Earnings Labs

OraSure Technologies, Inc. (OSUR)

Q1 2012 Earnings Call· Wed, May 2, 2012

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Transcript

Operator

Operator

Good day, everyone, and welcome to OraSure Technologies 2012 first 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. For opening remarks and introductions, I will now turn the call over to Judy Clarke at OraSure Technologies. Please go ahead.

Judy Clarke

Management

Thank you. Good afternoon, everyone, and thank you for joining us today. I would like to begin by telling you that OraSure Technologies issued a press release at approximately 4:00 PM Eastern Time today regarding our 2012 first 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 May 9, 2012, by calling 855-859-2056 for domestic or 404-537-3406 for international. The access code is 71939275. With us today are Doug Michels, President and Chief Executive Officer; and Mark Kuna, Senior Vice President, Finance and Controller. Doug and Mark will begin with opening statements, which will be followed with a question-and-answer session. Before I turn the call over to Doug, I must also remind you 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 SEC filings of OraSure Technologies including its registration statements, 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 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.

Douglas Michels

Management

Thank you, Judy, and good afternoon, everyone. Thank you for joining us on our call today. Before we begin, I wanted to let you know that Ron Spair, our Chief Operating Officer and Chief Financial Officer who normally joins me on these calls has had to attend to an urgent and unexpected personal matter involving a family member and will not be able to participate today. Instead Mark Kuna, our Senior Vice President of Finance and Controller will fill in for Ron. And Mark will present our financial results and then he will assist me in responding to your questions at the end of the call. With the first quarter under our belt now, 2012 is off to a good start. We are in the final stages of the FDA review process for our OraQuick HIV over the counter tests and we are gaining traction with sales of our OraQuick HCV tests. Consolidated revenues for the first quarter, which included revenue from our recently acquired subsidiary DNA Genotek, were up 20% compared to the first quarter of 2011. I am pleased to report that our consolidated results came in at the top of our guidance range for revenues and we exceeded our first quarter guidance on the bottom line. Mark will start with a detailed review of our first quarter financial performance and then I will follow with some additional comments on our business. We will close the call today by taking your questions. And now I will turn the call over to Mark.

Mark Kuna

Management

Thanks, Doug, and good afternoon, everyone. Our first quarter 2012 revenues were $20.9 million compared to $17.4 million reported in 2011. Revenues for the current quarter included $3.3 million from our molecular diagnostic collection subsidiary acquired in August 2011. Our product revenues increased 16% as a result of the molecular collection system 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 product. Our first quarter 2012 licensing and product development revenues included a $1 million milestone payment received under our HCV collaboration with Merck. Our infectious disease testing revenues were $9.8 million for the first quarter of 2012 compared to $10 million in the first quarter of 2011. The overall 2% decrease was primarily a result of lower OraQuick HIV sales in the domestic and international markets, partially offset by higher OraQuick HCV sales. Domestic HIV revenues were down $719,000 year over year or 8% as a result of ordering patterns by one of our large public health customers who placed a large order during the first quarter of 2011, which was not repeated in the first quarter of 2012. HCV revenues were $818,000 for the quarter and sequentially up from Q4 of 2011, largely as a result of receiving a CLIA waiver in November of 2011 which increased the number of customers to which we were able to sell the product. It is important to note that during the first quarter we saw a substantial increase in the number of customers purchasing our HCV products, which contrasts with the large bulk purchases by a small number of customers experienced in the fourth quarter of 2011. In substance abuse testing, revenues decreased from $3.1 million in the first quarter of 2011 to…

Douglas Michels

Management

Okay. Thanks a lot, Mark. A major priority has been the pursuit of FDA approval of our OraQuick HIV over the country tests. As you will recall we submitted the third and final module to our premarket approval or PMA application to the FDA at the end of 2011. Our PMA submission is under active review by the agency and we are preparing for Blood Products Advisory Committee or BPAC review of our clinical data at a public meeting to be held on May 15 of this year. We’re very pleased to be on the schedule and we look forward to presenting our data to the committee. Under the BPAC’s rules, our presentation for the meeting as well as presentations by the FDA and others will be made public about two days before the meeting. Our BPAC presentation will include a summary of our clinical study results, including the most recent phase 3 unobserved user study, a risk benefit analysis of the product and our rationale for why an HIV over the counter test should be approved by the FDA. As we’ve discussed previously, the CDC estimates that there are about 1.2 million people in the United States infected with HIV, approximately 240,000 of which are unaware of their status. According to the CDC, individuals who do not know their status are unknowingly responsible for up to 70% of the approximate 50,000 new HIV infections that occur each year here in the U.S. Unfortunately this is occurring despite the widespread availability of both laboratory based and rapid point of care HIV testing options. We believe these data clearly demonstrate that additional HIV testing options are urgently needed, and this is a major reason why we’ve invested so much time and resource into our over the counter clinical program. We believe…

Operator

Operator

(Operator Instructions) And we will take our first from Jeff Frelick from Canaccord.

Jeffrey Frelick

Management

Doug, could you maybe characterize the customers purchasing the HCV tests? I know you showed the difference on the public health side. Were there some physicians in that ordering pattern as well?

Douglas Michels

Management

Yes absolutely. And like I mentioned, we have seen a very encouraging response from the detailing efforts from Merck. And in previous calls, I said I don’t really believe we’re going to have a good handle on this probably until sometime in the second quarter as we've had the opportunity to follow up on the initial detail which we’re doing of course right now. But we certainly saw almost a 50% increase in the number of domestic customers purchasing the HCV product from first quarter 2012 versus fourth quarter 2011. And we anticipate that it’s just going to continue as we progress throughout the year.

Jeffrey Frelick

Management

And then just the follow up, maybe for Mark. The guidance assumed that infectious disease little bit more normalized, I guess, HIV patterns and increasing in HCV sales plays out 2Q.

Mark Kuna

Management

That’s correct. There is a more normalized pattern for HIV and there is an increase in HIV -- HCV sales included in Q2.

Operator

Operator

And we will take our next question from Charles Duncan from JMP Securities.

Roy Buchanan

Management

Hi guys, this is Roy for Charles. Thanks for taking the call. Sorry to hear about Ron. Hopefully all is well.

Douglas Michels

Management

Yes we will continue to work through that. Thank you.

Roy Buchanan

Management

Just a couple of quick questions on that HCV, have you got anything about it, update on the potential for new stream guidelines from CDC?

Douglas Michels

Management

We don’t have anything specific in terms of when the CDC expects to announce those, but all indications are that it’s still on track. There is no indication that, that’s not going to come out. I think it’s just a matter of timing by the CDC. There continues to be a tremendous support for the guidelines to be released to Chronic Liver Disease Foundation. I think you are probably aware in February announced, put out a statement in support of birth cohort screening for hepatitis C. There were 2, I think, very important articles published in the February 2012 Annals of Internal Medicine. They talked about - one talked about the cost effectiveness of birth cohort screening for hepatitis C in primary care settings. And there was another article in the same journal that highlighted the increases mortality from viral hepatitis in the United States, particularly HCV surpassing now HIV in terms of deaths per 100,000 people in 2007. And so I think there is a growing recognition and acknowledgement that age-based birth cohort screening, one time screening can have a significant impact on public health as well as on the growing economic burden that is hepatitis C. So I fully expect we’re going to see these revised guidelines hopefully sometime within the next several months, certainly this year.

Roy Buchanan

Management

A quick not related follow up but on the BPAC, can you tell us if you received the recent documents and potentially what - do you see it as a tone any positive or negative, and if you have any concerns about the panel?

Douglas Michels

Management

Yes, we anticipate that the FDA is going to release all of the documents, both our presentations which have been sent to them as well as the information that they anticipate presenting as well as the presentations that might be presented from other invited guests. They indicated that those documents will be made public no less than 48 hours in advance of the meeting. And obviously we look forward to seeing everything that is intended to be presented. I believe that as part of that we will also see the issue summary from the FDA that will highlight what kinds of questions they intend to pose to the advisory committee. And once all that is available obviously we’ll have an opportunity to comment on that.

Operator

Operator

And we will take our next question coming from Bill Bonello from RBC Capital Markets.

Bill Bonello

Management

I just have a question on the HIV trends in the quarter, just wondering if you can talk a bit more about the large order that was not repeated. Is that just a timing issue or is that customer that you lost to a competitive situation?

Douglas Michels

Management

No, it’s purely a timing issue, and we see these now and again, we’ve got several of these large public health jurisdictions that will order of anywhere between $0.5 million to $1 million worth of product at one time. And that’s indeed what happened from Q1 of 2011 to Q2 2012, purely a timing issue.

Bill Bonello

Management

And then on a loosely related follow-up, on the substance abuse side, you talked about losing volume there to one of your larger customers that has their own test. Are you seeing any beyond that lab not using your test, are you seeing further shake-out in the competitive landscape in terms of any another loss of customers or price pressure or anything like?

Douglas Michels

Management

Not of any significance and I should mention that the biggest impact to the change in the quarter, was the impact from the international business and that was an inventory adjustment with our UK distributor there. And we expect that to normalize through the back half of the year as well. So that was a one-time event.

Operator

Operator

And we will take our next question comes Caroline Corner from MLV.

Caroline V. Corner

Management

So just real quick on the HIV OTC, you’ve talked before about perhaps doing web-based sales, are you still planning on those doing those directly?

Douglas Michels

Management

We are definitely and our website is in the final stages of development and validation obviously. We are also going to be selling the product through online, through retailers’ websites. And that would be, what you would expect would be the wallgreens.com, CVS.com, Walmart.com and the like. So yes, our objective is to give the consumer as many options as we possibly can. All supported consistently through our consumer support center as well as an expanded consumer support network that we will be developing on our regional business with our public health jurisdictions and other healthcare providers.

Caroline V. Corner

Management

And then my other question, we were pleased to see your collaboration with Complete Genomix on the DNA Genotek side. Can you describe to us a little bit how that relationship works, does the Complete Genomix order the sampling kits from your directly in bulk or is it as they have orders come in, can you just walk us through that process a little bit?

Douglas Michels

Management

Yes, at this stage of the game, they have announced their willingness to accept oral samples for analysis and as demand comes in, if they choose to make those available to their customers, or potential customers they will do so.

Caroline V. Corner

Management

And have they already started ordering from you yet?

Douglas Michels

Management

I believe they have.

Operator

Operator

And we will take our next question from Spencer Nam from ThinkEquity.

Spencer Nam

Management

Just a couple of quick questions, one on HIV OTC and then one on HCV. On the HIV -- OTC HIV test side, we have heard in the past that with May panel, the approval from the FDA could come as early as summer time, if you will. Is that a fair expectation that we could think about or it is - could it take a little longer or maybe slip into the fourth quarter timeframe?

Douglas Michels

Management

Spencer, it’s very difficult for us to speculate on the timeline that the FDA might use to ultimately grant us approval. Our objective obviously is to be prepared to not only launch a product but they have all the support resources in place as soon as possible after the advisory review, based on the assumption that we could have a positive recommendation. But all that’s speculation, but we had to put a stake in the ground to make sure we were prepared and that’s what we are preparing for. And I can assure you that if we received a positive recommendation and the FDA chooses to move quickly, we will be prepared to make the product available sometime in the summer. There are other variables that come with any reviews like this. There may be request to alter labeling or change instructions for use, or modify those kinds of things. And depending on the lead time to have materials printed or things like that, that can always impact timing. And we won’t know any of those until we’ve gone to the advisory meeting. I can tell you this. We’ve worked so hard on this project over the last seven years. We’ve executed our studies as effectively as we can. We - the team did a super job of executing this final study. I think we’ve got a real solid package that’s going through the FDA. And we’re going to go there and we are going to present it as effectively as we possibly can, answer the panel’s questions and our hope is that they are going to give us a positive recommendation but we’re going to know on a couple weeks. We are excited about it.

Spencer Nam

Management

So the second question I have is on the HCV side, now that you’ve completed - you’ve now completed the detailing training with Merck’s team. I was curious if there was a specific sort of a launch plan if you will or launch, or the sales and marketing plan from the Merck team on how to integrate OraQuick HCV with their sales effort and clearly they - Merck is clearly making headways with their sales increase of controls. But as we think about HCV test, OraQuick HCV being part of that package going forward, I was wondering if there was any sort of specific plan that Merck guys have laid out that you guys could maybe share with us a little bit, if there is any?

Douglas Michels

Management

Right, so remember we are detailing the product into the physician office market through 2 different organizations within Merck. One is their infectious disease specialist that primarily is calling on gastro neurologists, ID docs and hepatologists. The other group is the new business group, that’s a telesales group that’s calling primarily on primary care physicians and internal medicine docs. And I tried to give you some color in the opening remarks about the first quarter statistics in terms of number of calls directed to each of those and what kind of interest we’ve received from them, in particular the people calling on the new business - out of the new business group the telesales group that are calling on primary care, remember it’s primary care that are doing most of the initial testing and referring to the specialists. And as I mentioned in the first quarter, there were about 600 calls made, 70% of which resulted in some expression of interest. I think that’s a very encouraging number, 13% of which expressed a high level of interest to begin to use the product. Now obviously remember, Merck is not selling the product, they are detailing the product. And then we’ve got to follow back up with our manufacturers’ reps and with the distributor reps to actually sell the product in. Merck’s organization is following a very disciplined 5 step selling model, which includes raising awareness, educating to the risk factors, and then encouraging screening and testing and going through that whole process. So early on, and that’s what I said in the last call, early on we are encouraged by the results. We’ve got to look and see how many of these expressions of interests and leads now translate into actual set up and sales and how the numbers continue to progress into the second quarter and the rest of the year. We will continue to report on that as we go forward with Merck.

Operator

Operator

We will take our next question from Bill Bonello from RBC Capital Markets.

Bill Bonello

Management

Just another question on the HSV customer growth and physician interest, do you have a sense of whether the public health customers that are purchasing tests are initiating new or expanded testing initiatives or are these customers that are just simply transitioning from sending out the tests to a reference lab to doing them onsite? And then a similar question on the interest on the physician side, especially the 13% that indicated the strong interest, are those the docs that are already ordering a lot of HCV testing and again they are just transitioning to doing it in their office, or are these docs that expect to do more screening?

Douglas Michels

Management

So let me start with the public health piece first. I think it’s a combination of both - both people who are currently using laboratory based method or perhaps sending out that can now use the test in house. But it’s also public health jurisdictions that are interested in setting up new programs. And we’ve had a significant expression of interest from jurisdictions that want to include hepatitis testing with HIV and I expect we’re going to see more integration of those activities as we go out through the remainder of 2012. On the physician’s office side, I don’t have quite the granularity yet until we see how the conversions take place, but my belief is that most of the expressions of interest are coming from those docs that are currently sending out, that can now perform the testing in house.

Operator

Operator

And we will take our next question from Jeff Frelick from Canaccord.

Jeffrey Frelick

Management

A follow-up, maybe just kind of follow up on the last question. If all the docs that you’re getting some traction with already, comfortable ordering some level of HCV testing. Curious your sense on if we get a changing guidelines in the near term how does that message get conveyed and what do you think the responses and with the Merck, I assume that we’re helping to deliver that message into the primary care setting.

Douglas Michels

Management

No question. So obviously Merck’s detailing efforts will be an effective vehicle to deliver that message but so will the medical societies, medical organizations, Liver Disease Foundation, the CDC will be highly effective in that our work with the AMA, with NMA that we are currently in contact with about this possibility, it will, I believe, a highly effective communication plan, we will obviously be marketing it very extensively.

Operator

Operator

I am showing the final question at this time from Spencer Nam from ThinkEquity.

Spencer Nam

Management

Just one follow-up question on the HCV Merck partnership, as the partnership will need to be revisited later in the part of the year, I was curious how, what sort of a lead time you guys will have in terms of having the discussion with Merck about continuing on, or coming up with some new set up if that’s necessary. Have you guys begun that conversation yet or is it going to be a little more close to the exploration time if you will?

Douglas Michels

Management

No, there are certainly some lead times associated with the need to - by each party to express their intention to renew or desire to renew the agreement or to modify or terminate. And we’ve begun the discussions. I’ve said all along that we’ve been quite pleased with the Merck relationship. Both parties have honored our respective commitments and the communication channels are pretty wide open. We meet regularly with them, have weekly conversations with them, meet in person with them no less than monthly. And so my hope is that we will continue to work with Merck and obviously as the marketplace develops, we will look at other opportunities to see how we can enhance our presence in the marketplace, possibly through other arrangements. But we will have more to say about that as those discussions continue and we make progress, I just want to be clear, and I hope you have seen from the data that I have shared with you today, we’re making some progress now, apparent progress with the detailing efforts, we’ve got to see that translate into meaningful revenue which we expect it will. And we will just continue to update you on both the progress of the business as well as our continued relationship with Merck.

Operator

Operator

Okay. Ladies and gentlemen due to available time that brings an end to the Q&A session of today’s call. I will now turn the call over to Doug Michels for closing remarks.

Douglas Michels

Management

I just want to thank everybody for participating on today’s call and obviously for your continued interest in OraSure. And I wish you all a good afternoon and a good evening. Thanks again. Bye bye.

Operator

Operator

Ladies and gentlemen this does conclude your conference. You may now disconnect. And have a great day.