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OPKO Health, Inc. (OPK)

Q1 2017 Earnings Call· Tue, May 9, 2017

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Transcript

Operator

Operator

Hello and welcome to the OPKO Health Business Update Conference Call. At this time all participants are in a listen-only mode. Following managements prepared remarks we will hold a Q&A session. [Operator Instructions] As a reminder this conference in being recorded Tuesday, May 9, 2017. I would now like to turn the conference over to Anne Marie Fields. Ma’am, you may being you conference.

Anne Marie Fields

Analyst

Thank you. Good afternoon, this is Anne Marie Fields with LHA. Thank you all for joining today’s call. I’d like to remind you that any statements made during this call other than statements of historical fact will be considered forward-looking and as such will be subject to risks and uncertainties that could materially affect the Company’s expected results. Those forward-looking statements include, without limitation, the various risks described in the Company’s annual report on Form 10-K for the year ended December 31, 2016 and its subsequent filings with the SEC. Before we begin, let me review the format for today’s call. Steve Rubin, OPKO’s Executive Vice President, will provide an update on the Company’s various businesses and clinical programs; followed by Adam Logal, OPKO’s Chief Financial Officer, for who will review of the Company’s 2017 first quarter financials performance. Dr. Phillip Frost, Chairman and Chief Executive Officer of OPKO, will provide closing remarks and then we will open the call to your questions. Now, I’d like to turn the call over to Steve Rubin. Steve?

Phillip Frost

Analyst

This is Dr. Frost. Before Steve Rubin and Adam Logal talk about the Company and this quarter in a more granular way I’d like to give you my view of where we are. We have a large diagnostics laboratory, Bio-Reference in which we are very proud. So much though that we have decided to invest heavily in its future. And we’ve restructured management with a new CEO Dr. Greg Henderson, a new COO of Warren Erdmann. And new genomics division head Dr. Ben Solomon and a new Director of Sales for GeneDx Vicky Laughman all experienced professionals who would be rated among the best by any standard. They joined in an existing team of dedicated leaders. Together they position us to launch forward with new products, greater revenues and more profit. We've been investing in new systems of every sort that will result in better financial data that will give us more information about our customers, our products, our sales team and very important will permit better collection of receivables. For GeneDx this means we'll be able to gather and store and analyze sequencing formation to provide new services for better patient diagnosis more family genetic information and more success with our marketing and sales effort. We're now ready to go to the next level. The 4Kscore test is being marketed and sold through Bio-Reference but our urology team has been busy designing and performing new trials to even further document the unique value of 4K to identify men with serious prostate cancer. These trials will of course result in more publications presentations of medical meetings and more embedded tools for our marketing and sales effort. My goal for the year is to increase sales of our 4Kscore test in a very meaningful way. On the therapeutic side we will…

Steve Rubin

Analyst

Thank you, Phil. Through the first quarter of 2017 also made important progress. And we are pleased with our U.S. launch of reality to treat secondary hyperparathyroidism or SHPT in patients with Stage 3 or 4 chronic kidney disease or CKD and vitamin D insufficiency. RAYALDEE is the only FDA approved product for this indication. We launched RAYALDEE in the U.S. at the end of November 2016 and have built a solid marketing and sales team of 50 professionals. Dr. Akhtar Ashfaq has recently joined OPKO as Senior Vice President, Clinical Research and Development and Medical Affairs of our Renal Division. Dr. Akhtar Ashfaq was previously with AstraZeneca where he served as Executive Director and Head of the CKD program within Global Medical Affairs. Before that he served as a Medical Director for Amgen. We are pursuing an aggressive marketing and sales effort as we continue to add new payers. Over the first quarter the number of physician prescribers for RAYALDEE is up eight-fold. The soon to be published KDIGO guideline for the treatment of chronic kidney disease, metabolic bone disease is expected to recommend against routine use of vitamin D receptor activators for VDRAs to treat SHPT in Stage 3 and 4 CKD highlight the unproven effectiveness of vitamin D supplementation. As these presently represent the only competitive products RAYALDEE used to be greatly enhanced. Moving forward we plan to leverage our investment in our RAYALDEE sales force and commercial infrastructure we will advance our clinical plans in a number of important programs. First is the final Phase 3 clinical study for Fermagate, a magnesium based calcium free phosphate binder for hyperphosphatemia in CKD patients on dialysis already shown to be safe and effective in treating hyperphosphatemia in Phase 2 and 3 trials. In preparation for the upcoming Phase…

Adam Logal

Analyst

Thank you, Steve, and good afternoon, everyone. The first three months of 2017 included number of important business activities that had an impact on our overall financial results. Revenue increased to $296 million from $291 million for the comparable period of 2016. There were several factors that impacted revenue during the first three months of 2017, which we expect to continue throughout the year. Our revenue cycle management program is in full swing of our reference and we've seen overall improvements in our main clinical lab operations, particularly during March, a trend we continue to – we saw continue into April and expect to see throughout the year. We anticipate the improvements to result in an increased profitability in our diagnostic segment with increasing pace during the second half of the year. The improvements in our clinical lab have been partially offset by pricing headwinds we face within our genomics testing. As we expected, overall patient counts continue to grow in the first quarter and we expect the growth to accelerate in the Q2 and throughout the rest of the year. As Steve reviewed, the RAYALDEE launch is underway and we have secured insurance formulary access for RAYALDEE in excess of 60% of all potential patients covered, and continue to see prescription trends improving month-over-month. During the next several quarters, we are focused on increasing our insurance formulary access particularly for Medicare Part D plans. And anticipation of the improved formulary access, we have begun the process to expand our commercial reach with additional field representatives. We expect to begin selectively hiring in territories where insurance formulary access is the greatest along with physicians and territories that would benefit from having sales representatives call more frequently. Turning to costs and expenses, during the first three months of 2017, costs and expenses increased over the comparable period of 2016, principally related to our introduction of RAYALDEE of approximately $13.5 million. We continue to invest in our pharmaceutical and diagnostics research and development programs and had approximately $26 million of R&D expense during the quarter, compared to approximately $28 million for the 2016 period. Net loss for the three-month period ending March 2017 was $31 million, compared to a loss of $12 million in the comparable period of 2016. The 2016 period included the non-recurring deferred tax benefit of $20.5 million principally related to an income tax rate change in Israel. Our balance sheet remains at a strong position to continue the development of our R&D programs as well as to support our commercialization efforts for RAYALDEE. In March 31, 2017 we had a $131 million in cash and cash equivalents, on our balance sheet with an additional $100 million in availability under our credit facilities. With that, I’d like to turn the call back to Phil. Phil?

Phillip Frost

Analyst

I want to thank you all for participating and we look forward to talking again at the end of the next quarter. With that, I will open the floor for questions. Thank you.

Operator

Operator

[Operator Instructions] And your first question comes from Kevin DeGeeter with Ladenburg.

Kevin DeGeeter

Analyst

Hey, good afternoon, guys. Thank you for taking my questions. Just a few for me; can you comment with regard to the potential expansion of the reality sales force? And just put some harder numbers on that. How many sales folks do you hope to add in the coming months?

Adam Logal

Analyst

Yes. So, I think we think about the right size for the sales force on a full basis, it would go up to 70. I think we're 30 – we launched with 35 and really in order for us to get to that 70 number we need to get our insurance at formulary access into the mid 70s to low 80s range and start to see prescription trends to go up. So I think it's going to be a bill throughout the year, Kevin.

Kevin DeGeeter

Analyst

Okay, thanks for that. And with regard to BLA filing for human growth hormone for the adult patient population, can you just elaborate on two points. First, in what form might we see the results from the – give more detailed outlier analysis. And then just be – you did reiterate plans to your file BLA your for that indication in 2017, given the mix top line results, what gives you incremental confidence, so that's the right step forward at this time?

Adam Logal

Analyst

Well, it would require that the modular analysis that we're undertaking to show that with the outlier analysis we would actually meet the primary endpoint. So that's what we're confident that data will show. We'll make that announcement once that – once the analysis is complete, and then assuming that it shows what I just said and what we believe it will, then we would have the confidence to submit the BLA with the modified analysis to FDA.

Phillip Frost

Analyst

I think your point is that, in order to get to that point, we have to go through all kinds of hoops that include validating all of the data that was obtained during the study. And then once that all the data is validated and we can do the analysis. And that’s what we’re confident about that when all that is behind us that it will turn out the way we wanted to. And we’ll be able to go forward with that.

Kevin DeGeeter

Analyst

Okay. That’s very helpful. And then maybe just one more for me then I’ll get back in the queue. With regard to 4Kscore and Medicare reimbursement can you provide us an updated timeline or set of metrics just how to think about a potential coverage decision, local coverage decision from Novitas and final clarity on that question.

Phillip Frost

Analyst

The important point here is that Novitas has been paying and continues to pay at the rate that what was indicated by the CMA and so we’re now getting over $600 and that’s schedule to go up to $750 in 2018. And we have every reason to believe that they will continue to pay. So for us there – actually issuing a positive LCD, we would like that to happen and toward that end we’re doing a lot of additional clinical trials that will cooperate with them and with the other [indiscernible] as well in getting them to think very favorably about the test. But in the meantime the important point for us and for the – from a financial point of view is that they continue to pay and with that basis we’re not going to embark on a very rigorous marketing program and attempt to dramatically increase the utilization of 4K and the revenues from the test.

Kevin DeGeeter

Analyst

Terrific. Thank you for taking my questions.

Operator

Operator

[Operator Instructions] And your next question comes from Yale Jen from Laidlaw.

Yale Jen

Analyst

Good afternoon and thanks for taking the questions. Maybe just kind of going little bit on Kevin’s earlier question, which in terms of the 4Kscore promotions how much effort the Bio-Reference reps currently at sort of non-urology reps and starting to promote the sales of that. And how would you measure the performance at this point and what do you anticipate over the next 12 months for them. A –SteveRubin: So currently we have 200 of the sales people at Bio-Reference trained detailed of 4Kscore. So our – as you heard Dr. Frost speaking, I think we’re at the point now with we’re comfortable enough with reimbursement on the Medicare side and service efficient on the commercial side to put in more focused marketing effort and dollars behind it. So we are working on the plan to utilize more of the Bio-Reference sales people and perhaps use some other marketing techniques incentives to really push the 4Kscore forward. So we are continuing to show growth, I think with a little more muscle efforts and applying some more sales people, we expect to have more significant incremental growth in the future.

Yale Jen

Analyst

Okay, great that’s helpful. And just one more question for me. Which is [Audio Gap] quarter conference earnings call you start to have a better sort of feeling toward it or it’s too early to suggest?

Steve Rubin

Analyst

Most of your question, were cut-off could you please repeat, I’m sorry, we still continue to obviously to have these technical difficulties.

Yale Jen

Analyst

Okay, not a problem. For RAYALDEE do you anticipate you will be able start talking a little bit more about this script trends would that be – if you can put a little bit timeframe on that, would that be in the second – later part of the second half of this year or you have a different thoughts.

Steve Rubin

Analyst

So, Yale I think as we’ve mentioned earlier this year the first half of the year is really focused on building out that insurance formulary access clearly we want to continue to see positive trends and positive growth in the scripts, but we don't think that you will have a significant build in scripts kind of a day-over-day or week-over-week until we take down some of those barriers on the insurance formulary access. Little bit over 60% we’re a little ahead of where we expect it to be – but we still face challenges as it relates to having doctors be willing to go through some of the medical exception process they have to go through. Particularly on the Medicare Part D, while we're getting a lot of our Medicare Part D scripts filled today we think will – we'll be able to accelerate it once we get those insurance formularies on board.

Yale Jen

Analyst

Okay, great. Thanks a lot and…

SteveRubin

Analyst

When a doctor writes a script and then the patient complains that the insurance doesn't pay for it. It discourages the doctor from writing future scripts. So you have to get the payers to pay in order to complete the cycle of – rightly having the script ready prescription bills. And so we’re emphasizing that point of the cycle on the one hand, on the other hand we’re appreciating that they’re more getting on sales [Audio Gap]

Yale Jen

Analyst

Hello.

SteveRubin

Analyst

Yale were you able to hear our response.

Yale Jen

Analyst

It was cut off. I heard in terms of the chicken and egg situation and after that it was cut off from that. I guess you want to pave the field before they will start to taking script. I guess that's one of things and you guys wanted to maybe do a little more marketing being able to get more awareness I get that, that's what I get but there's only some details I probably have missed it. Okay, great. Thanks a lot, I appreciate, maybe we can talk offline a little bit more later on.

SteveRubin

Analyst

Yes, yes. We do that for sure. It is unfortunate that we seem to continue to have these difficulties with our conference calls.

Phillip Frost

Analyst

Are there questions.

Operator

Operator

There are no further questions, at this time. Dr. Frost, I'll turn it back to you for closing remarks.

Phillip Frost

Analyst

There are no further closing remarks. So we will thank you once again.

Operator

Operator

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.