Ladies and gentlemen, thank you for standing by, and welcome to the BioCryst Fourth Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]I would now like to hand the conference over to your speaker today, Mr. John Bluth at BioCryst. Please go ahead, sir.

Thanks very much, Josh. Good morning, and welcome to BioCryst fourth quarter 2019 corporate update and financial results conference call. Today's press releases and slides to accompany our call are available on our website.Participating with me today are CEO, Jon Stonehouse; Chief Medical Officer, Dr. Bill Sheridan; and Chief Commercial Officer, Charlie Gaier. Following our remarks, we will answer your questions.Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and/or achievements.These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance, or achievements to be materially different from any future results or performance expressed or implied in this presentation. You should not place undue reliance on these forward-looking statements.For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website.Now, I'd like to turn the call over to Jon Stonehouse.

Thanks John. What differentiates BioCryst is our focus on bringing oral drugs to patients who suffer from rare diseases. These diseases have tough biological targets and very few companies even try to address them, let alone succeed, but we seek to do the extraordinary because patients have told us that the opportunity to take a pill or capsule for their disease is what they desperately want. They tell us this is a shot at an ordinary life because their disease and their treatment will play a much smaller role in their day-to-day living.Today, this is not just something we're shooting for; BioCryst is making it a reality for patients. With multiple approvals coming for our lead program in HAE and an even more exciting pipeline with our oral factor D inhibitor, rare disease patients around the world, and our company are moving into a new era.Our priorities this year are very clear. It's only March and we're making early progress in executing our plan. So, far this year, we've submitted our new drug application in Japan and the submission has been accepted for review. The review is under Sakigake designation, which means this would be the first approval in the world for Berotralstat.Next, we said we expected to hear from the FDA regarding our U.S. NDA submission, and we did. We now have a December 3rd PDUFA date and the agency has said that they are not currently planning to hold an advisory committee meeting to discuss the NDA.Lastly, we're on track to submit our MAA for approval in Europe by the end of the month.This all adds up to an approval in Japan and in U.S., both later this year and then in the first quarter of next year approval in Europe. Three approvals in approximately 12 months is…

Thanks Jon. What is so compelling about our market research is how favorably patients and physicians reacted to the berotralstat profile. After seeing the six-month efficacy and safety data from the APeX-2 trial, patients are very willing to use berotralstat regardless of how they treat their HAE today.Many physicians expect to switch current prophylaxis patients to our oral therapy, while also expanding their use of prophylaxis overall. And importantly, payers say, they will reimburse for our drug if its cost is within the range of what they pay for injectable prophylaxis drugs.Patients have told us for years that treating HAE with an oral medication is their dream, although, they are grateful for the advances in injectable treatments. They want to reduce the burden these therapies add to their lives. Our survey of 100 HAE patients gives us great confidence that many patients will realize that dream when we launch our drug.Nearly 60% of the patients are very willing to use berotralstat and likely to take action. What's particularly important is that 79 of the 100 patients are already on a modern prophylaxis therapy. And they too are very willing to switch to our drug.Even among the patients who say they are very satisfied with our Cinryze, Haegarda or Takhzyro therapy are very -- a half are very interested in switching to berotralstat. So why does so many patients want to switch? Many HAE patients have switched to new therapies in recent years, and they see oral therapy as the next big advance. Injectable treatments have helped them get their HAE under control, but no drug is perfect and most patients continue to have some breakthrough attacks.Takhzyro patients in our survey, for example, reported an average of just over 0.5 attack per month. But we hear from patients and doctors that…

Thanks, Charlie, and good morning. I'd like to start by taking a moment to share why targeting Factor D with BCX9930 is such a promising approach for diseases involved in the alternative pathway of complement.First Factor D is required for the alternative pathway to work. That means that doses of 9930 that block Factor D will succeed in inhibiting the alternative pathway, independent of the particular disease setting. And Factor D as a target is the same PNH as it is in nephritis and other alternative pathway diseases. So proof-of-concept in PNH provides proof-of-concept for other diseases of the alternative pathway, not just PNH. Next, Factor D levels as lowest of any complement pathway enzyme. This means that you need less drug to inhibit it compared to other complement targets.On top of that, Factor D levels do not increase with inflammatory illnesses. So the dose does not need to be changed when patients get illnesses like influenza. Lastly, in contrast to other complement enzymes, Factor D has a unique structure and bicruciates scientist have been able to design inhibitors like 9930 that intrinsically have better specificity against other serine proteases. This leads to a lower likelihood of off-target effects and, therefore, a better safety margin.Considering the attractiveness of Factor D as a target, we were very excited to announce today that we have started our PNH proof-of-concept study with 9930. In PNH, our goal is to develop an oral monotherapy with excellent efficacy, whether or not patients in PNH have ever been treated with the C5 inhibitor.Just recently, I returned from an advisory meeting with top world experts in PNH and diseases of complement, where we discussed the profile of 9930, favorable preclinical pharmacokinetics and pharmacodynamics with large safety margins and in healthy subjects, linear and dose proportional exposure and…

Thanks, Bill. You can see why we're so excited about the possibilities with BCX9930. With positive results from our proof-of-concept trial will be in a fantastic position by having both a very attractive pipeline with 9930 and on the home stretch to approval and launch with Berotralstat.As you look at our balance sheet and cash guidance for the year in our press release today, you see that we ended the year with $138 million. This reflects the $100 million we added in the fourth quarter of last year, but does not reflect the payment we received last month for the $14 million RAPIVAB shipment at the end of last year.We expect our net operating cash used to be in the range of $125 million to $150 million. This cash runway takes us through 2020 and funds the proof-of-concept for 9930 in the commercial and prelaunch activities for Berotralstat.Beyond that, we have sources of additional capital to provide financial flexibility that we will pursue over the course of the year. We expect up to $20 million for approval in Japan from Torii. We are evaluating royalty financing for Berotralstat that would bring in capital at approval to fund the launch and with the proof-of-concept data with BCX9930, we have options to add capital, such as a partnership to advance that program.We're going to be generating revenue starting early next year with a product that has north of $500 million in peak sales, followed by a pipeline in a molecule with BCX9930 and more oral drug programs for patients with rare diseases right behind it. All of this supports what I said at the beginning of the call, we are moving into a new era as a company.Before we open the call up for Q&A, we've received a lot of inquiries on…

[Operator Instructions] Our first question comes from Liisa Bayko with JMP Securities. You may proceed with your question.

Hi, thanks for taking my question. Congratulations on all the products.

Thank you.

Just curious on -- if you could provide any update on the regulatory process. This is a little bit different than some other kind of processes where we might have Adcom’s and so on and so forth. So we don't have a lot of visibility between now and year-end when we expect approval. So any updates you can give us on 7353? And FDA interaction, where you are in terms of any kind of review whatever would be helpful? Thank you.

Sure. I mean, it's a straightforward typical process. As we announced earlier, our fiber has been accepted by the FDA. We have a PDUFA date of December 3 and they are typical routine questions that regulators ask and we answer as the review progresses. So there’s really not a lot to report there and we expect that it will go in a typical way.

Any -- can you share any color you have on your pricing strategy and how you're thinking about that in that equation?

Yes. I think the research that Charlie and his team did in the summer, changed our view to some degree from what we had shared with you back when we got the data in -- around Memorial Day last year. I think originally, we went into this thinking, significant discounts were an important piece of what we needed to do when Charlie scrapped the surveys with I think it was insurance companies that cover 100 or 80 million lives in PBMs that cover over 100 million lives.They basically said they get the need for an oral and as long as we're in that range of our competitors, which is somewhere between $500,000 a year and $600,000 a year. That will get reimbursement. So we haven't made any final decisions. That's what the payers have told us, but that was good information for us to receive.

Okay. And then how do you think about that in sort of the European region?

Yes, it's interesting that the pricing in Europe is all over the board in rare diseases. In some cases, you see price parity, where there's no competition for rare disease drugs. And in other cases, you see significant discounts. We think there's a real opportunity in Europe for prophylactic therapy, it's largely an acute therapy market right now.We're watching the competitors ahead of us and the moves that they're making, and we -- the goal is to get as much access to patients in the countries where we get approval and to remove the barriers to that access. So we'll wait and see how things unfold.

Okay, great. And then just on 9930, can you talk about your goals in terms of changes in LDH, hemoglobin. For your proof of concept, kind of what are your objectives as, what's up for you on those actually?

Thanks for the question. There are a couple of objectives. Get through dose ranging quickly, that's an objective. And so that's why we've designed it in the way I described. Secondly, see how quickly and to what extent the LDH goes down and the hemoglobin goes up. I mean, the expectation here is that blocking Factor D will block all of the downstream events that turning to intravascular hemolysis and extravascular hemolysis and that's very attractive.The feedback we've had from our expert advisers is that they fully expect that to happen. At the right exposure, which we'll discover in the proof-of-concept, we expect the LDH to come back into the normal range and the hemoglobin to go up. So that's a monotherapy situation. Our first data will be in naive subjects, and we're very much looking forward to seeing it. I think being more quantitative than that is a bit difficult.

Okay, fair enough. Do you feel like you need to be as good as Polaris and some of these other molecules? Or do you think it's, sort of, akin to HAE where there might be some flexibility if you have an oral option. How do you think about that?

Because of the position of Factor D in the alternative pathway upstream of C5 and because PNH is an alternative pathway disease if we need to see, as I mentioned, that we can get adequate exposure and maintain that. The expectation from the experts if this will be superior to C5 inhibitors.

Okay, great. Looking forward to that. And then just finally, you talked about pipeline and molecule. Can you maybe prioritize where you see making your next few investments? And what would be the next points of visibility for us? Thank you.

So what we need to really understand what the priorities will turn out to be is regulatory interactions once we have that proof-of-concept data. And so we fully intend to explore that with several indications with the regulators. Some of these diseases have no approved therapies, some of them affect children and have pretty disastrous outcomes. So I think our reserve judgment on that, but we'd like to invest across the board, of course.

Okay. Thank you very much.

Thanks, Liisa.

Thank you. Our next question comes from Jessica Fye with JPMorgan. You may proceed with your question.

Hey, guys good morning. Thanks for taking my questions. I was hoping you could elaborate on the galidesivir comments this morning. I guess, how close are you to starting further work on the current coronavirus? And can you maybe compare and contrast any similarities or differences you see between your product and remdesivir?

Yes. So let me start with the latter first. I mean, they're both broad spectrum, RNA polymerase inhibitors. That's about as much as we can make in terms of comparisons. As I said in the prepared remarks, this is such a important reminder that we've got to get broad spectrum antivirals into the stockpile, because there's a lot of reacting rather than a lot of preparedness. And so because we have a contract in place, and we've got a relationship with NIAID and BARDA, our team has been in conversations and the three things that I laid out, getting testing against the virus, looking at participating in clinical trials and evaluating increased drug supplier, all things that were in motion currently, and we're working on.

Okay. And can you also say how many patients you've dosed so far in the 9930 study? And can you remind us how many you want to see complete dosing before reporting initial data? Would you want to fill any of these cohorts before releasing data to the street?

Thanks for the question. It's not our usual practice to give a blow-by-blow on patient recruitment, once we've announced it, we started. The trial is up and running. That's great news. And proof-of-concept here doesn't need a lot of patients. So, that will be assessed as we go. And as we've seen with other programs in the past, just a few patients can be just fine, and we'll have proof-of-concept in the second quarter. The protocol is designed to give us some flexibility in terms of how many patients we might need. We may or may not need all of those subjects that are outlined on the slide.

Got it. Thank you.

Thanks.

Thank you. Our next question comes from Tazeen Ahmad with Bank of America. You may proceed with your question.

Hey good morning guys. Thanks for taking my questions. Just a view maybe on Factor D. Since that's your next big pipeline asset, I just wanted to get some color from you on how you think your molecule might differentiate from the other factors, the inhibitors that are being developed, namely the ones from Alexion and then a couple of follow-ups?

So I think what we've seen in other rare disease programs is that at these early stages, it's impossible to predict the future. We just saw the palovarotene fill out of development in fibrodysplasia ossificans progressiva for example. And that's a blow to patients with that disease. So, now there's less competition, so, all of the oral programs that are at a very early stage. I think that we're very excited about the characteristics of our molecule, not a lot of information is in the public domain about the competitor molecule, so it's rather hard to comment on comparisons.

Yes. And the last thing I'd say is, this is a huge market and so the ability for multiple oral players. I mean, you see how many injectable players are in this space towards the oral. So, this is a really big market where multiple players can play.

Okay, great. And then, in terms of your proof- of-concept study, it looks like you're going to be looking at higher doses than the ones that you might have looked at already. I think you looked at 100 mg for your previous trial. So, if you go up to let's say 400, how are you thinking about balancing that out with any observation of let's say rash? Is that a big deal based on what you're hearing from physicians?

We have successfully dosed in the MAD, 200 milligrams twice a day and 400 milligrams twice a day now. We look forward to sharing the data from those, a healthy subject cohorts, when we report the proof-of-concept data in the second quarter. So, our plan is to use those doses in the PNH proof-of-concept study in addition to the 50 and 100-milligram twice a day dose as I outlined in our remarks. Overall, as we've mentioned before, rash has been seen in the majority of people in the MAD and we've been able to dose through in a couple of cases. And in PNH patients, that's the plan. So -- and we feel very, very happy about the profile of the drug that we've seen so far.

And Bill, when you talk to the KOLs about this, the disease -- the balance between the need to treat the disease versus the tolerability issue was?

Sure. It was a simple conversation. I mean, PNH patients are very sick, people with the nephritis disease as I mentioned are very sick. And when there's an expectation of benefit, it totally changes the approach. So, the protocol allows people with benign rashes to continue dosing. And the expectation is from us and from the hematologists and from our expert immunology advisers that these things will be a temporary inconvenience.

Is there any built in part of the protocol that allows you to lower the dose?

The expectation is that, with the same dose continued that the rash will go away by itself. And that's what we saw in a couple of cases in the healthy subject part of the study, where the protocol allowed people with limited rashes to dose through. So that's the plan.

Okay. And if I could squeeze on in on 7353. Or, sorry, Berotralstat, it's going to take me a while to get used to that name. So, in Japan, historically, they have provided pricing for rare disease drugs that can be higher than what's been in the U.S., is that still the case?

Yes. Like I said before, when -- I think it was Liisa that had the question about outside of the U.S., Japan is a country where there have been some pretty high prices on rare disease drugs. The fact that we have Sakigake designation, I think, helps as well.You get a premium for pricing, and it also has a positive effect in the math that goes into the price reductions that occur in Japan, I think, every two years or whenever that occurs. So, yes, I think both Torii and Biocryst believe that a really fair price that reflects the innovation and the benefit, especially in a market where there's no other prophylactic therapies.

Okay. Thanks, guys.

Sure. Thank you.

Thank you. Our next question comes from Tyler Van Buren with Piper Sandler. You may proceed with your question.

Hey, guys. Good morning. Could you just speak a little bit more about your future clinical strategy in terms of going after potentially both naive and C5 experienced patients once you see proof-of-concept data?

I'd be happy to describe it in general terms. The exact complete development program strategy for this drug will be defined in consultation with regulatory agencies and expert advisers in the usual way. But there's wonderful opportunity here to help patients with a diverse array of diseases that are driven by other activity of the alternative pathway of complement. So it's premature to predict exactly what the studies will look like or how many subjects we'll need, but monotherapy with this drug and superiority to C5 inhibitors are expected, and that's the goal of the program.

Okay. And you mentioned, maybe the comparison to C5, but what about C3. Maybe if you could just comment on your thoughts on the recent published data and potential differentiation there?

Yes. So in alternative pathway diseases, abolishing C3 is functionally equivalent to blocking Factor D. That's the way you should think about it. I think twice a week or a more subcutaneous injection of large volumes is unattractive for patients, oral treatments are far more attractive.

Got it. Thank you.

Thank you. Our next question comes from Brian Abrahams with RBC. Your may proceed with your question.

Hi. Thanks so much for taking my questions. A few for me. I guess, Charlie, thanks for the really interesting market research update. Would love to know a little bit more in terms of whether you have any clarity on the types of patients that may be switching off their existing therapies to 7353, are there certain types of attacks that are viewed as being equivalently or perhaps even better managed with 7353, you foresee switching from more often? Then I had a few follow ups.

Yes. No, great question. Thanks for that. And what we saw in our market research, and this is consistent with our conversation with patients is, it's really everybody. Patients come from all types who are interested in oral therapy. And so as I mentioned in my remarks about the market research, the majority of patients in our survey were actually already on and doing pretty well on injectable therapy, and they have a really high interest in coming over to oral. So we think we're going to pull from all different types of patients.

Yes. I would add that these patients are really satisfied in their current therapy. And some folks have asked us, is it just the people that are having breakthrough attacks on Takhzyro that are interested? And the answer is no. And these are patients that are very well controlled, very satisfied with their current therapy and half of them are willing to switch to our oral. And the answer, Brian, is real simple, they want more out of their therapy. There is a burden of therapy when you have to inject and so they want more.

Got it. Great. And then on the Factor D program, do you guys have any additional insights into the potential drug associated rash? And can you maybe clarify how the stopping protocols differ versus the healthy volunteer study, are they any looser to potentially enable patients to dose more patients to dose through the rash?

Sure. Happy to answer that. So the key insight here is that it's a benign phenomenon, and it's benign clinically, it's benign pathologically when you biopsy the skin and look down the microscope. And the expectation driven by a huge amount of experience in the field of allergy and drug rashes is that these things are self limited and tolerance develops with continued drug dosing. And that's the expectation. I was chatting with a local physician who runs the desensitization clinic because these things are so common, right, with Bactrim, for example.So there's a lot of learning in the field of drug associated rashes of this nature that are completely benign. So that's the key thing there. With regard to the protocol for proof-of-concept, obviously our clinical studies are done putting patient safety first. And patients are getting carefully monitored. If a patient develops a benign rash, the protocol allows continued dosing with the drug. The expectation is that the rash will last an average of 4 or 5 days and disappear, despite continued dosing of the drug. So that's the plan.

And Bill, if they have itch, they can use antihistamine or cream.

Yes, topical treatment. Yes.

Got it. And then just last one for me on galidesivir. Can you remind us the drug's potency versus related coronavirus's the types of studies you might consider just -- are these studies that you would fund or that the government would fund? And then just remind us of your economics relative to BARDA on the asset? Is this something you have full control over and how long the IP life is there? Thanks.

That's a lot of questions. So Bill, you might want to take the activity on other coronavirus's first?

Yes. So an interesting feature of the RNA polymerase inhibitors like galidesivir is they have to be taken up into cells. And converted into the triphosphate nucleotide in order to work, in order to disrupt viral RNA synthesis. And a lot of the in vitro testing is done with cell lines. The cell lines vary in their ability to do that. So you have to take the in vitro activity assessments with that in mind. And for example, with the MERS, coronavirus. We've had the Vero E6 cell line, which has about an 8% efficiency compared to normal human cells in making that conversion and the EC50 was around about 20 to 30 micromolars. At the end of the day, if there's in vitro activity and the government decides to go forward with a clinical trial, you learn in a clinical trial, whether or not the drug has activity.

Yes. And to answer your question on clinical trials, Brian. There's a number of them in China, there are some in the U.S., the virus is moving around now. And so we're exploring all the different options to give the best assessment of testing it. And also, that gives a clear outcome and it is done in a way that we believe gives a good answer, so high-quality study as well.With regard to IP, we have method of use out to 2031. And so there's plenty of runway there and then with regard to the arrangement we have with the government and funding, I mean, the ultimate customer here. This is not a commercial product. The customer is governments, right? And so working with governments has been the formula in this space, and we know it well with RAPIVAB, right? And we've been through one global health emergency with 2009 H1N1 pandemic.So we're not putting BioCryst resources towards this – because the government is funding it. We have people that are dedicated to this. And as I said before, we're following the government's lead on this at the end of the day.

That’s really helpful. Thank so much.

Welcome.

Thank you. [Operator Instructions] Our next question comes from Gena Wang with Barclays. You may proceed with your question.

Thank you for taking my questions. I will also follow Brian, asking a few more questions on galidesivir. Just wondering if you can give any color regarding the activity compared to galidesivir from Gilead and then…

Well, go ahead. Go ahead, Gena.

I can ask the rest later.

Okay. So the – I'd point you to that nature publication, and we can set – John will send you the link, so that you have a reference because I don't have it in front of me right now. There aren't comparisons, but we can show you the in vitro activity to things like SARS and MERS and get you that answer.

Great. That's very helpful. And also, it seems like – do you have to do a preclinical study before moving to clinic? And how soon you think you can move to clinical study?

Yes. No, I mean, this is a global health emergency. So the rules are very different. When you're in an emergency like we're in with COVID-19. But I think the three things that I talked about before are the three things that we're currently actively working with the government on.The testing of this specific strain of virus with galidesivir, the second is understanding how to participate in clinical trials, testing it in humans would be very helpful to the advancement of our program. And so we're evaluating that. And then the third is increasing drug supply.

Sorry, just to comment on your question about preclinical testing. Galidesivir has been successfully administered to healthy volunteers in two Phase I studies, so we've got quite a lot of information about the safety and the dosing and the pharmacokinetics of the drug in healthy subjects, which helps us a lot.And you recall that we opened a study in yellow fever in Brazil. So the – nobody has a relevant animal model for COVID 19 disease. So with this current coronavirus and the relevance of any animal model to decision-making or predictive value for human efficacy is anybody's guess. So, nobody is relying on that stuff.

Yeah. And if the question is around, which RNA polymerase inhibitor would the government choose the discussions we've had with the government is they'd like to have more than one broad spectrum antiviral in the stockpile, right? There's issues of resistance, because they're broad spectrum antivirals, one may work on one virus another may work on another virus. So all the indications we've gotten from the government is that they need more than one.

Okay. And when you see government, are you only referring to the U.S. or any other governments you are being in discussion? And then how quickly you think that, that will move to Phase 3 trial?

Okay. So with relationships, it's the U.S. government for sure since, I believe, it's been a number of years since we've had a relationship with both NIAID and BARDA and so that's our focus right now. And in terms of Phase 3, it's really difficult for me to predict the past year. Again, the rules change when you're in a global health emergency. I think the important thing now is how can we help? With this global health emergency and people getting infected because you've heard on the news that vaccines are going to take a while. So treatments are really the only defense right now. And so if we can help there, we'll be available to do that.

Okay. Thank you very much.

Thank you. Our next question comes from Serge Belanger with Needham & Co. You may proceed wit your question.

Hi, good morning. Just a couple of questions for me. As you get ready for the MAA filing here, can you remind us again what your European strategy is – will you be looking for a partner? And then – on the –

No.

No. Okay. That's pretty clear.

Yeah, but I'll expand finish your second question, go ahead.

The other one is related to guidance. So go ahead.

Sure. So we've already got a team that is doing work in Europe and an experienced team, Charlie and his GM leader in Europe are hiring, and really expert rare disease folks. One of the big things in Europe is the pricing process and people that have actually had hands-on experience and negotiating through to get pricing for rare disease drugs in the various countries in Europe. And the beauty in Europe is it's super concentrated. So it doesn't take a ton of resources. It's a fraction of a small fraction of what is necessary in the U.S. So no, we're not planning on partnering there, and we're building that team and getting ready for the launch.

Okay. Got it. And then on guidance, how much of the launch spend is built into the guidance? And maybe, if you can give us a little more color on the R&D spend in 2020? And then how is the search for new CFO going?

Okay. So let me start with the guidance. So that – all the work to be ready to all the prelaunch activities, the buildup of the sales force, all of that is in the guidance. So there's no skipping on that for sure. So all of that, and that includes building up the European organization as well. And your second question was?

R&D?

So I think the way you should look at the guidance is commercial increases over time, because we're getting closer and closer to launch. Clinical goes down a bit as the course of the year and manufacturing – but it's heavy in the front of the year, and then manufacturing is heavy on the front of the year. So it all kind of balances out and is fairly evenly spread quarter-to-quarter. But you get to how the various components are at a high point going down or at a lower point going up.

Sure. And then the CFO search?

Oh, I'm sorry. Yes. Now it's going -- progressing well. So we hope to have some news soon.

All right. Thank you.

And your final question comes from Maury Raycroft with Jefferies. You may proceed with your question.

Hi everyone. Good morning and thanks for taking my question. So I'm wondering for Japan. So you mentioned 500 are in the registry in Japan, but they're estimated to be about 2,500 patients in Japan. Can you say if the inventory have made progress in getting new patients on the radar and potentially warehouse? And then with the Sakigake status, does that accelerate anything on the reimbursement side? And can you provide any perspective into what a revenue launch ramp in Japan could look like?

Yes. So one of the reasons we chose Torii is, not only their successful experience that they had that Charlie mentioned with the Gilead partnership, but also just the reach that these guys have. They have, Charlie, correct me if I'm wrong, I think, close to 300 representatives in Japan. So they're actively doing medical affairs work and the like.And you're exactly right, Maury, it is a fine the patient market because there aren't treatments, but the fact that we've got an oral once a day, I mean, the feedback that we've gotten from investigators around how -- once a day pill has changed their life. We actually had 1 investigator, tell us a patient said they forgot they were sick.So the excitement around this is incredibly high. And what we've seen in other markets around the world is, when you get that kind of enthusiasm for a therapy, you're able -- and you have the pharmaceutical resources and you have the physicians that are educated in treating the disease and you have the patient association that recipe causes the market to change dramatically and quickly.

Got it. And with Japan contributing to revenue, could that start happening by the end of 2020? Or what are your thoughts?

Yes. So just to be clear, so the process is you get approval. And I think one of the other questions you had was about Sakigake and how that affects the process and pricing. And then there is a 60-day price negotiation period with the opportunity to add another 30 days, if you're still negotiating price. And since we've never been through the Sakigake process on this part, I can't really give you a lot of experience.

So the 1 thing I think you asked if Sakigake speeds up the pricing. It doesn't speed it up. It just -- as we mentioned, it's prestigious for the drug and then it gives some opportunities in pricing over time, but it doesn't speed up that initial 60 to 90 days.

But clearly, if it's got Sakigake designation, the Japanese government believes that it's a highly innovative drug for a huge unmet need. So I think that's really important. In terms of -- so if you add all that stuff together, I wouldn't put a lot of -- remember, it's a royalty as well. I wouldn't put any revenue in this year, but next year, certainly.

Got it. Okay. And then just one more on galidesivir, I guess you already have arrangements with the U.S. government. But could funding to BioCryst from the U.S. be expanded based on the $8.3 billion in funding that's coming through Congress right now. And does BioCryst positioning become more important, if Gilead for galidesivir trial is successful?

Okay. So let me take the first one first. So it's absolutely beneficial to have a contract in place, because the process to get a contract is pretty laborious, and we have that direct experience from all the years of doing it with both galidesivir and RAPIVAB. So the government has the ability to add money to the contract that is much better than starting from scratch to start a new contract.And so we'll see, I mean, there's still money in the existing $82 million worth. So no additional money has been added yet, but we'll see how that progresses but it's certainly an option. And then at the end of the day, I said it before, multiple drugs that that have broad spectrum activity are a must in the stockpile. It's just an absolute must. And it's not to take away from vaccines and antibodies and the like. But the whole idea of a broad spectrum antiviral is that you don't know what's going to pop up next, right?And so if you have that activity, then you've got a better shot at addressing the illness quickly. And again, it takes time to make vaccines. It takes time to make antibodies. And so we're hopeful that we'll continue to progress galidesivir. I'm rooting for remdesivir as well, because in this space, it's really important that we have options. And so we'll continue to work with the government and take their lead.

Got it. Okay, thank you very much.

You're welcome.

Thank you. And I would now like to turn the call back over to Mr. Stonehouse for any concluding remarks.

So as I said at the beginning, we're off to a great start in a year that we believe will be transformative for this company with approvals and proof-of-concept with a molecule that we believe can be an entire pipeline with one asset. So we look forward to updating you as we continue our progress over the course of the year. And as always, thanks for your interest in BioCryst. Have a good day.

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