Biotech Values

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InterMune ReadMeFirst

Edits: Q2 Call, Updated Financials, Updated Upcoming Events, Misc. Cleanup

Call Summaries
#msg-19408521 Q1 2007
#msg-23131457 Q2 2007
#msg-24264853 Q3 2007
#msg-25836765 JP Morgan 26th Annual Healthcare Conference Notes
#msg-26491473 Wachovia 2008 Healthcare Conference
#msg-26701562 Q4 2007
#msg-29981789 Needham / Goldman Sachs 6/2008
#msg-31934416 Thomas Weisel Partners 9/4/08
#msg-33658397 LCM 11/08
#msg-34751687 191 Phase 1B triple combo results
#msg-34858414 JP Morgan 1/15/09
#msg-35347863 2/3/09 CAPACITY Trial Results Call/Presentation notes and Speculations
#msg-35922220 2/26/09 Q4 2008 Call/PR Notes
#msg-36393012 3/17/09 Cowen Health Care Conference Notes
#msg-37312942 4/25/09 EASL INFORM-1
#msg-37496659 4/30/09 Q1 2009 Call/PR Notes
#msg-40340618 8/6/09 Q2 2009 Call/PR Notes
#msg-40563014 2009 8/12 Canaccord Adams Presentation

HCV
http://clinicaltrials.gov/ct2/show/NCT00801255 - INFORM Clinical Trials.gov
#msg-37309589 4/25/09 PR Combination of R7227, protease inhibitor, and R7128, nucleoside polymerase inhibitor, shows significant potency in reducing viral load in patients with hepatitis C
#msg-37306972 4/24/09 PR InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)
#msg-37208214 4/21/09 PR INFORM-1 Clinical Trial Amended to Further Explore Promising Direct Antiviral Regimen in HCV Patients
#msg-36388140 (EASL Abstract) FIRST-IN-MAN DEMONSTRATION OF POTENT ANTIVIRAL ACTIVITY WITH A NUCLEOSIDE POLYMERASE (R7128) AND PROTEASE (R7227/ITMN-191) INHIBITOR COMBINATION IN HCV: SAFETY, PHARMACOKINETICS, AND VIROLOGIC RESULTS FROM INFORM-1
#msg-36421384 (EASL Abstract) COMBINATION OF THE NS3/4A PROTEASE INHIBITOR ITMN-191 WITH THE ALLOSTERIC NS5B POLYMERASE INHIBITOR ITMN-8020 ENHANCES REPLICON CLEARANCE AND REDUCES THE EMERGENCE OF DRUG RESISTANT VARIANTS
#msg-36421330 (EASL Abstract) SUPPRESSION OF IN VITRO RESISTANCE DEVELOPMENT AFTER TREATMENT OF THE HCV REPLICON WITH NS3/4A INHIBITOR ITMN-191 (R7227) IN COMBINATION WITH NUCLEOSIDE INHIBITOR R7128 OR R1626
#msg-36421289 (EASL Abstract) INCIDENCE OF VIROLOGIC ESCAPE OBSERVED DURING ITMN-191 (R7227) MONOTHERAPY IS GENOTYPE DEPENDENT, ASSOCIATED WITH A SPECIFIC NS3 SUBSTITUTION, AND SUPPRESSED UPON COMBINATION WITH PEGINTERFERON ALFA-2A/RIBAVIRIN
#msg-36421248 (EASL Abstract) INTERFERON-GAMMA, INTERFERON-ALPHA AND RIBAVIRIN IN COMBINED THERAPY OF CHRONIC HEPATITIS C PATIENTS
#msg-34747018 InterMune Reports Results from Triple Combination Study of ITMN-191
#msg-33270432 (AASLD Poster) HCV NS3 helicase inhibitor screening
#msg-33270394 (AASLD Poster) phenotypic analysis of NS3 sequences
#msg-33270382 (AASLD Poster) ITMN-191 (R7227) with the Active Moiety of the NS5B Inhibitors
#msg-33270355(AASLD Poster) PK-PD for ITMN-191 in a Phase 1 MAD
#msg-33270341 (AASLD Poster) ITMN-191 Phase 1b
#msg-33270294 (AASLD Poster) ITMN-191 Phase 1A
#msg-33270262 (AASLD Poster) ITMN-5489
#msg-33446127 INFORM-1 Trial Initiation
#msg-33497987 INFORM-1 Study information (from DB webcast), #msg-36349693 detail on cohorts.
#msg-33967428 INFORM-1 clinical trials.gov info
#msg-36388140 (EASL Abstract) INFORM-1, #msg-36393100 some commentary
#msg-36421384 (EASL Abstract) COMBINATION OF THE NS3/4A PROTEASE INHIBITOR ITMN-191 WITH THE ALLOSTERIC NS5B POLYMERASE INHIBITOR ITMN-8020 ENHANCES REPLICON CLEARANCE AND REDUCES THE EMERGENCE OF DRUG RESISTANT VARIANTS
#msg-36421330 (EASL Abstract) SUPPRESSION OF IN VITRO RESISTANCE DEVELOPMENT AFTER TREATMENT OF THE HCV REPLICON WITH NS3/4A INHIBITOR ITMN-191 (R7227) IN COMBINATION WITH NUCLEOSIDE INHIBITOR R7128 OR R1626
#msg-36421289 (EASL Abstract) INCIDENCE OF VIROLOGIC ESCAPE OBSERVED DURING ITMN-191 (R7227) MONOTHERAPY IS GENOTYPE DEPENDENT, ASSOCIATED WITH A SPECIFIC NS3 SUBSTITUTION, AND SUPPRESSED UPON COMBINATION WITH PEGINTERFERON ALFA-2A/RIBAVIRIN
#msg-36421248 (EASL Abstract) INTERFERON-GAMMA, INTERFERON-ALPHA AND RIBAVIRIN IN COMBINED THERAPY OF CHRONIC HEPATITIS C PATIENTS

IPF
#msg-35288566 CAPACITY Trial Results PR
#msg-34138706 Shionogi announced the launch of Pirespa (Pirfenidone)
#msg-33518800 Differences between Shionogi Phase 3 and CAPACITY (Pirfenidone Phase 3)
#msg-32898098 Shionogi received marketing approval

#msg-26702328 Competitive Landscape
#msg-32434359 Update on Actelion (Tracleer) enrollment/results timeline
#msg-30869320 Update on Actelion (Tracleer) some BUILD-3 details
#msg-33788471 JNJ
#msg-30792742 Gilead (Letairis)

Financials
146 Million (End of Q2 ‘09) (20 Million expected on initiation of Phase 2 191 Study 8/09)
~138 Debt (2 convertibles 53 million due March ’11 convert price $21.63 other 85 million due March ’15 convert price $18.88)
46.1 million shares outstanding (not counting converts – 6.94 million shares and options 4.45 million) As of 3/31/09

Upcoming Events
. 8 '09 Roche initiating Phase 2B of 191 (R7227) should be posted to clinicaltrials.gov (20 million milestone)
. 9/14/09 European Respiratory Society (ERS) Annual Congress presentation on Pirfenidone (Primarily focus on Safety profile)
. Q3 '09 Initiate Phase 1B MAD study of ritonavir + 191 (QD & BID daily) + PEG/Riba
. 11/3/09 INFORM-1 presentations at AASLD
. Q4 '09 NDA Submission for Pirfenidone
. Q1 '10 MAA Submission for Pirfenidone
. Q1 '10 RVR Data from 12 week regimen of 191
Mid ’10: File IND for ITMN-520 (Pirfenidone Analog)


Company Website: http://www.intermune.com/wt/home
SEC Filings: http://tinyurl.com/8vdp2p
Most Recent 10-K: http://tinyurl.com/djxqq6
Most Recent 10-Q (Q2 ’09): http://tinyurl.com/p3hhpc