which is designed to hit an HIV virus target discovered about a decade ago. [PANC’s HIV program is probably doomed for reasons I’ve previously posted (#msg-28310435).]

Idenix ended 2008 with approximately $46 million in cash and cash equivalents.

Company officials said Idenix would need that money, plus the proceeds from the licensing of the HIV drug, to get through the next year. Sommadossi said the company’s ultimate goal is to become the first biopharmaceutical company in clinical development with hepatitis C drugs from three different classes.

Unless Idenix gets bought first. [The only company that could realistically buy IDIX is NVS, and the article does not even mention this!]

“It would be up to the board to decide if the sale of the company would be in the best interests of the shareholders. But the challenge for any deal over the past few months has been valuing the company. Our market cap has varied up to 20 percent to 30 percent in a single day,” Sommadossi said.‹
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DewDiligence

01/27/09 11:55 PM

#72306 RE: DewDiligence #71397

IDIX ReadMeFirst

[Updates:
Notes from the JPM conference;
HIV penetration and market-share info;
Elvitegravir/Quadro developments;
latest Sustiva sales;
revised table of biotech buyouts.]



What is IDIX’s business all about?
Business description from latest 10K filing
#msg-33722651 Link to 11/20/08 Needham webcast
#msg-31943984 IDIX’s drug portfolio
#msg-33247964 Link to 3Q08 conference call
#msg-29979703 Tidbits from Jun08 Needham webcast
#msg-26915744 Addressable markets for antiviral drugs


Valuation and finances
#msg-33234317 3Q08 financial results
#msg-34813718 $46M cash balance as of 12/31/08
#msg-35077734 Table of recent biotech buyouts


News flow
#msg-34772521 2009 clinical goals


Officers, directors, and major shareholders
#msg-33971771 Composition of Board of Directors
Capsule résumés of executive officers (click on a name)
#msg-33807169 Largest shareholders
#msg-33807081 Latest NVS “true up” purchase
#msg-33625817 NVS’ cost basis
#msg-29157548 Standstill agreement with NVS has expired
#msg-33972221 Current insider shareholdings
#msg-32238060 Recent insider transactions


HIV program: Economic rationale
#msg-28959639 Musings on size of an HIV partnership
#msg-33411254 GILD appears to be the main option
#msg-33921071 Revealing tidbits from RDEA’s PJ webcast
#msg-29985807 When and how NVS may get involved
#msg-26915744 HIV addressable market
#msg-31175781 HIV incidence is higher than previously thought
#msg-33898893 Half of untreated US carriers are in 350-500 CD4 range
#msg-26915314 IDX899 seeks to supersede Sustiva
#msg-27344078 Economics of the first-line setting
#msg-35109525 Sustiva sells $1.2B/yr
#msg-35137606 HIV market size and share (from GILD CC)
#msg-31419107 Increased HIV screening will expand market
#msg-33124429 New guidelines to recommend earlier treatment


HIV program: Clinical rationale
#msg-34772521 2009 clinical goals
#msg-29959114 7-day monotherapy data (200-800mg)
#msg-31925486 7-day monotherapy data (100mg)
#msg-31944395 7-day monotherapy data (viral-load chart)
#msg-24329960 IDX899 has no cross-resistance to Sustiva
#msg-29985830 Design of a late-stage HIV trial


HIV program: Competition
#msg-32355170 HIV market overview (detailed)
#msg-24673329 HIV market overview (for dummies)
#msg-26643515 Intelence 48w data in NNRTI-refractory HIV
#msg-30789106 TMC278 enters phase-3
#msg-31354706 TMC278 phase-2b data
#msg-33138650 RDEA806 advances to phase-2b
#msg-33921071 Revealing tidbits from RDEA’s PJ webcast
#msg-26610262 Pfizer’s UK 453,061
#msg-23282517 Miscellaneous early-stage NNRTI’s
#msg-33123339 Isentress bests Sustiva in 1st-line setting
#msg-35131829 Elvitegravir/Quadro to enter the 1st-line setting
#msg-35136159 Musings on Elvitegravir competitive threat


HCV program
#msg-34772521 2009 clinical goals
#msg-26915921 Why IDX184 is better than NM283
#msg-34771363 Nucleoside vs nucleotide
#msg-34763865 IDX184 begins phase-1/2 monotherapy study
#msg-28715477 IDX184 preclinical data from EASL
#msg-31043481 Introducing IDX136, IDX316, and IDX375
#msg-34334563 Blurb on IDX375 from hivandhepatitis.com
#msg-26915744 HCV addressable market
#msg-34694166 US prevalence of genotypes 1a and 1b
#msg-29018192 Factoids re US patient pool
#msg-30190435 Devastating risk of undertreating HCV
#msg-34770929 HCV: Most Likely to Succeed (IMHO)
#msg-34772664 Role of interferon in future combination therapy
#msg-34677952 Comments on the non-nuke “class”


HBV program
#msg-32683976 Estimated royalty income from NVS
#msg-23785846 Status of Sebivo launch in EU
#msg-23434932 Treating asymptomatic e- patients will boost market
#msg-11099728 US Asian immigrants largely untreated
#msg-32945811 Viread alters competitive landscape (1)
#msg-33257652 Viread alters competitive landscape (2)
#msg-33901499 Musings on HBV combination therapy


Reference links
http://www.idenix.com/hiv/about
http://www.aidsmeds.com/list.shtml
http://www.idenix.com/hepc/about
http://www.hcvdrugs.com/
http://www.hivandhepatitis.com
http://www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm
http://www.who.int/mediacentre/factsheets/fs204/en
http://www.idenix.com/about/media/Glossary_of_terms.pdf