Theravance, Inc. (THRX) Q3 2009 Earnings Call October 27, 2009 5:00 PM ET
I would like to welcome everyone to the Theravance Conference Call to review results for the quarter ended September 30, 2009. During the presentation, all participants will be in a listen-only mode. A question-and-answer session will follow the Company’s formal remarks. (Operator instructions) I will repeat these instructions after management completes their prepared remarks. Today’s conference call is being recorded.
Now, I would like to turn the call over to Mike Aguiar, Senior Vice President and Chief Financial Officer. Please go ahead, sir.
Good afternoon everyone, and thank you for joining us. With me on the call today is Rick Winningham, our Chief Executive Officer. Today's call will be in three parts. First, Rick will review highlights from the quarter and provide an update on our clinical programs, then I will review our financial results, and finally we will open up the call for questions.
Earlier today, Theravance issued a press release detailing third quarter 2009 financial results and recent corporate developments. A copy of the press release can be downloaded from our website or you can call Investor Relations at 650-808-4100, and we will be happy to assist you.
Before we get started, we would like to remind you that this conference call contains forward-looking statements regarding future events and the future performance of Theravance. Forward-looking statements include anticipated results, and other statements regarding Theravance's goals, expectations, strategies, and beliefs. These statements are based upon the information available to the Company today, and Theravance assumes no obligation to update these statements as circumstances change.
Future events and actual results could differ materially from those projected in the Company's forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the Company's most recent 10-Q filed with the SEC.
I will now turn the call over to Rick Winningham, our Chief Executive officer. Rick?
Thanks Mike. Good afternoon everyone. This has been a very exciting time for Theravance with the recent US and Canadian approvals of VIBATIV for the treatment of adult patients with complicated skin and skin structure infections caused by Gram-positive bacteria including MRSA.
VIBATIV's approval is a significant accomplishment for Theravance and it validates our drug-discovery and development strategy as well providing concession for the new treatment options for patient with these serious infections.
In the Horizon program, GSK and Theravance announced this morning the initiation of the Phase 3 program in chronic obstructive pulmonary disease another important milestone for Theravance and our collaboration with GSK.
Now I'll provide you with more details on these developments and then Mike will walk you through the financials later in the call. First let turn to our Horizon program with GSK.
GSK and Theravance reported in a press release this morning that the first patient was dosed in the Horizon Phase 3 program. The goal of which is to develop a next generation combination treatment for patients with COPD. This program consists of a broad range of large scale Phase 3 studies to evaluate the combination of investigational once-daily long-acting beta agonists 444 and the once-daily inhaled corticosteroid fluticasone furoate or F.
The overall program which will study more than 6,000 patients, includes two 12-month exacerbation studies; two, six-month efficacy and safety studies and a detailed lung function profile stud, and studies to assess the potential for superiority of the fixed combination of '444 and FF versus other strip treatments for COPD.
The Phase 3 program is designed to generate data comprehensive enough to meet global registration requirement. The initiation of the Phase 3 program in COPD is important due to the significant unmet medical need for better and more convenient treatment options for the millions of patients worldwide with this disease.
In addition to the COPD development program, GSK and Theravance remain committed to progression of the Horizon program for the treatment of asthma and we look forward to providing you an update when additional information becomes available.
As a reminder, Theravance is entitled to receive royalties of 15% on the first $3 billion of annual net sales and 5% on annual net sales above $3 billion for the approved single-agent LABA and combination LABA ICS medicines. We have no development costs associated with this program.
Now, we will turn to telavancin. VIBATIV the brand name of telavancin gained approval in the US and Canada for the treatment of adult patients with complicated skin and skin structure infections during the third quarter.
This is the first approved indication for VIBATIV and Theravance's first drug approval, marking a major milestone for the company. In October we announced that Theravance earned a milestone payment of $20 million for FDA approval of VIBATIV and supplying our partners Astellas, with the launch inventory for the first commercial sale in the United States. Astellas recently began notifying wholesalers that they are now accepting orders for VIBATIV in preparation for a commercial launch this quarter.
We have set our wholesale acquisition cost pricing at $150 for 750 ml vial and $50 for 250 ml vial. VIBATIV dosing is dependent upon the patients weight, as well as their renal function. The recommended dosing for VIBATIV is 10 mg per kilogram once-a-day.
We believe that we have a strong label and that the key attributes of VIBATIV will enable it to become an important medicine addressing the increasing health problems of complicated skin and skin structure infections caused by Gram-positive bacteria including MRSA.
Turning to the nosocomial pneumonia indication for telavancin. The FDA is continuing its review of the new drug application which has PDUFA goal date of November 26. We continue to believe that it is likely that the FDA will refer this to NDA to an advisory committee for a review and its likely that the review of the NDA will extend into 2010.
Based upon the status of the review today, we are not aware of any significant issues that have been identified by the FDA related to the conduct of the nosocomial pneumonia study and we do believe that the FDA is evaluating the use of mortality as an efficacy end point and this will an important component for a overall review.
We remain confident in the generated by the attained studies and believe nosocomial pneumonia is an indication with a significant unmet medical need as there are limited options for physicians treating patients with these serious infections.
We continue to maintain a active publication and presentation effort to communicate our understanding of the biological and clinical characteristics of telavancin. Presentation of telavancin data were made at ACAP at San Francisco last month and additional presentations will be delivered at the CHEST meeting in San Diego and the IDSA meeting in Philadelphia in the next few days.
Turning to our MABA program in COPD, also partnered with GSK, we are currently waiting for the completion and review of Phase 2b enabling studies later this year. As a result we will not start the Phase 2B dose-ranging study and COPD for our MABA compound 081 in 2009.
We are also making progress in our earlier stage clinical programs and now have four compounds in Phase 1 studies.
Last quarter, we announced that TD-8954, successfully completed a single ascending-dose Phase 1 study. A single ascending-dose Phase 1 study is a potential treatment for Alzheimer's disease. During the fourth quarter of this year, we plan to progress this program by initiating multiple ascending doses in Phase 1 that will include the evaluation of CNS penetration with both our 5-HT4 agonists, TD-8954 and TD-5108.
During the third quarter of this year, we began a Phase 1 BAL study with TD-1792, our next generation antibiotic for the treatment of resistant Gram-positive infections. The study will provide data on the penetration of 1792 into lung tissue and lung fluids in order to evaluate the potential of this compound as a treatment for nosocomial pneumonia. Also, our partner AstraZeneca recently initiated a Phase 1 study with AZD3043, the short acting sedative hypnotic licensed from us. AZD3043 is being developed as an agent for use in both sedation and anesthesia.
Finally, I'm pleased to announce that we completed a successful single-ascending dose Phase 1 study with TD-1211, the lead compound in our oral peripheral [mono] antagonist or PUMA program for the treatment of opioid-induced bowel dysfunction. In the study, TD-1211 was generally well-tolerated and had a PK profile consistent with once-daily dosing. In short, the third quarter has been productive.
Now I'd like to turn the call over to Mike Aguiar, our Chief Financial Officer. Mike.
Michael W. Aguiar – Senior Vice President & Chief Financial Officer
Thank you, Rick. Today I will discuss the results for the quarter ended September 30, 2009 and will update guidance for full year 2009 expenses.
For the quarter ended September 30, 2009, Theravance had a net loss of $22.2 million or $0.35 per share. Total research and development, and total general and administrative expense, excluding stock-based compensation totaled $21.6 million for the third quarter and $54.6 million for the year-to-date. Total spending continues to remain largely in line with our expectations and guidance.
Total R&D expenses for the third quarter of 2009 were $19.5 million, slightly lower compared to the R&D expense of $20.1 million for the same period last year. These lower expenses were primarily due to decreased external cost related to the regulatory process for telavancin.
Excluding stock-based compensation cost, non-GAAP R&D spending was $15.6 million during the third quarter of 2009, compared to $17.1 million for the same period in the prior year.
External R&D costs were $3.8 million compared to $5 million in the third quarter of 2008. General and administrative costs were $7.1 million during the third quarter of 2009, compared to $6.5 million for the same period last year. This slight increase was due primarily to higher employee related and stock-based compensation expenses that were partially offset by reduced facilities and external expenses.
Excluding stock-based compensation, non-GAAP G&A expense was $5 million during the third quarter of 2009 compared to $4.7 million in the same period of 2008.
Revenue was $5.5 million during the third quarter of 2009 and consisted entirely the amortization of upfront and milestone payments received in the company’s partnerships with GSK and Astellas.
Cash, cash equivalents and marketable securities totaled $154.2 million as of September 30, 2009. This decrease of approximately $21.5 million during the third quarter was primarily due to cash used in operation and does not include the $20 million approval milestone from Astellas.
Now, turning to our guidance regarding the expenses for 2009. For the full year, we are reducing our previous expense guidance range of between $90 million and $95 million to $87 million to $90 million. This includes total research and development expense; and total general and administrative expense, but excludes stock-based compensation and non-cash restructuring items. Total cash used will be offset by any other milestone payments earned or other cash inflows.
Now, let me turn the call back to Rick for final closing comments.
Thanks Mike. We had a great third quarter with the approval of VIBATIV in the US and Canada, the initiation of the Horizon Phase 3 program in COPD, which we announced today. We are also pleased with the significant progress we have made on both the regulatory and clinical front in our other programs since our last quarterly update.
I would like to express my appreciation to the Theravance’s team of about 200 employees. The Theravance team has shown incredible dedication in bringing VIBATIV to the market, while advancing a significant number of programs in both discovery and development.
Hurdles, challenges, obstacles are constant in this industry. I have great respect for the ability of this team to handle every challenge, every hurdle, every obstacle placed in its ways or along our path of bringing new medicines to patients.
Now, I’d like to turn the call over to the conference facilitator and open the call for questions.
(Operator Instructions) We'll take our first question from Tom Russo with Baird.
Tom Russo - Baird
Congrats for starting COPD. I was hoping first to start with exacerbations and ask if there is any signs or data that you can share on the correlation between FEV1 coverage in reducing exacerbations, basically what would generate yours and Glaxo's confidence in bridging from what you've shown in Phase 2 to the primary endpoint in Phase 3 ,where we haven't seen anything yet?
Tom, I think this has been a standard pathway for looking at medicines to treat COPD. I think given the airway expansion that we've showed in the Phase 2b studies, in particular the 600 patients that clearly were quite confident in the Phase 3 program and the Phase 3 design and the ability of the combination of 444 and FF as well as well as a 444, a monotherapy to demonstrate the benefit in the study, so it's a standard. We are following a relatively standard path to approval here, and I think the Phase 2 data supports the design of the studies, as well as the probability for being successful.
Tom Russo - Baird
Then last quarter, three months ago Glaxo made some comments about asthma and kind of what was left to resolve with FDA, and it didn't sound like much. Can you give any color now that three months have gone by and it sounds like it's kind of at a similar status, is there anything you can share on that front, the asthma front?
Other than what we both companies said in the press release, there's not much more that I can share. I think the tone in the press release was meant to convey a sense of optimism and the fact that we look forward to talking about the asthma program in the upcoming months.
Tom Russo - Baird
Are there any new obstacles, or is it just kind of working through what was already there last time we heard?
I would say that the discussions with the FDA are ongoing, and we look forward to updating the public in the upcoming months.
One quick comment I'd like to add Tom. While we continue to remain quite optimistic about the ultimate outcome in asthma, the most important indication for us really was, whatever the first indication was principally due to the royalty structure that we enjoy, which is that we get the majority of our royalties in the first $3 billion worth of sales. So, we were extremely pleased to have COPD started. That has the potential to take us largely, if not all the way through that first tier. So that has been probably the single-most important event that we've had occur here lately, and we're extremely happy about that. With that being said, we continue to remain confident that we're going to get to the right place with asthma.
Tom Russo - Baird
Then the last question, I'll jump out. On telavancin, can you give any color on the latest interactions with FDA on mortality? What's your confidence is in being able to pull trials and have an inclusive timeframe for mortality? Then also, what mechanism do you expect to see for FDA to give itself some more time beyond November 26th?
I think relative to the mechanism, we'll have to see whether it's an extension or a complete response or whatever. Not being November 26, I don't know what it's going to be, and historically with applications here. We’ve experienced both complete response in this, than just deferrals of action. I think relevant to the mortality; I think the confidence that we’ve expressed before the overall study, not showing us statistical difference in mortality with non-inferiority margins being acceptable from what was talked about in April. Then also just to draw people’s attention back to the April presentation by Steve Barriere from our clinical group and the treatment was not associated with higher mortality. So I think we feel today we’re in pretty good shape and certainly are preparing much in the same way that we prepared for the skin advisory committee to be successful and to be able to answer any question that the advisory committee may have on mortality.
Our next question comes from Michael Aberman with Credit Suisse.
Michael Aberman - Credit Suisse
Congratulations concerning the COPD trial. Can you give us any more color on whether or not the potential of superiority or something the FDA asked for? Is that going to be a rate limiting either in US or in Europe for filing approval.
Superiority is not a rate limiting factor for either regulatory approval. I think superiority versus the studies that will have superiority as an end point are important studies for us and for GSK and really the 3B program to properly position the agents for payors.
Michael Aberman - Credit Suisse
Then on the asthma side of things, have you heard anything from the FDA that whether you would need to go show any benefit over short-acting beta agonist and some of the outcomes that come up in previous panel is that the reason or could that be a contributor to delay or do you think that’s not the case.
I’m not exactly sure, I mean do we have to show a benefit versus short-acting beta agonist I would assume so given that its just maintaining history you would have to do that.
Michael Aberman - Credit Suisse
I guess on the more, harder outcomes other than just exacerbations or hospitalizations such as mortality outcomes etcetera?
We are not done with discussions with the FDA, we haven’t started, but I think clearly our expectation with regard to the asthma program is clearly within sort of broad historical ranges. So, that’s really all we can provide now, Mike.
I think even I will add Michael, I’m not sure that I think it’s highly likely there will be a mortality component versus some of other beta agonist. I’m not a statistician, but Glaxo has expressed they should do that given the historic rate their may have been in some of the earlier studies in the [small] study for example. It would take something in the order of couple of hundred thousand patients to show that.
So, it feels unlikely that particular one is there. So, I think really we would like to just wait until we get some more definitive feedback from them, whether it just purely a sizing issue or whether it there is something else they're ruffling through, but again I think we are little unclear on exactly what the final outcome is going to be.
Michael Aberman - Credit Suisse
Final question on Horizon, the decision to use a single-dose for 444 from the previous [profile], I don’t see it looked pretty good at 25 doses well with perhaps less change in heart rate or better heart rate profile than the safety, anything you can comment on that decision.
Yeah. I think clearly with 25 micrograms we saw a very good efficacy and as you mentioned it very good tolerability profile against the range of parameters and also you know giving a pretty broad therapeutic index is that you really didn't see much at 50 micrograms either and I think that decision really was based on strong efficacy in the COPD population at 25 and having a very good therapeutic index in other words doubling the dose related do anything the adverse event profile.
So it’s a strong, we think it’s a very, very, a dose with a very strong ability to show solid efficacy in both as mono-therapy and as in combination with FF and I think we ended up with the right place with the dose primarily because the time was spent in a extraordinarily large Phase 2b study.
Just to capitalize one more time on this, the 25 really was the dose we wanted and the biggest reason was because we saw such good safety across the board and really there wasn't a whole lot of difference on the safety side between these doses. By picking the 25 say versus 12.5 that gives us the best opportunity to capitalize on some of these key secondary endpoints that we think have the ability to show that this is really a different medication.
So we are talking about on these in the past, the time to onset, the peak area under the curve, things like that and the 25 really gives us a terrific opportunity to capitalize on that and I think this is also due to inherent properties of the compound, which is that today its look pretty good in the studies from the safety perspective and we are not getting a lot of systemic absorptions, so we have a pretty broad therapeutic index.
Our next question comes from Brian Skorney with ThinkEquity.
Brian Skorney - ThinkEquity
My first question, I'll just ask about telavancin. It appears that [ADAC] has two meetings in December scheduled. Have you guys talked to the FDA, how come you're not one of those? I mean, it seems like that both drugs that were filed after or one of them was filed after telavancin for hospital-acquired pneumonia, the other one should stay more of a workshop. How about we talk about that first?
I think when we get formal notice of an advisory committee, Brian of course we'll announce it, but we don't have that notice right now and I really can't provide any insight into what the [anti-infective] division is considering for the December meetings other than what they published on the website.
Brian Skorney - ThinkEquity
Then talking about the Horizon, just kind to get a general idea of how long this study is going to take. In which of the trials do you and GSK think that you can submit an NDA? Do you have to wait for the full twelve month exacerbation study to read out, or is there an opportunity to file off of just the six month efficacy study?
We really view this as a package of the studies in terms of registration that we announced today. So, the rate-limiting step, the filing is really the completion of the 12-month studies.
We'll go next to John Stephenson with Summer Street Research.
John Stephenson - Summer Street Research
In terms of the asthma indication, looking at the dose curve from the prior presentations, it looks like in the COPD studies you had some dose effect on I believe on one whereas in the asthma trial you didn’t really see much of a dose effect from 12.5 microgram to 50 and I was wondering whether or not A, you believe its likely you go with the same dosage shrink for asthma you have in COPD and then B, whether or not there is any question or potential question about whether or not you found a lowest effective dose for asthma?
With regard to the lowest effective dose, you may recall there are couple doses that were in addition to the doses that we put on to this slide, that has now reached statistical significance, so there were lower doses studies, specifically there was a 6.25 and that’s 3 microgram in that study. The question of lowest effective dose, I don’t think is particularly high on our radar screen at this juncture.
With regard to the specific dosing that we were going to go to the FDA and I think I would just say we’ll wait till we get a little further through regulatory process. We obviously put a lot of common thinking into this and have an opinion on it, but until we get to a conclusion with them, I think I’ll hold off to make any comments. Rick?
I would just add that, one has to be a little bit careful in looking at bars in the slide that have been presented and looking across COPD and asthma and trying to see a dose response effective. The confident intervals in the COPD study from 12.5 to 50 all overlap, so while there looks like a bit of a dose effect there, it wasn’t something, it was statistical based, statistical difference.
Then secondly, FEV1 at that trough is really one metric that we looked at and choosing the dose and clearly other metrics that we discussed before GSK discussed before such a kind of peak, absolute peak an area under the curve for bronchodilation over 24 hours, those were very important pieces of information of a dose selection for the COPD studies.
John Stephenson - Summer Street Research
Just one another follow-up, in terms of the path indication, I know you guys have presented the data on the pooled analysis of the mortality in the all-treated population and I was wondering if you could make any comment as to what the non-inferiority margin for mortality were met in both of the trials in the, both in the all-treated, on the modified all-treated and on the microbiological evaluable population, because I haven’t seen the MAT or ME population.
John as you pointed out we presented the pool data and we've also presented data that said when you look across the studies and do some different types of statistical analysis the treatment wasn’t a contributing effect to mortality. We didn’t do mortality studies, number one, while our primary endpoints were clinical cure in the all-treated population in the clinically evaluable population and of course in both studies and in the pool we get both of those.
We did not collect mortality in the studies as an efficacy endpoint. We collected mortality as a safety endpoint. We have presented the pool studies because in order to get a statistical representative sample you needed roughly as it has been discussed in a couple of different meetings, somewhere in the neighborhood of 15,000 patients and that as in fact the total number of patients that we have had in the studies.
So, that we believe if the strongest evidence of mortality, given that we didn’t really do a mortality study. We did a study to evaluate clinical cure and I think on the basis of that, plus the other statistical analysis that we have done, that will again is the basis for being confident in being able to discuss both with the FDA and the Advisory Committee should they chose to apply mortality as an endpoint in these studies.
John. The reason we have gaffed and thrown out all kinds of other metrics there, to be totally honesty, we are not sure where they are going to settle in, and I'm not sure that its really worth our time to go out and start fishing around and throwing out a bunch of different metrics.
If it turns out that we start to get some indication, the FDA is settling at any particular number where we might be able to add some value to a public discussion or if there were some data point that came up that would change our prior guidance, that might be a point of where we need to put out some additional data.
I think absent one of these events happening probably the next time, that we would have additional data would be in a briefing package for an Advisory Committee is most likely.
John Stephenson - Summer Street Research
Just to check, the one last thing I wanted to ask. Have you actually run the numbers for MAT and ME or no?
We look at the total sample size of both studies of 1,500 patients. Again, just to reconfirm what the type of studies that we've done. We didn't do the mortality study. We did a study based on clinical cure and again, in the AT and the CE populations, and collective mortality as the safety endpoint.
We'll go next to Biren Amin with FTN Equity Capital.
Biren Amin - FTN Equity Capital
Thanks for taking my questions. I had a question on the definition of exacerbation in the Phase 3 horizon COPD program, so how is GSK defining exacerbation in Phase 3, and also is the company looking at total number of exacerbations or time the first COPD exacerbation?
I'm going to have to get back to you on that, Biren. I don't have the precise definition in the protocol in front of me.
Biren Amin - FTN Equity Capital
I guess a question on VIBATIV. I noticed you disclosed a price, and I was just running the numbers. It seems that on a milligram for milligram basis, VIBATIV is charged, or it gets about a 15% to 18% premium over Cubicin. So I just wanted to, I guess the company's thoughts on the pricing strategy, considering Cubicin is pretty well ingrained, I guess I would have assumed that VIBATIV would have come in at slight discount to Cubicin to try to capture some market share.
Biren when you think about pricing, obviously we are a weight dependent dosing, which reflects directly into the pricing, and as a result, is a little bit hard to say exactly where you are at a premium or a discount because it can vary pretty broadly, particularly for Daptomycin based upon our indication and things like that. So I think where we are, we've done a ton of work here, and we've looked at all kinds of various pricing curves and demand curves, elasticity curves, and came to a conclusion that the best price was right in the middle, but toward the upper end of where the other branded products are, kind of given the combination of both of the two indications.
With regard to coming in at a slight discount, it doesn't do a whole lot for you. You don't pick up a tremendous amount there, and quite frankly, I'm not sure we've ever been to a place that thinks that the best place to compete is on price. I would rather compete on attributes as a product.
So on this, we spent a ton of time, I mean just as some ballpark numbers, a single 750 takes you up to about 155 pounds, and then up between 155 pounds and 220 pounds would be 750 plus 250. So again, it depends entirely upon the patient's size as well as their renal status in terms of where the ultimate price point is.
I'd just say, we're clearly looking at the product with not only the indications that we have to date with telavancin or VIBATIV, but the indications that we may be able to achieve in the future.
(Operator Instructions) We’ll take our next question from Ian Sanderson with Cowen & Company.
Ian Sanderson - Cowen & Company
Just a couple; first on the housekeeping question, the $20 million milestone from Astellas, will that be booked in Q4 or amortized? Then secondly on the Horizon program, will one of the active competitors in the superiority studies possibly be Advair? The n third, related to that, we’re hearing that one of the potential therapeutic benefit of once-daily dosing profile in COPD may be reduction of lung hyperinflation and would that actually show up in exacerbation scores or if not how may you show that?
I’ll let Rick take the two questions that you given him on the Horizon program. Just quickly on the milestone, we should see that this quarter and they will be treated like all of our other milestones, the day which is they will be hung up and amortized over a period of time. So with that I will turn it to Rick on the Horizon question.
The hyperinflation of the airways may lead to exacerbations in COPD in the moderate to severe patient population, so that may show up within the exacerbations end point. What was your second question, active competitor. The active competitor, we’ll talk about that when we launch these studies, but clearly we are interested in – we and GSK are interested in positioning the Horizon product as a superior agent in the field. So, I would just look at the agents that are currently being marketed for COPD and those are the agents that are under consideration for active comparator.
Ian Sanderson - Cowen & Company
With those active comparator trials most likely include both, exacerbation and FEV1 endpoints.
Its likely that yes, they would.
It appears we have no further questions on the phone. I’d now like to turn the conference back over to Mr. Winningham. Please go ahead sir.
Okay, I would like to thank everyone on the line for joining us for and sharing a very positive third quarter and month of October and hope you all have a very good day. Thank you.
This does conclude today's conference call. We thank you for your participation. You may now disconnect.
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