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Executives

Douglas A. Michels – President and Chief Executive Officer

Ronald H. Spair – Chief Operating Officer and Chief Financial Officer

Analysts

Amit Bhalla – Citigroup Inc.

OraSure Technologies, Inc. (OSUR) Citi Global Healthcare Conference Call February 26, 2013 9:35 AM ET

Amit Bhalla – Citigroup Inc.

I’m Amit Bhalla from Citi’s Life Science Tools and Diagnostics Team, and with me from Citi is Nick Morton to my left, and he is on our team as well. We are very happy to have our next presenting company, OraSure Technologies. And with us from the company are Doug Michels, President and CEO, and Ron Spair, Chief Financial Officer.

What we are going to do today is, we are going to have a fireside chat with Doug and Ron. And before we jump into the discussion itself, Doug, can you just give us a quick overview of the company and then we will go into Q&A.

Douglas A. Michels

Sure, I’ll be happy to and first of all thanks for inviting us to the conference today. We are obviously delighted to be here. So, for those of you who aren’t familiar with OraSure Technologies, OraSure was formed in 2000 as a merger between a publicly traded company Epitope which was based in Beaverton, Oregon and a small private company in Bethlehem, Pennsylvania. We came together in 2000 to form OraSure. Both of those companies contributed technology into the company primarily around oral fluid diagnostics, whether it was in the infectious disease or substance abuse diagnostic area. And the company has built leadership position in those businesses on the oral fluid diagnostic front since that time.

I joined the company in 2004, it was shortly after OraSure introduced the first ever rapid test for HIV here in the United States. It was FDA approved in 2002 with the OraQuick rapid HIV test. It’s approved for use with both the blood specimen and an oral fluid sample. And it is now the market leading rapid HIV test here in the United States, the dominant share is in both the public health market as well as the hospital market where our new test is primarily sold.

Since that time, the company has really capitalized on the innovation and leveraged our platform technology, this rapid HIV test. We now have a rapid test for Hepatitis C, it’s the first ever rapid test for Hepatitis C approved by the FDA and that was launched last year. I can talk more about that as we get into today’s discussion. But obviously exciting new developments in Hepatitis C therapy and obviously with some of these new developments it becomes very important to identify the large number of American people all over the world that are affected with chronic Hepatitis C, so they could go in for therapy and ultimately be cured.

Last year, we received FDA approval to make our rapid HIV test available direct-to-consumers. This was a long term program that we were investing in for about seven years. And in July of 2012, we received the first FDA approval for any self-test to be made available over-the-counter for an infectious disease. So it was a landmark decision for the FDA. It’s a very exciting opportunity for OraSure Technologies and for public health. There continues to be approximately 1.1 million, 1.2 million Americans infected with HIV and approximately 20% to 25% of those infected are unaware of their infection and despite the availability of rapid diagnostics and laboratory based HIV diagnostics available for sometime, they are still the significant portion of individuals chronically infected but unaware in our population. And unfortunately, those individuals who are infected but unaware are disproportionately responsible for the forward transmission of HIV responsible for somewhere between 50% and 70% of all new infections.

So we believe and healthcare leaders around the country believe that having a product available OTC available for consumers that they can purchase anonymously, confidentially and testing the privacy of their home would be an important tool, is an important tool in the fight against HIV. And I can talk a little bit about how that launch has gone and we were very excited about and we are very pleased with our progress to date and we expect that’s going to be a very important contributor not only to future sales but also profitability for the company.

Also about a year and half ago, we acquired a very exciting and dynamic company in Ottawa, Canada called DNA Genotek. DNA Genotek is a primary business is an oral collection system for molecular diagnostics leveraging proprietary technology regulatory market leader in oral collection systems into the academic research market, but they also have a growing commercial business where they provide this sample collection and stabilization technology to commercial entities like ancestry.com and 23andMe companies that serve the consumer and public with genetic testing services. And so a really exciting business, we’re also working on some new technologies for other types of specimen collection at DNA Genotek.

So if you look at how the company has progressed over the last 12 months to 18 months with these new product approvals, these are exciting new opportunities on the acquisition of DNA Genotek. We’re beginning to diversify our product offering into other growth areas, which we believe will serve not only the company, but our investor as well in the future. So that’s one feel good about OraSure.

Amit Bhalla – Citigroup Inc.

Thanks, Doug. So next overview, and I want to start with the new products. And when I think about value in healthcare, your home based testing would certainly help address some of the burdens that have caused. But you have to repel with adoption and that’s been for the wild card specifically thinking about – what specifically thinking about the HIV test as well as Hep C. Let’s start with home based HIV testing and walk us through some of the challenges that you’ve faced so far and some of the many surprises that you’ve seen with the test?

Douglas A. Michels

It’s an interesting time in healthcare delivery, right, there’s enormous pressure on institutions to reduce cost and improve quality to improve access to different services. And we believe that over-the-counter testing options particularly when you are using the exact same technology that’s used in the professional marketplace, represent a compelling value proposition for everybody involved in the chain.

I think it’s one of the reasons why our professional customers, whether it was in public health or in acute care provider market whether it is the HIV advocacy organizations or even the HIV activist groups, we are so supportive of making OraQuick available direct to consumers. I think there is a recognition that with these technologies that are highly accurate that has been proven, we’ve sold over 25 million of these devices into the professional market, its simple and easy-to-use, it’s highly accurate. And this model has been proven with confirmatory test since the mid 70s. So if people, if you can present the product to the consumer, you can educate them with your packaging and instructions for use. If they understand the limitations of the product, this can be another valuable tool.

And we conducted an extensive amount of market research which confirmed what we believe was a very large market opportunity at retail. Our market estimates suggest that opportunity at retail is in excess of $500 million. Our market research suggested based on all the critical studies that were required that consumers could after reading instructions for use could perform the test accurately, could interpret the results appropriately and they knew what to do with the results once they got it.

So if they had a positive testing even if it was a preliminary positive. They had to have it confirm by a healthcare professional. Over 95% of consumers indicated that if they tested positive, they would contact a healthcare provider and that was very reassuring to the policy makers and the FDA for that matter, because consumers knew what they were getting into and we’ve seen that play out now in the use of the product in the field.

So we have a 24X7 call center. The number of calls that we are receiving at the call center are very consistent with those that were received during our clinical study somewhere between 6% and 7% of all users. The types of calls that we are getting are more along the lines of how do I perform the test, may be they have some questions about interpretation of results or importantly if people test positive, some are calling the call center and looking for a referral either to confirmatory test or to additional provider services. So that’s looking exceptionally well. We have absolutely minimal number of complaints from consumers, so that’s now working very, very well.

Support from the retailers has been consistent and very strong from the beginning. So if you saw from previously at launch, the consumer or the major retailers, the Walgreens, CVS, Rite Aid, Wal-Mart took the product and put into broad distribution. We began to promote the product as you recall in the fall after the product got on shelf. We began with PR and some digital promotions, that was in the October, November timeframe. In December, we began our television advertising and with each increment of promotion, we saw an immediate response at retail, as well as [online].

And so the product has performed very well in response to our promotion efforts and our promotion placement. We moved into 2013 with plans to accelerate and increase our media spend, which we’ve done particularly in television and that continues to build. Consumption at retail grew in response to that promotion. So December, our sales were up about 30% over November. January, our sales were up about 40% over December and we expect to see continued increases as we go through 2013 all in response to our promotion.

Now in addition to keeping the foot on the grass if you will, in terms of keeping the product out with one of the consumer and continuing to raise awareness amongst our target population, we are also going to begin some local market consumer activation programs and we’re going to initially target those into six of the largest MSAs in the United States, those that form statistical areas that have the highest prevalence of HIV in the country. In those markets in addition to continually live on television and the like, we’re going to launch a National Radio Campaign and then heavy up radio with local talent in those MSAs.

And based on the research that we’ve done on this approach, we believe this is going to increase uptick in those markets even more significantly. That’s going to start in March and that will continue through June at least as we then evaluate how that launch goes. We are going to continue with Magic and Magic' Johnson will be out with us in March in LA. And so lots going on, I could talk about it, but another half hour and I will talk about some other things. But we are pleased with the progress to date and we expect more and better as we go out to 2013 and 2014.

Let me just stop this time, I have to ask my colleague over here if you want to…

Ronald H. Spair

No, you go head, you are on a roll.

Douglas A. Michels

Okay. Ron is going to put the numbers behind it.

Ronald H. Spair

Yeah, whatever he is holding to share I guess.

Amit Bhalla – Citigroup Inc.

I think it is the fair question. I mean, you have a lot of detail behind how the well out has been going. I know we can’t certainly push you for longer term guidance. But some perspective on this $500 million market opportunity, first is what the ramp is going to look like over the next 12 months would be helpful.

Douglas A. Michels

I will start and Ron afterwards. One of our challenges obviously is this is a new product and a new category never existed before and so its very difficult to project just where this is going to go with what kind of velocity and that’s why we’ve been pretty hesitant to put anything out there more than a quarter in advance. So I think the best that we are going to be able to do is just continue to keep you updated on the consumption trend, what kind of consumer response we are seeing to our promotion.

I think we’re very much in a learning mode. And this consumer activation work that we’re about to launch in these six MSAs, I think is going to be very instructive, in terms of where we put our promotion dollars. Our initial focus in promotion has been on sexually active adults, generally those $100 million to $120 million within that target market. But then, we’ve looked at sub-populations within that community that express the highest – higher purchasing sense and those sub-populations are men that have sex with men, African-Americans and Hispanics.

And so, if you look at our advertising plans, our promotional plans and you look at where we are buying media, we’re really targeting those websites and those channels where those different sub-populations get the healthcare information. So a lot of times I hear from people they say, well I haven’t seen your [commercial TV] well, okay are you watching Bravo, or are you watching E!, are you watching BET network, because that’s where you’re more likely to see our commercials.

Although we have now expanded into some national network programing, you may have seen this on the Grammy, we are going to be on the American Idol here in the next couple of weeks. So we’re looking at targeted opportunities to expand our presence, but obviously we’re trying to do this as intelligently as we possibly can, and as well as we continue to see this kind of growth rate at least from our perspective plans working and we’re on track to make this an extraordinarily successful and exciting product.

Ronald H. Spair

Well, I think another part of it is, what we’ve been able to accomplish as far as the media buy whereas we were buying 45 second spots earlier in the program, we’ve been able to now move to a mix of 30 and 15 which allows us more impact for the same amount of dollars and so more views that are being secured, again which makes it very difficult to try to extrapolate from the very small set of data we have now to project what our annual revenue would be for 2013 or 2014.

And so that together with the public excavation, we have a lot of information that we are going to be able to secure and I know you are following it weekly and we appreciate that and we’ll be in a much better place three to six months from now to begin to understand what the trajectory looks like after all the efforts that we put into building awareness and triggering consumer excavation over the next several months.

Amit Bhalla – Citigroup Inc.

So if I’m kind of hearing everything that you’ve said, on the plus side, the promotion sensitivity of the product has been a nice surprise for you?

Douglas A. Michels

Well, it has, because you can do all the testing in the world, but until you get that message out there and it gets the consumer of their rear end and either going to a store or buying the product online you never know. So that’s the plan.

Ronald H. Spair

Absolutely.

Amit Bhalla – Citigroup Inc.

The retailer support has been very nice. We’ve noticed that the online, the percentage of purchases online has been higher than we would have expected and that probably goes the privacy aspect of the test. My question is, what have been some of the surprised challenges with this launch that you didn’t expect?

Douglas A. Michels

I wish some came to mind right away, we still have somewhere in the single-digit retail locations that still have the product either behind-the-counter or with some kind of an anti-test device on it, [SpiderWire] or something like that and despite the fact that we agreed with the retailers at the headquarter level that the product would be easily accessible to consumers on shelf in the area. Some local store managers, it’s a very small percentage, but still had chosen either put it behind-the-counter, put some kind of anti-test device and that’s becomes the local store managers call ultimately so they’re responsible for the P&L on that store.

So we continue to work with the retailers and actually we’re getting support from the headquarters to work with their local store managers to try to make the product as easy as possible to access by the consumer. I think this point that Ron made about moving to more 30 and 15 seconds spots was a real important development for us, and we had a great meeting with the FDA just last month, where we laid out our plans to move from 45 down to 30 to 15, they are very supportive given the experience that we’ve had with the call center and like I said the minimal number of any kind of product complaint issues with consumers. So...

Ronald H. Spair

Also the impact of our web-based digital advertising campaign, the number of hits to our website, the views of the instructional videos that we have posted there and the interaction that we have and how much advertising has moved to that digital media is a surprise to me anyway.

Amit Bhalla – Citigroup Inc.

Okay, very interesting. Let’s switch over to rapid Hep C testing.

Douglas A. Michels

Sure.

Amit Bhalla – Citigroup Inc.

The trajectory there is slow, it’s moving forward and you have things such as guidelines that are supportive. Walk us through what accelerates that products pace of adoption.

Douglas A. Michels

The Hepatitis C product like I mentioned the first ever FDA approved rapid test for Hepatitis C, it couldn’t have come at a better time with all the new developments in Hepatitis C therapy whether you are looking 18 months ago with Merck and Vertex or the new therapies that are on the horizon with Gilead and others. In my diagnostic career which expands more than 30 years, I’ve never nearly participated in anything like this. We are really going to take a product disease and turn it on its head quickly. And so we really believe that we are in the right spot at the right time.

I think that’s evidenced by the support and recognition that viral hepatitis is receiving from governmental leaders at HHS with the viral hepatitis action plan. The CDCs support routine Hepatitis C test amongst the birth cohort individuals born between 1945 and 1965 was absolutely the right strategy. To estimate it based on their data, there is 3.25% of those individuals that are chronically infected with Hepatitis C. There is 80 million of them and so should that be adopted as a standard-of-care, we are going to get a very high yield of those 4 million to 5 million chronically infected Hepatitis C patients. We are going to get them identified and now with these new therapies, we can get them to treat them and cure it. So it’s an historic time in Hepatitis C. And we’ve got a great tool that’s highly accurate, easy to use, and the like. What is governing adoption right now, that’s the big question, and really it’s a couple of things.

In the public health market where we’ve embraced rapid HIV testing and there’s a large infrastructure established to support that it’s primarily a funding challenge. And I think that’s has been acknowledged by the CDC, and HHS and others, and we are an active dialogue with them about certainly the need for increased funding and potentially down the road how more funds can be made available to the different jurisdictions to expand testing. I can tell you categorically, that the jurisdictions are prepared and eager to adopt rapid Hepatitis C testing alongside HIV testing, because you are dealing with the same patient population and medications that are at risk for HIV and Hepatitis C, because of the modes of transmission and the like.

On the physician office front it’s a little bit different in that we’re changing physician behavior, and we had a positive development at the end of last year when the United States Public Health Task Force changed the grade for routine Hepatitis C testing within and at risk population they moved it from a C recommendation to a B recommendation, which recommends that people who had never had a history of STV’s or a history of intravenous drug user or what otherwise be considered at risk.

But they’ll be testing for Hepatitis C we were hoping that the task force would recommend that birth cohort that I mentioned also receive either a B or an A grade they gave it a C, which means that you would only test in the case of demonstrated risk and the community is working to affect that, to change that, to upgrade that recommendation, but for the first time those individuals at risk have a B recommendation, so that’s a positive. And we will benefit from that, but now you got to get the medical societies behind that and begin the routine testing.

We’ve got great support from our distributor partners who continue to have our rapid Hepatitis C test as one of their top promoted products. And we anticipate that this is going to be a – continue to be a very successful product for us. So a little bit slower than we would have hoped, but we are in a great position. I think as Gilead’s new drug hopefully get approval hopefully later this year and then into 2014 we’ll find additional opportunities to increase awareness and drive adoption.

Amit Bhalla – Citigroup Inc.

So talk a little about the partnership front for the product. We used to have a partnership that expired (inaudible) discussions on having new partner?

Douglas A. Michels

Well, you’re referring to our relationship with Merck which really predates started with sharing cloud five or seven years ago I would say this is when the product was in its early stages of development sharing. We get together with sharing and entered into a relationship where they supported both the development of the product. From an R&D perspective, we got it through the regulatory process and then they also provided some milestone payments as we achieved certain regulatory or commercial milestones and then they also committed to detail the product into the physicians office market for a certain amount of time after the product was first approved and there was a term limit on the original agreement for two years after which time we had an opportunity to determine whether we want to renew the agreement or modify it or terminate.

And so we enjoyed that relation, very productive relationship with Merck. Obviously in May of 2011, they received FDA approval along with Vertex for the first protease inhibitor. They went out and raised awareness about the product. It’s pretty clear that they were not the market leader with that product at the time. You should also know that, that original agreement had some restrictions on us that kept us from working with companies like Vertex or others, there is quite a long list.

And so two years after we began the co-promotion activities with them, we had the opportunity to determine whether we continue or take a break, and we decided we were going to pull back from that for the time being and really basically eliminate the restrictions that were on us from working with other companies.

So right now, we are unrestricted. We have an opportunity to work with Gilead or BMS or Abbott or Merck or Vertex or any drug company or a diagnostic company for that matter, and we have an open perspective on that. We see opportunities to promote the product alongside with therapeutic providers and we have ongoing dialogue with them, and we will continue. I would suggest that we are not looking to restrict ourselves now on a go forward basis given that we have this innovative and very valuable technology and I don’t see a need to restrict who we work with, but you never know, these are always the negotiations and hopefully we can find the right balance of value for one or more of the drug companies as well as the right balance for OraSure and our stockholders.

Amit Bhalla – Citigroup Inc.

Okay. So finding a new partner doesn’t sound like a priority right now?

Douglas A. Michels

I wouldn’t say that. I would just say that we don’t have anything to talk about right now, but discussions continue.

Amit Bhalla – Citigroup Inc.

Okay. I wanted to jump back to HIV for a second, one thing that I know Ron can give us some detail around in all of this discussion of promotion, talk to us about how much you are expecting to spend this year and how you think it will play out first half versus second half from an expense side?

Ronald H. Spair

Sure. As we’ve talked about our expectations for advertising and promotional spend for the HIV OTC product in 2013 will be in the upper teens of millions of dollars. We’ve also indicated that the skewing of that expenditures will be more front-end loaded during the year here. And so during the first half, we’ll see larger expenditure than we roll into back half of the year. And for the first quarter our expectations are that we will be spending just a little over $7 million in advertising and promotional spend, which will include all the TV and the promotional spend with Magic Johnson, the public activation that Doug spoke of earlier.

Amit Bhalla – Citigroup Inc.

Okay. Let’s switch over to the base business. The base business has been – I guess, if I take the base business in total, it’s been slightly – its been declining little bit faster than we would have thought and we really think of the new product that reflects to the story overall. Given the sense to the visibility you have on a quarter-to-quarter, or a yearly basis for the trajectory of the base business.

Douglas A. Michels

I think we have a pretty good visibility actually, and we obviously try to reflect that in our guidance. There are some aspects to the base business that can be somewhat lumpy. So, for example, our cryosurgery business is a great example of that. Last year the cryosurgery business was up little bit more than we anticipated. That had to do with some unexpected increases as our partner in Mexico and South America (inaudible). Resolve some of the regulatory issues that they had in Mexico and Brazil, and so we saw little higher purchases there.

And you recall that our European Cryo OTC business transitioned from SSO to rapid (inaudible), put some more promotion behind the business. So we saw really better than expected performance in our cryosurgery business last year. That will come down a little bit in 2013; we anticipate we’ve talked about that before. But the business remains quite healthy it’s actually our highest margin business in the company.

Some of the challenge we’ve had on the HIV professional part, you really have to look at it by segment. So our hospital business with HIV where we sell the product into hospitals for routine testing for labor and delivery for occupational health it’s actually has been quite healthy. And quite stable we haven’t seen any reduction in that business to speak of at all. Our physician office business in HIV has continued to grow and has grown quite nicely. And we would expect that with the new public health service task force recommendation on HIV screening, which now recommends routine HIV testing for individual 15 to 65 that – we should see some benefit from that with increased HIV testing overall.

Some of the challenge we’ve had in our HIV professional business has been in the public health sector, which is real sensitive to funding challenges, and the bulk of ours has been with some program contraction and funding challenges on the public health front.

I talked a little bit about DNA Genotek. We think of that as part of our base business right now. And like I mentioned we anticipate some exciting growth at DNA Genotek in 2013 and beyond. Base about 60% to 70% of DNA Genotek businesses in epidemic research on a global basis, and so that part of the business has come under some pressure, but really what they have done is they have offset any challenges in the epidemic research with growth in the commercial sector. So, some of their larger commercial partners are 23andMe which provides generic accessing services to the consumer and public, ancestry.com, council and others and we expect to see continued growth particularly on the commercial front and as the exit of research market stabilizes and perhaps even gets back into somewhat of a growth mode.

We anticipate solid growth from DNA Genotek in 2013 and beyond, if you want to add…

Ronald H. Spair

No, I agree.

Amit Bhalla – Citigroup Inc.

When do you guys see the change in behavior in the testing volume actually change from these national coverage decisions that have been implemented? I mean is this the three years to five years thing that you are going to see things change, or do you see change happening in 2013? And is there also any difference between the potential for HCV and the HIV side of that?

Douglas A. Michels

Yeah, so, there’s a lot of complexity in that question, right?

Amit Bhalla – Citigroup Inc.

Yeah.

Douglas A. Michels

So you have to go back and you look at the adoption of guidelines. These changes in the whole healthcare environment are happening pretty quickly now, largely driven by funding and reimbursement changes, right. And so I think that as more physician offices get acquired by Integrated Health Networks, as this continued pressure comes down on healthcare providers to reduce cost, improve quality, to be more efficient, I think that’s going to drive more behaviors towards prevention.

I think that presents a wonderful opportunity for the deployment of rapid technology, where you can get an accurate fast cost-efficient result, like here right now where you don’t have to have multiple visits by the patient to the doctor’s office or follow-up, because in tomorrow’s world the physicians are going to get reimbursed for that. They’ve reimbursed for that today, because it’s fee-for-service. But tomorrow when those patients are going to be managed from diagnostics to secure and the healthcare institution is going to get one a bundle payment for that.

The incentive to be a more essential is going to change position behavior. I mean, I said on a fixed hospital board and we have valid, and that’s all we talk about. Always talk about is how we are going to reduce costs, how we are going to improve quality, how we’re going to use data, how we’re going to align our physicians and our position behavior to deliver the best possible outcome at the lower possible cost. And that means deploying innovative technologies that are going to advance healthcare move the patient through the continuum and get them through that process as quickly and efficiently as you possibly get.

We are adding another $30 million plus into the system through the Affordable Care Act and we believe that presents a wonderful opportunity for companies like us who had technologies that are easily deployed at the point-of-care in preventive medicine and so it's not all (inaudible). There are opportunities as the government looks to shift some of their spending into some of these preventive services.

Amit Bhalla – Citigroup Inc.

Well, I think if there is no other questions in the audience that's a great point to – we do a have question in the audience, we’ll get a mike to you and...

Question-and-Answer Session

Unidentified Analyst

Just I would like to know if you have other types on the development if you can comment on this or do you think after Hep C and HIV, are there other opportunities?

Douglas A. Michels

Yeah I’d happy to answer that. So I don’t know if you seen our platform, but it is a very versatile platform. And so we’ve done, we’ve conducted numerous feasibility studies on other diseases, for example Hepatitis B, other infectious diseases are sexually transmitted diseases. We haven’t made any final decisions, which of those we’re going to take into full development, to be frank, we have a lot of opportunity with our existing products. I mentioned DNA Genotek is working on some new technologies for different types of specimen collection, that’s in feasibility right now as well. We have a wonderful opportunity we believe to expand our consumer diagnostic business outside the United States, as well as to potentially take up our product like Hepatitis C and make it available OTC. We haven’t made commitment to do that yet, but it’s one of the very near-term opportunities that we’re evaluating very seriously.

Unidentified Analyst

(Inaudible)

Douglas A. Michels

We have looked that multiplexing. And the platform lends itself to that. There’s a lot of complexities around multiplexing, particularly from a regulatory perspective. And these are, the HIV and HCV product specifically are both PMA approved products and they can be used with both the blood and an oral specimen, so when you get into multiplexing different analytes and then you begin to deal with these multiple specimen types. The costs of your studies become fairly significant. It’s not going to side the question, but we’ve looked at as we do not have an active program right now on that regard.

Amit Bhalla – Citigroup Inc.

Great. Well, with that we’re out of time. So I wanted to say thanks again Doug, thank you Ron and…

Douglas A. Michels

Thank you.

Amit Bhalla – Citigroup Inc.

The next presentation in this room will be logic.

Douglas A. Michels

Thank you.

Ronald H. Spair

Thank you.

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