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InterMune, Inc. (NASDAQ:ITMN)

Q4 2008 Earnings Call

February 26, 2009, 04:30 pm ET

Executives

Jim Goff - Senior Director IR

Dan Welch - Chairman, CEO and President

John Hodgman - SVP and CFO

Steve porter - CMO

Analysts

Brian Abrahams - Oppenheimer & Company

Howard Liang - Leerink Swann.

Liisa Bayko - JMP Securities

Presentation

Operator

Good afternoon ladies and gentlemen and welcome. My name is Gabe and I will be your conference operator today. At this time I would like to welcome everyone to the InterMune Fourth Quarter and Year End 2008 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question-and-answer session. (Operator instructions)

It is now my pleasure to turn the conference over to our Chairperson Mr. Jim Goff, Senior Director, Investor Relations at InterMune. Sir, please go ahead.

Jim Goff

Thank you operator and welcome everyone to the InterMune earnings conference call. This afternoon, we issued a press release that reported financial results for the fourth quarter full year ended December 31, 2008. In that release we also provided forward looking financial guidance for 2009 as well as guidance for major events and milestones in our R&D portfolio. That press release is available on our website at www.intermune.com.

During the course of this conference call, we will state our beliefs and make projections and other forward-looking statements regarding future events and the future financial performance of InterMune. We should caution you that such statements are predictions and the expectations, and actual events or results may differ materially.

We refer you to the company's publicly filed SEC disclosure documents for a detailed description of the risk factors affecting our business, especially our Form 10-K, filed with the SEC on March 14, 2008 and our prospectus supplement filed with the SEC on February 17, 2009. These documents identify important factors that could cause our actual results to differ materially from our projections and other forward-looking statements. These risk factors include regulatory, revenue, intellectual property, clinical development and other risks relating to our business.

We will refer to our commercial product, interferon gamma-1b, using its trade name, Actimmune, and we refer you to our website for complete prescribing information for Actimmune.

On the call today are Dan Welch, InterMune's Chairman, Chief Executive Officer, and President, and John Hodgman, our Chief Financial Officer. Also here to respond to your questions is Dr. Steve Porter our Chief Medical Officer.

Our agenda for the call is as follows. Dan Welch will make brief opening comments about the progress we made during 2008 and in early 2009. Dan will be followed by John Hodgman who will present the fourth quarter and full year 2008 financial results and our 2009 financial guidance. Dan will return to make closing comments including a summary on reporting R&D project milestones and our key corporate objectives for 2009. We will then open the call to your questions.

And I will now turn the call over to Dan Welch.

Dan Welch

Thanks Jim and thank you all for joining us today. The past 14 months have been a period of exceptional progress on our two key development programs pirfenidone for the treatments of patients with idiopathic pulmonary fibrosis or IPF and InterMune-191 for the treatment of patients chronically infected with Hepatitis C virus or HCV.

We and our partner Roche are very optimistic about the potential for HCV protease inhibitor compound 191.

On April 2nd of 2008 we reported strong top line viral kinetic and safety results from four dosage cohorts of 191 as monotherapy in treatment of naïve HCV genotype one patients and we presented these results last October at 2008 AASLD conference.

We announced in early September of last year that we had earned $15 million of development milestone under our development collaboration with Roche. Under the terms of our collaboration agreement the responsibility for 191 clinical program is now transitioning to Roche which starting in Phase 2 will have primary responsibility for completing the global development and registration program for the compound.

In November of last year we initiated our ground breaking clinical study in Form one which is studying the combination of InterMune-191 with another oral direct anti-viral compound and without standard of care medicines. This so called strategy approach could be an exciting new way for HCV patients to be treated in the future.

On January 12th of this year we announced top line results of our successful Phase 1B study of InterMune-191 in triple combination therapy. The study demonstrated that in both twice daily and three times daily regiments. InterMune-191 delivered excellent viral kinetic performance with a very strong safety and tolerability profile.

We expect to begin our Phase 2b study in the summer of this year, and on February 19th we announced that the US patent office had issued the composition of matter patent for InterMune-191.

Turing to our lead pulmonology program pirfenidone for the treatment of IPF. On October 16th Shionogi & Company of Japan which has rights to pirfenidone in that country reported approval of its NDA to market for pirfenidone in IPF under the trade name Pirespa. Most importantly to InterMune just a few week ago we reported results from our Phase 3 CAPACITY program of pirfenidone.

CAPACITY consisted of two multi-national randomized double-blind placebo-controlled clinical trials named it CAPACITY 1 and CAPACITY 2. The primary end point of change in percent predicted Force Vital Capacity a week 72 was met with stastical significance in CAPACITY 2 the p value of 0.001 as were the secondary end points of categorical change Force Vital Capacity and progression free survival.

The primary end point was not met in CAPACITY 1 but supported evidence of the pirfenidone treatment effect was observed on a number of measures and at a number of time points in the study.

When compared to placebo the pirfenidone exhibited an important treatment effect in CAPACITY 1 on the primary end point and on several secondary end points through the first four of six observation periods providing important supportive date for CAPACITY 2.

Further more in CAPACITY 1 there was evidence of pirfenidone treatment effect on the pre-specified secondary endpoint of Six-Minute Walk Test distance with a p value of 0.001 when compared to placebo.

Pirfenidone was safe and generally well tolerated in both CAPACITY studies, a very important aspect when considering the risk benefit equation of this compound in the context of rapidly lethal disease for which there are no approved treatments in the United States or in Europe today.

There was no difference between pirfenidone and placebo in the percentage of patients that experienced the serious adverse event and the pattern of adverse event was in general comparable to that observed in previous clinical studies of pirfenidone in IPF.

We are now preparing a new drug application or NDA for submission to the FDA to be followed by our marketing authorization application or MAA submission to the European authorities. Both of these files will be submitted under the respective US and EU orphan drug processes. And the priority review will be requested for pirfenidone in United States.

We believe that the treatment effective pirfenidone observed in both CAPACITY studies and supported by previous Phase 2 and Phase 3 trials conducted by Shionogi along with the safe and generally well tolerated profile of pirfenidone will make a very compelling case for the approval of this compound for the treatment of IPF. Rapidly lethal diseases for which no treatment exist in the US or Europe.

Now onto business highlights, during 2008 and early 2009 we have taken steps to significantly strengthen our balance sheet.

On June 10th of last year we have recorded that we had restructured our convertible debt by exchanging one half or $85 million of debt due in 2011 for a new convertible debt instrument of the same face value, carrying a maturity date of 2015.

On February 19th of this year we completed follow-on public offering of 4,025,000 shares of common stock including the underwriter over allotment had at an offer price of $16.35 per share.

Net proceeds were approximately $63.5 million after deducting underwriting fees and other related expenses.

We have also taken some cost containment measures to make sure that our cash is used as efficiently as possible.

Specifically we eliminated 28 positions at InterMune earlier this year, representing a 20% reduction in force. These position eliminations were primarily associated with the wind down of capacity and discontinuation of lower priority research programs.

Given the combination of our current cash resources anticipated cash in flows and steps taken to control costs we believe that we are in a very solid financial position. We believe that we can fund our operations comfortably through 2009 and well into 2010, past the date by which we expect at regulatory decision would be taken by the FDA on our NDA.

Many companies have expressed strong interest in participating in pirfenidone in various ways.

We have begun the process of exploring that interest and expect that it will take several months to evaluate these opportunities and determine whether to pursue any of them.

Now, I will ask John Hodgman to cover our fourth quarter and full year results as well as our financial guidance for 2009. John?

John Hodgman

Thanks Dan. I will focus first on the quarterly financial results. InterMune, today reported a net loss for the fourth quarter of 2008 of $32.3 million or $0.83 per share compared with a net loss of $25.9 million or $0.67 per share in the fourth quarter of 2007.

Total revenue in the fourth quarter of 2008 was $7.4 million compared with total revenue of $9.6 million in the fourth quarter of 2007. Total revenue in the fourth quarter of 2008 primarily consisted of Actimmune revenue of $6.6 compared with $8.8 million in the fourth quarter of 2007 a decrease of 25% reflecting lower off-label physician prescriptions of Actimmune for the treatment of IPF which InterMune does not promote.

Fourth quarter total revenue also included revenue from the collaboration with Roche for the development of protease inhibitors including InterMune-191, which totaled $0.8 million in the fourth quarter of 2008 unchanged for the same quarter of 2007.

Research and development expense in the fourth quarter of 2008 were $26.3 million, compared with $25.1 million in the fourth quarter of 2007, an increase of 5%.

General and administrative expenses were $7.8 million in the fourth quarter of 2008 compared with $6.6 million in the same period of 2007, an increase of 18%.

During the fourth quarter of 2008 we recorded other than temporary non-cash impairment charge of approximately $3.5 million on our auction rate securities as reflected in the statements of operation.

We will now discuss our financial results for the full year ending December 31, 2008.

The net loss for the year was $97.7 million or $2.51 per share, compared with a net loss of $89.6 million or $2.52 per share in 2007, an increase of 9%.

Total revenue in 2008 was $48.2 million compared with total revenue of $66.7 million in 2007, a decrease of 28%.

Actimmune revenue totaled $29.9 million in 2008 compared with $53.4 million of Actimmune revenue in 2007, a decrease of approximately 44% reflecting the lower off-label sales of Actimmune for the treatment of IPF, which InterMune does not promote.

Revenue from the collaboration of Roche was $18.3 million in 2008 compared with $13.3 million in 2007. Collaboration revenue in 2008 consisted of $15 million development milestone and $3.3 million in amortization of the initial upfront and manufacturing milestone payments.

R&D expenses were $104.6 million in 2008, a 1% decrease compared to the $105.9 million in 2007.

G&A expenses were $30.3 million in 2008 essentially flat when compared to the $29.6 million in 2007.

As of December 31, 2008, InterMune had cash, cash equivalents and available-for-sale securities of approximately $154.7 million compared with $185.6 million as of September 30, 2008.

The year end 2008 balance does not include net proceeds of $63.5 million from a public offering which closed on February 19, 2009.

I will now discuss our 2009 financial guidance. Revenue including Actimmune and anticipated milestone payments from Roche was expected to be in the range of approximately $40 million to $50 million. Actimmune revenue represents approximately 50% of that revenue range.

Now lets discuss our operating expense guidance for 2009 starting with research and development.

R&D expenses anticipated to be in the range of approximately $90 million to $100 million net of development cost reimbursement under the Roche collaboration. Of this amount, approximately 60% is attributed to pirfenidone which includes expense for CAPACITY, RECAP, and a preparation and support of NDA and MAA submissions and manufacturing.

Roughly, 35% of the R&D expense is attributed to the company's one third share of all the government expenses incurred by the collaboration with Roche on InterMune-191. The balance of our expected 2009 R&D expense is in research and preclinical, which we're now already focused on two high priority programs.

First, the development of the second generation HCV protease inhibitor, and second the advancement of name pirfenidone anti-viral compound. I'll briefly touch on each.

Our effort to name a second generation protease inhibitor is a very important life cycle management objective for the Roche InterMune collaboration. If we are successful, InterMune will enjoy very meaningful milestone payments from our partner Roche.

Specifically, the same economic terms of InterMune-191 also apply to additional compounds that InterMune and Roche develop and commercialized. For example, assuming its successful development in commercialization of a second-generation protease inhibitor compound, in the United States and other countries, InterMune could receive up to $470 million in milestones.

In addition, InterMune would participate in a 50-50 profit share in the United States and receive royalties on revenues outside of the United States.

Importantly and differently from the InterMune-191, Roche pays 100% of all R&D cost on the second generation protease inhibitor compound from research through Phase 1. After Phase 1, Roche pays two-thirds of all developmental cost related to that compound. We made significant progress on the advancement of second generation protease inhibitor compounds with differentiated and distinctive properties when compared to InterMune-191 and other protease inhibitors and development.

Regarding our pirfenidone analog program, we have initiated preclinical development of our compound designated as InterMune-520. This compound would enjoy a novel composition of matter patent protection, should patent application issue. Performance of InterMune-520 in preclinical studies suggest the potential for once a day dosing. And an enhanced therapeutic index relative to pirfenidone. An IND covering this pirfenidone analog could be filed in the first half of 2010, based on our current time lines.

Taking into account, the R&D objectives just described, our 2009 expenses are expected to be in the range of approximately $90 million to $100 million, compared to R&D spend in 2008, the projected 2009 R&D spend is anticipated to be approximately $5 million to $15 million lower, for a reduction upto 14%.

Now, turning to G&A expense. G&A expenses anticipated to be in the range of approximately $35 million to $40 million. The G&A guidance range includes approximately $5 million of various pirfenidone pre-marketing costs and a similar amount in legal fees associated with a Department of Justice action against a former InterMune executive covered by an indemnification agreement.

In summary our 2009 total operating expenses will be in the range of $125 million to $140 million.

Regarding other expenses beyond R&D and G&A we will incur approximately $1 million in expenses recorded as restructuring charges related to the reduction in force in February 2009.

In addition, we will pay a milestone of $13.5 million, which will be recorded as Acquired R&D and Milestone Expense in 2009, to Marnac and KDL in accordance with the pirfenidone purchase agreement and the our decision to submit NDA and MAA filings on pirfenidone.

Regarding cash the company finished 2008 with cash and cash equivalents and marketable securities of approximately $155 million.

In addition to guidance on revenue and operating expenses for 2009 we also provided in our press release the following information to help investors understand our expected uses of cash in 2009.

First according to the structure of the company's collaboration agreement with Roche, approximately $11.4 million of 2008 expenses on InterMune-191 were accrued and payment to Roche was deferred. This $11.4 million payment will be made to Roche in 2009.

Second we will make a scheduled Department of Justice payment of principal and interest of approximately $7 million in 2009. Additionally we anticipate that we maybe required to make an accelerated payment to the DOJ of approximately $4.4 million related to our recent financing event if both of these DOJ payments are made, the balance of the liability under government settlement would be approximately $13.2 million at the end of December 31, 2009.

I will also mentioned that the Medicines Company announced yesterday that it had completed its tender offer of all the outstanding shares of Targanta Therapeutics based on our ownership of approximately 3 million Targanta shares we expect to receive approximately $6 million as a result of this transaction in this quarter.

As previously described we received net proceeds of $63.5 million from a public offering and common stock completed this month. We were pleased by the strong demand of our shares related to this offering and by the strong trading there after. That concludes my prepared remarks on the financial results and 2008 projections.

I will now turn the line back over to Dan Welch.

Dan Welch

Thanks John. Now before we take your question I will outline our key R&D milestones and corporate objectives for this year. We now have four key corporate objectives, first is to submit the pirfenidone NDA and MAA on our time schedule.

Second is to continue to aggressively develop InterMune-191 with our partner Roche and with Roche funding continue our research on second generation protease inhibitors to advance one to the clinic.

Third, to advance our pirfenidone analog compound InterMune-520 toward the clinic. And fourth, to evaluate the interest expressed in pirfenidone by a large number of companies.

Moving from our four core objectives to R&D project milestones we expect to have a very eventful year. On pirfenidone we are actively working on the NDA and MAA files and expect to submit them in the summer of 2009 and around the end of this year respectively. On 191, we expect to achieve many tangible project milestones this year.

In this year, we and our partner Roche expect to achieve the following five milestones. First, to report results from the triple combination Phase 1b study at EASL in late April of this year.

Second, we expect to present with our partner Roche and their partner Pharmasset top line safety drug interaction and viral kinetic and safety results of the first cohorts of the INFORM-1 STAT-C study at the 2009 EASL conference assuming our scientific abstract is accepted.

Third, the initiation by Roche of the Phase 2b study of InterMune-191 in the summer of this year and the achievement of this milestone will trigger $20 million milestone payments to InterMune.

Fourth, we expect to report top line four week RVR data from the 12 week regiments of our Phase 2b study around the end of this year or possibly early into next year. And fifth, we expect to present result of all dosage cohorts of INFORM-1 at the November 2009 AASLD meeting subject to abstract acceptance of course.

So, over the next 10 months we expect to achieve many important and potentially value creating milestones on InterMune-191. We look forward to updating you on our progress on our four corporate objectives and on our key R&D milestones during the coming months. I will remind you that John, Steve, and I are here to respond to your questions.

Operator, please open the line for those questions.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Brian Abrahams with Oppenheimer. Sir you have the floor.

Brian Abrahams – Oppenheimer & Company

Hi thanks for taking my question and congratulations on all the progress.

Dan Welch

Thank you, hi Brian.

Brian Abrahams – Oppenheimer & Company

Couple of questions on 191, can you give us a sense of how many cohorts from INFORM-1 that we might say at EASL, do you expect that we will see any of the 14-day cohorts or just the 7-day cohorts?

Steve Porter

Yeah Brian, this is Steve we have not given specific details about what will be presented at EASL as you know from the study design the initial cohorts are low doses of both agents. This is the first time that two direct oral anti-viral have been combined and the study design calls for subsequent escalation to full dose to really fully interrogate the viral kinetics. So but we have said is that we will present whatever data we have available at the time of EASL but we have not give more specific information on that.

Brian Abrahams – Oppenheimer & Company

Okay then it maybe actually a follow-up can you maybe help us understand how we should interpret the efficacy component of the INFORM-1 data that we might see at EASL or at AASLD are we looking for is the a goal to show additive viral activity, viral lockdown compared to what we would expect to see in monotherapy, are we looking for similar viral reductions with safety being the main focus. How should we think about a short study like this combining two direct anti-viral?

Steve Porter

Yeah I think that as I mentioned this is the first time that these two agents both of which are at our investigational have been combined. So this is really a fairly normal approach and that hence is the reason why the initial cohorts start at low doses of each. And that’s a typical approach to interrogate safety as well as pharmacokinetics.

Of course, we will get early viral kinetic data from that as well. What I would say with the subsequent cohorts where we look at higher doses, the types of doses that have been studied independently for the two agents in conjunction with standard care and carry that out for 14 days. It's really, quite frankly, just to see what these two agents can do together in the absence of interferon and Ribovairin. Obviously, we have got both monotherapy data as well as triple combination data for each of these agents over similar doses and time frame and we will take a look at the data and see what they can do. I do not have an expectation to articulate you but we are going to find out.

Brian Abrahams – Oppenheimer & Company

Great. One last question, and then I will hop back into queue. I noticed that the initiation time line for the Phase 2b-191 study is being pushed back just slightly. I was just wondering if there was any additional work that now needs to be done before that trials gets underway? Thanks.

Dan Welch

Sure. No additional work. I think what it is, just a normal process of discussions with the FDA which are going through our expectations. And nothing to signal here we expect to start in the summer.

Brian Abrahams – Oppenheimer & Company

Fair enough. Thanks very much for the information.

Dan Welch

You are welcome.

Operator

Okay. Our next question comes from the line of Howard Liang with Leerink Swann. Sir you have the floor.

Howard Liang - Leerink Swann.

Thanks very much. Can you talk about what if any FDA interaction you have with FDA so far on pirfenidone. And whether you have pre-NDA meeting scheduled?

Dan Welch

Yeah. Hi Howard. We are as to our strategy and progress with NDA and MAA, that’s something we are not giving any disclosure on. Where what we have said is that we are assembling the files, we will file or submit the NDA in summer and the MAA around the end of this year. So, beyond that we are not commenting.

Howard Liang - Leerink Swann.

Okay. And just regarding, on partnership front, so how you think about when you will make a decision. Are you thinking about doing a deal after FDA decision or could that be before FDA discussions?

Dan Welch

Yeah it's a great question. The number of companies that have expressed a very strong interest in participating in pirfenidone is very large. And that's why we have signaled on this call that the process will take us several months to sort through.

And we are interested, potentially interested in an ex-US partnership for example or there could be other iterations, other types of collaborations that also could be interesting. And yes we could conclude one before the NDA decision for example. There might be some advantages for that, for shareholders in terms of preparation for the MAA, preparations for the European commercialization et cetera.

But we will of course evaluate whatever those transactions might be compared to going alone and obviously on a risk adjusted basis. So we have an open mind as we go into this process we will be evaluating all the alternatives and do what in our estimation is best for shareholders, but it could be before, could be after the NDA decision.

Howard Liang - Leerink Swann.

Yeah great and just a question about pirfenidone as anti-fibrotic in general I think from CAPACITY trials. It is my opinion, there seems pretty clear there is activity in that disease so I guess what other indications could pirfenidone be pursued in?

Dan Welch

Pirfenidone has been studied in a number of what I would call pilot studies of different levels of control and sophistication. However, there appears to be a pretty consistent treatment effect or anti-fibrotic effect in various diseases involving fibrosis. Liver fibrosis, renal fibrosis, neurofibromatosis, to name a few, also Hermansky-Pudlak Syndrome which is a genetic disease that is associated with pulmonary fibrosis. NIH-sponsored showed very compelling results in fact, granted the small study, with Force Vital Capacity as primary endpoint. So, the pattern is clear preclinical model is clear as well that this is a pretty broad anti-fibrotic.

The pirfenidone analog compound InterMune-520 is interesting because it would be covered if the patent is issued with very broad composition of matter and could have some advantages over pirfenidone that we described on the call. And that would likely be compound that would be more interesting to developed the future anti-fibrotic releases.

Howard Liang – Leerink Swann & Company

Can I just follow-up on 520 other than patent life and potentially dosing difference. Are there other differences that you are seeing --?

Dan Welch

Granted but it's only preclinical models, but we are pleased by the performance we talked about therapeutic index advantage meaning more banks for the buck or, more efficacy with less safety burden although in CAPACITY the safety looks quite good.

When you think about however expanding from IPF which is disease, which is deadly rapidly lethal et cetera and going to diseases that are not so lethal than you would be interested anti-fibrotic that had an even better safety profile. In other words in IPF you can tolerate a certain amount of safety burden but as you go more broadly away from lethal diseases you want to have an even better profile and 520 might fit that patent along with the dramatically pharmacokinetic profile.

Howard Liang - Leerink Swann.

All right thanks very much.

Dan Welch

You are welcome.

Operator

And our last question in the queue comes from Liisa Bayko with JMP Securities. Ma'am you have the floor.

Liisa Bayko - JMP Securities

Thank you very much. And again my congratulations on a productive year.

Dan Welch

Thank you.

Liisa Bayko - JMP Securities

Just want to ask you what commercial preparations you will be undertaking this year for pirfenidone.

Dan Welch

Yeah pirfenidone we will be doing all the things you might expect we would be doing in terms of brand name selection, the whole branding approach to the compound, marketing research to help us with positioning of pirfenidone, the messaging of the compound. We will be doing a reimbursement studies have already begun the reimbursement studies for Europe. Pricing analysis, pricing sensitivity analysis we have engaged in advertising agency to help us with the campaign. There also be medical education, steps taken in the medical education area as well. We would not be, in terms of engaging infrastructure, adding on a big infrastructure until very late in the year for obvious reasons. But there will be a kind of a timed infrastructure build that is backend loaded.

Liisa Bayko - JMP Securities

Okay that great. And then just a final question is, may be you can just give us a little bit more color on the difference between 181 and the next generation protease inhibitor.

Dan Welch

Yeah it’s a very competitive are so we do not want to give too much away, but the ways to improve care. If you kind of look at HIV and you say how do the compound evolve, it evolved from dosing regimens that were many times a day that were not so safe to compounds that were once-a-day that were quite safe and also had a cross resistance profile that was attractive. So those are some of the areas that would offer opportunities to create differentiated compounds.

Liisa Bayko - JMP Securities

Great thank you very much

Dan Welch

You are welcome.

Operator

Okay (Operator Instructions) okay at this time I'm showing no further questions in the queue.

Jim Goff

Great and thank you all for taking the time to be with us today. Good bye.

Operator

This concludes InterMune’s fourth quarter and year end 2008 earnings conference call. You may now disconnect your lines.

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