BioCryst Pharmaceuticals Inc (BCRX) 2009 Q3 法說會逐字稿

Good day, everyone, and welcome to BioCryst Pharmaceuticals third 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.

Thank you.

Good morning, and welcome to BioCryst's third quarter financial results conference call and corporate update.

Today's press release and accompanying slides are available on our Web site, BioCryst.com.

At this time, all participants are in a listen-only mode..

Later, we'll open up the call for your questions.

Instructions for queueing 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'll 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 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's documents filed with the SEC which can be found on our Company Web site.

This morning, Jon Stonehouse will provide an overview of highlights and progress from the last three months, including BioCryst's progress toward making Peramivir available during the ongoing H1N1 influenza pandemic for hospitalized patients.

Then Bill Sheridan will provide a clinical program update, and Stuart Grant will conclude with financial results before we open the call up for Q&A.

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

Thanks, Rob.

Good morning, and thanks for joining us today.

BioCryst has made significant progress on several fronts since we last reported results on July 30th.

First, the most rewarding and anticipated result was the issuance of the emergency use authorization, or EUA last Friday, for intravenous or IV Peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

This is the culmination of an incredible amount of work by dedicated people at BioCryst and government agencies, including the Department of Health and Human Services-BARDA, the Centers for Disease Control, and particularly, the Food and Drug Administration which led the EUA review.

The same day the EUA was issued, HHS picked up 1,200 courses of IV Peramivir that were donated by BioCryst to facilitate initial distribution of Peramivir by the CDC to treat patients in need.

Recall that on September 21st, we announced a request for proposal to supply Peramivir to the US government.

Since then, we have provided our written response, and the RFP negotiations are continuing.

The donation is intended to bridge demand to a potential government order.

During the third quarter, we undertook fill-and-finish operations to prepare approximately 130,000 courses of treatment in anticipation of possible orders from the US and other governments.

Outside the US, all three of our new partners have made progress toward determining interest, and the process to possibly make Peramivir available in their territories.

And we are receiving inquiries from other countries.

Since Peramivir is an experimental drug, the hurdles vary from country to country for import and use of Peramivir.

We are prepared to deliver IV Peramivir to other countries where the regulations allow us to do so.

We received an additional $77.2 million commitment from HHS to fund the Phase III development of IV Peramivir.

Which brings me to the second major accomplishment.

Clinical progress and advances in our late stage pipeline.

The HHS funding enabled us to start our two Phase III studies of Peramivir for hospitalized patients.

In recent weeks, we have completed several regional investigator meetings and advanced the activation of study sites.

Shionogi, our partner in Japan, is now close to filing for market authorization in that country.

This would be the first filing for Peramivir in any country and for any BioCryst discovered drug.

Additionally, we selected gout as the indication for development of our next generation PNP inhibitor, BCX-4208.

And we are excited to have the Phase II under way.

We think this is -- there is strong rationale for this mechanism, since PNP has demonstrated to reduce uric acid levels, the efficacy endpoint for potential gout treatments.

We have also made steady progress toward fully enrolling the pivotal study of Forodesine in CTCL and remain on track toward seeing data in the first half of 2010.

Now, our Chief Medical Officer, Bill Sheridan, will update you on emergency IND experience with Peramivir as well as our clinical programs.

Thanks, Jon.

In April, the FDA took steps to consider alternatives to address the unmet need for an anti-viral that might be used in hospitalized patients and started the Pre-Emergency Use Authorization review process for Peramivir considering data that included treatment experience in over 1,800 patients from various clinical trials.

Also, during that time, CDC verified through in-vitro analysis that neuraminidase inhibitors are potent against H1N1 virus, and that Peramivir was the most potent of those tested.

In May, we began making Peramivir available under the FDA's emergency IND process.

Our experience with this is summarized on Slide Eight.

This process requires a treating physician to contact the FDA to request authorization to treat an individual patient with Peramivir and to then notify BioCryst of this authorization.

After seeing few requests through the summer, from early September on, we saw a sharp increase in the number of referrals from the FDA and also direct calls to our hotline from treating physicians for patients who were extremely ill.

In total, we received 42 emergency IND requests.

Prior to delivery of drug for eight of the patients, four individuals died and four others had begun to recover and did not receive Peramivir.

Peramivir IV has been administered to 32 patients, who ranged in age from three months to 77 years.

Most were previously healthy adults and children with no known underlying medical condition.

Almost all had rapidly progressive viral pneumonia which required mechanical ventilation, and the cause of the illness was often complicated by failure of other vital organs.

38% of the patients treated were children, 17 years or younger.

And three patients were pregnant or had recently delivered a baby.

A follow-up for these patients is ongoing, and most currently remain hospitalized.

The predominantly young patient population, the severity of the illness, and the observed complications are in line with the experience described in recent publications in the New England Journal of Medicine and the Journal of the American Medical Association.

These pages describe the spectrum of illness in patients admitted to intensive care units in several countries including the US.

It has been less than a week since the Centers for Disease Control began distributing Peramivir under emergency use authorization.

CDC has already hosted educational phone calls regarding Peramivir, posted fact sheets and other information on the Internet, and is delivering Peramivir from a strategic national stockpile.

Licensed physicians in the United States can request Peramivir by completing a simple online questionnaire posted on the CDC Web site.

Turning to Forodesine, enrollment in our pivotal Phase II, cutaneous T-cell lymphoma study has continued steadily and is moving toward our target of 130 to 140 patients enrolled.

We continue to expect to have data from this study during the first half of 2010.

Enrollment is also progressing in the exploratory Phase II chronic lymphocytic leukemia protocol, testing 200 milligrams of Forodesine orally twice daily.

We remain on track to provide an update on this program before year-end.

Periodic reviews of the safety data have continued to show that Forodesine is generally safe and well tolerated in these clinical studies.

We have also initiated our Phase II study of BCX-4208 in patients with gout with the goal of identifying a dose level for further clinical development.

The first part of the study will be a randomized, double blind, placebo controlled evaluation of the efficacy and safety of three different doses of BCX-4208 versus placebo in subjects with gout.

After reviewing this data, we may evaluate up to three higher doses of BCX-4208.

The study's primary endpoint is a change of uric acid in the blood compared to baseline measurement prior to treatment.

The gout trial is expected to enroll up to 120 subjects.

Lastly, we are currently completing a portfolio review, which includes our pre-clinical product candidates.

This review will allow us to optimize our portfolio development plan for the near-term.

That concludes our clinical program update.

Our CFO, Stuart Grant will summarize our financial results.

Thanks, Bill.

Good morning.

As the year progresses, we continue to maintain our focus on moving the clinical programs forward and balancing cash burn.

Rather than repeat what we've included in the press release, let me my highlight the major changes that impacted R&D expenses and revenues for the first nine months of this year versus the same period a year ago.

R&D expenses were $10 million less in 2009 than they were in 2008.

And this reduction was due to two main factors.

Firstly, the manufacturing, work and support of Forodesine development was substantially completed in the 2008 period.

Secondly, in late 2008, we took a decision and communicated the restructuring of our organization and the slowdown of activities in our pre-clinical compounds to allow us to focus our efforts on our late stage assets.

That has favorably impacted our spend this year.

In addition, the level of clinical activity on Peramivir was slightly lower in 2009.

These savings were partially offset by approximately $2 million of manufacturing costs that we incurred for the production of IV Peramivir during Q3 of 2009.

We announced last week that we are in the process of preparing up to 130,000 courses of IV Peramivir for possible orders from the US and other governments.

By mid-November, we expect to have 40,000 courses available, and we plan to prepare the remaining 90,000 before the end of this year.

Revenues were $2.6 million lower in the first nine months of 2009 than they were in the same period of 2008.

This was primarily due to lower funding relative to the Forodesine program from our partner, Mundipharma, under the terms of the agreement we have with them.

As of September 30, 2009, the Company had cash, cash equivalents and investments of $38.5 million and a [sequent] $8 million reduction for Q3 is net of $5 million that was returned to BioCryst by HHS.

In July, we indicated that we were in the process of purchasing excess Peramivir API from HHS, as permitted under the development contract.

Q2 cash used included a $5 million payment to HHS to buy back Peramivir API.

HHS is still in the process of completing its review of the API [excess] in the light of the agreed development program, as well as a calculation of the acquisition costs.

And pending completion of that review, they have returned the $5 million payment to BioCryst.

HHS does acknowledge that at least half of the API is excess.

When HHS completes their review, we'll determine with them the mechanism for final acquisition of the total API excess.

As I said in July 2009, we are in a dynamic situation relative to potential supply shipment and manufacturing of Peramivir that would cause us to re-evaluate our cash use outlook quarterly.

We now expect the underlying net cash used in 2009 to be near the top end of the previous guidance range of $30 million to $38 million.

Cash used during the balance of 2009 will be heavily dependent on the level of IV Peramivir manufacturing, any potential stockpiling activities, and detaining of Shionogi's filing for Japanese approval of Peramivir.

Total IV Peramivir manufacturing costs could approach $8 million for Q4, and BioCryst may receive up to an additional $14 million in regulatory milestones from Shionogi between now and approval of the drug in Japan.

During the upcoming planning cycle, the Company will align its cash needs and the clinical development activities to carry its clinical program through 2010.

In closing, Jon's going to summarize our milestones.

Thanks, Stuart.

To date, we've delivered on all of our milestones for 2009 except for the CLL update which we will give before year-end.

Looking ahead for Peramivir, we expect completion of the RFP process with HHS, conclusion of pandemic use discussions in other countries, regulatory filings for Peramivir in Japan and possibly Korea, and progress in our Phase III enrollment.

We should close out enrollment in the Forodesine CTCL study and see initial data from the BCX-4208 gout study.

That's it for the update.

We'll now take your questions.

Thank you.

(Operator Instructions) We'll turn first to Charles Duncan with JMP Securities.

Hello.

First of all, congratulations on the progress in the quarter, and thank you for taking my call -- my question.

My first question is regarding the expense reimbursement for the Phase III expenses.

Can you provide us a little bit of color on how that works in terms of the timing relative to when you incur the expenses?

And based on your experience in Phase II, the risk of that expense reimbursement?

Hi, Charles, this is Stuart speaking.

So the $77 million that was awarded allows us to complete the full Phase III program through licensure of the drug.

Our experience to-date and my expectation as we go forward is that we incur costs within a particular month.

We bill those costs to the government.

We try to do that within about a 15-day period, and then we work with them to get reimbursement of that.

And that generally takes about 30 days.

So I expect that all of the costs that we're incurring on the Phase III program will be fully funded by the government, and that they'll reimburse us on a timely basis for that.

Okay.

Thanks, Stuart.

Then a quick question for Bill.

You mentioned the potency of Peramivir versus other neuraminidase inhibitors.

Can you give us a little bit more color on that data?

Yes.

The testing is an in vitro test, looking at the enzyme inhibition in an enzyme inhibition assay.

This is data presented in its initial stages in the Morbidity and Mortality Weekly Report Dispatch attached by [Larissa Puperator] at CDC.

At that stage, there were only about a dozen or so isolates tested.

Since then, that program has continued, and we got an update in July on over 200 isolates.

And the neuraminidase inhibitors that were included in the assay were Peramivir, Oseltamivir, and Zanamivir.

And a quick question on the EUA and a possible stockpiling, maybe for Jon or Stuart or whoever.

First of all, do you see that as a restrictive or controlled distribution?

And is it any more onerous than prescribing under the EIND?

As well, what is the end user stockpiling situation with that?

So I'll start it.

Go ahead, Charles.

I'm sorry, Jon, could you distinguish between the Phase III stocking versus, say, under the EUA stockpiling?

I'm not sure I understand the second question.

But let me take a shot at the first part, and then we can come back if we didn't answer it.

So with the EUA, the intent is to get more drug available to more people in need.

And so, we've donated the 1,200 courses.

They're in a central location, managed by BARDA and CDC.

The CDC has been doing education programs and has a Web site set up for physicians to get access to the drug.

We believe that's a much more efficient process than what we did with the EIND.

And relative to the stocking within certain institutions under the Phase III, they actually have drug -- correct?

And do you think that EUA is going to impact or could impact the Phase III trial enrollment?

According to GTP regulations, the clinical trial supplies for clinical trials only to be used for patients enrolled in those clinical studies.

So there's specific labeling and accounting and drug control requirements for clinical studies.

So in the sites where those studies are opened, that trial supply is intended for people who are enrolled in clinical trials.

With regard to potential impact on enrollment, I think it's difficult to predict.

However, the clinical trials have certain eligibility requirements.

In those institutions, patients admitted with influenza who are not eligible for the clinical study -- the physician has the option of going to the CDC Web site and requesting Peramivir.

I think one difference, Charles, is that the drug is immediately available in the clinical trial.

So in the clinical trials, we push the drug out to the sites.

So when the patient comes in, the doctor makes a decision and can immediately treat.

And then my final question with regard to the 130,000 courses, can you give us some sense of the logic behind that number, and what you're anticipating in terms of demand?

So I think there's a few pieces to it.

The first one is what could we afford.

The second is what did we see from various reports, like PCAST and the other.

And the third was, what kind of availability was there for manufacturing and primary packaging components.

Given the fact that it's IV, and there are a bunch of vaccine manufacturers that are competing for these slots.

And competing for the glass and stoppers.

There were limitations to that.

That's how we got to the 130,000.

And then I'm sure the pricing is still a part of -- under negotiation.

But it would seem to me that the pharmaco economic value of getting a patient out of the ICU a day or so early is pretty high.

Can you give us some sense of what you anticipate pricing to be?

And your view on pharmaco economic value, if you do have one?

I can't go into the details of the pricing because we're in negotiations.

But what I can -- I think you hit on a very important point.

The cost of a day's stay in the ICU -- I think there was a report out that came into some of the news wires today, around $3,000 for a day.

And I think you look at that -- you look at the cost of being on a ventilator.

You look at the cost of being on ECMO, and it's extremely expensive.

So if Peramivir, used in these patients, can get people out of the ICUs quicker, I think there's a lot of economic value in return.

Thanks, Jon, for the added color.

I'll hop back in the queue.

Charles, can I just clarify.

Jon missed a zero in that number.

The number was $30,000 to keep a patient in the ICU.

And that was a report from the CFO of one of the major healthcare providers this morning.

So it was 30,000.

That's a big difference.

That's a big difference.

Thank you.

Next, we'll turn to Joseph Schwartz with Leerink Swann.

Hello, thanks.

I think on prior calls you gave us some color in a broad sense about how the CDC and others expect the H1N1 flu season to shape out.

And I think the peak was expected in October at that point.

Obviously, vaccinations are way behind.

I think they've only vaccinated around 10,000 -- I'm sorry, 10 million patients in the US.

And I think at that time that they developed that report they were expecting to get to around 100 million citizens.

So what does that do -- or I guess in general, what are the current pandemic plans project now, and did they take any of this into account?

What are your thoughts on this?

First of all?

It's Bill.

I'll try to answer your question.

The first thing to say is that each flu pandemic is a learning experience for everyone involved, including people who are trying to project healthcare resource utilization and the like.

There are some recent publications in JAMA and New England Journal that I mentioned that specifically focused on intensive care.

And for example, in Australia, all of the ECMO machines at one point in the southern winter were in use in Australia and New Zealand treating patients with influenza.

So clearly, this pandemic does have serious impact of certain patients and for the healthcare systems.

It's very difficult to predict the tempo of the incidents and prevalence of the disease.

It's clear that in the US already, the numbers of patients being reported with influenza-like illness is higher than in the last seasonal epidemic peak a couple of years ago.

And it's very early in the season.

Some of the influenza specialists are worried that there might be a second wave.

That it could come in multiple waves.

It's very uncertain.

Could you give us some more help on the decision to manufacture 130,000 courses versus the RFP was asking you to propose prices for anywhere from one to 40,000?

What gives you the confidence that you'll be able to find a home for the incremental product, and where do you think that might be?

Hey, Joe, this is Stuart speaking.

The decision that we made to manufacture was made before the RFP process started.

So we took a decision as a Company based on, as Jon says, the lead time of the product is not insignificant.

There's about a three-month lead time from decision to go to having drug available.

We had looked at a variety of needs analysis, both in the US and extrapolated that across the world.

We view this as a worldwide opportunity.

Not just a US opportunity.

As you know, we have signed letters of intent with three countries right now.

Three agents in three different countries, and we continue to get in-bound calls.

We took that decision.

We balanced the cash requirement that would take, and we felt it was a prudent decision to go ahead and manufacture that capacity.

It's the kind of drug that you can't manufacture ten courses of therapy.

You go into a manufacturing campaign, and that's what we did.

And it was balancing the cash requirements of that versus what we think the need for this drug is.

And we've gone ahead and done that, and if we had waited until the RFP came, or we had a decision on the RFP, we would be looking at starting manufacturing now for drug available in the February, March timeframe.

So it was really a balancing of cash use and what we thought the opportunity and need was for the compound.

If I could just get one more on the Phase IIIs for IV Peramivir, then I'll get back in the queue.

The design now -- what gives you confidence that it's more likely to achieve success than the prior studies for IV Peramivir?

This is Bill.

The hospitalized influenza drug development is really pretty skimpy when you look at what other folks have done.

There's not much reported in the literature.

The FDA put out draft guidance on development of intravenous or influenza drugs for hospitalized patients including IV drugs in February.

And we've completed a Phase II study.

We worked with the Agency on developing the protocols for Phase III.

And obviously, met with them before concluding final protocols.

So one Phase III is a standard of care, randomized add-on design.

The other Phase III is primarily designed to increase the sample size of safety in the NDA.

So -- another element of this program that will be very important is to put it in the context of the pandemic, which is obviously now where we're going to study patients.

And there are reports coming out already on the hospitalization rates and survival rates, for instance, in patients being admitted to hospital in the pandemic.

We'll take the opportunity to collect that data and also have external controls that will help us interpret the results of the Phase IIIs.

Alright.

Thank you.

We'll take our next question from Yigal Nochomovitz with Rodman & Renshaw.

Good morning, gentlemen.

Congratulations on the progress in the quarter on the EUA and the funding for the Phase III.

Maybe we could just start out with the 1,200 courses of Peramivir that have been transferred.

Are those doses under lock and key now?

Or are they able to be disbursed immediately?

And if so, how many have been disbursed of the 1,200?

On Friday, we delivered to HHS -- or actually, they came and picked it up -- the 1,200 courses and put it into a central location.

From there, it's being managed by the CDC through the Web portal.

So where individual licensed physicians can get access to the drug through that.

We haven't received -- it's not been up for even a week yet.

We haven't received any detailed data on the use, but we look forward to getting that from the CDC.

The drug is available in that central distribution point at this point in time to physicians.

Thanks.

Is there a way for us to track the usage on the Web site of that 1,200, or is that not available?

No, that's not available on the website.

Just turning to the compassionate use request.

The data was a little fast.

Maybe Bill could just clarify.

I think I caught that there were 32 patients that are still under treatment.

Four had recovered.

Four had died.

That's 40.

The press release said 42.

Maybe my math isn't right.

Your math is correct.

In two cases -- in one case, the requester had withdrawn.

And another one, we never received the paperwork.

Okay.

Thank you.

And in those cases where four recovered and four died, would you be able to say whether those were pediatric or adult patients?

It was a mixture.

A mixture.

Okay.

We can't go down to individual patient level, obviously, because that's confidential.

Understood.

And then on the 130,000 doses that are in preparation.

I think Stuart mentioned that 40,000 would be available in mid-November, and the remainder, 90,000 by the end of the year.

How should we be thinking about that 40,000 in mid-November?

Is it safe to say those are all devoted to the United States?

Or will that be a hybrid between what requests will emerge from in the United States and foreign governments.

Those are available on a first come, first serve basis.

So it could be the United States.

It could be a foreign government.

The drug is being made available on a worldwide basis.

First come, first serve.

Okay.

And on the foreign government activity, the agreements earlier in September refer to Brazil, China, Mexico, and Israel.

And Jon, I think you mentioned that you had calls from other countries.

What sort of a geographic distribution have you had beyond those four countries?

All across the globe, Europe, Asia.

All across the globe.

Okay.

Terrific.

And I think that does it.

Maybe one final question, just separately.

The gout trial which started.

Do you have any sense there as to when we could see some top line data?

I think it's going to depend on the pace of enrollment, obviously.

We've been very pleased with the enthusiasm that we've seen from the investigators.

We've started the process, investigator meetings, start activations, and so on.

So this is a study where we will have an analysis of the first part of the study.

And for that complete analysis -- once we've got better tracking on enrollment, we'll be able to give more precise timing on when we'll see the analysis.

There are plenty of gout patients out there.

So we anticipate that the study will enroll at a fast clip.

Terrific.

Thanks very much for taking the questions, and good luck in the coming quarter.

Thank you.

Now, we move to Charles Duncan with JMP Securities.

Hello.

Thanks for taking the follow-up.

Just a couple of quick housekeeping things.

For Stuart, the cash guidance, does that assume that you keep all of the $5 million?

Or half of it that HHS has agreed is in excess?

I think about half, Charles, and then -- so our expectation is we're in continual dialogue with them.

I think let me just clarify.

I don't think they are saying only half is available, I think they're just working through the process.

I think they'll have worked through that process some time in the next three months.

So the gains that I've given assumes probably about half of that will be cashed out by the end of this year.

Okay.

And then back to the question, pricing for Peramivir versus, say, Tamiflu.

I know this is still under negotiation, but is it fair perhaps to assume that you'll get a premium to the price paid by the government for Tamiflu for Peramivir?

Or are you still discussing that in the pharmaco economic sense?

Again, I don't want to go into the details of the pricing, but one would assume that given the value that can be derived from an IV for seriously ill patients where the costs of hospitalization, ICU care, ventilators, ECMO, is extremely high.

There's a big difference versus somebody taking it in the outpatient setting and feeling better a day earlier.

Right.

I get that.

Okay.

Thanks, Jon.

You're welcome.

Joseph Schwartz with Leerink Swann.

Please go ahead.

Thanks for taking the follow-up.

I was wondering, since you've had the two arrangements to fund your clinical trial work with HHS for some time now.

In either of those, is the price at which you can charge the government for stockpiled Peramivir constrained in any way?

Are there any pricing provisions in there such that we're going to -- the government could say we're going to fund this development.

And in the event that the government wants to acquire some, it would obtain a discount or even go beyond that, and put a finer point on it?

So Joe, let me clarify.

It's one arrangement with the government with a second additional amount of money put into that original arrangement.

So it's one contract for advanced development, and it's clearly an advanced development contract for clinical research of Peramivir.

There's no connections with stockpiling orders.

It's not a procurement contract.

The RFP is a separate and completely different contracting process with the government.

No restrictions on the development contract at all, Joe.

No linkage.

Doesn't think into potential future procurement, then?

No.

Okay.

Now, I know that the numbers are small with the four patients that recovered and the four that died and 32 are still on.

So we'll have to see what happens with them.

But I can't resist looking at that and seeing that that's a 50% mortality rate so far.

Excluding those 32 of course, and there was a 50% or so mortality rate for Tamiflu for H5N1 I recall.

Something on that magnitude.

Do you know what the normal mortality rate of the H1N1 is in the patients that -- types of patients that would be included in the subset, and how this might compare?

First, a clarification.

The 50% that you quoted was in the people who did not receive Peramivir.

And you have to understand, this is not a clinical trial.

Peramivir is not at the sites.

We're getting a whole variety of different situations with different length of time since the patient was originally hospitalized or identified as having influenza.

And it's really not feasible to interpret the data in the people who either did or didn't get Peramivir in that EIND series in a way that allows comparison.

The second -- with regard to the second question, there is data in the publications I mentioned on the mortality rate reported from people admitted to intensive care units in Canada, the United States, Mexico, Australia, New Zealand.

And it varies from about 7%, 8% to about 40% in those series.

So that's pretty significant for people who get admitted to critical care units, obviously.

So the only thing I would follow up on is, with the patients that actually did receive drug, I think we see encouraging outcomes.

You've seen that CBS report with John Boudreau, and there's some encouraging stories that we've seen as a result.

That's obviously positive.

The four that recovered and the four that died, though, to clarify, they did not get Peramivir?

That's right.

That's right.

If you refer to the slide, you can follow the flow of those patients.

And the 32, they all did get Peramivir?

Correct.

Okay.

Good.

Alright.

Well, we'll continue to watch with interest.

Thank you.

We'll turn now to [Ander Beno] with Roth Capital Partners.

Just a quick question.

Looking at the chemical synthesis of Peramivir, how many chemical steps are there involved?

We can't give the detail of those steps.

It's a pretty straightforward chemical synthesis.

Just takes time to build the API.

Just takes time, but it's a straightforward process.

Okay.

And just in terms of the time, when you -- how much time does it take to go from the starting material to the final release drug product?

From initiation of finished drug product to release is probably 60 days.

Sorry?

That's from API, sorry.

Let me clarify.

So from API and to finished drug is in the range of 45 to 60 days.

Okay.

And how much -- how long from starting material to API?

I think it's about two months.

Okay.

So it's about three to four months total?

Yes.

Don't forget, we have the API on the shelf right now.

We've said that we're in the process of purchasing back $5 million worth of API that's excess under the contract.

So we have API on the shelf that we're using for the current manufacturing campaign, and we have additional API that's available above and beyond that campaign.

Okay.

And what's the total capacity you have to manufacture drug substance over the next year?

We have plenty capacity to go manufacture additional API.

We have suppliers ready to go and, we have plenty capacity to manufacture finished drug products.

So we have -- I don't want to say unlimited capacity, but we have plenty of capacity above and beyond 130,000 units.

Okay.

Thank you.

And gentlemen, that's all the time we have for questions today.

I'll go ahead and turn the conference back to you for any additional or closing remarks.

Thank you.

Our goal is to build an enduring, successful biopharmaceutical Company.

And last quarter, we made significant progress toward that goal.

So as always, we appreciate your interest in BioCryst and look forward to continuing to update you on our progress.

Thank you.

With that, we will conclude today's conference.

Thank you, everyone, for your participation.