Albireo Pharma, Inc.

Paul Bavier - General Counsel, Secretary and CCO Dr. Errol De Souza - Director, President and CEO Gary Gemignani - CFO Alan Krasner - CMO

Matt Kaplan - Ladenburg Thalmann Elemer Piros - ROTH Capital Partners

Thank you, and good afternoon. Welcome to our fourth 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 Web site.

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. After their prepared remarks, we will open the call to your questions.

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

Thank you Paul and good afternoon everyone. As you can imagine this has been difficult quarter given the delays and uncertainty surrounding our Glucagon Emergency Management, or GEM product candidate.

Further progress on GEM requires at least three registration batches of the fully filled and finished GEM device, so that we may conduct a pivotal clinical study, human factor study and stability studies required for an NDA submission to the FDA. Previously, we anticipated that Unilife would deliver the registration batches towards the end of the 2015 calendar year.

However, as we’ve disclosed previously Unilife has informed us that those earlier timelines are no longer accurate. Discussions with Unilife to resolve the dispute regarding the requirements of our customization and commercial supply contracts have been unsuccessful.

We have initiated formal legal proceedings in Superior Court in the State of Connecticut and with the American Arbitration Association to address Unilife's alleged violation of the Connecticut Unfair Trade Practices Act and alleged breaches of contract in connection with the GEM program. Until such time as we are able to resolve these matters if at all, we will be unable to continue to develop our GEM product candidate.

While our stock has been materially negligibly impacted, our cash position is relatively strong. We ended fiscal year 2015 with approximately $40 million.

As a result, we have received a number of inbound expressions of interest from companies pursuing strategic alternatives for their assets. We have therefore initiated a review to indentify strategic alternatives that will be in the best interest of our shareholders.

Commensurate to this review, we have decided to suspend our BIOD-531 clinical study, including study 3-250 and 3-157 to take other measures and take other measures to preserve cash. While a difficult decision, we believe it offers the best opportunity to maximize shareholder value from our clinical assets and cash resources.

I look forward to being able our investors on the process in the coming months. That concludes our prepared remarks and I would like to ask the operator to please open the call up for questions.

So maybe start off with, can you give us an update in terms of the process, where you are with the proceedings with Unilife?

Let me turn that over to Paul, Matt who can give you an update on the proceedings.

Hi Matt, the last time we were on an earnings call we had not yet initiated proceedings in Connecticut, but shortly thereafter under the Connecticut Unfair Trade Practices Act. That is the claim that is in court before judge, but is ultimately in jury trial in the process and proceedings and timelines for those proceedings are being established as part of the normal process.

In conjunction with that, we have also brought contract claims under the AAA, American Arbitration Association pursuant to our agreement with Unilife. That we instituted in November for the terms of the agreement and that process is usually different from a court case and you would expect it to be shorter, but there's no specific timeline that we have at this time.

So if -- just to help us understand in terms of process with the court case before judge and potentially jury, are you in the discovery phase or where are you and when could you potentially be -- could you have a trial?

Discovery has been, won't be in the middle of -- significant back and forth until early next year in 2016. And the trail would be likely sometime towards the end of 2016 or first half of 2017.

And then in terms of the arbitration, what would that still, depending on the outcome of that could you still be going to I guess the trail as well?

Yes, they're very much independent. The arbitration deal specifically would contract the claims and the Connecticut case deals with unfair trade practices, as I mentioned damages there are not limited by contractual limitations on liability, it allows for punitive damages and for potentially recovery of returning fees, of course we'd have to be successful on all of our claims in order for that to be the case.

The contract claims are being addressed in the AAA. And that process and the agreement projects a 90 day process, but I can't predict that it will take place exactly within that timeframe, it could be longer.

And then in terms of I guess turning a little bit to the -- your decision to suspend the studies, could you talk a little bit about what your strategy is there and for that portion of your pipeline?

Sure, Matt we believe in the assets and the value of the assets, but given that we are looking at the strategic alternatives really based historically to fund incoming interest, we thought it would be best for the shareholders if we conserve cash which is where a lot of the interest is from incoming companies. While we evaluate those in the short-term, instead of committing to trials which would be over the longer term and that's really the decision, it's less sort of a decision whether we believe in the assets we have, but just to buy a little time to be able to review all our alternatives that would maximize shareholder value.

And then I guess a question for Gary, if he's on the line. Could you talk a little bit about your current cash position and your current liabilities?

Yes, so our current cash, we're at about a $40 million as Errol mentioned earlier. In terms of liabilities, I apologize I don't actually have the number I'm in my car, driving, but in terms of liabilities that are minimal we don't have significant liabilities it's our regular working capital, so less than 50 million, so that should not -- again no significant liabilities.

Okay, excuse me you are out range but I didn't see that in your balance sheet just wanted to confirm that.

That's correct, that's correct.

So, Errol in very simplistic terms, despite you'd reconcile a couple of things, so you're suing Unilife and you've an arbitration ongoing, either you win or you lose. Would -- is there a future with Unilife for this product regardless of the outcome?

What we've been looking at Elemer is we really can't talk about the future at this program, because as we've talked about I think in our previous earnings call, we've tried to go in and audit to be able to answer your question in terms of the strength of having confidence that the device can be delivered and then fortunately we could not fully complete the audit through our satisfaction to be able to address your question. So the -- it's very difficult for us under the circumstance to provide any guidance in terms of the future of those programs.

In parallel and just as a side, we've also been looking at how we could leverage all the investments we've made in the program at Biodel in terms of formulation development, toxicology, the clinical studies that we've done that might be applicable to other auto-reconstitution devices to maintain value in the investments that we've made and that’s something that we continue to make some progress on, but it would be pretty mature to talk about any directions that we would move forward there, that's leveraging again value from the toxicology. But in the GEM program I mean it's as you can recall from the start of my call, it's been the frustration because we can't give clear cut guidance and the fact that we're being conservative in terms of saying we don't know what the future of the program would be.

So the other thing which I’d like to a little bit better understand your thinking is just a little over a month ago you provided an alternative on the clinical design for 531, started out in very nice details, the cash position was a little bit north of or maybe a little south because the current report it cashes as of September 30th, the stock went down, other people came in and if I can just don’t want to put words in your month but they allowed or offered for you to look at their assets, again I am trying to understand that why would those alternatives or what would the alternatives be would you acquire assets and then make a decision better those assets are more attractive to continue to develop and not to focus on 531 or do both 531 and those assets or are you contemplating and verging this a company potentially which would also have a balance sheet, I am just trying to see how does the share price going down precipitates a change in direction?

Right, let me try and address that question, in terms of if you look at what the strategic options might be for Biodel, given that currently from the Street’s perspective the strongest asset that we have is our balance sheet which is our cash position, relative to our market cap. From that perspective, we're looking to see how we can leverage the strength in the cash position to be able to look at internal assets, but also assets be it in the form private companies that have assets and maybe looking at a public option in terms of a reverse merger, synergistic to our assets other options that might be available.

And that’s why our intense at this point is really to hire a strategic adviser to help sort out both the incoming interest that we have received, but to do it expeditiously so that -- we believe in the assets that we have but we want to make sure that we don’t continue to drain the cash position. We will also look at other cost cutting measures in terms of making sure that we maximize the assets.

So a strategic adviser will be hired and many of the options that you've discussed and that I’ve sort of elaborated are ones that will be considered in the short-term in terms of maximizing shareholder value.

Thank you for your questions. I realized this has been a frustrating quarter for all of us as I started off.

We are confident that with the process that we have outlined that we can get back to you in terms of progress that we would be making in terms of looking at the strategic alternatives. Thank you very much.

Take care.