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OraSure Technologies, Inc. (OSUR)

Q3 2012 Earnings Call· Wed, Nov 7, 2012

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Transcript

Judy Clarke

Management

Good afternoon everyone and welcome to OraSure Technologies 2012 Third Quarter Financial Results Conference Call and simultaneous webcast. As a reminder today’s conference call 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, questionnaires 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 questionnaire can rejoin the queue for further questions. OraSure Technologies issued a press release at approximately 4 p.m. eastern time today regarding our 2012 third quarter financial results and certain other matters. The press release is available to you 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 news 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 November 14, 2012 by calling 855-859-2056 for domestic, or 404-537-3406 for international. The access code is 51186733. 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 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, and regulatory filings and approvals. Actual results could be significantly different. Factors that could affect results are discussed more fully in the company’s SEC filings, including its registration statement, its annual report on Form 10-K for the year ended December 31, 2011, 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 or any forward-looking statements to reflect the events or circumstances after this call. With that, I would like to turn the call over to Doug Michels.

Douglas Michels

Management

Okay, thank you very much, Judy, and good afternoon everyone. I want to thank you for joining us on our call today. Third quarter consolidated revenues fell within the low end of our guidance range, while our net loss beat our guidance for the bottom line. Revenues were up slightly over the third quarter of 2011 primarily as a result of our molecular collection system subsidiary DNA Genotek. The third quarter included truly historic achievements in OraSure. In July, we received FDA approval of our OraQuick In-Home HIV Test, the first and only rapid infectious disease test approved for sale in the over the counter our OTC market. We also completed initial shipments of this product to retailers around the country at the end of the third quarter. And in October, we commenced the commercial launch of our OraQuick In-Home HIV Test with support from celebrity spokespersons and the initiation of a nationwide promotional campaign. I will provide an update on the progress we’ve made with this exciting new product as well as certain other developments in our business. However, before I do that, let me ask Ron to review our third quarter financial results.

Ronald Spair

Management

Okay. Thanks, Doug, and good afternoon everyone. Starting with revenues, our third quarter 2012 consolidated revenues were $22.1 million compared to $21.7 million reported in 2011. Revenues for the current quarter included $3.3 million from our molecular collection system subsidiary, DNA Genotek acquired in August 2011. DNA Genotek’s revenues for the period post acquisition date through September 30, 2011 were $2 million. Our consolidated product revenues increased 1% as a result of the higher molecular collection systems sales and higher sales of our cryosurgical systems products. These increases were partially offset by lower sales of our infectious disease, substance abuse and insurance risk assessment products. Our infectious disease testing revenues were $10.7 million in the third quarter of 2012 compared to $11.9 million in the third quarter of 2011. The overall 10% decrease was primarily a result of lower domestic OraQuick HIV sales, partially offset by the higher OraQuick HCV sales. Third quarter domestic HIV revenues were down $1.5 million or 15% due to various factors including changes in public health testing programs and their timing of purchases, reductions in government funding, price competition and a shift to automated laboratory based blood test by some of our customers. HCV revenues were $919,000 for the quarter, a $494, 000 increase over the third quarter of 2011. In substance abuse testing, revenues decreased to $2.3 million in the third quarter of 2012 from $2.8 million in the third quarter of 2011, primarily as a result of lower intercept sales partially offset by higher sales of our Q.E.D. point-of-care, saliva alcohol test. The higher Q.E.D. revenues resulted from the absence of production issues experienced last year which were resolved in October 2011. The decrease in intercept sales as a result of lower purchases by our largest domestic laboratory distributor who began selling it’s…

Douglas Michels

Management

All right, great, thanks Ron. As mentioned earlier, during the third quarter we received FDA approval of our OraQuick In-Home HIV Test and we completed the first shipments of this product to retailers. We also sold $3.6 million of this product in Q3 although most of this revenue cannot yet be recognized for financial reporting purposes. Because we do not yet have a track record for this product, we can only recognize revenue upon the consummation of sales to retail customers, either in a store or over the internet. These initial shipments primarily represent pipeline fill for retailers and their distribution centers. From the time of new product such as our OraQuick In-Home HIV Test is purchased, it typically takes two to three weeks to start appearing on retailer shelves. As you might expect, there is variability in the timing of retailer shipments from their distribution centers to their stores and then and how quickly individual store managers placed new product on their store shelves. Our initial shipments covered the leading drug and mass merchandize chains including Wal-Mart, Walgreens, CVS, Rite Aid, Kroger and Duane Reade and we are also selling to large drug wholesalers such as AmerisourceBergen, Cardinal Health and certain regional food retailers. We’ve seen strong initial support by our key retailers as several have run multiple circular and internet ads for our OraQuick In-Home HIV Test. Since its launch in early October, our OraQuick In-Home HIV Test has been placed on the shelf in thousands of retail outlets across the country. We have started to conduct retail audits in order to help retailers optimize their execution. And based on initial data from these audits, we estimate that over 90% of the largest retail outlets have product on the shelf today. Most of these retailers are selling the…

Operator

Operator

Our first question comes from Amit Bhalla of Citi. Your line is open.

Unidentified Analyst

Analyst · Citi. Your line is open

Nikit (ph) for Amit today.

Douglas Michels

Management

Okay.

Unidentified Analyst

Analyst · Citi. Your line is open

So I want to first focus on the over-the-counter launch for you guys. You talked about the launch has been modest so far. Can you talk a little bit more about that? I mean what are your expectations for a ramp, when would you see that ramps sometime in significant – in the fourth quarter as this is more into 2015 that you see?

Douglas Michels

Management

Well so, this id Doug. So going back to the information that I shared with you in the script obviously, since product was shipped to retail and moved onto shelf, we’re very, very early into this launch. And the team has executed I think very well on those different logistical activities. We’ve secured distribution. We begun communicating now with the consumers and engaging them to learn more I think some of the data that is shared with you about the click-through rate, really shows that consumers are responsive to our message and they’re interested to learn more. I shared with you the number of visits we’ve had to our website, I think that again emphasizes that we’re engaging the consumer and encouraging them to act. We’re not going to see the impact of that immediately. We’re going to see it build through the fourth quarter and obviously as we continue to increase our advertising and our advertising message, we’re going to see that build throughout 2013. So that’s all that comment was designed to communicate and obviously when we come back with our fourth quarter call in February we’re going to have a much more robust status to share with you about how the product has sold at retail, online and what that velocity actually looks like.

Unidentified Analyst

Analyst · Citi. Your line is open

Okay that’s helpful.

Operator

Operator

Thank you. Our next question comes from Shaun Rodriguez of Cowen and Company. Your question please. Shaun Rodriguez – Cowen and Company: Thank you. On guidance, what are the key drivers of the expectations for the 6% sequential decline and I guess here I’m trying to think through the dynamic of hurricane Sandy versus maybe some challenges in the base business specifically in the HIV professional business.

Ronald Spair

Management

Right. So Shaun, some of the sequential decline is related to the cryo business in Q4 which has certain seasonality to it. And as we have in years past we’ve seen a bit of peaking in the summer time and then a reduction of the purchases in and over the winter time. So we do see a sequential decline in the cryo business which is a large contributor to the Q4 over Q3 2012 reduction. Shaun Rodriguez – Cowen and Company: Okay, that’s helpful. And on the U.S. professional HIV business, you’ve talked about that franchise being pressured for a few quarters now on changes in public health testing programs reduced government funding pricing and now we transitioned to lab-based testing. Is this still your biggest business? Can you just talk about your, the outlook there? We’ve been in the sort of the $8 million of $8.5 million of quarter range. This year, it’s hard to see government funding getting better, pricing getting less competitive and it doesn’t seem like the transition to automate a testing, is it temporary dynamics. I’m just trying to think through whether there are any positive offsets that you see in the near and medium term or should we think about this as kind of the run rate that we should expect?

Douglas Michels

Management

Yeah, we’re going to continue to manage these pressures I think for sometime certainly until the economy improves. Clearly rapid HIV testing has its benefits and we’re going to continue to sell those benefits as effectively as we possibly can. Data from the CDC indicates that greater than 98% of individuals receive their results with rapid testing, with non-rapid testing. It can be as low as 50%. And that’s not lost on public health jurisdictions or professional users who use our product. Shaun Rodriguez – Cowen and Company: Sure. Now that’s very helpful. And last one on OTC, can you talk about your dialog with the FDA following the advisory panel and then the formal approval with regard to any post-marketing studies that might be required of you. We noticed a couple listed on the clinicaltrials.org website, so just wondering if there are more of these studies that you’re expecting to have to do. Thank you.

Douglas Michels

Management

Thanks for that question. And over the years we’ve enjoyed an extremely positive and collaborative relationship with the FDA. We’ve committed to stay in very close touch with the FDA throughout this launch. We intend to engage them here shortly just to give them a perspective on what kind of response we received from the consuming public, how the consuming public has used our call center. What kind of frequency? What kind of questions they’re asking our call center representatives? It’s very interesting early on. Most of the questions to the call center were more around product availability and pricing and now that the product is more available at retail and online more of the questions to our call center are more about product use and interpretation of results and with some referrals. And I think that’s the kind of information that the FDA is very interested to understand. I have to tell you, the call center response in consumer support has been excellent. We’ve also begun to interact with our professional HIV customers and working with the Public Health Community to help build out our consumer support center to make it more of a consumer support network. And I think there are some interesting strategies that we can deploy to provide even better support to the consuming public. And I think that’s a keen interest to the FDA and to the whole HIV Aids community. So we’re going to continue with the regular dialog and obviously we’ll continue to keep you up-to-date as that progresses. Shaun Rodriguez – Cowen and Company: Thank you.

Operator

Operator

(Operator Instructions) Our next question comes from Jon Wood of Jefferies. Your question please. Jon Wood – Jefferies: Hey, good afternoon.

Douglas Michels

Management

Hi, Jon.

Ronald Spair

Management

Hey, Jon. Jon Wood – Jefferies and Company: Hey. So Doug, just look at the ACV business into US, kind of surprise to see that down a little bit sequentially and I know you kind of – there was a transition or at the beginning of the transition away from Merck and then to the physician office distributors, can you just describe what impact that had on that business, and we’d love to hear, you talked about some of that funding beginning to I guess hit later in this year, when does that start accruing to your business, the specific CDC grant you mentioned.

Douglas Michels

Management

Good yeah, thanks for those questions, Jon. So let me first address the Merck relationship impact and our decision to let that agreement lapse and that decision was taken really to eliminate any future restrictions on our ability to work with anybody in the therapeutic space in hepatitis C. I think we all know that it’s a very fluid space right now and likely will be for the next several years, and our relationship with Merck was a very productive one but it did have restrictions and we weren’t able to work with some of the players in the hepatitis C space under that agreement. We have an opportunity to just let the agreement lapse and we took that opportunity, that doesn’t mean that we can’t continue to work with Merck, which we’re happy to do but it also frees us up to work with Vertex and any of the other pharmaceutical players in the space. Relative to the CDC funding announcement and the grants that have now been communicated and money transferred and we should start seeing the benefit of that in Q4 as well as throughout 2013, that’s critical. Obviously these public health jurisdictions rely on public funding whether it’s from the feds or state, city governments and this is a great indication not only of the CDC’s commitment to support the implementation plan of these revised guidelines but also of congress’s support and we anticipate that there is going to be more of that. So we’ll report on that is through the fourth quarter and into 2013 as we work with the jurisdictions to deploy our rapid test, I gave you some indication as to significant percentage of those grantees have already indicated but they plan to use our rapid test as the device of choice and implementing their programs. We’re very enthusiastic about the future of our hepatitis C business, not just because of the guidelines but because of these developments in therapy and as well as the governments increase focus on prevention but funding is critical in the public health sector and on the physician office front obviously we’ve got to continue to drive awareness, this is a challenging activity because we’re trying to drive behavior change, but we continue to receive great support from our distributor partners and we’re going to continue to advance that forward. Jon Wood – Jefferies and Company: Okay that’s good color, thanks for that. I guess an unrelated follow-up, sorry about that. So Ron, is there – is it too early or do you have a better sense kind of how the gross margin kind of booked to ship more work in the HIV OTC business, if you’ve got any incremental color on that we’d love to hear it, if not, we’ll just stay tuned.

Ronald Spair

Management

Yeah, no I think that’s a great question, Jon. And in the early days there will be an impact because when you actually record the out sales which we’re going to be able to book as revenues, whether that occurs at the point of sale at a retail pharmacy or over the internet, the aggregation of those revenues will obviously ramp over time, but we need to deduct off of those revenues the trade spend that is put forth by our retail partners like the CVS, Walgreens, Rite Aid to the world. And so consequently as part of our total overall, that’ll affect the gross margin because it effectively reduces revenues. And so as I’ve mentioned before, as we move to scale which is obviously further out and when we have the VTC campaign running and product to shipping more robustly then the gross margins will pick up but in the early days the gross margin will be affected by the great investment from our trade partners out there who are supporting the product for us, or with us I should say. Jon Wood – Jefferies and Company: Okay, thanks a lot. Good quarter, thanks.

Ronald Spair

Management

Yeah.

Operator

Operator

Thank you. Our next question comes from Jeff Frelick of Canaccord. Your question please. Jeff Frelick – Canaccord Genuity: Hi Ron, can you comment, so as the guidance you have included in the guidance for fourth quarter HIV OTC revenues?

Ronald Spair

Management

We do. Jeff Frelick – Canaccord Genuity: Okay. And is that mostly on the retail chain pull through or is that more on the direct side over the internet?

Ronald Spair

Management

So it’d be all inclusive. Jeff Frelick – Canaccord Genuity: Okay. Any interest yet, and then just a quick follow-up, any interest for public health in obtaining HIV OTC product?

Douglas Michels

Management

We’ve had a number of discussions with the different public health jurisdictions Jeff, and some varied applications of how they might use the product. Obviously, we’ve got to be careful to make sure that how we interact with the public health market does not impact our commitment to the retailers, but there are certainly some unique applications, there is a lot of interest in studying the use of the product in certain populations which I think can be very valuable down the road. And so we continue to see a high level of interest and engagement within our professional customer base. Jeff Frelick – Canaccord Genuity: Okay, thanks Doug.

Operator

Operator

Thank you. Our next question comes from Nicholas Jansen of Raymond James. Your line is open. Nicholas Jansen – Raymond James: Some quick thoughts on the DNA business in terms of the academic funding challenges that are out there, what should we think about, can the commercial growth that you’re seeing offset those pressures or could ’13 be a little bit of a struggle to growth the top line in that business before kind of reaccelerating as commercial becomes the bigger piece of the pot?

Douglas Michels

Management

We certainly expect to see growth on both fronts in 2013, both academic research as well as commercial. And obviously like I commented in the prepared remarks, quite pleased with the growth that we’re seeing on the commercial front and we expect that to definitely continue. The DNA Genotek team has really done a great job in responding to some of these academic research challenges. We look at the customer, new customer acquisition on the academic research front that continues to grow year-on-year, one of their challenges is, is the accounts that are using the product in their research they’re using a little bit less of it because their projects aren’t funded to the level that they were previously, so they’re not going to have as many specimen involved in the studies and the like but there still a high level of interest among the academic research community. And then DNA Genotek has done a good job of identifying and cultivating opportunities on the commercial front. Nicholas Jansen – Raymond James: That’s helpful, thanks. And then just one of the – make sure I heard you correctly, in terms of the marketing spend regarding the OTC launch next year, you said it was going to be about similar to the fourth quarter number annualized, was that correct, did I hear that right?

Ronald Spair

Management

Yeah you did, Nick, that’s likely the area that we’re operating in and as Doug mentioned, it’ll be more front end loaded coincident with the initiation of the DTC campaign in early January and so the first half of the year we’ll see a significant spend in that area. Nicholas Jansen – Raymond James: Thank you very much.

Ronald Spair

Management

Okay.

Operator

Operator

That brings to an end the Q&A session of today’s call. I would now turn the call over to Doug Michels for closing remarks.

Douglas Michels

Management

Okay, I just want to thank everybody for being on the call with us this afternoon and this evening, and I hope you have a good week. Take care, bye-bye.

Operator

Operator

That does conclude the program. Ladies and gentlemen, you may disconnect your lines at this time. Have a great day.