Good afternoon, everyone, and welcome to OraSure Technologies’ 2014 Full Year and 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. [Operator Instructions] OraSure Technologies issued a press release at approximately 4:00 PM Eastern Time today regarding its 2014 full year and 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. This call is also available real-time on our website and will be archived there for seven days. Alternatively, you can listen to an archived recording of this call until midnight February 11, 2015, by calling 855-859-2056 for domestic or 404-537-3406 for international. The access code is 63824420. 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 remarks, 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 and other matters. 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, 2013, 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 may not be reliable. The company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call. With that, I’d like to turn the call over to Doug Michels.

Okay, thanks Rena and good afternoon everyone, and welcome to our call. We had a very active fourth quarter, advancing our HCV rapid testing program, our molecular testing business in our Ebola development program. The company’s fourth quarter results exceeded our guidance on the top line and fell within our guidance for the bottom line. Overall, 2014 was a very successful year. We had several noteworthy accomplishments, we delivered solid financial performance and we advanced many programs that we expect to drive our future results. Some highlights, for the first time in our history, annual revenues exceeded $100 million. Our molecular collection system business delivered strong growth in 2014 and ended the year up 17% over the prior year and this increasingly important part of our business now accounts for over 20% of our annual consolidated net revenues. We entered into an important HCV copromotion agreement with AbbVie last year and we believe this was a first of a kind collaboration between a diagnostic company and pharmaceutical company and provides us with a significant opportunity to realize the full value of our rapid hepatitis C test and to accelerate the growth of our HCV business. Our OraQuick HCV test continued to gain momentum with 2014 product sales of $7.3 million. This represents a 42% increase over 2013. And these revenues coupled with the exclusivity payments received from AbbVie resulted in total HCV-related revenues of $14.8 million in 2014. During the year, we also instituted a new promotional strategy for our OraQuick in-home HIV test, which is designed to bring this product to profitability. We generated almost $6.5 million in sales in 2014 and the adjustments we made to our strategy are expected to transition this product to profitability in 2015. Our revenue growth in 2014 and prior years coupled with continued cost management has substantially improved our bottom line performance. In 2014 alone, we reduced our operating loss by 61% and over the past three fiscal years, this reduction was 71%. One significant byproduct of this improved performance is that we ended 2014 with almost $100 million in cash which we can use to further grow our business. I’d also point out the benefits we’ve realized by diversifying our product offerings. In 2014, our newest product lines consisting of DNA Genotek, our HCV business and our in-home HIV test generated total net revenues of $45 million or roughly 42% of our annual consolidated net revenues. Later in this afternoon’s call, I will discuss in further detail our HCV collaboration activities with AbbVie, developments at DNA Genotek and the recent launch of our new Intercept collector along with a panel of high throughput drug assays. I will also briefly comment on our progress in developing our newest potential product a rapid point of care test for Ebola on our OraQuick platform. So with that introduction, let me turn the call over to Ron for his financial review of the fourth quarter.

Okay, thanks Doug and good afternoon everyone. Starting with our revenues, our fourth quarter 2014 consolidated net revenues were $28.7 million compared to $28.8 million reported in 2013. Our consolidated product revenues of $25.3 million decreased 12%, largely as a result of a change in revenue recognition policy related to our OraQuick in-home HIV test, which increased fourth quarter 2013 revenues by $2.5 million. You may recall that we transitioned to the sell in versus sell through model of revenue recognition in the fourth quarter of 2013. Without that adjustment, total revenues were actually up 9% quarter over quarter. Licensing and product development revenues were $3.4 million in the current quarter and represent the recognition of exclusivity payments under the AbbVie agreement. There were no comparable licensing and product development revenues in the fourth quarter of 2013. Our overall infectious disease testing revenues decreased 2% in the fourth quarter of 2014 compared to the fourth quarter of 2013, after eliminating the $2.5 million HIV OTC revenue adjustment. Sales of our OraQuick HCV professional product in the domestic market decreased 3% in Q4 to $1 million from $1.1 million in the prior year. This decrease is largely due to the timing of orders placed by our public health customers. International sales of our HCV test in the fourth quarter of 2014 decreased to $707,000 from $860,000 in the same period last year, and that’s due primarily to reduced sales and support of a testing program with an international NGO. Domestic sales of our professional HIV product were $8.4 million in the fourth quarter of 2014, largely unchanged from the fourth quarter of 2013. International sales of our professional HIV product where $587,000 in the fourth quarter of 2014 compared to $907,000 in the fourth quarter of 2013. This change was primarily…

Okay, thanks Ron. As you know, our HCV business has been and will continue to be an important growth driver for the company. A major component of this business is our copromotion agreement with AbbVie, which is organized around several principal initiatives. The largest initiative and the one to which we and AbbVie are devoting most of our resources is focused on primary care and specialty physicians. During the past several months, the AbbVie sales force has continued detailing our OraQuick HCV test to physicians around the country. At the same time, we’ve also been promoting our HCV test primarily through several large med surge distributors and manufacturer representative organizations or MROs. As a result of these efforts, approximately 2200 physicians encompassing more than 1700 practices have indicated a strong interest in the product and a desire to be trained on its use. These accounts are split approximately 40% gastroenterologists and 60% general practitioners and other specialists. Interest in our test is broad among the physicians we contacted. We also are finding that the AbbVie patient support program is viewed positively by the physicians who have reviewed it. And at this time, over 1200 providers are trained or scheduled to be trained on our product and over 600 physician practices have actually received training and either have started purchasing product or are in the process of deciding whether to purchase and use the test. Our experience over the past several months is that the final decision by a physician to offer our test and AbbVie patient support program is difficult to predict. Our initial estimate based on our prior experience selling the OraQuick HCV test to physicians was that it would take from 6 to 8 weeks from the time a physician’s office initially expresses interest, completes training and makes…

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

Doug or Ron, could you elaborate on the sequential revenue decline in the domestic HCV business, you called out public health customers, is this a handful, is it one, and to the degree you are able to comment, I would love your input on how you view the trajectory of that business going into the first quarter.

The sequential decrease is really accounted for by a couple of very significant public health orders that we were anticipating in the quarter that actually pushed into 2015 and had those been realized, the sequential growth would have been significant.

So should I interpret that as then falling in 1Q, do you have any visibility around timing?

They pushed into 2015, I would expect in the first half, whether they’d come in Q1 or Q2, that’s a TBD.

Okay. And then could you give us an update in terms of the doc training cycle times, you mentioned it being a little bit longer than I guess the 6 to 8 weeks that you initially anticipated, just what are you seeing in terms of after docs get trained, what is the hurdle to them actually putting through orders for tests?

I think what we are trying to describe there are that this is a continuous learning process and certainly we went into this whole effort with some expectation, some assumptions in terms of what that time frame would be from the time of physician expressed interest to the time they got trained to the time they placed their first order to the time that they began testing patients and enrolling patients into that process. So a lot of factors that factor into that whole process, not the least of which is in the fourth quarter was a holiday time and you can imagine, as we described in the script, we have a lot of activity with a whole lot of interest. But convincing a physician practice to implement testing between Thanksgiving and the end of year holiday, when a lot of their staff is going to be out on vacation and this is going to be a change in their workflow, obviously is a difficult thing to influence. Those are just some of the factors. The good news is that things are progressing largely as expected. That doesn’t mean that everything is going according to plan and – but that’s why we have smart committed people making the adjustments that are necessary, course correcting where we need to and we’ve made a number of changes. Let me give you just some examples. One of our processes has been that AbbVie once they uncover a physician or a physician office practice that’s interested in testing, they transfer that level of interest to OraSure, we then work with our third party PSKW to schedule that training and then PSKW gets back to the physician’s office to make those arrangements. We found that all of those different steps took too much time and…

Super, thank you.

Our next question comes from the line of Shaun Rodriguez with Cowen & Company.

Hi, this is [Ryan Blicker] signing in for Shaun. Thanks for taking my questions. Just continuing with HCV, looking at the sell side models right now for HCV, is looking at around 15 million or 16 million for 2015. Given the [indiscernible] from here, could you discuss it is this is still a reasonable target, obviously requires a lot from the AbbVie partnership? And are you still confident that you will reach that minimum earn out payment in 2015?

So we really don’t get into that level of granularity on some of the – our guidance discussion other than to – obviously the amortization of the exclusivity payments is a fixed component of revenue at $3.4 million per quarter. We’ve also indicated publicly before that we expect to hit the milestone payment in 2015, but as far as the total expectation related to annual revenues derived from the AbbVie relationship, we have not [indiscernible] as to what our expectations are surrounding those revenues.

And we don’t provide annual guidance on any for businesses. We are continuing to provide quarterly guidance.

Okay, thank you. And then two more quick ones on HCV. You previously said that when patients enroll in the AbbVie patient support program that it doesn’t matter if they end up using Gilead’s or AbbVie’s drug for treatment as long as they enroll on the program, but it still counts towards your milestone, is that still the case?

That’s correct.

Okay, thank you. And then lastly you mentioned the AbbVie opex, can you quantify that by what the opex associated with the AbbVie was in the quarter?

We are not prepared to give that level of granularity to our expenditures there.

Okay, thank you.

[Operator Instructions] Our next question comes from the line of Eric Criscuolo with Mizuho & Company.

Good afternoon. Just filling in for Peter today. I guess, just on the 23andMe partnerships that they have kind of announced beginning of this year, they seem to be – at least the ones that are blocked, they seem to be more of database carrying 23andMe already has, is there additional opportunities for you to sell more tests based on those partnerships or more collection devices for those partnerships to 23andMe or are these collaborations more of data already being there and these companies just kind of looking into the database?

I think there is many opportunities to expand our business with 23andMe, certainly 23andMe’s successful expansion of their product offering into other geographies and earlier in 2014 they launched in Canada, in the fourth quarter they launched in the UK, and we are aware that they are planning other launches in other geographies around the world. We are not at liberty to say which those are or when those might come to fruition. But certainly those of the present, we believe, nice opportunities for continued expansion. Certainly as they work through and ultimately we believe resolve some of their issues with the FDA, their product offer is going to continue to become more attractive to consumers here in the United States, we believe that represents another opportunity. And all of this represents – and I think these examples – the announcement they made about their relationship with Genentech and others just highlights that power of their product offer and the information that they are able to generate together with consumers, which can provide some real insight into populations as well as diseases.

And Eric, just another point. Currently, they’ve disclosed that their existing data base of genomes is less than 1 million, but they have certainly indicated aspirationally to be well north of that as far as collections that they want to get into the data base, which of course enhances the value of it from a clarity standpoint to pharma partners and others looking at relationships embedded within one genetic database that they’re going to miss. So I do think that there are plenty of opportunities yet to accrue to us in the form of being part of those collections.

I think it’s also important to understand that our collection system, the Oragene collection system has been at the foundation of all of those collections and represents trust and confidence in sample collection, sample integrity and obviously it starts with a high-quality sample. And so their database is really dependent on having a good sample upfront and obviously we expect that’s going to continue as they amass more specimens and more data into their database.

Thanks for that color. I guess going back to the HCV payments, the milestone payments potentially in 2015, I know you had just said there is potentially one milestone for the year, are there more than one opportunity?

The only thing that we’ve indicated to date and still are messaging is that we expect to receive at least one payment in that milestone structure. And we are not able to really talk about how many positives we have to enroll, we probably know that was redacted from the agreement that was made public as part of our second quarter Q. But when we qualify to receive that, we will obviously disclosed that at that time.

Could you say when in the calendar year that potentially could occur, is it middle, second half?

We will announce it when we receive it.

Thank you.

Our next question comes from the line of Mark Massaro with Canaccord Genuity.

Hey guys, thanks for taking the question. Not going to 23andMe too much, but I guess I would have expected may be flattening revenue, so can you kind of talk about what drove the 8% decrease, obviously there is different working parts obviously with the FDA seizing their ability to market the test in the US offset by launches, as you mentioned, in the other countries. So how should we think about it in Q1 and Q2 just directionally, flattening out or maybe lifting up a bit?

Right. So if you look at the 2013 quarterly number four the molecular collection systems, but that $6.8 million, that included the revenues from 23andMe that were $1.9 million greater than those enjoyed in the fourth quarter of 2014 in large part due to the fact that for the majority of that prior year’s quarter, they were able to sell their product into the US market, their personal genome systems. So I think you need – when you strip that out of there, Mark, and you get down to an adjusted number of $4.9 million range, that then neutralizes that the incremental revenue and then allows you to understand the total revenues were actually growing like 34% from the other component of the business, putting aside for a moment the contribution that 23andMe made in both the fourth quarter of 2013 as well as in 2014. So are very healthy business. And as you may recall, in the early part of 2014 we had very little in the form of contribution from 23andMe on the revenue line. So I would think that as we move forward into 2015 here, the early part will look pretty good for the business.

Great, that’s helpful. And how should we think about the HCV NGO outside the US, obviously I realize that can be lumpy, should we expect that lost business to recur for example when do you think we will see that lap if there was a lost customer or was that just a one-time blip in ordering?

It’s not a lost customer, be clear on that, it’s really just lumpy ordering pattern by the customer and actually the customer has committed to continue using our product certainly through 2015 and likely beyond. So I will expect we will see some variation on sales on a quarterly basis, but continue to be an important contributor to our international HCV revenues.

And then are there any developments on the microbiome product that you are working on?

There have been and collection system continues to be evaluated by numerous opinion leaders around the world. We are actually starting to generate some revenue is from that, but as I think we spoken about previously, we are really in the process of defining its value with key opinion leaders in the early stages of commercialization, but interest and enthusiasm for our product that’s able to stabilize a fecal sample at the point of collection and really enable researchers to get a good idea of exactly what that bacterial make-up looks like. It’s close to collection as possible is highly valuable and we are in discussions with numerous researchers around the world where they are looking at significant size studies of microbiome and considering the use of our product in those programs.

Great. And then maybe if I can sneak one more in, in your comments that you made about the retail opportunity and how you could realize financial impact in the second half of 2015, is there a scenario where there might be an uptrend purchasing component as part of that, or will be see maybe test ordering start to trickle in the second half?

I think it will be more of a gradual uptake. I think this is another example of learning and certainly the retailers, as I mentioned, have very high interest in potentially offering rapid hepatitis C testing, but as we mentioned these are now pilots, they are being scoped and planned and importantly they are going to define actually how the retailer is going to roll this out to their either national or retail chain. So these are critically important to understand workflow as well as how the retailers is going to be reimbursed for these services and involve multiple stakeholders obviously along with local stakeholders that are going to provide some of the follow-on services to the individual that test positive. So we’re very excited about these as are the retailers and look forward to kicking these off in the next couple of months.

Thank you.

Our next question comes from the line of Nic Jansen with Raymond James.

Two quick ones from me. You guys are sitting on nearly $100 million in cash for some time now, just wanted a sense of the M&A outlook, the prospects there, how we should be thinking about timing or anything regarding to dealer activity in 2015?

Nic, that’s a great question. We continue to be in the market, evaluating opportunities. We’ve looked at a number of them, but obviously we wouldn’t comment on timing or whether there is anything that would be actionable at the moment, but we do have an interest in expanding our business through business development activities, whether they would be partnerships, outright acquisitions, licensing transactions, so anything in that regard and we continue to be active in that area.

That’s helpful. And then on international HCV, I know you guys [indiscernible] affiliation there like you’ve done domestically with AbbVie, any comments or discussion surrounding that potential source of opportunity in the medium term?

I would say nothing in the near term, but we continue to be active in dialogue with multiple potential players.

Okay. And then lastly, Gilead talked about pretty significant price erosion in the HCV marketplace given the battle between them and AbbVie to sustain share, I would have assumed that that’s actually may be a good thing for your business, they are going to need more volume to hit the revenue target that they are discussing. So maybe talk to me a little bit about how you are viewing the pricing landscape and how that kind of impacts your business philosophy on HCV in the US longer term? Thanks.

I think we’re a little more interested in the fact that more and more patients are being put on therapy, which is depleting the number of those patients that have been previously diagnosed and are warehoused, that is the real driver for increased testing. And I read some of the transcript from Gilead’s remarks last night and they talked about capacity, put out 250,000 patients on treatment and those kinds of numbers deplete whatever is the remaining and we will house patients very quickly. We all know that AbbVie and Gilead are out there really in hand to hand combat, whether it’s with providers or with payers, we would expect that’s going to continue for some time. But in any case, the need for increased testing is going to continue to escalate. I don’t think we should lose sight of that. And we are in a wonderful position to capitalize on that, not only with our rapid test but with the relationship with AbbVie, and that’s what we’re working to capture and what we expect we’ll do.

And I’m not showing any further questions in the queue at this time. I’d like to turn the call back over to Doug Michels for closing remarks.

I just want to thank everybody for coming on the call this afternoon and this evening, and appreciate your continued interest and support of the company. Look forward to updating you on our progress in a few months. Have a good night everybody.