Ladies and gentlemen, thank you for standing by, and welcome to the Enanta Pharmaceuticals First Quarter Financial Results Conference Call. At this time, all participations are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to Ms. Carol Miceli, Director of Investor Relations. Please go ahead, ma’am.

Thank you, Erica, and thanks for joining us this afternoon. The news release with our fiscal first quarter financial results was issued today and is available on our website. On the call today is Dr. Jay Luly, President and CEO; Paul Mellett, our Chief Financial Officer, and other members of Enanta’s senior management team. Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those statements. A description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC. 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. On today’s call, I will discuss our recent clinical development progress on our lead RSV, NASH and HBV compounds, and upcoming milestones to look for in 2020. I’ll begin with EDP-938, the only N-inhibitor for RSV in clinical development today. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly and immune-compromised adults, and a condition for which there is currently no safe and effective therapy. At the end of 2019, we initiated our Phase 2b study, named RSVP, which is a randomized, double-blind placebo-controlled study of EDP-938, designed to enroll approximately 70 subjects up to the age of 75 years, randomized to receive either 800 milligrams of EDP-938 or placebo for five days. The primary objective of this study is to evaluate the effect of EDP-938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14-day study observation period. Any viral efficacy will be evaluated as a key secondary endpoint. We’re pleased to report that we’ve been able to identify many adult outpatients who’ve had cold-like symptoms that started within 48 hours of their visit to an RSVP study site. Identification of RSV patients in this group has been aided by the prompt on-site confirmation of RSV infection, which we have been providing by PCR testing. Unfortunately, it appears that the North American RSV season this winter peaked in December, which is approximately one to two months earlier than in most years. As a result, we have seen fewer RSV cases than expected, and therefore we are planning to continue the study into the southern hemisphere and have enrollment continue in all sites with the goal now to have data in the first half of 2021. In addition to this study, we have also announced plans to initiate additional Phase 2 studies in pediatric patients and transplant patients by the end of this year, concurrent with the RSVP study. We continue to believe that our N-protein inhibitor approach represents the best chance for success against RSV, because it attacks the virus’s replication machinery. Building on our success with viral infections such as HCV and our ongoing program with RSV, last month, we introduced our newest drug discovery program, which is seeking therapeutics for human metapneumovirus, also known as hMPV. hMPV is a pathogen identified in 2001 that causes upper and lower respiratory tract infections in young children and the elderly, as well as in COPD, asthma, and immunocompromised patients. During 2020, we will continue to perform optimization of our current nanomolar inhibitor leads against this virus. Now, let’s shift to HBV. Our HBV program with EDP-514 is moving ahead nicely. And today we announced positive results from the SAD and the MAD portion of our Phase 1 study in healthy volunteers. EDP-514 is our novel class 2 HBV core inhibitor, sometimes referred to by others as a capsid assembly modulator or CAM. The aim of part one of this randomized double-blind placebo-controlled first-in-human study of EDP-514 was to evaluate the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses in healthy subjects, while part two will assess the safety and antiviral activity of EDP-514 in nuc-suppressed patients with chronic HBV infection. Overall, EDP-514 in healthy subjects dosed for up to 14 days was well tolerated with a favorable safety profile. Treatment-emergent adverse events were infrequent and mild in intensity. No one discontinued EDP-514 due to adverse events, and there were no significant individual lab data findings or patterns of lab abnormalities. Additionally, the pharmacokinetic or blood level profile was fully supportive of once daily dosing. Following these promising results, which support further clinical evaluation of EDP-514 in HBV patients, Enanta has initiated a study in nuc-suppressed patients, these are patients with chronic HBV infection that is being suppressed with nucleoside reverse-transcriptase treatment. We plan to enroll a total of 24 subjects among three escalating dose cohorts with the study drug dosing for 28 days. Our goal is to have data from this study in the first quarter of calendar 2021. Next quarter, we plan to initiate a separate study in HBV patients who are not on therapy and who have high levels of virus in their blood or also referred to as viremic. EDP-514 was selected from our lead series of HBV compounds that are characterized by potent antiviral activity and promising preclinical data also support our excitement for EDP-514 and for this mechanism. An abstract of the healthy volunteer portion of the study has recently been accepted for presentation at the International Liver Congress as EASL. So, stay tuned for additional data in April. Switching to our NASH program, we are pleased to announce that the ARGON-1 Phase 2a proof of concept study of EDP-305, our lead FXR agonist candidate has been accepted as an oral presentation at EASL. We plan to further evaluate EDP-305 in ARGON-2, the Phase 2b study in which we expect to initiate dosing by early next quarter. ARGON-2 will be a randomized, double-blind placebo-controlled 72-week study in approximately 340 subjects with biopsy-proven NASH. The primary endpoint of this study will be improvement of fibrosis without worsening of NASH, and/or NASH resolution without worsening of fibrosis. We plan to use doses of 1.5 milligram and 2 milligrams with the aim of demonstrating stronger biomarker signals of efficacy than seen at 1 milligram in the ARGON-1 study and less pruritus than seen at the 2.5 milligram in that study. The study will include a 12-week interim analysis to generate dose information more quickly for potential combinations with other mechanisms in NASH. Also in our NASH program, Enanta has identified EDP-297 as its follow-on FXR candidate. Preclinical data on EDP-297 reveal a differentiated profile that delivers high target tissue distribution, along with potency greater than that published on any FXR agonist in clinical development today. Last month at the JPMorgan conference, we presented compelling data that demonstrate the high potency and tissue targeting characteristics of EDP-297 compared to other FXR agonists in development. This tissue targeting data showed that in preclinical models EDP-297 delivered the drug preferentially to tissues involved in FXR activity, namely liver and intestine while minimizing drug levels in plasma and skin. Two abstracts on EDP-297 have been accepted and will be presented at the EASL conference in April. We believe that having a highly potent and highly targeted FXR agonist like EDP-297 will allow for lower doses and reduced drug levels at non-targeted tissues, thereby potentially reducing pruritus, and less pruritus is FXR mediated by FXR receptors in the liver or intestine. We plan to initiate a Phase 1 study of EDP-297 in mid-calendar 2020 and to have data in the first half of 2021. Lastly, the INTREPID study of EDP-305 in PBC has completed dosing, and we expect to announce top-line data by early next quarter. So, keep your eye out for presentation of Phase 1 results of EDP-514 at EASL, the initiation of our Phase 1b study of EDP-514 in viremic HBV patients, Phase 2 results of EDP-305 in PBC and new creation of our Phase 1 study of EDP-297, all by midyear. I’d like to close by summarizing a couple of key takeaways from today. First that despite the vagaries of the RSV season in North America, we are advancing the RSVP study and have plans for two additional studies of EDP-938 to start another RSV patient populations later this year. And second, we had good safety and PK results with lead HBV core inhibitor in healthy volunteers, leading us to initiate the second part of the study in nuc-suppressed HBV patients. This is all good progress. I’ll now turn the call over to Paul to discuss our financials for the quarter.

Thank you, Jay. I’d like to remind everyone that Enanta reports on a September 30th fiscal year schedule. Today, we are reporting results for our first quarter ended December 31, 2019. In the quarter, total revenue was $52.6 million and consisted entirely of royalty revenue earned on AbbVie’s global HCV product sales. This compared to total revenue of $69.9 million for the same period in 2018. Royalty revenue is calculated on 50% of MAVIRET sales at a royalty rate for the quarter of 17%. Approximately 30% of VIEKIRA sales had a royalty rate of 10%. After adjustment for certain contractual discounts and rebates, which historically have been approximately 1.5% of AbbVie’s total reported HCV product sales. AbbVie will be recording their global HCV sales number on February 7th. As a reminder, our royalties are calculated on a calendar year basis. Therefore, royalties for our fiscal first quarter ending December 31 will be calculated as the highest royalty rate, and royalties for our fiscal quarter ended March 31st, will be calculated at 10%, our lowest royalty rate tier in our fiscal year. You can review our royalty tier schedule in our 2019 Form 10-K. Moving on to expenses for the three months ended December 31, 2019. Research and development expenses totaled $32.8 million, compared to $34.9 million for the same period in 2018. The decrease was primarily due to the timing of clinical trial costs associated with the progression of our wholly-owned clinical programs in RSV, NASH, PBC and HBV. General and administrative expense for the quarter was $6.9 million, a slight decrease to the comparable quarter in 2018. Enanta recorded an income tax expense of $1.5 million for the three months ended December 31, 2019, compared to an income tax expense of $3.7 million for the same period in 2018, reflecting the reduction in income tax in income before income taxes. For the three months ended December 31, 2019, Enanta’s effective tax rate was approximately 10%, compared to approximately 12.5% for the corresponding period in 2018. The reduction in rate was driven by both research and development credits, as well as a federal benefit from foreign-derived royalty income. Net income for the three months ended December 31, 2019, was $13.4 million or $0.65 per diluted common share, compared to a net income of $26 million or $1.25 per diluted common share for the corresponding period in 2018. Enanta ended the quarter with approximately $415 million in cash and marketable securities, an increase of approximately $15 million from our 2019 fiscal year-end balance of $400 million. Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed. I’d now like to turn the call back to the operator and open up the lines for questions.

Your first question is from Brian Abrahams with RBC.

First off on 938 on the RSV program. I know you mentioned that you’ll be getting the transplant and pediatric studies underway later this year. I was wondering if you could talk a little bit more about how you guys are thinking about the potential design there. And in particular, how - what’s going to be shaping elements like the dose selection potential duration as you look to get those studies going later? And then, I had a follow-up.

Yes. So, thanks for the question, Brian. The team is working right now on the fine details of both of those studies. So, I’d say, it’s a little bit premature on this call to get into that. I’d say, as the year progresses, we’ll report more on RSVP and as the exact design of these two new studies gels, we’ll have a lot more to say about it then.

Okay, fair enough. And then, it sounds like the hep B program is moving along well with 514. I was wondering if you could maybe just elaborate a little bit more on what you guys observed in the healthy volunteer Phase 1 study with respect to PK and safety, your thoughts on the therapeutic window for that agent. And anything, at least that you’re able to glean from the Phase 1 study that might support your view of this being differentiated from others in the same class and development? Thanks.

Well, certainly, I’ll just start with a little bit of a preclinical background on 514 too first. So, 514, we worked a long time to identify this candidate and picked it. We believe it has a great preclinical profile, not only in terms of virology but in vitro and in vivo where it certainly looks better than first-generation capsid or core capsid inhibitors. Everything about that preclinical profile, including the pharmacokinetic profile across multiple different species suggested that it had a pretty good chance of having a strong profile clinically too. So, we’ll have a lot of details around the status that presented formally at EASL. But, suffice it to say, it was generally safe, well-tolerated, again, nothing remarkable in terms of any findings. And importantly, and as you know, the PK is really all important when you’re looking at viral. And so, we think we’ve got good exposures and good troughs and so forth that would give us a good amount of pressure on the virus. So, this is a 14-day study, and it’s in healthy subjects. So, we’ll lay it out very clearly with all the details at EASL. But, the results are definitely strong.

Your next question is from Eric Joseph with JP Morgan.

A couple for me, first on 514. I guess, I’m thinking about the Phase 1b study portion in nuc-suppressed patients. If I heard it correctly, this would be a MAD study assessing 514 over a 28-day treatment period. Can you talk a little about sort of the study objectives in that trial portion? How are you looking at antiviral activity? Can you just walk us through sort of the surrogates for efficacy? Are you looking at conversion or pgRNA?

Yes. Again, I’ll remind you that this is a Phase 1b 28-day study. So, it’s a short-term study where we’ll be looking principally at safety as the primary endpoint. But, I’ll let Nathalie comment on some of the other aspects related to other things to be studied.

So, I think just to echo what Jay said, this is the second part of the first-in-man study. For the 1b, we will be looking obviously in nuc-suppressed subjects, safety, PK are the key, primary and secondary objectives. We will also be looking at exploratory endpoints that all the other companies I would say in that field are looking. Just to remind you that, so far all those endpoints in viremic patients or nuc-suppressed are still considered exploratory in essence. So, we would be looking at something such as HBV DNA, HBV RNA and others. And we will report that as we are obviously finalizing the study.

And maybe just a separate question on the RSVP study. I just wanted to revisit the trial design and powering assumptions there. Can you just talk about what the trial is powered to detect in terms of total symptom reduction versus no treatment? And I’m also curious to know whether looking at some of the flu antiviral programs are useful comps in terms of thinking about longer-term study design and whether if that’s appropriate looking at time to symptom - whether or not you’re looking at time to symptom resolution? Thanks.

So, I think, I heard very clearly your first question about the power of the RSVP study. I’m not sure I completely understood the second part. Maybe you can repeat once I address the first part. So, I think, we had that question a few times regarding the core or RSVP study. We have, as you know, run a challenge and that was what we used, as far as understanding our drug in context of the patient who received the placebo in the challenge study to really identify and analyze. Clearly, our design and ecosystem was evolving over time. I’m not yet ready to disclose completely how we power the study, as I think it’s more relevant when you present data. But, obviously we will be looking at seeing difference of the progression of symptoms from time to onset over 14 days of course study conduct. I know, it’s indirect way of responding. But, that’s what I can offer today. Would you really mind me the second part of your question, please?

Sure. I’m curious to know whether you’re looking at time to symptom resolution specifically in the RSVP study. And the reason for asking the question is that that is an endpoint used in the influenza antiviral studies. And I’m wondering whether that is a useful comparator set of studies to look at in thinking about longer-term development of the pivotal development potentially of EDP-938? Thanks.

Yes. Thank you. I appreciate your question. So obviously, we have looked at many of other flu studies to understand endpoint and symptoms in relationship to that patient population. There’s a series of key secondary endpoints as we’ll be looking at more details, time to resolution, time to progression. There would be obviously more detailed analysis of all the symptoms.

Our next question is from Yasmeen Rahimi with Roth Capital.

Paul is asking about RSVP. He wants to know more about how RSV diagnosis is confirmed and the best time frame for the study. He also inquires if PCR can be used to quantitatively assess whether patients’ viral loads are in the optimal range for intervention.

So, we are using PCR when the patient shows up at the clinic within the 48 hours of the window, which confirms at the site. And there will be a centralized also PCR that we do afterward.

Okay. And just one more question. Can you give some more color on what the profile of a viremic patient would look like in the next portion of the EDP-514 study?

The profile for 514 for the HBV involves patients who are viremic. There will be those with a higher level of HBV DNA compared to those who are nuc-suppressed. Some of these patients may be treatment-naïve, while others could have undergone treatment that includes a washout period where they do not receive any therapy, but they must demonstrate an elevated level of HBV DNA.

Your next question is from Akash Tewari with Wolfe Research.

So, maybe on the RSV trial, can you provide a little bit of color on why you chose AUC symptom benefit as your Phase 2b primary endpoint versus perhaps baseline viral load or something they use in Phase 1 or in some of the flu trials? Would love to get some detail on that. Additionally, in your protocol, you say that patients will have to present within 48 hours of symptom onset. Are there any tricks that you’re using for the trial to kind of ensure that patients are actually presenting within that treatment window? And finally, it seems like you had previously mentioned that the powering was going to be similar to Phase 1. So, I think that was around 80% powered. Is there a chance that you could increase your enrollment, now that the trials getting pushed to first half of '21? Thanks so much.

So, there, I don’t think there are any special tricks. I think we were taking people as they present and we have to rely on the reliability of what they say in terms of symptoms. Obviously, they’re the only people who can know. But, the good news is we’re seeing lots of people coming in within that time window with symptoms. Could you repeat your first question, the first part of your first question again?

Yes, absolutely. So, I think we were looking at like J&J’s outpatient RSV Phase 2, their pilot trial and they’re looking at a lot of primary and secondary endpoints, viral kinetics, clinical symptoms. So, why specifically, it’s an interesting endpoint, AUC symptom benefit as your primary endpoint. Does it somehow give you a bit of wiggle room than some of these exploratory endpoints that other companies are looking at?

I think the choice of the AUC as far as primary endpoint to look into the total symptom score was mainly driven also to the understanding and the very thorough analysis of our challenge study. As we worked with our statistician, we saw that AUC for symptoms score will be a better endpoint for what we are looking for in the context of that study.

It’s also easier on an outpatient basis to get more data points because people will be reporting symptoms in diaries, etc. So from a practical basis on an outpatient study, you can get more data sampling that way.

I just want to complement to what Jay said about the trick. I mean, there’s obviously a lot of work that went into educating the site, and site educating patients that come to see them. We are using family practice, emergency care, centers with patients with allergy, asthma, COPD. So, we have launched a large campaign that’s trying to attract patients with a clear understanding of the eligibility criteria for study. So, we were able to be successful in that sense to attract patients with symptoms within our window.

And just a quick question. Given the trial delay on the RSV side, is there any chance that you’d be looking at increasing the enrollment so suddenly you might have more of a flu-like total number of patients in your trial versus something more in line with other RSV Phase 2b studies?

There is no plan to increase the enrollment number.

Your next question is from Liisa Bayko with JMP Securities.

Just wondering if you’re going to be doing any interim cuts of the RSVP study. I thought that you needed some data in adult patients before moving into pediatric. So, just wondering how that’s all going to work. And if you’re still on time to start at the end of this year?

They’re not really interrelated, and there won’t be an interim cut. So, we’ll take the wealth of all the information we have in all the adults who have received study drug and partly that into our thinking about how we dose these subjects ultimately. But, our expectation is that these studies would be run concurrently.

Okay. So FDA doesn’t need to see the data in the adult population before starting the pediatric study?

No.

Okay. Got it. And then could you maybe talk a little bit more about the differentiated profile of EDP-297, as you mentioned it was differentiated? I’d just be curious and I think a little bit more about that?

Sure. Moving on to FXR, we have 297, which is a follow-on FXR agonist. We have dedicated significant efforts to optimizing various characteristics of the molecule, focusing on aspects like potency and selectivity. We were surprised to find that the doses we used for 305 in the ARGON study resulted in more pruritus than we anticipated based on Phase 1 data. As we consider how to improve the tolerability of 305 moving forward, it's become clear that tackling pruritus is more critical than addressing lipid levels. The challenge is that the cause of pruritus related to these FXRs is still not well understood—whether it's on target, off target, or dependent on certain tissues. Without a confirmed mechanistic understanding for reducing pruritus, we have explored alternative strategies. Firstly, we focused on maximizing potency as much as possible, and we’ve made significant progress. We initially shared some data at JP Morgan, with more to come at EASL, but it is a very potent FXR. According to our data, it ranks as the most potent FXR agonist currently in development. This is advantageous as it requires a smaller amount of the drug to achieve the desired effect. We recognize that FXR receptors are present in both the intestine and liver, which are essential sites for any compound targeted at treating NASH. Alongside enhancing potency for FXR, we aimed to minimize its potency for other effects we are not aware of, specifically targeting the liver and intestine and avoiding plasma and skin exposure as much as possible. Our dual approach involves achieving high potency while ensuring that the drug is directed to the necessary sites, thereby reducing exposure where it’s not needed, where unwanted effects might occur. We acknowledge a potential risk that if pruritus is indeed FXR mediated within those specific receptors in the liver or intestine, we might just create a more potent version of 305 or other existing FXRs. However, in any other scenario, we believe there is potential for benefit, which we intend to investigate. We expect to gain valuable insights from Phase 1 and anticipate starting the study in the middle of this year, with data expected in the first half of next year. Overall, our plan is clear; we are confident in the chemical profile of this promising molecule, with more detailed information to be shared at EASL.

Your next question is from Brian Skorney with Baird.

I guess first just on EDP-514. Can you just walk us through how to think about the dosing here and where you want to target to maximize antiviral activity? If I look at the results you have in the chimeric liver mouse model, it seems like dose escalation isn’t really topping out despite going to pretty high mg per kg doses? Any thought on how to think about translating that data into a target dose in patients?

Yes. I wouldn’t translate the rodent model numbers into humans. What I wouldn’t look at in that experiment is a very strong dose response and a very robust antiviral effect. In fact, it’s the most robust anti-viral effect that anybody has reported in that model. So, but in terms of comparing the doses and milligrams per kilogram to a rodent to the actual doses we’ll use in humans, I wouldn’t spend too much time thinking about that translation and again we’ll get into the whole dose escalation work that we did at EASL when we lay the whole data set out and you will be able to take a good look at it then.

And then if I could just ask a question on the patient flow in the RSVP study, can you just remind us how screening works here? Are you just first primarily screening for patients with respiratory symptoms and then screening them for RSV in the study? And do you have any data on how many patients coming in with respiratory symptoms screening for RSV versus screening out with influenza?

Yes. So, we take people again within 48 hours of symptoms. There’s an in-office PCR that’s done. We look for RSV versus flu A or flu B and if you’re positive for RSV and negative for flu A and negative for flu B, then you are a potential candidate. You know there is more flu out there than there is RSV. So you’re going to see more of that in these screening, but generally speaking, it’s a straightforward test worth a straightforward presentation of people coming in within 48 hours, which again, we’ve seen many people coming in that window.

I guess what I’m trying to get at is if eventually this moves into sort of a seasonal RSV treatment. I’m trying to see if in the real-world setting, what sort of as a reasonable number to assume as a percent of flu and we could obviously kind of comp it to what like Tamiflu does, get a feel for the commercial offers?

Yes. It changes every year; it doesn’t correlate perfectly every year. The seasonality is a little bit different and you know what might be a more robust RSV season could be lower flu season. There is just so overarching seasonality to it, the patient numbers are probably not as high as not as high as flu, but again I don’t think people really fully know yet and part because this testing is not routinely routinely done on a broad-scale basis in clinical practice. So and in part because it’s not that the test don’t exist, it is the drugs don’t exist. So people don’t often order the test. Also different to be thinking about the patient demographic that’s in the RSVP study, which is the adult outpatient study. We know adults in general are a fraction of what they are. All RSV cases in general are a fraction of what they are in peds so ultimately the question will drive down to what are those peds numbers, but they are very significant in peds again every every every peds gets typically an RSV infection by the time they are aged two or three. It’s just a question of severity and it’s a question of what happens once they get that infection.

Your next question is from Patrick Trucchio with Berenberg Capital Management.

Hi. This is Iris Long on for Patrick. Thanks for taking my question. So regarding EDP-938, can you tell us if you expect to evaluate the drug in elderly patients? And if so, would you move directly into a pivotal trial or would you anticipate running maybe another two Phase 2 trials in this patient population? And then finally, would you anticipate having to run two pivotal trials for each patient population or is one pivotal trial sufficient? Thank you.

Thank you for your question. I can address that, and they are good questions. So I think for now, we have informed that our next studies will be in the transplant and the peds. We know that those populations are really unmet medical need. We are not excluding for the next future to be looking into the elderly; obviously, they are also a population of good target for RSV. But the plan for now will be to focus on the transplant and the peds. To your next question regarding pivotal study, I think that’s a very good question. Today, if you look at the guidance issued FDA or EMA, I don’t think there is a clear understanding of if we will need one or two pivotal study like we usually do, when we register a drug. I think it’s going to be interesting to engage regulatory authorities as we are moving in the progress of our program. So we will know more as we obviously progress further.

Okay, got it. And then regarding RSVP, can you tell us what you would consider to be a highly successful top-line data result? Thanks.

Well, I guess, simply to make the per million with a nice p-value, I’ll be happy to see that. And I think RSVP is also an interesting study for us and maybe for the field, trying to understand the feasibility of how soon can you attract the patient with nasal symptoms that you can treat to present severity and progress to lower respiratory tract infection. And I think this is what we need to understand and if we understand it, then we can put it in practice. I think there will be probably half of winning cure for RSV, if you have a good product.

And there are no further questions at this time. I’ll turn the call back over to Ms. Carol Miceli.

Thank you everyone for joining us today. If you have any further questions, feel free to give us a call in the office. Thank you.

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.