Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q1 2017 Results Earnings Conference Call February 8, 2017 4:30 PM ET
Carol Miceli - Director, IR
Jay Luly - President and CEO
Paul Mellett - CFO
Jon Wolleben - JMP Securities
Brian Skorney - Robert Baird
Good day. My name is Victoria and I will be your conference operator. Welcome to the Enanta Pharmaceuticals 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'd now like to turn the call over to Carol Miceli, Director of Investor Relations. Ma'am, you may begin your conference.
Thank you, Victoria 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.
But 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 would 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.
As we began our new calendar year, Enanta's business strategy continues to proceed as planned and we remain in a strong position from both the financial and pipeline development perspective. Our cash position of approximately $244 million at December 31, as well as royalties earned on AbbVie's net sales of our HCV collaboration products are funding a drug discovery efforts and clinical development programs in several high value disease areas.
Non-alcoholic steatohepatitis also known as NASH, primary biliary cholangitis also known as PBC, RSV and HBV. Let's discuss these programs and the catalyst expected this year.
I'll begin with our NASH candidate EDP-305 which was recently granted fast track designation by the FDA for the treatment of NASH patients with liver fibrosis. We've done extensive preclinical work in a number of in vitro and in vivo models of NASH, PBC and fibrosis and we believe EDP-305 is promising candidate.
Last month at the NASH-TAG Conference in Park City, preclinical data presentations demonstrated the treatment with EDP-305 improved pre-established liver injury and hepatic fibrosis in an MCD induced model of steatohepatitis in mice. The state is highly encouraging because fibrosis has been shown to be a key predictor of clinical outcomes in NASH patients.
EDP-305 is a highly selective and potent FXR agonist and is currently advancing in Phase 1 clinical development. In addition to healthy volunteers, the design of our clinical study includes subjects with presumptive NAFLD in order to obtain initial safety data and additional data regarding the relationship between EDP-305 plasma concentration levels and certain pharmacological effects in the context of fatty liver disease.
This relationship will be explored by using biomarkers that are relevant to the disease and to the activity of EDP-305 such as evaluation of lipids, glucose, insulin resistance and specific markers of FXR activity.
In the second half of calendar 2017, we are planning to initiate a Phase 2 clinical study in patients with PBC and to perform NASH enabling studies and then in early 2018 we expect to initiate a Phase 2 clinical study in patients with NASH. We are aiming to report data from the Phase 1 study at an appropriate scientific conference later this year.
In keeping with our goal to have multiple approaches in each of our core therapeutic areas, in NASH we are pursuing several - we are pursuing research and other classes of FXR agonist and have identified several new follow-on FXR agonist leads which we continue to characterize and to advance this year.
Additionally we have discovery work ongoing in a new non-FXR mechanism for NASH. We hope to have more information to share later in the year. Our RSV and HBV programs are also progressing. Our program for Respiratory Syncytial Virus or RSV is advancing as expected and last month we selected EDP-938 as our first development candidate. RSV is a virus that infects the lungs and represents a serious unmet medical need in infants and children, as well as immune compromised individuals and the elderly. It is estimated that each year between 75 and 125,000 children in the United States are hospitalized due to RSV infection.
EDP-938 is a non-fusion inhibitor approach to target RSV. We believe that this approach is differentiated from fusion inhibitors currently in development by others because our non-fusion inhibitors target the viral replication machinery and have demonstrated high barriers to resistance against the virus in vitro.
Last month at the JPMorgan Healthcare Conference, we presented new in vivo efficacy data demonstrating a rapid reduction in viral load in animals treated with EDP-938. This data further builds on previous in vitro data demonstrating that EDP-938 is the potent inhibitor of both RSV-A and RSV-B activity. Given this favorable profile, we are planning to begin a Phase 1 clinical study in the fourth quarter of calendar 2017.
In HBV we continue to make progress in discovering, characterizing and securing patent position for new core inhibitors. We believe the estimated 240 million HBV patients worldwide represent a population with significant medical need that is still unmet. We are pleased with this promising and advancing pipeline and we are also excited by the recent progress of AbbVie's next gen regimen for HCV which contains our second protease inhibitor glecaprevir. This pangenotypic once daily ribavirin free combination known as G/P has been tested in over 2300 patients for the treatment of genotypes one through six chronic HCV.
AbbVie's stated that this regimen has demonstrated very high cure rates across these major genotype of HCV with just eight weeks of therapy for the majority of patients. And remember, eight weeks of treatment would be shorter than other approved therapies and all genotypes other than GT1 where subpopulation is easy to treat patients with low viral load can sometimes have an eight week treatment.
And G/P is demonstrated high SCR rates in several important hard to treat patient populations particularly HCV patients with chronic kidney disease, and patients who are not cured with previous DAA treatment. Today G/P has advanced expeditiously in the regulatory process in leading markets. Having received breakthrough therapy designation in the U.S. in 2016, the NDA for G/P has now been granted priority review and AbbVie anticipates approval in the August timeframe.
Also just last month, the Marketing Authorization Application for G/P in the European Union was validated as being reviewed by the EMA under accelerated assessment. We anticipate a decision in the second half of 2017.
Given that AbbVie is stated that it expects to commercialize G/P this year, we anticipate earning a substantial portion of the $80 million in commercialization regulatory approval milestone payments for glecaprevir in calendar 2017.
While there has been a lot of recent discussion about HCV market dynamics, we expect the market to remain a multibillion-dollar opportunity in which G/P should play an increasingly competitive role. In addition, if G/P is approved then the portion of AbbVie HCV net sales on which we currently earn most of our royalties would increase from 30% for the paritaprevir containing 3-DAA regimen to 50% for the net sales of the G/P combination. As you can see we are excited by the prospects for what G/P could do to further enhance our financial position.
In summary, 2017 will be an important year for Enanta. We plan to report Phase 1 data from our lead NASH candidate EDP-305 and we are planning to initiate a Phase 2 study of EDP-305 and PBC in the second half of calendar 2017. We are advancing our development candidate for RSV into the clinic, as well as aiming to identify our first candidate for our HBV program.
We expect significant milestone revenue later in the year from the commercialization and regulatory approvals of G/P and the results are good potential for G/P royalty revenue to start in 2017 and to grow in 2018. We have built a solid foundation for the company and we believe the best way to increase value for shareholders is to continue to advance our pipeline of assets.
I'd like to stop here and turn the call over to Paul to discuss our financials for the quarter. Paul?
Thank you, Jay.
I'd like to remind everyone that Enanta reports on the fiscal year schedule. Our fiscal year ended September 30, and today we are reporting results for our first fiscal quarter ended December 31, 2016. Enanta ended the quarter with approximately $244 million in cash and marketable securities as compared to $242 million at our September 30, 2016 fiscal year end.
We expect that these cash resources in our potential future milestone and royalty stream revenue from AbbVie will be sufficient to meet our anticipated cash requirements for the foreseeable future. For the three months ended December 31, 2016 revenue was $10.4 million compared to revenue of $48.4 million for the same period in 2015. The decrease in revenue in the 2016 period was primarily due to a milestone payment of $30 million earned in 2015 for the reimbursement approval of the Care Acts in Japan.
Revenue of $10.4 million in the current quarter consisted exclusively of royalty income earned on AbbVie's net sales of its HCV regimens. Milestone payments royalties and other payments that vary significantly from period to period and we expect that variability to continue in the future.
Moving on to our expenses, for the three months ended December 31, 2016 research and development expenses were $12.5 million compared to $9 million for the same period in 2015. The increase in research and development expense was primarily due to increased preclinical and clinical costs associated with the progression of our wholly-owned R&D programs in NASH, PBC, HBV and RSV.
General and administrative expense was $4.9 million for the quarter ended December 31, 2016 and $3.8 million for the comparable quarter in 2015. The increase in general and administrative expenses was primarily due to increases in stock-based compensation expense driven by increased headcount and achievement of milestones under existing performance-based restricted stock unit awards. Enanta recorded an income tax benefit for the three months ended December 31, 2016 of $1.5 million compared to an income tax expense of $9.7 million for the same period in 2015.
The company's estimated annual effective tax rate for fiscal 2017 of approximately 24% reflects federal research and development tax credits which currently have reduced the company's annual effective tax rate below the statutory rate of 35%.
For the three months ended December 31, 2015 the company's effective tax rate of approximately 27% was also driven by federal research and development tax credits. For the quarter ended December 31, 2016 we incurred a net loss of $5 million or $0.26 per diluted common share. Further financial details will be available in our Form 10-Q for this fiscal quarter.
I would now like to turn the call back to the operator and open the lines up for Q&A. Operator?
[Operator Instructions] Your first question comes from the line of Jessica Fye with JPMorgan.
Hi guys, this is Ryan on for Jess. Thanks for taking our question. I guess this is for Paul, now that you guys have outlined your pipeline goals for the year, I mean could you talk a little bit more about your expectations for R&D, the R&D expense trajectory. It sounds like it could be a little bit more backend loaded but just wanted to get your thoughts on this?
Yes we've guided previously, we expect to stand in the $50 million to $60 million range in R&D for this fiscal year.
And I guess what I'm getting at is with the potential start of a Phase 2, with 305 in the second half, I mean does that - is that cost off increasing the burn - sorry, the operating expense relative to the first half of the year, is there anything you can provide on that?
Well typically as you progress through clinical trials, the rate does increase. So it would be a reasonable, you could reasonably infer that the spend rate would increase for rest of the year for the first quarter.
Okay, great. Thank you.
Your next question comes from the line of Liisa Bayko with JMP Securities.
Hi this is Jon on for Liisa. Thanks for taking the question. Just a couple of questions on EDP-305, it seems like a lot of companies now have their own unique FXRs development, I was wondering if you could talk a little bit about what characteristics you've seen so far with your data that kind of differentiate and sets us apart from some of the competition?
Sure. So this is Jay speaking. So we - there are a few others who are also working on the target out there and what I would say about our molecule is that we aimed for an optimization of a number of different characteristics. So what do I mean by that, we aim to come up with the best balance of potency against the target, while having high selectivity versus other off target receptors that some molecules that typically bind FXR might bind to.
So, FXR is a bile acid receptor, in the body it binds bile acids for a living, there are other bile acid receptors in the body as well such as TGR5. So we aim to be very selective for FXR versus TGR5. We also are coming forward with the non-bile acid class that does not contain a carboxylic acid that could potentially be conjugated and subject to the enterohepatic recirculation and so forth.
So there is a number of different characteristics that we've changed in the molecule trying to optimize on target, on tissue activity while minimizing as many off target liabilities as we can do. So the rest of that we've done lots of further characterization and models of NASH and PBC and fibrosis there. There's probably no one best model I think is a safe thing to say at this point but we manage that uncertainty by looking at lots and lots of different models.
So, we've reported on several models so far we and that will undoubtedly be more data from additional models coming in uniformly what we see is a very good ant fibrotic effect. We've done this in multiple animal models, multiples species, multiple outside investigators and the data line very consistently that we have good activity against fibrosis and other read-outs in this models.
So we feel like we've done about as much as we can do pre-clinically and I think the real question is how are these going to compare clinically. We've designed our Phase 1 to try to capture as much information along those lines as you could capture in a Phase 1 by looking not only at healthy volunteers but also looking at a presumed NAFLD patients in the same study where we can again gather information about PK safety and tolerability, as well as biomarkers that could be regulated by an FXR agonist.
So time will tell and will have data coming out later this year as we wrap up that study.
Great. And then speaking a little bit to your other mechanisms you're looking at, what do you think would pair well with an FXR agonist and is that’s kind of your goal of the combination are you looking to develop this independent programs.
Obviously we've placed the first flag with FXR and the first molecule with EDP-305 and as I said earlier, we're trying to bring along other molecules that are also FXR agonist again just making sure we've got your backup molecules in place and looking for molecules that might have even further benefit over the existing data that we know about. But it's always been our mission for each of our therapeutic areas to come up with not just one approach but multiple.
Today we're - I guess announcing that we are working on additional non-FXR approaches in this area. We're not quite ready to say today what that is but I think, it's highly likely that NASH will come down to being a combination therapy and we just want to have multiple approaches, multiple approaches that we could combine together, combine in other ways down the line just gives you increasing optionality.
So, it's a combination game certainly that we played in hepatitis C and we see that sort of broad overlay applying to several of other therapeutic areas including NASH.
Great. And just one more for me, what are the national enabling work has to be done prior to starting the Phase 2 in 2018?
Well, you typically look at hepatic impairment and you want to do DDI studies looking for, dose adjustments of any that need to be with concomitant meds that NASH patients could be on that that sort of thing really. So, fairly straightforward things and again will be substantially working on those in the second half, also looking at formulation studies and so forth.
Perfect. Thanks for taking the questions.
[Operator Instructions] Your next question comes from the line of Brian Skorney with Robert Baird.
Thanks for the taking the question. Jay, when we think about expectations and what we will see for Phase 1 for EDP-305, are you guys going to be looking at LDL in these patients and what should our expectation be for 305's affect on LDL? Do you think it's on mechanism and we should see similar impact that we see with Ocaliva and also on the pruritus side, it doesn't seem to be as big of an issue in non-PBC patients but it does appear to be some signal. Likewise, would we also expect that you would see a similar signal with 305 around pruritus or do you think that structurally you may circumvent this issue?
They are all exactly the right questions to be asked. I mean we have - designed as many things as we can sort of pre-clinically to look at this but the real answer is truly going to come out of that the clinical trials and we really have – I mean there is a little bit of data - early data from Novartis and Gilead but as you know the majority of the data really comes from a single compound it's been studied much more extensively than the others and that is Intercept's OCA.
So I think we're going to - these are studies that we're going to - that will interrogate all these questions and I think the dataset will be the beginning of the story. Obviously we will be moving into PBC patients assuming everything is the fine in Phase 1. We’ll go into that PBC study which as you point out is a study or is a patient population that is more vulnerable if you will to exacerbations in pruritus and I think that'll be a really interesting study for us as well.
So we'll just look at the aggregate of the clinical data as it comes out, or reported out later this year.
Okay, great. Thanks.
[Operator Instructions] There are no further questions at this time. I will now turn the call back over to Carol Miceli for closing remarks.
Thank you everyone for joining us today. If you have any additional questions, please give us a call in the office. Thank you.
This concludes today's conference call. You may now disconnect. Thank you for your participation.
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