Q3 2007 InterMune Earnings Call Notes and Recent Releases/Filings
191/Hepatology
1A
. 64 healthy volunteers.
. well tolerated in all doses evaluated in the Phase 1a study.
. No Serious AEs. no discontinuations due to AEs. All AEs classified as mild (CTCAE Grade 1).
. No clinically significant laboratory abnormalities or electro-cardiogram changes were reported.
. Most common AEs mild diarrhea and abdominal pain predominately in highest dose group. All mild and all resolving spontaneously, appeared to be attenuated in presence of food.
. Have not seen anything that is cause for concern (RE Safety/tolerability)
1B
. September 26th began dosing patients.
. Approximately 40 HCV patients in three dosing cohorts
. Dosing BID or TID with a meal for a period of 14 days.
. Expect to announce initial top-line viral kinetic and safety in Q1 2008
. Safety and dosing differentiate compound.
. Don’t anticipate being in the range that those mild symptoms will be problematic in the MAD study, again very mild highest dose. Doses at mild symptoms observed were at many fold higher than those being studied in 1B.
. Nothing unusual about study design (at least re in terms of placebo group size 2-3)
General/Phase 2
. Various committees oversee in Phase 1 InterMune primary responsibility for conceiving, conducting and interacting with regulatory authorities in Phase 2 Roche becomes primary. Other party extremely active.
. Safe to say Phase 2 will be pursued in both US and Europe
. Goal to maximize SVR on ITT so while pushing to get a strong monotherapy result but dose that end up with in MAD end up taking into Phase 2 and 3, our view is to look at long view of SVR on ITT when in combination with Pegasys and Ribavirin (safety, tolerability and viral knock down) important lesson took to heart from watching Vertex and others.
. Differentiate?/Limit Ribavirin in future? On plate with discussion with Roche along with inherent advances potency, (perhaps) lower dose, fewer doses, broader resistance profile. With Roche Pharma Science (formulation, etc.) other iterations on how may optimize therapy.
Pirfenidone
. Quiet in terms of new development with study. Conduct remains excellent, very low rate of patient
dropouts observed 18 months since the first patient was enrolled/5 month since enrollment completed.
. Mentioned population in terms of > 200K in US+Europe (before was just talking of US)
. Refined top-line data as late December ’08 or January ‘09
. Shionogi filed in Japan in March ’07 believe Orphan registration takes around 1 year but can be significant variations.
. No interim efficacy analysis do have periodic safety reviews. DSMV monitoring but don’t expect that regularly scheduled meetings in protocol.
Financials
. Actimmune 10.6 million revenue (11.4 million total revenues)
. R&D 23.4 million
. G&A 6.4 million
. 7.5 million milestone payment to Marnac/KDL
. 6.9 million related to the settlement with the U.S. Department of Justice
. 264.3 million cash/securities (include 73.4 million from 9/07 Stock offering)
. 2007 R&D 100-110 million (net of Roche reimbursement)
. 2007 G&A 25-35 million (toward high end)
. 2008 R&D increase by 5-15% (NDA and MAA preparation and preclinical/clinical development)
. 2008 G&A same range as 2007)
