BioCryst Pharmaceuticals Inc (BCRX) 2009 Q2 法說會逐字稿

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  • Operator

  • Good day, everyone and welcome to BioCryst Pharmaceuticals' second quarter 2009 earnings results conference call. This call is being recorded. At this time, for opening remarks and introductions, I would like to turn the call over to Mr. Robert Bennett, BioCryst's Executive Director of Business Development and Investor Relations. Mr. Bennett, please go ahead, sir.

  • Robert Bennett - Executive Director of Business Development and IR

  • Thank you. Good morning, and welcome to BioCryst's second quarter financial results conference call and corporate update. I just want point out that today's press release and accompanying slides are available on our website, www.biocryst.com. At this time all participants are in listen-only mode. Later we will open the call up for your questions. Instructions for queuing up will be provided at that time.

  • Joining me today on the call are Jon Stonehouse, Chief Executive Officer of BioCryst; Dr. William Sheridan, our Chief Medical Officer, and Stuart Grant, Chief Financial Officer.

  • Before we begin, I will read a formal statement regarding risk factors associated with today's call. Today's conference call will contain forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information, and Company performance or achievements. These statements are subject to known and unknown risks factors 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 the forward-looking statements. For additional information, including important risk factors, please refer to BioCryst documents filed with the SEC, which can be found on our Company website.

  • This morning Jon Stonehouse will provide an overview of highlights from the last three months, including BioCryst's ongoing discussions regarding the potential use of peramivir during the ongoing H1N1 influenza pandemic. Then Bill Sheridan will review the status of the influenza pandemic and provide a clinical program update. Stuart Grant will conclude with the financial results before we open up the call for Q&A.

  • With that, I will turn the call over to Jon.

  • Jon Stonehouse - CEO

  • Thanks, Rob. Good morning and thanks to all for joining us today. Before I get to our highlights from the last three months, I'll make a few comments regarding the environment we are in with the ongoing influenza pandemic. I

  • In our discussions with the government and in press coverage of the pandemic, we have witnessed serious concern and uncertainty, balanced by strong commitment to preparedness, prevention and treatment. Concern and uncertainty relates to a lack of immunity to the 2009 H1N1 virus in the population. The implication is a high potential infection rate that spreads risk for more severe illness to normally healthy adults beyond the populations typically at risk - infants and the elderly.

  • Last week we heard US health officials stating that that 2009 H1N1 virus could strike up to 40% of Americans over the next two years and as many as several hundred thousand could die if a vaccine campaign and other measures aren't successful.

  • We welcome the preemptive action taken by President Obama's administration and the US Congress, including funding commitments from the US government approaching $8.0 billion. It is a positive development that these funds are already being deployed, including over $1.0 billion that has been released to purchase vaccine-related supplies.

  • We are prepared both for possible emergency use of peramivir and in pursuing a standard regulatory path forward towards approval. Government agencies are continuing to consider the future options of providing IV peramivir through an emergency use authorization. Over the last three months, we've had regular interactions with various agencies regarding the pre-EUA review, which continues to progress.

  • In addition, we are working with the government regarding the potential for additional funding to support our Phase III clinical program. At BioCryst we have worked with our peramivir contract manufactures to understand the range of potential production volumes and lead times. We are confident that large quantities of IV peramivir could be made available.

  • Other highlights of the last three months include positive data from two Phase III studies of peramivir reported by our partner Shionogi two weeks ago. These results were an important milestone for BioCryst, the first successful Phase III study of a molecule discovered by our Company. It also represents the final peramivir clinical data needed for Shionogi to file for Japanese approval and Shionogi is working to rapidly complete its filing package. Bill will discusses the study results in more detail.

  • In addition to peramivir, our PNP programs are on track. We've made good progress in the enrollment of our pivotal study of forodesine for CTCL, which is now at more than 70% of our enrollment goal and we reported long-term patient treatment data at ASCO.

  • Before turning it over to Bill, I refer you to our updated pipeline chart shown on slide five. The takeaways are, we continue to support Shionogi as they move towards the Japanese filing for peramivir; we are preparing the US peramivir development program to focus on Phase III studies of IV peramivir for hospitalized influenza patients for the upcoming flu season; forodesine programs are on track; and finally, we are preparing to initiate a clinical study of BCX-4208.

  • Now our Chief Medical Officer, Bill Sheridan, will update you on our clinical program.

  • Dr. William Sheridan - CMO

  • Thanks, John.

  • BioCryst reported in May that the potential use of peramivir to treat influenza in seriously ill, hospitalized patients, is undergoing a Pre-Emergency Use Authorization review by the FDA. An Emergency Use Authorization, or EUA, is an authorization by the Food and Drug Administration for the use of an unapproved medical product, a drug, biologic, diagnostic test, or device for an unapproved use of an approved product based on a declaration of an emergency by the Secretary of Health and Human Services.

  • This review process has been very thorough. Activities undertaken have included reviews of peramivir clinical and non-clinical data and site inspections of BioCryst officers as well as facilities of our suppliers, partners, contract manufactures and selected clinical investigator sites, including clinical investigator sites participating in the Phase II study conducted by our partner, Shionogi and Company.

  • We want to thank our partners and investigators for their cooperation and attention in this process. The review is continuing and we cannot predict when it will be completed.

  • On the traditional regulatory pathway, our partners, Shionogi in Japan and Green Cross in South Korea, have both announced that they are making their best efforts to expedite New Drug Application regulatory filings in their countries. BioCryst is fully supporting its partner's preparations by providing documentation necessary for these regulatory filings.

  • Less than two weeks ago, we reported positive results from two Phase III studies of peramivir that were sponsored by Shionogi. In a non-inferiority study of 1,099 patients with uncomplicated seasonal influenza, Shionogi compared the efficacy and safety of a single dose of peramivir, either 300 mg or 600 mg, with oral oseltamivir phosphate, or Tamiflu, twice a day for five days. Both of the single-dose peramivir groups demonstrated non-inferiority for the primary end point, time to alleviation of symptoms, compared to the oseltamivir group.

  • The second study evaluated IV peramivir dosing over multiple days in patients with influenza who are were at high risk of serious complications due to one or more qualifying conditions, such as chronic respiratory disease, uncontrolled diabetes or immunosuppression. In this study, the median time to alleviation of symptoms in all 37 evaluable patients treated with either 300 mg or 600 mg daily, was 68.6 hours.

  • The previously reported Phase II trial conducted by Shionogi confirmed the clinical efficacy of peramivir in comparison to placebo and this data will also be included in the filing packages in Japan and South Korea.

  • In the United States, our goal is to initiate our Phase III studies in the upcoming influenza season. In discussions with FDA and HHS-BARDA, we are finalizing the study design for a Phase III trial to test peramivir in the treatment of influenza patients who require hospitalization. We are in ongoing discussions with HHS-BARDA regarding funding for these studies.

  • The reason that emergency use of peramivir is under consideration in the context of the 2009 H1N1 pandemic is the potential for large numbers of patients to be hospitalized with influenza and may not be candidates for treatment with approved antivirals.

  • Hospitalized influenza represents a setting where there are currently no antiviral therapies approved and no marketed parenteral therapies available. The emerging profile of this pandemic explains the concern. This strain of influenza virus is highly contagious in all age groups and severe cases and mortality have been observed in typically healthy age groups, including pregnant women and in patients with no underlying medical conditions.

  • According to the World Health Organization, in past pandemics influenza viruses have needed more than six months to spread as widely as the new H1N1 virus has spread in less than six weeks. The WHO reported a mortality rate averaging 0.6% globally and greater than 2.0% in Argentina and Columbia. In most countries, including the US, the majority of pandemic cases are still diagnosed in younger people, with a median age reported to be 12 to 17 years.

  • Most of the deaths recorded in the US so far have been in 25 to 49-year-olds and it is estimated that over one million Americans have so far been infected. The pandemic is still in its early stages and it is difficult to predict how the pattern of infections will play out in the fall. The return of children to school and the onset of colder temperatures in the fall are expected to accelerate its spread and we also know that there is a risk that the influenza virus could become more virulent. This is always the case.

  • The HHS has published its own estimate of illness in a moderate 1957-like or severe 1918-like pandemic. These are summarized on slide eight.

  • In a typical season, approximately 200,000 Americans are hospitalized with influenza, according to the Centers for Disease Control, and a significant portion cannot take oral Tamiflu or inhaled Relenza. In a pandemic, hospitalization rates can jump by a factor of from four-fold up to fifty-fold in the severe case scenario, a disturbing possibility when you consider that an American Hospital Association 2007 report showed that there are approximately 950,000 staffed hospital beds in the United States.

  • The CDC has confirmed that in laboratory tests the pandemic influenza virus is susceptible to neuraminidase antivirals, including peramivir. The CDC findings of late April are summarized on slide nine, with the peramivir susceptibility results highlighted in green.

  • Recently, Dr., Larisa Gubareva at the CDC has expanded her earlier research on susceptibility patterns of the 2009 pandemic influenza H1N1 strain. These expanded studies of more than 200 unique clinical isolates have demonstrated that this new virus is very sensitive to peramivir, with a median IC50 in vitro of 0.09 nanomolars in a neuraminidase chemiluminescence assay. The IC50 for peramivir is significantly lower than that for either zanamivir or oseltamivir with a p-value of less than .001.

  • We can also report progress in our forodesine oncology studies. A pivotal study of forodesine in patients with cutaneous T-cell lymphoma has now surpassed 100 patients enrolled. We have seen some acceleration in enrollment toward our target of 130 to 140 patients following the addition of more investigative sites.

  • Various studies of forodesine demonstrated that this agent is generally safe and well tolerated. This finding was reinforced by data that was presented at the American Society of Clinical Oncology in 2009, summarizing information from nine CTCL patients who were treated with forodesine for more than 12 months.

  • In addition, we have now opened to enrollment the amended chronic lymphocytic leukemia Phase II protocol testing 200 mg of forodesine, twice daily, in patients who have failed prior therapy.

  • That concludes our clinical program update. Our CFO, Stuart Grant, will summarize our financial results.

  • Stuart Grant - CFO

  • Thanks Bill. As the year progresses, we continue to have seen a good balance between moving the clinical programs forward and controlling cash burn. The financial results for Q2 are summarized on slide 12.

  • R&D expenses for the quarter were $11.2 million, compared to $13.4 million in the same quarter last year. The decrease in R&D expenses was primarily attributable to a reduction in clinical development costs associated with the peramivir program, a reduction in manufacturing costs associated with the forodesine program, and a reduction in costs incurred related to the Company's preclinical programs. Lower general operating and personnel costs also contributed to this reduction.

  • For Q2 '09, the Company reported collaborative and other research and development revenues of $4.8 million, compared to $2.7 million in Q2 2008. Revenues related to HHS were higher in Q2 of 2009. You may recall that in Q2 '08 we included a $4.9 million reserve against revenue for amounts that BioCryst had previously expected to receive from HHS, but were under discussion with HHS. These amounts remain under discussion with HHS.

  • G&A expenses decreased to $2.3 million for second quarter of '09 from $2.7 million for the second quarter '08, primarily due to a decrease in consulting fees. The net loss for the second quarter of this year was $8.7 million, or $0.23 a share, compared to a net loss of $12.7 million, or $0.33 a share for the second quarter of 2008.

  • Results for the first half are on slide 13. R&D expenses decreased to $22.5 million for the first half of '09 from $35.3 million for the same period of the previous year. The decrease in R&D expenses was due to lower clinical development and toxicology costs for the peramivir program, a reduction in manufacturing costs associated with the forodesine program, and lower costs incurred on a preclinical compound.

  • In addition, general operating costs, as well as personnel-related costs, were lower in the first six months of '09, compared to the first six months of '08. These reductions in R&D expenses were partially offset by an increase in clinical development costs associated with the forodesine program.

  • Collaborative and other R&D revenues decreased to $9.1 million for the first half of '09, from $13.4 million for the same period last year. This change was driven by a reduction in revenues from the contract with HHS for the development of peramivir, as well as a reduction in revenue for the Company's collaboration with Mundipharma.

  • In addition, less revenue was recognized during the six months ended June 30, '09 related to the Company's deferred collaboration agreement. The net loss for the six months ended June 30, '09 was $18 million or $0.47 a share, compared to a net loss of $25.8 million, or $0.68 a share, for the sixth months ended June 30, '08.

  • As of June 30, '09, the Company had cash, cash equivalents and investments of $42.3 million. The $12.0 million reduction in cash during Q2 '09 includes a $5.0 million payment to HHS to buy back peramivir active pharmaceutical ingredients. BioCryst has determined that this is excess inventory beyond what is required to execute the clinical trials to support US regulatory approval. As permitted under the contract, BioCryst has purchased the excess API from HHS.

  • HHS has indicated that it is in the process of reviewing the purchase in light of the clinical development plan to complete US registration. Pending completion of that review, the payment has been treated as a prepayment and recorded on the Company's balance sheet at June 30, '09. The cash balance reported has been reduced by this amount.

  • Based on what we know today, BioCryst continues to expect that underlying net cash used in 2009 should be between $30 million and $38 million, depending on the achievement of certain clinical milestones. This guidance excludes the one-time cash payment of $5.0 million for peramivir API.

  • We will continue to review and communicate our cash fund guidance in the context of a dynamic environment. We do believe this cash position will support a clinical program well into 2010.

  • I'll turn the call back over to Jon to summarize upcoming milestones.

  • Jon Stonehouse - CEO

  • Thanks, Stuart.

  • The milestones for the remainder of this year are summarized on slide 15; the plan to finalize the US Phase III study plan for peramivir and implement this in the upcoming flu season. In parallel, we are working to obtain additional funding for these studies from HHS-BARDA.

  • We can't forecast the timing, but we should see peramivir filings by our partners in Japan and Korea in the near future. Later this year we plan to initiate an additional study with our PNP inhibitor BCX-4208 and to further update you on the status of the forodesine CLL exploratory Phase II study.

  • With that, we will open it up to questions.

  • Operator

  • (Operator Instructions) Yigal Nochomovitz; Rodman & Renshaw

  • Yigal Nochomovitz - Analyst

  • Hi guys. Good morning and thanks for taking the question and congratulations on the progress on the quarter. I'm standing in for Ren. So the first question pertains to the design for the Phase III trial upcoming in the United States.

  • I'm just curious. Is this going to be a non-inferiority trial, for example against oseltamivir or zanamivir and what other end points could we anticipate, for example the composite end point of TTCS, time to clinical stability? Will that be featured?

  • Dr. William Sheridan - CMO

  • It's Bill. Thanks for the question. At the moment we're not disclosing the details of the design or the endpoints of those studies. We're still in discussion and you can look forward to learning more about that later.

  • Yigal Nochomovitz - Analyst

  • Okay, thank you. And Bill, with regard to the funding, you mentioned that you're in discussions with HHS-BARDA with regard to funding the program. Will this be a cost-sharing plan? Are you hoping that they'll be able to fund the entire Phase III program?

  • Stuart Grant - CFO

  • Yes, hi. This is Stuart speaking. So far we've had full funding for the program and the ongoing discussions with them are in that type context as well. So we would look for full funding of the program and we're in ongoing discussions with them relative to that right now.

  • Yigal Nochomovitz - Analyst

  • Okay, thanks. And then turning to the EUA, Emergency Use Authorization, for peramivir in the United States with the current H1N1 outbreak, I'm just curious. How is HHS thinking about potentially deploying peramivir in the EUA setting? Would this be restricted to just hospitalized patients and those at risk, for example children, high-risk diabetics, immunosuppressed and others? Or is there the potential for a more broad application of peramivir to the general population under an EUA?

  • Dr. William Sheridan - CMO

  • The context of the EUA is obviously the pandemic and the pre-EUA review process has been focused on the use of peramivir in seriously or hospitalized patients in whom other antivirals can't be used.

  • Yigal Nochomovitz - Analyst

  • Okay, thanks for the clarification and then just more of a housekeeping question. If I recall, there was a small shipment of 1,000 doses to the CDC. Has that taken place yet and was there any reimbursement from the government associated with that shipment or was it included in the HHS contract, the large $103 million contract?

  • Jon Stonehouse - CEO

  • So what we said last quarter is that we were preparing these 18,000 vials that equated to 1,000 courses of treatment. Those have not been shipped yet.

  • Yigal Nochomovitz - Analyst

  • Okay.

  • Jon Stonehouse - CEO

  • And as I'd said last quarter, you shouldn't expect any major impact financially from that.

  • Yigal Nochomovitz - Analyst

  • Okay, thanks and then just one final question. You mentioned that there's a possibility of starting a Phase II for BCX-4208 towards the second -- towards the end of 2009. From what I recall, the original -- the Phase I was in plaque psoriasis, but there was also some very good data on uric acid lowering and the potential for a trial in gout. So I'm just curious what indication you may pursue or if that's been determined as yet.

  • Dr. William Sheridan - CMO

  • We'll announce the indication once the trial starts. We're on track to start the study in the second half.

  • Yigal Nochomovitz - Analyst

  • Okay. Thanks again, guys. I appreciate taking the questions and good luck.

  • Jon Stonehouse - CEO

  • Thank you.

  • Dr. William Sheridan - CMO

  • Thank you.

  • Operator

  • Joseph Schwartz, Leerink Swann & Company

  • Joseph Schwartz - Analyst

  • Hi. Thanks, good morning and let me add my congratulations on the progress too. I was wondering if you can share with us the endpoints or design yet of the Phase III that you're contemplating? Do you have a sense of how many and can you share how many patients would be enrolled in such a study and how many centers you'll need and whether you think it'll be possible to complete that all-in-one flu season in North America?

  • Dr. William Sheridan - CMO

  • So let me take the last part of the question first. The shape of the pandemic incidence curve remains to be seen and whether or not studies required can be completed in one flu season, therefore also remains to be seen. That's a big ask and you should, I think, plan conservatively that we made need to go over several seasons to do that.

  • The other part of the question is it's our practice, really, to have studies finalized and actually implemented and we notify those studies on ClinicalTrials.gov when that occurs and you'll be able to look at the design elements and the endpoint elements at that time.

  • Joseph Schwartz - Analyst

  • Okay and then on the EUA, I'm wondering if you call tell us. How long do you think it would take you to manufacturer say a million doses of peramivir?

  • Jon Stonehouse - CEO

  • So, as Stuart mentioned in his comments, we have a decent amount of API as a result of doing validation runs on a commercial scale and so I don't want to get into the specifics of what that would cover. But if you looked at the incidence of hospitalized patients in the US in seasonal flu, it's about 200,000 cases or patients each year and that supply that we have would more than cover those kinds of numbers.

  • Stuart Grant - CFO

  • Yes, we're in ongoing discussion with a supply base, as well, Joe. So we're comfortable that if we needed to go ahead and produce we can do that.

  • Joseph Schwartz - Analyst

  • Okay and can you tell us what it would cost to produce one million doses?

  • Jon Stonehouse - CEO

  • No. We don't give out our costs.

  • Joseph Schwartz - Analyst

  • How about -- so what about the, I think it was, $5.0 million that was moved around this quarter. How much drug does that represent?

  • Stuart Grant - CFO

  • Again, Jon has said, Joe, we have to be careful what details we give out from competitive reasons. But Jon said that the amount of API that we have purchased is more than sufficient to treat the kind of incidence of hospitalizations that we see on a seasonal basis.

  • Joseph Schwartz - Analyst

  • Okay. No, that's very helpful. Thanks.

  • Jon Stonehouse - CEO

  • And Joe, back to your question on the cost of goods. I mean, for an order of magnitude it's a small molecule and consistent with small molecules.

  • Joseph Schwartz - Analyst

  • Okay and let me see here what hasn't been asked. The 2009 and '10 flu season could be very different than 2008. Do you think this will hurt you or help you, anything related to the placebo or control arm response, if people are resistent to Tamiflu? From what we know about how the drug behaved in folks last time around, can you help us think about how these issues could impact a future study, if the flu virus is the same or if it mutates away?

  • Dr. William Sheridan - CMO

  • Okay, so a couple of components to that. Will this pandemic help complete studies in influenza and provided that the hospital system is not completely overwhelmed, then the answer should be yes. It depends on how many people get admitted to hospital and how many of those are prepared to sign informed consent to enter into clinical trials. But we'll obviously make our best efforts to get sites activated and patients enrolled in the context of this pandemic is critical public health need to understand the activity of antiviral agents in this context.

  • The second part of the question was related to how the virus might behave and the first thing to say there is we need to remember that in the hospitalized setting, we'll be giving peramivir over multiple days. So, in our Phase II study, we tested five days of peramivir and it's a multiple-day setting of seriously ill patients in hospital. So that's very different to a single dose of the drug given as an outpatient, a lot more drug.

  • So we're quite confident in the data from the CDC about the sensitivity of the virus and so far, the reports of mutations to more resistent forms have been exceedingly rare. And if you look back on the trajectory of what happened with the seasonal flu strain that became resistent to Tamiflu, that evolved over about a three-year period. So it's a good setting to do clinical research and we'll be requesting prioritization of review of our protocols given the public health emergency.

  • Joseph Schwartz - Analyst

  • Okay and then just two and then I'll get back in the queue. Do you know what proportion of patients have been hospitalized for the Swine Flu so far?

  • Dr. William Sheridan - CMO

  • It's a difficult number to really pin down, because the denominator is hard to know. I'm in regular contact with infectious disease experts and flu experts around the world. For example, certain intensive care units in cities that have been hit hard have been completely filled with influenza cases. And in some hospitals that I'm aware of, the rate of admission to the ICU is about 50% of the people that get admitted to the hospital. So this is not a trivial thing.

  • Joseph Schwartz - Analyst

  • Okay and then of them, do you know what proportion can't pay oral options?

  • Dr. William Sheridan - CMO

  • Well, I think --.

  • Joseph Schwartz - Analyst

  • Oral or intranasal.

  • Dr. William Sheridan - CMO

  • I hesitate to make an estimate of that. I think that what I will say is that every time we talk to the influenza community we get strong support for the notion of developing a parenterally-delivered agent that you know you've given a high dose of agent and there's no issue with worrying about absorption. Or having to take special measures to try to dissolve a tablet or put it down a nasogastric tube or something in somebody who can't take an oral medicine. Sot there's plenty of interest in and medical need for a parenteral agent.

  • Jon Stonehouse - CEO

  • Yes and the longer you wait to take action the worse it can be, so getting the proper diagnosis quickly and getting them treated properly. An IV fits perfectly for that setting when people are in the hospital.

  • Joseph Schwartz - Analyst

  • Okay, great. Thank you.

  • Operator

  • Charles Duncan, JMP Securities

  • Charles Duncan - Analyst

  • Hi guys. First of all, good work in the quarter and congratulations on the recent data out of Shionogi.

  • Jon Stonehouse - CEO

  • Thanks, Charles.

  • Charles Duncan - Analyst

  • I had a quick question related to that Japanese NDA timeline. I know that you're not in control of that, but could you help us understand, one, the drivers to a filing date and two, what you might anticipate out a review period? I believe that some folks think that Japanese regulators take a long time.

  • Dr. William Sheridan - CMO

  • So, the circumstances here are pretty special with the World Health Organization declaring a Level Six pandemic and the anticipation of the need for new agents . So I think that you can assume that that everybody involved in influenza in clinical research, in industry, in regulatory bodies is highly motivated to get safe and efficacious agents available.

  • So I can't comment on the timeline. As we mentioned already, we're doing everything required to support our partner's regulatory filings and Jon, do you have a comment?

  • Jon Stonehouse - CEO

  • Yes. I think pulling together, you know that it's not a small task to pull together a filing once you've completed the study. But you've seen in their press release, you've heard from us that they are using best efforts. So, I've spoken with the president of Shionogi and they're putting all resources towards this to move as quickly as possible, so there's a real sense of urgency from the company.

  • Secondly, you're right in your statement about the typical timeframe for a review of a drug. In Japan, the average is two years. We get no sense that it's going to be a typical review. The fastest, to kind of bookend this, the fastest ever has been four months. We don't know if it'll be there either, so, but the sense we get is that this is both important for the company and for the regulators in Japan.

  • Charles Duncan - Analyst

  • Jon, is there any additional work in it, besides just pulling together the filing, like for example, any clinical or call it laboratory work that's required to get that prepared?

  • Dr. William Sheridan - CMO

  • No. Shionogi has completed all of the research required for their filing.

  • Charles Duncan - Analyst

  • And then is there any other way for that market to get the drug if it's not approved? For example, are they really driven to get an approved commercial agent out there or can they pull some sort of an EUA? I know that that results in an approved drug. But is there some other way for them to get the drug, unless it's approved?

  • Jon Stonehouse - CEO

  • Yes, I think they're in a slightly different situation than us, right?

  • Charles Duncan - Analyst

  • Yes.

  • Jon Stonehouse - CEO

  • Where the FDA is reviewing it because we've completed Phase II or going into Phase III. In their situation, they've just completed a Phase III. So it makes more sense, at least from my perspective, that you get the full approval and try to go as fast as you could.

  • Charles Duncan - Analyst

  • Sure. That makes sense to me as well. Can I hop over to forodesine? Because despite most of the focus of peramivir. I'm intrigued with the prospects for the forodesine progress to be shown to the Street with possible data at ASH. Is that a possibility or is that first half of next year?

  • Dr. William Sheridan - CMO

  • So the -- we won't be able to show the data at ASH, because it won't be available. We have to follow the patients for up to six months after they come onto the study and if a patient demonstrates a response, then they follow it until progression or a minimum of six months. So all of that has to happen with the last patient enrolled and then we'll be able to analyze the data and as we've said before, we're looking forward to sharing the data in the first half of next year.

  • Charles Duncan - Analyst

  • And then final question for Stuart. You gave a year-end cash balance projection of $30 million to $38 million. Its' a decent sized range. Could you give us a little bit more information on the assumptions behind that?

  • Stuart Grant - CFO

  • Yes, you know -- hi Charles. If you take away the one-off payment in the first half, the underlying [bond] was about $16 million.

  • Charles Duncan - Analyst

  • Yes.

  • Stuart Grant - CFO

  • And I think that's fairly representative of where we'll be for the rest of the year. So we're guiding to $30 million to $38 million. A lot depends on how fast we move ahead with the clinical program, the preclinical program. So I think we're well on track to deliver that guidance. At this point in time I think the quarters may be a little bit lumpy, so don't be surprised by that and we'll give you another update.

  • If anything significant happens, we would give us an update, but otherwise we'll continue to update by year-end. So I think that $30 million to $38 million is a comfortable range for us right now, again excluding the one-off exceptional payment we just made, Charles.

  • Charles Duncan - Analyst

  • Okay, good deal. Thanks for the added color, guys.

  • Stuart Grant - CFO

  • Thank you.

  • Jon Stonehouse - CEO

  • Thanks.

  • Operator

  • (Operator Instructions) Matt Bernie, Green Coast Capital

  • Jon Stonehouse - CEO

  • Hello?

  • Operator

  • Mr. Bernie, your line is open.

  • Matt Bernie - Analyst

  • Yes, I just had one question about peramivir. There was a report -- and you touched on it a little about the risks to pregnant women with the H1N1 virus. I was wondering if your drug has any risk more towards them than anyone else and if so, if that will affect the EUA review?

  • Dr. William Sheridan - CMO

  • So thanks for the question. It's typical in drug development to get quite a lot of evidence about the safety and efficacy profile of the drug before exposing pregnant women and their fetuses for obvious reasons. And we also, typically, in drug development, develop non-clinical studies that are relevant to that equation. So, for peramivir there are no safety signals.

  • We're advancing the drug into Phase III into the United States and in the context of an emergency use the point about an emergency use is to make the drug available to seriously ill patients in hospital, as I described before. And so under those circumstances, pregnant women would not be excluded. So does that answer your question?

  • Matt Bernie - Analyst

  • Yes. Thank you and I'm all set. Thanks. Good luck, guys.

  • Jon Stonehouse - CEO

  • Thank you.

  • Operator

  • And Mr. Bennett, there are no further questions at this time, sir.

  • Robert Bennett - Executive Director of Business Development and IR

  • So, I guess in closing, these are really exciting times for us at BioCryst. We look forward to giving you updates through the course of the remainder of the year and as always, thanks for your interest. Have a good day.

  • Operator

  • Thank you, sir. That does conclude today teleconference. We thank you all for your participation. 10