Catalyst Biosciences, Inc.
Q4 2009 Earnings Call Transcript

Published: 12 Feb 2010

[Operator:]

Good afternoon, and welcome to the Targacept's fourth quarter and full-year 2009 financial results conference call. (Operators Instructions) I would now like to turn the conference over to Targacept's management. Please proceed.

[Alan A. Musso:]

Thank you, Amity. I am Alan Musso, Targacept's Chief Financial Officer. Before we get started today, I would like to remind you that on this call we may make forward-looking statements under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are not purely historical in nature regarding, among other things, the progress or scope of development of any of our product candidates or program such as the size, design, population, conduct, duration or objective of any clinical trial, the timing for initiation or completion of or availability of results from any clinical trial or for submission or approval of an NDA or the indications for which any product candidate may be developed, the competitive position of any product candidate or the commercial opportunity in any target indication; any payments that AstraZeneca or GlaxoSmithKline may make to us; or our plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, such as those described under the heading Forward-Looking Statements in the press release that we issued earlier today or under the heading, Risk Factors in our most recent Annual Report on Form 10-K or in other filings that we make with the Securities and Exchange Commission. Such forward-looking statements speak only as of today and should not be relied upon as representing our views as of any date after today. We disclaim any obligation to update any forward-looking statement, except as required by applicable law. I will now turn the call over to Dr. Don DeBethizy, our President and Chief Executive Officer.

[J. Donald DeBethizy:]

Good afternoon and thank you for joining us today. In addition to Alan, Dr. Geoffrey Dunbar, Targacept’s Vice President, Clinical Development and Regulatory Affairs is here with me. Earlier today we issued a press release describing our quarter and year-end financial results highlighting our 2009 accomplishments and providing updates on some of our clinical programs. We will take just a few moments here to review key highlights from the release and then we would be happy to take your questions. As you know, 2009 was an extremely exciting and rewarding year for Targacept. We again demonstrated the promise of NNR Therapeutics to make a tremendous impact on the lives of patients with CNS disorders. Two key clinical trials translated into significant business success for the company and our stockholders last year. In July, we reported positive results from our Phase 2b study of TC-5214, showing its potential as a new mechanistic approach for the treatment of depression for the millions of patients who do not respond well to first line antidepressant therapy. With over 42 million estimated who suffer from major depressive disorder worldwide, and the National Institutes of Mental Health’s large STARD study, indicating that approximately 63% of patients with depression don’t achieve remission with first line SSRI therapy, this is clearly a very large unmet medical need. Our augmentation trial of TC-5214 catalysed significant interest leading to a $1.24 billion collaboration and license agreement with AstraZeneca. And earlier in the year, we reported positive results from our Phase 2 trials of AZD3480, a non-stimulant with a therapeutic profile that could represent an important advancement for treating patients with ADHD, and we received a $10 million milestone payment from AstraZeneca based on these results. Our success in 2009 sets the stage for additional progress in 2010 and beyond. Our pipeline now includes five clinical stage programs. Following an end of Phase 2 meeting that we and AstraZeneca recently had with the FDA, we continue to anticipate the initiation in mid 2010 of Phase 3 development of TC-5214 as an adjunct therapy for adults with major depressive disorder who do not respond adequately to first line antidepressant therapy, with the goal of an NDA filing with the FDA in 2012. We also continue to expect a Phase 2 trial of TC-5214 as a switched mono-therapy approach for similar MDD patient population to be initiated in the second half of 2010. Beyond TC-5214, we remain very enthusiastic about the prospects of our three novel compounds in phase 2 development for cognitive disorders, AZD3480, AZD1446 and TC-5619. These product candidates represent potential new treatments for ADHD, Alzheimer’s disease and Cognitive Dysfunction in Schizophrenia, conditions that affect millions, for which currently available therapies either have safety or efficacy limitations, or in the case of CDS, don’t exist at all. As we proceed in 2010, we will continue with AstraZeneca to consider the development programs for these product candidates, with the shared goal of optimizing the promise of NNR Therapeutics to help patients suffering from impaired cognitive function. Our fifth clinical stage product candidate TC-6987 is currently in Phase 1 and under consideration for downstream development in various indications. Our goal is to expand our portfolio by leveraging our Pentad drug discovery platform and establish preclinical capabilities to advance at least one product candidate into the clinic each year. Towards that end, we conduct research programs where both the medical needs and the commercial potential are significant, such as Parkinson’s Disease and other therapeutic areas of our alliance with GlaxoSmithKline. Our scientific leadership in the NNR space has been reinforced with our receipt of two grants from the prestigious Michael J. Fox Foundation as well as several recent publications that highlight critical disease area where rationally designed compounds capable of affecting select NNRs may be of particular benefit. In total, the programs I’ve outlined to you this afternoon should provide multiple opportunities for important progress in 2010 and we look forward to updating you as we move forward. I will now turn the call over to Alan for a few brief comments on the financials. Alan?

[Alan A. Musso:]

Thank you, Don. In addition to the significant business successes that Don outlined, we were also to solidify our financial position in 2009. In October we completed a public offering of $2.2 million shares of common stock at a price of $21 per share, generating net proceeds to Targacept of $44.4 million. With this financing, we ended the year with $111.1 million in cash, cash equivalents and short-term investments. In January 2010, we supplemented our cash balance with the receipt of a $200 million upfront payment under our TC-5214 agreement with AstraZeneca. For the fourth quarter 2009, we reported net loss of $26.4 million compared to a net loss of $5.4 million for the fourth quarter of 2008. For the year ended December 31, 2009, we reported net loss of $39.4 million compared to a net loss of $25.7 million for 2008. The increased net loss for the fourth quarter in year ended December 31, 2009 was primarily due to a $16 million license fee obligation to the University of South Florida Research Foundation triggered upon the December effectiveness of our TC-5214 agreement with AstraZeneca. Overall our 2009 financial performance reflected our sustained focus on capital efficiency. Moving to our 2010 financial guidance, based on our current operating plans and expectations related to our collaborations with AstraZeneca and our reliance with GlaxoSmithKline, we expect net operating revenues for the year to be in the range of $80 million to 90 million, our operating expenses for the year to also be in the range of $80 million to $90 million and have a balance of at least $230 million in cash, cash equivalent and investments at year-end. This financial guidance includes both cash and non-cash revenue and expense items. In addition, we expect that our current cash resources will be sufficient to meet our operating requirements, at least through to the end of 2013. Now let me turn the call back over to Don.

[J. Donald DeBethizy:]

Thanks, Alan, and thanks again to everyone for joining us on today’s call. In closing, I couldn’t be more thrilled with our performance in 2009 or more enthusiastic about our prospects for the future. 2009 was a breakthrough year for Targacept. In 2010, we will remain focused on the prudent management of our resources as we look to capitalize on an unmatched portfolio of NNR Therapeutics to build upon our success and achieve our vision of building health and restoring independence for patients. Now with that, we’d like to open it up for questions. Operator?

[Operator:]

(Operators Instructions) And your first question comes from the line of Terence Flynn with Lazard Capital Markets. Please proceed.

[Terence Flynn:]

Hi, thanks for taking the questions. Just wanted to ask first in terms of your end of Phase 2 meeting with FDA, so that’s already occurred?

[J. Donald DeBethizy:]

Yes.

[Terence Flynn:]

Can you give us any insight from that meeting in terms of the size of the Phase 3 program, as well as the design?

[J. Donald DeBethizy:]

Yes, Terence, I’ll let Geoffrey Dunbar answer that question

[Geoffrey C. Dunbar:]

Thank you, Don. First let me say, give you a little flavor of the meeting itself, it went very well. It was very cordial, very professional, of course, and the agency did reflect on their pleasure at seeing an antidepressant with a new mechanism of action. Importantly, there were no roadblocks that were developed at the meeting, so it does mean that we can be starting our Phase 3 clinical program as planned by mid this year. The program, just to give you a little flavor of it, will consist of four pivotal trials, and one -- which are relatively short term, eight week trials, and also one long-term safety trial. Two of the trials will be two arm studies with flexible dosing and the other two will be a fixed dose parallel group design trials with three doses of 5214 and placebo. They all have the same or very similar approach as we used in our very successful Phase 2 trial, in which non-responding patients identified prospectively and then randomized into double blind phase of the study. Overall, we will be exposing over 2,000 subjects with 5214 acutely, and there will of course be at least 300 patients to six months and 100 patients out to a year, according to ICH guidelines.

[Terence Flynn:]

Okay, and in terms of the background therapy that they are non-responding to, can you tell us a little bit about that?

[Geoffrey C. Dunbar:]

Yes, they will be poor responders or non responders to a basket of seven SSRIs or SNRIs, all of which are commonly prescribed.

[Terence Flynn:]

Okay. And then the criteria that you're using to judge the nonresponders, can you just review that if it's similar to Phase 2?

[Geoffrey C. Dunbar:]

Yes. It's basically identical to Phase 2.

[Terence Flynn:]

Okay, great. And then just a question on -- so I'm guessing the guidance you gave includes, takes into accounts these trials and your cost of these trials in 2010, is that correct?

[Alan A. Musso:]

Yes, Terence. That is correct.

[Terence Flynn:]

Okay, great. Thanks a lot, guys.

[Operator:]

Your next question comes from the line of Bret Holley with Oppenheimer & Co.

[Matt Lowe:]

Hi. It's actually Matt Lowe [ph] in for Bret today. The first one is if you could just remind us of the plans of filing 5214 in Europe? And secondly if you could share any thoughts on the Phase 2b program for 3480 in adult ADHD? That'd be great. Thank you.

[J. Donald DeBithizy:]

Well first of all, I'd like to just say that our overall program is a global development program, but our plans are to file initially in the US. And with that I'll ask Geoffrey to provide a little more color to that.

[Geoffrey C. Dunbar:]

Okay. Thank you, Don. We are in the process of organizing to visit and talk to the European agency, which of course is an important prerequisite before finally designing the European part of the plan. As Don has already mentioned, what I shared with you so far, it will be used for global registration, but there will be the need for some extra studies for European consumption, if you'd like. Primarily there will be two extra studies; one would be a study in geriatric patients, patients that are 65 to 85, and the other, a bigger perhaps more important or as important trial for European usage is a relapse prevention trial, which assesses the effectiveness of 5214 in relapse prevention. Patients on meds [ph] got better and then the medication is continued out to show that they're stabilized, and then there's a randomized placebo controlled withdrawal phase.

[J. Donald DeBithizy:]

And the second part of that question was around the plans around ADHD and 3480, and we're still in the process of working with AZ on the development of those plans, and we'll be disclosing more detail around those as we get closer to initiating them.

[Matt Lowe:]

Okay, that's great. Thank you very much.

[Operator:]

Your next question comes from the line of Alan Carr of Needham & Company.

[Alan Carr:]

Hi. Good afternoon, everyone. There was actually, I think, another trial that you had mentioned in your opening comments to start in the second half of this year, a monotherapy trial, can you elaborate on that one?

[J. Donald DeBithizy:]

Sure. That's the monotherapy switch trial and Geoffrey can describe that.

[Geoffrey C. Dunbar:]

Yeah. Again, unlike the program which I described before which is a Phase 3 series of trial, the monotherapy will be a Phase 2b dose range finding study and as Don mentioned it will be looking at patients who have failed first-line therapy, antidepressant therapy, and then will be switched to our medication which in this trial will be monotherapy.

[Alan Carr:]

I think in past discussions with you, this is something that maybe the Europeans had expressed an interest in, but you just mention that a few minutes ago, Geoff why, or do you think this is something that would help get approval here or over there?

[J. Donald DeBithizy:]

Yeah, Alan, it's neither of those reasons. It's just we believe that this compound has the potential to work as a monotherapy in the same patient population that it has worked as an augmentation. So it's entirely possible based on the mechanism and the preclinical data that people that are not responding well to their first-line therapy, either SSRI or SNRI, could respond on 5214 alone. So this trial will be asking that question, and as Geoffrey indicated, will be a dose-range finding study because we don’t know, we've only done studies now as add on or augmentation with citalopram. So it'll be an important study for us to get our minds around how well it performs as a monotherapy in the very same patient population where we have these inadequate responders.

[Alan Carr:]

Okay. And then a numbers question, I take it -- I mean, expenses going up quite a bit this year, I take it it's all related to the 5214, that's the program going into Phase 3? Is that how we should model it for the year?

[Alan A. Musso:]

Yeah. That is a big driver of the increase in cost, the most significant factor on that. And the other things are, we are going to be continuing to invest in our pipeline in our research program, but the biggest driver of the cost increase is definitely the Phase 3 co-development obligation and the overall co-development obligations on 5214.

[Alan Carr:]

Okay. Are revenues going to mirror that as well? I mean, is that related to maybe a milestone from…

[Alan A. Musso:]

I think it's actually the recognition of that up-front payment which is going to be taken in over about a 33 month period is the current estimate, so that'll actually drive incremental revenues in 2010 of about $72 million.

[Alan Carr:]

Is there a milestone around starting Phase 3 or something like that?

[Alan A. Musso:]

We don't have any clinical milestones projected in this year's forecast.

[Alan Carr:]

Oh, okay. And then one last item about 6987, when do you think you'll have results from that in terms of, is this just a safety trial or is this going to have some efficacy in it too somehow?

[J. Donald DeBithizy:]

We're in the Phase 1 program now, so we've been working through the single ascending dose and we're moving into the multiple ascending dose, and then we're still evaluating all the preclinical data that we’ve generated around 6987. 6987 is an alpha-7 targeted compound. It's quite different than 5619 and we're quite excited about having two alpha-7 compounds, one moving forward in cognition. And now there's a broad opportunity around 6987 and we just need to identify what's the low-hanging fruit from an indication and efficacy standpoint and where do we want to take it. So we just haven't made that decision because we're still generating some preclinical data, but I can tell you we had a research team meeting this morning where we were just brainstorming about where the opportunities were in the pipeline and the list of potential indications around 6987, there's a lot of enthusiasm around that molecule.

[Alan Carr:]

Well, great, thanks for taking my questions.

[Operator:]

(Operators Instructions) Your next question comes from the line of Jon LeCroy with Natixis Bleichroeder.

[Jon LeCroy:]

Hey. I wanted to touch on the USF payment just a little bit. So it looked like it was 8% of the $200 million you're getting from Astra, how should we look at that going forward once you start generating sales on this product because I think let's say you book it in the 20% royalty range, is it going to be that high that you're paying back eight to USF or is that a one-time anomaly?

[J. Donald DeBithizy:]

No, basically the USF agreement has two sort of areas of obligation. One is for milestone payments that we receive and then the second is a royalty component that applies to product sales and we’ve disposed that we expect that our royalty obligation will be in the low single-digit range. So when we get royalties and the product gets on the market, that's the obligation that we anticipate for USF.

[- Jon LeCroy:]

And that's on overall sales, not what you book?

[J. Donald DeBithizy:]

That's on overall sales, that's correct.

[- Jon LeCroy:]

And I think you get something like a $350 million royalty on approval, would that get paid out at an 8% or is that different as well?

[J. Donald DeBithizy:]

Yeah. We actually disclosed that we have total milestone eligibility of over $1 billion going forward, I think $1.04 billion going forward which is divided into regulatory, first commercial sales milestones and then sales based milestones and the applicable portion to USF is on all that. And it's actually a 10% royalty rate. In this particular case, because we are committing ourselves to co-development funding of the program that was an offset to the amount, so 10% of the net up front exclusive of sort of our anticipated sort of funding to the next milestone event.

[- Jon LeCroy:]

Okay, great. Thanks.

[Operator:]

Your next question comes from the line of Juan Sanchez with Ladenburg.

[Juan Sanchez:]

Good afternoon, guys. What are the three doses that you're testing in the Phase 3 clinical trials? I mean, what's the lowest and what's the highest?

[J. Donald DeBithizy:]

We'll be covering a similar dose range that we have in our flexible dose design and we are also going to explore some lower doses.

[Juan Sanchez:]

So you don't expect the low dose to be efficacious, right?

[J. Donald DeBithizy:]

We're exploring low enough doses that we don't expect to see the kind of efficacy that we've been seeing in the dose range we've explored so far.

[Juan Sanchez:]

Got it. Thank you, guys.

[J. Donald DeBithizy:]

When we move the protocols to clintrials.gov you'll be able to see the doses, we just haven't disclosed them yet.

[Juan Sanchez:]

Okay. Thanks a lot.

[Operator:]

Your next question comes from the line of Joshua Schimmer of Leerink Swann.

[Joshua Schimmer:]

Hey, guys. Thanks for taking the question. Just curious as to why the 3480 Phase 2b study isn't starting until mid-2010 given that the data was towards the end of 2009? What are kind of the interim steps that are under way that are occurring up until that trial starts?

[J. Donald DeBithizy:]

Thanks, Josh, for the question. What AZ wanted to do was, because of the remarkable Phase 2 results that we had where we had stimulant-like effects with 3480 and placebo-like side effects, they really wanted to get the pediatric opportunity caught up with the adult opportunity. So they've been running juvenile talks and doing the clinical trial material and getting prepared for a larger program. And that will align both the adult and the pediatric and have them run somewhat staggered, but in parallel.

[Joshua Schimmer:]

Why is it important to have a pediatric catch up to adult?

[J. Donald DeBithizy:]

It was just a decision that AZ wanted to do, it also allowed them to do some other enabling studies and some preparation of clinical-trial material so it was their decision to wait while they’ve got the juvenile talks going.

[Joshua Schimmer:]

Got it. Thanks very much.

[J. Donald DeBithizy:]

Thanks, Josh.

[Operator:]

This concludes today's question-and-answer session. I would now like to turn the call back over to Mr. Don DeBethizy for closing remarks.

[J. Donald DeBithizy:]

Thank you very much. Well thanks, everybody, for participating in this exciting time for our company. It was really gratifying. Biotech companies, I always tell the employees that the kind of success we have in 2009 is elusive in biotech, and we're really looking forward to a year in 2010 where we're focused on execution and efficient cash management. So we're excited, thank you for participating along with the company, and I look forward to our next update. Thank you very much.

[Operator:]

Ladies and gentlemen, that concludes today's conference. Thank you for your participation. You may now disconnect. Have a great day.