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Biodel Inc. (NASDAQ:BIOD)

F1Q 2014 Earnings Conference Call

February 6, 2014 17:00 ET

Executives

Paul Bavier - Corporate Secretary and General Counsel

Dr. Errol De Souza - President and Chief Executive Officer

Gerard Michel - Chief Financial Officer and Vice President, Corporate Development

Analysts

Matt Kaplan - Ladenburg Thalmann

Jason Butler - JMP Securities

Liana Moussatos - Wedbush Securities

Operator

Good day, ladies and gentlemen. Thank you for standing by. Welcome to Biodel’s First Quarter of Fiscal Year 2014 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. (Operator Instructions) I would also like to remind you that this call is being recorded for replay.

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

Paul Bavier - Corporate Secretary and General Counsel

Thank you. Good afternoon and welcome to our first quarter fiscal year 2014 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 the 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 and Gerard Michel, our Chief Financial Officer and Vice President of Corporate Development. After their prepared remarks, we will open the call to your questions.

Now, I will turn the call over to Errol.

Dr. Errol De Souza - President and Chief Executive Officer

Thank you, Paul. Good afternoon everyone. We are pleased to report on another quarter of steady progress across our portfolio of pipeline candidates. This afternoon, I will provide updates on our concentrated ultra-rapid acting insulin candidate, BIOD-531; two, glucagon programs and our portfolio of ultra-rapid acting recombinant human insulin, or RHI; and analog-based prandial insulin formulations. I also want to take some time to discuss the strategic implications of our extended portfolio, specifically how we will prioritize and stage investments across the portfolio. We will conclude with a brief overview of our first quarter financial results and time for questions.

Let me begin with our concentrated insulin program. BIOD-531 is a proprietary novel concentrated U-400 formulation of recombinant human insulin, disodium EDTA, citrate and magnesium sulfate. Studies in diabetic swine demonstrated that BIOD-531 has a unique time-action profile combining both a rapid absorption phase of mealtime coverage as well as an extended duration of action consistent with basal insulin.

I am pleased to announce the completion of dosing for study 3-150, a Phase 1 clinical trial comparing BIOD-531 for the marketed products, Humulin R U-500 and Humalog mix 75/25. The goal of this study was to compare the relative pharmacokinetic, or PK and pharmacodynamic, or PD profiles of BIOD-531 with leading products in two distinct insulin categories, concentrated insulin and premixed insulin. The end life portion of this study has been completed and we are only waiting for the results of lab analysis in order to launch the final database. Thus we anticipate that the top line data from this study will be released within the next two weeks.

In anticipation of this, I would like to review the characteristics of the potential market for BIOD-531, the study design, the results we have previously generated in the diabetic swine model and the implications of the human data if they are consistent with the swine data. The primary outpatient use of concentrated insulin is to treat Type 2 diabetes patients with severe insulin resistance. This market is increasing at a greater rate than the overall market and currently represents approximately a few hundred million dollars in annual pharmacy revenues.

Insulin-resistant patients often require more than 200 units of insulin daily and are not well served by the standard insulin concentrations of 100 units per millimeter, or U-100. Eli Lilly’s Humulin R U-500 is the only concentrated insulin product currently available for these patients. Because the Humulin R U-500 duration of action is long enough to provide basal coverage, it is often administered by patients twice or three times per day. However, it’s onset of action is delayed and it does not well-suited to provide optimum mealtime insulin coverage. In the diabetic swine model, BIOD-531 has an onset of action that is more rapid relative to Humulin R U-500 and even somewhat faster than that of standard U-100 Humalog.

BIOD-531 also demonstrated a comparable duration of action relative to Humulin R U-500, which indicates that like Humulin R U-500, BIOD-531 maybe able to address basal insulin needs as well. Our hope is that the pharmacokinetic and pharmacodynamic results of the clinical study will be similar to the diabetic swine data and indicate that BIOD-531 may provide superior prandial coverage compared to Humulin R U-500 while providing adequate basal control.

Insulin premixes provide basal and prandial bolus therapy with fewer injections per day. Currently, Eli Lilly and Novo-Nordisk market presentations of human insulin or rapid-acting insulin analogs such as NovoLog or Humalog premixed with intermediate acting basal neutral protamine insulins in a variety of ratios such as 70:30, 75:25, and 50:50. In the U.S., analog-based premixes sell approximately $1.5 billion annually. While the premixes offer prandial basal coverage with one injection, the prandial and basal coverage, I should say, with one injection, the prandial coverage is suboptimal. Again, the pharmacokinetic and pharmacodynamic results seen in the diabetic swine, but it also indicate that BIOD-531 may provide superior prandial coverage compared to the mixes while providing adequate basal control.

With the human data consistent with the animal model results, we will have a proof-of-principle necessary to justify developing this formulation for this market segment. The study 3-150 Phase 1clinical trial, just completed with a double-blind four-way crossover design with 13 subjects in which the pharmacokinetic, pharmacodynamic and injection site tolerability profiles of BIOD-531 were compared with Humulin R U-500 and Humalog prandial basal premixed insulin.

On two of the test days, BIOD-531 and Humulin R U-500 were administrated at doses of 1 unit per kilogram, which is in the dose range used by patients with Type 2 diabetes and severe insulin resistance. On the other two days of the full period study, 531 and Humalog 75/25 premixed insulin were administered at a dose of 0.5 units per kilogram, which is a lower dose range that might be used by patients with more moderate degrees of insulin resistance who use the premixes. This comprehensive trial design should give us a clear indication as to whether BIOD-531’s ultra-rapid acting onset and basal duration profile coupled with its high concentration could offer a truly novel therapeutic that provides basal coverage and improved prandial coverage to patients who are insulin resistant and/or use premixed insulins. We look forward to sharing the top-line results with you in the near future.

Let me now turn to our glucagon program, which is focused on developing a portfolio of rescue presentations for diabetes patients experiencing severe hypoglycemia or very low concentrations of blood glucose. Currently marketed glucagon products are complicated and difficult to use, which has considerably and impeded their acceptance and use. Our goal is to introduce intuitive, portable and easy to use devices that both convert and expand this poorly served existing market.

We continue to make steady progress in developing our two unique proprietary devices and companion formulations to accomplish this goal. Our most advanced program for which we expect to submit an NDA in 2015 is a device that we refer to as the GEM. The GEM is a customized version of a dual chamber auto reconstitution syringe manufactured by the Unilife Corporation that we are developing for use as a rescue treatment for severe hypoglycemia. The GEM is intuitive, easy-to-use and specifically designed to address and expand an underserved market currently wrestling with cumbersome kits that are especially difficult to use and to operate during an emergency.

In the past quarter, we have manufactured an engineering batch and completed a dose-ranging safety study in preparation for initiation of the GLP toxicology study in the first calendar quarter. We will remain on track for an IND filing in the third calendar quarter, initiation of pivotal trial in the fourth calendar quarter of 2014 and an NDA submission in 2015. The second component of our glucagon program is the Uniject device, which is being developed as a follow-on product to complement the GEM.

As we announced in December 2013, we entered into a long-term supply agreement with Becton, Dickinson or BD, one of the world’s leading suppliers and innovators for injection and infusion based drug delivery. This agreement granted us worldwide exclusive rights to the novel and proprietary Uniject disposable device for the delivery of liquid glucagon to treat severe hypoglycemia.

The Uniject device is a very small portable, all in one pre-filled drug delivery system for intramuscular and subcutaneous injections. Uniject’s low unit cost will allow us to develop liquid glucagon-filled multi-packs that enabled users to remove a single device from long-term refrigerated storage every four months to be carried as a go anywhere ultra portable defense against the threat of severe hypoglycemia. This multi-pack approach markedly lowers the hurdle of room temperature stability duration from two years to four months and allows users who suffer frequent hypoglycemic event to avoid the need to refill a prescription immediately after using one of the devices. Uniject’s ultra-portability and simplicity may be particularly compelling to active people with diabetes as well as parents and caregivers of children with diabetes.

Our portfolio of hyperglycemia rescue devices should expand the overall glucagon rescue market to a greater degree in a single product offering. Having obtained exclusive access to the Uniject platform from Board of Directors, we have reinitiated our program to develop stable liquid glucagon formulations and plan on testing stability and compatibility in the Uniject device along with the pharmacokinetic and pharmacodynamic properties in dogs. We also continue to develop stable, comfortable liquid glucagon formulations that could further expand the market and address other applications such as the development of an artificial pancreas.

Now, let me shift gears and touch upon our ultra-rapid acting prandial insulin portfolio. Our later stage program is RHI based ultra-rapid acting insulin candidate, BIOD-123. As we reported in September 2013, BIOD-123 achieved the primary efficacy endpoint of non-inferiority and change from baseline HbA1c relative to Humalog in our 18-week Phase 2 clinical trial. We are currently soliciting regulatory feedback from the FDA and discussing the results with potential corporate partners. We have delivered a comprehensive background package to the FDA to which we anticipate a response in this calendar quarter. Based on these inputs, we will decide on the path forward for the RHI based ultra-rapid acting prandial insulin program.

Let me now turn to our analog-based ultra-rapid acting insulin program, which offers opportunities independent of the RHI-based program. We have previously presented data showing that our prototype analog-based formulation, BIOD-250, has a significantly more rapid of absorption at the decline from peak concentration and injection site tolerability comparable to Humalog. We are currently developing both lispro and aspart-based formulations with a focus on improving the overall stability profile while maintaining the more rapid absorption profile of these analog-based ultra-rapid acting insulin formulations. As a reminder, lispro is the active pharmaceutical ingredient, or API, in Humalog and aspart is the API in NovoLog. Humalog sold by Eli Lilly and NovaLog sold by Novo Nordisk are the two dominant rapid-acting insulin analogs on the market and both off patient in 2014.

Substantial progress has been made in identifying stable ultra-rapid acting analog-based formulations that are made using the API lispro or aspart. Work is focused on optimizing stability, which would allow for a commercially viable shelf life. We have made good progress in developing formulations with acceptable criteria for stability and accelerated absorption relative to Humalog in diabetic swine. We are in discussions with a number of manufacturers to source DNP supplies for both lispro and aspart to further enable development. As we advanced this program, we continue to remain engaged in discussions with the major players in the insulin space.

With the continued advancements of BIOD-531 and our glucagon program, Biodel’s portfolio has expanded beyond our historical focus on ultra-rapid acting prandial insulin. The portfolio now includes programs in niche market segments of several hundred million dollars such as the glucagon rescue for the treatment of severe hypoglycemia and concentrated prandial basal insulin for the treatment of Type 2 diabetes patients who are highly insulin resistant. This expanded portfolio enables both through internal development and external in-licensing opportunities to offer shareholders the benefits of nearer term, lower risk returns while maintaining a significant upside potential as one or more of the programs in the large market segments achieve a critical inflection point. A diverse portfolio requires a tailored development and commercialization strategy.

To optimize the risk-adjusted returns across the portfolio, we intend to fund the more expensive and higher risk ultra-rapid acting prandial insulin programs only to critical inflection points, such as proof-of-concept, giving us the opportunity for significant upside upon a possible partnership deal, while minimizing funding requirements. Programs with shorter timelines, lower risk profiles, and lower development costs, such as a GEM program will be funded through to an NDA allowing us to realize more of the upside. I look forward to reporting on key milestones in 2014, such as the pending BIOD-531 Phase 1 data and the initiation of the GEM pivotal study as we execute upon the strategies that I have described.

Now, I will turn the call over to Gerard for a quick review of our first quarter fiscal year 2014 financial results.

Gerard Michel - Chief Financial Officer and Vice President, Corporate Development

Thank you, Errol. Biodel reported a net loss for the three months ended December 31, 2013 of $2.4 million, or $0.12 per share of common stock. R&D expenses were $3.7 million and G&A expenses were $1.4 million for the quarter. Biodel did not recognize any revenue during the three months ended December 31, 2013. At the end of the quarter, Biodel had cash and cash equivalents of $35.2 million and 21.1 million shares of common stock outstanding. We anticipate that this cash runaway will take us to the second calendar quarter of 2015.

That concludes our prepared remarks. Now, I would like the operator to open the call to your questions.

Question-and Answer Session

Operator

Thank you, ladies and gentlemen. (Operator Instructions) First question is from Matt Kaplan of Ladenburg Thalmann.

Matt Kaplan - Ladenburg Thalmann

Hey, guys. Can you hear me? Thanks for taking my questions.

Dr. Errol De Souza

Hey, Matt.

Matt Kaplan - Ladenburg Thalmann

Hi. Thank you again for all the detail you provided in terms of the pipeline and the update. First off, can you give us a sense in terms of what you think the spending or the burn will be for 2014 in terms of getting the ultra-rapid-acting insulin program to the inflection point and then figuring out what to do with 531 and most importantly driving the glucagon programs to the next step as well?

Dr. Errol De Souza

Okay. Let me give you an answer at a high level and then Gerard can address the numbers.

Matt Kaplan - Ladenburg Thalmann

Thank you.

Dr. Errol De Souza

Matt, coming back to the strategy that I described towards the end of my prepared remarks, that’s really a strategy that drives us with regards to the spend and the investment that we make. So the money that we currently have we are going to improve the GEM program all the way to NDA. We are based on the data with BIOD-531 that should be coming in a couple of weeks assuming that the data are comparable to what we have seen in the diabetic swine model. We think this is a great opportunity. And what we would be thinking about a study like a meal study, which is really critical to make the case for a faster, rapid absorption better prandial coverage and a comfortable basal duration. And the funding for that particular study is currently in the budget as far as the other glucagon programs related to the Uniject. That’s primarily a research program where we are looking at the liquid formulations that we are working on. And so that’s built into our current budgets and our anticipation is over the next few months to make progress there and then once we have a formulation that has the right kind of stability that is four months, at least four months at room temperature then we can come back and talk about the timelines related to that program.

And then finally let’s talk about the ultra-rapid-acting prandial insulin programs and they fall into two categories, Biodel 123 and lispro and aspart-based analog-based programs. Biodel 123 the package of the FDA has been filed. So, the feedback from the FDA is critical in terms of partnering discussions but that is a program that we’re lining up from a partnership standpoint. The analog-based programs also are coming to the conclusion from a research standpoint. We got some very good candidate formulations in particular the lispro-based formulations that should be close to moving into development as soon as we can source lispro GMP quantities of lispro. And again, that program we’re looking at it primarily as a partnering program and as I mentioned in my remarks we’ve got active discussions with the major players.

And those discussions could even be bundled with the 123 discussions. So, this spend there I think it’s going to be limited because it’s been driven to inflection point that we have either gotten to in terms of a Phase 2 data or candidate formulation that will allow us to maximize the partnering opportunity. The other programs we will drive in terms of the internal sourcing. Throughout any comments in terms of how far our cash position takes it with the plan that I had described.

Gerard Michel

Yes, Matt. So as we mentioned this $35.2 million of cash what we’re trying out to do is break out those – and that will take us to the second calendar quarter of 2015. We have in the past and I’m reluctant to break out precisely what you expect to see in terms of spend allocated across the program but I don’t have any problem directionally helping you think through that.

As Errol, mentioned we are going to take the ultra-rapids through at inflection point. I think what that really means is you’re probably not going to see large multi-dose trials for any of those programs going forward. There may be something that’s modest for example for an analog-based. 531, on the other hand I think you can anticipate seeing some more significant investment in the near-term as we take that formulation into another trial. Exactly what that trial will be, will be partly dependent on some feedback from the FDA. And then the glucagon, the Uniject is primarily formulation work regime will be probably the greatest amount of spend going forward at about portfolio as we push that towards an NDA.

With the cash we have in hand, but I think through the milestones that Errol has articulate with the cash we have in hand getting through mid 2015, we certainly are going to get our registration batches manufactured and up going, we certainly are going to get our IND filed, we’re certainly going to get our Phase – our pivotal trial run exactly where we are in terms of the clock ticking on registration batches and the NDA, it’s a little hard to say at that point when we get to the second calendar quarter which is again where actually cash takes us to. So, hopefully that’s somewhat is helpful for your model.

Matt Kaplan - Ladenburg Thalmann

No, that’s great guys. Thank you for all the other detail and the detail that you provided in the call and congratulations on the progress.

Dr. Errol De Souza

Thanks.

Operator

Next question is from Jason Butler of JMP Securities. Your line is open.

Jason Butler - JMP Securities

Just on the concentrated insulin. Can you talk about what’s the right patient population or patient populations are to look at it in a mealtime study and what will be most helpful for you when looking at all other different potential commercial applications to this product?

Dr. Errol De Souza

Yes, we’re looking at it in terms of – so we’re looking at it for really two very different segments that are currently served by either concentrated insulin or the insulin mixes. So, the concentrated insulin right now that’s the Humulin-R U-500 is labeled for patients who are severely insulin resistance and whom I take more than 200 units of insulin and pay. That’s a great target population I think for the U-400 BIOD-531. Then there is a – that population currently several $100 million that growing very rapidly. Then we’ve got a much larger segment that’s related to patients that are moderately resistant to insulin but who want the convenience of maybe two injections a day covering both prandial and basal and these are the folks that take either the NovoLog or Humalog versions of the mixes, 70/30, 75/25 or 50/50 and that’s $1.5 billion market, that we could also talk. But it’s going to depend on the profile that we see in the Phase 1 study. What we feel is very confident with Jason is the design is very comprehensive Phase 1 study which is like two Phase 1 studies and one what we got the appropriate dose of 531 to compare with the Humalog 75/25 mix and the high dose to compare that we could go after both of these segments in the meal study. But it will really be dependent on the data that we see not only on the PK side but even more importantly on the pharmacodynamic side. Just as a reminder this study will have hypoglycemic client data also.

Jason Butler - JMP Securities

That’s great. That’s helpful. Thanks a lot, Errol.

Dr. Errol De Souza

Thank you, Jason.

Operator

Thank you. (Operator Instructions) Our next question is from Liana Moussatos from Wedbush Securities. Your line is open.

Liana Moussatos - Wedbush Securities

Thank you. Do you plan to commercialize the glucagon programs on your own in the United States or partner everything?

Dr. Errol De Souza

We’re certainly moving forward and will ask Gerard to comment more because as if we’re going to commercialize the glucagon GEM program because that’s the best way we feel that we can build shareholder value for now. Gerard maybe you can comment on sort of the feasibility of what company you like Biodel being able to commercialize the glucagon because you’ve done a lot of work in this area.

Gerard Michel

Yes, so about two-thirds of three quarters of all the glucagon right now that is prescribed in the retail setting are from endocrinologists. So, if you wanted to capture that markets and expand it it would be a fairly finite audience that one would need to address that marketplace somewhere in the range of a couple of dozen reps, it would probably do an adequate job. Now I think that market also is not one way share of voice is really critical, what’s critical there is making the case to payers that they will save money as they keep people out of the ER which is a fairly in a phase but it’s fairly simple case to make although we’re working with someone right now to develop that model and make that argument.

The second part of the strategy is to see if we can get a little more piece so a little more detail on the guidelines about who should be at glucagon and that’s been a very tough difficult thing either to do in terms of the top down effort to change prescribing practice. So I think this is a product that does not take a lot of share of voice a lot of fit in the ground both to switch share as well as expand the market. Now with that said while we’re going to act is if we’re going to launch the product because also that is the best way to develop a drug not to forget any details as you’re moving further. We’re always very open to any other alternative that create by for the shareholders. So we’re not vetted to any single strategy. We want to make sure, we do our homework and have the best possible program for commercial steps and again that’s what we’re going to think through all the details as if we’re going to commercialize it, but again willing to talk to anybody about any other alternative.

Dr. Errol De Souza

And just to add to what Gerard said those kinds of decisions will also be reinforced by the BIOD-531 data on concentrated insulin because that market that’s going after sort of the severely insulin resistant patient could be targeted by the same sales force that would be marketing the GEM device. And so those two programs we see as one that would sort of drive our decision in terms of commercializing on our own so we’re always open to the right kind of thoughts and opportunity as long as it makes sense to build shareholder value by doing that.

Liana Moussatos - Wedbush Securities

And can you talk about how far behind the Uniject is from GEM, if it’s been filed in NDA for GEM in 2015. When do you think you could file one for Uniject and will Uniject cannibalize GEM? Can you talk about the differences in the patients that you’ll target?

Dr. Errol De Souza

Yes, Liana, let me talk about the timelines and then I’ll ask Gerard to talk about the market space. Our goal for Uniject is really to get the formulation of a period of maybe in the second half of this year we should have a pretty good idea of the feasibility of the formulations we’re working on because you need at least six months of real time stability on some of these formulations.

Now if you assume that we’d have a formic candidate formulation identified towards the end of this year, the timelines for the Uniject will be a little longer than GEM program for the following reasons. The toxicology package maybe for the GEM program it is really straightforward, it’s two weeks toxicology in rats. But depending on the major, the excipient that we use to stabilize the liquid glucagon formulation we may have to do separate toxicology which may make the timeline a little bit longer. The rest is the same. So I would say to be conservative you’d assume that you’ve got a candidate formulation towards the end of the year, add a little bit more in terms of the toxicology then you’re talking about late 2016 or so. But again those are timelines that will provide much more color as we progress in the formulation. Gerard, can you talk about how the two different presentations would work together?

Gerard Michel

Yes, I think the first thing to realize is the market is tremendously under-penetrated right now. So even if Uniject cannibalize that wouldn’t be feeling a lot of tears because between the two of them the markets kind of grow – we hope significantly three-fold or more. Under 10% of Type 1 have a currently unexpired downshift. And although it’s hard to define what Type 2 should get it it’s probably well under 10% there too of those at risk for a Type 2s.

And this is also a fairly large segment of the sales that go to institutions primarily long-term care. In that segment they want needlestick protection and that’s where the GEM program will maintain its share regardless of what happens to Uniject because it does have an automatic needle of attraction. Similarly that’s the case for ambulances and ERs. Again there are also requirements that require needlestick protection, so we think it will hang on to that part of the business. There are probably a lot of Type 2s at risk. We probably are going to chose not to carry something around who want something on this in a drawer somewhat it’s very easy to use that will be the GEM. But there are tremendous number of pipelines we spoke into, we want have something in their front pocket at all times.

Basically a reserve parachute if eating that snickers bar or the glucose tabs or orange juice does not feel like it’s bringing them around fast enough. They want something they will put out and get some help with quickly. So we think the Type 2 market, adult Type 2 would migrate greatly towards the Uniject once it’s available. So I think there will be some cannibalization but outweighing that will be market growth overall. And quite frankly if some competitor does come along we want to make sure we have the best portfolio possible to blocking the inroads from them, so that’s not a rationale to have the Uniject come out.

Liana Moussatos - Wedbush Securities

You said Type 2s would have – would want something in a drawer and you said GEM, did you mean Uniject?

Dr. Errol De Souza

Yes.

Gerard Michel

Yes, I would say thank you.

Liana Moussatos - Wedbush Securities

Okay.

Gerard Michel

Well the Type 2s I think might migrate towards the GEM because something that’s…

Dr. Errol De Souza

You said Uniject.

Gerard Michel

Sorry thanks about it, Errol. And so that yes thanks for the clarification, Liana.

Liana Moussatos - Wedbush Securities

Right. Thank you.

Operator

Thank you. This concludes the Q&A portion of today’s call. I’ll now turn the call over to Dr. De Souza for any closing remarks.

Dr. Errol De Souza - President and Chief Executive Officer

Great. Thank you so much for your questions and for joining us this afternoon. Look forward to presenting the BIOD-531 data in a couple of weeks and we want to thank our shareholders and employees for their continued support.

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the program. You may now disconnect. Have a wonderful day.

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