Albireo Pharma, Inc.
Q1 2015 Earnings Call Transcript

Published: 13 Feb 2015

[Operator:]

Ladies and gentlemen, thank you for standing by. Welcome to Biodel’s First Quarter Fiscal Year 2015 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 General Counsel.

[Paul Bavier:]

Thank you. Good afternoon and welcome to our first quarter fiscal year 2015 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 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; Mr. Gary Gemignani, our Chief Financial Officer; 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.

[Errol De Souza:]

Thank you, Paul. Good afternoon everyone. This afternoon we will provide a status report on our concentrated upper rapid active insulin candidate BIOD-531, and discuss next steps for this program on the heels of the positive data from our two phase [0

[Gary Gemignani:]

Thank you, Errol. Biodel reported a net loss of $4.7 million, or $0.20 per share, for the quarter ended December 31, 2014. These results compare to a net loss of $2.4 million, or $0.12 per share, for the quarter ended December 31, 2013. Biodel did not record any revenue during the quarter ended December 31, 2014 or 2013. At December 31, 2014, Biodel had cash and cash equivalents of $19.7 million and 23.5 million shares of common stock outstanding. During the period from January 1, 2015 we sold possible 1.1 million shares under the APN and equity line of credit facilities as well as net proceeds of $1.7 million.

[Errol De Souza:]

We would like the operator now to open the call for questions.

[Operator:]

Thank you [Operator Instructions]. Our first question is coming from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with question.

[Matt Kaplan:]

Hi guys, good afternoon. Just a couple of questions, first on the Glucagon program. It sounds like you are right on track to announce your initial PK/PD study data at the end of the quarter. Talk to us a little bit about after you’ve completed that, what really needs to be done with Emergent and Unilife to be on track to follow your NDA as you hope to.

[Errol De Souza:]

Matt, as we talked on the call about hosting of the final subject I think it’s going to occur mid February so we are right on track and then it takes us a few weeks for that PK analysis. So we will announce the data before the end of this quarter. And that will give us the comparator that Alan can then use to design your pivotal trial. Let’s talk the activities related to your question. Currently, Unilife, Biodel and Emergent are working together in terms of preparing for the manufacturing, this is a unique manufacturing process and from that perspective there is new equipment that’s involved, there's a whole technology transfer process that is occurring, some of the process of development is occurring at Biodel, it will be transferred over once all the new equipment is there. Given that it’s a new process, the facility at Emergent would have to do just media cell as an example. The reason they would do media cell is to make sure that there is no contamination to any of the other clients. So this is sort of a normal process that we would go over. Following the media cell you would have also additional technology transfer that would occur and engineering runs would be done in order to minimize any risk to manufacturing the registration lots and just as a reminder the manufacturing of the registration lots would involve three adult registration lots and three pediatric registration lots and that’s all slated to happen towards the latter half of 2015. So again, there's a complexity involved given that it’s a new manufacturing process and there are some checkups that the manufacture would have to do in terms of additional media cells to de-risk any contamination that might occur.

[Matt Kaplan:]

Okay, very good. That puts you on track, I guess that’s see [indiscernible] stability in manufacturing lots for submission of your NDA in the first half of next year?

[Errol De Souza:]

Yes. I mean that would enable us to then initiate the pivotal study which will be with the final group of products and also have stability study that would be sufficient to how the NDA and that’s the dialogue that we would have with the FDA in regards to the manufacturing process in terms of what we would -- what we will call it an end of phase 2 meeting because no phase 2 in this study but after Alan gave the phase 1 data that they're announcing at the end of the quarter and both data along with some human factors study to arrange a meeting with the FDA just to make sure. Even though we've had a continuing job with the FDA to make sure that we present it under final plan of what we anticipate filing as part of the NDA process and getting the body in the last point.

[Matt Kaplan:]

Okay, fair enough. And then shifting gears a little bit to 531, similarly you’re in the process of launching the formal GOP talks study there on the manufacturing as well and that’s in preparation to phase 3 that you can start next year. And at the same time you’re launching the phase 2b to inform your, I guess the phase 3. Can you give us little bit of vent in terms of the timing and the scope of the phase 2b that you’re planning?

[Errol De Souza:]

Yes. I’d ask Alan to describe the design in a little more detail. But the timeline is we are on track for starting phase 2b early next quarter and reporting of the data in the middle of 2016. Alan why don’t you describe the design of the study again, the number of centers you’re looking at in the U.S.

[Alan Krasner:]

Hi Matt. So we are looking to enroll approximately 130 patients with Type 2 diabetes. As I mentioned on the presentation, it could be patients who use insulin and [indiscernible]. And they will be randomized to receive either BIOD-531 twice a day versus Humalog Mix 75/25 twice a day and they would be treated for a total of 18 weeks. But it’s a profit parallel group study. It’s really the same basic design that we would use in the phase 3 trial, considering the sort of the dress rehearsal for our phase 3 study through the two columns. The primary end point of course is H313 which is the regulatory end point. But we are also very interested in measuring other important secondary variables including post prandial glucose at meal time per day. 531 would give better post prandial glucose control one time than the comparatives. Of course we also measure hypoglycemic exemplary rate changes as a routing phase B adverse events and that kind of thing. So after that we have to design the phase 2b study will be very similar to what we would do in phase 3 and the main difference will be simplified. The phase 3 of course within that market.

[Errol De Souza:]

Just to add to Alan’s comments, Allan and his team has been extremely busy, GMP lot are available for the start of the trail additional market which is manufactured, so we’re going to the packaging of the lots to submitted to the various sites and it will involve 20 some odd sites across the US. So we’re very much on track starting the study on the prime lines that we’ve talked about before.

[Matt Kaplan:]

Thanks for taking the questions and congrats on the quarter.

[Operator:]

[Operator instructions] Thank you. That concludes the Q&A portion of the call. I will now turn the call back over to Dr. De Souza.

[Errol De Souza:]

Great. Thank you so much for your questions. It's been a short time since our December call and now we've had a fair amount of progress and we look forward to another great quarter on multiple fronts and delivering the promise with Biodel. Thanks so much. Take care.

[Operator:]

This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.