Joe Schepers - Executive Director, IR and Corporate Communications Michelle Berrey - President and CEO Garrett Nichols - Chief Medical Officer Tim Trost - CFO Linda Richardson - Chief Commercial Officer Mike Rogers - Chief Development Officer.

Brian Klein - Stifel Daniel Brims - Cantor Geoff Meacham - Barclays Jessica Fye - JPMorgan Katherine Xu - William Blair Marc Frahm - Cowen and Company Josh Schimmer - Piper Jaffray.

Good morning, and welcome to the Chimerix First Quarter 2015 Financial Results Conference Call. [Operator Instructions] At this time I would like to turn the conference call over to the company's Executive Director of Investor Relations and Corporate Communications, Joe Schepers. Please go ahead..

Thank you, and welcome to Chimerix first quarter 2015 financial results conference call. On the call today are Michelle Berrey, President and CEO; Garrett Nichols, Chief Medical Officer; Tim Trost, Chief Financial Officer; Linda Richardson, Chief Commercial Officer and Mike Rogers, Chief Development Officer.

Before we begin allow me to read Chimerix Safe Harbor regarding forward-looking statements.

During the course of this conference call, the company will be making certain forward-looking statements such as statements relating to certain R&D programs, including our Phase 3 SUPPRESS and AdVise trials for future trials of brincidofovir, also known as brinci and related matters.

These statements involve risk and uncertainties that may cause actual results to differ materially from those projected in forward-looking statements.

These risks and uncertainties are discussed more fully in Chimerix filings with the Securities and Exchange Commission, including without limitation its most recent quarterly report on Form 10-Q to be filed later today, its most recently filed reports on Form 8-K and other documents subsequently filed or furnished to the Securities and Exchange Commission.

All forward-looking statements made on this call speak only as of the time they are made and Chimerix undertakes no obligation to update these statements to reflect subsequent events or circumstances. We issued a press release this morning containing financial results for the first quarter 2015.

The press release is available on the company's website at www.chimerix.com. Dr. Michelle Berrey will begin with an overview of the highlights of recent company news, Dr.

Garrett Nichols will then discuss the progress of our clinical development programs, Linda Richardson will provide an update on our commercial initiatives and Tim Trost will review our first quarter financial results. Dr. Berrey will close by reviewing our expected milestones for 2015 and an overview of the Chimerix 2020 strategic plan.

At this time I would like to turn the call over to Michelle Berrey..

Thank you, Joe, and thank you all for joining us this morning.

As you know, our lead clinical candidate is Brincidofovir, which if approved will be the first and only medicine for the prevention of cytomegalovirus or CMV in patients undergoing a stem cell transplant, the first and only treatment for adenovirus infection and the first and only antiviral for the treatment of small pox.

In a few minutes Garrett will provide an update on enrolment for SUPPRESS, our pivotal study for CMV prevention in allogeneic stem cell transplant recipients. We are on track to complete enrollment this summer and to report data in 2016.

In addition, we continue to rapidly enroll patients in our Phase 3 AdVise study for the treatment of adenovirus infections. To-date, we have enrolled 150 of our targeted 200 patients.

As most of you know, we presented data at the BMT Tandem Meeting earlier this year, which suggested an improved survival in this aggressive infection compared to published data.

This morning, we also announced the design of two Phase 3 clinical trial for the prevention of CMV in kidney transplant recipients, SUSTAIN and SURPASS, studies of brinci versus valganciclovir in two different kidney transplant populations. Garrett will provide further details on these studies, which we plan to initiate in the second half of 2015.

Although there have been significant improvements in rates of organ rejection over the past decade, we’ve not seen similar advances in antiviral therapy for this population. There remains a clear need for approved care for these patients as less than half of transplanted kidneys survive 10 years after transplant.

We’re looking forward to the opportunity to evaluate brinci’s potential activity against CMV and BK virus and associated preservation of kidney function. Due to the importance of brincidofovir’s potential to address these high unmet medical needs, it has received fast track designation by the FDA for CMV for adenovirus and for small pox.

Garrett will also review our ongoing pivotal study in animal models of small pox and Tim will discuss the potential of the recent announcement by BARDA regarding their intent to procure brincidofovir for the treatment of small pox.

We have begun our preparation for an IND for the new clinical candidate CMX669 and anticipate discussions this fall with the FDA regarding how best to take this oral antiviral forward into clinical studies. We anticipate being able to provide more details on CMX669 later in the year.

I will now turn the call over to our Chief Medical Officer Garrett Nichols, who will discuss our clinical development programs in greater detail. .

Thank you, Michelle. First let me begin with SUPPRESS, which is in its final stretch of enrollment. As of this morning, nearly 95% of the planned 450 patients have been enrolled in this study. We look forward to enrolling our last patient this summer. With six months trial duration, we remain on track for topline data presentation early next year.

During the past few months, I had an opportunity to visit many of the sites enrolling patients in SUPPRESS. Investigators expressed their strong interest in leveraging brincidofovir’s potent anti-CMV activity and also it’s activity against other double-stranded DNA viruses to improve outcomes in its stem cell transplant recipients.

They also noted that the prevention of clinically significant CMV reactivation allowed them to avoid the toxicities of the currently available antiviral such as ganciclovir and foscarnet, which are associated with bone marrow suppression and kidney toxicity.

Turning to AdVise, our Phase 3 trial of brinci for immunocompromise patients with serious adenovirus infections, we’ve enrolled 150 of the planned 200 patients to-date. Approximately 80 patients are in the highest risk cohort that’s Cohort B those with disseminated adenovirus infection after allogeneic transplantation.

Preliminary data presented earlier this year at the BMT Tandem Meetings in San Diego shows that these subjects had improved survival when compared to outcomes reported in the literature.

Although a majority of the patients enrolling in AdVise are allogeneic stem cell transplant patients, we are also enrolling patients with live-threatening adenovirus infections who have not had a stem cell transplant.

We are continuing to advance our understanding of adenovirus infections and the types of patients whose lives are threatened by them including patients undergoing chemotherapy and those taking biologics for autoimmune or other diseases. All patients who are involved in AdVise received 12 weeks of brinci.

In order to provide a controlled group for AdVise, we are collecting historic data from patients from the same medical centers who were diagnosed with adenovirus infection as they did not receive brinci.

Although the use of historic controls is not common in pivotal studies, there are recent precedents, which resulted in FDA approvals, particularly when there are no alternative therapies.

The preliminary results from our AdVise trial demonstrate the potentially meaningful benefit it may offer patients with weakened immune systems, who have life-threatening adenovirus infection.

To lower a 11% mortality rate that we observed in asymptomatic transplant recipients compared to the 37% mortality rate in patients with disseminated disease at the time of treatment initiation suggests that when you treat adenovirus like other infections or diseases, the earlier the treatment starts, the better.

We expect to report data on AdVise in early 2016. We’re planning on multiple NDA filing for brincidofovir for the prevention of clinically significant CMV infections in at-risk allogeneic stem cell transplant recipients and for the treatment of adenovirus infection in immunocompromise patients.

As previously announced, we plan to discuss our filing strategy with both the EMA and key health technology assessors this summer in order to refine our plans for an MAA in Europe. Let me now move to our Phase 3 kidney transplant studies.

First I would like to take a step back and thank our clinical and regulatory teams for their efforts in finalizing these type of designs. So let me begin with the SUSTAIN study. SUSTAIN is a Phase 3 study in kidney transplant recipients who are at the highest risk for CMV disease.

It is a blinded, non-inferiority study of brincidofovir versus the current standard of care valganciclovir. The study will target kidney transplant recipients who have never been infected with CMV and have no antibodies to CMV. These patients are therefore called CMV seronegative or R-.

CMV seronegative patients who receive a kidney from a CMV seropositive donor, the so called D+ or minus situation are thus infected with CMV for the very first time via the transplanted organ at the same time that they are being heavily immunosuppressed to prevent rejection.

Therefore, they need antiviral protection for extended period with current guidelines recommending 200 days of prophylaxis with valganciclovir. The primary endpoint for SUSTAIN is CMV disease but the study has secondary endpoints related to kidney function at 12 months after transplant which hasn't correlated with long-term graft survival.

The trial is expected to enroll approximately 750 patients with one randomization to 200 days of valganciclovir or brincidofovir and follow it up through the first year.

This study population makes up less 20% of patients who are receiving a kidney transplant, but it is the label patient population for the current standard of care with valganciclovir. If positive, SUSTAIN would support traditional approval in the US for the CMV prevention indication.

Because this highest risk population makes up less than 20% of the patients who are receiving a kidney transplant, it was important for us to also study brincidofovir in the more common setting, namely those who are already CMV seropositive when they receive their new kidney. This group represents well above half of kidney transplant recipients.

These patients are at increased risk of CMV reactivation due to the significant immunosuppression they receive to avoid rejection of their new kidney. The SURPASS trial will thus enroll these CMV seropositive transplant recipients.

It has a similar blinded non-inferiority design as SUSTAIN, but here we are comparing 100 days of antiviral prophylaxis with brinci to 100 days of valganciclovir as per current treatment guidelines. The primary endpoint is the occurrence of CMV disease with key secondary endpoints related to kidney function at six months after transplant.

The trial is expected to enroll approximately 520 patients with one-to-one randomization to 100 days of valganciclovir or brincidofovir and follow-up through for the first six months after surgery. These studies are both designed to compare brinci to the established standard-of-care for CMV prevention in these renal transplantations.

We will also be able to look at risk factors such as immune function for late CMV and other viral diseases such BK virus in these patients. Importantly, both of these studies are also designed to evaluate the potential of brincidofovir to maintain stable renal function in the critical first months after transplant.

Plans are underway to initiate both SURPASS and SUSTAIN at the same transplant centers in North America and Europe in order to facilitate efficient recruitment. We plan to enroll our first patients in the second half of this year. Now the latest on our development for brinci for the treatment of smallpox.

Thankfully smallpox has been eradicated after a successful worldwide vaccination program. Therefore we are developing brinci under the animal rule which allow testing of investigational compounds in validated animal models of the disease.

We are currently conducting a pivotal trial in the rabbit model designed to demonstrate that brinci prevents mortality after challenge with rabbitpox virus. We expect these results in the second half of 2015.

As we move forward with our development programs, we are simultaneously planning and preparing our files for US NDA and MAA submissions to come and are building a medical affairs organization that will be able to support the proper use of brinci after launch.

Our physician investigators share our excitement as we near completion of our first Phase 3 studies and the initiation of a new chapter in clinical development of brinci with our kidney transplant studies. Now, I'd like turn the call over to Linda Richardson for a commercial update..

Thanks, Garrett. Good morning, everyone. I’ll be providing a brief update on some of the key commercial activities and insights that we've been progressing to support the launch of brinci.

Our market research program has involved more than 1,000 healthcare professionals and payers worldwide as we seek to better understand the antiviral needs of the transplant community.

The feedback we've obtained points to the need for new therapies with less renal toxicity, therapies that do not suppress bone marrow and that provide strong protection from CMV infection in the high-risk stem cell transplant recipient. We believe that that the brincidofovir profile we've seen to-date is well matched to these needs.

Our market research and advisory board participants have helped us understand the handset mindset behind the common approach of waiting for CMV viral loads to rise prior to initiating a CMV antiviral.

Unlike the universal prophylaxis strategy often used for antifungals and antibacterials in the same patient population, this wait-and-see approach before initiating antiviral therapy is really part of a workaround strategy that evolved largely because of the limitations of current CMV antiviral therapy.

To paraphrase one physician, you don't want to give the medications and then suppress the bone marrow. This approach of waiting for CMV replication to reach certain levels before intervening with an antiviral is not without inherent risks.

Recent research from the University of Washington showed that these patients who reactivate CMV with even a single positive viral load have twice the risk of dying in the first year after transplant as patients who don't reactivate CMB. So clearly the watch-and-wait strategy is not having the positive benefits we need for our patients.

Because of its lack of kidney toxicity and bone marrow suppression, brincidofovir may become the first and only agent to provide proactive protection against CMV infections in allogeneic stem cell transplantations.

Our inside work also reveals that adenovirus, BK virus, EBV and HHV-6 infections are top of mind among physicians as other DNA viruses have concerned in both stem cell and kidney transplantations.

Our market research shows the potential for broad spectrum antiviral activity in a single therapy is of significant interest to the transplant and infectious disease communities.

If clinical trial data support activity against more than just CMV, which we hope to see in our secondary endpoints in SUPPRESS and in the AdVise trial, the broad spectrum benefit of brinci is likely to become an important driver in prescribing preferences.

On the previous earnings call, I shared that Chimerix is committed to fully understanding the access and reimbursement landscape. We continue to expand our work in these areas. We're preparing for our upcoming meeting with the EMA and several HTA bodies and continue to map out the payer landscape in the US.

Lastly, I'd like to close by stating that we are actively evaluating and refining commercial structure in the US and other regions as we anticipate accelerated activities in 2016 and preparation for launch. Now, I'd like to turn it over to Tim Trost..

Thanks, Linda, and good morning, everyone. As Joe mentioned in his introductory remarks, earlier today we issued a press release containing our financial results for the first quarter of 2015.

Starting with our balance sheet, at the end of the quarter we had $267.2 million in capital available to fund operations, $2.9 million in debt and approximately $41.3 million outstanding share of common stock.

Turning to our statement of operations, Chimerix reported a net loss of $22.3 million or $0.54 per basic and diluted share for the first quarter of 2015. During the same period in 2014, the company recorded a net loss of $10.4 million or $0.39 per basic and diluted share.

Revenues for the first quarter of 2015 increased to $1.2 million compared $780,000 for the same period in 2014 due to an increase in the first quarter of 2015 in reimbursable expenses associated with the company's ongoing contract with BARDA.

Research and development expenses increased to $17.4 million for the first quarter of 2015 compared to $8.3 million for the same period in 2014. This increase was primarily due to the cost related to the Phase 3 SUPPRESS and AdVise trails and growth of the company's clinical, regulatory and development groups.

We continue to expect significant increase in R&D expenses for the full-year 2015 compared full-year 2014 due to the costs related to both of our ongoing Phase 3 trials and two planned kidney transplant trials, continued development on our commercial process development and preparing for the anticipated NDA filing in 2016.

R&D expenses maybe uneven from quarter-to-quarter. General and administrative expenses increased to $6.1 million for the first quarter of 2015 compared to $2.7 million for the same period in 2014.

The increase was primarily due to the growth in the Company's infrastructure, which included the addition of new employees throughout the organization as we prepare for the expected commercialization of brincidofovir. For the full-year 2015, we expect an increase in G&A expenses compared to the full-year 2014 based on these same factors.

Loss from operations was $22.3 million for the first quarter of 2015 compared to a loss from operations of $10.2 million for the same period in 2014. The variance was due primarily to the increased research and development, and general and administrative expenses as previous discussed.

Let's turn now to the recent BARDA posting of April 13 regarding it’s intend to award a sole source contract to Chimerix for the procurement of brincidofovir for the treatment of smallpox. This represents a significant opportunity for us, as BARDA's total estimated dollar value for the 60-month base period contract is approximately $100 million.

If all options are exercised by BARDA, the total dollar value of the contract could reach approximately $435 million. BARDA anticipates announcing the award of this contract in 2H of this year.

According to the posted notice of intent, the estimated period of performance for the 60-month base period is September 2015 through August 2020 for initial delivers of brincidofovir to the U.S. Centers for Disease Control and Prevention for the Strategic National Stockpile or SNS.

The options may be exercised at BARDA's discretion to achieve the potential delivery of a maximum of 1.7 million treatment courses. Any award would be subject to negotiation and execution of a definitive agreement by BARDA and Chimerix.

As a remainder, the first quarter 2015 financial results as well as this morning's announcement are available on the investor section of our website. I'll now turn the call back to Michelle Berrey..

Thank you Tim. On our call this morning, our team has provided you with some examples of the work that we're doing to bring brinci to the patients who may benefit from it. As Garrett shared with you, we're nearing completion of the enrollment of SUPPRESS, we will update you all as soon as that last patient has enrolled.

As a reminder, the SUPPRESS trial is 24 weeks in duration, from the last patient enrolled to the last visit is approximately six months. We anticipate data in early 2016.

As we present the safety and preliminary survival data from our AdVise study, the number of requests for brinci from physicians taking care of patients undergoing transplant continues to escalate both here in the U.S., and notably for medical centers in Europe, Asia and South America.

Although the number of patients with life-threatening adenovirus infection each year is difficult to estimate, it is increasingly clear to us that there are many lives taken too early because this aggressive viral infection has no currently available therapy.

We are committed to working with the scientific community to help identify patients early who maybe at increased risk of disseminated adenovirus infection, data that we believe can be supported by the AdVise trial and by our boarder commitment to understanding how brinci can best be incorporated into the care of immunocompromised patients.

We anticipate discussions with BARDA during the next several months regarding our ongoing development of brincidofovir for smallpox and the potential procurement for the National Stockpile. We're looking forward to initiating our two kidney transplant trials later this year.

We believe brinci has the potential to reduce the risk of CMV and BK associated disease, and kidney transplant recipients, issues significantly impacting thousands of the approximately 90,000 kidney transplant worldwide each year.

Looking beyond 2015, our team is developing a five-year business plan focusing on the strengths and assets we already have in hand and identifying areas for growth that are consistent with our dedication to improving lives of patients whose needs are not being addressed with current therapies.

Our short-term goals include preparing for the regulatory filings and successful launch of brinci, leveraging our proprietary lipid conjugate technology, and longer term, bringing forward promising new molecules from our compound library. Our active discovery programs include research and respiratory syncytial virus, hepatitis B virus and influenza.

We announced earlier this year, our discovery program in norovirus, a virus which results in a miserable 48 hours for most of us, but which can result in chronic infection and death for immunocompromised patients. We have identified a lead candidate for norovirus and look forward to updating you on potential progress with that molecule later in 2015.

We've made some substantial additions to our teams to prepare for the next stage of development of brinci and have sufficient capital to take us through data readouts from SUPPRESS and AdVise. Thank you all for joining us this morning for a recap of the early months of 2015 and to hear about our plans for the rest of this year and beyond.

I will now turn the call over to the operator for questions..

[Operator Instructions] The first question is from Brian Klein of Stifel. Your line is open..

Hi, guys thanks and nice progress.

First question is, in terms of the AdVise versus the SUPPRESS trial, can you tell us which one you think we’ll get data on first?.

Thanks Brian, I'll hand that over to Garrett to address..

We are currently as we stated, finishing up recruitment with regards to the SUPPRESS trial and the data from SUPPRESS will be available approximately six months plus a couple of weeks after the last patient ends up coming in.

Our intention has always been to pull down the AdVise data that is available at the time that we complete SUPPRESS, such that it will be available for a dual indication NDA file and so the current plans would be that the data would be available about the same time in early 2016..

Great. And then just a little bit more on SUPPRESS.

Can you talk about what are other data points we might expect with that top line readout? Will we see things like engraftment times or percent engraftment rate?.

So we're looking at a number of secondary endpoints as far as the SUPPRESS trial is concerned which includes incidence of clinically significant double stranded DNA virus infections other than CMV which of course is a primary endpoint.

Some of these viral infections including HHV-6 are associated with graft failure in the literature and so that's one of the key secondary endpoint that is very important to transplanters because maintenance of the stem cell allograft is a top priority for their patients knowing that loss of the allograft usually leads to the death of the patient.

And so I guess the question about when the data will be available, the data will be available at the same time as the primary analysis..

Great, thank you taking my questions..

Thanks Brian..

Thank you. And the next question is from Daniel Brims of Cantor. Your line is open..

Hi, thanks for taking my question. On the last call, I believe you had mentioned that the enrollment was slower than you had expected in SUPPRESS.

Now that the weather has gotten nicer, have you seen that that has changed and you've seen uptick in enrollments or how is the -- and also on the kidney study, do you expect any cyclicality there as far as the seasons are concerned..

Well, thanks for the question, I think as far as SUPPRESS is concerned, we saw a significant uptick in enrollment after our presentations at the Tandem BMT conference when really investigators were energized by the efficacy of brincidofovir against adenovirus both from antiviral and from a promising early preliminary look at mortality versus the literature.

So, we saw certainly an uptick in the March time frame. Things continue to go according to plan. And as we just announced, we’re nearly 95% of the way there. So, we anticipate that we’ll be finishing up in the coming weeks and look forward to presenting the data in the early part of 2016..

Okay, thank you..

Just to address as part of the kidney transplant study is concerned, kidney transplants are more common procedures in the United States and Europe. We don’t anticipate any competing studies as far as that indication is concerned and so, we anticipate a fairly brisk enrollment in that particular study.

There is a lot of excitement from [technical difficulty] transplanters who have been eager to investigate brincidofovir in the patients..

Okay. Thank you for taking my question..

Thank you, Dan..

Thank you. And the next question is from Geoff Meacham of Barclays. Your line is open..

Good morning, guys. Thanks for taking the question. So, question for you on SUSTAIN and SURPASS.

So, now that you have the design of the kidney studies done, how much consideration can you tell us from your regulatory discussions was given for other solid organs beyond kidney and then other viruses, double-stranded viruses beyond just CMV and BK in the kidney transplant itself? And then couple of other follow-ups..

It’s a great question.

We debated quite a bit with regards to the first study that we would do in the solid organ transplant setting and kidney transplants, being the number one organ that is transplanted globally, it is clearly a key opportunity, but on top of that, it really is the situation that is in most need of advances in antiviral therapy, because of persistent problems with CMV in these individuals but also that significant impact that BK virus has on the function of the kidney long-term.

So, really there is a couple of different reasons why we’ve selected kidneys as our first studies in the solid organ transplant setting. Number one, the number of procedures that are done and number two, the potential benefits that brinci could potentially bring to patients.

We did discuss the possibility of other studies and we have lots of interest from solid organ transplanters to conduct other studies and we’ll be entertaining those going forward. So, this is the first studies that we were -- that we will be kicking off..

And just with respect to detection of viruses or I guess when you look at just BK and CMV, the endpoints are pretty straightforward but are other double-stranded DNA viruses an issue in the transplant setting?.

Other viruses are an issue. I think the EVV is one of the issue -- one of the viruses that comes top of mind to transplant physicians. These patients are pretty heavily immunosuppressed.

They receive quite a few different immunosuppressive regimens and therefore these patients are at risk for either primary EBV infection with post-transplant lymphoproliferative disorder or even reactivation of EBV in the setting of heavy immunosuppression.

Adenovirus is obviously also a significant concern in solid organ transplant recipients, particularly in recipients of liver and small bowel transplants and this is certainly going to be an area that we’re looking at further. These infections also do occur on an incident basis in kidney transplant recipients as well..

And just a final question. On the renal function endpoint, I mean I realize that these studies are not inferiority, but seems like a tougher hurdle against an active competitor.

Would you guys expect any really -- any real difference here in either one of these studies?.

I think if we demonstrate the types of improvements in kidney function that we saw in the stem cell transplant setting in Phase 2, that pulls through to the renal transplant setting, then we would project that we would see an improvement in GFR at both six months and one year after transplant.

This may be due to our activity against BK virus, it may be due to our activity against the other double-stranded DNA viruses but from a solid organ transplanters’ perspective, improvements in renal function and prolonged survival of the renal allograft are really what’s important..

Got you. Okay, thank you..

Thanks, Geoff..

Thank you. The next question is from Jessica Fye of JPMorgan. Your line is now open..

Hey, guys. Thanks for taking the questions.

Recognizing that you’re expecting brisk enrollment in the kidney studies, I guess how do you think about the differences in one you might complete enrollment and potential readouts for SUSTAIN versus SURPASS, given there are fewer SUSTAIN patients that you need to enroll more of them? And then also, I just want to make sure we understand the regulatory path here.

I think you called SUSTAIN a confirmatory study that would support traditional approval. I guess first, are you leaving open the door for more accelerated approval based on SURPASS alone and what would that data mean to look like and second, if SURPASS is maybe numerically similar to Valcyte, would that mean waiting for SUSTAIN? Thanks..

Thank you. So, with regards to the enrollment period for SUSTAIN and SURPASS, we’re in the process of doing feasibility at the moment. These will be global studies. There will be studies that will be conducted in North America and Europe, potentially in Australia, New Zealand as well. We’re evaluating the opportunities there.

So, with the number of different countries and sites up, we anticipate being able to complete enrollment quickly but we will provide an update with regards to planned periods of enrollment. As we highlighted as far as the duration of therapy is concerned, it’s 100 days in the SURPASS study, 200 days in the D+/R- SUSTAIN study.

And so, we anticipate that the SUSTAIN study being larger and with longer follow-up, we’ll complete slower than SURPASS, the SURPASS will read out earlier.

Depending on what the outcomes of that study are, we could potentially file a supplemental NDA with the SURPASS data prior to having the SUSTAIN data in hand, but the SUSTAIN study is designed as our study in order to support traditional approval for the CMV indication and this is aligned with the fact that it is the SUSTAIN study, the D+ R- population of patients that is the labeled population for Valcyte and thus from a regulatory perspective, supportive of the traditional approval..

Okay, got it.

And then, I guess as we think about the SURPASS hurdle and what data could support maybe filing an approval based on that study, how are you expecting Valcyte to perform in that patient population?.

We’re expecting to see a rate of CMV infection on the order of 10% to 20% in that patient population. The study is designed to demonstrate non-inferiority with regards to the CMV endpoints at the end of study at the six month time point.

If we end up demonstrating improvements in renal function and that would be a clear win for brincidofovir over valganciclovir, which as you know, does not have any activity against BK virus nor does it have activity against the other double-stranded DNA viruses such as EBV that may compromise kidney function in these patients over time..

Got it, thanks. And maybe just one more on those kidney trials.

Can you just talk about your expectations for the cost of those studies?.

I think the cost is really dependent on the country footprint, the number of sites that we end up putting together as far as the studies are concerned. So, I think that we’ll come back to you with estimates of that as we work out the feasibility in the logistics of the final studies..

Got it, thank you..

Thanks, Jess..

Thank you. And the next question is from Katherine Xu of William Blair. Your line is open..

Yeah. Hi. Good morning.

I'm just wondering with the Smallpox Phase 3 rabbits, what kind of endpoints -- can you remind us the endpoints of how you're going to release that data?.

We're going to have Mike Rogers respond on that study..

So, this is Mike Rogers. So the primary endpoint is the mortality endpoint, it's a very large shady, but we look at viral load, mortality and a number of other issues. We expect to see that top line data sometime in the summer..

And with the BARDA contract, is that contingent on this Phase 3 data?.

Sorry. I didn't catch the question..

So, the question was, is the BARDA the potential for stockpiling, is that contingent on the data. And no, it's not contingent on that. There is an expectation that was noted in their notice of intent to obtain brinci for the stockpile. It was anticipated that we would have an FDA approval.

However, BARDA does not require that drug and the Strategic National Stockpile have an FDA approval. It is one of the advantages of brinci that we have a large safety database and that we are moving forward with multiple FDA approvals, but again, it's not necessarily required for stockpiling..

Okay.

And so for the total dollar of last month, 435 million and a max of 1.7 million treatment courses, can we just do the division to see that's the price per course or it's just wrong?.

This is Linda. We're working out what the price would be, so that is something that's in process and when we receive the RFP if we were to continue shortly, we will start working that immediately, but we're certainly evaluating our options at that point..

So, Katherine, just to reiterate Linda's point, it is part of the negotiation after we receive the RFP moving forward..

I guess for the SUSTAIN and SURPASS, primary endpoint is powered for non-inferiority, I guess because the comparator is pretty low, at 10%, 20% infection, so it's pretty hard to show superiority based on the powering, is that fair to say?.

For the CMV primary endpoint, I think that is true and so it is powered as a non-inferiority study with the primary endpoint of CMV, but as Garrett pointed out, with no activity against BK virus and the other double stranded DNA viruses, we believe there is a possibility of showing superiority on some of those key secondary endpoints..

Sure, great. Thank you..

Thanks, Catherine..

Thank you. The next question is from Marc Frahm of Cowen and Company. Your line is open..

Hi, guys. Thanks for taking my question.

On the SUSTAIN and SURPASS trials, can you talk about why you are following for one-year on renal function in SUSTAIN and six months on SURPASS?.

Sure. So as far as SUSTAIN is concerned, that is the design, we're following the design of a study called the IMPACT study which was a study that looked at 100 days of valganciclovir prophylaxis versus 200 days of valganciclovir prophylaxis in the D+/R- population. That study showed that days of prophylaxis was more effective than 100 days.

All the patients in that study were followed out to one year after their surgery. And that is again the indicated population in the Valcyte label. 200 days of prophylaxis with the primary endpoint assessed at one year after surgery. So that's the reason for the follow-up with regards to SUSTAIN.

For SURPASS, which is the R+ population, that is not indicated in the Valcyte label, however treatment guidelines currently recommend 100 days of antiviral prophylaxis in that patient population and the most common studies that have been comforted conducted in the R+ population, again not label, but studies that have been conducted typically enrol patients, treat them with 100 days and follow them up for six months after their surgery..

Okay, thanks.

And then on the Smallpox notice quickly, have you heard of any objections being filed?.

We were not made aware of any protests during the 15 day posting period, no..

Okay, thank you..

Thank you, Marc..

Thank you. And our last question comes from Josh Schimmer of Piper Jaffray. Your line is open..

Thanks for taking the questions.

First on the BARDA contract as part of the -- to the SNS, what are the parameters, frequency or requirements for each opting consideration, do you have any color on what that may look like? What kind of lead time you would get?.

No, we've been given a visibility on that to this point..

Okay.

And for brincidofovir, there is always some discussion about pursuing other indications beyond transplants such as HPV, et cetera, can you give us an update on how you're thinking there, what the stage of development might be?.

We're conducting a number of physician advisory boards to map out next steps as far as brincidofovir is concerned.

We are very excited about kicking off the next stage of clinical development with the kidney transplant studies and we'll get those started in the fall or certainly in the second half of this year and we're evaluating what those next studies could look like with regard to activity against a wide variety of other double stranded DNA viruses..

We're very excited to have a new Head of Medical Affairs joining us very soon and we look forward to having his input onto some of those additional collaborative trials..

Great.

And then maybe one last question or maybe a little bit more philosophical, it seems as though anti-viral development is relatively underserved by the broader biopharma development communities, wondering if you have a sense as to why that maybe, why it does seem to be overlooked, whether it has to do with challenges of developing the drug or whether it has to do with perceived market concerns or some other factor?.

It's a great question, Josh and certainly been an area that all of us here at Chimerix have dedicated our careers to. We do agree with your assessment that that continues to be significantly underserved.

I think given the high probability of success for the compound once they do get into clinical development, you would expect to see more interest in the field, but it is certainly something that we're dedicated to continuing to bring forward anti-virals to meet a lot of unmet needs as you continue to point out there are many additional areas, even for brinci as we continue to carry brinci forward for initial indications and then moving into other trials.

The continued need is why we are bringing forward 669 and the virus lead, we do believe there are significant opportunities to continue to bring good medicines to work for these viral diseases..

Got it, thanks very much..

Thanks very much..

Thank you. And at this time, I'd like to turn the call back over to Michelle Berrey for closing remarks..

Thank you and thank you all for your participation this morning and we look forward to updating you again very soon..

Thank you. Ladies and gentlemen, this concludes today's conference. You may now disconnect. Good day..