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Biodel Inc. (NASDAQ:BIOD)

F3Q12 Earnings Call

August 8, 2012 5:00 pm ET

Executives

Paul S. Bavier – Corporate Secretary and General Counsel

Errol B. De Souza – President and Chief Executive Officer

Gerard J. Michel – Chief Financial Officer, Vice President of Corporate Development and Treasurer

Analysts

Matthew Kaplan – Ladenburg Thalmann Securities

Jason Butler – JMP Securities LLC

Richard Reznick – William Blair & Co. LLC

Marc Stutman – Trimark

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Biodel’s Third Quarter Fiscal Year 2012 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 Corporate Secretary and General Counsel.

Paul S. Bavier

Thank you. Good afternoon and welcome to our third quarter fiscal year 2012 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; Gerard Michel, our Chief Financial Officer and Vice President of Corporate Development; 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 B. De Souza

Thank you, Paul. Good afternoon, everyone. Since the last quarter, we’ve continued to build on our momentum in advancing our three key programs. In today’s call, we will discuss our successful financing, progress made in our glucagon program, details regarding our planned Phase II trial for ultra-rapid-acting formulation of recombinant human insulin or RHI, and the status of our analog-based ultra-rapid-acting insulin program.

Let me begin by discussing our recent financing. As we announced on June 22, we successfully completed a private placement financing of $18.5 million. We’re gratified that this financing was supported by high-quality institutional investors, including both existing and new shareholders.

We’re also pleased that the offering was oversubscribed, which afforded us the opportunity to prudently permit inclusion of funds beyond our initial expectation. Prior to the financing, we disclosed the timing of several key milestones, including the completion of the Phase II BIOD-123 trial and submission of the glucagon NDA for the treatment of severe hypoglycemia, that will were beyond our previously stated cash runway of mid-2013.

The recently completed financing will enable us to reach these critical milestones, and consider prospects that may enhance the value of our research and development programs, which I will touch on in the course of this afternoon’s call.

The first program I want to discuss is the development of our stabilized liquid glucagon product candidates. On June 8, we announced a partnership with Aegis Therapeutics that provides us with an exclusive worldwide license to Aegis’ proprietary ProTek and Intravail technologies, for the development and commercialization of pharmaceutical formulations of glucagon.

ProTek protein stabilization technology comprises the use of proprietary excipients that prevents aggregation of proteins and peptides, thereby improving the stability of the drug product formulated with these excipients. Intravail comprises a broad class of transmucosal absorption enhancement agents that allow non-invasive systemic delivery of peptide, protein, nucleotide-related, and other small and large molecule drugs.

The agreement with Aegis allows for the development and commercialization of a wide variety of glucagon presentations including our lead glucagon product candidate, which is a liquid formulation intended to use as a rescue treatment for diabetes patients experiencing severe hypoglycemia.

Other potential presentations and indications include the use of glucagon in the treatment of hyperinsulinemia with continuous subcutaneous infusion and the treatment of mild to moderate hypoglycemia, we have both an intra-nasal formulation and a subcutaneous infusion pump. The pump formulation and indication is a critical step that was a development of an artificial pancreas.

The liquid glucagon formulations utilizing the Aegis technology show improved stability profiles in shorter-term studies under room temperature conditions and at 37 degrees centigrade, when compared to the earlier Biodel proprietary formulations, which have demonstrated almost two years of real time stability under refrigerated conditions. Given this improvement, we are focusing on the ProTek based formulations as our lead clinical candidate.

We envision our initial commercial product will be a refrigerated liquid formulation of glucagon with at least 18 months of stability, presented in an auto injector which is easy to use, requires minimal training, and has needle stick protection.

We continue to optimize the ProTek based formulations and presentations, and are hopeful that we can also introduce a room a temperature stable rescue product. As our development of the glucagon product presentation continues to progress, so too does our knowledge of the potential markets we plan to address and expand. The current glucagon market for the treatment of severe hypoglycemia is approximately $125 million annually in the U.S.

Our market research reveals opportunities to penetrate and expand the glucagon market over the next six years which could result in growth by two to three folds. The glucagon rescue market contains four major segments in which potential growth could be realized, including institutional use such as nursing home and emergency responders and retail segments of the market targeting patients with Type 1 and Type 2 diabetes.

While we project low-to-moderate growth in the nursing home and emergency responder segments, which represent approximately 50% of the current market, we would anticipate capturing most of this market due to the OSHA requirement to use a product with needle stick protection that’s available.

The current glucagon emergency rescue kit from Lilly and Novo do not have needle stick protection, which would be available in our auto-injector presentation. We project the greatest growth in the Type 1 and Type 2 diabetes segments of the market, which are currently, severely underpenetrated for a variety of reasons, including the need for multi-step reconstitution of the product, and the requirement for caregiver training. Our auto-injector presentation does not require reconstitution like the current glucagon emergency rescue kits, and it is easy to use, minimizing the need for a special training visit.

Improving existing glucagon presentations and generating new ones that are able to address unmet needs such as the ease of use and portability are key elements of the plan we are pursuing to realize the full potential of these opportunities.

We look forward to reporting on these opportunities as we advance the program and achieve important milestones. One such recent achievement was the execution of a commercial glucagon supply agreement that grants us access to sufficient long-term commercial quantities without mandatory purchase commitments. The program is progressing steadily, and we remain on track to submit an NDA for our first glucagon auto-injector product in early 2014.

The glucagon program is complementary to our ultra-rapid-acting insulin program in a number of ways. As previously mentioned, our stabilized liquid formulations of glucagon have potential utility in a bi-hormonal pump, which is also a critical component of some prototype artificial pancreas systems.

On July 26, we announced an NIH Small Business Innovation Research grant award for approximately $600,000 to develop concentrated RHI and analog-based ultra-rapid-acting insulin formulations for use in artificial pancreas systems as well as for the treatment of insulin-resistant patients.

Allow me to focus for a moment on the RHI-based component of our ultra-rapid-acting insulin program. In June, we presented positive Phase I clinical data at the American Diabetes Association Meeting for our lead RHI-based ultra-rapid-acting candidate BIOD-123 and BIOD-125, demonstrating that both formulations met pharmacokinetic, pharmacodynamic and injection site tolerability selection criteria for advancement into Phase II clinical trials.

As previously announced, BIOD-123 has been selected as the lead candidate for Phase II clinical trials. The Phase II study will be a randomized, open-label parallel group study conducted at investigative centers in the U.S. Subjects with Type 1 diabetes will be randomized to receive either BIOD-123 or insulin lispro sold as Humalog to use as a mealtime insulin.

Both arms of the study will use insulin glargine sold as Lantus as the basal insulin. The treatment duration will be 18 weeks. This study will evaluate HbA1c control as the primary end point, and secondary end points including postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.

We’ve completed a thorough examination of the opportunities to enhance the utility of the data from this study, and have determined that increasing the sample size from the originally planned 70 randomized subjects to 130 subjects would allow us to make go-no-go decisions based on analysis of the primary and key secondary end point with substantially increased confidence.

We’ve contracted with an experienced CRO to implement this study, and we anticipate that initiating additional investigative sites will allow for the increased number of subjects to be enrolled without extending timeline. We look forward to reporting initiation of the study this quarter, and top line Phase II clinical data in the third calendar quarter of 2013.

As for our insulin analog-based ultra-rapid-acting formulations, BIOD-238 and BIOD-250, we are pleased to report that the development continues to progress as we remain on track to initiate a Phase I study to evaluate the pharmacokinetic and injection site tolerability profiles of these formulations, relative to the market at insulin analog, later this year, and to obtain Phase I clinical top line data in the first calendar quarter of 2013.

As we entered the last quarter of our fiscal year with the balance sheet strengthen beyond expectations, we’re examining measures in our usual and customary annual budgeting process that will enable us to capitalize on the strategic opportunities in the execution of our development programs, while maintaining our focus on the prudent utilization of resources.

Previously, we provided guidance that our cash run rate would last until the middle of 2013. We are pleased to report that our current cash run rate forecast extends beyond the RHI-based Phase II top line data readout targeted for the third calendar quarter of 2013, and also the submission of our glucagon NDA projected by early 2014. One time annual budgeting process is behind us. We look forward to providing additional updates on the goals and achievements regarding these promising products candidate development programs. That concludes my introductory remarks.

Now I’ll turn the call over to Gerard for a review of our third quarter 2012 financial results.

Gerard J. Michel

Thank you, Errol. Biodel reported a net loss for the three months ended June 30, 2012 of $6.1 million or $0.52 per share compared to a net loss of $4 million or $0.48 per share for the same period in the prior year. Research and development expenses were $3 million for the three months ended June 30, 2012 compared to $2.9 million for the same period in the prior year.

General and administrative expenses were $1.8 million for the three months ended June 30, 2012 compared to $2.4 million for the same period in the prior year. The decrease in G&A expenses was primarily attributable to lower stock-based compensation expenses.

The results for the three months ended June 30, 2012 and 2011 included an increase of $1.4 million, and a decrease of $1.4 million respectively in the fair value of common stock warrant liability. Expenses for the three months ended June 30, 2012 and ‘11 included cost of $300,000 and $1.3 million respectively in stock-based compensation expenses related to options granted to employees and non-employee directors. Biodel did not recognize any revenue during the three months ended June 30, 2012 or 2011.

On June 12, 2012, we implemented a shareholder approved one-for-four reverse stock split, and on June 27 of 2012, we announced that we regained compliance with the listing requirements authorized and continued uninterrupted trading on the NASDAQ stock market.

On June 27, 2012, the company completed a private placement of an aggregate of 4.3 million shares of the company’s common stock, 3.6 million shares of the company’s Series B convertible preferred stock, and warrants to purchase of aggregate 2.75 million shares of common stock at an exercise price of $2.66 per share. The company received net proceeds after deducting placement agencies, and other transaction expenses of approximately $17.2 million from the private placements.

At June 30, 2012, Biodel had cash and cash equivalents of $43.7 million. At the end of the quarter, shares outstanding included 14 million shares of common stock, and preferred stock, which upon conversion would represent an additional 4.1 million shares of common stock. That concludes our prepared remarks.

Now, we’d like the operator to open the call to your questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) Our first question comes from Matt Kaplan of Ladenburg. Your line is now opened.

Matthew Kaplan – Ladenburg Thalmann Securities

Hi, guys. Can you hear me?

Errol B. De Souza

Yeah. Hi, Matt. How are you doing?

Matthew Kaplan – Ladenburg Thalmann Securities

Doing well. Thanks. How about yourself?

Errol B. De Souza

Good.

Matthew Kaplan – Ladenburg Thalmann Securities

Good. Just wanted to get a little bit clarity with respect to the clinical programs you have planned. Can you give us a little bit more detail in terms of the glucagon’s timeline, and then also the costs associated with getting to the NDA you expect in early 2014?

And then similarly for the ultra-rapid insulin, I guess 123, and I guess, earlier-stage 238 and 250, can you give a sense of those, the cost of those programs, and also the timelines with respect to potentially getting to NDA for the ultra-rapid insulin as well?

Errol B. De Souza

Okay. Let me do this. Let me talk briefly about the timelines for each one of the programs, and then I’ll ask Alan to elaborate on those, and then I’ll turn it over to Gerard in terms of talking about anything related to costs.

Matthew Kaplan – Ladenburg Thalmann Securities

That’d be great.

Errol B. De Souza

Okay. Let’s start off with the glucagon program. As we had mentioned previously, we’ve already initiated top finding studies in terms of dose escalation. Those studies are underway and those are critical in terms of looking at our IND filing, which we’ve projected for either late this year or early next year, it’s right on the costs. And we anticipate starting our first study, and again Alan can elaborate on his thoughts there, would be what we’re calling a proof-of-concept study, which would be looking at various doses of our formulation relative to the competitor, which would be sort of the Lilly Glucagon Emergency Kit, and that would be followed by a pivotal trial. Both of those trials are going to take place in 2013. Whereas we’ve also mentioned, clinical development here is really not the gatekeeping item, it’s really more putting lots in stability in terms of the commercial registration batches, which would be required there.

And pulling that all together, we anticipate filing the NDA in early 2014. Alan, do you want to add anything to sort of the clinical development; I’ve just projected sort of the timelines?

Alan S. Krasner

No, I think, Errol summarized the two key studies we would do in clinic. They’re pretty straightforward studies and have been done before in glucagon development programs, and would be single dose type studies. And usually normal, healthy volunteers, and generally the PK and PD end points are pretty straightforward, and had been published. We would use that kind of published data to model the design of these studies.

Errol B. De Souza

All right. So now let me talk about sort of the timelines where we’re going to try and deal with timelines in my end.

Matthew Kaplan – Ladenburg Thalmann Securities

With respect to the glucagon, what do you need to show for a safety database?

Alan S. Krasner

In clinical safety?

Matthew Kaplan – Ladenburg Thalmann Securities

Yes.

Alan S. Krasner

Well, again, typically what has been done are these PK/PD type studies for the approval of the currently marketed glucagons, this is an unusual drug, in the sense that it’s not something that’s intended to be used in any way chronically or regularly. It’s really just kept by patients as an insurance policy around the house typically, in case they should have a severe hypoglycemic event. Hopefully, patients would never use it, and if they do use it, certainly not more than once a year. So this is not the kind of product we would expect chronic dosing for.

Errol B. De Souza

All right. The only other thing I can think of, Alan is, we could measure antibodies, but this is again an acute situation. And then, by the way one of things that I failed to mention is all of the clinical studies are being done in normal human volunteers. They’re not being done in patients.

So let me move to sort of the ultra-rapid programs, and then Gerard can deal with all of the timeline, the budget-related question. The ultra-rapid program, as we just mentioned on the call will start the Phase II for BIOD-123 versus Humalog as the comparative. We’ll start this quarter. We’ll put our announcement when we add those patients in. But we are on target to start that.

One of the things we just talked about is, we have close to double the size of the trial from 70 to 130 patients. But we’ve made sure that, that will not impact the timelines. As you may recall, previously we had projected this study to readout in third quarter 2013. The extended trial we project to readout also in the third quarter of 2013, and the way we’re achieving this is through having additional sites, but the recruitment rate, I mean, the total recruitment timelines should not be impacted.

Following those data, then we could be looking at a pivotal trial that could start late 2013, early 2014, and we anticipate that kind of a trial would take about 18 months. Obviously, it would be a multi-national trial in terms of moving forward. So that gives you sort of overall timelines there.

And then the final thing that I want to talk about in terms of timeline is, we have a second arm to the ultra-rapid-acting program, which is an analog-based program, which has two candidates BIOD-238, BIOD-250. They’re going to go head to head with the analog comparator. We’re going to look at PK/PD, and we anticipate top line data in the first quarter, early 2013 is what we’re projecting.

Let me turn it to Gerard in terms of what he can talk about overall from a budget standpoint, or cash runway standpoint.

Gerard J. Michel

Hey, Matt, I think I heard you ask two questions. One was related to the cost to complete the trials that we are initiating now, glucagon as well as on RHI Phase II, and then perhaps the analog Phase I. I don’t want to give specific numbers for specific programs. I will say that the cash we have right now is adequate to reach significant milestones for each of those programs. So for example, we will get through our analog Phase I, we’ll get through our RHI Phase II with the top line data targeted to readout in the third quarter of 2013. We will get through our proof-of-concept trial for glucagon as well as our pivotal trial for glucagon, and which will occur in 2013, and filed with the NDA in early 2014, with the cash we have.

In terms of moving forward, I think you asked about the cost to complete an ultra-rapid-acting trial, I don’t want to forecast what that will be going forward. I can’t – it’s at the past when we’ve been asked about that, what I’ve referenced is what it cost us in the past to do that work, which is approximately $10 million a pivotal trial, plus we’ve had to throw in some CMC registration trial cost and such registration batches, which might run upwards of $3 million or $4 million. Those are previously disclosed ranges in terms of what we spent in the past.

Matthew Kaplan – Ladenburg Thalmann Securities

Great. Great, and I understand you’re in the budgetary process, and I think we can kind of tease out some of the future R&D that you expect, I guess, for calendar year 2013, as we’re getting close to that. Can you give us a little sense of that? I mean it looks like perhaps for this year, if you’re continuing on this run rate, your R&D is probably in the $11 million to $13 million range. Do you see a significant ramp up in your R&D costs expenses in 2013 in terms of calendar year or in fiscal year?

Gerard J. Michel

Yeah. I respect you need to kind of put a model together here. I hesitate to give you specific numbers because we are a small company with small number of programs ongoing. And therefore our R&D expenses can really be lumpy. So I don’t want to give you something that’s going to put you way off on the model. What I would say is, you know our funds are going to last through at least the first quarter of 2014, which is what we said in terms of the milestones.

And it’s likely that the R&D research would increase overall, we’ve done in the past because we’re doing a bit more clinical development, and that happens to be the more expensive end of things.

Matthew Kaplan – Ladenburg Thalmann Securities

Fair enough. Then, do you expect your SG&A to remain relatively flat?

Gerard J. Michel

Yeah, of course.

Matthew Kaplan – Ladenburg Thalmann Securities

Good. Well, congrats on the progress, and thanks for taking the question.

Errol B. De Souza

Thank you, Matt.

Operator

Thank you. And our next question comes from Jason Butler of JMP. Your line is now open.

Jason Butler – JMP Securities LLC

Hi, guys. Thanks for taking the question. A question on the 123 program and the Phase II trial, given that the PK/PD profiles of this formulation is very similar to the old Linjeta formulation, when you think about the results you could get from the Phase II trial, are you looking for a similar outcome to previous pivotal trials? Or is there any reason to believe that the results could be better or at least as good, maybe not in terms of A1c, but maybe in terms of weight gain or hypoglycemia?

Errol B. De Souza

Let me ask Alan to comment on both primary and secondary end points.

Alan S. Krasner

Well, our primary end point for this trial is, it has to be HbA1c, a non-inferiority, but in addition to that we have key secondary end points, which do include the things you mentioned. In addition to what you mentioned postprandial glucose excursions are an important end point as well as weight and hypoglycemia.

I mean the fundamental hypothesis underlying ultra-rapid-insulin development does imply, and based on that hypothesis, you would hope to see such benefits, particularly lower postprandial glucose and potentially less weight gain and less hypoglycemia as well, based on the improved ability to match that mealtime dose of insulin that you need to the insulin requirement after the meal.

This study will include Humalog as the comparator of lispro. And we have not done a multi-dose trial against lispro before the previous Phase III studies you’re referring to or comparing to regular insulin. But again, we do think that the difference in PK profile, which is easily measurable in Phase I should translate into these clinical outcome benefits, which we should see in the multi-dose trials.

Jason Butler – JMP Securities LLC

Okay. And then was there any evidence in the previous pivotal trials that the injection site tolerability was impacting compliance?

Alan S. Krasner

Well, we know that about 5% of the patients dropped out of the study because of that problem, because of the discomfort. And that was with our older prototype formulation. We know that the current formulations have improved tolerability relative to those, and we believe they’re comparable to Humalog or lispro. So we expect that to be less of a problem.

In terms of affecting compliance, that’s hard to measure. Compliance is always a very hard thing to measure. We do know that again 5% have stopped using it for that reason. But we have no reason to believe that patients were less compliant, those who continued in the study were less compliant as a result of that.

Jason Butler – JMP Securities LLC

Okay. Great. Thanks for taking the questions.

Errol B. De Souza

Thank you, Jason.

Operator

Thank you. Our next question comes from Richard Resnick of William Blair. Your line is now opened.

Richard Reznick – William Blair & Co. LLC

Hi, guys. This is Rich Resnick for John Sonnier.

Errol B. De Souza

Hey, Rich.

Richard Reznick – William Blair & Co. LLC

Hey, congrats on the progress. And I guess most my questions have been answered. But one thing I’m kind of intrigued by is this, is that the room temperature and the refrigerated versions of glucagon, and I was wondering if you could talk about the potential regulatory steps that might be a little different for the room temperature formulation such as – are there actually different excipients being used for room temperature formulation versus a refrigerated formulation? Or would it be so simple as just submitting a supplemental NDA going from the stabilized refrigerated version to the stabilized room temperature version?

Errol B. De Souza

Yeah. Rich, we obviously need to meet the requirements for stability, whether it’s a room temperature or a refrigerated formulation in terms of the specs both USP specs, which is what the FDA follows in terms of moving forward. So that wouldn’t change. And if we are looking at – again, we’ve really got a suite of formulations now with the in-license agreement that we have with Aegis. But we don’t anticipate any for using this similar kind of formulation for both a refrigerated and a room temperature presentation. The clinical trials would piggyback, and it would just be a supplemental filing in terms of the room temperature’s stable formulation that was there.

Richard Reznick – William Blair & Co. LLC

Okay, great. Thanks a lot and congratulations again.

Errol B. De Souza

Great, thank you so much.

Operator

Thank you. (Operator Instructions) We’ll give it another moment’s for questions. And we do have a question from Marc Stutman of Trimark. Your line is now opened.

Marc Stutman – Trimark

Hi, I’d like to have a follow-up question to the last one, just to get a clarification. Is the NDA that you’re going to submit for the emergency glucagon, is that going to be a refrigeration stored product?

Errol B. De Souza

Yes. Our first product presentation that we’re looking at now is a refrigerated liquid formulation of stabilized glucagon in an auto-injector. But as we’ve alluded to in the call and followed up in the questions, we’re looking at other presentations that would also have room temperature stability.

Marc Stutman – Trimark

Okay, and does the Aegis technology enabled you to do that room temp storage?

Errol B. De Souza

From what we know, and again, we just announced Aegis license in June. So our experience is more limited with Aegis than with the older formulations we’re working with at Biodel. But from what we can do look at in head-to-head studies at room temperature or accelerated stability under 37 degrees Celsius, it looks like the Aegis technology is tracking better than the formulations we’ve discussed before, which gives us the promise of room temperature stability products also.

Marc Stutman – Trimark

Okay. And one other, just to follow-up, 238 and 250, are those different formulations of the same analog?

Errol B. De Souza

Those are two different formulations of the same analog, you’re correct.

Marc Stutman – Trimark

Okay. All right, very good. Thank you.

Errol B. De Souza

Thank you so much.

Operator

Thank you. That concludes the Q&A portion of the call. I’ll now turn the call back to Dr. De Souza.

Errol B. De Souza

Thank you all for participating in today’s call, for your questions and have a great day.

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes today’s program. You may all disconnect. Everyone, have a great day.

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