Albireo Pharma, Inc.
Q3 2015 Earnings Call Transcript

Published: 14 Aug 2015

[Operator:]

Greetings and welcome to the Biodel 2015 Third Quarter Earnings Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Paul Bavier. Thank you. You may begin.

[Paul Bavier:]

Thank you. Good afternoon. Welcome to our third 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 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; Mr. Gary Gemignani, our Chief Financial Officer; and Dr. Alan Krasner, our Chief Medical Officer. After their prepared remarks, we open the call for questions. Now, I will turn the call over to Errol.

[Errol De Souza:]

Thank you, Paul and good afternoon everyone. During today’s call, we will provide a status report on our Glucagon Emergency Management, or GEM program and discuss next steps for this program on the heels of positive data from the BIOD-961 Phase 1 proof-of-principle study and the GEM device formative human factor study, which we announced in our last earnings call. We will also provide an update on BIOD-531, our concentrated ultra-rapid acting prandial insulin candidate with a basal duration of action and we will conclude with a brief overview of our third quarter 2015 financial results, leaving time in the end for questions. Let me start off with some background information on our glucagon emergency rescue program. Biodel’s glucagon emergency managed product candidate is intended to treat diabetes patients experiencing severe hypoglycemia. The GEM presentation is comprised of lyophilized glucagon and a liquid diluent in a proprietary injection device from Unilife Medical Solutions Incorporated. The GEM device is a dual chamber design that facilitates reconstitution of glucagon immediately prior to injection and features automatic needle retraction after dose delivery. The GEM device is designed to optimize ease-of-use for patient caregivers in an emergency. Although glucagon injections are useful in treating for the hypoglycemia, glucagon is inherently unstable in a liquid solution. Therefore, injectable glucagon for the treatment of severe hypoglycemia is currently available only as a rescue kit consisting of a vial containing a dry powder or 1 milligram glucagon in a syringe containing a liquid solution. Two such kits are currently available to patients

[Gary Gemignani:]

Thank you, Errol. Good afternoon everyone. Biodel reported a net loss of $6.5 million and $15.5 million or $0.12 and $0.46 per share for the quarter and nine months period ended June 30, 2015 respectively. These results compare to a net loss of $3.2 million and $11.8 million or $0.15 and $0.56 per share for the quarter and nine months period ended June 30, 2014, respectively. Biodel did not record any revenue during the quarter in nine months period ended June 30, 2015 or 2014. As of June 30, 2015, Biodel had cash and cash equivalents of $44.4 million and 62.2 million shares of common stock outstanding. That concludes our prepared remarks. I would like to ask the operator to please open the call up for questions.

[Operator:]

[Operator Instructions] Our first question comes from the line of Matt Kaplan from Ladenburg Thalmann. Please proceed with your question.

[Matt Kaplan:]

Hi, good afternoon guys.

[Errol De Souza:]

Hi Matt.

[Matt Kaplan:]

So, just a little bit more follow-up on in terms of the GEM program, seems like the manufacturing has always been the right moving step to filing the NDA and it continues today, can you give us a little bit more sense in terms of what the issue is with respect to getting the manufacturing completed on the registration batches necessary, I guess is it and more specifically does it have anything to do with the API or it has everything to do with the device at this point?

[Errol De Souza:]

Let me ask actually Paul Bavier to comment on this, Matt.

[Matt Kaplan:]

Great. Thank you.

[Paul Bavier:]

Hi, Matt. Thanks for the question. As you know, there are a number of components that go into the timeline for the manufacturer of the devices and ultimately the trials and the submissions of the NDA as we have discussed at a high level in our disclosures and in our contract. Biodel is responsible for the formulations development also for working Unilife to establish the device design requirements and for the clinical studies and obviously the submission of the NDA. Unilife is responsible for the device of course and then during the development phase, they are the manager of the activities with Emergent and Emergent is the fill finisher. If it were just – and so all that has to come together in the right way to make sure that everything stays on track, which is complicated. But we are just – issues about bringing all that together then I think we could still give you timeline that we were confident and even if we didn’t like the timelines or appreciate the delay. However, there is another element of it that we referred to, that we are in discussions with our device collaborator in this case on contract requirements. It’s premature to comment on the details of those at the moment, but we do feel that the resolution of those discussions may have an important impact on our timelines overall. And so at this point, we aren’t able to discuss in detail the timelines and so we are working diligently as we can to bring to resolution of discussions and come back with a meaningful report.

[Errol De Souza:]

And Matt, just to add one thing to the other part of your question, no issues with the API manufacturer, which is biochem, that is all on track and the formulation development is continuing.

[Matt Kaplan:]

So, it sounds like the – with respect to you are being responsible for the device design requirements and then interacting and Unilife implementing those requirements that’s where the discussion hinges on that aspect of it more so?

[Errol De Souza:]

Yes. I really can’t give more details on that, Matt, I am sorry. We are within a position where some of these discussions are sensitive and ongoing in fluids. So, we are focusing on bringing those to conclusion, so we can provide a more subject to look to.

[Matt Kaplan:]

Okay, fair enough. And then just in terms of your end-of-Phase 2 meeting with the FDA, it sounds like now you have got good clarity in terms of what needs to be done with respect to the summative human factor study and then the pivotal bioequivalence, PK/PD study. Can you – and I guess in terms of using – being able to – be ready to use the GEM device to deliver, to perform in both the summative and pivotal BE study, does the manufacturing hinge on that as well?

[Errol De Souza:]

Yes, that is the gating item for us to be able to conduct the summative human factor study, the pivotal clinical trial and the stability studies. As we said, the registration lots need to be delivered in order to conduct these studies. As we have previously communicated that was towards, we expected to have those registration lots towards the end of this year and that’s where the delay has occurred in terms of moving forward. The end-of-Phase 2 meetings will increase with the FDA. We have got total clarity on exactly what we need to do and are ready to go if and when we can get the registration lots to implement the Biodel portion of the plan for the NDA filing.

[Matt Kaplan:]

Okay, good. And then shift gears just to 531, can you give us a little bit more detail in terms of when you think you can reopen enrollments in that study using the – I guess, the syringe with the new markings of the U-400 dosing?

[Errol De Souza:]

Yes, Alan, maybe I will ask you to comment on that, please?

[Alan Krasner:]

Sure. Hi, Matt.

[Matt Kaplan:]

Hi.

[Alan Krasner:]

I can’t say with certainty, because we need to submit our response to the FDA based on the additional laboratory studies we conducted on these syringes and we will do that very shortly. The FDA has about a 30-day timeline to review the response. And as long as they agree, I would hope that’s only a short pause that we are experiencing here, but I can’t say for certain until we have FDA buy into our proposal on the data we are submitting soon.

[Matt Kaplan:]

No, when I guess an extension, a follow-up question on that. When the FDA got the temporary hold based on the device, did they ask you for specific data before you could reopen that study with the syringe you are using?

[Alan Krasner:]

Well, what I would say is they cite specific concerns and it all has to do with dose accuracy of these U-400 syringes. These U-400 syringes, there is no U-400 syringe that’s approved in the market. And although we generated data that was – that showed the syringes were accurate with respect to ISO standards, they came back with these requests, which go well beyond ISO standards to look at the dose accuracy of these graduations and also the accuracy of the minimal dose increments. Basically, it means just testing a lot more dose graduations for volumetric accuracy than we had before and I suspect we will be able to reassure them that these syringes meet all standards.

[Matt Kaplan:]

Okay. Thanks, guys.

[Errol De Souza:]

Thank you, Matt.

[Operator:]

Our next question comes from the line of Elemer Piros from ROTH Capital Partners. Please proceed with your question.

[Elemer Piros:]

Yes, good afternoon gentlemen.

[Errol De Souza:]

Hi, El.

[Elemer Piros:]

So, just some follow-ups here related to the GEM device. So, I understand that you have discussions ongoing and at the minimum we are dealing with a nine-month delay. The question is, am I correct in stating that or can you envision a solution by which this would be a less than nine-month delay? Is this what you are working on at the moment or to try to minimize the nine plus months delay if you could? And then I have a second question, please.

[Errol De Souza:]

Let me ask Paul again to address this question.

[Paul Bavier:]

Elemer, it’s a good question, good clarifying question. At this time, we do not have a plan to minimize the delay beyond that nine-month period and that disclosure refers to timeframe that would take at least that. We are working that could change, but we are not holding that out right now as a big possibility. Instead, what we are focusing on is trying to have bringing discussions on contract requirements to a conclusion, so we can come back to you with real timelines and clarifications on the timelines.

[Elemer Piros:]

So, it’s safer to think about it as 9 to 12 months as opposed to fantasizing about less than 9, just to…

[Paul Bavier:]

Yes.

[Elemer Piros:]

Okay. And how long will the stability testing take once you have the material?

[Errol De Souza:]

The stability testing is as per the previous plan, because if you recall we were expecting to receive the registration lot from our device manufacturers towards the end of this year that would have led to registration lots – sorry, that would have led to the pivotal clinical trial stability studies and all of that would be ongoing. And then about six months later, we would have been ready to file the NDA and then we would have supplemented the NDA with additional stability studies. So, that plan again is, in fact, none of that’s changed. The gating item is receiving these registration lots, which are really beyond – which are not in Biodel’s control solely.

[Elemer Piros:]

Yes, I understand. And going to the syringe, this syringe has been used in previous clinical trials and apparently you already screened 7 patients in this study. So, the question is what precipitated this request from the FDA or is there an observation on the field or it just came out of the blue?

[Errol De Souza:]

Yes. I am going to ask Alan to answer it, but there was no clinical observation or anything that led to this. But Alan, why don’t you provide more input to Elemer?

[Alan Krasner:]

Sure. Elemer, so first of all, this syringe was developed specifically for use in this clinical trial. It hasn’t been used before. Although this based on is an approved standard insulin syringe, a standard U-100 insulin syringe, which basically was reprinted, recalibrated with units that are appropriate for U-400 insulin. Why did this come up? Well, the FDA is concerned about the risk of dose errors associated with any concentrated insulin. This is based on their experience with the marketed product, Humulin R U-500. U-500 currently is marketed only in vials and there is no special pen or syringe available for U-500. So, what happens in clinical practices, patients are taught to convert their doses into readings that are appropriate for a U-100 insulin syringe, or for a tuberculin syringe. So, as you can imagine teaching patients to do this and depend on them doing this day-in and day-out is a complex process and prone to error. And so it is our understanding that multiple adverse events have occurred in clinical practice related to the use of U-500. Hence, the regular concern pertaining to concentrated insulins in general. So basically, we, Biodel, developed this U-400 syringe in advance of this Phase 2b study. We thought it would be appropriate for use in this study and actually address the FDA’s concerns proactively by giving patients a syringe they can actually read the dose in units right off the syringe. And we thought that would, if anything and I personally continue to believe that will help reduce the risk of these kinds of dose errors the FDA is concerned about. But because this syringe has not been used in practice before, I should say the printing on the syringe, the syringe itself, mechanically is the same as used in practice, but the printing is new and the calibrations are new. They requested more expensive testing than we were aware of based on ISO standards and that’s what were in the process. We have just completed this testing and we will be submitting it very shortly.

[Elemer Piros:]

I know you can’t control the FDA, Alan but can you characterize what – how do you define shortly, is it days, weeks, a few months?

[Alan Krasner:]

I would say a matter of a week or two, of course we said and again now the FDA has to review that.

[Elemer Piros:]

Yes. Of course, yes. Thank you so much.

[Errol De Souza:]

Thank you, Elemer.

[Operator:]

Our next question comes from the line of Larry Litton from Second Line Capital. Please proceed with your question.

[Larry Litton:]

Thank you. Errol I am a little confused about the GEM delay and why this was not anticipated or how you wake up sometime in the last few weeks and someone has a conversation with Unilife, which should have been ongoing and realizes that they are 12 months behind schedule or they are not on schedule at all, why does this not reflect management incompetence or management weakness, why was this not in your control, why wasn’t somebody on top of this?

[Errol De Souza:]

Paul.

[Paul Bavier:]

Yes. This is Paul again. There is an element that we have talked about before which results in flings of several months very quickly once you cross the threshold which relates to again that coordination of all the activities that I was referring to. And in particular, we have to – there are the timelines that need to be coordinated with the fill finish in order to be able to do immediate fills during – twice a year shutdown periods. We were operating under the assumption on our last earnings call, well, until very recently actually that we will be receiving the devices fill finish following the biannual shutdown for fill finisher taking place towards the end of this year. So to provide a little bit more detail, we no longer expect that the devices are going to be going through that immediate fill process towards the end of this year as we previously anticipated. So the only next time that that could come about is in the next biannual shutdown period, which is in the middle of 2016. So it does result in some wide swings that are uncontrollable once if a certain threshold is met.

[Larry Litton:]

Alright, I will leave it at that. But again, you make certain assumptions and presumably someone is checking these assumptions on a regular basis and have these assumptions lined up as accurate and I am not clear why it happened all of a sudden that the assumptions turned out to be wrong, but maybe I will follow-up later.

[Operator:]

It appears that there are no further questions in the queue. Management, do you want to make any closing remarks?

[Errol De Souza:]

Sure. Thank you for your questions and for joining us this afternoon. Have a good evening.

[Operator:]

This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.