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BioCryst Pharmaceuticals Inc.

Q4 2007 Earnings Call

March 6, 2008 8:30 am ET

Executives

Jon P. Stonehouse – President, Chief Executive Officer, Director

Stuart Grant – Chief Financial Officer, Senior Vice President

Analysts

Rain Benjamin – Rodman & Renshaw

David Bloustein – Southern Brook

Douglas Chow – Caris & Company

Joseph Schwartz - Leerink Swann

Operator

Thank you for standing by. Welcome to BioCryst fourth quarter and fiscal year 2007 financial results and corporate update conference call. (Operator Instructions) I would now like to turn the conference over to Mr. Stuart Grant, BioCryst Chief Financial Officer.

Stuart Grant

Welcome to BioCryst fourth quarter and fiscal year ended December 31, 2007 financial results conference call. Before we begin, I would read a formal statement regarding risks factor associated with today’s call.

Today’s conference call and the accompanying slides will contain forward-looking statements regarding future events and the future financial performance of BioCryst. Such forward-looking statements may include predictions regarding current and proposed clinical trials of forodosine HCl, BCX-4208 and peramivir, potential development of compounds not in clinical testing and cash flow projections including the benefit of the US Department of Health and human services funding of peramivir.

These statements involved known and the unknown risks uncertainties and other factors that may cause the actual future events or actual future financial performance to be significantly different from those expressed or implied by the forward-looking statements. Please refer to the section risk factors in the company’s most recent press releases and the documents that the company files from time to time with the SEC.

Specifically, you may refer to the company’s most recent Form 10-K, Form 10-Q and Form 8-K, all of which are readily available on our website at www.biocryst.com. These documents contain and identify additional information regarding important factors that could cause the actual results to differ from those contained in the forward-looking statement. But the information can typically be found in the section marked risk factors for forward-looking statements.

These statements may reflect the company’s views with respect to future events. BioCryst is under no obligation to update or revise these statement. BioCryst cautions that you should not place undue reliance on these forward-looking statements.

Now, I would like to turn the call over to Jon Stonehouse, BioCryst’s Chief Executive Officer. Supporting slides for this call can be found on our website.

Jon Stonehouse

Thank you Stuart and thank you everyone for joining us today. 2007 proved to be a year of both lessons learned and progress made. The results we saw from clinical trials with our lead candidate in 2007 provided more clarity and further validated the scientific strength of our pipeline. Despite some setbacks, our intramuscular peramivir trial demonstrated a strong safety profile. And further evaluation of the Phase II trial, we also saw a trend of clinical and virologic activity with the dose response.

I would provide more detail of these results and the progress made with our other candidates, forodosine HCl and BCX-4208 in a moment. But now I’d like to turn it back to Stuart to discuss our financial performance.

Stuart Grant

Thanks Jon. I refer you to slide number two. For the fourth quarter ended December 31, 2007, BioCryst reported revenues of $28.2 million compared to $2.1 million in the fourth quarter of 2006.

The increase in revenues is primarily due to revenue from our contract with the US Department of Health and Human Services for the development of peramivir, a $7 million milestone payment received and continuing amortization of deferred revenues from our collaborative agreements.

The net loss for the quarter was $2.3 million or $0.06 per share compared to a net loss of $10.1 million or $0.34 per share for the quarter ended December 31, 2006. R&D expenses for the fourth quarter were $29.1 million compared to $11.2 million in the fourth quarter of 2006. R&D expenses is attributable to an increase in clinical trial related expenses, manufacturing costs for our lead product candidate and costs related to an increase in the personnel support in the development of our product candidates.

G&A expenses for the fourth quarter were $2.5 million compared to $1.6 million in the fourth quarter of 2006. The increase in G&A expenses is based on an increase in personnel related costs as a result of increased headcount including an increase in unknown cash share based compensation expenses for the quarter and an increase in professional fees.

On slide three, you will see that for the full year ended December 31, 2007. The company reported revenues of $71.2 million comparable to $6.2 million in 2006. The year-end increase is primarily due to revenue from the contract with HHS for the development of peramivir to $7 million milestone payment received from Shinove and the continue amortization of deferred revenue from our collaborative agreement.

The net loss applicable to common shares of 2007 was $29.1 million or $0.89 per share as compared to $43.6 million or $1.50 per share for 2006. The net loss for the year includes known cash charges of $1.4 million or $0.04 per share and stock-base compensation of $5.7 million or $0.17 per share.

R&D expenses were $94.1 million for the year ended December 31, 2007 compared to $47.1 million in 2006. The increase in R&D expenses is attributable to an increase in clinical trial related expenses, manufacturing cost for our lead product candidates and cost related to an increase in the personnel supporting the development of our product candidates.

G&A expenses were $9.5 million for the year ended December 31, 2007 compared to $6.1 million in 2006. The increase in G&A expenses is from personnel related costs including an increase of $1.2 million in unknown cash share-based compensation expenses for the period and an increased in professional fees.

Slide four shows our cash position as of December 31, 2007, the company had cash, cash equivalents in investments of $85 million which is in line with our previous expectations.

For 2008, we expect our net cash use to be between $25 and $30 million. This bond rate could vary significantly depending on the timing of such expenses and related reimbursement from HHS. Please also be aware that this expected bond rate is positively impacted by the expected receipt of a significant receivable from HHS that we’ve hold at 3first December 2007.

This concludes our financial report and I will now return the call back to Jon.

Jon Stonehouse

Thank you Stuart. As I’ve mentioned previously, we gained significant scientific insight in 2007 for all of our lead product candidates. These results combined with our strong balance sheet will allow BioCryst to further advance our lead candidates in 2008.

With the results obtained from the peramivir studies conducted in 2007, we are well prepared to initiate a new Phase II trial for the intramuscular form of peramivir during the 2008 flu season.

At this time, I would like to recap what we observed in the fourth quarter for our Phase II IM peramivir trial. This was a multi-center, randomized, double-blind, placebo-controlled study in 344 subjects with uncomplicated acute influenza.

We evaluated both the safety and efficacy of IM peramivir in two-dose groups, 150 mg and 300 mg. The primary endpoint was timed to alleviation of symptoms and there were also other relevant secondary endpoints such as time to resolution of fever and viral shedding.

Slide six shows our top line efficacy data in the primary efficacy analysis population of 313 subjects. This data showed that there was a trend in both the 150 mg and 300 mg dose groups in improvement of time to alleviation of symptom. This was not statistically significant.

In a pre-specified sub-group analysis of males versus females, we saw meaningful difference in our primary efficacy endpoint in males that showed a 58.8-hour improvement in time to alleviation of symptom.

In addition, based upon data collective to date, peramivir is safe and well-tolerated. There were no significant differences in adverse effects reported between subjects who received peramivir versus subjects who received placebo.

Slide seven shows data on our most relevant secondary endpoint, viral titers. This endpoint measures the amount of virus that is being secreted in the nasal passages, the primary site of infection. We measured viral titers at baseline and had a number of time points post-injection.

As you can see, subjects who are administered a 150 mg of peramivir demonstrated a statistically significant decrease in viral titers at 24 hours. However, this effect was not significant at 48 hours.

In contrast, those subjects treated with 300 mg of peramivir showed a statistically significant decreased in viral titers with P values of less than 0.001 at 24 hours and at 48 hours. Our interpretation of these results is that a higher dose of peramivir provides sustained antiviral activity.

To further explore the results from the study, we conducted a series of additional analysis. One of this analysis suggested that only a portion of subjects received an adequate intramuscular injection. This post-talk analysis is presented on slide eight and includes subjects with an increase in creatine kinase levels 48 hours post-injection. This is a validated indicator of muscle injury.

In this subset of subjects, there was a 44.6-hour reduction compared to placebo in the time to alleviation of symptom in subjects receiving a 150 mg peramivir and a 64.8-hour reduction in subjects receiving 300 mg of peramivir. Our interpretation of these results suggests that an adequate intramuscular injection is an important factor in achieving clinical response. In the fourth quarter of 2007, we also initiated two pharmacokinetics studies of peramivir.

Slide nine shows the results of study 117, a PTA study in healthy volunteers to evaluate the administration of IM peramivir according to standard nursing guidelines. We enrolled male and female subjects with the range of BMIs from normal to obese. An adequate injection was achieved in all male subjects.

In women who are overweight or obese, a longer needle was required to achieve plasma concentration similar to those in women of normal BMI receiving an adequate injection. In overweight and obese women, needle shorter has been recommended in nursing guidelines resulted in approximately 25% lower drug exposure.

This data enable us to provide clear guidance on the correct choice of needle length to ensure adequate and consistent exposure across subjects in the future trial. To confirm our observations from the 117 PK study, a second study was conducted in obese subjects using needles shorter than those recommended in nursing guidelines.

As seen on slide ten, study 111 versus 118 confirmed that over-all drug exposure is decreased by approximately 20% when peramivir is not administered into the muscle.

Comparing the PK profile across studies when peramivir is administered intramuscularly according to nursing guidelines, a clear dose response is observed between 150 mg and 600 mg.

Our interpretation based on the results obtained to date is that adequate and sustained exposure is necessary to produce a decrease in viral titers and demonstrate the clinical benefit of peramivir. Therefore, we will follow nursing guidelines for needle lengths based on gender and BMI and evaluated dose higher than 300 mg in future trial.

The next step in the development program includes conducting a PK study with our new IM formulation of peramivir at 300 mg in a higher dose. We’re in the process of designing the next Phase II trial for peramivir which is expected to begin later this year.

Slide 11 shows our pipeline. I’d like to point out, that our pipeline includes two important other drugs candidate, forodesine HCl and BCX-4208. Forodesine HCl is also well positioned to make progress in the upcoming year.

In 2007, we saw a positive interim data from our ongoing Phase I, II trial involving forodesine HCl for the treatment of patients with refractory cutaneous T-cell lymphoma which was presented at the American Society of Hematology meeting.

Patients who received oral forodesine HCl showed an over-all response rate of 39%. This over-all response rate included two patients who had a complete response 6% of the population.

Patients with the retroderma also demonstrated positive results showing a 65% improvement in a retroderma. Additional trials for forodesine HCl in combination with Bendamustin also displayed a positive significant synergistic effect in patients with chronic lymphocytic leukemia. While making the decision to discontinue our T-cell ALL trial involving the IV formulation of forodesine HCl and shift our focus to CTCL was difficult. We believed this was the right strategic move.

This positive clinical data from the Phase I-II trial forodesine HCl for the treatment of patients with refractory cutaneous T-cell lymphoma and our oral forodesine HCl’s excellent safety profile reinforces our confidence about the future of forodesine HCl.

Enrollment in the pivotal forodesine HCl trial evaluating patients with CTCL is ongoing in some tract to be completed in 2009. We expect the results to be available on the second half of 2009.

Our third clinical drug candidate and one of our most promising is BCX-4208, our next generation PNP inhibitor with the potential to address multiple auto-immune indications. Roche is our partner on this program and is advancing this candidate further and ongoing Phase II and an ongoing Phase II trial in Psoriasis.

You will see on slide 12, our goals for 2008. In March, we expect our partners Shinove to give an update on their Phase II IV peramivir trial. In the second half of the year, we expect to initiate the Phase II IM peramivir trial.

In the third quarter of 2008, we expect to file in I&D on one of our preclinical auto-immune drug candidate. We also expect in the fourth quarter, we will have preliminary data from our trial evaluating forodosine HCl in patient with CLL.

With our three-lead candidates well-positioned, 2008 looks to be a year of development in advancement for BioCryst.

I’d now like to open up the call to questions.

Question-and-Answer Session

Operator

The first question comes from Rain Benjamin of Rodman & Renshaw. Please go ahead.

Rain Benjamin – Rodman & Renshaw

Hi! Good morning and thanks for taking the question. Can we talk a little bit about how much of the HSS funding is still available for use? And I believe in the last conference call, you mentioned that, HSS will fund the development of peramivir for certain trials and not others. Can we get some more clarity regarding that reimbursement for this year?

Stuart Grant

Good morning. Nothing really has changed significantly from the last time we spoke. We continue to work with them. HSS have indicated that the ongoing IV trial and the upcoming IM trial that we’ve talked during the call this morning will be funded.

So, that’s been the key to the discussion at that point and time and we are planning to get through both of those trials and then we’ll just continue dialogue with HSS as to how we move forward in the future. But those two programs continue to be funded and nothing new from HSS at this point in time.

Rain Benjamin – Rodman & Renshaw

Okay. Regarding the amount in revenues in reimbursement that you got from HSS was quite good for 2007, do you expect something similar in 2008. So, I guess another way of asking that is, do you expect the expenses to be at around the same level in the 2008?

Stuart Grant

I think we had a lot of activity last year on peramivir in particular. And the focus of attention this year as I’ve said is the IV program and the IM programs. So, whatever expenses we incurred and those are two typical Phase II programs. Whatever expenses we incurred on those will be fully reimbursed on those to be reflected in the revenue this year.

We’ve talked about borrowing this year of somewhere between $25 and $30 million. And that reflects the clinical program that we have ongoing and reflects the reimbursement from HSS that we expect in support of those programs.

Rain Benjamin – Rodman & Renshaw

And I must admit that earlier in the call that you mentioned that there was a large receivable from HSS that’s the authority on those, on the books or is it impacting this cash burn? Can you just repeat what your guidance was?

Stuart Grant

Yes, we had a fairly large receivable from HSS that was set the 3first of December. That was audited by our auditors as a clean receivable. That will flow in to as over the early part of this year. So, that is positively impacting the bottom for 2008 and what I want to just to say was that, we will bond between 25 and 30 this year.

As we get out towards 2009 and ongoing, we will not see that positive impact from that kind of receivable. So, for a company at our stage in the development cycle was the program that we got ongoing.

I will just caution that beyond 2008, I would expect the more reasonable bond rate to be in this $3-$4 million range. And I think it was people just beating that in May and beyond 2008.

So, that’s a fairly normal bond rates for a company with our kind of pipeline. But this year’s bond will be between $25 and $30. Again, positively impacted by the receivable left in HSS.

Rain Benjamin – Rodman & Renshaw

Right. Okay. So, maybe moving on to Jon. What’s happening with the ongoing IV study? We didn’t mention that on the call or at least spend any time on. So, can you give us an update as to what’s happening there?

Jon Stonehouse

Sure. And let me also mention that Tom Simon, our Interim Chief Medical Officer is here with us and will be fielding in question. So, with regard to the IV study, as we had mentioned in the summer, we enrolled our first patient in the Southern hemisphere and make good progress in the enrollment.

In the Southern hemisphere, we have since moved that trial to the Northern hemisphere in continue to enrolling patients. And I think one thing that I want to point out is that, this is for hospitalized patients. So, these are very sick patients and we still need to fit that timeline of onset of symptoms of 72 hours or less. You know, recruiting patients for this trial, it goes a little bit slower than the normal seasonal flu trial.

Rain Benjamin – Rodman & Renshaw

Do you think that this trial will get completed in the Northern hemisphere’s flu season?

What do you think that we will have to go back to the again?

Jon Stonehouse

That’s a tricky one to answer because remember it’s the endpoint is, a new endpoint, exploratory endpoint that we worked out with the FDA. And as you know, there aren’t drugs approved in this indication.

And so, deciding of this study was based on some estimates of this endpoint and the original sighting, the 120 patients. They’ll be at data monitoring committee that will do an interim analysis at a certain target, pre-specified target point.

And then, based on what they see, they’ll make a recommendation either keep in this study at a 120 or increasing the study. And so, you know, given that is difficult when we don’t know what the ultimate total enrollment will be to predict when the study will be completed.

Rain Stonehouse – Rodman & Renshaw

Can you remind me of what this new primary endpoint is? And then also, you know, that the DSMB is going to meet to do an interim, what, you know, what triggers the interim analysis?

Jon Stonehouse

I will let Tom answer that.

Tom Simon

Primary endpoint is primed to clinical stability. There are five dimensions of clinical stability. If fever, respiratory rate, blood pressure, pulse and oxygen saturation can already be considered clinically stable. You have to hit on normalization of fever and oxygen saturation and then two or the other until three. So, that’s the endpoint.

The data monitoring committee looks at that at a pre-specified point and based on that makes the necessary recommendation.

Rain Benjamin – Rodman& Renshaw

And in that pre-specified point, just in it, you know, particular in Rodman when the people who have enrolled or some…

Tom Simon

[inaudible]

Rain Benjamin – Rodman & Renshaw

Okay. And you guys, I mean based on sort of the enrollment rates that you see right now, you don’t know when that interim analysis will happen or do you have an idea as to when that could happen?

Jon Stonehouse

Yeah, again, I don’t want to predict when the enrollment, how the enrollment will go at this point in time.

Rain Benjamin – Rodman & Renshaw

Okay. Maybe we can, I guess one question is, I think the last time we had this conference call, you had mentioned that you’d like to get the IM trials started by mid-year. So, it feels like, you know, you’re taking a little bit more of a cautious step and looking for South in next year’s flu season, you know, can you talk to us a little bit about, you k now, what additional studies or what additional thought processes are you going through that’s causing this slight pushback?

Jon Stonehouse

What we said is later this year and our intent is to start the trial in the Southern hemisphere. We have experienced there and that’s our plan. I think one gaining factor is that we said we’re using a new formulation and it’s important that we do the clean pharm work on that new formulation to make sure that it has the viability that we expect that we’ll have in the safety and tolerability.

Rain Benjamin – Rodman & Renshaw

And so, when is that, that was going to get done and when might we see those results?

Jon Stonehouse

In terms of the clean pharm?

Rain Benjamin – Rodman & Renshaw

Right.

Jon Stonehouse

Or at Phase II?

Rain Benjamin – Rodman & Renshaw

Oh, the clean pharm.

Jon Stonehouse

Yeah, we’re not, we’ve, it’s unlikely that will report the clean pharm. And we, there’s no reason for us to believe that this won’t have the viability that we expected to have and be safe and well tolerated. So, you know, at the next update I will give you is that we’ve enrolled the first patient in Phase II study. Like I’ve said, our targets, you know, assuming all goes well, is the southern hemisphere.

Rain Benjamin – Rodman & Renshaw

Okay. Okay. Thank you for the clarification. The Phase IIb study or the Phase II study that I’m going with Roche right now in Psoriasis, can you give us any idea that A. How is that to proceeding and B. when that might get completed and I guess C. correct me if I’m wrong but when that trial, when Roche takes us to a Phase IIb study, you know, I remember vaguely that those are a significant milestone that’s triggered with that. And so, do you have any clarity on one that might happen?

Jon Stonehouse

To remind you when the summer, I believe it was July of last year’s Roche had enrolled the first patient in this IIa study. Enrollment, you know, continues to progress. We’re very pleased with how Roche has been managing the trial and continue to progress it.

But we leave it to Roche communicate when they expect this trial to be completed. You know, the logical next step assuming that all goes well. Remember the primary endpoint here is safety. And so, assuming that all goes well in this trial then you’re right, we would move to a Phase IIb with Roche. And the timing of that’s difficult to predict at this point in time.

I think, you’re also correct that the initiation of that IIb would trigger a milestone to BioCryst from Roche.

Rain Benjamin – Rodman & Renshaw

And then I guess one final question and that is, the ongoing CLL trial. Can you give us some details as to, you know, that trial, how it’s being conducted? And I believe you said there will be some data at the end of this year, I assume that this year’s ash meeting but maybe you can fill us in.

Jon Stonehouse

Yes. So we have two trials for CLL. One that’s been running for quite some time and actually enrollment is starting to pick up and another trial that we expect to start shortly. Both studies are single-arm studies using the 200 mg forodosine HCl per day. And the endpoint is complete response or partial response after two cycles of therapy which is eight weeks.

And we expect to have some signaling data from both two studies by the end of this year that will be able to share.

Rain Benjamin – Rodman & Renshaw

And both the studies ongoing in day and how many patients are scheduled to be enrolled?

Jon Stonehouse

We haven’t communicated the total enrollment on those trials at this point in time but one study has been up in running for a while and as I’ve said the enrollment starting to pick up and we’ve got a second study that we hope to start in the very near future.

Rain Benjamin – Rodman & Renshaw

Terrific! Thank you very much.

Jon Stonehouse

You’re welcome.

Operator

The next question comes from David Bloustein of Southern Brook, please go ahead.

David Bloustein – Southern Brook

Hi. Thanks for taking the question. Well, it’s just a quick question. Can you remind us, since you targeted or brought up a higher dose, I think its 600 mg and you showed from CMAX in AUC data on the slides? Can you remind us how we think about the therapeutic index and those limiting talks with this compound and whether we have a lot of room here, whether we’re going against the ceiling?

Tom Simon

Thanks for the question David. So, we have very solid pre-clinical data indicating that we have a lot head room above 300 mg. So, we’re not pumping up in any ceiling from that respect.

We’re going to select our higher dose based on the additional PTA in to our ability data we get with more concentrated formulation. And at this point, I can say, we will be above 300 mg, I don’t want to specify exactly what…

David Bloustein – Southern Brook

Tom, when do you see the [inaudible]?

Tom Simon

We haven’t seen any safety issues at this point.

David Bloustein – Southern Brook

Okay. Thank you.

Operator

The next question comes from Douglas Chow of Caris & Company, please go ahead.

Douglas Chow – Caris & Company

Hi! Thanks. I just wanted to follow up on the new compound. Is that a PNP inhibitor or something else?

Jon Stonehouse

Yes. So, it’s a next generation PNP inhibitor. Its got titer binding, we believe that it’ll allow us some better dosing flexibility and so far it seems to be fairly straight forward to synthesize and manufacture. So, this is one that we retained full global commercial rights to. And assuming all goes well, to the third quarter of our plans are to file an I&D and to start to pursue that in an auto-immune indication.

Douglas Chow – Caris & Company

I see and this one is designed to have different properties all the way to BCX-4208?

Jon Stonehouse

Yes. It’s a next generation and there’s some subtle differences with this compound as compared to previous earlier generation PNP inhibitors.

Douglas Chow – Caris & Company

Okay. Thanks.

Operator

The next question comes from Joseph Schwartz of Leerink Swann, please go ahead.

Joseph Schwartz – Leerink Swann

Thanks for taking the question. I was wondering if you could give us some sense of when you think the optimal time for a forodosine partnership in the US and the rest of the world might be.

Jon Stonehouse

Yeah, you know, the key with forodosine is how big is this compound going to be and the answer to that is, you know, where can we use it? Right now, we’re pursuing a latter stage CPCL pivotal trial. On that test in itself probably doesn’t support a commercial organization for BioCryst.

But if we see signals in CLL with this trial that we’re doing, if we’re able to move it up in the earlier stages of CTCL then it becomes a much more commercially attractive compound for us to move forward ourselves.

So, we’re going to just continue to move these two studies forward, our three studies forward and make that decision on a later day.

Joseph Schwartz – Leerink Swann

Okay. And then, to my follow up, the next generation PNP inhibitor, you noted that there was some subtle differences with this drug come to market. Do you think after forodosine and 4208, or is there a way that you can develop it faster in the niche type of indication. And then how would you contemplate that you’ll be able to prevent the other two drugs from being used in whatever indication you go forward with for the new PNP inhibitor if there are price differences.

Jon Stonehouse

Yeah, I want to be careful not to try to differentiate this from previous PNP inhibitors because it’s really early days. And I think it’s premature to say that, I think that main message we want to get across to you from a strategic standpoint is, this is a PNP inhibitor that we retained full global commercial rights to.

And if our thought process is, if PNP works in one auto-immune indication, it’s likely to work in others. And so, the opportunity to move it into, you know, different areas, different indication;’ it’s pretty significant and as I’ve said we retained full commercial right to that.

Joseph Schwartz – Leerink Swann

Thank you.

Jon Stonehouse

You’re welcome.

Operator

At this time, I would like to turn the conference back over to Jon Stonehouse for closing remarks.

Jon Stonehouse

Again we appreciate your participation in the call. We really look forward to the progress in the opportunity that we have ahead of us in 2008. We believe it’s an important year for BioCryst and believe we can make progress.

So, as always, we appreciate your interest in BioCryst and have a good day. Thank you.

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