Earnings Labs

Gyre Therapeutics, Inc. (GYRE)

Q4 2008 Earnings Call· Thu, Feb 12, 2009

$7.70

+0.85%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the fourth quarter and year ended December 31, 2008 earnings conference call. My name is [Latrise], I will be your coordinator for today’s conference. At this time, all participants will be in a listen-only mode. We will conduct a question-and-answer session towards the end of this call. (Operator instructions) Any statements made, or responses given during this call that are not purely historical in nature constitutes forward-looking statements, made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the timing for decision by AstraZeneca whether to conduct further development of AZD3480 in Alzheimer's disease or ADHD. The progress or scope of the research and development of our product candidates, such as the number of subjects to be enrolled in any clinical trial, the timing for initiation or completion of or availability of results from any clinical trial or the indication for which any of our product candidates may be developed, the possible therapeutic benefits of our product candidates; any future payment that AstraZeneca or GlaxoSmithKline may make to us; or our plans, expectations of future operations, financial position, revenue, cost, or expenses. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including, without limitation, 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 and 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 obligations to update any forward-looking statements, except as required by applicable law. As a reminder, this conference is being recorded for replay purposes. And at this time I would like to turn the call over to your host for today's conference, Dr. deBethizy. Please proceed sir.

Donald deBethizy

Management

Thank you, [Latrise]. Good afternoon ladies and gentlemen, I am Don DeBethizy, Targacept's President and Chief Executive Officer. And with me on this call is Alan Musso, Targacept's Chief Financial Officer who in a few moments will review with you our financial results for the fourth quarter and year-ended December 31, 2008, which we have just released. In these very challenging times for emerging biotech companies, we have a deep and sustainable pipeline that presents multiple opportunities for clinical success. Productive alliances designed to capitalize on the proven abilities of both parties, and cash resources at the end of 2008 of over $88 million, which we expect to be sufficient to fund our operations at least through the first half of 2011. As we begin 2009, we remain focused on the prudent management of our financial resources, and the execution of key business objectives designed to build value in both the near and long-term. Let me now review with you our programs. I'll begin with an update on our depression program where we have retained the commercial rights. We are developing TC-5214 as an augmentation treatment for Major Depressive Disorder or MDD. We completed enrollment in a Phase IIb clinical proof-of-concept trial of TC-5214 in January 2009 with 586 subjects enrolled into the open label phase and expect to report top line results from the trial in mid-2009. The design for our ongoing Phase IIb trial is similar to and incorporates the learning from our successful Phase II TRIDMAC study. In the first phase of the trial, following a washout period, subjects diagnosed with MDD are treated once daily with a 20 milligram dose of the marketed SSRI Citalopram for four weeks, and then with a 40 milligram dose for the next four weeks. Following the eight weeks of Citalopram…

Alan Musso

Management

Thank you, Don. Let me now review with you our financial results for the fourth quarter and full year 2008. We ended 2008 with over $88 million in cash, cash equivalents and short-term investments. During 2008, we extended our cash runway with the addition in January of $29.1 million of capital that we raised in a public offering of common stock, with increased revenue generated into our agreements with AstraZeneca and GlaxoSmithKline, and through careful management of our expenses. As we announced in December, we expect that our current cash resources will be sufficient to meet our operating requirements at least through the first half of 2011. Between now and then, we are eligible to receive multiple milestone payments contingent on the achievement of clinical development related events, and our agreements with AstraZeneca and GlaxoSmithKline that aren’t captured in our baseline forecast and if achieved could extend our cash runway further. We continue to focus on the efficient use of capital in controlling our expenses as we execute our business plan. Turning to our operating results, we had a net loss of $5.4 million for the fourth quarter of 2008 compared to a net loss of $7.6 million for the fourth quarter of 2007. For the full year 2008, we had a net loss of $25.7 million, compared to a net loss of $28.1 million for 2007. For the fourth quarter of 2008, our net operating revenues were $6.5 million, compared to $3.6 million for the fourth quarter of 2007. The increase was primarily due to an additional $3.2 million of milestones and license fees from collaborations, which resulted primarily from a $2 million payment received from AstraZeneca upon initiation of Phase I clinical development of AZD1446 and $1 million in aggregate payments received from GlaxoSmithKline upon the achievement of…

Donald deBethizy

Management

Thanks, Alan. In summary, as we continue to execute our business plan in this challenging economic and financial environment, we believe that with over $88 million in cash at year-end, a diverse product pipeline, a dedicated and productive workforce and alliances with two leading global pharmaceutical companies, we are well positioned for future success. Thanks to everyone, again, for joining us on today's call. We would be happy to take any questions you may have.

Operator

Operator

(Operator Instructions). And our first question comes from the line of Terence Flynn with Lazard Capital Markets. Please proceed sir. Terence Flynn – Lazard Capital Markets: Hi, good afternoon. Thanks for taking the questions. Just wondering around some of the start of these Phase II trials for 5619 and 6499. Just wondering, 5619 if you could give us anymore insight into what's kind of holding up the start of that trial. I think you guys have previously said year-end ‘08 was a target and then with respect to 6499, just wondering if the recent setback with the NeuroSearch compound is having any impact on your thoughts about design of that study? Thanks a lot.

Donald deBethizy

Management

I think the timing had been pushed into, the start of Phase II had been pushed into the beginning of 2009 because of just development things that had happened along the way. It was unrelated to the recent report out on ABT-894. In addition, though we've run two big trials with 3480 in Alzheimer's disease, as well as, in cognitive dysfunction and schizophrenia and AstraZeneca has been studying an Alpha7 compound, AZD-0328. So, with all of those data coming in and being available, we have been looking at those and spending time in first quarter working through that. But we had been planning for quite sometime, I think in our last couple of conference calls, reporting that we would start Phase II, around the second quarter of 2009. So, we're on track for that. We do have the advantage of the learning now, in the trials that we've done, and we're very fortunate to have a very safe Alpha7 compound and well tolerated with over 100-fold therapeutic index based on the preclinical data. So, we're excited about the compound. We want to make sure that we design the Phase II trials in such a way that we can tease out the Alpha7 effect and we are really looking forward to getting them started. Terence Flynn – Lazard Capital Markets: Okay, great and then the start of both of those Phase IIs with 5619 and 6499, is reflected in the guidance you gave today?

Donald deBethizy

Management

Yes.

Terence Flynn - Lazard Capital Markets

Analyst

Okay. Thanks a lot, guys.

Donald deBethizy

Management

Thank you.

Operator

Operator

And our next question comes from the line of Bret Holley with Oppenheimer. Please proceed sir. [Matt Lowe] – Oppenheimer: Hi, this is actually [Matt Lowe] in for Bret. I was just wondering if you could speak to the market potentials specifically for an adult ADHD drug both in terms of the number of patients in the U.S. and outside the U.S.? And I guess how you kind of see this evolving overtime?

Donald deBethizy

Management

Well, it's an emerging market and it has been difficult to tease out the adult ADHD market completely, because they are captured in a lot of [adult] ADHD in general, but I think there is a sense that as the pediatric population or adolescent population ages that many of those patients will continue on ADHD therapy and as the awareness of course has spread, there are more and more adults choosing to seek medication for their inability to focus. We don’t have specific numbers right now. But we know that over the course of our collaboration with AstraZeneca, where we started that collaboration in December of 2005, they’ve had increasing interest in this area and in addition we know that Abbott has continued to look at alpha4beta2 compounds in ADHD, specifically adult ADHD as well. And just to remind people, Duke ran a trial many years ago now using the nicotine patch in adult ADD and had a statistically significant improvement in a double-blind placebo-controlled trial with nicotine, that Conners ran with 11. So, we’re excited about the area. We are hopeful that this trial that we’re running now will prove positive and that we will have a good strong developing commercial opportunity around 3480. [Matt Lowe] – Oppenheimer: Okay, that’s great. Thank you.

Donald deBethizy

Management

Thank you.

Operator

Operator

And our next question comes from the line of Jon Lecroy with Natixis. Please proceed sir. Jon Lecroy – Natixis Bleichroeder: Yeah, thanks. Can you talk a little bit about 5214? If that trial comes out successful and you are unable to partner it in the near-term, what would be your development path for that?

Donald deBethizy

Management

That’s a good question Jon. As you know we mentioned that we had a Type C meeting in August of 2007, and in that meeting with the FDA, we got guidance from them on what a Phase III development program could look like, so we are looking at being able to study [allcomers] in the sense that we would be looking at people with depression that weren’t responding well to a variety of therapies that are on the market, doing an add-on trial, expanding the patient database and we are looking at doing three trials in Phase III. Our expectation is with the interest and with the introduction of Abilify now as an augmentation for major depressive disorder that there is significant interest out there. We have had positive signals from companies in response to our TRIDMAC data on mecamylamine where we hit the primary endpoint on an improvement in the Hamilton Depression Scale versus placebo. And hit all five secondary endpoints. So, we feel like strength of the data, the movement of the market in that direction, the publication of the STAR*D results from The National Institute of Mental Health showing that a full two-thirds of people still have depressive symptoms after their first course of therapy that we should have support as we move into Phase III. Naturally if that doesn't come to fruition, then we'll be looking at our programs and prioritizing our activities to be able to advance an important opportunity. Jon Lecroy – Natixis: All right, thank you.

Donald deBethizy

Management

Thank you.

Operator

Operator

(Operator Instructions) And our next question comes from the line of Kathleen Carey with Bay Point & Bass Institute . Please proceed ma'am. Kathleen Carey – [Bay Point & Bass Institute] : Hi guys. My question is regarding the AstraZeneca decision. And my question is if you plan to move forward why have you suspended all the Phase I clinical trials?

Donald deBethizy

Management

That's a good question. They had observed a significant adverse event in one of those drug-drug interaction studies in healthy volunteers, and suspended those trials, so that they could sort through that. They have sorted through it and have now made a decision to restart those trials. If you look on clinicaltrials.gov, there is a statement on there about that and we’ve just gotten a word from AstraZeneca that they're prepared to restart those trials. Kathleen Carey – [Bay Point & Bass Institute] : Great, thank you.

Operator

Operator

And there are no further questions. At this time I would like to turn the call back over to Dr. deBethizy for closing remarks.

Donald deBethizy

Management

Thank you, [Latrise]. I want to thank everybody for joining us on the call and thank everybody for their continued interest in Targacept. Thanks very much.