Earnings Labs

Arcturus Therapeutics Holdings Inc. (ARCT)

Q4 2013 Earnings Call· Mon, Feb 17, 2014

$8.89

+7.11%

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Alcobra Fourth Quarter 2013 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later we'll conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, this call may be recorded. I’ll now introduce your host for today's conference Michael Rice of LifeSci Advisors. You may begin.

Michael Rice

Analyst

Thank you. Before the market opened this morning, Alcobra announced financial results for the fourth quarter and yearend 2013. If you've not yet received the news release or would like to be added to the company's distribution list, please call LifeSci Advisors in New York at 646-597-6992 and speak with Paul Arndt. Before turning the call over to management, I’d like to make the following remarks concerning forward-looking statements. This conference call contains forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Because such statements deal with future events and are based on Alcobra’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described and/or implied by the statements on this conference call. For example, forward-looking statements include statements that imply that MDX may be helpful to treat cognitive dysfunctions, such as ADHD, including Primarily Inattentive-ADHD and Fragile X syndrome, or that we will receive favorable results in clinical trials of MDX. Statements regarding the timing of initiation and successful completion of enrolment of our Phase III trials, Phase II paediatric clinical trials and, and Phase II Fragile X programs, if such trials or other trials are commenced at all or the timings and conclusion, reporting of data from the trials and statements regarding Mr. Baker's responsibilities and successful execution thereof. Statements regarding initiation of other clinical trials and timing thereof, as well as statement regarding the sufficiency of the company's financial resources to be at certain milestones and whether such milestones may be achieved at all, in addition, historical results of conclusions from scientific research do not guarantee that the results – future results would not suggest different conclusions or that historic results referred to on this call would be interpreted differently in the light of additional research. The forward-looking statements contained or implied on this call are subject to other risks and uncertainties, including those described under the headline Risk Factors in Alcobra Ltd registration statement on Form F-1A filed with the SEC on October 22, 2013 and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise. At this time, it is now my pleasure to turn the call over to Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. Yaron, please go ahead.

Yaron Daniely

Analyst

Thanks, Michael. Welcome everyone. Good morning, thank you for participating in today’s conference call. With me today is Mr. Udi Gilboa, our Chief Financial Officer. Today, we’ll update you on the progress we’ve made in our development programs for our lead drug candidate, extended-release Metadoxine, which I'll be referring to on this call as MDX. I'll also summarize our expected milestones for the year ahead and Udi will take you through the financials for the fourth quarter of 2013. After our prepared remarks, I’ll be happy to answer any questions you may have. Before going into some detail on our development activities, I want to highlight two recent management changes at Alcobra. In January, we announced a very significant new hire, with the appointment of Mr. David Baker as our Chief Commercial Officer. David is a highly respected and seasoned pharmaceutical executive and in our view, certainly one of the leading people worldwide in the development and marketing on CNS drugs, particularly in the ADHD space. David will be responsible for all pre-commercial activity for MDX and will lead our effort to establish brand awareness for the product in the medical community. He will also look at new opportunities and potential uses for both MDX and other molecules in Alcobra's pipeline and will support our general, investor and public relations activities at the company. David joins Alcobra after spending about 10 years at Shire where he was instrumental of building their pipeline at ADHD and CNS brands. He led the launch of Vyvanse in 2007, oversaw the launch of the adult indication for Vyvanse and led the early work that later resulted in the launches of Vyvanse in international markets such as Canada, Brazil, Australia and Europe. Also under David's leadership, Adderall XR became the number one selling ADHD brand…

Udi Gilboa

Analyst

Thank you, Yaron and thank you to our shareholders for joining us today. Operating expenses for the fourth quarter of 2013 were $5.26 million of which $0.5 million was non-cash charges for stock-based compensation. Excluding stock-based compensation, operation expenses for the fourth quarter of 2013 were $5.1 million. As we've mentioned in the past, the Company expected quarterly operating expenses to increase in Q4 and an increase is expected over the next few quarters due to an acceleration of our clinical development as well as pre-commercial and strategic activities. Net loss for the fourth quarter of 2013 was $5.7 million, or $0.45 per basic and diluted share, compared to $295,000 or $0.04 per basic and diluted share for the same period of 2012. As of December 31, cash, cash equivalent and short-term deposits totalled $50.1 million compared with $19.5 million as of September 30, 2013. The increase is a result of the $38 million in gross proceeds from the public offer we completed in October this year. And with nothing further, we’ll open up the call for questions.

Yaron Daniely

Analyst

Go ahead, sorry.

Operator

Operator

Thank you. (Operator Instructions) Looks like we have a question from Annabel Samimy of Stifel. Your line is open. Annabel Samimy - Stifel, Nicolaus & Co.: Hi guys. Thanks for taking my questions. I actually have several. The IND situation, I was under the impression that you had already filed the IND and that you are just waiting for approval of that IND to start [open], the IND was just filed, so if you could just explain whether this resubmission of the IND or is this the actual IND and how long might we -- might it take for its approval before you can start?

Yaron Daniely

Analyst

Thanks Annabel. No, this is the original and only submission of the IND in the U.S. INDs are submitted as kind of the last step before dosing patients in the U.S. and the review period for FDA is capped at 30 days. Once 30 days elapse and assuming there is no word or any kind of feedback from FDA, you are allowed to dose patients. So at most we anticipate or expect to dose patients no later than 30 days after submission of the IND in the U.S. Outside of the U.S., there are slightly different regulatory path which were actually initiated earlier. So potentially outside of the U.S., treatment of patients may occur before that. Annabel Samimy - Stifel, Nicolaus & Co.: Okay. And then just on the dosing, you already established the 700 milligram dose was obviously not an effective dose. Is there any other reason should look at other doses where the FDA won any other doses given that other drugs in the space have multiple options from a dosing perspective?

Yaron Daniely

Analyst

So it's a great question. It's kind of composed of two parts. We do not have reason to believe that at this point that additional doses will be required to be evaluated, but it's certainly a possibility that I can't rule out, but we don't believe that that would be required based on now two studies showing that 700 mg was not effective in the adult ADHD population. With regards to other drugs and particularly talking about the approved stimulants and Strattera, those have some dosing stairs or levels, primarily because of a body weight adjustment, especially when kids grow older and become bigger. In the adult population, there is a lot less variability in terms of wait and so those doses are usually fixed. As we move our program for paediatric there is likely going to be may be one or two ideal doses, but we'll have to investigate that and decide on it's future. Annabel Samimy - Stifel, Nicolaus & Co.: Okay. Great. And then I want to ask about the latest milestone you reached that Metadoxine did have an effect on AKT and ERK signalling pathways. I think at one point you had mentioned there is potential for diagnosing patients based on the levels of these signalling pathways, so how realistic is it that you can incorporate a diagnostic in either ADHD or in Fragile X or what not to be able to target the therapy a lot better?

Yaron Daniely

Analyst

I think that there is a possibility and we will be collecting data in our Phase II programs to see whether number one, how prevalent the elevated levels of [phosphate] for example are found peripherally in these indications and number two, how highly correlated they are to improvement in clinical symptoms following treatment with Metadoxine. If those hypothesis are validated in our original Phase II studies, they could be used for identifying patients in consequent studies or even post marketing and patients who are more likely to respond. But I think an interesting hypothesis based on both published literature and our observation in the preclinical studies and it remains to be validated in the clinical setting. Annabel Samimy - Stifel, Nicolaus & Co.: Okay. And then one last question, I guess in the past I guess commercialization has been a question and now obviously we have David Baker on Board, so how realistic is this, is it that you could potentially commercialize this yourself and retain the value of this program.

Yaron Daniely

Analyst

I think it's always been realistic on an operational level. I think that the ADHD field and many of you have had the chance to interact with David and hear his kind of deep insights and cumulative experience on this, but the ADHD field can be handled with a specialized sales force that target the vast majority up to two thirds of three quarters of prescribers in a very efficient way. So operationally it's certainly feasible whether you are asking if it's likely or probable that this will be the case, that I think is a completely different question, but it's certainly feasible. Annabel Samimy - Stifel, Nicolaus & Co.: Okay. Great. Thank you.

Operator

Operator

Thank you. (Operator Instructions) I am not showing any other questions in queue. I would like to turn the call back over to management.