Good afternoon, everyone. And welcome to OraSure Technologies’ 2016 Second 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 the questioner can rejoin the queue for further questions. OraSure Technologies issued a press release at approximately 4 PM Easter Time today regarding its 2016 second 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. This call is also available real time on our website and will be archived there for seven days. Alternatively, you can listen to an archive of this call until midnight, August 10, 2016, by calling 855-859-2056 for domestic or 404-537-3406 for international. The access code is 46406766. 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 and 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 Report 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, Rena, and good afternoon, everyone and welcome to our call. We are very pleased to report that our second quarter 2016 results have exceeded our expectations on both the top and bottom lines. Consolidated net revenues for the second quarter of 2016 were $31.4 million, a 3% increase over the same period of 2015. Consolidated net product revenue increased 5% in the period. And these increases resulted primarily from higher infectious disease and molecular collection systems sales. International HIV sales, driven primarily by additional orders for our new OraQuick HIV self-test in Africa, increased 230% from Q2 of 2015. Sales of our OraQuick HCV test increased 37% over the second quarter of 2015. And this increase reflects both higher domestic and international sales. Molecular collection systems revenues rose 4% from the prior year quarter, largely due to higher sales to customers in the commercial genomics market as well as revenue growth from our portfolio of microbiome products. We exceeded our bottom line guidance with $3.8 million in consolidated net income for the quarter. And this represents a $1.9 million improvement from the year-ago quarter. Ron will provide some further detail on our second quarter financial performance along with our guidance for the third. I will then discuss some additional business developments. So with that, let me turn the call over to Ron.

Thanks, Doug, and good afternoon everyone. Let’s start with our revenues. Our second quarter 2016 consolidated net revenues increased 3% to $31.4 million, compared to $30.4 million reported in 2015. Our consolidated net product revenues of $27.6 million increased 5%, largely as a result of higher sales of our OraQuick HCV, OraQuick HIV and molecular collection systems products, partially offset by lower sales of our risk assessment products and the absence of sales of our OraQuick Ebola product during the current quarter. Other revenues were $3.8 million in the current quarter, of which $3.4 million represents the recognition of exclusivity revenue under the AbbVie HCV co-promotion agreement and $417,000 represents revenue associated with Ebola-related funding we received from the Biomedical Advanced Research and Development Authority, or BARDA. Other revenues in the second quarter of 2015 also included $3.4 million of exclusivity revenue from the AbbVie agreement and $714,000 of BARDA funding. Our HCV product revenues increased 37% to $3.2 million in Q2 from $2.3 million in the prior year. International sales of our HCV test in the second quarter of 2016 rose 121% to $1.4 million from $646,000 in the same period last year primarily due to the expansion of our business in Asia and higher sales to a multi-national humanitarian organization. Domestic OraQuick HCV product sales increased 6% in the second quarter of 2016 to $1.8 million from $1.7 million in the prior year period. This continued expansion of our core domestic HCV business resulted from higher sales to current customers who have expanded their testing programs and the addition of new programs primarily in the public health market. In 2015, we began selling our OraQuick Ebola Rapid Antigen test to the CDC for field testing in Africa. Sales of this product contributed $396,000 in product revenues during the…

Okay, thanks, Ron. The highlight for the second quarter was our infectious disease testing business. As you heard from Ron’s overview, revenue growth for the second quarter was largely the result of continued progress in international markets. A primary example of this was the $1.2 million in sales of our new OraQuick HIV self-test into Africa. These tests were purchased by Population Services International, PSI, a leading global health organization. PSI has launched the Self-Testing in Africa or, S-T-A-R, STAR project with support from UNITAID, the World Health Organization and health officials from Malawi, Zambia and Zimbabwe. As noted on prior calls, this is a pilot program being funded by UNITAID designed to deploy approximately 750,000 OraQuick HIV self-tests that we developed specifically for developing markets. PSI has advised us that our test has been well received in the field. Our expectation is that the initial orders from PSI will lead to a much larger, long-term opportunity that is expected to expand into other countries in Africa, in Latin America and Asia. To help ensure the long-term success of this effort, we are pursuing pre-qualification of our HIV self-test by the WHO and we are targeting September for our submission. WHO pre-qualification is important to be eligible for sustainable funding from sources such as the Global Fund, from UNITAID and from PEPFAR. Sales of our self-test to PSI more than offset the decline in our domestic HIV business during the second quarter. When we turn to HCV, the 37% overall increase in product revenues for the second quarter was largely driven by a 121% increase in international sales, compared to the second quarter of 2015. As with our HIV business, we believe the international marketplace is becoming an increasingly important opportunity for our OraQuick HCV test. As recently disclosed, we…

Thank you. [Operator Instructions] And our first question comes from Nicholas Jansen at Raymond James. Your line is now open.

Hi guys. Congrats on the quarter. Just wanted to learn a little bit more about this international HCV announcement this $18 million opportunity, just wanted to kind of get a better sense of how the economics work there both from a sustainability of that revenue stream and the margin profile given the kind of international component to it?

I’ll talk broadly about the deal Nick, we want to give more specifics once all the requirements of the contract have it finally executed are complete, which we would expect in the next 30 days or so, but this is the opportunity that we referenced in our last call. The $18 million in revenue is predominantly HCV revenues. There is some HIV revenue associated with the agreement. The contract cost for all of that revenue to be delivered in the 12 month is contemplated in the agreement and that 12 month period will start, as soon as all these additional activities are completed. Like we highlighted in the call, the agreement has been signed and really all that we are working now right now are finalizing some of the logistics and some of the banking details, letters of credit and the like. So that’s where we are at on the deal. I think we should make a few points here. Number one, this is the culmination of some significant work by our team. And it represents just one of a number of HCV elimination programs that are being planned on a global basis. And we’re engaged with a number of different countries that are planning these types of programs. It’s important to understand this is a12-month commitment and there is as renewal option and so that’s a TBD, but there is an opportunity to extend this. And obviously a third point worth making is that this represents a significant increase in unit volume that we can both accommodate in terms of capacity and we will have the benefit from in terms of over head absorption and future potential material cost savings. So, we are very excited about this. I want to frame it in the context of other opportunities that we’re also pursuing on a global basis, but this is a real big deal for us, and we’re very excited about.

Thanks for all the detail there, and secondly I think you mentioned on the DNA Genotek side of the house a couple of customers who unfortunately went through the bankruptcy progress, when do we start to lap that from a year-over-year perspective so we would get a better sense of when the strong underlying performance will be more showing up on the actual revenue line?

Great question Nick. I think you will have to wait a couple of quarters to get clear of the contributions that were made in the year ago period from these two companies, but we also can share with you that one of them has emerged from Chapter 11 bankruptcy and they are continuing the business. So at some point, we may see contribution from them, but as of the moment we don't have visibility to when that will occur in 2016. So, it is probably safe to carve them out of the balance of the year.

Okay and then my last question would be on domestic HCV obviously, the AbbVie co-promotion agreement terminated, how do we think about the contribution in the short-term, it seems like we are on the decelerating path the last couple of quarters of sequential down domestic HCV revenues just wanted to kind of get your thoughts on when we could potentially see that reaccelerate again, do we have to wait until 2017, when you’ve changed strategies or how do we think about modeling that part? Thank you.

I think the domestic market is going to continue to be an important market for us. As we commented in our prepared remarks, we are seeing new programs start to increase revenues from existing programs, primarily on the public health front and we anticipate that is going to continue. We’re excited about some programs like the southern cities initiative, which is being launched right now in several states down in the South, but there is an eye towards expanding that. After these programs get launched and their our strong support both from the CDC, from other partners in the program to deploy, in particular a rapid test to reach those individuals who may not have ready access to healthcare. So, this is going to help drive domestic growth of our hepatitis C product and of course we continue to deploy this product against the backdrop of a cure for this disease, a significant number of people who don't know that they are infected and pressure on the pharmaceutical manufacturers to diagnose more patients so that they can get more patience on drugs. And so we continue to see increasing interests across the entire industry and diagnosing new patients and getting them into care and cured.

Thanks for the color guys. I’ll hop back in queue.

Thanks Nick.

Thank you. And our next question comes from Brandon Couillard at Jefferies. Your line is now open.

Hi good afternoon it is Sachin in for Brandon.

Hi Sachin, how are you?

Doing well. How should we think about the trajectory of the DNA Genotek in the second half and is there any update on the large new genomic customer you mentioned a few weeks ago and maybe you tell us about the launch timeline, seems like you guys would benefit from initial stocking ahead of formal launch?

I will take the first part of your question first, what do we think about the trajectory of DNA Genotek's business in the back half of the year? It will accelerate. So, we definitely expect an acceleration of their business in Q3 and then a further acceleration in Q4 and we also expect that we will see revenues from this new customer in Q4 and our expectation is that this new customer will have a significant impact to our molecular growth in 2017.

And then today we have not enjoyed any stocking orders related to that new customer.

Got you. In terms of the AbbVie issue, will you quantify the expenses associated with that roll off, I know that there should be some in the back-end any color on it would be very helpful.

We actually haven’t gotten down to that level of granularity, but it’s all built into our guidance for Q3 and will be for Q4.

Got it. Thank you.

Thank you.

Thank you. [Operator Instructions] And our next question comes from Mark Massaro at Canaccord Genuity. Your line is now open.

Hey guys, nice quarter, and thanks for taking my questions.

Hi, Mark.

Hi, Mark.

The first question is for Ron. Ron, can you just clarify that the Q3 guidance for revenue includes the higher uptick in the AbbVie payments, given that they roll off at the end of the year?

It does Mark. I can confirm that, yes.

Okay, great. My second question is related to your project with Ebola. And can you comment if you've initiated clinical trials to pursue the 510(k)?

We have not. And we will let you know when we do that.

Okay. And maybe just at a high level, can you maybe comment on how a 510(k) clearance could potentially accelerate your initiatives in Ebola beyond what you have today?

I think it’s important to appreciate that our Ebola product is being made available around the world under emergency use authorization from the FDA as well as from WHO. And at some point in time, the regulatory bodies encourage manufactures like us to go through the entire process to gain formal regulatory approval 510(k) or PMA depending on the case which happens to be 510(k) process. The BARDA funding that we received for this program contemplates supporting our efforts through the clinical study process to the achievement of 510(k) at which time then we wouldn’t have any future use or need for emergency use authorization of the product. That’s really the background behind our efforts there.

Excellent. And one last one if I can, congratulations on the $18 million deal to come. I imagine it has taken a good amount of time, management time and the like. But I would be curious to know if you've—where you're at. Obviously you have to finish that contract, and then announce that and execute on that. But Doug, you did comment that there could be a similar type contract in other countries around the world. Have you initiated conversations with other global health agencies for a contract similar to this? Or is that just given the secular demand and the need for testing, you're encouraged by it. But are you actually having discussions to do another one?

We have been in discussions with other countries who have similar programs. I wouldn’t say they are of this magnitude, but the objective is the same. Let’s go back to an appreciation of HCV infection. The estimates are there is a 170 million or 180 million people infected around the world, about 5 million or so are here in the United States. So the vast majority of Hepatitis C infection is outside of our country. And now with a cure available, these countries are realizing the opportunity they have to reduce the global health burden as well as the economic burden that comes along with later stage chronic Hepatitis C infection. So this is really what’s driving this. And WHO is behind it and very supportive, the U.S. government is very supportive. And I think we are going to see more of these kinds of opportunities, we are certainly pursing them and I expect that they there going to opportunities for the long term.

Terrific. Good work.

Thank you.

Thank you. [Operator Instructions] Our next question comes from Eric Criscuolo at Mizuho. Your line is now open.

Hey. Good afternoon. Thanks for taking the question. Ron, I guess on the gross margin, slightly weaker this quarter. And I know you had mentioned mix. Can you maybe just call out which products in particular were pulling down on that mix?

Yeah, so thanks. Thanks for the question Eric. The HIV self test in Africa is at a lower gross margin than our typical corporate average, which was a bit of a drag on our margin profile versus the year-ago quarter.

Okay, great. So that would be the vast majority of the mix that you talked about.

Right. Yes.

Okay, great. Thanks. And then just on the operating expenses in the second half of the year, with the AbbVie co-promote going away, are there still incremental expenses that are going to roll off in the second half? Or have they already been kind of taken out in the second quarter?

No, we still have some expenses excise out of the business, which we will do over the course of the balance of the year. But being mindful that we have an obligation to fulfil under the contract that we have with AbbVie and [indiscernible] absolutely fulfil our obligation that they are under.

Understood. Thank you. And lastly, just on the guidance for I guess 3Q and then implied into 4Q, the accelerated AbbVie co-promote, you're looking for about $6 million in 3Q and 4Q for that line item. Is that correct?

That’s right. The actual exclusivity that we will record in both Q3 and Q4 will approximate $6.1 million per quarter. Just to be perfectly clear.

Okay, great. That helps a lot. Thank you very much, guys.

You are welcome, Eric.

Thank you. And that brings an end to the Q&A session of today’s call. I will turn the call back over to Doug Michels for closing remarks.

Okay. Thanks, everybody, for begin on the call this afternoon. We look forward to keeping you posted on the developments here at OraSure and look forward to talking to you in a few months. Have a great evening.

Ladies and gentlemen, thank you for your participation in today’s conference. This does conclude the program and you may now disconnect. Everyone have a great day.