Good day, ladies and gentlemen and welcome to the BioCryst Third Quarter 2013 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we’ll conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, this call may be recorded. I’ll now introduce your host for today’s conference, Robert Bennett, Vice President of Investor Relations. You may begin.

Good morning and thanks, everybody for joining us for our BioCryst Third Quarter 2013 Conference Call. Today’s press release and accompanying slides for the call are available on our website at biocryst.com. At this point, as Ashley said, everyone’s in a listen-only mode and we’ll open up the lines later for your questions and provide further instructions about Q&A [ph] at that time. With me today is our CEO, Jon Stonehouse; Bill Sheridan, our Chief Medical Officer; and Tom Staab, our Chief Financial Officer. Before we begin, I will read a formal statement, as shown on Slide 2 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, 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 website. With that, I will turn the call over to Jon.

Thank you, Rob. Good morning and thanks to everyone for joining us today. Throughout 2013, our team has focused on executing a strategy to advance our core assets while managing our operations with financial discipline. Our strategic goal is to build a company that becomes a market leader in the treatment of HAE. This can be accomplished by bringing to market the first oral kallikrein inhibitor, BCX4161, and then following that up with an improved version from our second generation HAE program where we are seeking to develop a one pill once a day treatment to prevent attacks. In addition, we have assets that are funded by the government that could provide meaningful, non-dilutive capital to fund HAE and other future programs. Stock piling orders from either peramivir or BCX4430 have the potential to provide large capital inflows that could be used for HAE trials or building our commercial infrastructure. With this combination of assets, we have the potential to commercialize HAE assets by ourselves which likely translates into a more valuable company. Now let me describe the progress we have made recently on each of these programs starting with HAE. 4161 continues to advance since our July announcement that the Phase 1 trial met all of its goals. The safety, tolerability, drug exposure and on-target effect we saw on plasma kallikrein strongly supported advancing 4161 into a proof of concept Phase 2a trial we now call the Oral ProphylaxiS-1 or OPuS-1 Trial. We are in the ramp up stage of this trial and we have recently initiated screening of HAE patients. We expect the dose of the first subject soon and to complete the clinical trial during the first half of 2014. Our second generation oral kallikrein inhibitor program is advancing nicely as well. Our discovery team has finished…

Thanks, Jon. In July, we presented kallikrein inhibition results for the 400 milligram, 800 milligram and placebo every eight-hour cohorts in a multiple ascending dose portion of the Phase 1 study. Since then, we have had some questions pertaining to the details of the kallikrein inhibition assay. In brief, the assays run on plasma samples prepared by centrifugation of anticoagulated whole blood samples. [Indiscernible] plasma are frozen and the analyses are performed in batches up to completion of all sampling. Fluid samples are prepared into triplicate microwells with 25 microliters of plasma in each well. As we explained in the last call, the assay involves activation of the contact system with allergic [ph] acid and measurement of kallikrein enzyme activity using a specific artificial substrate. The total volume of reagents added to the microwells is 75 microliters per well, thus the final concentration of drug derived from the oral dose of BCX4161 is 25% of the actual PK value at the time of blood sampling. I’m pleased to report that we have now completed analyses of kallikrein inhibition assays in plasma samples across all dose cohorts in the study. These analyses have shown that there is a clear and statistically significant dose effect on the degree of kallikrein inhibition. These effects are shown on Slide 5 with the left panel showing the results of steady state after dosing every eight hours. In the repeated measures and analysis of variance test, the P value associated with the dose effect is less than 0.01. The full results confirmed that the dose regimen of 400 milligrams every eight hours results in plateau effects in this assay of on-target pharmacodynamic effect of 4161 on plasma kallikrein. The right panel displays the relationship between the achieved drug concentrations after oral dosing and the degree of…

Thank you, Bill, and good morning everyone. Today I will summarize the key elements of our third quarter 2013 financial results and performance against our financial guidance. Our guiding principle throughout 2013 has been to focus our cash resources directly to the advancement of our key development programs to value creating milestones and to minimize non-critical spending. Consistent with previous quarters, the third quarter represents another period whereby we continue to strictly adhere to this focused approach and a quarter whereby you see the benefits of this strategy. Year-to-date and for the third quarter, we have delivered the following positive financial results. 2013 operating cash utilization decreased 45% and 38% from the third quarter and nine-month 2012 levels. 2013 operating expenses decreased 32% and 31% from the third quarter and nine-month 2012 levels. And we closed the third quarter with $43.4 million in cash and investments following a successful and well received public equity offering which added $18.5 million of net proceeds to our cash runway. On Slide 6, you will note that revenue for the third quarter of 2013 decreased to $2.4 million as compared to $5.8 million in 2012. This decrease is due primarily to the recognition of $2.8 million of previously deferred RAPIACTA royalty revenue in the third quarter of 2012, as well as a decline in third quarter 2013 reimbursable peramivir expenses resulting from reduced development activity compared to the third quarter of 2012. Third quarter 2013 R&D expenses were $8 million, down 34% from $12.1 million in the third quarter of 2012. This decrease was primarily associated with a reduction in ulodesine and BCX5191 development expenses, and overall decrease in R&D infrastructure costs and the conclusion of peramivir clinical development activity. All of these identified reductions were partially offset by higher BCX4161 development cost in…

Thanks, Tom. As we head into the last two months of the year, our primary focus will be on enrolment in the BCX4161 Phase 2a trial and selection of at least one second generation kallikrein inhibitor to take into preclinical development. We also expect to file our company’s first ever U.S. NDA for peramivir before year-end. These are exciting times at BioCryst, and our employees are firmly committed to delivering on these milestones in order to move closer to our strategic goal of building a successful company. This concludes our prepared remarks. We’ll now open it up for your questions.

Thank you. (Operator Instructions) Our first question comes from Brian Abrahams from Wells Fargo. Your line is open.

Hi, thanks for taking my question. This is Shin [ph] calling in for Brian. I have a couple of questions on your second generation kallikrein inhibitor strategy. Could you remind us whether the second gen molecules belong to a different genus compared to BCX4161? And any additional details about the structural characteristics of the molecule would be helpful. And maybe your thoughts on the potential overlap on efficacy and safety profiles between the two molecules as a quick follow up.

Sure. Hi. Yeah. This is Bill. Thanks for the question. So to answer the first part, it’s completely different basic structure. So rather than try to tinker with the structure of BCX4161, we started fresh with a new round of structure base, structure design, so they’re new totally new scaffolds and have nothing to do with the structure of BCX4161. We have not and don’t intend to disclose any other details about the structure of the compounds at this stage, so I can’t go into the second part of your question. With regard to what we can expect, the goal here is to improve oral bioavailability, eliminate the off-target effect on tissue factor/factor VIIa and maintain potency. And the set of compounds that we currently have has made all those goals.

Okay. And so the second question relates to your comment. If your goal is to have a similar potency as BCX4161, but improve on bioavailability for dosing convenience and to reduce co burden [ph]. Do you think that’s sufficiently high enough bar to fend off generic versions of BCX4161 when it goes generic? And what do you think would be sufficiently high bar for the second generation molecule to set the bar high enough to overcome such competition?

So listen, we’re still in early days here, and having two molecules gives us a better shot at having one that gets to market. But we are setting a high bar for the second generation molecule. We’ve now told the team that we want one pill once a day. And as you know, if we can get kallikrein inhibitory activity similar to normal C1 level, there’s a potential to wipe all attacks. That’s the ultimate goal. Will we get there? We don’t know. But that’s what we’re shooting for. So I don’t want to get into the strategies of how we’re going to fend off competition and the like in this call. But we’ll be very thoughtful about how we move these molecules forward.

Okay great. One quick last one. Maybe your expectations for the orphan status for BCX4161?

So clearly hereditary angioedema in terms of its prevalence qualifies as an orphan disease and we will be applying for orphan drug status in [indiscernible].

Great. Thank you very much.

Thank you.

Thank you. Our next question comes from Heather Behanna of JMP Securities. Your line is open. Heather Behanna – JMP Securities, LLC: Hey guys, congrats on the progress. Thanks for taking the question. Just a quick question about the ongoing Phase 2 study. If you could give us any color at all just sort of what the background rates you’ve been seeing during the screening or how the population that you’re bringing in fits with the expectations of before starting the trial?

So I think at this stage, what we can say is that the centers are actively screening. And as Jon said, we expect that the first patient on the study will be [indiscernible]. And I think that as you recall, we’ve set again a pretty strict inclusion criteria around the attack frequency that qualifies the patient for entering into the study. So that’s going to be the minority of patients with hereditary angioedema. They’re going to have an attack frequency of at least one per week. So also as we’ve said before, I think that until we’re further into the study, it’s premature to give guidance on how long it will take to complete the enrolment and how fast or slow that will go. But I’m very cognizant of the length of time it took our predecessors in this field to do their study. So I think let’s watch this space at the moment.

Yes. And I think there’s constant and thorough interactions between our team, the CRO, and the investigators. And a critical element to this study is getting the right patients in. And so we’re not going to rush to getting enrolled. We’re going to have to ensure that we get the right patients in. Heather Behanna – JMP Securities, LLC: Great, thank you.

You’re welcome.

Thank you. Our next question comes from Rahul Jasuja of Noble Capital Markets. You’re line is open. Rahul Jasuja – Noble Capital Markets: Hi, good morning, guys. Just a few questions on BCX4161 and peramivir. So Jon, on to you [ph], I think I’ve kind of discussed this with you guys in the past, but let’s sort of go back and think about the potential future market with an oral. Obviously, the synright [ph] market is the direct grab for BCX4161. But looking at the current oral which is the androgen group, could you add some more color and discuss if really if there’s an opportunity for something that’s pennies of the androgen group, although, sort of the attenuated androgen group moving on to a BCX4161 therapy. Is that a clear opportunity or is that debatable?

So let me first say that synright [ph] market is a moving target. They’re doing very nicely in growing their share. And so that appears in a way to be a growing market with each quarter that passes. And I think with regard to androgens, the side effect profile of these drugs while they might be inexpensive is really difficult for patients to deal with. And so I’m confident that if we end up with an effective, safe, and well-tolerated oral, the opportunity to get some of those patients is high. So I don’t think the profile is such that people want to put up with the risk of the side effects. Rahul Jasuja – Noble Capital Markets: Right. And then sort of related to that is assuming success with the sub-Q versions of the [Audio Gap] maybe a sub-Q versus your oral. So that [indiscernible] effect. The marketing you’ll mind too much because clearly the oral is dramatically better than a sub-Q versus obviously an IV.

Yes, I mean, improvements on existing therapies is always a good thing for patients. But at least my experience has been, and I think if you look at other therapeutic areas in the industry, oral beats needles every time. So we’re confident that we can be the market leader, assuming that we’ve got an efficacious, safe and well-powered [ph] drug. Rahul Jasuja – Noble Capital Markets: Okay. And then moving on to peramivir, so the stock piling opportunity is clear – and clear in the sense that the clear opportunity, when that happens is debatable and it’s hard to model. But this particular NDA submission is for acute uncomplicated influenza that’s kind of based on the Shionogi Phase 1I and the previous PCRX studies. So this gives an opportunity for seasonal sales in the retail market. So how should we look at that particular aspect, also of the hospitalized complicated influenza which is potentially and awfully produced?

Yes. So with the label that we anticipate that we’re going to get in acute uncomplicated and given the statement I just made about oral beating IV every time, we don’t expect to go head-to-head in a primary care doctor office and beat Tamiflu. That’s not realistic. What is realistic is in emergency rooms and urgent care centers where you’ve got high risk of at-risk patients, elderly people with concomitant disorders. The opportunity to get a drug in fast, know that they got it all, got the full dose with one infusion is important. And we did some market research over the past few months and I think there’s a real opportunity in that space. Rahul Jasuja – Noble Capital Markets: Great. And that’s all I have. I look forward to the Phase 2a results. Thanks.

Thanks, Rahul.

Thank you. (Operator Instructions) Our next question comes from Steve Byrne of Bank of America. Your line is open. Steve Byrne – Bank of America: Jon, you mentioned your goal in the second gen HAE drug collection of molecules was to achieve one pill one per day. And I was just wondering, what you’re looking at so far is the hurdle for bioavailability more achievable than lengthening the half-life and do you think this group of molecules you’re looking at now you can get something on both of those fronts?

Yes, Steve, it’s Bill. So I think that right now, we are completing the relevant PK work that hopes to answer your question. So we don’t have the complete answer on that yet. And we’ll rank – I mean, it’s pretty easy to imagine how to rank these compounds. We’ve got so many good compounds that we’ve had to do extra work to select what we need to take forward. So the ones with the best PK and the best potency are going to win. And so I think that the goal looks very achievable from the data that we currently have in front of us. Steve Byrne – Bank of America: And Bill, are you satisfied with your assay as you have it now or do you think that it would be worth developing an HAE animal model?

The time it takes to develop the animal model doesn’t suit our current purposes. Those types of models are certainly very valuable. But right now, I think that we can rely on the kallikrein inhibition assay and other research level types of replicon [ph] release assays that we’ve talked about in the past to help us distinguish between the molecules. And those assays are performing extremely well in our laboratories. So we certainly do not need an animal model to make the selection of the second gen related [ph] candidates.

I think what’s interesting too with the information Bill presented today in the slide is this really nice correlation between PK and PD. And if we see that PD is predictive of clinical benefit, meaning reduction in attacks, then the PK could be the measure and we could potentially not even have to do the PD in future studies. So that’s a nice timing [ph]. Steve Byrne – Bank of America: And just one 4430, is the Marburg virus the target here, because you could do it through an animal model or an animal study and can you just comment on more broadly the antiviral activity of this molecule?

So what we’ve talked about in public so far is its activity on yellow fever virus and some other viruses that are being screened in vitro. Yellow fever we had in vivo data. That was presented about a year ago at the 2nd Antiviral Congress. With regard to why select Marburg virus, I think that the approach we’ve taken is to base it on the type of animal model data that we currently have and our collaboration with USAMRIID on filoviruses has generated that data. And certainly, the class of compound that we’re dealing with and its potential benefit as a broad spectrum medical counter measure that would cope with many bugs with one drug is quite attractive from a government need perspective rather than having every time you have a new virus you have to get a new drug. So I think that the broad spectrum activity of the virus I think is something that we look forward to evaluating in the future. But the first funded program is focused on Marburg virus for those reasons.

And it ends up being a real cost-efficient approach to drug development because to expand to other viruses, you just have to do the animal efficacy study and you’ve got another indication with another virus. So that’s way less expensive than big clinical trials. Steve Byrne – Bank of America: Okay, thank you.

Yes.

Thank you. Looks like we have a follow up from Rahul Jasuja of Noble Capital Market. Your line is open. Rahul Jasuja – Noble Capital Markets: Yes, thanks. Bill, I think this is for you. Looking at Slide 5 in your presentation, just a clarification on the kallikrein inhibition, at the end of a dosing and the [indiscernible] trial, that is not dose-related. Can you explain that?

So I think the – you’ll notice there’s no error bar on the 100 milligrams – Rahul Jasuja – Noble Capital Markets: Right.

– Ctab [ph] point. That’s because the sample size there was too small, so you should basically discount that particular bar. Rahul Jasuja – Noble Capital Markets: Okay.

So there is indeed a dose response. Rahul Jasuja – Noble Capital Markets: Okay, very good. Thanks.

Thank you. Not showing any further questions in the queue, I’d like to turn the call back over to management for any further remarks.

Thanks. As always, we really appreciate your interest in BioCryst. We’ll be giving you updates as the year unfolds and we enter 2014. And have a great day, thank you.

Ladies and gentlemen, thank you for participating in today’s conference. This concludes today’s program. You may all disconnect. Everyone have a great day.