InterMune Inc. (ITMN)

[ghmm]

Q4 2007 Earnings Release and Conference Call Notes
Some things cut and pasted from seeking alpha transcript http://tinyurl.com/3cjsdx

Pirfenidone/IPF
. No new information on Shionogi hearing from Japan. Not at liberty to comment if they have or have not heard anything. Based on traditional review of Orphan drug 9-15 months from data of submission (Shionogi Filed March 2007).
. November 26th announced new agreements with the licensors of pirfenidone, Marnac and KDL that eliminated all future royalty and milestone payment obligations for pirfenidone under the prior license agreement completed in 2002.
. Shiongi data sharing agreement always for purchase of data to use in regulatory submission. Did not think data could be sold to another party without InterMune permission (Did not know for absolute certainity).
. In 2008, we plan to do more of preliminary marketing, research, branding, positioning type studies, reimbursement type studies. In 2009, that would be done more robustly. And in 2009, we would be thinking about fielding sales force, management, et cetera, and then finally, around the time of approval, making the decision to hire actual sales representatives. But that wouldn't be until well down the line into 2009. But 2008, some preparation; 2009, classical pre-launch preparation, but not a big staffing infrastructure increase until well down the line towards the end of 2009. [though Pirfenidone is not technically available for partnering x-US the company is sure sounding like that is their intention].

ITMN-191 (R7227)
. January 7th reported that we had completed the first two dosage cohorts in the study with total daily doses of InterMune-191 of up to 300 milligrams administered for 14 days. The safety and tolerability results of InterMune-191 in these first two cohorts were excellent. Trial achieved its principal goals, namely the demonstration of a viral kinetic safety and tolerability profile of 191 sufficient to advance the program into a triple combination study with Pegasys and ribavirin.
. Completed enrolling cohort 3 in MAD study in late January. While blinded no reports of any signal that's
crossed up in the day-to-day monitoring of those patients. As patients go through the third cohort, we are aware of whether the significant issues develop from a safety and tolerability standpoint. And today, we continue to be extremely pleased with what we're seeing.
. In conjunction with our partner, Roche, we have decided to complete a fourth cohort of the Phase Ib MAD study to further inform the planned 14-day triple therapy study and potential direct antiviral combination studies in the future.
. Regarding the timeline for our 14-day triple combination study of 191 combined with Pegasys and ribavirin, we expect to initiate the study in the second quarter of this year. The study design and timeline will be shared at the time of study initiation. I would certainly anticipate that we will do dose range in that study and that we will explore different doses and likely different schedules as well.
. We have said all along that the design of the study includes a single cohort of treatment-experienced patients that we
would envision being enrolled after we complete the treatment-naïve experience. And so, just to be clear on that, that would be an additional cohort beyond the four that Dan was alluding to today.
. IND is expected to be filed for 191 in the second half of 2008 by our collaboration partner, Roche, to allow the compound to be studied in the United States. Phase 2 to include US expect it to be multinational like other Phase 2’s by other programs.
. Release of 1B MAD monotherapy data - It could be a press release. It could be an abstract. It could be both at either of the
conferences [EASL and DDW] or both.
, On mfg in Roche’s hands - they've made excellent progress in terms of cost of goods reductions, volumes, quantity, process improvements, et cetera. And at this time, we are extremely comfortable with the status of our manufacturing. And I'm very comfortable that at the time of commercialization, we'll be in a very strong position in terms of cost of goods and margins, for example.
. [Why the 4th cohort is mostly likely a higher dose though the company was intentional vague when asked directly] as I alluded to earlier how pleased we've been with safety and tolerability and other aspects of the program, we, along with Roche, decided to go ahead and in fact confirm that we are going to roll that fourth cohort.
. We have not seen the results of the third cohort. So we have what we had a month ago. Since a month ago, we've had quite a number of conversations with our partner, Roche, on how to bring the program forward in combination studies, potential direct antiviral combinations in the future. And the decision was jointly made that do a fourth cohort to get more data to inform the triple combination, to inform potential future studies.
. what we'd like not to do is have to go back and do more Phase I type work down the line if we decide when we start doing directly antiviral combinations that we need to go higher.
. In conjunction with our partner, Roche, we are talking about treatment-experienced patients and how we would conduct studies and engross designs or what those studies might look like in treatment-experienced and further down the line, and we have only just begun the discussions with our partner to direct antiviral combinations in treatment-experienced patients. But that's somewhat down the line, and conversation has just begun. [At a prior conference Dr. Porter indicated that Roche intended to pursue studies with various combinations of their entire Arsenal of HCV products]


Financial/Misc.
• Q4 2007 Results
o Net loss of $25.8 million, or $0.66 per share
o R&D expenses of $25.0 million
o G&A expenses were $6.6 million
o Actimmune revenue of $8.8 million (Total Revenue $9.6 million)
o $6.2 million charge for acquired R&D (related to Marnac license/royalty buyout)
o Unrealized gain of $5.7 million on 630,000 shares of Targanta
• Cash/securities 235.3 million (end of Q4 2007)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• 39 million shares outstanding
• 2008 Guidance
o R&D 100-110 million, net of Roche reimbursement (they pay 2/3 of all PI development costs).
o G&A 25-30 million

Time-Line/Medical Presentations
• EASL and/or DDW All available Data on 4 cohorts of Phase 1B ITMN-191 (R7227). May also PR on or before meetings.
• After 4th cohort of treatment naïve patients in Phase 1B MAD study will have a single cohort of treatment-experienced patients
• Q2 2008 Initiate triple combinations study of ITMN-191 (R7227) in EU (14 day with Pegasus and ribavirin)
• 2nd Half 2008 Roche to file IND for ITMN-191 (R7227) in US
• January ‘09 Top line results from CAPACITY Trials