Good afternoon, everyone and welcome to OraSure Technologies’ 2017 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 a questioner can rejoin the queue for further questions. OraSure Technologies issued a press release at approximately 4 PM Eastern Standard Time today regarding its 2017 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 could 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, 2016, 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 this forward-looking statements to reflect events or circumstances after this call. With that, I would like to turn the call over to Doug Michels.

Okay, thank you Jonnie and good afternoon everyone and welcome to our call. It's certainly a pleasure to report that we had an exceptional second quarter. As you can see from our earnings release we exceeded our published financial guidance and consensus analyst estimates on both the top and bottom lines by a fairly wide margin. I am delighted with our performance. Our message to investors since the end of last year has been that OraSure is in the early stages of several market opportunities and is well positioned to capitalize on them. Our second quarter performance shows that we're doing just that. Many of the countries and customers we serve have only just begun executing on their goals and objectives and there are many more businesses and countries with which we currently do not transact business and we think many of these potential customers could benefit from our products. For this reason we still believe we are in the early stages of our growth potential. Demand for our molecular collection kits has been extraordinary, primarily because of the growth in the personalized medicine market. Our HCV business continues to perform very well especially in international markets in support of broad based testing and treatment programs. We are very confident and enthusiastic about the growth of the OraQuick HIV self-test after receipt of WHO prequalification, our new agreement with the Gates Foundation, and the announced expansion of the self-testing in Africa or STAR Project. And we are making strategic investments to substantially expand manufacturing capacity in anticipation of continued strong demand for our products. In short, our recent performance demonstrates that we are successfully executing on our strategic growth objectives for both the infectious disease and our molecular businesses. So turning to the quarter, our consolidated net revenues grew 28% compared to the year ago period and topped $40 million for the first time. Product revenue growth was 42%. Our molecular business delivered another record performances, second quarter revenues reached $16 million. This is almost double the revenue generated in Q2 of last year and is by far the best quarter ever for this business. Our infectious disease business also performed extremely well with 29% revenue growth from the year ago period. Significant increases in international and domestic sales of our HCV product were the primary growth drivers here. And on the bottom line our consolidated net income also improved nicely from the year ago quarter and we ended the quarter with over $160 million in cash and cash equivalents. In short our second quarter results were outstanding and as Ron will explain we expect this trend to continue as we are projecting similar performance for Q3. So with that brief introduction let me turn the call over to Ron for his detailed financial review, and I will then provide some business updates after which we'll take your questions. So Ron?

Thanks Doug and good afternoon everyone. As you can see in our press release 2017 continues to be a very successful year. Our second quarter consolidated net revenues increased 28% to 40.2 million compared to 31.4 million reported in the second quarter of 2016. Notably our consolidated net product revenues rose 42% to 39.1 million compared to the prior year period. Higher sales of our molecular products and our OraQuick HCV product were the primary drivers of this performance. Our molecular revenues rose 90% to 16.1 million in the second quarter of 2017 compared to 8.4 million in the second quarter of 2016. Sales of our Oragene product to commercial customers increased 122% largely due to higher customer demand. Academic sales increased 2% largely due to customer ordering patterns. Our international sales of the HCV test in the second quarter of 2017 rose 268% to 5.3 million from 1.4 million in the same period of 2016 primarily due to the continued shipment of product to a foreign government pursuant to a previously announced countrywide elimination program. Domestic OraQuick HCV product sales increased 33% in the second quarter of 2017 to 2.4 million from 1.8 million in the prior year period primarily due to business growth and customer ordering patterns. Domestic professional HIV sales decreased 16% to 5 million in the second quarter of 2017 compared to 5.9 million in the second quarter of 2016 as a result of customer ordering patterns and competition from other products. It should be noted though that while domestic HCV sales were down compared to the prior year period, second quarter 2017 domestic HIV sales increased 30% sequentially over the first quarter of 2017. Other revenues were a million dollars in the current quarter representing funding we received from BARDA for our Rapid Ebola and…

Okay, thank you Ron and I'll now walk you through some of the progress we're making in our various businesses. As noted in the infectious disease area international product sales and domestic sales of our OraQuick HCV test continued to be the primary growth drivers. The largest contribution in the second quarter came from international sales growth primarily in support of large scale Hepatitis C testing programs including in particular the country elimination initiative and related government supply agreement we previously highlighted. Our execution against this contract has gone very well. During the second quarter we shipped over 1 million Hepatitis C tests under this agreement and we anticipate continued strong demand from this customer. As previously discussed, this customer has the option to renew the contract and purchase up to 100% of the original quantities of product on the same terms and conditions as provided in the original contract. Discussions around a renewal are progressing well with conversations occurring on specific volumes and the timing of future shipments. Assuming the successful conclusion of these discussions, we expect future volumes will exceed those shipped under the original contract. Negotiations regarding this expanded supply arrangement should be completed during the third quarter. Apart from this government customer, both the level of interest in HCV testing and treatment programs remain strong. We previously mentioned that we fulfill the initial orders from two other countries that have initiated broad HCV testing programs. We anticipate additional orders from these countries later this year depending of course on continued funding which in turn will impact the ability of these countries to add the needed infrastructure and define the ultimate scope of their programs. We previously reported that the WHO has announced its goal of eliminating Hepatitis C by the year 2030. The list of countries…

[Operator Instructions]. Our first question comes from the line of Brandon Couillard of Jefferies. Your line is open.

Thanks, good afternoon. Doug following the Gates Foundation announcement and WHO pre-qualifications, I am curious how the conversations have changed since that time and if we look longer term what do you think it's a reasonable expectation for the percentage of the 100 million or so Rapid HIV test, do you think you could ultimately I guess convert to self-testing?

Yes, thanks for the questions Brandon. So, I'll answer both those questions. The first one is how the landscape changed. We just got back from the International AIDS Conference in Paris last week. I haven't seen the level of enthusiasm and excitement around the OraSure booth like we saw last week since more than a decade ago when the OraQuick test was first approved. We were swapped with interested countries and interested programs in our HIV self-test. Certainly the prequalification was a big driver for that because that enables now these country governments to use their public funding whether that's from the Global Fund or PEPFAR to now buy the product and to incorporate that into their country plans. Second, the announcement by UNITAID and PSI of the second phase of the STAR Program which we anticipated was going to include the provision for 2 million test was actually announced for 4 million tests. So that was an epic huge positive for us and obviously that expanded the STAR Program from the three countries Malawi, Zambia, and Zimbabwe to six countries adding South Africa, Lesotho, and Swaziland. So that 4 million test is still just going to six countries and there's 40 countries as of July this year that have policies there in support of HIV self-testing, that's up from 16 countries that had policies supporting self-testing just one year ago. So that should give you some indication of the enthusiasm for self-testing just over the last year. And now there's 48 additional countries that are planning to introduce HIV self-testing policies, a third of which intend to have those completed by the end of 2018. So, the enthusiasm at this conference where all the international players in HIV were in attendance was palpable. And we are certainly leading the…

That is very helpful, thank you. One for Ron, any chance you could perhaps parse out the contribution in two areas; number one, from the $18 million contract in infectious disease and then number two, the $20 million contract within DNA Genotek in the second quarter?

Yeah, certainly we can look at the contribution from the countrywide elimination program and that's probably in the neighborhood of a little over 4 million for HCV in the quarter Brandon. As far as the contribution from the $20 million contract value, I am reticent to give that kind of granularity on that particular contract award out of deference to our customer.

Understood, super, thank you.

Yeah.

Thank you. Our next question comes from Drew Jones of Stephens Incorporated. Your line is open.

Thanks, congrats guys. Trying to think about the molecular collection growth another way, last quarter I think you guys called out 17 of your top 20 customers were up year-over-year, do you have a similar stat for this quarter or was it really heavily dependent on a handful of those commercial customers?

We followed a very similar pattern to the first quarter. The majority of our top customers showed quarter-on-quarter growth and seeing this kind of performance two strong quarters in a row really suggest the strong momentum that we have in our molecular business. As Ron mentioned we delivered revenues against that $20 million contract but some of our newest customers with bold plans delivered in the quarter as well, the Helix, WeGene [indiscernible] along with other. So we have great momentum in this business and that's on a commercial front. We also mentioned our microbiome business grew nicely delivering over $800,000 in revenues in the quarter up from slightly over $200,000 in the second quarter of 2016. So good momentum across the Board and we expect it to continue.

And then last one from me, if I go back to last summer it seemed like you guys had a high degree of confidence in finalization of the large HCV elimination program before you had the contract in hand. Your commentary today sounds like we're approaching kind of similar levels of confidence when we look out to what this could contribute to 2018, is that fair to say?

I think to be honest we're probably more confident at this point in time than we were a year ago only because now we have that experience with this customer. We know that the product is being deployed and deployed successfully. We know that they're identifying positive individuals and getting them on treatment. And we know that that they've got a aggressive goal to eliminate Hepatitis C by 2025. And we know also that they need to ramp up their testing if they are to reach the number of individuals that are affected in the country to achieve that goal. So we've had as we mentioned in our prepared remarks very positive and productive discussions. It's not done until it's done but we're talking specifics about volumes, delivery dates, and the like. And like we said we expect -- we believe it will be successfully completed. We would expect that that would happen in Q3 here and as soon as that happens we'll report on it. We also indicated that we do expect that it will likely be for a higher volume commitment than the initial term, exciting.

Thanks guys.

Thank you. Our next question comes from Nicholas Jansen of Raymond James & Associates. Your line is open.

Hey guys, congrats on a really strong quarter. Two questions from me, first I think on Amazon’s Prime Day last month 23andMe DNA collection device or a platform was one of their top selling, some of them -- one of the top selling things on Prime Day so it’s certainly a very strong performance as we think about demand for Genomic testing. So just wanted to get a better sense of how we think about not only that customer but your other large customers that are just ramping up, what level of visibility do you have beyond let’s say three months or so in terms of their purchasing patterns, so I get 2Q is very strong, 3Q is going to be even stronger but beyond 3Q what's the level of visibility that we see on some of these larger customers that are just now launching quite aggressive programs to reach out to consumers? Thanks.

You know we worked very closely with them and enter into agreements with them that are usually at least a year and oftentimes multi-year types of contracts for certain volumes of product, at certain prices. And then generally they provide us rolling 12 month forecast with usually the most current 90 days being a firm commitment. We're seeing across the board a high level of interest in these kind of DTC personalized medicine kinds of offerings. We did see that enthusiasm on Amazon Prime Day for 23andMe’s offering. We talked to 23andMe about that. They're very excited about that. I think to get more color on that you probably should talk to them about just what that represented. But, there's a heck of a lot of enthusiasm around this. We expect it's going to continue and then of course with new businesses like Helix's of the world they're creating something new. And so in these early stages we're both doing the best we can to forecast and project and we're going to continue to work very closely with our customers to anticipate demand. Obviously we're investing in the capacity to serve what we expect is going to be significant increase in demand over the future periods.

That is very helpful. And then my second question just would be on the update of STAR Phase 2, pilot 2. I think you said 4Q is when we will see some purchases towards that 4 million or so volume, any sense of how we should be thinking about the cadence of that over the next 12 to 18 months beyond 4Q, certainly it can be a pretty solid contributor to next year's growth? Thanks.

Yeah, we expect it will be a solid contributor to future growth. I think we'll have better visibility as to the cadence in future periods. Remember UNITAID and PSI just announced that this new grant was funded and just announced an increase in the volume of this new grant from what was expected 2 million units to 4. So, the timing on that is going to have to be worked out with the countries. But, certainly represents a nice opportunity for us. And we do expect that there will be programs funded respectively by the Global Fund and PEPFAR, this according to WHO and those will likely be announced in the months to come.

Thank guys, I will leave it at two. Congrats again.

Thank you.

The next question comes from David Westenberg of CL King. Your line is open.

Hey guys, thanks for taking the question. So just a quick one on the DNA Genotek business, was there any usual or unusual large or one time orders that you don't normally see in the quarter or you expect in this quarter?

No, they were not Dave.

Great, alright, so thank you. And then in terms of the $20 million deal that you signed in the DNA Genotek business, if this deal -- I know it's for a little bit more than a year, if things go say beyond projections, does this have a chance to be shortened or is it just kind of a new deal, I mean how does that structure look?

Well, so there's a contract period that we anticipate that $20 million of product will be purchased over. Certainly if business ramps faster than anticipated we will exhaust that 20 million and we will get into a position where we will begin to discuss the renewal and expansion of that.

Perfect, and then in terms of domestic both HCV and HIV, do you have any estimates in terms of percent of the population that they know, that have those respective disease and has it changed rapidly now that there is obviously a cure for HCV and pretty much antiviral therapies, or almost a cure for HIV?

Yeah, so I will speak to both of the conditions. So there's estimated somewhere around 1.2 million to 1.4 million individuals infected with HIV here in the United States. Estimated somewhere in the neighborhood of 12% to 14% of those are unaware of their infection. That's down from more than a decade ago when approximately 30% of individuals infected were unaware. So there's been good progress in diagnosing infected individuals here in the United States. There's still ways to go but good progress has been made. On the Hepatitis C front it is estimated there's around 4 million Americans infected with Hepatitis C and it's believed that more than 50% of those are unaware of their infection. So this represents obviously still a very large market opportunity and it is supported of course by the CDC's testing recommendations that all baby boomers get tested for Hepatitis C as well as individuals at risk. So we think in both cases there's a big opportunity. Certainly with Hepatitis C the fact that people can be cured is a real benefit and the fact that most of the chronic Hepatitis C infection is within the baby boomer population they've been infected for a long period of time. They're now presenting with later stage liver disease, fibrosis, cirrhosis, and liver cancer. So there's an incentive by all providers and the government to identify these individuals and get them on treatment and cured so as to reduce the morbidity and mortality costs associated with later stage liver disease. So those are the factors that are really playing into our hand here in the domestic market. Certainly on the global front the opportunities we've talked about both with HIV self-testing and Hepatitis C with the availability of generic drugs really makes the case even more compelling for these governments to implement broad based screening programs so that they can cure the large number of people that are infected worldwide. There's over 170 million people believed to be infected with Hepatitis C on a global basis. So this is a huge market with most of those individuals unaware of their infection.

Great, thank you guys and congrats on another very, very strong quarter.

Thank you.

Thank you. [Operator Instructions]. Our next question comes from Mark Massaro of Canaccord Genuity. Your line is open.

Hi, it's Max on for Mark. Congrats on the great quarter. How many countries are you in dialog with for the HIV self-test and how many for HepC and have you seen any new countries coming to table in the recent weeks or months and how should we think about these, are they large or small countries?

So I can tell you on -- I don't have the compilation from last week's meeting in Paris but, I can tell you on the HIV self-testing front its way more than 20 countries that we are in discussions with. And as I mentioned as part of my comments, 40 countries have policies supporting HIV self-testing as we speak. And so we know who those are and obviously we're reaching out to them. We've also as I mentioned reached out to the 50 countries that would be eligible for pricing subsidy under the Gates agreement. And we've had a good response from our communications with those countries. And to your point, indeed there are some new players that we’ve engaged with primarily as a result of our WHO prequalification. Because some of these countries have a policy that in essence prohibits their use of any product until such as prequalified by WHO. On the Hepatitis C front we're actively engaged with these several countries that we talked about and believe we will purchase product before the end of this year and some volume. And then there's at least a half a dozen other countries that we are in discussions with as they begin to consider and plan for expanded Hepatitis C testing. So that's a very exciting, very big opportunity as we spoke about as well.

Great, thank you. And one more, can you generally characterize the M&A environment, is there anything heating up relative to your prior quarter with Phil Jensen [ph], is there any appetite to maybe repurchase stock over the next year or so?

So Max we been looking at a great number of opportunities out there in the M&A space and business development area whether it be for outright acquisition, licensing, partnering transactions, and competition for quality assets is high. And sometimes valuation expectations are occasionally unrealistic. But we continue to go down that path and are committed to it. Thank you.

Great, thanks. Congrats on a great quarter.

Okay, thanks Max.

Thank you. This brings us to an end the Q&A session of today’s call. I’ll now turn the call over to Doug Michaels for closing remarks.

Okay, thanks everybody for joining us this afternoon -- this evening. Look forward to delivering another great quarter in Q3 and discussing our performance in a few months. Have a great rest of the summer.

Ladies and gentlemen, thank you for your participation in today's conference. You may disconnect and have a wonderful day.