Replies to post #77152 on Biotech Values

[ghmm]

Q2 2009 Earnings Call/PR Notes

191/HCV
. 6 month rat and 9 month monkey tox studies completed (no significant drug related findings). Necessary preclinical data for both Phase 2 & 3 as currently envisioned.
. Completed Phase 1 safety study of ritonavir PK showed marked improvement (no remarkable safety findings).
. INFORM Study patients enrollment "virtually completed" for all cohorts, data presented to AASLD 11/3/09
. Roche formulation efforts on 191 (outside of addition of ritonavir) are still ongoing
. Ritonavir addition could result in better results and for down-the-road possibly a smaller mass pill for use in combo regimen (as DD pointed out). Were looking at it even before SGP presented their data. Ritonavir AE's at therapeutic dose (600mg BID) has some overlap with 191 (GI effect) but aren't seen at boosting dose (100mg BID) didn't see any in initial study.
. If ritonavir addition shows promise may be possible to incorporate in current and planned studies (both triple combo and future INFORM studies) with minimal delay

Pirfenidone/IPF
. Hired sales & Marketing VP (was consulting with company for past year). Incrementally build infrastructure (Sales reps won't be hired before approval).
. Pre submission meeting with EMEA July '09 (characterized as successful)
. 520 improves AUC but does not increase C-max think will improve therapeutic index (dosing).
. Build-3 (Bosentan) in IPF final event expected year end.
. Partnership talk primarily for EU

Of 100 million R&D Guidance ~60% Pirfenidone, ~35% 191 (1/3 share with Roche paying 2/3), ~5% ITMN-520

Upcoming Events/Milestones
. 8 '09 Roche initiating Phase 2B of 191 (R7227) should be posted to clinicaltrials.gov (20 million milestone)
. 8/12/09 10:30am Presentation Canaccord Adams 29th Annual Global Growth Conference (Dan Welch)
. Q3 '09 Initiate Phase 1B MAD study of ritonavir + 191 (QD & BID daily) + PEG/Riba
. 9/14/09 European Respiratory Society (ERS) Annual Congress presentation on Pirfenidone (Primarily focus on Safety profile)
. 11/3/09 INFORM-1 presentations at AASLD
. Q4 '09 NDA Submission for Pirfenidone (1+ Quarter delay from prior guidance)
. Q1 '10 MAA Submission for Pirfenidone
. Q1 '10 RVR Data from 12 week regimen of 191 (1+ month delay from prior guidance)

[ghmm]

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