Akebia Therapeutics Inc (AKBA) 2015 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Akebia Therapeutics earnings call.

(Operator Instructions)

I would now like to turn the call over to your host for today, Nikki Hadas, General Counsel. You may begin.

Thank you. Good afternoon everyone, and thank you for joining us today to discuss Akebia's 2015 year-end financial results. Today's call will be archived and a replay will be available after this call. This conference call includes forward-looking statements. Each forward-looking statement contained in this call is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.

Additional information regarding these factors appears under the heading Risk Factors in our 10-K filing and press release filed today with the Securities and Exchange Commission and available at www.SEC.gov and on our website at www.Akebia.com. The forward-looking statements in this call speak only as of the original date of this call and we undertake no obligation to update or revise any of these statements. I'd like to now turn the call over to our Chief Executive Officer, John Butler.

Thanks, Nikki, and good afternoon everyone, and thank you all for joining us today to review our 2015 financial results and corporate progress. During today's call I'll review our major accomplishments over the past year. Jason Amello, our Chief Financial Officer, will then review our financials. I'll close with our outlook for 2016 before opening the call for questions. Joining us for Q&A will be Dr. Brad Maroni, our Chief Medical Officer; Nikki Hadas, our General Counsel; Michel Dahan, our Chief Business Officer; and Dr. Ramin Farzaneh-Far, our Vice President of Medical Research.

2015 was a transformative year for Akebia marked by significant clinical regulatory, intellectual property and corporate progress. We successfully executed all of our key objectives and are well positioned to build on this momentum in the coming year as we advance our global development and commercialization strategy for vadadustat, and further demonstrate the therapeutic potential of HIF stabilization.

As many of you know vadadustat is a novel small molecule inhibitor of hypoxia inducible factor-prolyl hydroxylase, or HIF-PH, in development for the treatment of anemia related to chronic kidney disease or CKD. Vadadustat enables normal physiologic levels of EPO to be restored, allowing for a gradual, stable and controlled hemoglobin response. We believe that managing anemia through this pathway has the potential to translate into an improved safety profile over today's standard of care, injectable Erythropoiesis Stimulating Agents, or ESAs, which has been shown to clearly increase cardiovascular events in CKD patients.

Further, we believe that vadadustat mechanism of action provides a specific response in the same manner as naturally occurs with a moderate increase in altitude. This response provides an enhancement in the normal daily variation of EPO, and relative to other HIF compounds, we believe has the potential to the yield a best-in-class product profile.

The data that has emerged from our 15 completed clinical studies reinforces the advantages of our approach in both non-dialysis and dialysis CKD patients. And last year we had the opportunity to highlight our Phase 2 data at several high-profile medical meetings. Investigator for the Phase 2b study of vadadustat in non-dialysis patients, including Dr. Bruce Spinowitz of New York Presbyterian Hospital, Dr. Pablo Pergola of Renal Associates of Texas, and Dr. Volker Haase of Vanderbilt presented data from that study at the leading kidney disease meetings his last year.

Most recently, at the American Society of Nephrology Kidney Week, they presented the data demonstrating that treatment with vadadustat controls hemoglobin levels in a sustained manner, and in a clinically relevant range, producing a coordinated physiologic response to resolve anemia while avoiding the excessive fluctuations in hemoglobin levels which have been associated with increased cardiovascular risk. Also at the ASN meeting, to Dr. Haase presented the data from our Phase 2 study in dialysis patients. In patients converting from ESA therapy vadadustat maintained stable hemoglobin levels over 16 weeks of treatment, whether dosed once daily or three times weekly.

Overall the collective data from our vadadustat studies suggests an efficacy and tolerability profile that fits squarely within the goals of new anemia treatments, which is focused on tightly controlling hemoglobin levels, minimizing hemoglobin excursions above 13 g/dL and improving the safety profile. Our Phase 3 development program is designed to build on these positive results. Support the registration in major markets worldwide and collect the data required to establish a new standard of care for CKD patients.

In October we announced that we had reached agreement with both the FDA and EMA on our Phase 3 program for vadadustat in non-dialysis dependent CKD patients, known as the Pro2tect Program. We launched Pro2tect at the end of last year. It includes two separate studies: a correction study and a conversion study. The correction study addresses anemia patients not currently being treated with recombinant ESAs. The conversion study includes patients currently receiving ESAs, who will be converted to either vadadustat or the active control, darbepoetin, with the goal of maintaining their baseline hemoglobin levels.

Both studies will include a 1:1 randomization and an open label active control non-inferiority design and will collectively enroll approximately 3,000 patients across 500 sites globally. Primary end-points include an efficacy assessment of the hemoglobin response and an assessment of cardiovascular safety measured by major adverse cardiovascular events or MACE. We're now actively enrolling patients in both the correction and conversion studies and expect to complete enrollment in late 2017.

Now during our interactions with the regulatory authorities last year, we also discussed a parallel Phase 3 program for vadadustat in CKD patients undergoing dialysis, known as INNO2VATE. We are now in the process of presenting full results from our Phase 2 dialysis study to both agencies. We look forward to providing an update on our discussions with the regulatory authorities in the near term, but importantly remain on track to commence that program in the middle of this year.

A critical element of our global commercialization and corporate financing strategy is centered on partnering vadadustat in key territories outside the US. A stated goal for 2015 was to secure a Japanese partnership by year-end, and we were pleased to deliver a high-value collaboration with Mitsubishi Tanabe in December. Mitsubishi is widely recognized as one of the most successful companies in Japan, with a large established sales force and a strategic focus on renal disease and diabetes that will serve to maximize the potential of this innovative product in this region.

Under the terms of our agreement Mitsubishi has exclusive rights to market and promote vadadustat in roughly two dozen Asian countries. The major markets include Japan, Taiwan, South Korea, Indonesia and India. In exchange Akebia received a $40 million payment upfront and will receive an additional $60 million in payments for our global Phase III program, bringing in a total of $100 million in committed capital to support the development of vadadustat.

We are also eligible to receive up to $250 million in additional milestone payments based on the achievement of certain development and sales milestones. In addition Mitsubishi will make tiered royalty payments from the low teens up to 20% on sales of vadadustat in the covered territories. This transaction offers important validation for the vadadustat value proposition and importantly provides us with a partner who shares our vision for the development of vadadustat and significant funding for our global Phase 3 program.

With respect to our European partnering activities we are advancing discussions with multiple parties. Our goal is to secure a partner with significant expertise who's aligned with our strategy and willing to make the financial commitment necessary to continue development and support potential commercialization of vadadustat. We succeeded in finding this with Mitsubishi and we're pleased with the progress we are making on this front in our European partnering discussions.

In support of our commercial efforts for vadadustat, we've reported tangible progress on the IP front in order to preserve our access to key markets worldwide. We've successfully challenged the FibroGen anemia patent family and reported favorable outcomes with proceedings in both Japan and more recently Europe. Specifically, in January we reported that the Japanese patent office had accepted amendments to the claims of the FibroGen131 patent, significantly narrowing the scope of the patent. As a result, the 131 patent does not cover vadadustat or any pyridine carboxamide compounds.

In Europe just last week, we announced that we had prevailed in our efforts to challenge FibroGen 823 patent. After two days of comprehensive review the opposition division of the European patent office ruled that the patent as granted did not meet the requirements for patentability and revoked the patent in its entirety. We are pleased with this clear unambiguous decision by the EPO. While we expect the revocation will be appealed we are very confident that the comprehensive and definite ruling of the opposition division will be confirmed. This is a pattern that has been rejected multiple times and is never been granted in the US. Narrowed to exclude vadadustat without an appeal right in Japan and now as revoked in its entirety in Europe. Each of these objective rulings has confirmed our perspective of the invalidity of this patent. With these recent IP developments we have preserved commercial access to all team markets worldwide and further strengthened our value proposition for vadadustat. We do not believe that there is any other valid IP granted that will negatively impact that access.

Beyond vadadustat we've been leveraging our HIF platform to deliver additional innovative candidates that address major unmet needs. We filed an IND late last year for our second clinical candidate, AKB-6899, a small molecule HIF stabilizer with potential therapeutic benefit in oncology, ophthalmology as well as other indications. In in-vitro studies 6899 reduced VEGF levels in the presence of hypoxia and therefore has the potential to reduce VEGF in tumor cells specifically. In several preclinical models 6899 reduced tumor growth and the development of metastases. As we reported in January the IND is clear and we are on track to initiate a Phase I clinical study for 6899 in oncology toward the middle of this year.

As our pipeline matures we have also continued to expand and strengthen our Management Team to build on our expertise in HIF biology and support our transition to the Company's next phase of growth. For example in September we welcomed Dr. Ramin Farzaneh-Far as Vice President of Medical Research. Ramin previously served as Director of Cardiovascular Clinical Research at Gilead. His experience in designing and executing multi-sensor cardiovascular outcome trials complements the deep renal experience of our clinical team as we advance our Phase 3 programs. In addition, his experience in translational medicine will be of great value as we work to expand our HIF-PH pipeline.

2015 was a year of significant progress on multiple fronts, and I'm very proud of what the Akebia team has accomplished. In 2016 we're committed to maintaining our high level of execution as we advance our Phase 3 program for vadadustat, further drive our commercial strategy for this innovative product and initiate clinical studies for a second HIF candidate. And now I'll turn the call over to Jason to review our financials.

Thank you, John, and good afternoon, everyone. As John outlined the significant progress we've made in 2015, and our financial results follow in line (Technical Difficulty). Today I'll focus on the full-year 2015 results, but the details of the fourth-quarter results are also included in our press release. For year-end 2015 we reported a net loss of $60.7 million or $2.29 per share. That compares to a net loss of $123.9 million or $8.04 per share for the year-ended 2014. Keep in mind that the majority of that 2014 net loss is due to $86.9 million of accretion expense on our preferred stock through March 25, 2014, which was the date of our IPO and the date in which the preferred stock and the accretive dividends were converted to common stock.

Looking to the components of the P&L, on the revenue side we entered into the collaboration agreement with Mitsubishi Tanabe in December. Although the transaction closed in December and provided for an upfront payment of $40 million, no revenue was recognized in 2015. The $40 million upfront payment was contingent upon the Company receiving certain tax residency certifications directly from the IRS which we received in January 2016, and accordingly the cash was received from Mitsubishi in January. Since this is a multiple element arrangement under the revenue recognition guidance, that $40 million will not be recognized all in one period. We will provide more specifics on the revenue recognition policy and the methodology in our first-quarter 10-Q.

Moving to our research and development expenses, for the full-year 2015 R&D expenses increased $19.8 million or 85% to about $43 million compared to $23.3 million for the full year of 2014, driven primarily by costs related to the continued development of vadadustat. To that end we've initiated the PRO2TECT Phase 3 program which included CRO engagement and site selections, regulatory and CMC activities, all of which culminated with the dosing of the first patient in December. Research and Development expenses were further increased by the development of our second product candidate, AKB-6899, leading to the opening of an IND with the FDA at the end of 2015. And lastly, in support of these activities and developments we increased our R&D headcount. These costs were offset by the completion of our non-dialysis Phase 2b study in 2014 for which there's no comparable cost in 2015.

On the G&A side, general and administrative expenses were $18.5 million in 2015 compared to approximately $14.7 million for 2014, representing an increase of approximately $3.8 million. This increase goes hand-in-hand with the advancement of our clinical programs. Accordingly we expanded our G&A support with additional headcount and office space and continued to invest in commercial planning and patent-related activities for vadadustat.

Turning to our capital position, during 2015 we raised approximately $83 million through follow-on financings and our ATM facility. We ended the year with cash, cash equivalents and available for sale securities of $138.5 million. In January, 2016, we raised an additional net proceeds of $61 million through a public offering and also received the $40 million upfront payment from Mitsubishi related to the collaboration we completed in December. We anticipate that these cash resources will support our operations through at least the second quarter of 2017.

We ended 2015 with 30.7 million shares outstanding, but after the January financing our outstanding shares are now 37.9 million. With that let me turn it back to John for closing comments.

Thanks, Jason. Well, we're off to a great start this year. We have what we believe is potentially a best-in-class HIF candidate with vadadustat. We have a solid balance sheet that likely benefit further from a potential European collaboration. We also have an experienced leadership team, strong IP and a commercial strategy designed to maximize the value of vadadustat in key markets.

As we look towards 2016 we will continue to advance our clinical programs and further demonstrate the therapeutic potential of HIF stabilization. First we'll advance our PRO2TECT program in non-dialysis patients. We also look forward to reaching alignment with both FDA and EMA on key elements of our INNO2VATE program in dialysis patients, and then initiating the studies the middle of this year. We plan to initiate a study of evaluating the potential of vadadustat in ESA hyporesponders, and we're currently working with our clinical advisors on the design of that trial. We'll expand our clinical experience with HIF-PH, initiating a Phase 1 for 6899 in oncology, and finally we'll continue to advance our collaboration discussions for vadadustat, covering regions outside of the US and not covered by our Mitsubishi deal. Our goal is to strike the right deal with the right partner.

The therapeutic potential of HIF biology is increasingly being recognized by clinicians, scientists, and leading biopharma companies, and Akebia is really at the forefront in translating that promise into high-value therapeutics. And we look forward to reporting our progress to you in the coming months. And with that, we'll open the call for questions. Sonia?

(Operator Instructions).

Jonathan Aschoff Brean Capital

Thank you. Hello, guys, I was wondering if any potential EU partners wanted any IP clarity regarding the FibroGen EU patent or if your victory last week was for them as well as a foregone conclusion?

Hello, Jonathan, thanks for the question. So I think that the folks who are looking at the opportunity were very much aligned with us, that the this clearly was a patent that was properly revoked. But let's be clear, it's always a benefit when you get that ruling from the European patent office. So that was something that was very much a positive for everyone looking at the opportunity.

Thanks. I was also just wondering, when do we see perhaps initial results from this first 6899 trial that starts about mid-year, and could you describe that trial at all at this point?

So we expect to start the trial around mid-year, our expectation is that latent 2017 will have results from that trial, and if Ramin or Brad, do you want to comment on?

Happy to comment. Going to take a standard approach in the Phase 1 oncology looking at solid tumors. There is a dose escalation phase that's incorporated in those studies which means that you can't necessarily clearly predict exactly when the study will end or the degree of judgment that comes as you're escalating the dose and looking at the effects of the compound. But it is going to be a very standard Phase 1 approach to ontological drug development in all kind of tumor patients with solid tumors

Thank you very much

Thanks, Jonathan.

Kennen MacKay, Credit Suisse.

Thanks for taking my question. Quick question maybe for Jason, on the financial guidance into Q2 2017, does that including payments from Mitsubishi Tanabe? And any expectations for an EU partner there?

No, the cash guidance that we gave to Q2 2017 includes basically the cash on hand at the end of the year plus the financing of $61 million that we did in January, and then inclusive of that upfront payment. That cash alone will carry us to the second quarter of 2017.

Got you, thank you for clarifying that. And then just one for John, on the EPO revocation of the FibroGen patent, I was just wondering a little bit about sort of the appeal process there, the potential for length of an appeal, and then from your ongoing discussions with potential European partners whether you think we could expect a partner to come on maybe prior to the resolution of that potential appeal?

Well, absolutely. So we do expect the ruling to be appealed. That's the expectation we're going in with, but that -- the time to get through that process can be as much as three years or even more. But the end of the day, last week FibroGen had the opportunity to present its best arguments for patentability and the opposition division found that the claims didn't meet that requirement. The OD does not like to revoke a patent. And I think you can see from the fact that we spent two days on this process that they worked very hard to find a path forward for FibroGen to maintain a patent. But it simply did not meet the sufficiency requirement for being patentable and therefore it was revoked.

So we expect, we feel very, very confident that will continue to be revoked. And we certainly, as I mentioned before, the folks that we're talking to, the potential partners that we're talking to expected the same and understand the process in Europe. And we certainly don't expect to have to wait for the appeal process to work through before we will be able to sign a partner.

Got you. Okay, terrific, thank you for that color and clarity, and then maybe one other question if I may on the ongoing PRO2TECT study, is there anything you can comment on enrollment in the studies? Both the correction and conversion as well as maybe how many sites have been opened on that trial?

So we are very pleased, it's very early days obviously, still in the first quarter of enrollment, but we are very pleased with how that's going and it's meeting our expectations. As I mentioned, we expect to have full enrollment in PRO2TECT toward the second half of 2017.

Okay got it, thanks so much.

(Operator Instructions).

Ed Arce, H.V. Wainwright & Company.

All right, thanks for taking my question.

Hello, Ed.

Hello. Just a couple, if you could just talk us through the final preparations ahead of the initiation of INOVATE in a year and what's left there?

Sure, sure. So as I mentioned, we are still in the regulatory process there. As I mentioned previously, when you're trying to harmonize a study between the FDA and EMA, there's some back-and-forth that has to happen. I think we feel quite comfortable having described the overall program, the key components of the program to both agencies while we were going through the non-dialysis process. I think we feel very confident where we've disclosed what our expected patient numbers are, et cetera.

But obviously there's details you want to make sure you have harmonize between the two agencies to make sure you are able to execute the global study, and we are well on the way with that and look forward to updating you shortly. So once we feel that we have that agreement between the regulators, then we go about finalizing the protocol, submitting that to IRBs et cetera, and that's what we will then take the time before we would initiate the first patient. And the expectation can, based on the way the timeline is moving now, that in the July maybe August timeframe we'll be dosing the first patient in INOVATE.

Okay. And then another on the plans for hyporesponders trial that you mentioned, if you could just give a little more details around what you're thinking in terms of design, perhaps, and overall objective there?

Yes. We are still working on the design. I will let Ramin and Brad comment, but it is very much still a work in process.

Very clearly the biology which support why a product like Vadadustat would make a significant difference in the hyporesponder population. This is still a population than where in dialysis, dialysis providers use a significant proportion of the ESAs managing this 10% to 15% of patients and we had a poster that was at the AFN this past November describing that the complexity of this population and that even in a post-bundling environment, there's still -- these patients are still using 3 times the average dose at initiation and 2 times the average dose even a year later. So it's an important population for us to study and one that I think the providers particularly are looking for clarity around the impact that a product like Vadadustat can have. But I don't know if Ramin you want to comment a little bit on how we're approaching design?

Yes, happy to. As mentioned, we are currently consulting with our clinical advisors regarding the best way to approach this population. There's clear consensus that the unmet medical need is high. Some of the challenges include defining exactly what the population is, sometimes it's done by percentile, 10% to 15% in terms of the dose of ESA required. So that's one of the issues that we are working through is how best to define the target population and then also just the timing of therapy. As you know, acute intercurrent illness can often contribute to this kind of hyporesponder situation.

And just defining the length of treatment on the population in question are the technical questions that we're currently working through, and we expect to have an update later when we have a more firm trial design to present.

Great. And then if I may, just a couple quick finance questions for Jason perhaps. On the G&A for the quarter, is that reflexive of one-time litigation costs or is that closer to a new level with higher headcount? And also if you could remind us, I didn't get the share count that you mentioned basic and fully debited.

Sure. From the G&A standpoint, I think the way you need to look at G&A, particularly as it relates to the patent, is we'll continue to invest in our patent protection whether there's a litigation or not. So we'll continue to invest, ensure that we have the strongest protection, now includes the development of the drugs. I wouldn't expect any particular decreases there. What you will see as a decrease is the percentage of G&A. Certainly as the R&D program gets underway more fully and the cost of that increases our percentage of G&A, that total is going to be very insignificant.

And then headcount, obviously we'll be still continuing to invest there as the trial expands. We won't be doubling our workforce, but we will be increasing our workforce to make sure that we are meeting our timelines and goals. And on the shares, the end of the year share count was 30.7 million. After the January financing it's 37.9 million, those are the outstanding shares. There's about a $2.2 million reserve for options -- (multiple speakers) sorry, 2.2 million shares for, reserved for options, so our fully diluted account is around 40 million.

Great. Thanks, Jason.

Matt Roden, UBS.

Hello, thanks. Geoff Ng in for Matt. I believe you previously said that early 2016 will be, your expectation for getting a Europe partner deal done, so has that changed? Then what are the gating factors that you need to clear in order to secure a European partner?

Sure, so we've never given a timeline for European partnership. We are obviously -- we told you that we had started working on this last year and it is moving along very, very well. We are very pleased with the process as we were with Japan, it is following a very similar cadence to that very successful process. So there's no gating items, this is a process that has to work itself through. Now obviously we're very pleased with the ruling from the EPO last week. It simply confirmed what the potential parties believed, but that's always an important box to check, and so we will continue working the process until we find a partner who we are as pleased with as we are with Mitsubishi Tanabe.

Chad Messer Needham & Company

Great, thanks for taking my question, and congratulations on all the progress, it really has been great to watch. In addition to the right partner at the right time for your European deal, is one of your objectives to get the rest of the Phase 3 paid for, whether through upfronts or other economic contributions to the studies?

That's right. Our goal from this partnership will be financing the Phase 3 program, that is clearly front and center. We obviously want to do that while maintaining as much of the backend value as we can, because we think that the upside of the product is tremendous. But we recognize that we have a significant Phase 3 program to finance and our goal through this partnership is to complete that financing.

Is it possible to give any estimate of our about how much we are talking about in dollar terms?

I think it's -- we've disclosed what the cost of the Phase 3 is, we've told you it's about $80,000 per patient and that we're treating between the four studies, the two PRO2TECT and the two INOVATE, around 5,700 patients. So you're talking about $450 million to fully finance that trial. And as Jason pointed out today, we have about $240 million, call it. Now I would say that some of that $80,000 per patient we've already spent in the run-up, and Jason pointed that out as well, so it's a little less than that, but that will give you a perspective of what we're, what we need to finance.

All right, great, thanks. That's very helpful.

Thank you, Chad.

Mike King, JMP Securities.

Good afternoon, guys. Thanks for taking the question, and let me also add my congrats on a great 2015 for you guys. Most of my questions have been answered, just maybe a couple of subtopics within some other items we've talked about already. So with regard to the European partnership, John, I don't want to parse your words to finely, but you did say a partner, so do you think you're going more towards -- more the direction of a single partner for Europe or would you still be considering multiple partnerships?

So Mike, at this point I don't want to rule anything out. We know how complex it is to manage multiple partners in a development program. That's why we're so pleased that we are so close to initiating INOVATE, so the Phase 3 program is off and on. But it is always more complicated to manage multiple partners. So, but as I mentioned during Chad's question, our goal is to finance the Phase 3. And if the best way for us to do that, with the best partnership is multiple partners, then we will.

But we balance all of those pieces to give us the most, the greatest opportunity to finance the study and a partnership that will deliver the most in the long-term.

Okay, thanks for that. And just on 6899, are there any gating items or can you maybe enumerate the gating items now that IND is allowed? And what's standing between you and the actual first patient in? Is it typical IRB?

No, Mike, actually it's really more internal resources. We really want have people focused on getting PRO2TECT up and running and executing that well and getting INOVATE ready to go. And unfortunately we've decided that putting 6899 out of it to the middle of the year is the right way to deploy our resources to maximize value, so that's the only thing that's really gating the start of that study.

Okay, make sense to me. And then finally, I think you guys have done a great job managing the business in terms of clinical IP et cetera, just wondering if there's any way that, we've seen other agents with improvements or benefits over standards of care that have had tough launches, and I'm just wondering as you think about INOVATE, are there things that you could learn from things like either -- whether it's Omontys or Arixtra or Veltassa that can help you launch in a more robust way than the typical put a new product entering the dialysis space? Thank you.

Yes. That's, so I think you have a variety of different types of launches that you referenced there. Some that are extremely early stage that I think are actually going to do quite well. But I think it's our goal to learn from every one of these launches. I went through the Renvela launch, it was a long time ago, but we learned a lot from that and every launch of every product in renal since then. You've got a team here people who have been quite intimate with most of the products launched in this space over the last 20 years. So I think we will take all of that learning and translate it into the launch of Vadadustat and hopefully drive that to be a successful launch.

The data obviously will speak quite a bit to it, and we have a couple years to put those plans in place and learn more from the products that are launching today. But given the clarity around this market, you think about the size of the renal anemia market, compared to even something that's near and dear to my heart like phosphate control. Renvela is a billion dollar product. We're talking about a $7 billion category here that has significant focus from the providers as well as from physicians. So I think it's a very different kind of market that we're going to launch into, competitive in a different way. And so much is going to happen over the next couple years in the US with the potential to bring biosimilars into the market, what happens with the development of the other compounds in the HIF class and how does the data compare?

So much of that will really influence how we approach the market, but I feel fortunate that we're starting from a prospective where we have phenomenal relationships with the providers, with dialysis providers, with KOLs in the space and with the practicing nephrologist. And I've been working all of the above since about 1991, so and I think Brad probably even longer than that. So I think we can use that experience to our advantage as we look to launch the product.

Thanks for taking my questions.

Thank you, Mike.

Thank you. And that does conclude our question-and-answer session for today. I would now like to turn the call back over to John Butler, CEO, for any further remarks

Thank you very much. I appreciate it. Thank you everyone for joining us on the call today. We are very pleased with the progress we've made, we made in 2015, I think we are off to a great start in 2016, and we look forward to coming back to you very soon with an update on our continued progress. Thanks for joining us today.

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.