Biodel Inc. (BIOD)

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Biodel Inc. (BIOD)

F3Q08 (Qtr End 06/30/08) Earnings Call

August 6 2008 4:45 pm ET


Erik Steiner - VP of Operations

Solomon Steiner - Chairman and CEO

Gerard Michel - CFO and VP of Corporate Development


Cory Kasimov - JPMorgan

Corey Davis - Natixis

Sarah Jessica - Morgan Stanley

Liana Moussatos - Pacific Growth Equity

Geoffrey O'Brien - Punk Ziegel



Welcome to Biodel's third quarter fiscal year 2008 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will open the call for your questions. Instructions for queuing up will be provided at that time. Today's call is being recorded.

Now at this time, I would like to turn the conference over to Mr. Erik Steiner, Biodel's Vice President of Operations. Please go ahead, sir.

Erik Steiner

Thank you. Good afternoon, and welcome to Biodel's 2008 third quarter Earnings Call. With me today are Dr. Solomon Steiner, Chairman and CEO of Biodel and Gerard Michel, Biodel's Chief Financial Officer and Vice President of Corporate Development.

Before we begin, I would like to remind you that our discussion today will include forward-looking statements subject to risks, uncertainties and other factors that can cause actual results to differ materially from those statements. Additional information about these factors is detailed in the company's press releases and public filings with the SEC.

I will now turn the call over to Sol.

Solomon Steiner

Thank you, Erik. Good afternoon, and thanks for joining us today. I will begin by reviewing our recent clinical and corporate activities, and then have Gerard discuss third quarter financial results. After his remarks, we will open up the call to your questions.

To begin, we have continued to make great progress with VIAject, our ultra rapid acting injectable insulin. We recently completed 2 pivotal Phase III clinical trials with this product candidate and planned to report top line results from these studies later this year. The interim results published by the EASD in July were encouraging and we believe the final results will be positive.

As a reminder, these international multi-center open-label six months studies compare the effects of VIAject to Humulin R, the leading recombinant human insulin in patients with type I and type II diabetes. These non-inferiority studies compare VIAject to Humulin R in terms of hemoglobin A1c levels, safety and other measures.

The recent publication of positive findings from Phase I and Phase II glucose clamp studies with VIAject also gave us confidence in the design and potential outcome of the Phase III studies. We are currently working to file an NDA for VIAject by the end of 2008, but it is possible we will file in the half of 2009 to augment the package with additional data beyond what is required for approval, which may be required by potential partner. We will keep you posted on our plans, which are currently on track.

As a reminder, our pivotal Phase III trials tested it through vial 25 IU/cc dose formulation, for which we will be prepared to file an NDA. We will also file an additional 100 IU/cc single-vial liquid formulation. By bridging to the 100 IU dosage form, we will allow patients to reduce the dosing volume to a quarter of the 25 IU/cc formulation.

In addition to our clinical progress, we are also making good progress preparing for commercialization of VIAject. Organon recently agreed to supply Biodel with recombinant human insulin for use in our VIAject insulin formulations. The supply agreement will help ensure that we have a technical manufacturing support we need to defend our marketing application, and that we have sufficient finished product on-hand for launch and several years after VIAject's approval.

We also made some key appointments in recent months. Dr. Alan Krasner joined us in May as Chief Medical officer. Dr. Krasner is a Board of Diabetologists who was Director of Clinical Research and Metabolic Disease at Pfizer and brings great expertise in clinical trials design and execution. He will play a key role in the development of our product candidates going forward and continue to work with Dr. Andreas Pfutzner, who is now our Senior Vice President of Medical Affairs in Europe and a member of our Scientific Advisory Board.

We also named Dr. Barry Ginsberg to our Board of Directors. Barry has more than 25 years of experience in diabetes from his work in academia, clinical practice and industry, most recently as CEO of Diabetes Technology Consultants and as the Vice President of Worldwide Medical Affairs for the Diabetes Division of Becton Dickinson.

I am pleased that we continued to attract experts in this field and believe we have a very strong team to guide the development and commercialization of our product pipeline. As Gerard will describe in a moment, we are managing our cash carefully and believe we have sufficient funds on-hand to take us through the NDA submission and finalization of our commercialization plans.

Now, I would like to turn the call over to Gerard to review our financial report for the quarter.

Gerard Michel

Thank you, Sol. We reported a net loss for the third quarter of $10.1 million, or $0.43 per share, compared to a net loss of $5.3 million, or $0.30 per share, for the comparable period in the prior year. Our net loss for the quarter includes $1.9 million of stock-based compensation expenses. R&D expenses were $6.9 million for the three months ended June 30, 2008 compared to $2.6 million for the comparable period in the prior year.

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