Earnings Labs

OraSure Technologies, Inc. (OSUR)

Q4 2008 Earnings Call· Wed, Feb 11, 2009

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Transcript

Operator

Operator

Good day ladies and gentlemen and welcome to Orasure Technologies 2008 Fourth Quarter and Full Year Financial Results Conference Call and simultaneous webcast. (Operator Instructions) For opening remarks and introductions I will now turn this all 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 2008 fourth quarter and full year 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 accessed by opening the Investor Relations page and clicking on the link for news 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 February 16, 2009 by calling 800-642-1687 for domestic or 706-645-9291 for international. The access code is 83800004. With us today are Doug Michels, President and Chief Executive Officer and Ron Spair Chief Financial Officer and Chief Operating Officer. Doug and Ron will begin with opening statements which will be followed with question-and-answer sessions. 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 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, 2007, 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. Also, please note that today’s results will include a discussion of certain non-GAAP financial measures. Non-GAAP reporting is provided to help you better understand our business and certain items which impacted our results; however non-GAAP financial results are not meant to be considered as a stand-alone measurement of performance or as a substitute for, or as superior to GAAP results. You should be aware that non-GAAP measures have inherent limitations and should be used only in conjunction with Orasure’s consolidated financial statements prepared in accordance with GAAP. Our press release includes a table detailing the non-GAAP measures together with the corresponding GAAP results and a reconciliation to GAAP. We encourage listeners to view these items. With that I would like to turn the call over to Doug Michels.

Douglas Michels

Management

Thank you Judy and good afternoon everyone. Welcome to our fourth quarter and full year 2008 earnings conference call. For today’s call Ron Spair will begin with a review of the fourth quarter and full year 2008 financial performance. You will note our adjusted full year financial results exceeded the guidance provided on the third quarter earnings conference call. Ron will also provide our financial guidance for the first quarter of 2009. After that we will discuss some additional updates including progress we are making on the company’s major clinical development projects. We will conclude by opening the floor for your questions. Now let’s turn to Ron’s financial overview. Ron?

Ronald Spair

Management

Thanks Doug and good afternoon everyone. I will start with a brief review of our full year 2008 financial results. 2008 revenues were $71.1 million representing a 14% decrease from the $82.7 million reported in 2007. Increased sales in infectious disease and insurance risk assessment testing together with an increase in licensing revenues were offset by an expected decline in sales of our cryo surgical, wart removal, and substance abuse testing products. The overall 6% growth in our infectious disease revenues in 2008 was a result of strong sales of our OraQuick rapid HIV-1/2 antibody test. Sales to public health increased 28% over 2007 and benefited from the growth in our base business and from the incremental sales driven by the Centers for Disease Control and Preventions efforts to increase HIV testing. Our sales to Abbott decreased 18%. This was driven by our decision to go to a direct sales model in 2009 for US hospitals which resulted in a reduction of Abbott’s purchases late in 2008. Our overall cryosurgical revenues decreased 55% compared to 2007. The absence of US and Mexican over the counter sales coupled with reduced OTC sales in Europe were large contributors to this decrease. As we explained in prior calls our Latin America OTC distributor Genomma, reduced its purchasing levels in 2008 in response to an increase in return product from retailers due to over stocking during the winter months. The absence of US OTC sales resulted from the termination of our domestic distribution relationship with Prestige brands at the end of 2007 and European OTC sales declined due to lower revenues experienced by our distributor SSL in key markets outside of the United Kingdom. Our combined cryosurgical sales in the professional market decreased by 15% as the business was affected by the diversion of…

Douglas Michels

Management

Okay thanks, Ron. I will now provide an update on several important initiatives and programs. As you know and as Ron indicated we terminated our distribution agreement with Abbott Laboratories at the end of 2008 and on January 1, 2009 we began selling our OraQuick ADVANCE HIV-1/2 test directly to US hospitals and reference laboratories. These customers were previously served on an exclusive basis by Abbott. I am pleased to report that the transition to a direct sales and service model has been very well executed. We have secured contracts either through assignment or a new agreement with all major hospital group purchasing organizations previously buying OraQuick from Abbott. These GPOs represented approximately 80% of Abbott’s OraQuick business in 2008 with the balance being conducted with hospitals without GPO affiliation. We now have agreements in place to serve over 1,500 hospitals and we have already received, in January alone, orders from customers that represent nearly 35% of Abbott’s 2008-customer base. In short, our direct sales effort is off to a great start and we have the necessary resources in place to capitalize fully on opportunities in the hospital market in 2009 and beyond. Turning to some of our strategic priorities, as you know, during the fourth quarter we filed a pre-market approval application or PMA with the FDA for our OraQuick HCV test. Since the filing we’ve been in frequent communications with the FDA and we’ve responded to questions and provided additional information to the agency as they have progressed through the review process. We expect this process will continue over the next several months. As part of its review, the FDA came to our Bethlehem facilities to conduct the first audit related to our filing called a Bioresearch Monitoring or BMO audit. This is a normal part of the…

Operator

Operator

(Operator Instructions) Your first question comes from Sean Bevick of SIG. Sean Bevick – SIG: I have a couple of questions about the false positives that were reported a few months ago at the NYC clinics. Have those false positives been leaking to any other regions? Also, you guys mentioned before that you guys monitor the false positives in your own database. Has there been any change in those false positives over the last few months?

Douglas Michels

Management

No. You know we have a very robust sentinel site-monitoring program and the OraQuick product continues to perform exceptionally well. I think testament to that is the recent approval of our request to actually extend the dating of the OraQuick product based on enhancements that we’ve made to the product raw materials as well as the manufacturing process. So, no the product in the field continues to perform to its FDA approved specifications and we believe that the enhanced product is going to make that performance even more robust. Sean Bevick – SIG: Okay and then has the FDA had any concern with oral fluid testing with regards to what happened with this NYC stuff and the HCV approval?

Douglas Michels

Management

You know, our position with the FDA has always been one of complete transparency and the FDA has access to all of our records, they have access to all of our complaint files. I think testament to the strong performance of the OraQuick product is the fact that they’ve approved an extension of the products dating recently announced by us. The hepatitis C application has been submitted. It’s a complete submission and as I mentioned in my prepared remarks, the FDA has already conducted a BMO audit here, has audited one of our clinical sites and that process continues to progress. The FDA continues to be extremely supportive of our efforts and things are actually going very well.

Operator

Operator

Your next question comes from Aaron Lindberg with William Smith & Company. Aaron Lindberg - William Smith & Company : I have a quick question on the cryo product. Do you anticipate launching additional cryosurgical products in 2009 or just the one that you mentioned earlier, the wart product, the branded wart product?

Ronald Spair

Management

Right now our plans are to launch the wart product. As we mentioned we are launching that in Rite Aid. We expect that product to be in excess of more than 4,500 stores. We are having ongoing dialogue with other retailers. Obviously we are going to monitor how the brand performs and we will make future decisions on expansion as the year progresses. Aaron Lindberg - William Smith & Company : Okay unrelated to the wart though, one of the things you’d talked about previously was other indications. Is that something where you continue to progress or is that something that’s kind of a secondary objective here for this year?

Douglas Michels

Management

No, we are still highly interested in looking at other professional indications that we can take over the counter. We have ongoing efforts to bring another product to market right now. We haven’t disclosed what that indication might be, for competitive reasons, but it’s an active program. Aaron Lindberg - William Smith & Company : Okay and so that’s still possible in 2009?

Douglas Michels

Management

We haven’t really put any time parameters on that, but we’re trying to move it through an approval process as quickly as possible. Aaron Lindberg - William Smith & Company : Okay and I have one other quick question for you, as it relates to HIV, have you made progress on a new city wide initiative and can you update us on results with New York City, DC or others where you have had an effort like that?

Douglas Michels

Management

The OraQuick business just generally, as Ron indicated in his financial summary, continues to perform extremely well, within the public health sector in particular. Our efforts in Washington DC, in Philadelphia, in New York City, those jurisdictions continue to expand testing as testing rolls our more outside of the public health venues and begins to be adopted for routine testing in other clinical settings like hospitals and corrections institutions environment, etc… The CDC, as I mentioned, recently expanded the number of jurisdictions that are eligible for the grant monies related to the heightened response to focus monies on prevention efforts among the African American communities and the two new jurisdictions added in 2009 were Mississippi and Texas. We’re actively involved with both of those jurisdictions, particularly Texas and Texas very broadly is going to represent some nice growth for us in 209. Obviously we’re working with all of the jurisdictions and I think we’ve talked about this previously, that well more than 80%, 90% of the jurisdictions use OraQuick and use OraQuick virtually exclusively and so we’re benefiting from that increased focus and we believe that the public health sector is going to continue to drive nice growth for us in 2009.

Operator

Operator

Your next question comes from Ed Shenkan with Needham & Company. Ed Shenkan - Needham & Company: Thanks. Doug, we noticed that Abbott ordered over $1 million in the quarter. We were surprised there. Are you expecting any future orders from Abbott?

Douglas Michels

Management

No. As I thought we tried to make clear, the Abbott relationship is terminated as of December 31, 2008. On the first of January we began serving the hospital customers directly. This was a huge effort that took most of the fourth quarter to affect. We had to build the operational capability. We had to hire the sales force. We had to make sure we had the contracting capability. All of the order to cash functions had to be either built or the infrastructure shirred up such that we could take orders, fulfill those, invoice, and collect on those orders. Since that time we’ve been out with our field force securing the base. Making sure that customers could transact business with us and they have been very successfully. Knock on wood; we have had not glitches in any transaction related situation. I mentioned the success we’ve had in either assigning or contracting with customers and with the group purchasing organization and now our focus is on growing the business. We made this decision because we believed that we could accelerate growth in the hospital market by taking this business and serving these customers directly and not only that, it set the stage for the introduction of new products, additional products, like the hepatitis C test once it’s approved. As Ron mentioned, there was a transition payment that we made to Abbott. That really signaled the last of our obligations to Abbott under that agreement. Ed Shenkan - Needham & Company: And I think you mentioned 80% of the GPOs that Abbott had you’ve now got under contract. What percent of those have sales force from Orasure presence currently?

Douglas Michels

Management

No, what I described is that the GPOs that were under contract with Abbott represented approximately 80% of their sales volume. I indicated that we have contracted or signed contracts with all of them to Orasure. I also referenced that more than 1/3 of Abbott’s customers from 2008 ordered from us in January alone. We’re monitoring this very carefully. We want to make sure that all of that business converts over and we’re tracking what customers order. What customers ordered in the fourth quarter get ordered now in the first six weeks or so of 2009 and we’re very pleased with the metrics that we’re seeing so far. Ed Shenkan - Needham & Company: What impact did foreign currency have on your business in the fourth quarter and what is the expected impact in ’09?

Ronald Spair

Management

The business wasn’t really impacted by foreign currency in the fourth quarter of 2008 to any material level. Our expectation is that it won’t have a major impact on us in 2009. If anything potentially favorable visa vie ’08 as a result of the decline of the euro versus the dollar and we do purchase product in euro and we also have sales folks overseas where we have compensation arrangements denominated in euros and pounds. So with both of those currencies declining we’ll see a little bit of an advantage there versus ’08 in the comps. Most of our revenues are denominated in dollars. We’ve tried to work that so we think that foreign currency will not be a significant impact and if anything a potential benefit for us as the dollar strengthens. Ed Shenkan - Needham & Company: Thank you, that was very helpful. On the R&D budget for 2009 can you give us any idea on what the total spend might be and then what might be some variances? Obviously depending on what the FDA comes back to you on as far as how to set up your protocol.

Ronald Spair

Management

With respect to the spending in 2009, we do have an expectation that R&D will be down by several million versus the level attained in 2008. As a result of our completion of the HCV clinical trials and the submission of the PMA, that large expenditure has gone away. So although we expect to conduct and complete the OraQuick OTC HIV trials in ’09 together with CLEO waiver studies, CE Mark submission, the high through put assay collaboration with Roche, overall we do expect the clinical and R&D spend to be down by several million versus ’08. Ed Shenkan - Needham & Company: That’s very helpful, thank you.

Operator

Operator

Your next question is a follow up question from Aaron Lindberg with William Smith & Company. Aaron Lindberg - William Smith & Company : Thanks. Have you guys signed additional distributors internationally for ADVANCE particularly in developed countries, Europe or the Far East?

Ronald Spair

Management

We have. We’ve signed several new distribution agreements, particularly in Eastern Europe, several in the Middle East and we’ve also signed others in the Far East. That effort to expand our business on a global basis continues and we still believe that it represents a significant opportunity for the company. Aaron Lindberg - William Smith & Company : That is excellent. Did that impact Q4 or when do you expect that to start to have a material impact?

Douglas Michels

Management

Well we think that the International business will continue to expand in 2009. Aaron Lindberg - William Smith & Company : It will expand sequentially through the year likely?

Douglas Michels

Management

Yes. Aaron Lindberg - William Smith & Company : Then in regard to your HCV submission, is there any information requested by the FDA that has not yet been provided by Orasure?

Douglas Michels

Management

No. Aaron Lindberg - William Smith & Company : With the 2009 gross margins do you anticipate that they’ll remain consistent from current levels?

Ronald Spair

Management

You know, looking out at 2009 I think we will see an improvement as a result of the improvements in scrap and spoilage across our product lines, together with the positive impact of the decision to go direct in the hospital channel and improving our gross margins on the OraQuick sales there. Aaron Lindberg - William Smith & Company : Okay. Then you said with the HCV you plan to submit for CE Mark in a few months, is that May or can you help tighten that down for us at all?

Douglas Michels

Management

It will be somewhere around mid-year. Aaron Lindberg - William Smith & Company : Mid-year, okay thanks.

Operator

Operator

You have no other questions at this time. Do you have any closing remarks?

Douglas Michels

Management

I just want to thank everybody for coming on the call this afternoon. As we tried to communicate we are extremely excited about the many programs that we have ongoing that are certainly in the final stages of development. We are looking forward to a very successful 2009 and certainly appreciate all of your support. Have a great evening.

Operator

Operator

This concludes today’s conference call.