Biodel Inc. (BIOD)

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Biodel Inc. (BIOD)

F1Q2013 Results Earnings Call

February 12, 2013 5:00 PM ET


Paul Bavier - Corporate Secretary and General Counsel

Dr. Errol De Souza - President and CEO

Gerard Michel - Chief Financial Officer and VP, Corporate Development

Dr. Alan Krasner - Chief Medical Officer


Matt Kaplan - Ladenburg Thalmann

Jason Butler - JMP Securities

Richard Reznick - William Blair



Ladies and gentlemen, thank you for standing by. Welcome to Biodel’s First Quarter Fiscal Year 2013 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After opening remarks, we will open up the call for your questions. Instructions for queuing up will be provided at that time. I would also like to remind you that this call is being recorded for replay.

I will now turn the conference call over to Paul Bavier, Biodel’s Corporate Secretary and General Counsel.

Paul Bavier

Thank you. Good afternoon. And welcome to our first quarter fiscal year 2013 conference call. On the call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that are described more fully in our filings with the SEC, which are also available on our website.

Forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we disclaim any obligation to do so even if our estimates change.

Joining us on today’s call are Dr. Errol De Souza, Biodel’s President and Chief Executive Officer; Gerard Michel, our Chief Financial Officer and Vice President of Corporate Development; and Dr. Alan Krasner, our Chief Medical Officer. After their prepared remarks, we will open the call to your questions.

Now, I’ll turn the call over to Errol.

Dr. Errol De Souza

Thank you, Paul. Good afternoon, everyone. Since the last quarter we continue to steadily advance our pipeline candidates with particularly emphasis on our three prong ultra-rapid-acting insulin program.

Today, we will discuss details regarding the recent topline data from a Phase I study of our ultra-rapid-acting insulin analog-based formulation, our ongoing Phase II clinical trial of BIOD-123, our ultra-rapid-acting formulations of recombinant human insulin or RHI, and developments in our concentrated ultra-rapid-acting insulin formulations. We will also provide a brief status report on our glucagon program.

Let me begin with the latest news generated by our ultra-rapid-acting insulin analog-based formulations, BIOD-238 and BIOD-250. During our last earnings call in December, we announced the initiation of a Phase I clinical trial designed to evaluate the pharmacokinetic or PK and injection site toleration profiles of BIOD-238 and BIOD-250 relative to Humalog, a rapid-acting insulin analog.

Both of our formulations were manufactured using a marketed presentation of Humalog together with our proprietary excipients which we designed to increase the rate of absorption of Humalog and to address injection site toleration using two different approaches.

BIOD-238 contains a reduced concentration of EDTA compared to our prototype RHI-based ultra-rapid-acting formulations, BIOD-100 also known as Linjeta.

BIOD-250 contains twice the concentration of EDTA than the BIOD-238 but also contains magnesium sulfate which were shown in the previous study to mitigate the injection site tolerability issues we identified with BIOD-100.

The single-center, randomized, double-blind, three-period crossover trial in 12 patients with Type 1 diabetes was conducted in Australia. Each study drug was administered subcutaneously on separate days.

Pharmacokinetic measurements were made using an assay to quantify lispro the active pharmaceutical ingredients in the study drugs and Humalog. The trial was powered to measure differences in time to half-maximal insulin concentrations.

The study sought to test the hypothesis that Biodel’s formulations of Humalog would have ultra-rapid absorption profiles with comparable or faster declines from peak concentration and comparable injection site tolerability profiles relative to Humalog. In January we recorded very encouraging results particularly with regards to BIOD-250.

The pharmacokinetic profiles of BIOD-238 and BIOD-250 prove to be consistent with our target product profile for an analog-based ultra-rapid-acting insulin. Absorption rates of BIOD-238 and BIOD-250 were significantly more rapid than that of Humalog as indicated by 35% to 45% reductions in the meantime to half-maximal insulin concentrations and times to maximal insulin concentrations.

The total amount of insulin absorbed over the first 30 minutes following injection of BIOD-238 and BIOD-250 was approximately double that seen for Humalog. The decline from peak concentration as indicated by time to half-maximal concentration after the peak was significantly shorter for both BIOD-238 and BIOD-250, compared to Humalog. All of these comparisons were highly statistically significant.

Local injection site tolerability was measured with a 100 millimeter visual analog scale or VAS and patient questionnaires. 100 millimeters is defined as the worst possible discomfort and zero millimeter is defined as having no discomfort.

In the trial, BIOD-250’s mean VAS score of 2.7 millimeters was numerically lower than Humalog mean VAS score of 8.2 millimeters was not statistically significant. BIOD-238 mean VAS score of 24.2 millimeters was significantly higher than that associate with Humalog which suggest that reducing EDTA concentration alone is not sufficient to achieve our desired injection site toleration characteristic.

Furthermore, the data with BIOD-250 which contains twice the concentration of EDTA as BIOD-238 but also contains magnesium sulfate replicates our earlier finding with BIOD-123 that magnesium sulfate can improve injection site discomfort that some patients experience with Linjeta.

In summary, the Phase I clinical trial of BIOD-250 demonstrated a rapid-on and rapid-off PK profile as indicated by the significantly faster absorption and decline from peak compared to Humalog with comparable injection site tolerability.

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