Vertex Pharmaceuticals Incorporated (0QZU.L) Q1 2008 Earnings Call Transcript
Published at 2008-04-21 23:02:07
Michael Partridge-Senior Director, Strategic Communications Joshua Boger, Ph.D.,-President, and Chief Executive Officer Ian F. Smith-Chief Financial Officer, Executive Vice President John J. Alam M.D.-Executive Vice President of Medicines Development, Chief Medical Officer Kurt C. Graves-Executive Vice President, Chief Commercial Officer, Head of Strategic Development
Rachel McMinn, Ph.D.-Cowen & Co Geoffrey Porges-Sanford Bernstein LLC Karim Defillipe [ph] - Citigroup Annabel Samimy-UBS Securities Hari Sambasivam-Merrill Lynch Brian Abrahams, M.D.-Oppenheimer & Co. Inc. Lisa Bayko-JMP Securities Howard Liang, Ph.D.-Leerink Swann and Company Thomas Russo-Robert W. Baird George Farmer, Ph.D.-Wachovia Securities Jason Zhang –BMO Capital Markets
Good afternoon, my name is Lamonte and I’ll be your conference operator today. At this time I would like to welcome everyone to the Vertex Q1 Financial Results Conference Call. (Operator Instructions) After the speakers remarks there will be a question-and-answer session. (Operator Instructions) Thank you. Mr. Partridge, you may begin your conference. Michael Partridge-Senior Director, Strategic Communications: Thank you and good evening. This is Michael Partridge. Welcome everyone to Vertex’s First Quarter 2008 Conference Call. Vertex had a very strong start to 2008 and we have made important progress in all aspects of our business. First, we have commenced a Phase 3 registration program in HCV genotype 1 patients, focused on 24-week duration of treatment. Second, we have received our first early data in HCV patients who failed prior treatment with pegylated interferon, a ribavirin, suggesting an opportunity to treat this important patient population and third we have our first early results from a study evaluating every 12-hour dosing of telaprevir that suggests an opportunity for a twice-daily dosing regiment. In addition to these advances with telaprevir we continue to push forward with our second-generation HCV program and have the first clinical results from our cystic fibrosis program. Supporting our pipeline investment, we strengthen our financial position by raising approximately 400 million in gross proceeds from a public offering and as we finished the first quarter we have a total of $750 million in cash and marketable securities. At the EASL conference later this week, we hope to see some of you and we look forward to presenting data that supports telaprevir’s leadership and differentiated product profile in HCV. On today’s call we will cover first quarter financial highlights, telaprevir’s profile and broad first to market opportunity and other progress in our pipeline. These topics will be discussed and expanded upon during today’s call by Ian Smith, Dr. John Alam, Kurt Graves, and Dr. Joshua Boger. I will remind you of the following: information discussed on this conference call includes forward-looking statements, which are subject to the risks and uncertainties discussed in detail in our reports filed with the Securities and Exchange Commission, including our 10-K. GAAP and non-GAAP financial measures will be discussed on this call. Information regarding our use of non-GAAP financial measures and the reconciliation of those measures to GAAP is available in our first quarter 2008 financial press release, which can be accessed on our website at www.vrtx.com Unless otherwise noted, all 2008 expenses and guidance discussed in this call are inclusive of stock-based compensation. As always, you can visit our web site to listen to the conference call and view a PowerPoint presentation or download a podcast. Lastly, after our prepared remarks we will take as many questions as we can until we conclude the call at about 5:45 pm. After the call our investor relations team, joined by John, Kurt, and Ian will be in the office to answer any additional questions. Before I turn the call over to Ian I’d like to remind everyone that we are hosting an investor event on the lawn during EASL this Thursday, April 24, for those of you who will be there, and we’ll have prepared remarks starting at 11:00 am local time in Milan. We are planning to webcast this event at 5:00 am Eastern Daylight Time for members of the investment community who are unable to attend. A replay will also be available. I will now turn the call over to Ian.
Thank you Michael and good evening to everyone. I’ll be brief with my remarks. The financial highlight in the first quarter was one of strengthening our financial position. We added approximately $400 million to the balance sheet through our financing, which allowed us to end the quarter with $750 million of cash and marketable securities. We’re well positioned to support the breadth of investment into our business. Now for the first quarter 2008 financial results: The first quarter non-GAAP loss before certain charges was $82 million, compared to the first quarter 2007 non-GAAP loss of $63 million. The increased loss was principally due to a reduction in cooperative revenues compared to the prior year, but was partially offset by lower R&D expenses. The GAAP net loss for the first quarter of 2008 was $96 million compared to 81 in the first quarter of 2007. Total revenues for the first quarter of 2008 were $42 million, compared to $69 million for 2007. The decrease in revenue was primarily driven by a reduction in non-recurring milestone revenue achieved in 2007 and other R&D reimbursement. As we look forward our revenues continue to be substantially supported by R&D revenues and more specifically, revenues that support telaprevir development. To this point in early April we achieved a $45 million milestone for the dosing of patients in our telaprevir registration program. This milestone is an important financial contribution and we expect that it will be fully recognized in the second quarter. Now to the R&D investment: Our total R&D expense was $115 million compared to $133 million in the first quarter of 2007. This decrease over the prior year reflects investment activity in 2007 to support PROVE 1 and 2 clinical trials and the investments into our commercial supply chain. While in 2008 investment reflects the period of lower activity as we prepared for advancement of telaprevir into the Phase 3 registration program. We anticipate the R&D investment will increase commensurate with the increased development activity as telaprevir progresses through the year. Our first quarter SG&A expense was $22 million compared to $17 million in the first quarter of 2007. This increase was a result of infrastructure build to support our business and the initial commercial steps we have taken to support telaprevir. Now to guidance: We are reiterating guidance for 2008 GAAP and non-GAAP loss that we originally provided on our year-end 2007 conference call of February 2011. I will close by stating the first quarter was financially important as we strengthened our financial position to close with $750 million of cash and marketable securities and we have continued that progression with the recent achievement of the $45 million milestone. Balancing investments with financial strength continues to be an important under pinning with balancing our business. John, over to you. John Alam M.D: Thank you, Ian. I’ll begin today by highlighting some of the key telaprevir results to be presented at EASL this week, focusing particularly on the opportunity with telaprevir in the hard to treat patients who failed prior pegylated interferon and ribavirin treatment including non-responders, partial-responders and relapsed. Data from preclinical studies are being presented at EASL, PROVE 1, PROVE 2, and study 107. For PROVE 1 and PROVE 2 the key new data are the final SVR results in the telaprevir arms and SVR 24 results in the PROVE 1 control arm and SVR 12 results in the PROVE 2 control arm. We believe the data supports the potential of telaprevir in treatment-naïve patients to increase the risk benefit over current therapy with significantly higher SVR rates and by shortening the current treatment duration in most patients. Next, study 107. Because it is the first promising data in patients who failed treatment with prior pegylated interferon and ribavirin, many of our investigators have said, “perhaps the most exciting clinical results in all of EASL are the interim analysis results from this study”. Study 107 enrolled patients from those who failed the control arms are PROVE 1, PROVE 2, or PROVE 3. These date provide significant insight into the potential opportunity for telaprevir to address this important patient population, and also helped to differentiate telaprevir relative to other protease inhibitors in development. Study 107 is on going and is still enrolling patients. The abstract, that is already online, highlights four-week on treatment data from 32 patients who were in the control arms of the PROVE studies and failed to achieve an SVR and that elected to receive a 12 week triple regiment of telaprevir pegylated interferon and ribavirin followed by an additional12 weeks of pegylated interferon and ribavirin. At the time we submitted the abstract a total of 54 patients had been enrolled in the study. In addition to the data disclosed in the abstract, at EASL we expect to present all available data for more patients who have now reached the four-week time point and we will disclose on treatment data for patients in study 107 who have reached 12 weeks of therapy. These data are early and we do not know yet what percentage will ultimately achieve an SVR result, but the level of response we have seen so far in all patient sub groups make the results very encouraging. A real strength of study 107 is that we are dealing with patients who were enrolled in a prior controlled study and we know their recent treatment history and their response to prior standard of care treatment in exquisite detail. This insight is valuable in clearly defining the potential effect of telaprevir in treating well-defined non-responders, partial-responders, and relapsed patients. I look forward to reviewing the specific results across each of these patient subgroups after the data are disclosed on Thursday. In terms of this patient population otherwise, as you know, we have PROVE 3 on going. PROVE 3 is a Phase 2b trial evaluating telaprevir combination therapy in 440 patients who failed prior treatment with pegylated interferon and ribavirin. In May, we expect to complete and submit to the NDA the first interim analysis for PROVE 3. We expect those results to form the basis for the first of multiple discussions on the development and registration path for telaprevir in patients who have failed to achieve SVR with prior pegylated interferon and ribavirin therapy. It is too early to speculate on the exact next steps for development with the US and European health authorities. As we’ve said consistently, our primary objective remains to achieve a broad and differentiated label in both treatment-naïve patients and patients who have failed prior treatment with pegylated interferon and ribavirin as quickly as possible. At present our guidance on our core development plan and timeline remain unchanged. We plan to have SVR data from our treatment-naïve program in the first half of 2010 with a subsequent NDA filing. In addition to study 107 and PROVE 3, we are conducting a range of Phase 2 studies that can further enhance the profile of telaprevir. Today we provided the first information from a study evaluating the safety and efficacy of telaprevir dose to either twice daily or three times daily together with either pegylated interferon or ribavirin. The twice-daily regimen consisted of three tablets of telaprevir totaling 1125 mg given every 12 hours while the three times daily regimen is the same regimen we’re evaluating in our other clinical studies, 2 tablets totaling 75o mg given every 8 hours. This study began in October 2007 and is now fully enrolled. We reported today the first pharmacokinetic analyses of the study have been completed and the results support continuation of the twice-daily dosing regiment. Specifically, preliminary pharmacokinetic analyses of pre-dose samples taken on day 8 of dosing in approximately 50 patients indicate that the trough concentrations in these patients receiving a twice-daily dosing schedule were approximately 2300, 2,300 ng/ml, a value that is better than we expected and similar to the trough concentration of the three times daily telaprevir based dosing schedule in the study. This concentration is also similar to the trough concentration that we observed in the PROVE 1 and PROVE 2 studies when telaprevir was dosed every 8 hours and when we found a substantial increase in SVR over standard of care treatment arms. For reference in PROVE 1 and PROVE 2 from the population PK sampling analysis, trough concentrations were approximately 2,300 ng/ml in PROVE 1 and PROVE 2 was similar. While we still need further efficacy and safety data, we are optimistic that with these pharmacokinetic results there is real potential for telaprevir to be dosed in a twice-daily dosing schedule. We expect to have additional efficacy and safety data to fully compare the regiments in the second half of the year. If those results are successful, we will determine the best path forward to get twice-daily dosing on the label as soon as possible after launch. In summary for telaprevir, we have made great progress in the firs quarter of 2008. We commenced dosing and our registration of study of treatment on each patient, we had the first data in patients who failed prior treatment with pegylated interferon and ribavirin, and we have the preliminary pharmacokinetic results suggesting a twice-daily dosing opportunity for telaprevir, all very important advancements. Now briefly to two of our other development opportunities. I’ll start with the VX-770, an oral drug candidate we have in development for cystic fibrosis. In late March we announced the data from part 1 of a two-part Phase 2a trial in patients with a mutation known as G551D. Part one enrolled 20 patients. Our goal in testing this compound in a small subset of patients was to see if a potentiated compound could improve the gaiting of the defective CFTR channel that causes CF. These data showed a mean 10% improvement of lung function at the highest dose, as well as significant reduction in sweat chloride levels and changes in chloride ion transport in the upper airway as measured by changes in nasal potential differences. Results from the interim analysis support the hypothesis that improving chloride ion transport in CF patients may correlate to improvements in lung functions. We expect to present these data at the 31st European Cystic Fibrosis Society Annual Conference taking place from June 11 to June 14 in Prague. Following presentation of these data we expect to complete part 2, which is a 28-day study of the Phase 2a study in the second, with the 28-day part of the Phase 2a study in the second part of 2008. Also in the cystic fibrosis program we are conducting a Phase 1a trial of VX-809, a corrector compound for CF that can treat a greater number of patients living with this disease. We expect results from this study later in 2008. Finally, briefly to our Aurora kinase program. We expect that our collaborator, Merck, will initiate Phase 1 clinical development of MK-5108, also known as VX-689 in the second quarter. These drug candidates are currently being evaluated in patients with advanced or refractory tumors; additionally, Merck continues to evaluate efficacy and safety data for the Aurora kinase inhibitor MK-0457 or VX-680 for the treatment of cancer following the previously announced suspension of clinical trial enrollment for this compound. These programs reflect ours and Merck’s conviction that Aurora kinases are an important potential mechanism for the treatment of cancer. In summary, we have made tremendous progress and still have a lot to accomplish in 2008. I will now turn the call over to Kurt.
Thank you, John, and good evening everyone. I will keep my remarks brief tonight and in the context of what we’re doing to build on our lead and strengthen our position. Our number one priority remains the same, fully leveraging our first to market opportunity with telaprevir. With the new data we’re developing and the data we have going into even next week, we’re now seeing the potential, more than ever, to build on telaprevir’s strengths and our HCV portfolio strategy to create a sustainable leadership position in this dynamic category. Telaprevir continues to raise the benchmarks and differentiate its profile amongst STAT-C therapies. Today it has number one generated unprecedented SVR rates ranging between 61 and 68%, together with the potential of shortened treatment duration of 24 weeks for the majority of treatment-naïve, genotype 1 patients and two it is the first and only STAT-C to enter a registration on Phase 3 program focused on 24-week treatment durations. On top of that we’re seeing a differentiation in our early antiviral data in patients who failed prior treatment with pegylated interferon and ribavirin and we’re also seeing early PK results, which shows the potential for telaprevir to be a twice-daily drug. While these data are early and more data are required in both cases, they are highly relevant to strengthening our competitive differentiation and the breadth and depth of our market opportunity. As John mentioned, in a week four interim analysis of data from study 107, telaprevir significantly brought down the viral load in patients who had not responded to current therapies, most notably in all three subgroups including no-responders, partial-responders and relapsers, many of whom had very limited or no treatment alternatives at all. Many of these patients represent the highest unmet need populations in hepatitis C and are a very important piece of the hepatitis C market opportunity. We recognize that these data from study 107 are early, but we are encouraged by the viral responses at week four and look forward to discussing further on treatment data with you in more detail at EASL. Beyond this promising data in parallel, we’re not standing still. We are seeking to leverage our first to market position and are pursuing a number of potential collaborations and deals with companies that have future complimentary therapies to telaprevir and our second-generation protease inhibitors. Once telaprevir is launched and well established, prescribers will want to know how to use the next evolution of potentially complimentary therapies once they are approved. We think it makes sense, as a leader in the area, to address that opportunity and to provide the telaprevir combination data as early as possible, working with companies who share a common vision of the opportunity created by our lead position. This is a high priority for us in 2008 and we look forward to keeping you updated as we progress. In summary, as more and more data emerge from our global development program, I believe we are strengthening key aspects of our product profile and our potential differential advantages, which should improve launch uptake and also provide a stronger and more durable competitive position. If our early 107 data and our preliminary twice-daily results translate into our desired results, we have even more reasons why we are well on the way towards establishing telaprevir as a cornerstone therapy in the treatment of HCV. There is more to do and challenges will always lie ahead, but we are serious about our commitment to eradicating this disease, and we fully intend to leverage our lead position, our profile enhancing studies, smart business development collaborations, and our expanding STAT-C portfolio. Joshua, over to you. Joshua Boger Ph.D.: Thank you, Curt. 2008 is an important year for demonstrating the strength of telaprevir’s profile. We recognize and respect that other companies also see the unmet need for patients with HCV. The HCV market has tremendous opportunities for growth. There are increasing numbers of HCV patients entering the health care system and we are developing product candidate to address this severe, unmet, medical need. With the first STAT-C to enter a Phase 3 registration program, we are one step closer to capitalizing on the first to market opportunity in treatment-naïve patients. I’m also pleased with the progress telaprevir is already demonstrating in treatment failures. Telaprevir has shown an early effect in non-responders and relapsers and most impressively in no-responders, where others have shown that they are not likely to show success in this population. We have a deep commitment to HCV. In addition to our progress in treatment-naïve and treatment failures, we are also focused on building a category leadership position. We are exploring opportunities to evaluate telaprevir in combination with other STAT-C therapies. Beyond HCV, we are diversifying our pipeline with a number of other novel, first in class product candidates. We are demonstrating our commitment to high-growth, specialized diseases. The VX-770, our oral compound for the treatment of cystic fibrosis, showed it has potential in the early studies, to restore lung function in CF patients. It’s a very exciting time to be at Vertex, we are making important therapeutic advancements, we are lighting the way forward in the number of disease. Michael, back to you.
Thank you. At this time, we will now open the call to questions. ------------------------
(Operator Instructions) We’ll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Rachel McMinn with Cowen & Co. Rachel McMinn, Ph.D.-Cowen & Co: Yes, thank you very much for taking the question. I guess I wanted to ask you a little bit more about the bid study. I think you mentioned, you say that the trial will continue as planned. Is there a specific, pre-specified analysis at week four that we should be thinking about and if there is, is there some sort of nomentheoryrity [ph] that you would need to see in order to continue on past week four? John Alam M.D: Yes. Rachel this is John, thank you for the question. We are, the study is actually now fully enrolled and it’s proceeding very smoothly and very nicely. There is no pre-specified stopping point at week four, week twelve; there will be an analysis of the 12-week safety and antiviral data that we expect early in the second half of the year. I think in terms of the RVR or antiviral data, our expectation at this point is that the results between given the pharmacokinetic data that we’ve seen, that the results between the two arms in terms of twice-daily and three times daily will also actually be quite similar, given that for an antiviral drug, trough concentration is a key driver of antiviral activity, whether it’s measured in hepatitis C as RVR, undetectable ACVR, RA and ultimately SVR. It is the blood concentrations and the trough concentrations that consistently for antiviral drugs, that trough concentrations drive the result We have with PROVE 1 and PROVE 2 established a particular trough concentration as a benchmark to be able to achieve the SVR rates that we achieved, which RVR and SVR rates that we achieved, which was a approximately 2300 nm/ml and then with all that, with the analysis that we’ve done, which is, you know, the first third, about a third of the patients in the study, but with that data, at a time point that you are at steady stage 4 trough concentrations, they aren’t going to go up any further; they are stable at that point. With the similarity in trough concentrations, the antiviral effect should follow with similar antiviral effect as well. Rachel McMinn, Ph.D.-Cowen & Co: Should we take that to mean, in your perspective then, if there is a risk, if you will, in the trial and that the bigger risk would be safety as opposed to efficacy? John Alam M.D: I think that’s the one that in terms of an antiviral effect, that you’re right. Our expectation at this point, it is actually to confirm what we’re seeing in terms of the antiviral results. In terms of safety, we obviously, at this point, haven’t done the detailed safety analysis, but the results that are available at a high level, it is consistent with what we’ve seen in PROVE 1 and PROVE 2, and nothing really stands out as going with one arm or another. In terms of, if your question is in terms of peak concentrations and what that might play out in terms of its safety profile, in our prior analysis in PROVE 1 and PROVE 2 we haven’t seen any of the, whether it be GI side effects, rash, any of the adverse events that we’ve seen in that particular combination have not been correlated to peak concentrations, but we will confirm that with the more detailed safety analysis that’s coming up. Rachel McMinn, Ph.D.-Cowen & Co: Okay, so and then just last question on this: do you have a significant proportion of patients out through 12 weeks? John Alam M.D: We haven’t provided the specific numbers of patients. It started in October 2007 it is now fully enrolled. Rachel McMinn, Ph.D.-Cowen & Co: Okay, thanks very much, I appreciate it.
Your next question is from the line of Geoffrey Porges with Bernstein. Geoffrey Porges-Sanford Bernstein LLC: Yes sure and congratulations on the bid, I think it’s certainly intriguing at this time. A question there, you obviously breadth on these patients, at least at eight days. Can you confirm whether the same percentages of patients are undetectable at eight days or roughly the same in the two arms? And a fair question, if you would just talk to, John, what the regulatory strategy might be for bid. You’re Phase 2s your big Phase 2s and now you’re Phase 3 around bid, how can you sort of incorporate bid in the potential label and what is your thinking on that at this point? Thanks. John Alam M.D: I can’t comment on the ATVR and A data, we haven’t disclosed that information. Again, I think with the PK data that we have with the trough concentrations with an antiviral drug, with the PKPD relationships that we’ve already established to this point across our various studies. In terms of antiviral effect, we are definitely optimistic in terms of being able to ultimately establish the similarity of antiviral profiles for twice daily versus three times a day. In terms of strategy going forward, we will need the full set of data to define the profile and it may be that at that point it’s a better time to specifically go in terms of what the long-term strategy is going to be. We will be working, obviously, with the data and with regulatory authorities. If it’s confirmed, our expectations in terms of safety and efficacy, to bring it to the market as soon as possible after launch; in the short-term, I think it does provide that much more confidence in the three times daily regiment. Overall what we found in the data that we’ve obtained in PROVE 1 and PROVE 2 and now in this study, that the blood level profiles are in fact flatter and more sustained than we had originally expected coming out of Phase 1 and that’s presuming a combination of the formulation being in HCV patients and all around it’s performed better in terms of a sustained trough concentration, which may in fact explain the very good results we’ve obtained in PROVE 1 and PROVE 2, particularly in terms of the very low break through rates. Geoffrey Porges-Sanford Bernstein LLC: So, could I just follow up with one: should we be thinking about this as [indiscernible] it’s okay for a patient to miss a day or should we be thinking about this in terms of this being a drug that’s labeled for bid administration routinely? John Alam M.D: Both. Geoffrey Porges-Sanford Bernstein LLC: Okay, thank you.
Your next question is from the line of Yaron Werber with Citi. Karim Defillipe [ph] - Citigroup: Hi, this is Karim Defillipe I’m just filling in for Yaron Werber, but thanks for taking my question. In regards to the PROVE 3, what interim data exactly do you expect to submit to the regulatory authorities in May and could you elaborate, perhaps a little more, what the next steps would be, when we would see that data and also, the possibility of PROVE 3 serving at the second registration trial? Thank you. Joshua Boger Ph.D.: The key data in the interim trial are the SVR 12 results in the two 24 week arms in PROVE 3, including in particular the 12+12 regiment in that study. That interim analysis will be completed and submitted in May and we’ll talk further in terms of specific registration paths or how we would move forward from there after we’ve had our initial set of discussions with the regulatory authorities; the focus of which will clearly be as the first set of data that they will have seen in this particularly hard to treat patient population to get a full understanding of the data and the implications of the data. Karim Defillipe [ph] - Citigroup: Great, thanks very much.
Your next question is from the line of Annabel Samimy with UBS Securities Annabel Samimy-UBS Securities: Sorry, all my questions have been answered thank you. Joshua Boger Ph.D.: Thanks, Annabel.
Your next question is from the line of Hari Sambasivam-Merrill Lynch Hari Sambasivam-Merrill Lynch: : Joshua Boger Ph.D.: Hari, thank you for the question. So on the safety profile, we haven’t seen any, and again it’s a high-level analysis at this point. We haven’t seen any subsequent differences between the regiment and the – but what we’ve seen is consistent with what we’ve seen in PROVE 1 and PROVE 2. In terms of the VX-770 and dosing, we do have an ongoing PKPD analysis and a dose response analysis. I think as we said in our call and I know we said in our call, there was an underlying dose response. With the number of patients we have in the study, a more robust analysis in terms of where we are in terms of does response curve will be a PKPD analysis and that will drive whether we add additional doses in the 28 day part of the study or not. Otherwise our focus will be on the 150 mg dose level twice a day. Hari Sambasivam-Merrill Lynch: That’s great, thank you.
Your next question is from the line of Brian Abrahams, with Oppenheimer & Co. Brian Abrahams, M.D.-Oppenheimer & Co. Inc.: Thanks for taking my question. I’m just wondering, going back to the bid study, if you could talk in a bit more detail about how the PKPD profile that you’re seeing compares to what you saw in that original 14 day model therapy study. I guess I’m just wondering how much of an impact do you think the different formulation that you used back then is, how much of an impact do you think that might have on the potentially different outcomes in the two studies, or should we think about it more in terms of the bigger impact, the larger impact coming from the combination uses of interferon and ribavirin in this study versus the prior study. John Alam M.D: Thanks for the question Brian. At this point, just to be clear, the ATV, R&A data are blinded and they are not, we have not evaluated any antiviral data and so I can’t comment on PKPD for twice daily versus three times a day. The key information at this point are that the blood levels of telaprevir with trough concentrations, which have been consistently across our studies that what drives the antiviral effect, those trough concentrations are in the twice daily regiment at 12 hours after the last dose are and immediately prior to the next dose, they are approximately 2300 nm/ml, similar to what was seen in the three times daily and similar to what we reported in PROVE 1. Brian Abrahams, M.D.-Oppenheimer & Co. Inc.: I guess just to clarify my question, I was just wondering how those trough levels compared to the trough levels you observed at a similar time point in that initial study. John Alam M.D: All right, great question. As we came out of the mono therapy study our objective, as you might recall was, we targeted a concentration of maintaining 1000 nm/ml at trough in all patients. In PROVE 1 and PROVE 2, we3 actually were able to achieve, with the formulation, in the combination we evaluated it in, in ATV patients, everything together immediate of around 2300 nm.ml, so about 2x above our initial target. Again, it may be the reason why that regiment has performed as well as it has in PROVE 1 and PROVE 2. Again, those are the trough concentrations that we’re achieving, so we’re, with twice daily as well, more at a median, more than twice above that initial target. Brian Abrahams, M.D.-Oppenheimer & Co. Inc.: Great and just a quick follow up. Any updates on when the second pivotal study might begin? John Alam M.D: We have no further update as of today. Brian Abrahams, M.D.-Oppenheimer & Co. Inc.: Okay, thanks for taking my questions. I look forward to seeing you guys on Thursday. John Alam M.D: Thanks.
Your next question is from the line of Lisa Bayko with JMP Securities. Lisa Bayko-JMP Securities: Hi guys and congratulations on the bid data, it looks very encouraging. Joshua Boger Ph.D.: Thank you. Lisa Bayko-JMP Securities: I just have a couple questions on the, is the trial being run in both the US and Europe or just in Europe? John Alam M.D: It’s being run only in Europe. And in, just to be clear, in PROVE 1 and PROVE 2, PROVE 1 all in the US, PROVE 2 all in Europe. The PK and trough concentrations between, there were no significant differences between the US and European populations. Lisa Bayko-JMP Securities: Okay and then can you just give us the specific blood concentration that was established in PROVE 2? John Alam M.D: We have not provided that, but it’s very similar to the 300 nm/ml which we did report in IR Jacobson’s presentation at ASLD. Lisa Bayko-JMP Securities: Okay, so I’m just trying to follow the train of logic that perhaps you’re seeing a different blood concentration because of the difference in population size. John Alam M.D: The comparison within the study is within the same population. So the first part of the result is that in the study we’re reporting on, the study C-208, the twice daily regiment and our otherwise, you know the three times daily regiment do in fact have very similar trough concentrations. Lisa Bayko-JMP Securities: Okay, great. Thanks for the clarifications. John Alam M.D: Yep.
Your next question is from the line of Howard Liang with Leerink and Swann. Howard Liang, Ph.D.-Leerink Swann and Company: My question is on the bid trial. I think you mentioned the concentration you mentioned, 2300, was that median or mean? And I guess my, really my question is what about the variance, was the center deviation the same between the bid and the arm? John Alam M.D: So that’s the, thank you for the question, great question. The median is what we’re providing, but you are absolutely right. When we say similar trough concentrations, we are not just looking at one number. We are looking at actually all the data from the 50 patients, about half of whom received half daily regiment, half who received three times daily regiment and it’s looking at all available data, the range, you know we basically plotted the individual patients of where their trough concentrations were and data comparison is where the conclusion that there are similar trough concentrations comes from. Howard Liang, Ph.D.-Leerink Swann and Company: Okay great. Then why only 50 patients? I thought each trial had 200 patients and also what is the breakdown, of the 50 patients, between the Pegasus and second trial arms? John Alam M.D: So the trial has enrolled approximately 150 patients that was the original target. This pharmacokinetic analysis was basically set up and run at the point that about a third of the patients had been to the point and then the PK was run and you know, run and analyzed. There is an ongoing data generation. The next planned interim analysis is a full PK as well as safety and efficacy analysis that will include as much of the up to week 12 data as possible. Howard Liang, Ph.D.-Leerink Swann and Company: Okay and a question on the 107 study, can you say how many more patients you are going to see, Thursday, and how many have reached week 12? John Alam M.D: Let’s talk about it on Thursday, Howard. We will have more week four data and we will have up to week 12 data and this is an advertisement for everyone here, it is going to be a good discussion and I hope to see you there to talk about the full set of data that we’ll be presenting on Thursday.
Your next question is from the line of Tom Russo with Baird. Thomas Russo-Robert W. Baird: Most of mine have been answered, but can you give any update on any commercial inventory builds so far this year and also the numbers and types of positions that you might be adding within sales and marketing?
So, thanks, Tom, it’s Ian here. First totally we’re increasing our investments in niche customer markets area and Kurt may have a brief comment there. Not significantly at this point, but as we get more data and as we get more understanding with the FDA with how quickly we can bring this drug to the market, you’ll find we can’t wait to investment. Let’s face it that’s the story in our customer’s market area. As far as our commercial inventories build, we’re not being specific on how much the investment is there. It’s very similar to customer markets investment as well, based on our path, based on our timeline, we’re going to invest based on risk to build inventory for launch. We won’t give any specificity on the amounts we’re building at this time; maybe something will be clearer on closer to market. Thomas Russo-Robert W. Baird: Okay and then you may have already given this in the past, but the primary Phase 3 trial in treatment-naives, can you tell how many patients are on a 12+12 versus an 8+16 regiment? John Alam M.D: Well the studies – sorry, John, go ahead. The study is 1050 patients divided by four, it gives you the size of the three arms. So 350 patients per arm, controlled 8 week telaprevir duration with peg interferon duration driven by either RBR of 24, 48 weeks and then the 12-week telaprevir duration with 24, 48 weeks of pegylated ribavirin. With the focus obviously being on the 24-week regiment. Thomas Russo-Robert W. Baird: Okay, thanks a lot. John Alam M.D: Thank you.
Your next question is from the line of George Farmer with Wachovia Capital. George Farmer, Ph.D.-Wachovia Securities: Hi, thanks for taking my question. John, can you comment a little bit more on the bid trough levels? I’m just expanding on a previous question. Going back and looking at the original mono therapy data, the trough levels that were attained with tid were about 1000 nm/ml and with bid there were 780, I’m just reading this directly from the flyer right now. You mentioned that you got to 2500 in both PROVE 1 and PROVE 2, how did you achieve that? Was this a different formulation than the mono therapy study or might have there been an effect due to pegliva? John Alam M.D: The primary affect is the formulation. The mono therapy study, their call was a suspension. Our work subsequent to that is with a tablet formulation with which we actually do achieve on it, by itself, about two-fold higher concentrations than we achieved in the original mono therapy study. There is an affect of interferon – we assume it’s the interferon that does modestly increase the levels ultimately to that around 2300 nm/ml level but the major increase in trough concentrations comes from the formulation. George Farmer, Ph.D.-Wachovia Securities: Okay thanks. Ian do you expect any other milestone payments this year?
Yes, we haven’t given specificity. They’re included in our revenue guidance that we provided for the full year. Just to remind you, that revenue guidance for the full year that we gave back in February of this year was between 200 and $220 million, and that would include other milestones. George Farmer, Ph.D.-Wachovia Securities: Okay, thanks very much. John Alam M.D: Thanks, George.
Your next question is from the line of Jason Zhang with BMO Capital Markets. Jason Zhang –BMO Capital Markets: Thanks a couple of questions. When will be the first time that we can see the bid study data presented at a medical meeting? The second is the supply channels, supply management, how many suppliers have you identified [indiscernible] and how are you going to, do you raise that by securing more suppliers or are you going to rely on one of two main suppliers
Thanks for your question Jason. So first on the data question on the bid study. So, given that it is a Phase 2a type study, 160 patients, what you should expect is a disclosure that would probably be top line data in a press release that would come later this year. We’ve tended to preserve the detail of the studies for medical conferences and we’ve also preserved the disclosure of medical compasses for those trials that could potentially be used for registration. But, in summary, the bid study would be a top line press release and in the later part of this year. On the supply question, first of all we have a supply chain in place that starts over seas and comes through Europe and into the US and it’s had its validation and we’re productive and already producing commercial product. As far as diversifying the risk in our supply chain, we’ve also got J&J, a very capable partner, J&J and Tevotech and they are replicating a process and they are a very able back up in terms of diverse funding our risks. We’re at a very good place to scale up in commercial supply of our product, including where J&J is today as well. Jason Zhang –BMO Capital Markets: Okay. I think a quick question on your collaboration. I think it it’s not the first time, but certainly the first time you have emphasized exploring opportunity and seeking a collaboration of other products in the future development and I know you’re not going to disclose the company you’re talking to, but from a philosophical point of view, you know given there are so many different opportunities, there are different types of drugs, you know polymers inhibitor, protease inhibitor and your new modulator. How are you going to evaluate this opportunity and to whom are you going to focus more on, you know, versus the others?
Yes, Jason it’s Kurt. It’s a good question. Right now, we at Vertex are really trying to take a view that we’re trying to build a leadership position in the category of hepatitis C and we’re looking at novel therapies that can be combined with either telaprevir. We’re also looking at potential therapies in the time frame that could be combined with our second-generations proteases as well. Right now our current thinking based on all the data that comes out and we’re tracking all the different complimentary therapies and we’re in discussions with not just one company, but multiple companies. We tend to be leaning towards the STAT-C therapies that are most advanced with, what looks like so far, potentially promising and efficacy and safety data to the point where they could be potentially combined with telaprevir and get to the market based on the leadership position we have with telaprevir potentially quicker. Jason Zhang –BMO Capital Markets: Financially how are you going to arrange these collaborations? Do you have any preference?
It really depends, company by company, the different types of collaborations we’re looking at. Some of them include just doing joint studies for potential inclusion in labeling right up through different kinds of deals where we would have the asset ourselves in our own portfolio. So it’s not something I can give you one response on, there is a number of different companies we’re talking to in different structures. Jason Zhang –BMO Capital Markets: Thanks.
(Operator Instructions) And there are no further questions at this time. Joshua Boger Ph.D: Okay, if there are no further questions, we’ll say thank you very much for listening to the call tonight and let you know that we will be in our offices to answer any follow up questions that you have. Thanks again.
This concludes today’s Vertex Q1 Financial Results Conference Call. You may now disconnect.