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Biocryst Pharmaceuticals Inc (BCRX) Q2 2019 Earnings Call Transcript

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Biocryst Pharmaceuticals Inc (NASDAQ: BCRX)
Q2 2019 Earnings Call
Aug 6, 2019, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to the BioCryst's Second Quarter 2019 Earnings Call. [Operator Instructions] I would now like to turn the call over to John Bluth at BioCryst. Sir, you may begin.

John Bluth -- Senior Vice President, Investor Relations and Corporate Communications

Thank you, Sidney. Good morning and welcome to BioCryst's second quarter 2019 corporate update and financial results conference call. Today's press release is available on our website. Participating with me today are CEO, Jon Stonehouse; Chief Medical Officer, Dr. Bill Sheridan; CFO, Tom Staab; and Chief Business Officer, Megan Sniecinski. 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.

I'd now like to turn the call over to Jon Stonehouse.

Jon P. Stonehouse -- President and Chief Executive Officer

Thank you, John, and thank you all for joining us this morning. We're excited to update you on our progress since announcing our positive Phase 3 results for our HAE prophylaxis program and share some important advancements in our pipeline.

Since May, we've been engaging directly with treating physicians and HAE patients to gather important insights to build out our commercialization strategy. The demand and excitement they are expressing for our once-daily oral prophylactic therapy BCX7353 has been resounding and consistent. Ten days ago, we had the privilege of attending the HAEA Patient Summit in Atlanta, which gathered over 1,000 attendees from HAE community. Over the course of the summit weekend, we had one-on-one interactions with hundreds of patients.

So what did we learn? Many patients are doing better preventing or treating their attacks, but they want more. Patients are tired of sticking themselves with needles. During the conference, patients were pulling BioCryst team members aside to remind us they're waiting for our oral therapy and we need to go fast. Some are experiencing challenges with access. It causes stress and anxiety for these patients, which is a known trigger for HAE attacks. Access is an important topic we are in the process of planning for and we will be prepared when we launch so that we are able to knock down as many of these barriers as we can. There is a strong desire for our products profile and the benefits it can provide. An oral drug that reduces attacks and brings the convenience and a lifestyle patients want. Patients told us they're excited. Their wait for once-daily oral prophylactic therapy is nearly over and they want our products.

So what have we concluded? We have an amazing drug and they want it approved. This is a direct quote from a mother of a teenager in our clinical trial. They want more than they have now with injectables. Being controlled is not enough for many. While there are new treatment options available to them, patients tell us, they are still having breakthrough attacks, no drug is perfect.

With the finish line now in sight, the excitement building among patients is amazing. The enthusiasm for 7353 is not confined to the US. Representatives from outside the US attended as well, and their response was the same. No real prophylactic market exists outside the US and they want to build it with 7353, an oral therapy, in Europe, Japan, Latin America and across Asia-Pacific.

This global commercial opportunity is one of the many reasons we're happy to add Megan Sniecinski, our Chief Business Officer, to our leadership team. In her leadership role at PTC Therapeutics, Megan helped drive significant global revenue for multiple products through a mix of their own commercialization and partnerships. And she will add tremendous value to BioCryst as we evaluate and then execute a similar strategy. Our patient and physician interactions, including our ongoing market research, are aligning. Overall, 7353 represents a significant market opportunity and we are actively preparing for the launch next year.

So what's next? We're in the process of completing patient, physician and payer market research to refine our go-to-market strategy. Bill is making great strides in filling out his medical affairs team that's holding Regional Advisory Boards to build physician relationships and gather their feedback much more broadly than we've been able to do in the past. We are also developing the US and ex-US commercial launch and resource plan, and are filling critical roles to support a successful launch. We look forward to sharing more on our commercial launch strategy with you this fall.

Let me now move to our oral Factor D program, which is another exciting priority for us. We are just months away from reporting clinical data from our Phase 1 trial for our oral Factor D inhibitor, BCX9930, which represents an even larger commercial opportunity for our Company. The current market for complement-mediated disease therapy is $4 billion, double that of HAE, and could double again as treatments in development target more indications.

The well established development path, and widely available and accepted biomarkers enable rapid advancement of 9930, and allow us to show meaningful clinical differences in a small number of patients over a short period of time. The timeline to show progress is very attractive with this program. Bill will go into more detail here, but the takeaway is that you get to a much faster answer to understand if you have a drug and we'll get an important answer soon when we report out the PK and PD results of the Phase 1.

Following our Phase 1 readout, we will move to a proof-of-concept trial in a small number of PNH patients. This patient data will provide further proof and set us on a path to bring another valuable oral drug to many patients with rare disease.

And finally, another important piece of the puzzle is the capital to fund all of this. The good news is, we have roughly $100 million on the balance sheet and a number of different options to bring in more capital.

And I'd like to turn the call over to Tom to discuss this in more detail. Tom?

Thomas R. Staab -- Senior Vice President and Chief Financial Officer

Thank you, Jon. With the upcoming commercial launch of 7353 and the predictive clinical data coming from our oral Factor D program, we are evaluating the best approach to fund these opportunities and have a range of options to consider. These options cover both equity and debt approaches as well as global business development opportunities. We are pleased that we have multiple alternatives to support our progress.

As you may recall, earlier this year we extended our cash runway and enhanced our financial flexibility by closing $100 million secured credit facility. Based on our successful APeX-2 trial, we currently have the ability to draw $30 million of non-dilutive capital at our option. That would be additive to our current cash balance as well as an additional $20 million that would be available to us following FDA approval of 7353.

I'm thrilled to have Megan's experience on the team to help us evaluate the global market opportunities for 7353 in order to assess where we will -- want to commercialize it ourselves and where we want to explore partnerships that provide non-dilutive capital. In order to gauge our future capital requirements to support all of our programs, we need to complete our launch planning and understand BCX9930 Phase 1 data. We can then pair that information with our commercial investment, clinical development and partnership plans to develop the right financing mix. We look forward to sharing more details on our capital plans with you in the fall.

Our detailed second quarter 2019 financial results can be found in the press release we issued this morning. But there are few items I need to highlight. We incurred a non-cash charge of $2 million in the second quarter of 2019 associated with realizing compensation expense on two performance-based tranches of stock options. Although a cashless event and outside our guidance ranges, it is important to note there will be a continuing charge of approximately $3.5 million as these options continue to vest throughout the remainder of the year. And thus, these continuing charges will increase our loss per share in the third and fourth quarters of 2019 beyond our normal run rate. This charge has no impact on our cash utilization or our operating expense guidance for future quarters in the year.

With two quarters under our belt, I also wanted to call your attention to cash utilization. We ended the second quarter with approximately $98 million in cash. Our operating cash used for the first half of 2019 was $53 million and is annualizing at the lower end of our projected range of $105 million to $130 million. Additionally, we continue to expect our 2019 operating expenses will be comfortably in the previously guided range of $120 million to $145 million. As we consider the best options for raising additional capital, it is very rewarding to see the strong patient and physician enthusiasm for 7353 and the rapid advancement of our oral Factor D inhibitor program.

Now I'd like to turn the call over to Bill.

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Thanks, Tom. Like Jon, I attended the HAE Association Patient Summit in Atlanta, and it was wonderful to see the engagement of patients and caregivers with our team and the tremendous encouragement that they gave to all of us in launching our oral once a day kallikrein inhibitor. They came up to our booth or found us in the halls to tell us just how much this treatment option means to them and their families. After years of IV and subcutaneous injections, many patients, even patients who are well controlled on these therapies, told us that an oral drug is a dream come true.

Since we announced the APeX-2 data and first shared it with our clinical trial investigators in the United States, Canada and Europe, the response to the data has been very positive with growing momentum. In the last few months, our medical team has conducted a series of Regional Advisory Boards comprised of US allergists and immunologists who treat patients with HAE. Universally, these physicians have responded enthusiastically to the efficacy safety profile and approvability of 7353 based on the APeX-2 results, and tell us that the patient experience on the study with 50% of patients experiencing at least a 70% reduction in attack frequency with the once-daily oral drug will absolutely translate into patients using this medicine.

Last week, I also had the opportunity to visit with staff of an experienced HAE clinical trial site that has been a major contributor to trials of every new treatment introduced for HAE and was told this drug will be life changing for the HAE community. So I'm very happy to report that all the activities needed to wrap up the 48-week dosing and analysis in APeX-2 and APeX-S are on track, and we are very confident in our Q4 target to submit the US NDA and Q1 2020 target to submit both the European MAA and JNDA in Japan.

Moving on to our oral Factor D inhibitor program for complement-mediated diseases. I'm very pleased to say that we have also had strong support from US and international expert physicians for progressing 9930 in the clinic as fast as possible. Because of the medical need across multiple different disease indications we're the alternative pathway of [Indecipherable] bad actor because they have been hoping for Factor D inhibitor and especially an oral complement inhibitor drug.

The non-clinical profile of 9930 is extremely promising. The key findings were absolutely dose-proportional exposure over a big range. Human equivalent doses of the oral [Phonetic] dose level of five grams per day, prompt and sustained suppression of the alternative pathway of complement after oral dosing at a fraction of an oral dose in non-human primates.

What these findings mean is that we should have a very wide margin of safe dosing in the clinic to achieve our therapeutic goals in complement inhibition. The Phase 1 clinical trial in healthy subjects is off to a great start and is progressing rapidly. We look forward to sharing the safety tolerability PK and PD results of this study in the fourth quarter.

As you've seen with other programs in the field, Phase 1 healthy subjects studies with complement inhibitors provide vastly more information than the usual Phase 1 clinical trial because we can measure suppression of this pathway in healthy subjects using alternative pathway biomarkers that are predictive of clinical effects and because this greatly facilitates dose selection for trials in the target diseases.

Also very important, and unlike many other disease areas, they are commercially available standardized assays like [Indecipherable] assay that enable comparison across programs. Progression of 9930 from discovery project non-clinical development to Phase 1 in the clinic has gone very fast and we have closed most of the gap with the oral Factor D inhibitor competition. We look forward to moving quickly to clinical proof-of-concept in patients with PNH in 2020. That will be very exciting as we can easily measure multiple biomarkers like [Indecipherable] that are both predictive of clinical benefit and very quick to obtain after very brief durations of dosing. You can look forward to seeing data on 9930 in PNH subjects in 2020.

Now, I'd like to turn the call over to Megan.

Megan Sniecinski -- Senior Vice President and Chief Business Officer

Thanks, Bill. For all the reasons Jon, Tom and Bill have laid out, I'm really excited to be here at this pivotal stage for BioCryst. It's a privilege to be part of a company that's fully dedicated to bringing life-changing oral treatments to patients with rare diseases. Looking at what's ahead, I'm eager to bring my experience and energy to building the capabilities and infrastructure we need to commercialize 7353 and to advance our pipeline, with the ultimate goal to create value for our patients. In this role, I have accountability for business development and corporate strategy, supply chain and program management. Right now, my focus is on execution across three key areas: Launch readiness; advancing our development programs; and exploring BD [Phonetic] opportunities that fit with our strategy.

First, for launch readiness, these activities include finalizing our launch plans based on the physician, patient and market insights, Jon mentioned earlier. Actively building out our supply and distribution channel both in the US and ex-US to be well positioned to support the strong patient demand we anticipate. And concentrating our effort on the key resources and investments we need to support a highly successful launch.

The regulatory submissions are also the team's top priority. And we remain on track for the FDA submission in the fourth quarter, and the EMA and Japanese submissions in the first quarter of 2020. Knowing every day matters to the patients we serve, we will be fully focused on ways to rapidly advance our HAE programs as well as our early stage assets, like 9930.

Lastly, on the BD [Phonetic] front, as Tom noted, we're actively exploring potential partnering opportunities to maximize the value of our assets. For example, the accelerated regulatory path with 7353 Sakigake designation in Japan presents a real opportunity to consider a local partner, one who has the capabilities and strength to bring our product to a market which currently has no approved prophylactic treatments.

I, too, was overwhelmed by the reception BioCryst received at the recent HAEA Patient Summit. This is a highly engaged, aligned and driven patient organization, and I'm very excited to be here and to partner with this amazing community to bring our product to patients in need.

Now, let me turn it back over to Jon.

Jon P. Stonehouse -- President and Chief Executive Officer

Thanks, Megan. Let me wrap up with this. In my 12 years at BioCryst, the Company has never been in a stronger position. We are hearing extraordinary customer demand for BCX7353. Next year, we will launch the first oral prophy HAE treatment and a proof-of-concept data on a potential blockbuster oral Factor D inhibitor is coming soon. And finally, we have the financial flexibility to get the capital we need to get there.

That concludes our prepared remarks. Operator, we're now ready to open it up for questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] And our first question comes from Jessica Fye with JPMorgan. Your line is open.

Daniel Wolle -- JPMorgan -- Analyst

Hi. This is Daniel for Jessica. Thanks for taking our question. A couple of questions here. First, have you met the FDA to discuss the results of APeX-2? Second, given that APeX-S is an open-label trial, can you speak at a high level to whether the safety in that study is consistent with or meaningfully different from what you have described in APeX-2? And last, with the Phase 3 acute study now postponed to 2020 for initiation, is it possible that it goes on the backburner for a period of time to preserve cash and focus on the filing for prophylactic? Thank you.

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Yes. Hi, Daniel. I'll take the first couple. With regard to regulatory interactions on the NDA plan, we've had our pre-NDA meeting that went fine. So, all of the elements that we need to submit for the NDA are on track in the fourth quarter, including the rate-limiting elements, which are the long-term safety from APeX-S and APeX-2. On that front, there is no news really. We haven't learnt anything new that we haven't seen previously in the Phase 2 and the Phase 3 program. As mentioned on previous calls, we have an independent data monitoring committee that meets regularly to review cumulative data and they have not suggested any changes to the protocols. So that's ongoing and we look forward to completing that work later this year.

Jon P. Stonehouse -- President and Chief Executive Officer

And then, with regard to your question about HAE priorities, the prophy program and the filing and the approval is absolutely the Number 1 priority. You heard Megan talk about her -- one of her main priorities and focus is launch and execution, successful execution of the launch. So that takes the resources. That takes the focus that is the priority. The acute program has been delayed a bit due to continued regulatory interactions and figuring through the CMC pieces to get to our Phase 3. And as you said, we plan to get that started sometime in 2020.

Daniel Wolle -- JPMorgan -- Analyst

Thanks.

Operator

Thank you. And our next question comes from the line of Maury Raycroft with Jefferies. Your line is open.

Swapnil -- Jefferies -- Analyst

Hi, this is Swapnil on for Maury. Thank you for taking our questions. So, just one for 7353. So, would you like anticipate any unique risks with approval process, especially due to available of such strong potent prophylactic therapies out there? And then, I have a follow-up.

Jon P. Stonehouse -- President and Chief Executive Officer

I didn't completely catch your question. I think it was a market competition question. But could you just -- could you restate it?

Swapnil -- Jefferies -- Analyst

Yes. So it's -- do you like -- think that are like any unique risks with the approval process for this 7353, especially given availability of potent prophylactic therapies?

William P. Sheridan -- Senior Vice President and Chief Medical Officer

None. So, no, we don't anticipate any unique regulatory assessments with regard to competition. It's all about this drug in front of the regulators, and its safety and efficacy profile, and the accumulated database that we have in Phase 1, Phase 2 and Phase 3 studies. So, no, I don't think competition will play into that at all.

Jon P. Stonehouse -- President and Chief Executive Officer

Yes. And I'll point you to -- I can't remember if it was 2018 or 2017. 2018, I guess. The FDA had their patient meeting with the HAE Patient Association and it was crystal clear from the audience response when they were asked a question, what's your number or what's your top priorities with regard to new therapies and convenience was Number 1. So they've heard loud and clear that patients want more convenient therapies.

Swapnil -- Jefferies -- Analyst

Okay. Thank you. And I have one follow-up question on other programs. So, for FOP molecule, which is especially targeting ALK-2, do you see any like off-target pre-clinical signals, especially because of closely related target such as TGF beta or Activin Type 1 receptors?

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Yes, thanks for the question. So the FOP program is on track to enter the clinic in coming months, this year. As you may recall, just to manage regulatory and clinical resources, earlier in the year, we made the decision to prioritize 9930. So that's going great. FOP is on track. All kinase inhibitors are multi-kinase inhibitors as -- if you're familiar with the field, it's been very interesting to see how that's evolved. But there is no such thing as a mono-kinase inhibitor. So at some dose level, all kinase inhibitors will have off-target effects. We're very comfortable with the non-clinical profile of the drug supporting entry into the clinic. And I don't anticipate that will be an issue. Obviously, all of our Phase 1 studies are done very carefully with single ascending dose and multiple ascending dose components. And the Phase 1 trial for this particular drug will be conducted in healthy subjects.

Swapnil -- Jefferies -- Analyst

Okay. Thank you. Thank you for taking my questions.

Jon P. Stonehouse -- President and Chief Executive Officer

You're welcome.

Operator

Thank you. And our next question comes from Brian Abrahams with RBC Capital Markets. Your line is open.

Bert Kinsey -- RBC Capital Markets -- Analyst

Hi, this is Bert on for Brian. Thanks for taking our question. Just wanted to get kind of an update on your current thoughts on the 7353 pricing in terms of what you may be able to charge compared to competitors in the space to capture share and/or to be tried in earlier lines?

Jon P. Stonehouse -- President and Chief Executive Officer

Yes. So we're still conducting the payer research and doing the pricing analysis. The key, and I said this before, is to be able to price it at a point where you knock down the barriers, but you don't leave a lot of money on the table, and we haven't gotten the data to make those decisions at this point in time. But what I will tell you is with our competitors having drugs of upwards of $600,000 per patient per year, we have a lot of flexibility and a lot of room, especially with the small molecule cost of goods. So we'll know more about that later. The key here, and I think this is really important, is with some of the early market research that we're getting, showing that the majority of patients want to use an overall medicine with our profile, the feedback we got from hundreds of patients at the HAE Patient Summit, there is a significant opportunity with this drug.

Bert Kinsey -- RBC Capital Markets -- Analyst

Great, thank you.

Jon P. Stonehouse -- President and Chief Executive Officer

You're welcome.

Operator

Thank you. Our next question comes from Liisa Bayko with JMP Securities. Your line is open.

Liisa Bayko -- JMP Securities -- Analyst

Hi, great. Thanks for taking my question. Can you maybe eliminate us as to when we might see presentation of the data and a little bit more on quality of life, and those kind of metrics? And I guess, how important is that latter point?

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Sure. Hi, Liisa. It's Bill. We are working hard on producing materials to present at scientific meetings and also publication planning for the manuscript for APeX-2. It's always a bit hard to predict when those things are coming out, but our objective is, of course, to support our launch with high-quality publication in a great journal. And the data is terrific, so we feel pretty confident that we can do that. We got complete engagement from the principal investigator and other key investigators on the study to help us get those publications out. The upcoming meetings, the College Allergy meeting later this year, and AAAAI early next year, and then [Indecipherable] we'll be trying to have materials at all of those meetings.

Liisa Bayko -- JMP Securities -- Analyst

Great.

William P. Sheridan -- Senior Vice President and Chief Medical Officer

On the last point, with regard to other elements, I think that one of the interesting sets of conversations or theme of conversations at the Patient Summit was also over the long-term what happens and improvement in patients well-being after months of therapy, and that's probably true for all of these drugs. So I think that story is still evolving and it will be interesting to see what type of quality of life data we get out of our long-term safety study as well with APeX-2.

Liisa Bayko -- JMP Securities -- Analyst

Okay. Great, thanks. And then, for the Factor D program, can you maybe comment on recent data from the competitive landscape. I know there were some data release recently from Achillion. And then how your comp -- how you anticipate your quantum [Phonetic] like compare/contrast? What are the key differences even from a kind of chemistry perspective? Just help us understand where you see kind of the next chapter [Phonetic] what you've seen -- what we've seen so far with Achillions program. Thanks.

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Sure. So -- a lot of respective course for all of our competition. The data presented, I think, is encouraging for the field, and indicates that they're making some progress on their programs. I think, it's very difficult at this stage to give you a direct answer in terms of head-to-head comparisons. We'll have more information that everybody will be able to assess once we have our safety PK and PD profile from the Phase 1.

Just in general, it's worth pointing out that the serine protease field and serine protease inhibitors are difficult targets. That's why there are only two companies that we know off most likely, actually entering the space of oral Factor D inhibitors. We're really thrilled with our pre-clinical data and we're closing the gap on our competition. So given the market size, I'm not worried that there is more than one player.

Liisa Bayko -- JMP Securities -- Analyst

Okay, great. Thanks.

Operator

Thank you. And our following question comes from Serge Belanger with Needham & Co. Your line is open.

Serge Belanger -- with Needham & Company -- Analyst

Hi, good morning. First a question on the prophylactic program. I think the last time you talked us back in May, you talked about a potential marketing strategy that would emphasize sampling in a lower price product. So after the Patient Summit and some of these other HAE meetings, and the feedbacks you've had with patients and physicians, is that still the marketing strategy going forward or has that evolved?

Jon P. Stonehouse -- President and Chief Executive Officer

Yes. I think, well, the strategy is the same that we want to position ourselves by making it easy for patients to get our drug and to move to the front of the line. I think, what's different is the opportunity here is much, much, much bigger. Price discounts, I'm not going to talk about that until we get the pricing research done. But we really see the demand for this drug to be huge. And so, I think the opportunity is very big.

Serge Belanger -- with Needham & Company -- Analyst

Okay. And how would you compare, I guess, the European opportunity and how that market has evolved over the last few years with some of these new products?

Jon P. Stonehouse -- President and Chief Executive Officer

Yes. So there really isn't a prophylaxis market to be honest with you. I think, that's the key difference. Pricing pressure, as we know, in any therapeutic area is harder and heavier in Europe. But our goal is to build the prophylactic market. And so, as I've mentioned before, the drugs that have been successful in this space had 90% of their sales come from US and 10% from abroad. I see a real opportunity to build value in outside the US as well. So I think, it's not that the US won't bring us great value, we think there is significant value in the US, but we think there is significant value abroad as well. And the feedback, our experience with patients and the KOLs in Europe, I mean, remember we've done a lot of our trials in Europe, and we've gotten a lot of excitement, we were approached by people from Brazil, Europe, other parts of South America, Japan, and just a lot of enthusiasm from around the world to get access to our drug.

Serge Belanger -- with Needham & Company -- Analyst

Okay. A couple of questions for the acute HAE program. Any feedback, I guess, from your meetings at these recent meetings about the appetite for an oral product. And then, can you also talk about how extend should the additional CMC formulation work that is -- that needs to be done before you undertake the Phase 3 trial?

Jon P. Stonehouse -- President and Chief Executive Officer

So in terms of the feedback, I don't think I got a single question from a patient on acute, it was all about prophylaxis. And you can understand that that they much rather prevent attacks and treat attacks. So that answers your first question.

On your second question, we just -- we want to have a formulation that's -- in Phase 3 that's better than what we had in Phase 2 and we're still working through that. We're confident we'll get there, but we are still working through it.

Serge Belanger -- with Needham & Company -- Analyst

Got it. Alright, thanks for taking my question.

Jon P. Stonehouse -- President and Chief Executive Officer

You're welcome.

Operator

Thank you. [Operator Instructions] Our next question comes from Gena Wang with Barclays. Your line is now open.

Peter -- Barclays -- Analyst

Thanks for taking my questions. Just two quick ones from...

Jon P. Stonehouse -- President and Chief Executive Officer

We can't hear you.

Peter -- Barclays -- Analyst

Hi, can you hear me?

Jon P. Stonehouse -- President and Chief Executive Officer

Yes, better. Thank you.

Peter -- Barclays -- Analyst

Hi, this is Peter on for Gena. Thanks for taking my question. Just two quick ones from us. One is for BCR -- BC -- 7353 program, do you expect to have any outcome meeting? And my -- and our second question is on the CMC formulation for the ZENITH-2, was that a request by FDA or was it more initiated on your end? Thank you.

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Yes. Hi, Peter, it's Bill. It's always hard to handicap whether or not you're going to have an outcome. But you always need to be prepared, so we will be prepared.

Jon P. Stonehouse -- President and Chief Executive Officer

Yes. And on the formulation front, there was ours, not FDA. We just -- as I said before, we want a better formulation in Phase 3 than Phase 2, and so is ours.

Peter -- Barclays -- Analyst

Great. Thank you very much.

Jon P. Stonehouse -- President and Chief Executive Officer

You're welcome.

Operator

Thank you. And our following question comes from Tazeen Ahmad from BofA Merrill Lynch. Your line is now open.

Tazeen Ahmad -- BofA Merrill Lynch -- Analyst

Hi, good morning, guys. Thanks for taking my question. Jon, just [Indecipherable] to follow-up on your plans for commercial organizations. So you've got your application under way and almost ready to submit, how are you thinking about the size of the sales force that you might need. Obviously, you are rare disease focused company, so you won't need a large infrastructure. But have you started the interview process? Do you think that you might be open for hiring, folks from competing companies, and can I also ask what your current cash runway is? Thanks.

Jon P. Stonehouse -- President and Chief Executive Officer

Sure. So with regard to the commercial infrastructure, we're hiring and we're filling jobs as we speak. So in fact, we're -- and I think it's posted, we've got a head of sales that were currently recruiting. In terms of the size of the sales force, you rightly pointed out that these are really small sales forces in rare disease. We haven't nailed own exactly what that is until we complete the market research and have a better idea of what the segments are or what the physician population is. We got a pretty good idea now, but we haven't completed it. And we'll share more of that in the fall.

Tazeen Ahmad -- BofA Merrill Lynch -- Analyst

And then on cash runway?

Thomas R. Staab -- Senior Vice President and Chief Financial Officer

Hey, Tazeen, it's Tom. Thanks for the question. So on cash runway, it continues to be into 2020. And like I said in my prepared remarks, we have a lot of financial flexibility. Obviously, our cash runway is largely dependent on the commercial outlay and some of the research that Jon mentioned as well as our plans with the 9930 program. And so, it continues to be in 2020 and well refine the cash runway as we get more information.

Tazeen Ahmad -- BofA Merrill Lynch -- Analyst

Okay. Thanks, Tom. And that includes your plans for commercial structure built out, correct?

Thomas R. Staab -- Senior Vice President and Chief Financial Officer

Yes, it does.

Tazeen Ahmad -- BofA Merrill Lynch -- Analyst

Okay. Thank you.

Operator

Thank you. And the last question comes from Tyler Van Buren with Piper Jaffray. Your line is now open.

Tyler Van Buren -- Piper Jaffray -- Analyst

Hey, good morning. I had a question on 9930 and the initial data you're in. Probably interesting that you guys mentioned that it influences financing options, given how early it is. Obviously, safety is important. But can you just -- you spoke about PK/PD, suppression of the pathway in standardized assays. So could you give a little bit more specificity on what type of PK/PD measurements you will be looking at to measure suppression of the pathway and what magnitude of suppression would be promising as you guys think about moving into PNH patients?

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Sure. So I would frame it up as follows and a lot of this you can get from the literature on complement and the development of other products and investigational drugs in the field of complement inhibitors. So there are some commercial standardized assays that interrogate the alternative pathway, which is -- Factor D is the critical enzyme in the alternative pathway. And one of those is the [Indecipherable]. So that's the first thing. And the reason that's important is because you can buy the kit and follow the instructions. So if everybody buys the kit and follows the instructions that makes the data a bit more interpretable one program to the next to the next. The remaining assays are more bespoke, but they are well published. And there are a whole range of them, including [Indecipherable] assays and the like. And a lot of that is in the literature. So we have a comprehensive set in healthy subjects that you can measure.

You might ask, how can you measure these things in healthy people, they don't have the disease. The reason is the alternative pathway is always switched on, it's always ticking over. So you can measure suppression of that in healthy people. So that's -- it's very comprehensive set. And what we are really looking for here is very strong suppression of the alternative pathway. If we don't get very strong suppression with our drug, that will be a big surprise on the basis of -- that would be a big surprise on the basis of the data we've shown with oral dosing in the monkey, that's in our published slide decks. So we're looking forward to seeing very strong suppression of the alternative pathway and that will be the -- that will be a key element in interpreting the Phase 1.

Tyler Van Buren -- Piper Jaffray -- Analyst

Great. Thanks so much.

Jon P. Stonehouse -- President and Chief Executive Officer

You're welcome.

Operator

Thank you. And I'm showing no further questions at this time. I would now like to turn the call back to Jon Stonehouse for closing remarks.

Jon P. Stonehouse -- President and Chief Executive Officer

Yes, thank you. So as I said in the prepared remarks, I don't think we've been in a stronger position at BioCryst. We are about to file and launch a drug that, I can tell you having been at the HAE Patient Summit, patients really want. The demand is extremely high and that leads us to conclude that the opportunity here is significant. And the great news is filing at the end of this year and launch next year.

On top of that, we've got oral Factor D inhibitor with 9930, that's a pipeline in a molecule. As I said, the current market doubles that of HAE and it could double from there with additional indications. And so advancing that and [Indecipherable] quickly so that we get another great oral drug out to patients, many patients with different rare diseases is another great opportunity. And we look forward to starting to update you on all the progress that we make this fall. So thanks again for your interest in BioCryst and have a great day.

Operator

[Operator Closing Remarks].

Duration: 39 minutes

Call participants:

John Bluth -- Senior Vice President, Investor Relations and Corporate Communications

Jon P. Stonehouse -- President and Chief Executive Officer

Thomas R. Staab -- Senior Vice President and Chief Financial Officer

William P. Sheridan -- Senior Vice President and Chief Medical Officer

Megan Sniecinski -- Senior Vice President and Chief Business Officer

Daniel Wolle -- JPMorgan -- Analyst

Swapnil -- Jefferies -- Analyst

Bert Kinsey -- RBC Capital Markets -- Analyst

Liisa Bayko -- JMP Securities -- Analyst

Serge Belanger -- with Needham & Company -- Analyst

Peter -- Barclays -- Analyst

Tazeen Ahmad -- BofA Merrill Lynch -- Analyst

Tyler Van Buren -- Piper Jaffray -- Analyst

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