Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA)
Q1 2016 Earnings Conference Call
February 08, 2016 04:30 PM ET
Carol Miceli - Director of IR
Jay Luly - President and CEO
Paul Mellett - CFO
Carter Gould - Barclays
Ryan Tochihara - J.P. Morgan
Bill Dezellem - Tieton Capital
Good afternoon. My name is Mike, and I will be your conference operator today. At this time, I would like to welcome everyone to the Enanta Pharmaceutical First Quarter Financial Results Conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] Thank you.
I will now turn the call over to Carol Miceli, Director of Investor Relations. You may begin your conference.
Thank you, Mike, and welcome to Enanta Pharmaceuticals' fiscal first quarter financial results conference call. The news release with our financial results was issued this afternoon and is available on our website at www.enanta.com. You can also listen to the webcast or the replay by going to the Investors section of our website.
On the call today is Dr. Jay Luly, President and CEO; Paul Mellett, our Chief Financial Officer, and other members of our senior management team.
Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements including plans and expectations with respect to our licensed products and our product candidates and financial projections, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause our actual developments and results to differ materially from these statements. A description of these risks is in our most recent Form 10-K and other periodic reports filed with the SEC. In addition, Enanta does not undertake any obligation to update any forward-looking statements made during this call.
I'd now like to turn the call over to Dr. Jay Luly, President and CEO.
Thank you, Carol. Good afternoon, everyone, and thank you for joining us today. Last quarter I walked you through the key pieces of our business and pointed out why we believe Enanta is positioned for success in 2016. Today I'm pleased to report that because of Enanta’s disciplined business approach, it is making great progress on all areas of its business operations so on target to meet our objectives for the year.
Enanta is one of the few biotechs that is sustained by recurring royalty revenues and we have an advancing pipeline with clinical stage assets and a promising R&D programs in high value disease indications. Last month at the JPMorgan Conference we announced two new R&D initiatives within our core areas of virology and liver diseases. These initiatives are in hepatitis B virus and respiratory syncytial virus also known as RSV. We now have wholly-owned programs focused on four disease areas, HCV, HBV, RSV and non-alcoholic steatohepatitis also known as NASH.
Our goal is to be in multiple new therapeutic areas and to have multiple therapeutic approaches within each of those areas. I will go into more details in a few minutes. To sustain this research, our business is being funded by royalties received from AbbVie on sales of HCV regimens containing our first protease inhibitor paritaprevir. Paritaprevir is part of multiple HCV combination treatment regimens now marketed globally by AbbVie in over 60 countries.
Our second protease inhibitor ABT-493 is being developed as part of a 2-DAA HCV treatment that AbbVie plans to have approved in the US in 2017. To that end AbbVie recently initiated six global Phase 3 studies on this regimen in over 1,600 chronic HCV patients with genotypes 1 through 6 and expects data starting in the second half of 2016.
These trials are evaluating the safety and efficacy of an all oral once-daily, ribavirin-free HCV treatment consisting of a co-formulated combination of ABT-493 and ABT-530, AbbVie’s next-gen NS5A inhibitor. Marketing approvals of this next generation regimen in major markets would make Enanta eligible for up to $80 million in commercialization milestone payments as well as additional royalties from this product.
So, in summary, the collaboration with AbbVie has provided the financial resources on which Enanta can grow and we have used these resources to make great progress with our internally developed wholly-owned pipeline.
Two promising candidates I’d like to highlight now are EDP-494 for HCV and EDP-305 for NASH. In anticipation of resistance arising to DAA HCV therapy that targets viral proteins, we've been developing an alternative host targeted anti-viral approach. EDP-494 has a high barrier to resistance mechanism that targets the human host protein cyclophilin which is essential for replication of HCV. The hepatitis C virus actually depends upon and uses the human cyclophilin protein to complete its replication cycle and we have developed EDP-494 as a cyclophilin binding compound that has shown in vitro that it inhibits HCV’s ability to use that protein for replication.
Since the human cyclophilin protein is not part of the virus and therefore not directly subject to viral mutation, we've been pleased to find that it has consistent activity across many variants of the hepatitis C virus. Cyclophilin inhibiting mechanism of EDP-494 is designed to be part of a pan-genotypic once-daily offering to target RAVs, DAA failures and other hard to treat HCV patient populations.
Last month at JPMorgan we presented excellent preclinical data demonstrating pan-genotypic activity and uniform activity of EDP-494 against many of the known RAVs across all of the DAA classes, namely NS5A, NS5B, both nuc and non-nuc and NS3 protease RAVs. Many of the drugs on the market and currently in development have some level of reduced activity when they encounter many of the known HCV mutations in existence today. However, EDP-494 suffers no loss against any of the major HCV mutations, because it’s a host target.
Because of these properties, we believe the cyclophilin inhibitor could become increasingly important to treat – for the treatment of RAVs and the growing number of DAA failure patients. We recently initiated a Phase 1 study and our next step with the program is to advance into proof-of-concept studies. Initially we are going to look at GT1 which is the largest patient population as well as GT3 which is the hardest to treat genotype. After that we plan to move on to combination studies.
Since nuc inhibitors are also known to enjoy a high barrier to resistance, we plan to combine our cyclophilin inhibitor with an externally developed nuc to create a combination with two high barrier mechanisms. If it would add to the effectiveness of such a combination, we also have available our NS5A inhibitor EDP-239, which has completed Phase 1 and a proof-of-concept study in HCV patients.
We will aim to have a Phase 1 data later this year and to initiate a proof-of-concept study. Before then, we will present additional preclinical data on EDP-494 at EASL in April. Having successfully defined a path forward in all major HCV patient populations with our HCV franchise, we do not plan to conduct further discovery research in HCV. Instead these resources will be deployed on our newer programs.
Our second most advanced wholly-owned program is for NASH and PBC, and we recently announced our development candidate EDP-305, which is an FXR agonist. NASH is reported to be the number one of cause of liver disease in western countries and is associated with diseases related to diabetes, insulin resistance, obesity and hyperlipidemia and hypertension. The progression of NASH increases the risk of cirrhosis, liver failure, and hepatocellular carcinoma, and is a large problem within the US with the prevalence estimated to be approximately 9 million to 15 million individuals.
We have spent the last year generating several promising FXR agonist leads and last month we presented pre-clinical data comparing EDP-305 to OCA, which is the only clinically validated FXR agonist and the most advanced NASH candidate in development today. Data we presented at JPMorgan shows that EDP-305 is a highly selective FXR agonist and shows more potent activity in a variety of in vitro and in vivo models compared to OCA. This and other data give us confidence to move ahead with EDP-305 and we remain on track to initiate clinical development in the second half of calendar 2016. The data slides for these candidates I just discussed are available to download on the investors section of our website, under the JPMorgan Conference webcast event.
Keeping with our mandate to diversify our pipeline beyond HCV, I would like to briefly highlight our recently announced new research and development initiatives in HBV and RSV. RSV is a viral lung infection that is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States. Each year 75,000 to 125,000 children in this age group are hospitalized in the US due to RSV infection. RSV also causes serious complications in immune compromised populations and the elderly. There are currently no safe and effective treatments available.
Now, let’s shift to HBV. HBV is potentially a life-threatening liver infection. It is estimated that 15% to 25% of patients with chronic HBV infection will develop chronic liver diseases including cirrhosis, hepatocellular carcinoma or liver decompensation leading to more than 780,000 deaths worldwide every year.
We have made significant progress in discovering, characterizing and seeking patent protections for new core inhibitors for HBV and new non-fusion inhibitors for RSV, and we expect to initiate Phase 1 clinical development in at least one of these new programs in 2017.
I would like to pause here and have Paul Mellett discuss our financials for the quarter. Paul?
Thank you, Jay. I'd like to remind everyone that Enanta reports on a fiscal year schedule, our fiscal year ended September 30, and today we are reporting results for our first fiscal quarter ended December 31, 2015.
Enanta ended the quarter with approximately $237 million in cash and marketable securities as compared to $209 million at our September 30, 2015 fiscal year-end. That $237 million balance includes a $30 million milestone payment we received from AbbVie for the reimbursement approval of VIEKIRAX in Japan in November 2015. We expect that these cash resources will be sufficient to meet our anticipated cash requirements for the foreseeable future.
We have now earned all milestone payments related to our first product paritaprevir. The remaining milestone payments, which Enanta is eligible would be triggered by commercialization, regulatory approvals in major markets for AbbVie’s next-generation HCV regimen that includes ABT-493, our next-generation protease inhibitor. AbbVie is planning for an approval of this regimen in 2017.
Our revenue for our first fiscal quarter ending December 31, 2015 was $48.4 million, compared to $77.5 million for the three months ended December 31, 2014. Revenue consisted primarily of $17.9 million of royalty income earned on AbbVie’s net sales of paritaprevir containing regimens as well as the $30 million milestone payment received from AbbVie. Milestone payments, royalties and other payments from collaborations have varied significantly from period to period and we expect that this variability will continue. We expect to have significant royalty cash flow in the near-term, which will continue to be dependent on our collaboration with AbbVie.
As we did last quarter, we thought it would be helpful to give some guidance as to how to translate AbbVie’s future reported sales of VIEKIRA, TECHNIVIE and other paritaprevir containing regimens into estimated royalties for Enanta on a one step basis.
It's important to remember that in January, we started a new royalty year, which means cumulative net sales start at zero for the purposes of determining royalty tiers. For the quarter ending March 31, 2016, we expect royalties to Enanta on reported VIEKIRA sales to be at least 3% of such sales. This calculation includes our expectations for the amounts of VIEKIRA sales allocated to paritaprevir, the net sales adjustment for our collaboration agreement and the annual royalty tiers under our agreement. Any of these factors could change in subsequent quarters.
For example, if AbbVie's sales included a higher percentage of 2-DAA regimen sales such as those in Japan then our royalties would increase even if total HCV sales stay the same. Given that Enanta's future revenue and cash flow will be dependent upon AbbVie's commercialization efforts, we offer this guidance to provide our investors a simpler way to estimate the expected royalty flow to Enanta for the quarter ending March 31, 2016.
Moving onto our expenses, research and development expenses were $9 million and $4.5 million for the first fiscal quarters ending December 31, 2015 and 2014 respectively. The increase in the three-month period was due primarily to increased preclinical and clinical costs associated with our wholly-owned R&D programs.
We expect that our R&D expense will continue to increase in fiscal 2016 as we continue our cyclophilin inhibitor clinical trials, advance our NASH program into the clinic and increase our R&D capabilities.
General and administrative expense was $3.8 million for the quarter ended December 31, 2015 and $2.8 million for the comparable quarter in 2014. The increase in G&A in the three-month periods is due primarily to higher stock-based compensation expense as well as additional expenses to support our expanding operations.
Net income for the first quarter was $26.2 million as compared to a net income of $42 million in the first quarter of 2014. We are revising our effective federal and state tax rate for fiscal 2016 to 29% to reflect the extension of the federal research and development tax credit for calendar 2016. Further financial details are available on form 10-Q for this fiscal quarter.
I'll now like to turn the call back to Jay.
Thanks Paul. I’d like to wrap up my final remarks by reminding everyone that as we began 2016, Enanta is in a very strong position to expand and execute on its business objectives. We are one of the few profitable biotechs today and have a recurring revenue stream from our successful HCV collaboration with AbbVie, as well as a strong cash position. This allows us to be able to fully fund our wholly-owned assets including targets in four high-value disease areas. HCV, HBV, Nash, and RSV. In 2016, we plan to complete a Phase 1 study and to initiate a proof of concept clinical study with our cyclophilin inhibitor EDP-494 in GT1 and GT3 HCV patients.
We expect to initiate a Phase 1 study with EDP-305 our FXR agonist for NASH and PBC. And we plan to advance several leads within our HBV and RSV programs with a goal of a Phase 1 start in 2016 in at least one of these programs. In addition, our financial resources will allow us keep our options open for future business development opportunities and also to fund other ongoing discovery programs within our core areas of virology and liver disease.
I'd like to stop now and open up the call to Q&A. Operator?
[Operator Instructions] Your first question comes from Geoff Meacham from Barclays.
Hi guys, this is Carter on for Geoff, thanks for taking our question. First one is on the Merck label and specifically around the language on the recommendation to test for the resistance associated polymorphisms. We’re wondering how this align with your expectations and if any way changed your underlying assumptions around the next generation regimen and what that potential label might look like. And then second real quickly, any chance we get some preclinical data on the HBV or RSV programs this year? Thank you.
Thank you. So, with regards to the Merck label, I mean, I think a number of us sort of saw that one coming, I think it was after EASL, when some of the data came out on the RAVs with that regimen. So, to us it wasn't really surprising at all to see that language show up in the label, we just weren’t quite sure how that would be exactly written. So if those RAVs are present and it's recommended that you have that testing then it's recommended that you have 16 weeks of therapy not 12 and it's recommended that you add ribavirin on top of that. Unfortunately you do need to do that RAV testing in order to determine that.
That's very different than VIEKIRA that’s on the market today and I think you mentioned how it could impact our next gen. Our next gen is designed to go even where VIEKIRA left off and as I mentioned, we don't need to have the RAV testing with VIEKIRA. The next gen actually is specifically designed to have a good activity both in the protease member of the regimen as well as NS5A member of the regimen, to have good activity against a lot of those known resistance mutations already. So that's something that we expect to have some good data on down the line as all of this unfurls just based on how the molecules were designed and the fact that they’re already superior to what is in some of the regimens today including VIEKIRA. So we’re looking very much forward to having all that data come out in time.
The other part I think of your question was what we have more to say on pre-clinical data on HBV and RSV this year. I think the answer is that it’s quite possibly - possible that we could -- we just want to wait until we've got very specific molecules that we want to showcase and we've got a lot of data now. But we’ll work it up carefully as we have with all of our other programs to put data out when it’s properly cooked and at the right meetings and so forth.
Your next question is from Jessica Fye from J.P. Morgan.
Hey guys, this is Ryan on for Jess. Thanks for taking our questions. Could you discuss a little bit about how you’re thinking about Phase 1 study for the FXR inhibitor, 305? I guess given the given the increase in competition in NASH and PBC, how do you see 305 differentiating itself from other candidates in development?
So the Phase 1 data for FXR I mean is substantially will be -- it will be a healthy volunteer study, I think we’ll be looking at certain kinds of other readouts and markers and anything that we can reasonably help complete a picture on the profile of the molecule and a healthy volunteer study. But with regards to the differentiation, we put out some of the data that we’ve started to accumulate, it’s not everything that we have but what we have shown is, is that it’s a highly, highly selective agent.
FXR is a nuclear receptor, so you need to think about other nuclear receptors and we've paneled them extensively. Other agents, OCA is a bio-acid derivative, and you know combined not only to FXR but it can -- in theory is a derivative like that combined to TGR5, we’ve looked at [selectivity] [ph] with our molecules extensively in that regard and 305 is highly selective for FXR over TGR5. We've done a lot of other [selectivity] [ph] work in other receptor panels, GPCRs, ion channels, a whole of slew of things that you would be working on.
So we like the profile that we've come up with. There is a lot of the pre-clinical work in PK and other kinds of things that give us good characteristics on the molecule that are favorable as well. And then, we took it in as we showed at JPMorgan and to a variety of different in vitro and in vivo models. Again looking at FXR driven read-outs in human hepatocytes and animal models and NASH models. And in every instance, we saw more potent activity than OCA, and again I think we're good -- we're feeling pretty good about the molecule in terms of having a solid profile.
So, we plan to take it in later this year in the clinical studies, we're very much on track with that and we'll have more to say on that program as the year progresses as well. So, as I -- anyway, yeah, I'll leave it at that.
And maybe just a follow-up, so is it possible that you guys will present some of that preclinical data later this year?
Yes. I think we'll be -- as I mentioned, we'll have more to say on the program as the year unfolds.
Great. Thank you.
[Operator Instructions] The next question is from Bill Dezellem from Tieton Capital.
Thank you. A couple of questions. First of all, did you have any revenues that fell into the second tier this quarter?
I -- so this is Jay speaking. We can't -- I've answered this similar question I think on previous calls. We can't get into the discussions around where the break points are for the royalty tiers. So until or unless we have permission to do that in the future we really can't comment on that.
Thank you. And then secondarily, will you break out the dollars that were in the 30% bucket, and those that were in the 45% bucket?
Yeah. The 3D breakdown and the 2D breakdown?
Yeah. So that -- unless that's disclosed by AbbVie, we won't disclose it. But what can I say, so as you know, the sales in the 2D bucket are quite helpful to us overall, because we do get a double digit royalty on 45% of that. That then brings in sales -- net sales numbers faster to us and helps us rise through the tiers. So, there is a couple of factors that can be helpful over time, which is an enrichment of 2D over 3D in those sales, which we're again hoping to see that begin based on Japan sales which the quarter we're in now will be the first full quarter of sales of the 2D regimen in Japan. So, the 2D blend will ultimately give us a chance to rise and as well the royalty tiers. But unfortunately, I can't give you that granularity. I think whether it's one or the other, you'll know when it happens, because you'll be able to see changes in the percentage over time.
Understood, and in addition to Japan, if I recall correctly, there are some European countries where you do have the 45% on the 2-DAA. Which countries are the important countries are those again?
Well, we've got the 2D, so VIEKIRAX is approved in numerous countries in Europe. So and all the major countries, major European countries, and where you would think about that is in the GT4 indication. So VIEKIRAX in particular, the 2D regimen in Europe is indicated for use in GT4. So that's increasingly a problem. A lot of people think that it's really restricted to Egypt and parts of the Middle East, but it's actually through immigration, moved into Europe and France and Italy and Germany and so some of the major markets. GT4 is not the largest genotype, but it's not horribly small either, so it will contribute.
We also have that label in the US for GT4, again not as much GT4 in the US, but it's sold as the 2D regimen is called TECHNIVIE in the US. I really do think that the largest of the 2D markets is actually going to be Japan, where that is the principal regimen that will be sold and it's for genotype 1B, genotype 1, but predominantly in Japan, it's genotype 1B. So I think it's a pretty competitive offering given that it's once-a-day, ribavirin free, has very high cure rates. And so we're looking -- we're really looking forward to how things start to rollout in Japan. Gilead has obviously had tremendous success there this last quarter, which was I think their first full quarter, sort of, pulling in, I think, it was about 1.4 billion in Japan alone. So, stay tuned and we'll see how it goes.
There are no further questions at this time. I will turn the call back over to Carol Miceli for closing remarks.
Thank you for joining us today. Feel free to contact us if you have any additional questions. We'll be in the office.
This concludes today's conference call. You may now disconnect.
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