Earnings Labs

OraSure Technologies, Inc. (OSUR)

Q2 2015 Earnings Call· Wed, Aug 5, 2015

$3.04

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Transcript

Operator

Operator

Good afternoon, everyone and welcome to OraSure Technologies 2015 Second Quarter Financial Results Conference Call and Simultaneous Webcast. As a reminder, today’s conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks there will be a question-and-answer period. [Operator Instructions] To allow time for as many questions as possible questioners are asked to limit themselves to only a single question with no more than one follow-up question related to the same topic. Once the follow-up is completed the questioner can rejoin the queue for further questions. OraSure Technologies issued a press release at approximately 04:00 PM Eastern Time today regarding its 2015 second quarter financial results and certain other matters. The press release is available on our Web site at www.orasure.com or by calling 610-882-1820. If you go to our Web site, 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 Web site and will be archived there for seven days. Alternatively, you can listen to an archive of this call until midnight August 12, 2015, by calling 855-859-2056 for domestic or 404-537-3406 for international. The access code is 78882836. 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. 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, 2014, 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.

Doug Michels

Analyst

Okay. Thank you, Rena and good afternoon everyone and welcome to our call. We delivered strong performance in the second quarter. Consolidated net revenues reached a he record high and exceeded $30 million for the time in our history. As a result we exceeded our guidance on both the top and bottom line. The primary driver for this performance was our molecular collection systems business which also delivered a record level of revenues. This segment increased 65% over the prior year period. Domestic sales of our OraQuick rapid HCV test increased 39% over the second quarter of 2014. This also represents 41% sequential growth from first quarter of this year. Together with the $3.4 million in exclusivity payments recognized under our HCV co-promotion agreement with AbbVie, total HCV related revenues were $5.7 million for the second quarter. The revenue growth combined with favourable margins generated a $2 million net profit for the second quarter. Ron will provide more detail on our second quarter performance and following his financial overview I will provide additional commentary on specific segments of our business including recent developments involving our rapid Ebola test. So with that, let me turn the call over to Ron.

Ron Spair

Analyst

Okay. Thanks, Doug and good afternoon everyone. Our second quarter 2015 consolidated net revenues increased 15% to 30.4 million compared to 26.4 million reported in 2014. Our consolidated net product revenues of 26.3 million increased 3% largely as a result of higher sales of our molecular collection systems, OraQuick HCV and intercept products. Other revenues were 4.1 million in the current quarter of which 3.4 million represents the recognition of exclusivity payments under the AbbVie agreement. In addition $714,000 represents revenue associated with Ebola related funding we are receiving from the Biomedical Advanced Research and Development Authority or BARDA. Other revenues in the second quarter of 2014 included $775,000 of AbbVie exclusivity payments. Our overall infectious disease testing revenues decreased 7% in the second quarter of 2015 when compared to the second quarter of 2014. Total HCV related revenues, including the recognition of AbbVie exclusivity payments, increased 92% to 5.7 million in the second quarter of 2015 compared to 3 million in the second quarter of 2014. HCV product revenues increased 7% to 2.3 million in Q2 from 2.2 million in the prior year. Sales of our OraQuick HCV professional product in the domestic market increased 39% in the second quarter of 2015 to 1.7 million from 1.2 million in the prior year. This increase is largely due to the addition of new HCV customers and higher sales to current customers who have expanded their HCV testing programs. International sales of our HCV test in the second quarter of 2015 decreased 34% to 646,000 from 974,000 in the same period last year, primarily due to lower purchases by a multinational humanitarian organization. Purchases by this organization can be variable. Influenced by its worldwide field activities and our thus difficult to predict. Domestic sales of our professional HIV product decreased 15%…

Doug Michels

Analyst

Okay. Thanks, Ron. As previously indicated DNA Genotek had another record quarter with revenues 65% higher than the year ago period. In fact the $8.1 million in revenues reported by DNA Genotek exceeded its previous record revenue level by almost 20%. This performance was above expectation and was driven by very strong sales in the commercial market and continued strength in the academic market. Revenues from commercial customers comprised approximately 66% of DNA Genotek second quarter total while academic revenues represented the remaining 34%. A big contributor on the commercial side was 23andMe which delivered almost $1.5 million of revenue for the quarter compared to no revenue in the comparable 2014 period. But even without the 23andMe contribution our molecular collection systems segment grew approximately 40%. This is strong evidence of the benefits of customer diversification which has been a priority for this part of our business. As I noted during our last earnings call one promising new area of focus is the breast cancer screening market. During the second quarter we experienced almost 800% growth in that market compared to the year ago quarter primarily because of the addition of one of the largest breast cancer screening providers in the market. Our pharmacogenomics revenue also showed good growth with an almost 80% improvement compared to 2Q 2014. The increase in DNA Genotek’s product sales has led to further expansion of our manufacturing capacity. As you may recall a new automated manufacturing line was installed at DNA Genotek's contract during the summer of 2014. In order to continue to meet product demand, we are now in the early stages of purchasing additional automated manufacturing equipment which is expected to become operational early next year. This additional equipment should double our existing production capacity. In addition to diversifying its commercial customer…

Operator

Operator

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

Kate Blanton

Analyst

This is actually Kate in for Brandon. And thanks for taking the questions. Just to start I guess first on the AbbVie relationship so is it fair to say you didn’t see any progress on AbbVie’s contractual obligations in the period in the second quarter and are you so confident they are going to meet these minimums throughout the second half?

Doug Michels

Analyst

Yes. Absolutely like I mentioned, we've seen detailing activities increase to what we saw at the end of 2014 and we fully expect that they will meet their obligations.

Kate Blanton

Analyst

And maybe Ron then can you discuss how we should expect sales and marketings tend to step up in the second half as a result of those recent activities and how that will pace for maybe 3Q to 4Q?

Ron Spair

Analyst

Right, so that's a great point and with the increased detail and our activities in the domestic marketplace will come additional expenditures for our sales and marketing and right now we are anticipating that that will step up by from Q2 to Q3 by over $1 million dollars in expenditures and we don’t have a perfect view on Q4, but we certainly expect it to be significantly higher than where we were at Q2 and it will depend on the activities that we’re engaged in at that time, but I think it's safe to say that the second half expenditures to sales and marketing will be sequentially higher than the first half.

Kate Blanton

Analyst

And just one last one on Ebola maybe did you recognize any orders to CDC in the second quarter and do you expect they are going to come through in the second half now with the approval, what are observations?

Doug Michels

Analyst

We did we recognized about a little shy of $400,000 in Q2 in Ebola revenues. And we’re working to secure additional revenues in the back half of the year we believe that we will realize revenues not prepared right now to dimensionalize those, but as I mentioned in my prepared remarks we are looking to secure significant and sustainable procurement contracts.

Operator

Operator

Thank you. Our next question comes from the line of Peter Lawson from Mizuho Securities. Your line is open.

Peter Lawson

Analyst

Wondering if you’d give anymore color around the increased detailing you are seeing with AbbVie?

Doug Michels

Analyst

Well. I think the only color we can provide is, is that AbbVie as we indicated last quarter has stepped up their activity and they are back providing primary or secondary details into the physician office market for the agreement. And we've spent time refreshing training with their organization and with ours and the two organizations continue to work together in the field to promote both the rapid test as well as the patient support program so it's back being executed as we indicated and anticipated.

Peter Lawson

Analyst

And then just any additional color you can give around the refocusing of the co-promotes with AbbVie and where is that headed and I wonder if you could elaborate upon the markets challenges anything new emerging?

Doug Michels

Analyst

No I don’t think it's anything new but clearly there have been challenges in terms of encouraging adoption in terms of transitioning from interest to deployment and we've taken steps through the training to streamline some of those processes with AbbVie to make it easier both for their organization as well as ours to implement training on a more timely basis. Certainly there have been challenges on the broader therapeutic front with authorizations and challenges like debt with insurers but those things are working through the system and one thing is for certain these drugs whether delivered by Gilead or AbbVie are working people that have been quietly infected are getting cured and all indications are is that we continue to work through the large number of warehouse patients that have been previously diagnosed and as we continue to work through that patient population interest in identifying new patients is going to continue to increase.

Operator

Operator

Our next question comes from the line of Nicholas Jansen from Raymond James. Your line is open.

Nicholas Jansen

Analyst

A couple of quick questions, first on the strength in DNA Genotek just wanted to kind of get a better sense I think Ron you said that the academic customer revenue might step down sequentially, but bigger picture is this an asset that continues to reprise more and more every quarter how should we think about the sustainability of the long-term revenue here and even more importantly as you add more product to the platform with the -- you have got Microbiome and thinking on those lines how do we think about those being incremental to the revenue trajectory?

Doug Michels

Analyst

Yes so Nick this is Ron here, I think if you look at the long-term prospects we're very bullish on the future growth opportunities for the molecular collection business. In the quarter we saw strength both academic and commercial. The academic strength is a little bit a timing of orders and so that's why we indicated we're probably going to see a decrease in revenues from the academic market in Q3, but still business is very strong. Commercial was up significantly, we highlighted the order from 23andMe in the quarter that or the contribution from 23andMe in the end of quarter that we didn't have in Q2. We also secured a couple of new significant customers, particularly in the breast cancer screening area and one of those was substantial such that they placed large orders on us in the quarter, some of that is stocking, some of that is to provide our collector to their customers. We expect that customer to continue to purchase through the remainder of the year probably not at the same level that they did in Q2 but again significant contributor to the business. With regards to new products, we did realize about $100,000 from contribution from the Microbiome in the quarter. And we have a lot of interest in that product offering and we expect that's going to continue throughout the remainder of 2015, I caution that I really -- I don't expect significant contribution from that product line this year as we continue to validate its value but interest level is extremely high and we expect that will contribute more substantially in 2016. The OMNIgene Sputum product directed to the tuberculosis market, wow, I mean it's in the hands of researchers all around the world. We're beginning to generate data on the performance of that product that is in the early days, they are encouraging. But once again, it's not going to contribute in any significant way to revenues in '15, but will begin in '16 and probably a little bit more towards the end of '16 and into '17. So, the business is very healthy, and the team is really doing good job managing both the revenue as well as the expense line at DNA Genotek.

Nicholas Jansen

Analyst

Then secondly, Ron, the strength in gross margin I would assume some of that has to do with mix on HCV bouncing back, DNA Genotek obviously quite strong, just wanted to get a better sense of -- and then you have the royalty -- incremental royalty from the BARDA contract but just want to kind of get your views of how we should be thinking about gross margins over the near to intermediate term?

Ron Spair

Analyst

Sure, so your observations are spot on Nick the mix did contribute and certainly the magnitude of the other revenues, the amortization of the exclusivity payments as well as the BARDA revenues have contributed approximately 500 basis points of a difference between 2014’s Q2 and 2015’s Q2, looking forward I think some of them -- a lot of that will be sustainable from the exclusivity payments as well as ongoing contributions from BARDA assuming obviously that we continue work with them which we have every expectation to doing so. Then it will come down to the mix and the contribution from the DNA Genotek HCV revenues as you pointed out and the magnitude and proportion of them in relation to the other pieces of the business. So, looking at it we feel comfortable that gross margins will comfortably stay in the mid-60s and on occasion trend up towards the higher 60s where we have the kind of mix that we had in Q2.

Nicholas Jansen

Analyst

And then lastly, Doug, the HIV franchisee obviously is going from some pressures associated with next generation devices and tests and I was wondering if there's anything that you could do from an FDA standpoint in terms of enhancing your product capabilities or from a competitive standpoint in terms of pricing or something along those lines where you can see less pressure then down low-teens that you have seen in the first half of this year? Thanks.

Doug Michels

Analyst

Yes so we've indicated previously that we were going to -- we expected continued pressure on that business at least for the remainder of this year, and revenues were soft in the public health and hospital market. Our business in the physician office lab was up actually. It's a challenging situation with challenges on the funding front, point of care, HIV testing is actually down here in the United States with this migration to lab based fourth generation test systems, I hate to say this but that’s true and it's a good thing incidence is down, right. So as we have made progress over the years with testing more people and identifying more positives the incident HIV infections continues to decrease here in the United States, the number of people who are unaware of their infection continues to be reduced and that all puts pressure on the HIV testing business, and obviously being a leader in rapid point of care testing here in the United States we get disproportionally impacted. We have been able to maintain our pricing pretty effectively and we’re going to continue to try to manage that as best we can. We’re looking for growth opportunities where we can leverage the technology advantage we have with HIV and hepatitis C from a deployment, execution and ease of use perspective and then we believe there is some opportunities on the international front. So we’re still swinging hard at the ball but like I said we expect to have continued pressure on that franchise for the rest of this year for sure.

Operator

Operator

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

Dave Westenberg

Analyst

So I wanted to ask just on the strategic front. Is there any sort of opportunity you are looking for in the M&A front, and what sort of areas that I think we would or would you think sort of benefit you right now?

Ron Spair

Analyst

Yes so Dave it's Ron here and we’re actively looking and evaluating a number of different opportunities out in the marketplace. As we have talked about before looking at products licensing of products and those technologies, companies that would generally compliment what we’re doing in the DNA Genotek area more in the molecular than in the immuno-acid area. And so we continue to look but we’re maintaining our discipline as far as criteria to move forward and execute a transaction.

Dave Westenberg

Analyst

And then on DNA Genotek, can you maybe highlight some of the high profile wins or if not that I know you've given sort of some of the customer types but maybe just on a go forward basis maybe some of the areas that you are looking into for new customers on the DNA Genotek?

Ron Spair

Analyst

Yes for competitive reasons we’re reluctant to disclose who some of these new customers are, but suffice it to say a big focus area has been in the pharmacogenomics area in the carrier screening area in reproductive medicine and then of course more broadly on the academic front. So pretty broad focus but certainly those areas that I highlighted represent we believe to be some of the bigger opportunities in the growth areas for DNA Genotek's business.

Operator

Operator

Thank you. [Operator Instructions] And it looks everybody is in the queue at this time. So I would like to turn the call back over to Doug Michels for closing comments.

Doug Michels

Analyst

Okay. I just want to thank everybody for dialing into our call this afternoon. And appreciate your time. Look forward to updating you on our Q3 performance in a few months. Have a great afternoon and evening everyone.