Vaxart Inc (VXRT) 2015 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Biota Pharmaceuticals fourth-quarter and fiscal year-end 2015 conference call.

(Operator Instructions)

I would now like to turn the call over to Will O'Connor of Sterne Investor Relations, please proceed.

Thank you, operator. My name is Will O'Connor of Stern Investor Relations. I would like to welcome you to the Biota conference call and webcast to review the Company's fourth-quarter and FY15 earnings results and to provide an update on recent corporate developments.

This morning we issued a press release which outlines the topics that we plan to discuss today. The release is available at www.biotapharma.com. With me today from Biota are President and CEO, Dr. Joseph Patti; Vice President of Clinical Development, Anna Novotney-Barry; and Vice President of Finance, Peter Azzarello.

Before we begin the call, I would like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the Company's recent filings with the Securities and Exchange Commission, which we are due to read. Our actual results may differ materially from what is discussed on today's call.

With that I will now turn the call over to Biota CEO, Dr. Joseph Patti

Thanks, Will, and good morning, everyone. As we highlighted in our press release this morning, operationally we had an outstanding last 12 months. We made substantial progress growing our pipeline of first-in-class, direct acting antivirals, and we now have four clinical stage programs, three in phase 2 and one and phase 1 clinical development. I anticipate these programs will provide a steady flow of data readout over the next 10 to 15 months.

Even though we are investing significantly in our pipeline we were still able to maintain our strong financial position, ending the quarter with $65.5 million in cash, cash equivalents and short- and long-term investments. I would now like to review our antiviral clinical development pipeline in a little bit more detail.

Let's start with BTA585, our fusion inhibitor in development for the treatment of acute RSV, A and B infectious. We were pleased to announce a few weeks ago that oral dosing of healthy volunteers in a phase 1 single ascending dose clinical trial had commenced. The phase 1 trial has five dosing cohorts and is designed to evaluate the safety and pharmacokinetics of a single dose of BTA585. We are also planning to evaluate whether the PK of 585 is effected if it is dosed with a high-fat meal. Following a safety review of initial dosing cohorts we plan to begin a phase 1 multiple ascending dose clinical trial with 585. Additional details on the multiple ascending dose study will be forthcoming upon initiation of dosing, which we expect to occur next quarter.

In addition to BTA585, we are excited with the progress made in our RSV non-f inhibitor program. We have identified multiple compounds that possess excellent therapeutic indices in our cell-based assays. We plan to continue the characterization of these compounds, as well as others over the next few quarters, and should be in a position to select a clinical candidate by mid-2016. We believe that having two RSV antiviral compounds with different methods of action may be beneficial both from an efficacy and a resistance perspective.

Now I'll turn to our phase 2 clinical candidate, BTA074. In June we announced the closing of the acquisition of Anaconda Pharma, a privately held biotechnology company based in Paris France. The acquisition brings to Biota AP611074, or renamed BTA074. Our first-in-class, direct acting antiviral in the development for the treatment of condyloma or anal genital warts, as well as the orphan disease recurrent respiratory papillomatosis, or RRP, both of which are caused by human papillomavirus types 6 and 11. We are making great strides on the clinical development front and plan to initiate a double-blind, placebo-controlled, randomized phase 2 study to assess the safety, tolerability, PK and efficacy of up to 16 weeks, twice-daily topical application of BTA074 5% gel, in approximately 210 adult condyloma patients in the fourth quarter of calendar 2015.

Turning next to our vapendavir program and the ongoing phase 2b SPIRITUS trial. As we reported in today's press release, we still anticipate top line data from the SPIRITUS trial to be available in mid-2016. The multicenter, randomized, double-blind placebo-control dose ranging study is designed and powered to equally randomize approximately 190 laboratory confirmed HRV infected patients across three treatment arms.

The primary endpoint of this trial is change from baseline to study day 14 in asthma symptoms and lung function, as measured by the asthma control questionnaire six total score. Key secondary endpoints include safety and tolerability, specific lung function assessments, forced vital capacity, peak expiratory flow and daily beta 2 agonist use, and the incidence of moderate and severe asthma exacerbations.

As far our financials, we ended the fiscal year in a strong financial position. And at the end of last fiscal year we announced a restructuring plan that will reduce the overhead and footprint of the Company to better match the stage of our clinical portfolio. We were successful with the plan, and this achievement was further supported by increased royalty revenues and our ability to successfully negotiate a favorable termination settlement with BARDA.

Let me review our financial results for the fourth quarter and fiscal year end 2015 in a little more detail. For the quarter ending June 30, 2015, we held $65.5 million in cash equivalents, cash, short and long-term investments, and in early July we collected an additional $10.9 million related to the FY15 Relenza royalties. We reported a net loss of $19.9 million for the three-month period ended June 30, 2015, as compared to a net loss of $10.2 million in the same quarter of the prior fiscal year.

The $9.7 million increase in net loss from the prior-year was primarily due to the $17.6 million nonrecurring in-process research and development expense recorded with connection -- in connection with the acquisition of Anaconda Pharma in June 2015. Under US GAAP, the total consideration paid at closing for Anaconda was accounted for as an asset acquisition.

Further contributing to the increase in net loss was a $7.5 million decrease in revenue from services related to the termination of our BARDA contract in May 2014. $0.2 million reduction in income tax benefit offset in part by $9.7 million decrease in cost of revenue, $3.1 million increase in royalty revenues, $1.1 million decrease in research and development expense, and $0.9 million decrease in G&A and $0.8 million decrease in foreign exchange loss.

Revenue decreased to $4.1 million for the three-month period ended June 30, and from $8.5 million in the same period last year due to a decrease in revenue from services related to the termination of the BARDA contract, offset in part by an increase in royalty revenues. R&D expense decreased to $5.2 million for the three-month period, from $6.3 million in the same period last year. The decrease in R&D expenses is primarily associated with the closure of the Melbourne, Australian research facility in March of this year. G&A expense decreased to $1.3 million for the three-month period ended June 30, from $2.2 million in the same period last year, primarily driven by a reduction in legal and professional fees.

To summarize the financial results for the fiscal year June 30, 2015, we reported net loss of $19.1 million as compared to a net loss of $11 million for the prior year. The increase in net loss from the prior year was primarily due to a one-time expense associated with the Anaconda Pharma acquisition, a decrease in revenues related to the cancellation of BARDA contract, and a change in the foreign exchange from a loss to a gain.

That concludes my prepared remarks, and I'll open the call for questions. Operator?

Thank you.

(Operator Instructions)

I'm showing no questions at this time, I'd like to hand the call back over to Dr. Patti for any closing remarks.

Thank you. Over the next 10 to 15 months we anticipate announcing several key milestones, including phase 2 data readouts for three of our antiviral programs. The first result should come from the vapendavir phase 2b SPIRITUS trial, followed by BTA585 viral load data from an RSV challenge study, and finally results from the phase 2 trial with BTA074 in adult condyloma patients. So as you can see, calendar year 2016 will be a big year for Biota and we look forward to updating you on our progress. Thank you for joining us this morning and have a nice day.

Ladies and gentlemen, thank you for participating in today's conference. That does conclude today's program; you may all disconnect. Have a great day, everyone.