OSUR
#Thanks, Nick.
And the great results in the quarter, a big contributor to those was our HCV business.
We saw great growth as we mentioned on both the domestic and international front, 78% year-on-year growth in the domestic market.
And that's the result of active discussion and work with current customers as they expand their testing programs, and then of course a lot of activity with prospective customers and trying to get new customers to begin testing.
Our work with AbbVie continues.
We continue to work together on our co-promotion activities as well as on the special programs and that's going to continue through 2016.
We've got a meeting with them in a couple weeks to review the 2016 plans and make sure we're aligned on those.
And we're seeing new entrants into the therapy space, and I think that, from our perspective, that's expected, right.
That's no surprise.
And I think that the fact that more of the therapy providers are competing for patients, that's going to continue to create demand for diagnostics.
And I think that we're in a great position to continue to capitalize on that.
You mentioned the future prospects that we have to work with AbbVie.
We're completely focused on building the AbbVie relationship and making it successful.
You're probably aware that, as outlined in the redacted copy of the AbbVie co-promotion agreement which was filed with our previously filed 10-Q, that we both have termination rights which could be exercised at the end of 2016.
But that's neither here nor there for what we're doing today and our intent for 2016.
We're looking forward to working with AbbVie and making the effort successful.
It's our policy not to comment on litigation.
And so really at this point in time we really have nothing to say with regard to that other than we continue to assert our IP and our contractual ---+ our contracts and we'll just continue in the process.
I think we're going to continue to have some headwinds there in 2016, although the team is working diligently to stabilize that business, and I think we're going to make some progress in that regard in 2016.
At the same time, I mentioned opportunities we have to grow our professional HIV business, particularly in the international space.
We are super excited about the work we are doing with PSI and UNITAID in Africa and I mentioned the three countries that are specific to the STAR initiative ---+ that's Zimbabwe, Malawi and Zambia, but we're also working with several other African countries as well as some Asian countries to roll out a similar kind of pilot programs.
And these are really designed for high-prevalence countries where today's routine HIV testing just aren't reaching the affected population as effectively as these governments would like.
This is a very large pilot that's being initiated in Africa with PSI and UNITAID and there's plans to scale this significantly in the out-year.
We're, like I said, very excited about it.
Our product is ideally suited for this application: the ease of use, the accuracy, the oral fluid application.
And we have a lot of learnings from our in-home HIV test here in the United States that we have now transferred to a simple, low-cost, easy-to-use device that can be deployed into these developing markets.
So more on that to come, but we wanted to highlight that in our call this evening.
Thank you, <UNK>.
Yes.
Thanks for the question, <UNK>.
And you probably noticed that we didn't speak specifically to 23andMe in the prepared remarks today, and that's really for some competitive reasons.
And so we're going to try to refrain from doing that in future calls, much like we don't really speak to specific accounts in other parts of our business as a general rule.
With that said, our sales to entities that are in the personal genomics space have been very strong in 2015 and they were a significant contributor in 2014.
And we continue to supply product to 23andMe and work very closely with them, as you can imagine, and it's been a very productive relationship, I think, for both parties.
And we expect it will continue to be.
So the very fact that Ebola is still out there, the unfortunate fact that these countries over the last, at least couple of, quarters have declared their countries Ebola-free only to have to update that declaration and announce that there's new cases and people dying, suggests that this is going to be an issue for quite some time.
And highlight the fact that these countries are going to need to perform surveillance to understand, if there's new cases, where might those cases have originated.
They have people who are diagnosed infected.
There's contact testing or tracings that go on and, of course, a rapid test is ideal for those applications.
As we've previously mentioned, the product sales that we've made to date have been to the CDC for both clinical studies as well as deployment in the field for this kind of application.
While that's been going on we've also been pursuing WHO pre-qualification and we've submitted data to the WHO for such.
WHO pre-qualification is important because that authorization allows different countries to purchase the product using Global Fund and other public provider, third-party funding.
So hopefully in the early part or first part of 2015 (sic) we'll see WHO pre-qualification and then that will hopefully open up additional purchase opportunities for the product.
We're also continuing in discussions with different entities about stockpiling the product.
We don't have anything to report on that right now, but it's another important pursuit of the company.
We were waiting for that question, for sure, because there's no doubt it's all over the news.
We're all being inundated with that.
We have had multiple discussions with the leadership of different organizations in the US government, as well as around the globe, about the need for accurate diagnostic tools to deal with Zika.
It reminds me of some discussions we had a year ago or more when the Ebola crisis was raging.
I think it's important to understand that it's a little different than Ebola.
I don't think that it's as well understood.
And health authorities around the world are in discussions and collaborating on what they believe is the right next step with regard to both diagnostics and therapeutics and really just what to do with ---+ in this current outbreak.
I'll emphasize that our approach to this is going to be very similar to what we did in response to the Ebola crisis.
Number one, if we're capable of developing a diagnostic ---+ and that's what health authorities say they want and need ---+ then we're willing to do that, provided that there's some support for that development as well as some commitment to ongoing purchase, much like we were able to secure with the Ebola project.
I don't have anything to report on that right now, but should anything develop, obviously we would make an announcement in that regard.
Thank you.
Hey, <UNK>.
I'm sorry, I didn't catch the end of that.
We haven't dimensionalized that publicly, but it was a nice contributor to fourth-quarter revenues.
Yes, we haven't broken that out.
I will say demand continues to be very high in the public health market and that's where we continue to see the greatest demand for the product, largely because they have large budgets and they're able to deploy some of their HIV prevention monies to hepatitis prevention under the CDC and other state and local grants.
So that's been the biggest contributor to our growth in the HCV market, along with the international contribution, of course.
The patient advocacy organizations have been very active across all the market segments, that's for sure, because, I think, of some of the constraints that have been put on therapy and the payers' desire to stage patients and, in some respects, carefully allow, or on the flip side, restrict access to these drugs because of their cost.
So the advocacy effort continues to grow and I think will continue to grow as the effectiveness of these new therapies and awareness about Hepatitis C continues to build among the consuming public.
One thing that we are seeing that I think is very interesting, and I think this will come out down the road, I think health care providers are finding a higher prevalence of Hepatitis C infection in young adults, particularly individuals 18 to 45 years old.
And this increase in HCV incidence is believed to be driven by the significant increase in injection drug use in America.
And so we're seeing some pretty significant prevalence rates in the different testing programs that we see in the public health market and in different hospital or other large group screening programs.
And again we're happy that we have got a tool that can be used in those situations and delighted that there's therapies that can treat these people, but it's a big issue, I believe, and I think we're going to hear more about that down the road.
Um-hm.
Okay.
I just want to thank you all again for your interest in the company and your support and look forward to updating you in a few months on our first-quarter performance.
Thanks again for joining us, everyone.
Have a great afternoon and evening.
