Albireo Pharma, Inc.

Paul Bavier - General Counsel Errol De Souza - President and Chief Executive Officer Gary Gemignani - Chief Financial Officer Alan Krasner - Chief Medical Officer

Matt Kaplan - Ladenburg Thalmann

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.

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 [0:01:35] [indiscernible]. We will also provide you an update on our Glucagon Emergency Management or GEM program for the treatment of severe hypoglycemia.

We will conclude with a brief overview of our first quarter 2015 financial results and leave time for questions. We are pleased to start 2015 with the announcement in early January of the positive topline data from study 3-151, the second phase 2a meal study of our concentrated ultra-rapid insulin candidate BIOD-531.

As most of you know, BIOD-531 is Biodel’s proprietary formulation of recombinant human insulin or RHI with EDTA, citrate and magnesium sulfate. It is formulated at a concentration of 400 units of RHI per milliliter.

Before we get into the update, I just want to go over a few key points of the BIOD-531 development today. In February 2014, we provided extensive details on the positive data from Study 3-150, a Phase 1 clinical trial which demonstrated that BIOD-531 is associated with a unique combination of an initial ultra-rapid absorption profile, along with a basal duration of actions.

This profile makes BIOD-531 suitable for twice daily dosing. Recall that BIOD-531’s rate of absorption was clearly superior to that of the marketed products which are used as prandial/basal products such as Humalog Mix 75/25, and Humulin R U-500.

Confirmation that the unique pharmacokinetic or PK and pharmacodynamics or PD prolife seen in the initial Phase 1 study translated into clinically superior glucose control, was clearly demonstrated in two subsequent phase 2a standardized meal challenge studies. Study 3-152 performed in moderately insulin-resistance patients with Type 2 diabetes read out in August 2014 and showed that the BIOD-531 dosed before or after a standardized breakfast resulted in superior glycemic control compared to Humalog mix 75/25 and Humulin R U-500 dose prior to the breakfast.

Just last month, we reported the data from the second phase 3 trial. We called it study 3-151, enrolled patients with both type 2 and type 1 diabetes.

We used greater than 150 units of insulin per day or greater than 100 units with a single injection, that is, patients who have significant insulin resistance and may be candidates for concentrated insulin with an ultra-rapid acting profile such as BIOD-531. BIOD-531 again showed superior prandial glucose control and demonstrated utility when dozed before or after meals in the second patient populations.

Neither Humulin R U-500 or Humalog Mix 75/25 are approved for afternoon dosage. We can say that demonstrating superiority of the BIOD-531 over both Humulin R U-500 and Humalog Mix 75/25 in controlled glucose following meals along with clarify from the FDA of requirements for clinical trials, we announced in December that we are rapidly advancing BIOD-531 into a later stage development We will be initiating later this year a formal GLP toxicology study along with the chemistry manufacturing and controls or CNC which are required to be performed prior to Phase 3.

These activities usually take about 12 to 18 months to complete and would enable the initiation of pivotal trials in 2016. In parallel preparation is under way to initiate a multi dose Phase 2b Study 3-250 in Type 2 diabetes patients with moderate insulin resistance in the second calendar quarter of 2015.

Study 3-250 will randomize patients with Type 2 diabetes who use at least 40 units of insulin per day to receive either BIOD-531 or Humalog Mix 75/25 twice daily for a total of 18 weeks. The primary objective will be to show HbA1c non-inferiority.

Secondary end points will include assessments of hypoglycemia, weight, and post prandial glucose. If successful these data will significantly de-risk a Phase 3 program.

We project that the top line results from Study 3-250 will be available in mid-2016 which will coincide with the completion of the toxicology and CNC studies or initiation of pivotal phase 2 trials. Our goal is to demonstrate that BIOD-531's unique time action profile along with its high concentration is better suited then currently available products to address the needs of modern insulin resistant patients of diabetes who have more typical insulin requirements of under 150 units per day and also severely insulin resistant patients who require large volume or a concentrated insulin to cover daily needs which typically often exceed 150 units a day.

The use of concentrated insulin to treat diabetes patients with severe insulin resistance continues to increase at a greater rate than the overall market with an annual revenue projection for 2014 of approximately $400 million. In the U.S, Eli Lilly's Humulin R U-500 is the only concentrated insulin product currently available for these patients.

Humulin R U-500 duration of action is long enough to provide basal coverage prior to, its onset of action is delayed relative to equivalent doses of R U-100 rapid acting insulin analog and does not provide optimum mealtime insulin coverage. Many of these patients with moderate insulin resistance use insulin premixes because these products are to provide basal and prandial bolus therapy with fewer injections a day.

Currently Eli Lilly and Novo Nordisk market presentations of human insulin or rapid-acting insulin analog such as Novo Log or Humalog premixed with intermediate-acting basal neutral protamine insulin in a variety of ratios. In the U.S., analog-based premixes sell approximately $1.5 billion annually.

While the premixes offer prandial and basal coverage with one injection, the prandial coverage is sub-optimal. Let me now turn to our Glucagon program which is focused on developing a portfolio of rescue presentation for diabetic patients experiencing severe hypoglycemia or very low concentrations of blood glucose.

We continue to make steady progress in developing our two unique proprietary devices and companion formulations to accomplish its goal. Our most advanced program, for which we expect to commit an NDA in the first half of 2016, is a device that we refer to as a Glucagon emergency management of GEM product.

The GEM device is a customized version of an auto reconstitution syringe manufactured by Unalive Corporation. The device is specifically designed to address and extend an undeserved market currently wrestling with cumbersome kits that is especially difficult to use and operate during an emergency.

The initial phase one study is nearing compilation of the dosing phase. In this sixth arm crossover study in normal human volunteers we're evaluating the PK and glucose, that is the pharmacodynamic response for the Biodel's Glucagon formulation compared to Lilly and Novo Glucagon given such containers with subdue and intramuscularly or IM.

We expect to report top line PK and PD results in the late first calendar quarter of 2015. With this data we are planning to choose one of the markets where Glucagon has the comparative for the subsequent physical trial in which approximately 30 healthy volunteers will receive the Biodel Glucagon formulation and the marketed comparator both separately on separate days in a very similar cross over design as a phase one study.

In addition human factor studies are planned to further compare the usability of the GEM device to existing manually reconstituted commercial Glucagon kits in the hands of representative caregivers in the first half of 2015. The final pivotal human factor study is planned to complete in the third calendar quarter of 2015.

We continue to work closely with Unilife who has the responsibility for manufacturing ability of registration laws and our manufacturing partner in merchandise solutions to perform all the necessary technology transfers and manufacturing activities for our NDA submission. We expect this to be completed prior to year end 2015.

The second component of our Glucagon program is the Uni-Check device which is being developed as a follow on product to compliment the GEM product. Having obtained a source of access to the Uni-Check platform from Becton Dickinson, we reinitiated our program late last year to develop stable liquid Glucagon formulations.

We made good progress improving the stability of the liquid Glucagon formulations and are now testing several formulations with promising stability in animal model and anticipate selecting candidate formulations in the first half of 2015. In closing I look forward to reporting on key milestones in 2015 such as the Phase 1 proof of concept trial with our Glucagon formulation towards the end of the first calendar quarter of 2015.

And the initiation of the BIOD-531 Phase 2b trial in the second calendar quarter of 2015 as we execute upon on our strategies. Now I will turn the call over to Gary who will present our first quarter fiscal year 2015 financial results.

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.

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

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.

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.

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?

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.

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?

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.

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.

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.

Thanks for taking the questions and congrats on the quarter.

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.