Good afternoon, everyone. And welcome to OraSure Technologies’ 2016 Fourth Quarter Financial Results Conference Call and simultaneous webcast. As a reminder, today's conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer period. [Operator Instructions] To allow time for as many questions as possible, questioners are asked to limit themselves to only a single question with no more than one follow-up question related to the same topic. Once the follow-up is completed a questioner can rejoin the queue for further questions. OraSure Technologies issued a press release at approximately 4 PM Easter Time today regarding its 2016 fourth quarter financial results and certain other matters. The press release is available on our website at www.orasure.com or by calling 610-882-1820. If you go to our website, the press release can be found by opening the Investor Relations page and clicking on the link for press releases. With us today are Doug Michels, President and Chief Executive Officer; and Ron Spair, Chief Operating Officer and Chief Financial Officer. Doug and Ron will begin with opening statements which will be followed with a question-and-answer session. Before I turn the call over to Doug, you should know that this call may contain certain forward-looking statements, including statements with respect to revenues, expenses, profitability, earnings or loss per share and other financial performance, product development performance, shipments and markets, business plans, regulatory filings and approvals, expectations and strategies. Actual results could be significantly different. Factors that could affect results are discussed more fully in the company's SEC filings including its registration statements, its Annual Report on Form 10-K for the year-ended December 31, 2015, its quarterly reports on Form 10-Q and its other SEC filings. Although forward-looking statements help to provide complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely information available to management as of today. The company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call. With that, I would like to turn the call over to Doug Michels.

Thank you very much, Rena. And good afternoon, everyone and welcome to our call. I'm very pleased to report that the company had a terrific fourth quarter. Our financial performance exceeded expectations and we delivered record revenues and earnings for both the fourth quarter and the full 2016. We also moved forward on all of our strategic initiatives which will be key to continuing our growth in 2017 and beyond. We presented our new strategy at our analyst day at the NASDAQ market site in New York City in late November and I am very pleased with the progress we've made this quarter. Later in today's call, we'll provide an update on each of the initiatives outlined at our analyst day. But before that, we will provide a detailed financial review of the quarter and we will also take your questions. So with that, let me turn the call over to Ron for his review of our financials.

Okay. Thanks, Doug, and good afternoon, everyone. Our fourth quarter of 2016 consolidated net revenues increased 10% to $35.5 million, compared to $32.4 million reported in the fourth quarter of 2015. Our consolidated net product revenues is $28.6 million, approximated those in the prior year period. Higher international sales of our OraQuick HIV and HCV products, along with higher sales of our molecular collection systems product were largely offset by a decline in domestic sales of our OraQuick HIV and HCV product and lower sales of our OraQuick Ebola in-home HIV test. Other revenues were $6.9 million in the current quarter, of which $6.1 million represents the recognition of exclusivity revenue under the AbbVie HCV co-promotion agreement and $747,000 represents funding we received from Florida related to our Rapid, Ebola and Zika products. Other revenues in the fourth quarter of 2015 included $3.4 million of exclusivity revenue from AbbVie and 319,000 of BARDA funding. International sales of our HCV test in the fourth quarter of 2016 rose 123% to $2.9 million from $1.3 million in the same period of 2015, primarily due to the first shipments of products to [indiscernible] as well as the continued expansion of our business in Asia. Domestic OraQuick HCV product sales increased 18% in the fourth quarter of 2016 to $2.2 million from $2.7 million in the prior year period, primarily due to the inclusion last year of a $1.3 million order for US government HCV testing program which did not repeat in 2016. This was partially offset by an increase in both the number and size of direct orders placed by public health and other customers during the current quarter. International sales of our HCV products increased 217% to - $1.3 [ph] million in the fourth quarter of 2016, compared to 415,000 in the…

Okay. Thank you, Ron. During our analyst day in November we describe the focus of our long-term strategy, as growing our business in two key areas, which we refer to as our growth pillars. The first pillar is our infectious disease business, which includes our HCV, our HIV self-test, our Ebola, our Zika and our TB program. The second pillar is our molecular business, which consists of our personal genomics and microbiome products. Let me first comment on the infectious disease business. The strong growth that we are realizing and that we expect in our international HCV businesses is attributable to countrywide or large scale HCV elimination or testing programs. Last year, we entered into a supply contract with a foreign government for $80 million worth of both HCV and HIV products. The majority of this contract is for our OraQuick HCV test to support a nationwide HCV testing and treatment program. Initial shipments occurred in the fourth quarter and these will continue throughout 2017. This is the largest product supply contract in our company's history. And we believe it is just the beginning for these types of opportunities. At the analyst day we indicated that we are working with other countries that are initiating large scale HCV testing programs. As a result of these efforts, we recently received a large order for both HCV and HIV test from one of those countries. Some initial smaller purchases were also made by another country, which is typical as a precursor to initiating a larger scale HCV testing program. The list of countries evaluating broad testing programs is growing and we believe that additional significant opportunities will emerge over time. While our international HCV business has stolen the spotlight lately, we are equally optimistic about growth opportunities in the domestic market. We…

Certainly. [Operator Instructions] And our first question comes from the line of Brandon Couillard with Jefferies. Your line is now open.

Thanks, good afternoon. I guess, Doug, question for you, with respect to the HCV countrywide testing program, you mentioned you received another large order from another country and [indiscernible] chance you could give us some sense of a magnitude of that program and when you expect to begin initial shipments? And then, one for you Doug on the same topic, how much revenue contribution is baked in from the $18 million order in the first quarter revenue guidance?

I'll let Ron speak to the guidance question. Let me comment, you know, I guess more broadly on the HCV elimination program effort and what we're doing there. I mean, you know, it’s extremely exciting, the level of interest that we're seeing in the HCV product and in its utility in these elimination programs. We mentioned in the prepared remarks that we shipped into you know, the large order that we received in 2016. We made shipments in the fourth quarter and we'll be shipping against that throughout 2017. During the analyst day we also highlighted several additional countries that were in various stages of either evaluating a product or elimination programs or that were planning to deploy and there are various stages - various stages of development. One of them has placed a significant order for delivery in the first quarter, we fulfilled most of that already. We do expect there will be additional orders from this second country and they are - they are significant. They are not to the level of - the first country that we spoke about, but they are going to be meaningful in future periods. I want to also emphasize that we said we're engaged with several other countries and one of the additional countries has made a public statement, it says they intend to eliminate HCV from their country by 2020. They have planned a pilot that's going to begin in the first quarter with a local drug supplier and assuming that pilot successful which we have every reason to believe it will, there are going to be another - we would expect there will be another elimination programs that will likely begin in Q2 or Q3 with volume and we have several other discussions ongoing with additional countries. So you know, this is going to be an ongoing, their developing effort, but it's going to be a meaningful contributor to our revenues and revenue growth in 2017 and beyond.

And coming back to the second part of your question, Brandon, regarding the contribution from that large contract in the first quarter, our expectations are that we'll record approximately $2.9 million worth of revenue split between primarily HCV, but some component of HIV tests in the first quarter of 2017.

That’s helpful. And then on the DNA Genotek business, any chance you could help us understand what the growth of that segment would addend if you kind of back out the two customers that went bankrupt and when do we begin to normalize or lap the headwinds from the dynamic?

Yes, that’s a great question. I don’t have that metric on top of my head here. Let me see what I could do to derive something and come back to you on that, either on the call here or after the fact. But you know, suffice to say that the contributions from those two companies that went out of business were significant for 2016 and we are, as I think we mentioned previously expecting that one of them will be back as a customer in 2017, having emerged from bankruptcy, but the other did go into liquidation and our expectation is that they will not be a customer for DNA Genotek in 2017. I'll come back with things I can on the other components.

Thanks. I'll hop back in the queue. I appreciate it.

And our next question comes from the line of Andrew Cooper with Raymond James. Your line is now open.

Hey, guys. Thanks for taking the question. Starting I guess with DNA Genotek again, can you give us any color to help frame the ancestry royalty opportunity and what that could be over time as they continue to grow that business?

Yes, so unfortunately we're precluded from giving detail on either the ancestry - on either the royalty rate or the expected volumes, the proprietary and covered under confidentiality of the agreement, expected royalties would begin in 2018, pursuant to the settlement agreement.

Okay, thanks. And just one more from me then, as we look at HIV, it looks like the core domestic market still continue to trend downward, just wanted to get your thoughts on where you think the floor might be or what you might expect for 2017 in that market in terms of any potential rebound?

Yes. So thanks for that question. So we would expect – we're going to continue to pay some headwinds in the domestic HIV market in 2017. Although I think that the client is going to moderate somewhat year-on-year. I want to emphasize that any decline in that business is going to be more than offset by international growth and we expect the total HCV business in 2017 to grow in strong single digits and perhaps even higher growth rate than that. I think it's also important to understand that that in addition to some of the comments were made in our prepared remarks, that total testing for HIV is down in the markets that we serve here in the United States and obviously being the market leader in rapid HIV testing here the US were disproportionately impacted when testing volumes decrease, reasons that I think are well-known, funding spent been decreased the number of undiagnosed individuals continues to go down which was a good thing, not necessarily for testing company like us, but this is data from that we get from the National Association of State and Territorial or AIDS [ph] directors in their 2016 report, that said the total volume - total HIV testing volume is down 16% from 2011 to 2014. So these are some of the factors that have impacted us and it's actually one of the key reasons why we pivoted to the significant opportunities we have outside the United States to not only make up for some of the decline we're seeing domestically, but to really get this business back on a growth track. And that's what we're beginning to see and that’s we're going to see in 20 17 and beyond.

Great. Thanks. I'll hop back in the queue.

Yes. So just in the meantime while we're waiting for the next question, Brandon to follow up on your question regarding the contribution from the two labs that has [indiscernible] last year, we did not record any revenues in 2016 from either one them. And so those comps should be clean for 2017 going forward. And the magnitude is they are collective purchases in 2015 was north of $2 million, collectively. So you can pro forma that out and you see that the DNA Genotek business in total grew in a very strong double-digits on a pro forma basis with those two customers taken out of the equation, near 20%.

And our next question comes from the line of Mark Massaro with Canaccord Genuity. Your line is now open.

Hey, guys, congratulations and thanks for taking the question.

Hi, Mark.

The first question is on the BARDA funding, I think the total BARDA funding, I believe that you been awarded to 16.6 million, so may be the first question is, how much funding is embedded in your Q1 '17 guidance?

So just to step back, the total BARDA funding to date its been awarded is approximately $27 million and that split between the Ebola of little over 10, with the balance being for Zika. And so we're executing against those contracts for our first quarter I will say it’s approximately to $1 million worth of BARDA funding for the first quarter that we had in our guidance and for the year our expectations are in and around the $5 million mark.

Okay. My second question is on the regene [ph] is there anyway that you could size the opportunity you are - you maybe discussed the agreement even at a high level, is there any - one is it exclusive and two, are there any minimums or can you discuss maybe size of the contract?

I'd love to, unfortunately precluded from a dimensionalizing that by our contract with regene, it is a multiyear agreement and the revenues are significant. I would also say that while we frame those in our contractual relationship, and there's a commitment there. How quickly this ramp is a PVD right, their goal is to help always and better understand and benefit from their genetic information, they are going to be providing both health reports, plus they are the first and only ancestry service in China right now. And so they're well-positioned to capitalize on these opportunities just like other commercial entities here in the United States have capitalized on these opportunities in a huge market. So we're very excited about regene selecting our technology. I think it again reinforces what we know from other experiences that our customers value the quality and integrity of our product is the fact that we collect a large volume of DNA, high quality DNA and obviously like other recent settlement highlights people know that we've got a strong proprietary position, intellectual property and we're going to defend that. So we're excited about that. I'll just say also, Regen's just won a bunch of opportunities, that relationship with Luigi [ph] Lugi next code, our academic business is growing we captured some nice new accounts on the academic front, which we highlighted some of those, at least described the businesses there and we're also working to develop the academic channel in China right now, which we believe can be significant. So lots of opportunities across the molecular collections business.

Excellent. And If I can sneak one last one in, on Helix, my understanding is that they're targeting a full-blown launch around the summer of '17, are you seeing any – do you even have visibility on any ordering ahead of the launch just for maybe new genomics companies that are potentially validating you know that their test ahead of the consumer launch?

I think you're probably reading some of the same materials that we have access to and that’s what we see. We're in close communications with Helix on their plans. We have a plan for 2017. I really can't tell you the dimension of that, but the Helix feel that we have with them is a multiyear, its multimillion dollar contract and like I tried to emphasize in the prepared remarks, they have a very different business model than anything that’s out there in the marketplace right now and as they add these new partners in different market segments they are going represent new consumers that are all going to need to be sequenced and with each one of those comes opportunity for OraSure. So we're going to grow with Helix and looking forward to supporting their growth initiatives.

Great. Thank you.

You're welcome.

Thanks, Mark.

[Operator Instructions] And our next question comes from the line of David [indiscernible] with C.L. King. Your line is now open.

Hey, guys, congrats on the good quarter.

Thank you, David.

Thanks, Dave.

So you've talked about the three countries in HCV elimination pilot programs, and you talked about behind that you have a number of countries that you are in discussion with, can you talk about the process and sort of the timing of moving a country from discussion into a more formal pilot kind of program?

Yeah, I wish there was a defined process. I think if you know one, you know one, because each one is going to be different, lot's going to depend on what they've done in hepatitis C historically, what their testing programs that looked like, what kind of infrastructure they have in place both on the laboratory or in the public health front. Do they have a process for managing a patient from this point of initial screening through confirmation and linking that at patient to treatment because this is all about eliminating hepatitis C. So the screening is up at the front end. One of the valuable advantages that we have in this space is that generally speaking, we've been working with these ministries, these ministers of health in HIV, or in some early stages of hepatitis C and so we're able now because our technology has been chosen for some of these lead countries, we're in a position to be able to advise and consult with these countries and to help them navigate through this process. It doesn't happen overnight, okay, so it is generally months and often times the countries they don’t want to do a pilot program in a city or region or with different population, once again it really depends on the state of the academic or prevalence of the disease in their country and what kind of infrastructure they have in place to roll these things out. Ultimately too it’s going to depend on funding and sometimes they may develop the greatest plan and then they've to work with their government officials to identify the funding. It’s going to be available to execute on those plans and they may start out slowly and then increase funding as they realize, more success. So I wish I had a cookie cutter answer for you, I don't, but I hope you can tell from my response that we understand how to work through this process and I think our expertise is to continue to grow, we'll be able to accelerate the process wherever it’s possible.

Well, that was actually very helpful. So there appears to be some competitive shifts or maybe some price undercutting in that HCV market domestically, what might some of the impacts be if it's just - there is some of that an increased pricing competition that’s coming in and coming in actually a lot stronger than Gilead might have thought initially?

So actually you're talking on the therapeutic front, Dave?

On the therapeutic front, yes

Yeah, so you know, as certainly when AbbVie entered the market they introduced pricing lower than Gilead. I know that Gilead largely matched their pricing less or more. I know through negotiation all the different drug companies also enter into other discount programs with large purchases. I don't have privy to what that looks like, but I am aware that that those kind of arrangements exist. I think the reality is, is prices have absolutely come down for a cure here in the United States and they come down dramatically outside the United States as Gilead, you know, in essence license the number of different generic manufacturers in the developing markets and that's what's really fueling this interesting countrywide elimination programs because now they actually can cure someone who's been in fact [ph] for less than $1000 and as a little as 8 to 12 weeks. So they can identify the patients, they can get him on drug and its going to be well tolerated and its going to lead to a cure, its great stuff.

And that brings to an end of question-and-answer session of today's call. I would now turn the call over to Doug Michels for closing remarks.

Okay. I just want to thank everybody for coming on the call this afternoon, this evening, as you can say we're very excited about the position we're in, we're looking forward to delivering a really terrific 2017 start with the first quarter and we look forward to getting back together with you in a few months and talking about our progress. Thanks again everybody.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone have a great day.+