Q2 2020 BioCryst Pharmaceuticals Inc Earnings Call
2020, <unk> earnings call.
Operator: 2020 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press Star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star 0. I will now like to hand the conference over to your speaker today, Mr. John Bluth of BioCryst. Thank you. Please go ahead, sir.
Time, all participants are in listen only mode. After the speaker presentation, there will be a question and answer session.
Ask the question during the session you would need to press star one on your telephone. Please be advised that todays conference is being recorded if you're acquiring any further assistance. Please press star zero I would now like they had the conference over to your speaker today Mr. John Lewis about your Chris. Thank you. Please go ahead.
Fair.
Thank you to me.
John D. Bluth: Thank you, Tamia. Good morning and welcome to BioCryst's second quarter 2020 corporate update and financial results conference call. Today's press release and slides are available on our website. Participating with me today are CEO Jon Stonehouse, CFO Anthony Doyle, Chief Medical Officer Dr. Bill Sheridan, Chief Business Officer Megan Snizinski, and Chief Commercial Officer Charlie Geyer.
Good morning, and welcome to Biocryst second quarter 2020, corporate update financial results Conference call.
Today's press release on slides are available on our website.
Dissipating with me today, our CEO, Jon Stonehouse, CFO, Anthony <unk>, Chief Medical Officer, Dr., Bill Sheridan, Chief Business Officer, Megan Zinski, and Chief Commercial Officer, Charlie Guy.
Following our remarks will answer your questions.
Jon P. Stonehouse: 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 on audited 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.
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 Exchange Commission, which can be accessed on our website I'd now like to turn the call over to Jon Stonehouse.
Thank you John and thanks to everyone for joining us this morning.
Jon P. Stonehouse: Thank you, Jon, and thanks to everyone for joining us this morning. BioCryst is going through a major transformation, and it's happening now. This transformation is from a company primarily focused on R&D to one that's about to launch its first major product this year, start generating real revenue next year, and ultimately lead to global peak sales potential of greater than a half a billion dollars with this first product. HAE patients have been waiting for an oral drug to prevent their attacks, and we are excited their wait is nearly over. The transformation continues with a pipeline and a molecule.
Well, Chris just going through a major transformation and it's happening now its transformation is from a company primarily focused on R&D to one that's about to launch its first major product. This year start generating real revenue next year, and ultimately leading to global peak sales potential of greater than a half a billion dollars.
With this first product.
80 patients have been waiting for an oral drug to prevent their attacks and we are excited their weight is nearly over.
The transformation continues with the pipeline in a molecule.
Our oral factor de inhibitor program led by be 690, 930 will fill up our pipeline because of its broad application to complement mediated diseases in many different indications.
Jon P. Stonehouse: Our Oral Factor Deinhibitor Program led by BCX9930 will fill up our pipeline because of its broad application to complement mediated diseases in many different indications. We have proof of concept in hand for P&H, and Bill and his team are driving forward with a plan next year that will run multiple studies in different indications in parallel. And lastly, this transformation is from a company with one key data readout a year to a company with a steady drumbeat of milestones across multiple programs, indications, and geography. Our regulatory timelines for Orladeo are on track, and we expect two approvals this year in the U.S. and Japan, and European approval early next year. And starting with Q1, we will be reporting sales for Orladeo each quarter beginning next year.
We have proof of concept in hand for P. in age and Bill and his team are driving forward with a plan next year that will run multiple studies in different indications in parallel.
And lastly, this transformation is from a company with one key data read out a year to accompany with a steady drumbeat of milestones across multiple programs indications and geographies.
Our regulatory timelines for or the day are on track and we expect to approval this year in the U.S. in Japan.
The European approval early next year.
Starting with Q1, we will be reporting sales for Orla Dale each quarter beginning next year.
On the clinical trial front, we expect data in treatment naive patients at higher doses with 90 930 in the third quarter.
Jon P. Stonehouse: On the clinical trial front, we expect data in treatment-naive patients at higher doses, with 99.30 in the third quarter, and more data by year-end in poor responders. In addition, we expect data from Part 1 of our COVID-19 trial with Galadezavir in Brazil by the end of this quarter. And finally, we expect more clinical progress with 9930 and Galidesivir over the course of the next. We have never been in this position with so many ways to deliver value to patients and to share. We are laser focused on Orladeo approvals and launches and accelerating the oral factor de-inhibitor program. We have a strong balance sheet, and we're allocating this capital to these top priorities. And finally, we're working with urgency on our government-funded program that has the potential to provide value for patients infected with COVID-19 and patients in future viral outbreaks. We are making great progress on all these fronts, and to give you more detail, I will first turn it over to Charlie to talk about getting ready for the Orla Deo launch.
And more data by year end in poor responders.
In addition, we expect data from part one of our Cobot 19 trial with Gallaudet severe in Brazil by the end of this quarter.
And finally, we expect more clinical progress with 90 930 in Gallaudet severe over the course of next year.
We have never been in the spot with so many ways to deliver value to patients and the shareholders. We are laser focused on that or the dale approvals and launches and accelerating the oral factor de inhibitor program.
We have a strong balance sheet and we're allocating this capital to these top priorities.
And finally, we're working with urgency on our government funded program.
Has the potential to provide value for patients infected with cobot 19.
And patient and future viral outbreaks.
We're making great progress on all these front end to give you more detail I will first turn it over to Charlie to talk about getting ready for the or Ladell launch. Thanks John.
Charles K. Gayer: Thanks, Jon. Orlando is coming soon. We're just over a quarter away from our December 3rd deadline. Patients have waited a long time for an oral, once-daily therapy to prevent their HAE attacks, and our commercial team is ready to bring it to them. In fact, we just passed a major milestone by completing the hiring of our U.S. sales force, and we could not be more pleased by the quality of these sales professionals. They average 20 years of experience in the industry, including 8 years of recent work in rare diseases, and all of them have been consistent top-tier performers. What we hear over and over is that they joined BioCryst because they really want to sell the first targeted oral drug for HAE, and they can't wait to bring Orladeo to patients. The rest of our preparations for the U.S. launch are in their final stages.
Orlando is coming soon.
Just over a quarter away from our December 3rd PDUFA date.
Patients have waited a long time for an oral once daily therapy to prevent their EG attacks and our commercial team is ready to bring it to them.
In fact, we just passed a major milestone by completing the hiring of our U.S. salesforce and we could not be more pleased by the quality of these sales professionals.
They averaged 20 years' experience in the industry, including eight years of recent work in rare disease and all of them, it's been consistent top tier performers.
What we hear over and over as they joined Biocryst, because they really want to sell the first targeted oral drug for HIV and they can't wait to bring Orlando to patients.
The rest of our preparations for the U.S. lontra and their final stages.
Orla Dale value proposition of controlling attacks and reducing the burden of treatment has been clear and motivating to patients and physicians during market research and we are finalizing our core marketing tactics.
Charles K. Gayer: The Orladeo Value Proposition of Controlling Attacks and Reducing the Burden of Treatment has been clear and motivating to patients and physicians during market research, and we are finalizing our core marketing tactics. HAE patients and providers want rapid, burden-free access to medicine, and our Orladeo Service Hub is in place and ready to help. Consistent product supply is also critical, and we have plenty of supply ready to support strong demand. We're also making significant progress toward launching Orladeo in Europe in early 2021. We retain rights to Orladeo in Europe because the HAE market there is concentrated in large treatment centers. And we've formed strong relationships with physicians and patient organizations during our clinical trials. That's allowing us to build an efficient and experienced European organization that we expect to contribute meaningful sales. As we approach the US launch later this year and in Europe early next year, we are even more confident that Orladeo will exceed $500 million in peak global sales. Now, I'd like to turn the call over to Megan to describe our medical team's progress.
Ha patients and providers want rapid burden free access to medicine, and our Orla Dale service is in place and ready to help.
Consistent product supply is also critical and we have plenty of supply ready to support strong demand.
We're also making significant progress toward launching in Europe in early 2021.
We retain rights to Orlando in Europe, because the AG market. There is concentrated into large treatment centers and we've formed strong relationships with physicians and patient organizations during our clinical trials.
That's allowing us to build an efficient and experienced European organization that we expect to contribute meaningful sales.
As we approach US launch later this year and in Europe. Early next year, we're even more confident that orla Dale will exceed $500 million in peak global sales.
Now I'd like to turn the call over to Meghan to describe our medical teams progress.
Thanks, Charlie and good morning.
Megan Snizinski: Thanks, Charlie, and good morning. Alongside the onboarding of our sales team, we've remained focused on executing our medical strategy, which is fundamental in this pre-launch phase. As Charlie mentioned, physicians and patients see the benefits Orladeo can provide to reduce both the burden of a tax and the burden of treatment. It's exciting to see how consistent this is with what we're learning from our KOL engagement and the insights we have from our clinical trial data. Let me start by recapping a few recent highlights on the data front.
Alongside the Onboarding of our sales team, we remain focused on executing our medical strategy, which is fundamental in this pre launch phase.
Charlie mentioned physicians and patients the the benefits or ladell can provide to reduce both the burden of attack and the burden of treatment.
It's exciting to see how consistent this is with what we're learning from our kalo engagement and the insights we have from our clinical trial data.
Let me start by Recapping a few recent highlights on the data from.
Megan Snizinski: At YACI in June, we presented our longer-term clinical data, which continues to show the meaningful clinical benefits of once-daily Orladeo therapy. Significant and sustained attack rate reductions and clinically meaningful improvements in quality of life were observed over 48 weeks. In APEX II, patients who completed 48 weeks on 150 mg Morladeo went from an average baseline of 2.9 attacks per month down to 1.0 attacks per month at 12 months. In Apex-S patients who had one year of treatment on 150 mg Orladeo, we saw that in 5 of the last 6 months of treatment, at least 50% of patients experienced no attacks. As patients continue longer on treatment, we see continued improvements, and we are excited by this additional evidence that our drug works. We look forward to generating further data and insights from the APEX II study and our ongoing APEX F study, which continues to enroll patients in the U.S., including patients recently on other PRO-FET treatments. And we were pleased to open a U.S. Expanded Access Program in June, enabling enrollment for a broader population of patients.
At Yankee in June we presented our longer term clinical data, which continues to show the meaningful clinical benefits of once daily Orlando therapy.
Significant and sustained attack rate reduction and clinically meaningful improvements in quality of life were observed over 48 week.
In apex to patients who completed 48 weeks on 150 milligram Orlando went from an average baseline of 2.9 attacks per month down to 1.0 attacks per month at 12 months.
And the eight excess patients with one year of treatment on 150 milligram Orlando, we saw that in five of the last six months of treatment at least 50% of patients experience no attacks.
As patients continue longer on treatment, we see continued improvements and we are excited by this additional evidence that our drug works.
We look forward to generating further data and insights from the apex, two study and our ongoing apex study, which continues enrolling in the U.S., including patients recently on other prophy treatments.
And you were pleased to open a U.S. expanded access program in June enabling enrollment to a broader population of patients who do not have access to Orlando through our clinical trials.
Megan Snizinski: who do not have access to Orladeo through our clinical trials.
We are even more confident in the potential for Orlando.
Megan Snizinski: We are even more confident in the potential for Orladeo, based on the totality of data and patient experience.
Based on this totality of data and patients experience as more continue treatment or initiate through enrollment or the day was clearly a valuable treatment for patients who want more.
Operator: Transcription by CastingWords
Megan Snizinski: Transcript by Transcription Outsourcing, LLC, for patients who not only want to reduce their attacks but also want to eliminate the difficulties and life challenges presented by today's injectable medicine. We are hearing consistent insights from our ongoing KOL engagement activities, which are in full gear even during this unprecedented time with COVID. HAE patients may feel satisfied with today's treatment, but as our research shows, patients are still experiencing breakthrough attacks. However, no treatment is perfect.
For patients, who not only wants to reduce their attacks, but also want to eliminate the difficulties and life challenges presented by today's injectable medicines.
We are hearing consistent insights from our ongoing cable engagement activities, which are in full gear. Even during this unprecedented time that's coated.
Megan Snizinski: In fact, our research presented at YACI showed the majority of patients still expect to have some attacks even while on today's prophytherapy. Physicians acknowledge that what matters is determining the treatment paradigm that's optimal for the individual patient, especially when considering the complete HAE disease burden, that is the attack burden and the treatment burden. With significant reductions in attacks and ease of administration, physicians recognize that Orladeo presents a meaningful treatment option for patients. This gives us great confidence in the opportunity for Orladeo, and we're excited to be just four months away from the PDUFA date in the U.S. Charlie covered our commercial update in the U.S. and EU, so I'll briefly touch on Japan and the launch plans underway with our partner, Tory.
Have some attack even while on todays prophy therapies.
Physicians acknowledge what matters is determining the treatment paradigm that optimal for the individual patient, especially when considering the complete 80 disease burden that is the attack burden and the treatment burden.
We have significant reductions in attacks and ease of administration physicians recognize that Orlando presents a meaningful treatment option for patients.
This gives us great confidence in the opportunity for Orlando and we're excited to be just four months away from the PDUFA date in the U.S.
Charlie covered our commercial update in the U.S. and use so I'll briefly touch on Japan, and the launch plans underway with our partner Tory.
Let me remind you that unlike the U.S. in the EU Orlando would be the first approved ha prophylactic treatment in Japan.
Megan Snizinski: Let me remind you that, unlike the U.S. and the EU, Orladeo would be the first approved HAE prophylaxis treatment in Japan. This represents an exciting opportunity for Torrey to build the prophy market and to address a significant unmet need for HAE patients. On the regulatory front, the Orladeo Review has been ongoing under the Sakagaki designation. The PMDA meets quarterly to review and approve new drug applications. They've confirmed to us that Orladeo is on the schedule for review during their fourth quarter cycle, with an approval decision expected in December. In the months ahead, TORI will continue focusing on efforts to understand the market landscape, raise disease awareness, and increase patient identification. From their current product portfolio, TORI has a strong base of relationships with leading KOLs and allergists, and their experience building the HIV market translates nicely into establishing the profi market for HAE.
This represents an exciting opportunity for Tory to build the prophy market and to address a significant unmet unmet need for peak ha patients.
On the regulatory front the Orlando review has been ongoing under the Sacca Gawky designation.
The PMTA meets quarterly to review and approved new drug application. They have confirmed to us that Orlando is on the schedule for review during their fourth quarter cycle with an approval decision expected in December.
In the months ahead, Tory will continue focusing on efforts to understand the market landscape to raise disease awareness and to increase patient identification.
From their current product portfolio Tory has a strong base of relationships with leading county wells and Allergan.
And their experience building the HIV market translates nicely into establishing the prophy market for ha.
I know biocryst inventory share the same eagerness enthusiasms to bring once daily or the day of the first prophy treatment to ha patients in Japan.
Megan Snizinski: I know BioCryst and Tauri share the same eagerness and enthusiasm to bring once daily Orladeo, the first prophylactic treatment for HAA patients in Japan. Lastly, in terms of launch readiness, as Charlie noted, our supply chain is ready to support the demand we anticipate. Having started my career in API manufacturing, I appreciate the investment BioCryst made early on to secure dual sourcing at each step with established CMO partners. This approach provides redundancy and de-risks our supply chain. We're exactly where we need to be from a supply perspective and are eagerly awaiting the two approval decisions later this year in the U.S. and Japan and in Europe early next year. In terms of our other strategic priority, our Oral Factor D program, I'll turn the call over to Bill for an update.
Lastly in terms of launch readiness as Charlie noted our supply chain is ready to support the demand we anticipate.
Having started my career and Apiay manufacturing I appreciate the investment Biocrysts made early on to secure dual sourcing at each step with established CMO partners.
This approach provides redundancy and de risks our supply chain, where exactly where we need to be from a supply perspective and are eagerly awaiting the two approval decision later this year in the U.S. in Japan and in Europe early next year.
In terms of our other strategic priority, our oral factor Deprogram I'll turn the call over to Bill for an update.
Thanks, Megan and good morning.
William P. Sheridan: Thanks, Megan, and good morning. Our goal with BCX9930 is to develop this oral, potent, and selective factor D inhibitor as a monotherapy across multiple disease indications driven by the alternative pathway of complement. The scientific foundation for alternative pathway involvement in disease is deep, and the evidence is clear. FACTiD is an excellent drug.
Our goal would be 690 930 is to develop this oral potent and selective effected inhibitor as a monotherapy across multiple disease indications driven by the alternative pathways complement.
The scientific temptation for alternative pathway involvement in disease is deep and the evidence is clear.
Thank you, ladies and excellent drug targets.
William P. Sheridan: It is the first enzyme in the alternative pathway, and it is solely responsible for activating Factor B. It is rate-limiting for alternative pathway activation. It has the lowest circulating level of any complement protein, and blockade of Factor D prevents downstream amplification of complement. So, that means that regardless of the indication, we can apply the same drug, BCX9930, across all diseases driven by the alternative pathway. The first indication that we chose for 99.30 is paroxysmal nocturnal hemoglobin urea. And we were very pleased to report earlier this week that the FDA has granted fast-track status for 99.38% of the time for this indication. This designation recognizes the unmet need for treatments in P&H and is intended to accelerate development and achieve earlier approval. We look forward to upcoming regulatory discussions on the advanced development of 9930 and PNH and to working closely with FDA and other regulatory authorities as the program progresses. Our first trial in PNH was designed to test dose response and provide proof of concept. In this trial, 9930 is administered in two groups of patients. In those naive to C5 inhibitors, 9930 is used alone.
It is the first enzyme in the alternative pathway.
It is solely responsible for activating fact today it is rate limiting for alternative pathway activation.
It has the lowest circulating level of any complement protein.
Blockade affected deed prevents downstream amplification of completion.
Sorry that means that regardless of the indication we can apply the same drug PCX 99 cities across all disease is driven by the alternative pathway.
The first indication that we chose for 90 930, just paroxysmal nocturnal hemoglobin urea.
And we were very pleased to report earlier this week that the FDA has granted fast track status for 99 city.
For the syndication.
This designation recognizes the unmet need for treatments in tier one is intended to accelerate development and achieve earlier approval.
We look forward to upcoming regulatory discussions on advanced development of 90, 930 mph any working closely with FDA and other regulatory authorities as the program progresses.
At first trial in Canada, which was designed to test dose response and provide proof of concept.
In this trial 99 cities administered in two groups of patients in those naive to see five inhibitors 99 cities used alone and those with poor response to see five inhibitors 99 cities added to include summit Revelus summit.
William P. Sheridan: In those with a poor response to C5 inhibitors, 9930 is added to eclizumab or ravelizumab. In May, we were excited to present data for treatment-naive patients receiving initial doses of 50mg and 100mg orally BID as monotherapy. We showed there were dose-dependent reductions in LDH and increases in hemoglobin, with no drug-related serious adverse events. At the same time, in healthy subjects, we saw a strong dose response on pharmacodynamics with superior alternative pathway activity at the higher doses of 200mg and 400mg BID and no dose-limiting adverse events. Following completion of the lower dose periods, patients enter an extension phase where these higher doses can be used. In newly enrolled patients, dosing now starts at 200mg BID for 14 days, followed by 400mg BID.
In May we were excited to present data for treatment naive patients receiving initial doses of 50 milligrams and 100 milligrams.
Early VIP as monotherapy.
We showed they with dose dependent reductions in LDH and increases in hemoglobin with no drug related serious adverse events.
At the same time in healthy subjects, we saw strong dose response on pharmacodynamics with superior alternative pathway activity at the higher doses of 200 milligrams and 400 milligrams be I'd and no dose limiting adverse events.
Following completion of the lowest dose periods patients entering extension phase, where these higher doses can be used.
In newly enrolled patients dosing now stands at 200 milligrams be I'd for 14 days, followed by 400 milligrams be I'd.
We are on track to report monotherapy data at these higher doses in treatment naive teenage patients later this quarter and plan to report data from teenage patients who are poor responders to treatments the block C. Five before year end.
William P. Sheridan: We are on track to report monotherapy data at these higher doses in treatment-naive P&H patients later this quarter and plan to report data from P&H patients who are co-respondents to treatments that block C5 before year-end. So, with those data in hand by year-end 2020, we expect to have the evidence we need to support further trials of 9930 as an oral monotherapy in PNH. The key role of the Alternative Pathway of Complement, and therefore Factor D, in many diseases makes the opportunity for 9930 far larger than PNH alone, more like a pipeline in a molecule. All of the growing number of rare diseases driven by the alternative pathway of complement are serious and potentially life-threatening, and most have no approved treatment.
So with those data in hand by year end Twentytwenty, we expect to have the evidence we need to support further trials of 90 930, as an oral monotherapy in piano edge.
The key role as the alternative pathway of complement and therefore affected d. in many diseases makes the opportunity for 90 930 far larger than PNM alone more like a pipeline in a molecule.
All of the growing number of rare diseases, driven by the alternative pathway complement a serious and potentially life threatening and most have no approved treatments.
And next set of target indications after PNM affect the kidney.
William P. Sheridan: Our next set of target indications after PNH affect the kidney, often leading to end-stage renal disease or death. The combination of high unmet need, strong scientific validation for the pathway, and our proof-of-concept PNH data is driving an enthusiastic response for clinical trials of 99.30 in nephritis from our nephrology experts. So our plan for accelerating our investment in the 9930 development program includes both progressing P&H into advanced clinical trials and also expanding clinical trials to additional indications in nephritis. To support an expanded clinical program in multiple indications in 2021, we are now ramping up drug supply, advancing our non-clinical studies, and completing our consultations with hematologists, nephrologists, and patient advocates. We plan to meet with regulators in the coming months to agree on our advanced development programs for both PNH and selected complement-mediated nephritis conditions.
Often leading to end stage renal disease with this.
The combination of high unmet need strong scientific validation for the pathway and proof of concept PNM data are driving an enthusiastic response for clinical trials of 90 930 in the Freitas from end of from GE experts.
So our plan for accelerating our investment in the 99 City development program includes both progressing PNM each into advanced clinical trials and also expanding clinical trial through additional indications in there for us.
To support and expanded clinical program in multiple indications in 2021, we are now ramping up drug supply advancing on Nonclinical studies, and completing our consultations with Hematologists nephrologists and patient advocates.
We plan to meet with regulators in coming months to agree on our advanced development programs for both pinch and selected complement mediated nephritis conditions.
I would now like to turn to the Galidesivir program and provide an update on progress for the coated 19 clinical trial and future drug supply.
William P. Sheridan: I would now like to turn to the GALADESIVIR program and provide an update on progress for the COVID-19 clinical trial and future drug supply. Brazil has been hit especially hard by the pandemic. Although there are many COVID-19 patients, the healthcare system is under enormous stress, making it difficult to go as fast as we would like. Nevertheless, we are now enrolling patients at four sites in Brazil, and we expect to have information to report from Part 1 of the trial by the end of this quarter. We are also making progress with our government partners to improve the manufacturing process and increase the drug supply, which will prove to be critically important if the clinical study results are positive. In this global health emergency, we hope GALADESIVIR will have an important role to play. We have no doubt that the COVID-19 pandemic has reinforced for governments around the world the importance of having broad-spectrum antivirals like GALADESIVIR in their stockpiles before outbreaks arrive, and we believe that GALADESIVIR could be an important component in those stockspiles. Now, I'd like to turn the call over to Anthony.
Brazil has been hit, especially hard by the pandemic.
Although there are many coated 19 patients the health care system is under enormous tourists, making it difficult to go as fast as we would like.
Nevertheless, we are now enrolling patients at four sites in Brazil, and we expect to have information to report from part one of the trial by the end of this quarter.
We're also making progress with our government partners to improve the manufacturing process and increased drug supply, which will prove to be critically important if the clinical study results are positive.
In this global health emergency, we hope Galidesivir it could have an important role to play.
We have no doubt that the coated 19 pandemic has reinforced for governments around the world the importance of having broad spectrum antiviral slight Keller this severe in their stockpiles before outbreaks of arrive.
And we believe the Galidesivir galidesivir it could be an important component in those stockpiles now I'd like to turn the call over to entity.
Anthony J. Doyle: Thanks, Phil. As the CFO, I'm very excited to be approaching the time when we'll be generating revenues with Orladeo. As Charlie and Megan have said, with approvals in the U.S. and Japan just over a quarter away, that day is coming. Supporting the successful launch of Orlodeo, while also investing in driving the 9930 program forward, both in running trials, as Bill mentioned, and enhancing our drug supply, continue to be the main areas where we're focusing our resources right now. You can find our detailed financials in today's earnings press release, and I'd like to call your attention to a few items. On the back of our equity financing in May, we ended Q2 with $192 million in cash. Our operating expenses, not including non-cash stock compensation, for the quarter were $41 million, and were $81 million through the first half of the year.
Thanks, Phil.
As the CFO I'm very excited to be approaching the time, where we'll be regenerating revenues with order today.
As Charlie and Meg and I've said with approvals in the us in Japan, just over a quarter or way Dante is coming soon.
Supporting the successful launch of Orlando, while also investing and driving the 90 930 program forward both in running trials as Bill mentioned and enhancing our drug supply continued to be the main areas, where we're focusing our resources right now.
You can find our detailed financials in today's earnings press release, and I'd like to call your attention to a few items on the back of our equity financing in May We ended Q2 was $192 million in cash.
Our operating expenses, not including noncash stock compensation for the quarter were $41 million and were 81 million through the first half of the year.
The additional capital raised in Q2, and the safety and efficacy data generated MPN age patients has increased our confidence to continue to invest in the accelerated development of 90 930 in the second half of 2020 beyond.
Anthony J. Doyle: The additional capital raised in Q2 and the safety and efficacy data generated in PNH patients have increased our confidence to continue to invest in the accelerated development of 9930 in the second half of 2020 and beyond. This increased investment will see net operating cash usage for the full year of 2020 in the range of $150 million to $165 million and operating expenses for the full year in the range of $180 million to $195 million. This gives us cash runway through Q2 of next year. With the inclusion of revenue from Orladeo and our potential capital sources, in addition to evaluating royalty and our debt financing, partnerships for 99.30, and other financing options. We continue to have strong optionality in how we provide financial flexibility moving forward.
This increased investment, we'll see net operating cash usage for the full year 2020 in the range of 150 265 million and operating expenses for the full year in the range of 180 to 195 million. This gives us cash runway through Q2 of next year.
With the inclusion of revenue for more today on our potential capital sources. In addition to evaluating royalty and our debt financing partnerships for 90 930, and other financing options. We continue to have strong optionality and how we provides financial flexibility moving forward.
I'm very much looking forward to the second half of the year with catalysts such as approvals in revenue for Orlando data for 90, 930 in both naive and per responders and information from part one of our cobot trial with Gallaudet severe the company continues to be in a strong financial position on as well placed for future growth now pass back to John for.
Anthony J. Doyle: I'm very much looking forward to the second half of the year. With catalysts such as approvals and revenue for Orladeo, data for 9930 in both naive and per-responders, and information from part one of our COVID trial with Calidesivir, the company continues to be in a strong financial position and is well-placed for future growth. Now I'll pass it back to Jon for his closing remarks.
Using remarks, thanks, Anthony will there be habit as Charlie in Megan explain we'll be ready to successfully launch our first oral drug for patients suffering from a rare disease.
Orlando has a profile patients have been waiting for and we have assembled an experienced.
Jon P. Stonehouse: Thanks, Anthony. Well, there you have it.
Team and are actively developing and executing plans to successfully launch or ladell a product upon approval and take nothing for granted we will be ready.
Jon P. Stonehouse: As Charlie and Megan explain, we'll be ready to successfully launch our first oral drug for patients suffering from a rare disease. Orladeo has a profile patients have been waiting for, and we have assembled an experienced team and are actively developing and executing plans to successfully launch Orladeo upon approval. We will not take anything for granted. We will be ready.
Megan describe how the medical affairs team is actively working with leaders in the field of HP to advance the practice of managing ha patients to go beyond the management of attacks.
Jon P. Stonehouse: Megan described how the medical affairs team is actively working with leaders in the field of HAE to advance the practice of managing HAE patients to go beyond the management of a tech. Partner Tory is getting ready as well, and we now have a clear line of sight to an approval decision in Japan later this year. If that weren't exciting enough, Bill shared we're on target to deliver high-dose data from our oral factor D inhibitor 9930 later this quarter and then later in the year. He also gave you a glimpse into how broad we can go with his insights into the many indications we can pursue starting next year. He also shared how we're working with our government partners to evaluate our broad-spectrum antiviral, Galidesivir, in this global pandemic with the hope of advancing this program more broadly later in the year. Lastly, Anthony shared with you how we will allocate capital to the approvals and launch of Orladeo and the acceleration of the Factor D program. These investments, plus program advancement and product revenue, will give us options for access to additional capital to continue the industry. As I said at the start of the call, BioCryst is transforming.
Our partner Tory is getting ready as well and we now have a clear line of sight to an approval decision in Japan later this year.
If that were in is exciting enough bill shared we're on target to deliver high dose data from our oral factor de inhibitor 90 930 later this quarter and then later in the year.
He also gave you a glimpse into how broad we can go with his insights into the many indications we can pursue starting next year.
He also shared how we're working with our government partners to evaluate our broad spectrum any antiviral gallaudet severe in this global pandemic with the hope of advancing this program more broadly later in the year.
Lastly, Anthony shared with you, how we will allocate capital to the approvals and launch of Orlando and the acceleration of the factor de program.
These investments plus program advancement and product revenue will give us options on access to additional capital to continue the investment.
As I said at the start of the call Biocryst is transforming.
These aren't just words look at what we've done so far this year and look at what's coming soon.
If you take a moment.
To look deeper into our company.
Jon P. Stonehouse: These aren't just words; look at what we've done so far this year and look at what's coming soon. If you take a moment to look deeper into our company, you will see we have a marketed product with meaningful revenue potential, a highly attractive and full pipeline, and a world-class research engine that discovered all these valuable assets and will continue to make new exciting discoveries of oral drugs for patients with rare diseases.
You will see we have a marketed product with meaningful revenue potential.
A highly attractive and full pipeline.
And a world class research engine that discovered all these valuable assets and we'll continue to make new.
Exciting discoveries of oral drugs for patients with rare diseases.
These are the ingredients that creates significant value for patients and shareholders.
Operator: These are the ingredients that create significant value for patients and shareholders. We are laser focused on executing our plan and look forward to sharing further progress. That concludes our prepared remarks. Camille will now open the floor to questions.
We are laser focused on executing our plan and look forward to sharing further progress on this transformation.
That completes our prepared remarks to me, we'll now open it up for questions.
As a reminder to ask a question you would need to press star one on your telephone to withdraw your question press the pound our hands.
Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Tyler Van Buren with Piper Sandler.
Please standby what compiled acuity roster.
Okay.
Your first question comes from the line of Tyler Van Berman with Piper Sandler.
Unknown Executive: Congratulations on all the progress during the quarter. The first question is relating to 9930, the pH data we're going to get by the end of the quarter, and the high dose data with 200 and 400 milligrams. I guess, should we expect to get a similar set of data as we got recently with the 50 and the 100? Are we expecting greater magnitudes of clinical benefit that we saw in LDH for ticks, bilirubin, hemoglobin, and the various endpoints, or greater consistency, or both? And then the second question is just related to the Gallaudet severe COVID-19 data that we'll also get by the end of the quarter from part one. Will it be all three cohorts, or how many patients' worth of data should we expect to get? And will we get viral load reduction and changes in clinical symptoms? Thanks.
Congratulations on all the progress during the quarter.
The first question is relating to 90 930.
Okay that we're going to get by the end of the quarter. The high dose data showed the 200 400 milligrams.
I guess should we expect to get a similar set of data as we got recently with the 50 in the 100 and.
Or the expectations to.
Greater magnitude of clinical benefit that we saw in LDH vertex really rubin hemoglobin and the various on points or greater consistency workload.
And then the second question is just related to the Gallaudet severe.
Koby 19 data that will still get by the end of the quarter from part one will it be all three cohorts or.
Or how many patients worth of this.
What we get viral load reduction and changes in clinical symptoms.
Thanks.
Hi, Tyler this is bill thanks for the question the general answer to you all of your questions is yes.
William P. Sheridan: Hi Tyler, this is Bill. Thanks for the question. The general answer to all of your questions is yes. So the nature of the data that we'll present on C5-inhibited naive subjects at higher doses is just like we showed before. We do expect that higher doses will lead to better outcomes. However, there are differences between subjects with this disease, depending on the background of aplastic anemia, and the controlling complement cannot improve bone marrow stem cell activity. With regard to the GALADESIVIR program, yes, we expect to be able to present data on all three cohorts in Part 1 by the end of the quarter.
So the the nature of the data that will present on the.
Cfive inhibitor nave subjects at the higher doses as just like we will we showed before.
We do expect that higher doses will lead to better outcomes.
There are differences between subjects with this disease, depending on the background of plastic anemia.
And the controlling complement.
Cannot improve bone marrow stem cell activity, while it can do is control hemodialysis, sorry, the LDH biomarkers to leading biomarker analysis.
With regard to the Galidesivir program years, we expect to be able to present tighter on all three cohorts in part one by the end of quarter.
And in that will be.
William P. Sheridan: And in that, there will be viral information and chronicle data as well. And remember, the goal of that is to choose a dose to then go into part two.
Viral information and radical data well and remember the goal of that is to choose a dose to that go into part two.
That's great. Thanks for taking the questions.
William P. Sheridan: That's great. Thanks for taking the questions.
You're welcome thanks.
Maurice Thomas Raycroft: You're welcome.
Your next question comes from the line of Maury Raycroft with Jefferies.
William P. Sheridan: Your next question comes from the line of Maurice Raycroft with Jefferies.
Hi, This is Kevin here for Marni.
Kevin: Hi, this is Kevin here from Maury. I just had a question about Taxiro for, you know, patient switching. So, you know, one KOL we spoke to said that the antibody may remain in the body for around 150 days. And, you know, if patients switch to 7353, how would you differentiate the activity of taxiro versus 7353? And the follow-up to that is, from a pathophysiological or mechanistic standpoint, what gives you the confidence that patients on current prophylactics that had breakthrough attacks would behave in the same way on 7353, and their responses won't worsen.
I just had a question about.
Tax IRO for for.
Patient switching.
So you are one care, while we spoke to said that the antibody may remain in body for.
Around 150 days.
Patients switch to.
70, 353, how would you differentiate the activity of tax IRO versus 70 grew 53.
And the follow up data from a pathophysiological or mechanistic standpoint.
What gives you the competence that patients on.
Heard prophylactics that have breakthrough attacks.
Behave in the same way on seven 753, and the responses won't worsen.
Okay, Hi, Kevin This is bill a couple of questions in there.
William P. Sheridan: Okay. Hi Kevin. This is Bill.
William P. Sheridan: A couple of questions in there. So we've had patients come into our clinical studies who've had Taxiro. Taxiro is a monoclonal antibody that binds to an epitope on calocrine. Olodeo is a small molecule that binds to the active side of calocrine.
So we've had patients come on track clinical studies suit head Txi are.
Text sorrow, ASM monoclonal antibody that binds to an epitope.
On Kelatron.
All the data was a small molecule that binds to the active side of Kelatron.
So there is no issue there there's no issue with safety by starting all the dialer when somebody has residual techs are on board.
William P. Sheridan: So there's no issue there. There's no issue with safety by starting Olodeo when somebody has residual Taxiro on board. You know, I think that it's great for patients to have choice of therapy. And, you know, what we're hearing is that people want an oral drug. So we've been able to successfully transition patients from Taxiro to Olodeo in the clinic without a problem, and I don't expect it will be a problem in the marketplace. All prophylactic drugs in HAE are associated with some incidence of breakthrough attacks, so it's going to be an individual choice about the burden of therapy as well as the burden of illness and what the patients are seeking.
I think that the.
It's great for patients to have choice of therapy, and what we're hearing is that people want an oral drug.
So we've been able to successfully transition patients from tech sorrow to all the data into the clinic without a problem and I don't expect it will be a problem in the marketplace.
All prophylactic drugs United Shay.
Associated with some incidence of breakthrough attacks.
It's kind of an individual choice about the burden of therapy as well as the burden of illness, and then what the patients seeking and for the patients in our trials that have switched from.
Jon P. Stonehouse: Yeah, and for the patients in our trials that have switched from current injectable prophytherapy, we don't see the worsening that you describe. I think that the most important point here is that you can't lump all patients together in one basket and make some blanket statement. Each individual patient has a different desire around what their attack burden is and what they can deal with, and then what the treatment burden is. And we think that's a really important benefit of our drug. And ultimately, we believe that that'll lead to a lot of switching to our oral drug.
Current injectable Prophy therapy, we don't see the worsening that you described I think that the most important point here is that you can't lump all patients together in one basket and make some blanket statement each individual patient has a different desire around what their attack burden.
It is and what they can deal with and then what the the treatment burden is and so with an oral drug we hit both of those and we think Thats, a really important benefit of our drug and ultimately we believe that that will lead to a lot of switching to our oral drug.
Great. Thank you that's helpful.
William P. Sheridan: Great, thank you; that's helpful.
Your next question comes from the line of Brian Abrams with RBC capital markets.
Brian Corey Abrahams: Your next question comes from the line of Brian Abrahams with RBC Capital Markets.
Hello. This is a leo on for Brian Thanks for taking my question.
Leo: Hi, hello, this is Leo on behalf of Brian. Thanks for taking my question. You mentioned in the press release on Factor D that the three patients from the low-dose cohort are now taking the high dose.
You mentioned in the press release.
On Saturday that the three patients from the low dose cohort cohort are now taking the at the high dose.
That's correct.
Operator: That's correct. Was there a question?
Was there a question Leo.
We really like you seem like his line disconnected.
Operator: It seemed like his line was disconnected. We will proceed with the next question.
With the next question. Your next question comes from the line of Gino Wayne with Barclays.
David Dai: Hi there, this is David Dai on behalf of Gina, and congrats on the progress. My question is about the Factor D inhibitor. Since you're planning to go into additional indications, when should we expect an update on that? And then, given Alexion reasonably disconnected their Factor D for C3 glupinoprathy, what are the key differentiations of your compound to cease the cell's translation to these additional indications? And then the third question, this would be, what are your thoughts on the clinical design for these suspended indications?
Hi, This is David down Regina and congrats on the progress. My question is on the faculty Hibner on things and plan to go into additional indications.
Should we expect an update on the and then.
Given Alex Scyon recently disconnecting their factor Ddrfour few suite alum.
Moving now briefly what are the key differentiations of your compound to see systems gestation to these additional indications.
And then third question this may be what your thoughts on the clinical design for this expense indications.
Sure Hi, David yet Bill.
William P. Sheridan: Sure. Hi David. Yeah, it's Bill.
So at practices that when we started a clinical trial. We let you know so you can expect updates along those lines in 2021 for the new indications that we select.
William P. Sheridan: So, our practice is that when we start a clinical trial, we will let you know. So, you can expect updates along those lines in 2021 for the new indications that we select. With regard to the Alexion first-generation compound, that was three times a day. However, the doses were limited by liver toxicity in phase one, and they could never get adequate exposure. So, any clinical trial results with that compound are basically irrelevant to our program.
With regard to the Alexey on first generation compound that was three times a day the doses with limited by liver toxicity in phase one and they could never get adequate exposure. So any clinical trial results was that compound to basically irrelevant.
For our program.
The clinical design on the design Thats, a medafor discussion with regulators basically so until we have had those discussions and be premature to talk about the design of studies in when we start studies in new indications in the knowledge that we'll have the design at those studies.
William P. Sheridan: The Clinical Design
William P. Sheridan: On design, you know, that's a matter for discussion with regulators, basically. So until we've had those discussions, it'd be premature to talk about the design of studies. Yeah, and when we start...
William P. Sheridan: And when we start studies on new indications and announce that, we'll have the design of those studies.
I think you guys.
William P. Sheridan: I thank you guys. You're welcome.
Welcome.
And as a reminder, if you would like to ask a question. Please press star one on your telephone keypad again best Star one.
Operator: And as a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Again, that's star 1. Your next question comes from the line of Jonathan Wolleben with JMP Securities.
Your next question comes from the line of Jonathan Wala, Ben with JMP Securities.
Hi, good morning, Thanks for taking my question.
Jonathan Patrick Wolleben: Hey, good morning, and thanks for taking the questions.
Just.
Got it does severe.
Operator: All right, just...
William P. Sheridan: A couple of questions on galdesivir. Can you remind us of reasons why we think this should be differentiated from remdesivir? Do you expect the activity to be mostly in line with what we've seen from that compound? Do you have enough drug supply to move to Part 2?
Can you remind us of reasons why we think this should be differentiated from disappeared.
The activity to be mostly in line with what we've seen from that compound do you have enough drug supply to the part two.
Well take the first part I'll take the second sure.
William P. Sheridan: You want to take the first part; I'll take the second. Sure.
So each drug is different so our although they are in the same general class of viral are in a nuclear side.
William P. Sheridan: Sure. But each drug is different, so although they're in the same general class of viral RNA nucleoside polymerase inhibitor, the way the body handles those drugs is different from what's been published in the public domain. It looks like the effective half-life of Galadezivir could be about four times longer than that of Remdesivir. I think what matters here are clinical results, and so we'll, you know, we'll see that emerging by the end of the quarter, as we discussed earlier.
Polymerase inhibitor.
The way the body handle those drugs is different.
From what's being published in the public domain it looks like the effective half lots of galidesivir. It could be about four times longer than Rem density I think what matters here is clinical results and so we'll see that emerging but ended the quarter as we discussed earlier.
Yeah, and I've said before that this is in a market where you're competing for market share governments won multiple weapons in the arsenal in their stockpile and so we could easily see and this is evidenced by the fact that the government supporting our program that they would have more than one.
Jon P. Stonehouse: Yeah, and I've said before that this isn't a market where you're competing for market share. Governments want multiple weapons in the arsenal in their stockpile, and so, you know, we could easily see, and this is evidenced by the fact that the government's supporting our program, that they would have more than one RNA polymerase nuke in the stockpile. And then on your question, Jon, around drug supply, so the answer is yes, we have plenty of supply for part two, and then some, and we're continuing to expand that, and we're continuing to expand the process in terms of improving the yield and taking out steps to make it go faster so that when we have real evidence that the drug is working in these COVID-infected patients, we're in a position to get the drug supply that will come with it.
Our in April Emory's, new get in the stockpile and then your question John around drug supply. So the answer is yes, we have plenty of supply for part two and then some and we're continuing to expand that and we're continuing to expand.
The process.
In terms of improving the yield and taking out steps to make it go faster so that when we have real evidence that the drug is working in these cobot infected patients were in a position to get the drug supply that will come with the demand.
Jon P. Stonehouse: Great, and then just one more question on the control set review. Can you remind us where your manufacturing sites are and if FDA has scheduled or completed those inspections?
Great and then just one more if I can on Churchill review.
Can you remind us where your manufacturing sites are enough.
We did those inspections. Thanks.
Jon P. Stonehouse: Yeah, so as Megan said in her remarks, we have redundancy, so we've got dual manufacturers for both API and finished product. I think of four; only one is overseas, the rest are domestic.
Yes, so as Megan said in her remarks, we have redundancy. So we've got dual manufacturers for both Apiay in finished product I think of for only one is overseas. The rest are domestic and we did that as Megan said to make sure that we de risk the program right. So if someone wrong with one play.
Jon P. Stonehouse: And we did that, as Megan said, to make sure that we de-risked the program, right? So if something went wrong with one place, we had a backup. So that, and that was a decision we made years ago and invested money in years ago. In terms of inspections, you know, this is in the public domain from the FDA, that they're looking at things a bit differently given the COVID situation. And if there's been recent inspections at certain sites without any findings, they'll accept those inspections. We're using, you know, big name CMOs. And as Megan said, you know, we are where we need to be with supply.
Yes, we had a backup.
So that that and that was a decision we made years ago and invested money years ago in terms of inspections.
This is in the public domain from the FDA that that they're looking at things a bit differently, given the covance situation and if theres been recent inspections, Ed Ed certain sites without any findings.
Well, except those inspections were using.
Big name.
CMO isn't as Megan said, we are where we need to be with supply and so we're really excited about.
Jon P. Stonehouse: Great. Thanks for taking the questions and congrats on the progress.
Getting ready for the launch and supply will not be an issue.
Great. Thanks for taking the questions and congrats on the progress.
Jon P. Stonehouse: Thanks, Jon.
Thanks, John.
Your final question comes from the line of Brian Abrahams with RBC capital markets.
Brian Corey Abrahams: Your final question comes from the line of Brian Abrahams with RBC Capital Markets.
Leo: Hi, yeah, sorry, it's Leo on for Brian again. I think I got disconnected mid-question. Hopefully, you haven't answered it already.
Hi, Yes, sorry. Please go on for Brian again, I think I got disconnected mid mid question hopefully you haven't answered it already yes.
Looking at the at the press release, it seems like you're going forward with the joint in 400 milligram doses in the low dose cohort patients by investigator assessment and also.
William P. Sheridan: Yes, I was looking at the press release. It seems like you're going forward with the 200 and 400 milligram doses in the low-dose cohort patients by investigator assessment, and also that the next study is skipping the low dose. So should we take this to mean that the ultimate go-forward dose is going to be in this higher dosing range? Are you still considering multiple doses? And, I guess lastly, can you frame expectations for what we might expect in naive versus poor responders?
That the.
The next studies skipping over the the low dose so should we take this to mean that the ultimate go forward dose is going to be in this higher dosing range are you still considering multiple doses and.
How much window to you potentially have to push above 400 milligrams and and I guess lastly, can you frame expectations for what we might expect in naive versus poor responders.
William P. Sheridan: Sure. Let's start with your last question first.
Sure.
Let's start with the last question first.
William P. Sheridan: The underlying cause of the disease is identical, and in poor responders and in naive subjects, factor D is identical, and the activity of the drug will be identical, and therefore, we expect that you can extrapolate the data we're generating in naives across the board in PNH. So that's actually a very important point. You know, there's no fundamental difference in the biology, and what the difference is the extent of opsonization and extravascular hemolysis that varies between subjects. That, of course, you can't control with a C5 inhibitor, and you have to have a proximal inhibitor to do it. With regard to dosing, a principal goal of this initial study was to select one dose to move forward with, so that's what our goal is.
Underlying cause of the diseases identical and in correspondent lending nave subjects affected these identical Andy activity at the drug will be identical and therefore, we expect that you can extrapolate data beyond the data, we're generating naive across gord NPL coverage.
So thats actually a very important point.
There's not a fundamental difference.
In the biology and.
The difference is the extent of optimization, an extra VESCO hemodialysis it varies between subjects.
Of course, you can't control with Cfive inhibitor and you have to have approximately inhibited the do it.
With regard to dosing.
A principal goal of this initial studies to select one dose to move forward. So thats. Our goal, yes, we expected that will be in the higher dose range not the lower dose range, we've already rolled out the safety and 100 milligram doses.
William P. Sheridan: Yes, we expect that it will be in the higher dose range, not the lower dose range. We've already ruled out the 50 and 100 milligram doses, and based on the pharmacodynamics that we shared in May, it's impossible for me to distinguish the effect of 200 and 400, but, you know, what I'd like to see is the LDH and the other parameters, and then we'll make a decision.
And the pharmacodynamics that we shared in May.
It's impossible for me to distinguish the effect of 200 400, but what I'd like to see is the LDH and the other parameters and then we'll make a decision.
Yeah remember the goal is to get as many patients into or close to the normal range. So with monotherapy. So thats the goal.
Jon P. Stonehouse: Yeah, you know, remember the goal is to get as many patients into or close to the normal range with monotherapy, so that's the goal.
William P. Sheridan: Got it. Thank you. You're welcome.
Got it thank you.
Okay.
At this time I would like to turn the call over to Mr. Stonehouse for any concluding remarks.
Jon P. Stonehouse: At this time, I would like to turn the call over to Mr. Stonehouse for any concluding remarks.
Well, thank you and thanks for joining us today as I said at the beginning our company is changing and it's extremely exciting and you're going to see evidence of this starting this quarter with hitting major milestones and more come in later in the year and so we'll continue to update you with the progress in our.
Jon P. Stonehouse: Well, thank you. And thanks for joining us today. As I said at the beginning, our company is changing, and it's extremely exciting. And you're going to see evidence of this starting this quarter, with hitting major milestones and more coming later in the year. And so we'll continue to update you on the progress in our transformation. And, as always, thanks for your interest in our company. Have a great day.
Transformation and as always thanks for your interest in our company have great day.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: Tazeen Ahmad, Brian Abrahams, Jon Stonehouse, William Sheridan, Liisa Bayko, Jonathan Wolleben, Charles Gayer, Helen Thackray, Anthony Doyle, Brian Arnold, BioCryst Pharmaceuticals Inc. Tazeen Ahmad, Brian Abrahams, Jon Stonehouse, William Sheridan, Liisa Bayko, Jonathan Wolleben, Charles Gayer, Helen Thackray, Anthony Doyle, Brian Arnold, BioCryst Pharmaceuticals Inc.
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