Titan Pharmaceuticals Inc (TTNP) 2010 Q1 法說會逐字稿

Thank you for holding and welcome to the Titan Pharmaceuticals first quarter 2010 financial results conference call. At this time all participants are in listen only mode. There will be a question and answer session following today's remarks. Please be advised this call is being taped at the Company's request and will be archived in the Company's website for two weeks from today. At this time I would like to turn the call over to Sunil Bhonsle, President of Titan Pharmaceuticals. Please go ahead.

Thank you, Matt, and thank you all for joining us this morning and welcome to the Titan Pharmaceutical's call for the first quarter of 2010. With me today is Marc Rubin, our Executive Chairman, and Brian Crowley, Vice President of Finance. But before we get into the details of the first quarter performance and an update on the product development program, I wanted to remind everyone that certain matters we'll discuss today other than historical information consist of forward-looking statements relating to, among other things, our expectations concerning our financial results, available cash, clinical programs, and regulatory strategies. The forward-looking statements are not guarantees of future performance and are subject to a variety of risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements.

These risks and uncertainties are described in our form 10 registration statement filed with the SEC and subsequent SEC filings. You're cautioned not to place undue reliance on these forward-looking statements, which speak only as of today. We undertake no obligation to update or revise the information provided in this call, whether as the result of new information, future events or circumstances or otherwise. Well, having said all of that, let's begin and I would like to first turn over the call to our Executive Chairman, Marc Rubin for his perspective. Marc.

Thank you, Sunil, and hello, everybody. I am delighted to be here today, along with Sunil and Brian, to share with you some of our thoughts and perspectives. It has been a year and a half since the last update call and a lot has transpired over this period of time. It's been a bit of a rollercoaster ride, but we've come out of it in what we believe is a very good place. In the spectrum of biotech companies, we have a unique and, I think, an attractive profile. Our expenses are a bare bones and our resources are very carefully managed. We have just a handful of very dedicated and loyal employees and consultants, with a high level of expertise in drug development, all supporting our Phase III program for the treatment of opioid addiction. This is a therapeutic area that's growing fast by any measure and we have a product, Probuphine, that we believe offers potential for major advances.

It has had its risk profile substantially reduced through the very positive results from the first Phase III study, with both clinically meaningful and statistically significant outcomes. In addition, as we've been informed by the US Patent and Trademark Office, Probuphine will have method abuse patent protection. Also the Phase III study has received a $7.5 million grant from the NIH and we believe this to be an important endorsement of the potential for this approach in opiate addiction to ultimately offer meaningful therapeutic option for patients. And finally, we have royalty income from the sales of Fanapt, a product that's marketed now by Novartis. So there really are not many biotech companies with a profile like that. Small, efficient, with minimal debt and well controlled expenses, with a relatively low risk, high value Phase III program and an ongoing royalty revenue stream.

Titan is once, again, registered with the SEC and we are all very pleased to be here today restarting the process of ongoing communication and dialog with our shareholders. I would like to thank all of you for your continued support. And with that said, I will now turn the call back over to Sunil. Sunil.

Great, thanks, Marc and hello once again. I would like to provide a summary of our financial results and then provide an update on the ongoing Probuphine development program for all of you this morning. And as you all know, the first quarter marked a key milestone for Titan with the commercial launch of Fanapt in the US by Novartis. This generated approximately $1.7 million in royalty revenue to Titan. We also received approximately $700,000 in grant revenue from the NIH for a total revenues of $2.4 million, our first quarter with a lot of revenues. Total operating expenses for the first quarter were approximately $2.6 million, comprising of research and development expenses of approximately $1.7 million and general and administrative expenses of approximately $900,000. Other expenses were about $100,000.

The net loss for the first quarter was approximately $300,000 or about $0.01 per share. Now, just yesterday the press release that we issued, it has a lot of additional details of the R&D and G&A expenses, as well as a comparison to the first quarter of last year. So I won't repeat it here. I thought it would be better to spend time talking about Probuphine, but obviously if there are any questions, I'm sure Brian here will be happy to address them. So with that, in a nutshell, there are two very important accomplishments this quarter. We are now a revenue generating Company and we have successfully completed registration with the SEC and re-focussed the Company's efforts on the completion of the development of Probuphine. I want to just add one more thing, as you know, one of the market makers in Titan stock has filed the forms to obtain approval from FINRA to start trading on the OTC bulletin board and we expect this will be completed shortly, as well.

Getting back to Probuphine. I would like to first thanks Dr. Kate Beebe and her team for their tremendous efforts in obtaining the NIH grant, which has helped us continue the development of Probuphine. For those of you who do not know Dr. Beebe, she is our Senior Vice President of Clinical Development and Medical Affairs. So just to recap the Probuphine program, which was previously discussed in quite a bit of detail by Marc in late 2008. In the summer of 2008 we reported very positive results of the first placebo controlled Phase III study of Probuphine in the treatment of opiate addiction. At the same time we have also commenced a second Phase III study for the retreatment of patients completing the first control study. This way we were able to obtain safety information on patients treated for a year. And in the fall of 2008, we also commenced a pharmacokinetics study to evaluate the relative bioavailability of buprenorphine in our product Probuphine compared to the sublingual product. So there were several studies in progress at that time.

And although by the spring of 2009 we had completed almost 60% of the Probuphine development program, we were rapidly running out of funds. The NIH grant provided a very timely means of supporting the second controlled Phase III study and helped in the continuation of this potentially important option for the treatment of opioid addiction. The confirmationary Phase III study, with support from NIH, is now underway and it is on track to meet the timelines previously presented, namely completion of patient enrollment by the end of this year and completion of the study in early Q3 2011, with the results shortly thereafter. And just like before, would also like to retreat the patient completing this study so that we can add to the safety data base of patients treated for a year. We continue to interact with the FDA and we hope to meet with them later this year to review all the information collected to date and look for ways to efficiently complete the development program.

Also as you all know, in November last year, we received a letter of notice of allowance for claims made in a patent application covering a method of use of Probuphine for the treatment of opioid addiction. Although we had expected to have the patent issued by now, the US PTO has indicated that it may take another two to three months before this is done. I just want to mention that the patent term will be extended by the number of days between April 30, 2010 and the actual issuance date, so we actually will have several days added to the end of the patent term, which is always good. It gives us better terms at the end of the patent time. So for today, this is all that I wanted to go through and we truly thank you for your continued support and we look forward to updating you about our future progress. We will have a little bit of time for some questions and with that, I will turn over the call to the operator and let him instruct you on how to handle the questions.

(Operator Instructions) There are currently no questions on the phone lines, gentleman, please continue with the presentation.

Excellent. Well I am really glad that all of you feel comfortable with the information provided and, operator, thank you very much. And thank you all for joining our call today. I'm sure we will look forward to speaking with you again in another few months. Good bye.

Ladies and gentlemen, this conference will be available for replay after 12 noon Pacific Time today through Tuesday, June 1, 2010, at midnight Pacific Time. You may access the AT&T Executive Replay System at any time by dialing 1-800-475-6701 and entering the access code 158191 followed by the pound key. International participants may dial area code 320-365-3844. Those numbers again are, 1-800-475-6701 and 320-365-3844 and access code 158191 pound key. That does conclude our conference for today. Thank you for your participation and for using AT&T Executive Teleconference. You may now disconnect your lines.