Albireo Pharma, Inc.
Q4 2014 Earnings Call Transcript

Published: 18 Dec 2014

[Operator:]

Ladies and gentlemen and thank you for standing by. Welcome to the Biodel’s Fourth Quarter 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 call over to Paul Bavier, Biodel's General Counsel. Thank you, please begin.

[Paul S. Bavier:]

Thank you. Good afternoon and welcome to our fourth 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 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.

[Errol De Souza:]

Thank you, Paul. Good afternoon everyone. We are pleased to report on another quarter of rapid progress across our portfolio of pipeline candidates. This afternoon we will provide a status report on Study 3-151, second of two Phase 2a clinical trials of our concentrated upper rapid active insulin candidate BIOD-531, elaborate on the feedback that we have received from the FDA on requirements for pivotal trials and toxicology studies necessary to support an NDA filing for BIOD-531, and discuss next steps for the program. We will also provide 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 fourth quarter and year-end fiscal year 2014 financial results and we answer questions. Let me start off with some background information on our concentrated insulin program. BIOD-531 is a proprietary formulation of recombinant human insulin or RHI, EDTA, citrate and magnesium sulfate. It is formulated at a concentration of 400 units of RHI per milliliter. In February 2014 we provided extensive details on the positive data from Study 3-150 a Phase 1 clinical trial in which the pharmacokinetic or PK, pharmacodynamic or PD an injection tolerability profiles of BIOD-531, will compare to Humulin R U-500 and Humalog Mix 75/25 combined prandial/basal insulin. The data showed that BIOD-531 had a unique combination of an initial ultra rapid absorption profile with a basal duration of action. In our last earnings call in August we announced a positive top line results from Study 3-152, a Phase 2a clinical trial in Type 2 diabetic subjects with moderate insulin resistance compelling BIOD-531 to the marketed products Humalog Mix 75/25 and Humulin R U-500. Many of these patients with moderate insulin resistance use insulin premixes because these products are vastly 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 Humalog or NovoLog premixed with intermediate-acting basal neutral protamine insulin’s 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. Study 3-152 was designed to quantify the expected advantage in postprandial glucose excursions after standardized meals. Study 3-152 assessed post prandial glucose profile of subjects with Type 2 diabetes and moderate insulin resistance. We use to treat 50 and 150 units of insulin per day. A single subcutaneous injection of 0.6 units per kilogram of the study drugs was administrated with a standardized breakfast on separate days in a randomized forearm crossover sequence and that subjects received pre-meal BIOD-531, pre-meal Humalog Mix 75/25, pre-meal Humulin R U-500, and post-meal BIOD-531. In order to assess the duration of glucose lowering, subjects received a standardized lunch at 5.5 hours after test insulin dosing at breakfast and no insulin was administered with a standardized lunch. Blood glucose levels were measured every five minutes during the 12 hours after test insulin dosing at breakfast. The data validated the benefits of the ultra rapid acting lines of action of BIOD-531 seen in our Phase 1 study and clearly demonstrated a clinical superiority of 531 on parandial, post prandial glucose control compared to Humalog Mix 75/25 and Humulin R U-500. Furthermore the beneficial effects of 531 on controlling glucose responses was maintained following lunch and was seen even when dosed to 20 minutes after the breakfast meal. With unique pharmacokinetic and pharmacodynamic profile coupled with a high concentration record low volumes of projection has the potential for consider clinically significant benefits rate sub optimally sort of population updations with that meters [ph]. Our long term goal is to demonstrate that Biodel's 531 unique climax in profile along with its high concentration is better suited then currently available products to address the needs of not only moderately insulin resistant patients of diabetes who have more typical insulin requirements of under 130 units per day but also severely insulin resistant of diabetes who may require a concentrated insulin to cover their daily needs which often exceed 150 units per 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 up approximately $400 million. Eli Lilly's Humulin R U-500 was the only concentrated insulin product available for these patients. Humulin R U-500 duration of action is long enough to provide basal coverage but its onset of action is delayed relative to doses of R U-100 rapid acting insulin analogs and does not provide optimum mealtime insulin coverage. During the time we initiated a second Phase 2a Study 3-151, to evaluate the utility of the BIOD-531 in severely insulin resistant patients. Study 3-151 had a similar design for their study we presented in August except that it involved patients with diabetes who used more than 150 units of insulin per day or greater than a 100 units worth of insulin injections. That is patients who have significant insulin resistant with bits [ph] of concentrated insulin. In Study 3-151 we monitored glucose over a 24 hour time period following both a breakfast dose and a dinner dose each associated with standardized meals. This stimulates clinical factors in which Humulin R U-500 and Humalog Mix 75/25 are dosed twice daily with breakfast and with dinner. And secondary patients tested in this study is because of its greater speed of absorption after meal dosing of the BIOD-531 will provide glucose coverage at least as good as [indiscernible]. Many patients prefer to dose meal time insulin after meals. Study 3-151 was a single blinded forearm crossover study. On separate days in a randomized treatment sequence, subjects were treated with the BIOD-531 before the meal designated as pre-meal, the BIOD-531 after the meal designated as post meal, Humulin R U-500 pre-meal or Humalog mix 75/25 pre-meal. After glucose stabilization overnight, single 1.2 units per kilogram doses of steady drug were injected subcutaneously with a standardized breakfast. In order to assess the duration of glucose lowering subjects then received a standardized lunch, five and half hour after breakfast, and no insulin was given with lunch which again stimulates the real usage of the comparative products. Subjects then received a second dose of 0.8 units per kilogram of the same test insulin either before or after a standardized dinner. Glucose levels were monitored frequently for over 24 hours after breakfast dosing. We are pleased to report that the clinical portion of the study has just completed. 12 subjects were randomized and 11 patients completed their studies. We are targeting release of the top line data during the week of January 5, 2015 prior to the JP Morgan conference. In parallel we are conducting two Phase 2a trials. We contacted the FDA in early summer for filing the safety and clinical development program that will best characterize and assess the BIOD-531. We received written feedback from the FDA in late September and based on our preliminary market assessment that BIOD-531 had primary utility for the treatment of Type 2 diabetes patients with moderate to severe insulin resistance. We have proposed a single pivotal Phase 3 study in this patient population. The FDA referred us to a paper about Biodel which was recently published in Endocrine Practice Journal in July 2014 reporting that approximately 20% of patients who use Humulin R U-500 and approximately 25% of patients use 150 units a day of U-100 insulin are Type 1 diabetes patients. This is crucial in the potential market for BIOD-531 to include both Type 1 and Type 2 diabetes patients along with the work of off label use in patients with Type 1 diabetes led the FDA to request two pivotal Phase 3 trials for BIOD-531, one in patients with Type 1 and one in patients with Type 2 diabetes. The FDA also requested that a toxicology study for BIOD-531 be performed prior to conducting the Phase 3 pivotal trials. While the feedback resulted in us conducting a more extensive program than originally in patients of BIOD-531, but market opportunities is significantly greater from that limited to severe insulin resistant patients. Based on the exciting data from our previously reported Phase 2a Study 3-152 in Type 2 diabetes patients with moderate insulin resistance demonstrating greater superiority of BIOD-531 over Humalog Mix 75/25 in controlling glucose following meals. Along with the clarity from the FDA on requirements for pivotal trials we are pleased to announce our decision to rapidly advance BIOD-531 into late stage development. We will be initiating in 2015 a form of GLP toxicology study along with chemistry manufacturing and controls the CNP requirements which must see performed prior to Phase 3 pivotal trials. These activities usually take about 12 to 18 months to complete and would enable 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 8 weeks, that is 6 weeks dose titration followed by 12 weeks of stable dosing. The primary objective will lead to show HbA1c non-inferiority. Secondary end points will improve assessments of hypoglycemia, weight, and post prandial glucose. If successful these data will significantly de-risk a Phase 3 program which is based on the FDA feedback, we will need to include one study in patients with Type 1 diabetes and another with patients with Type 2 diabetes. We project that the top line results from Study 3-250 will be available in 2016 which will coincide with the completion of the toxicology and CNP studies for initiation of Federal trials. Interest in the use of concentrated insulin and insulin pumps is also increasing. The Biodel studies are to be first and previously reported at approximately 25% of Humulin R U-500 use is off label in insulin pumps. As part of the small business innovation research grant has been funded by the National Institute of Health. We have conducted studies in diabetic swelling to evaluate BIOD-531 for use in insulin pumps in comparison with Humalog and Humulin R U-500 data from these studies which demonstrate that the rate of absorption and all set of action of BIOD-531 is similar to Humalog and faster than Humulin R U-500 fall in pump – administration will presented in an old fashion at the 30th Annual Meeting of the European Association for the study of diabetes in Vienna, Austria on September 18, 2014. This will lead to the evaluation of BIOD-531 administered using insulin pumps for diabetes patients who are highly insulin resistant and require large doses of insulin. BIOD-531 along with the rest of our ultra rapid acting insulin portfolio is protected by patents issued in the U.S. and European Union that expire in 2026 and 2025 respectively. We have several additional patent applications that could extend the patent life of these products beyond 2026 in the U.S. and other parts of the world. The strength of our patents was recently reinforced by the successful defense of oppositions to two of our granted European patents for ultra rapid acting insulin formulations. A third party opposed Biodel patents in July 2013. The opposition division and the European patents office recently ruled and favored the validity of the Biodel patents. It was held that all claims of both patents are novel and inventive by Biodel therefore regains all of its patents and claims as originally granted. Let me now turn to our Glucagon program which is focused on developing a portfolio of rescue presentation for diabetes 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 these goals. An advanced program for which we expected to meet 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 is a customized version of an auto reconstitution syringe manufactured by Unilife 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 strategy for clinical development is demonstrated both pharmacokinetics and pharmacodynamic by equivalents between Biodel's Glucagon formulation designed for use in the GEM profile and even Lilly and Novo's marketed formulation of Glucagon. In the last few months we have continued progress on GEM including filing up the IND in July in order to initiate clinical development. Earlier this month we announced that we had initiated a Phase 1 proof of concept study for which we will measure both the pharmacokinetics and glucose response after the pharmacodynamics, Biodel's Glucagon formulation compared to Lilly and Novo Glucagon. We plan to enroll 12 healthy volunteers and put them on fixed arm cross over trial so administering all three Glucagon formulations following both intramuscularly or IM and subcutaneously or subcue and separate dosing days. We would like to report top line PK/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 Federal trial in which approximately 30 healthy volunteers will receive the BIOD-961 and the marketed co-imperator [ph] both subcutaneously and intramuscularly on separate days in a very similar cross over design. In parallel we are carrying out human factor studies which we are planning to further compare, the usability of the GEM device with existing manually reconstituted commercial Glucagon kits in the hands of representative caregivers and this will take place in early 2015. The final submitted pivotal human factor study is planning to complete in the third calendar quarter of 2015. Lastly and our contract collaboration with Unilife adds the responsibility for the manufacturing ability of registration loss. We continued to work closely with Unilife and our manufacturing partner in merchandise solutions, will perform all of the necessary CNP requirements and device manufacturer activities for our NDA submission. 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 course of action as 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 now are testing several formulations with promising stability in our model and anticipate selecting formulations in the first half of 2015. We also continue to develop stable, pumpable, liquid Glucagon formulations that could further extend the market and address other applications such as development of an artificial pancreas. In closing I look forward to reporting on key milestones in early 2015 such as the top line data from BIOD-531 Study 3-151 in early January. 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 fourth quarter fiscal year 2014 financial results.

[Gary G. Gemignani:]

Thank you Errol and good afternoon everyone. Biodel reported a net loss of $2.3 million and $14.1 million or $0.10 and $0.62 per share for the quarter and year ended September 30, 2014 respectively. These results compared to a net loss of $800,000 and $19.3 million or $0.04 and $1.24 per share for the quarter and year ended September 30, 2013 respectively. Biodel did not recognize any revenue during the quarter and year-ended September 30, 2014 or 2013. At September 30, 2014 Biodel had cash and cash equivalents of $24.6 million and 23.1 million shares of common stock outstanding.

[Errol De Souza:]

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

[Operator:]

Thank you. [Operator Instructions]. Our first question comes from the line of Liana Moussatos with Wedbush. Please proceed with your question.

[Liana Moussatos:]

Congratulations on all your progress, I was writing really quickly to try and keep up. So sorry if I missed something in the questions I am about to ask. For the Glucagon program for GEM you just repeated the 2015 catalyst or the Phase 1 proof of concept data. After that what are the steps to get to NDA filing?

[Errol De Souza:]

Liana beyond proof of concept study is really to take the competitors that we are going to do the pivotal studies. And so once we got the competitor to pick the pivotal studies which require the manufacturing or registration lots using that material of pivotal studies which we anticipate will happen in the second half of 2015. And then the other aspects will be the human factor studies. As I mentioned we will be conducting a second formative human factor study in terms of looking at how the GEM price compares to the kits that are currently there. As you may recall in our last earnings call we mentioned how pleased we were with the first human factor study that we did where with frankly no training whatsoever subjects looked at the device, looked at the instructions, and delivered the full dose with needle retraction with an average of 34 seconds. Which is ideal for an emergency setting but we’d like to do another one just to see, we anticipate 34 seconds is a lot better than the current commercial kits but we would like to quantify the benefits there as well as to quantify the benefits that you would have in terms of limiting dosing average as an example. And that will be followed by the affirmative human factor study which will be done probably in about 150 subjects and that’s equivalent of the pivotal trial for my human factor study for the NDA filing. And then the final thing is the manufacturing of the registration lots which is the responsibility of Unilife and we are working with them and Emergent and we will come back with specifics on that time line. But that becomes sort of a gating item for stability, putting the lots up on stability which is the gating item for the NDA filing. And obviously we need those logs for the pivotal trial. So, that takes you through nearly the whole development plan as we currently envision it and we are pretty excited. The other thing I should mention that we’ve done in parallel and we don’t have the full data set, we have commissioned an independent -- to do a whole marketing analysis related to the market opportunity and as soon as we have those numbers we will share with you because that is very helpful in terms of also building the models. But the preliminary data looks very encouraging in terms of the market opportunity that depends for this product.

[Liana Moussatos:]

That’s great and for concentrated insulin 531, what would we get out of the early January data that will help us think about the Phase 2 be it from the start in the second quarter?

[Errol De Souza:]

Great question Liana. Actually the Phase 2b that Alan is planning on starting in the second -- late first quarter for second quarter is actually based on the study that we released back in August. That’s really the basis for the study and you might recall there was superiority where you really didn’t need those statistics where we showed benefits in terms of real time coverage following -- in comparison with both the Humalog Mix as well as U-500. The primary comparative there was the Humalog Mix in terms of looking at it and it also tells us that we have the duration of action in that and those benefits were maintained for lunch hour, so that we would be similar but we were better than that. So although the data that are actually the basis for the trial that Alan has already started planning for where we, Alan why don’t you describe the trial for Liana in terms of the number of subjects and the basis of that.

[Alan S. Krasner:]

Sure, so the Phase 2b trial we are planning is we will enroll a very similar patient population compared to that new study that we reported earlier in the year. In Type 2 patients who take moderate doses of insulin typically in the 40 to 50 mg and above and these are that patients necessarily who take super high doses of insulin say over 150 units per day. So it is more the larger population of Type 2 patients that we have enrolled in the Phase 2 trial and again that's the same population we had in the previous study. So at least about 130 of these patients will be randomized to receive either our concentrated insulin BIOD-531 or Humalog Mix 75/25. And it is clear study so they will be treated, they will be titrated for a period and then treated stably for about three months. And as is the case with parallel group trials with insulin, the primary endpoint would be HbA1c majority. However, based on our new test results reported during the year and it just looks like BIOD-531 is clearly a more efficient glucose lower than Humalog Mix and we would hope to be able to show materially very easily in such trials. The secondary endpoints are standard for these trials, things that will carefully manage our hypoglycemia, patients weights, and meeting safety parameters as well.

[Errol De Souza:]

The attendance, this really gives I think -- so that we truly derisk pivotal trials. It also fits in very nicely with the time that we need to prepare for the pivotal trials for 2015. So in parallel we will be doing the toxicology, so we will be doing the manufacturing of logs that will be required for the pivotal trials, and those two are going to ducktail growing nicely in terms of the data coming out of the Phase 2b in 2016 and hopefully initiated the pivotal trial. So we won't slow that process down because we will be preparing for the pivotal trials in 2015 while we get additional data. We are really pleased with 531. This year we have reported PK/PD data we have during the year and will have completed two Phase 2a trials. So I will stop there, I hope I have given you probably more detail than you were looking for.

[Liana Moussatos:]

That was great. And can you give us run rate guidance on the $24.6 million cash at the end of the…?

[Errol De Souza:]

That's Gary.

[Gary S. Gemignani:]

Sure I will handle it. The $24.6 million will take us through the fiscal 2015 year. We also had some remaining capacity of the two -- of the equity line and APM facilities of approximately $23 million as well.

[Liana Moussatos:]

Thank you very much.

[Errol De Souza:]

Thank you.

[Operator:]

Thank you. [Operator Instructions]. Our next question comes from the line of Wangzing Lee [ph] with Ladenburg. Please proceed with your question.

[Unidentified Analyst:]

Hey, thanks for taking my question. Congratulations on your progress. This one is Wangzing [ph] for Matt Kaplan. So my question is regarding the FDA feedback on the pivotal study design, I wonder if you can add more color or give more details on design of the pivotal study?

[Errol De Souza:]

Sure. You want me to just remind you what I said in the call where the FDA required really one study in Type 1 patients given that there is quite a bit of use of both Humulin R as well as the mixes and a study in Type 2. And Alan why don’t you describe what are the trial design and the approximate number of patients that you would need for these trials.

[Alan S. Krasner:]

Great, so the trial design is similar for both the Type 1 and Type 2 study. It would be kind of parallel group study in which patients are randomized to receive BIOD-531 first as a competitor. Competitor in Type 2 study may very well be Humalog Mix, the Phase 2b study that we described earlier is really sort of a smaller version of that pivotal Phase 3 trial. These trials will be six months in treatment duration likely with extensions of about six months each. So subjects for each trials would approximately 500 patients and again a fairly straightforward -- in the sense that there was a period where as the doctors will titrate the doses for the patients, the last three months of the dosing will be relatively stable and HbA1c non-inferiority would be the primary objective with the same sort of secondary objective as we confessed earlier.

[Unidentified Analyst:]

Okay, each will be 500 patients for six months and the difference between Type 1 and Type 2 because of sort of Type 1 maybe smaller size?

[Errol De Souza:]

Well any difference in the size of the trials for Type 1, Type 1 represent a smaller percentage of the whole target population but what you got to think about is that the FDA frankly we don’t need that many patients for efficacy. These studies mandated by the FDA are more from a safety perspective. Alan, what are your thoughts.

[Alan S. Krasner:]

I agree, we certainly don’t need 500 patients HbA1c in our experience and I think the FDA wants extra patients to evaluate for safety signals and things like that. Right now I am not aware that we have a difference in the sample size between the Type 1 and Type 2 patient studies. But during -- the protocol is an open process and with further discussion there may be some truth into that.

[Errol De Souza:]

The other thing that happened in our experience in the past although you can never take this for granted is when we’ve done a Phase 2b, we have almost got credit for some of that because that gives you also a safety database but right now we are being very conservative in terms of the feedback we’ve achieved from the FDA, in terms of what is the size that Alan is talking about.

[Unidentified Analyst:]

Okay thanks. Do you want to be ahead of starting dose determined for the pivotal study or we have to determine after the Phase 2b study.

[Errol De Souza:]

Why don’t you describe how you determine the doses are really a titration.

[Alan S. Krasner:]

Well so we don’t have any particular reason to believe right now that we have to sort of adjust the starting doses of BIOD-531 versus any other insulin. And so the starting dose will probably be similar to the kind of doses patients already taking. That factor they want to starting on new insulin doses are titrated based on the patient self monitored glucose levels. So we will see particularly in the Phase 2b study we will have a very good read on how our drug and Humalog Mix is titrated sort of in real world conditions. And that will help us if there needs to be any sort of dose initiation, special dose initiation instructions will have in Phase 2b study.

[Unidentified Analyst:]

Okay, guys. Thanks very much. One last question is about the GEM program regarding of the manufacture of the injector. I mean do you have more color in terms of the speed or capacity that you mentioned there as well as creating -- do you have kind of projection when that it can be completed?

[Errol De Souza:]

It’s a great question. That is exactly the dialogue we’re having with our partner right now Unilife since they are the ones who are the manufacturing them all as we speak. And we hope that, that will be completed. I know we have some meetings in terms of Unilife as well as Emergent and Biodel in terms of nailing down those studies. And we’ll obviously come back to you in terms of the specific that we are working now in terms of making sure that all of things are together in terms of moving forward.

[Unidentified Analyst:]

Alright, great. Thanks for answering my questions. [Inaudible]

[Errol De Souza:]

Great, thank you so much.

[Operator:]

Thank you. Our next question comes from line of Jason Butler of JMP Securities. Please proceed with your question.

[Jason Butler:]

Hi, thanks for taking the question. Errol I know you touched on the commercial opportunity both the premix and the insulin resistant markets, can you maybe give us any updates you have from market research or interactions you had with physicians throughout the quarter on what you think the ultimate commercial opportunity could be for 531? And then second to that is a broader question, could you give us any insights into what you think the strategic or partnerships interest might be in all of your various insulin programs?

[Errol De Souza:]

Thanks Jason. No, I think you are really asking about the Biodel opportunity in moving forward which we are very excited by. Let me answer in sort of the Glucagon because it really is related in some ways to our strategy. The -- opportunity is obviously larger than we were first hoping to move forward on and if you look at the lets say the prandial basal mix market, worldwide it's about 3 billion right now. U.S. alone 1.5 billion to 2 billion and the concentrated insulin market with Humulin, if you look at the price points of that old products it is now that there has been a threefold price increase over the last 2.5 years. And then it’s probably going to be $400 million or $500 million product now and keep on increasing. So clearly that’s a segment I think that’s increased. So you are talking about some really meaningful potential revenues from that. You know the GEM program with the backup that we have I should say second generation with the Uni-Check also represents I think a very significant opportunity of not a billion but several hundred million which I think is an exciting time at Biodel in terms of let’s have a strategy in terms of moving forward. And part of the reason we have commissioned a study for the GEM program first, is to make the decisions whether we want to market on our own this program which would be primarily the endocrinologists so limited sales force. You know I could envision Biodel marketing the GEM program which would be late 2016, 2017 in terms of looking at that opportunity with a limited sales force. We are also getting the numbers that if you decided to partner in terms of what we would look at from an NPD standpoint, but if you go down the path that we have a sales target to and endocrine sales force then for BIOD-531 it becomes really very nice for us to be able to leverage that sales force to target endocrinologist or maybe the resistant population of Type 2 diabetics which will be several hundred million dollar opportunity. Currently sales with Humulin 500 while we partner with primary care physician market, that’s not an area that we think about. So the excitement for us at Biodel is with these two opportunities was actually synergies in terms of how we see ourselves moving forward. And we really look forward to sort of unveiling that whole strategy but we don’t want to put sales forces and promotional strategies ahead of cynical data which is really where 2015 is with lots of milestones.

[Jason Butler:]

Great that’s really helpful thanks a lot Errol.

[Errol De Souza:]

Thank you Jason.

[Operator:]

Thank you. That is all the time we have allotted for questions. I will now turn the call back over to Dr. De Souza

[Errol De Souza:]

Great. Thank you everyone. We really appreciate you joining the call. We want to wish everyone a happy holiday and for those of you who are going to be out in San Francisco in early January we look forward to getting together with you and we should have the data from 3-151 which we anticipate releasing before that. So look forward to a great dialog. Happy holidays everyone.

[Operator:]

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