OPKO Health, Inc.
Q1 2019 Earnings Call Transcript

Published: 8 May 2019

[Operator:]

Welcome to the OPKO Health Conference Call. At this time all lines have been placed on a listen-only mode. Following management’s prepared remarks, we’ll hold a Q&A session. [Operator Instructions] As a reminder, this conference call is being recorded, Tuesday, May 7, 2019. I would now like to turn the call over to Ms. Miriam Miller. Please go ahead, ma'am.

[Miriam Miller:]

Thank you, operator. Good afternoon. This is Miriam Miller with LHA. Thank you all for joining today's call. I'd like to remind you that any statements made during this call by management 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, 2018, and subsequent quarterly reports on Form 10-Q. Importantly, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, May 7, 2019. Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. Before we begin, let me review the format. Dr. Phillip Frost, Chairman and Chief Executive Officer, will open the call; followed by Steve Rubin, OPKO's Executive Vice President; and Dr. Jon Cohen, Executive Chairman of BioReference Laboratories, who will provide an update on the company's various business and clinical programs. After that, Adam Logal, OPKO's Chief Financial Officer, will review the company's 2019 first quarter financial results. And then we'll open the call to questions. Now let me turn the call over to Dr. Frost.

[Phillip Frost:]

Welcome to OPKO's discussion of its first quarter report. So where are we? RAYALDEE sales have grown but a bit more slowly than hoped. Our 4Kscore tests that help evaluate the possibility of a serious prostate cancer in men with an elevated PSA, which had been experiencing nicely increasing sales, hit a stumbling block when our Medicare contractor issued a negative local coverage determination. Our BioReference Laboratories suffered a bit from lower reimbursements, and we continue to spend on our drug and diagnostics development programs. So what's the good news? Well, let's take RAYALDEE. We have a new and powerful and, I believe, irresistible message for our salespeople to use within nephrologists. In an important paper recently published in the American Journal of Nephrology, the authors explained that in patients with stage 3 and 4 chronic kidney disease with abnormally high levels of parathyroid hormone, vitamin D normally administered in one form or another to lower PTH levels has been ineffective in raising blood vitamin D levels enough to lower PTH significantly. And here's what's important

[Steven Rubin:]

Thank you, Phil. And good afternoon, everyone, and thank you for joining us today. I'm going to jump right in here, starting with Diagnostics. While increased reimbursement pressures negatively impacted our revenues at BioReference Labs this quarter, our team has implemented some impressive operational improvements and expanded payer access, which bode well for the future. BioReference and GeneDx were selected for inclusion in the UnitedHealthcare Preferred Lab Network beginning July 1, 2019. This was a comprehensive process that evaluated service standards, turnaround time, quality and accreditation. Over 300 laboratories were invited to apply. Only 100 submitted applications due to the complexity of the requirements, and BioReference and GeneDx, along with 5 other laboratories, earned a place in the Preferred Lab Network. In addition, effective April 1, 2019, BioReference and GeneDx are now in-network providers with Humana, which provides access to 11 million additional lives. BioReference was also recently reorganized by Forbes as one of America's Best Large Employers of 2019. This list includes 500 large companies, and BioReference is one of only 15 companies in the health care equipment and services category to be selected for this designation. I think everyone on this call understands the importance of 4Kscore and believes in the need for this test. Since launch, more than 12,000 practicing physicians worldwide have ordered more than 227,000 tests. The test has been extensively studied in more than 25,000 patients, with results presented in 18 peer-reviewed scientific publications. The clinical utility of the 4Kscore test continues to be assessed, validated and reported by independent urologists who incorporate the test in their practice, showing solid value for the 4Kscore test as compared to other diagnostic paradigms for improving the accuracy of detecting aggressive prostate cancer. With all required documentation nearly complete, we plan to submit the 4Kscore to FDA for approval or clearance shortly. We have also submitted a request for reconsideration by Novitas of its local coverage determination. Utilization of our 4Kscore test has nonetheless remained strong as we processed approximately 19,400 4Kscore tests this past quarter, representing only a 1% decline compared to the fourth quarter of 2018 and an 8% decline compared to the first quarter of 2018. GeneDx continued to experience strong volume growth in Q1 2019 with approximately 17% growth in overall sessions as compared with Q1 2018. March was particularly strong and represents the single-highest session month in GeneDx history. Typically, our session volumes tend to increase cyclically, with Q4 where we're seeing the highest volumes. Continuing to ensure a comprehensive testing menu, GeneDx launched additional new tests in Q1, including a test for chronic kidney disease risk as well as for hematologic, cardiac and prenatal conditions. GeneDx's research and development program continues to develop many new tests. Over the course of this year, GeneDx has over 40 tests planned for launch, including additional testing for renal, urologic, gastrointestinal, pulmonary, skeletal and other conditions. Now before I continue, I'm pleased to turn this over to Jon Cohen, Executive Chairman of BioReference Laboratories, to talk a bit about his perspective and ideas for our laboratory and diagnostic business.

[Jon Cohen:]

Thank you, Steve. I was asked to comment on my first 4 months with some observations and what the plan looks like going forward. I am very optimistic about the strength and future of both BioReference and GeneDx. With a transformation plan in place, we are making remarkable progress on all 6 of the plan's components. First, Geoff Monk and his team have done a terrific job on significantly improving productivity and reducing costs. These operational improvements will continue at a vigorous pace. Second, our payer strategy is working, as you've heard from Steve, with the announcement of becoming part of the Humana network with its 11 million lives and as one of the 7 preferred labs for United. Third, our revenue cycle initiatives continues to move forward aggressively in putting in place better processes around denials, prior authorization and quoting. Reimbursement headwinds, as you'll hear, are our single biggest challenge, and we are focused on successful implementation of these initiatives. Our IT plan is focused on our recently released patient portal, better live technical support for our clients and upgrading our business and laboratory systems. Sixth, our multiple commercial initiatives to grow the top line. So let me be more specific and briefly discuss our commercial initiatives. The business is now structured around 3 pillars

[Steven Rubin:]

Thank you, Jon. Turning now to Claros 1. We were pleased to announce on February 1 that the FDA approved our point-of-care Sangia Total PSA Test using the Claros 1 Analyzer. The test is designed to give quantitative total PSA results in the point-of-care setting, utilizing a finger-stick whole blood sample in 10 to 12 minutes. The accuracy of the Sangia Total PSA Test is compared to an FDA-approved total PSA assay. And it supports that the assay can quantitatively measure total PSA levels from 0.08 nanogram per milliliter to 15 nanogram per milliliter using capillary whole blood samples taken from the finger stick. There are 25 million PSA tests performed in the United States annually, so this approval represents a significant market opportunity. Sangia Total PSA Test is determined by FDA as a moderately complex test which requires CLIA waiver by the FDA. A CLIA waiver requires demonstration of minimal erroneous results when used in the field. We expect to submit our CLIA waiver request to FDA later this year. We believe there are many advantages both to patients and to physicians of offering test results right at the point of care. Further, with the momentum of this approval, we have accelerated the development of additional tests utilizing this technology platform, with testosterone being the most advanced. Turning now to our pharmaceutical business, let me start with RAYALDEE, the first and only therapy approved by the FDA that both raises 25-hydroxy vitamin D and lowers parathyroid hormone, or PTH, levels in patients with chronic kidney disease, with a safety profile similar to placebo. RAYALDEE provides a single-drug solution for SHPT, replacing the use of both nutritional vitamin D and active vitamin D. The Marketing Authorization Applications for RAYALDEE submitted by Vifor Fresenius last month have been accepted for review in several European countries. These applications are for approval for RAYALDEE for the treatment of secondary hyperparathyroidism in adult non-dialysis patients with chronic kidney disease. We are pleased with Vifor's progress that supports our global development and commercialization plans for RAYALDEE. Potential approval in multiple European countries offers us an opportunity to significantly increase the number of patients who may benefit from RAYALDEE. We are also excited, as Phil mentioned, by a recent publication in the American Journal of Nephrology and an associated editorial in March. A post hoc analysis of RAYALDEE pivotal trials provided the first prospective data demonstrating that the current clinical practice guidelines target for serum total 25-hydroxyvitamin D in chronic kidney disease is too low to decrease elevated serum PTH levels in chronic kidney disease patients. These data suggest that the correct target is at least 51 nanograms per mL and possibly as high as 93 nanograms per mL, levels which no competitive therapy can reliably attain. This analysis received a favorable review in a copublished editorial by prominent key opinion leaders in nephrology. From a commercial perspective, the RAYALDEE numbers for the quarter break down as follows. We are continuing to build sales momentum and have seen a growth of 121% in total prescriptions for Q1 2019 versus Q1 2018. Total prescriptions of RAYALDEE in Q1, as reported by IQVIA, increased almost 12% compared with Q4. New patient starts increased 13% in Q1 versus Q4. Since launch, there has been a total of approximately 9,400 patients taking RAYALDEE. We also increased the number of health care providers who prescribe RAYALDEE. As of Q1, over 1,900 prescribers have written for RAYALDEE, of whom 225 were new prescribers in Q1. We ended Q1 2019 with 86% of commercially insured patients having access to RAYALDEE. Over 60% of Medicare and commercial lives are covered without prior authorization or other restrictions. After 6 months, most patients pay around $5 per month out of pocket for RAYALDEE. We completed our sales expansion -- sales force expansion last month from 70 to 85 sales professionals. The expanded field force will provide additional reach and frequency needed to drive increased use of RAYALDEE amongst our customers. We anticipate RAYALDEE growth to gain momentum throughout the year, driven by the improved unrestricted coverage, increased sales force size and new clinical analysis from the American Journal of Nephrology publication. Our team has begun to deliver the new publication information this quarter, and the message has been well received by physicians. Regarding our clinical development programs. We remain focused on expanding the clinical utilities of RAYALDEE in different patient populations and advancing other key programs. Last September, we initiated a global Phase II trial with a higher-strength RAYALDEE in patients with stage 5 CKD and vitamin D insufficiencies who require regular dialysis. Costs of this study are being shared with Vifor Fresenius and Japan Tobacco. The first cohort of approximately 44 patients is being treated for 26 weeks in a randomized, open-label fashion with either RAYALDEE or placebo to identify the appropriate dosing for the second cohort. The initial data readout of this first cohort is expected in Q3 2019. In 2020, we plan to initiate a second cohort of more than 200 patients to be treated for 26 weeks in a randomized, double-blind fashion with 1 of 3 different doses of RAYALDEE or placebo. The primary efficacy endpoint will be correction of vitamin D insufficiency and control of SHPT. Patients would then be treated with RAYALDEE for another 26 weeks in an open-label extension. Other ongoing and upcoming clinical trials for RAYALDEE extended-release calcifediol include an ongoing 80-patient open-label Phase IV study designed to demonstrate that RAYALDEE is superior to commonly used competitive therapies

[Adam Logal:]

Thank you, Steve. As Jon and Steve highlighted, we have continued to make progress within our business and research and development activities. The underlying financial performance was within our previously issued guidance, and substantially all areas are showing improvement as we build momentum going into the second quarter. Overall, our net loss during the first quarter of 2019 increased to $80.8 million or $0.14 per share compared to a net loss of $43.1 million or $0.08 per share for the comparable period of 2018. Net revenues were $222.5 million for the first quarter of 2019 compared to $254.9 million for the 2018 period. Revenue from services for the 3 months ended March 31, 2019, were $178.9 million compared to $211.3 million for the 2018 period. The decline in net revenue from services reflect the ever-challenging environment within the -- within payers for our laboratory business, specifically the compounding of the PAMA rate decreases along with payers implementing pre-authorization requirements and enhanced denial rates on both our clinical laboratory testing as well as our genomic testing. On the positive side, we believe the overall reimbursement environment is the largest near-term opportunity to show improvement in our financial performance. We are aggressively working to manage these payer procedural changes and are increasing our appeals efforts. Revenue from product sales during the first 3 months of 2019 was $25.3 million, down from $27.9 million in the comparable period of 2018. Revenue from RAYALDEE was $5.8 million during the quarter, with revenue being negatively impacted by a decrease in our net price as a result of increased discounting and utilization of our copay discount program and a change in our mix of utilization by patients covered by Medicare Part D. Based on an assumption that increased utilization of these programs and the mix of Medicare patients persists, we anticipate our net revenue to be between 45% and 50% of gross revenues going forward. Offsetting the increase in RAYALDEE revenues were decreased revenue in our foreign businesses of approximately $4.8 million, which we expect to recover throughout the year. Moving to costs and expenses. We continue to invest in our R&D programs where we incurred $36.5 million for the first quarter of 2019 compared to $32.9 million for the comparable period of 2018. Our biggest R&D spend was attributable to our pediatric trials within our hGH-CTP long-acting human growth hormone product. We saw significant improvements in our cost structure within our laboratory business. Geoff and his team have been working hard to improve the cost structure and have done a great job in those efforts. And overall, we saw a decrease of $18 million in the cost of service revenue and SG&A within that business line. These decreases were partially offset by a legal reserve recorded during the quarter. Overall, SG&A expenses increased in comparison to the 2018 period as we increased our RAYALDEE sales efforts along with increased legal fees. Looking forward to the second quarter of 2019. We expect revenues from services to be between $170 million and $180 million. This anticipated year-over-year decrease is principally as a result of continued reimbursement pressures, with the range reflecting varying volume expectations. Turning to product revenues. We expect second quarter to come in between $27 million and $29 million, including revenues from RAYALDEE between $6.5 million and $7 million, while revenues from the transfer of intellectual property are expected to be between $17 million and $22 million. Looking at anticipated expenses for the quarter. We expect costs and expenses to be between $280 million and $290 million, including research and development expense of $38 million to $43 million. Based on these ranges, we anticipate cash utilization, including CapEx, to be approximately $50 million during the second quarter of 2019. In addition, during the second quarter of 2019, we recently repaid approximately $40 million of our line of credit with JPMorgan due to changes within the borrowing base calculation that reduced our overall available credit. Our cash position at March 31 was $207 million, and we will continue to invest heavily in our R&D programs throughout 2019. We have expectations for improved cash contributions and financial performance within our diagnostic and RAYALDEE commercial businesses as the year progresses. However, we will have to be mindful of our planned investments into new R&D programs. With that, I'll open the call for questions. Operator?

[Operator:]

[Operator Instructions] Our first question is from the line of Maury Raycroft from Jefferies. Please proceed with your question.

[Unidentified Analyst:]

This is Mitchell on for Maury. Thanks for taking the question. The first question is, can you talk about the need to reach an agreement with Pfizer regarding the hGH program and the cost sharing for overruns? What are the likely scenarios for this going forward?

[Steven Rubin:]

So there's no need to do anything. So the contract that exists pretty much takes care or deals with anything that's over budget.

[Unidentified Analyst:]

Okay. So I think what we have seen is that -- your development cap. Is that something that's still a concern? Or is that taken care of?

[Adam Logal:]

I'm not 100% sure. So we haven't said what the development cap numbers are specifically, but we have exceeded the original plan. We've got overall cost increases to the program. So again, I'm not 100% sure what the question is that you're trying to come to.

[Unidentified Analyst:]

Got it. I think that answers that one. And then could you talk about how large your sales force is and the breakdown between the drug franchise and then the services side?

[Adam Logal:]

Sure. Within the BioReference segment, we -- our commercial organization as a whole is about 300 people, with a little over two thirds of that is field force, et cetera. On the RAYALDEE side of the business, we've got about 75 reps in the field today and another 25 or so non-field reps but within the commercial organization.

[Unidentified Analyst:]

Okay. Thank you so much.

[Operator:]

And our next question is from the line of Yale Jen from Laidlaw & Company. Please go ahead with your question.

[Yale Jen:]

Good afternoon. Thanks for taking the question. Two questions here. Number one is that RAYALDEE, you're going to file for the European for RAYALDEE, and you mentioned that it was for individual countries. The question is, why not file for centralized approval? And with that, was there a specific rationale for doing that?

[Steven Rubin:]

So Vifor decided -- it elected to do a decentralized procedure. They selected countries that have the largest opportunity based upon the size of the market and competitive landscapes and the like. So we -- it was their decision to do go after kind of the largest ones. And it has a lot to do with pricing. As you certainly are probably aware, some countries offer better pricing than others. And I think they prefer at this point not to go into those countries that are going to get pricing that's not favorable.

[Yale Jen:]

Okay. That's helpful. And also, in terms of filing for, I guess, approval from -- to FDA for 4Kscore, any specific time line on that? And what do you anticipate the potential benefit if it gets approved in terms of improvement of sales or other reimbursement acceptance?

[Steven Rubin:]

Well, I'll handle the first one. Obviously, we -- one of the issues raised by Novitas in their LCD or local coverage determination was that it's not FDA-approved product. That's obviously not a requirement, but it's an issue that they have raised. So it also gives at least some imprimatur to customers and physicians that if FDA has reviewed it, it at least adds some additional gravitas to the test. So we believe that will help with some reimbursement on the commercial side, should help with Novitas. And then of course, as an FDA-approved test, it gives you additional flexibility and, I suppose, a laboratory-developed test in the future should you want to move operations and manufacturing to different sites. As to timing, as I mentioned, we're pretty much done with most of the packet or submission, so it should be -- it will be later this year.

[Yale Jen:]

Okay. Great. And maybe just sneaking in one more question here, which is that for the long-acting growth hormone, one of the company, Ascendis, has their -- should have positive Phase III readouts this March. Do you see that have any impact on, obviously, your product if you also have a positive outcome and any commercial sort of impact might be on that?

[Steven Rubin:]

So Yale, as you'd probably remember since you've been with us for a while, when we started this program, there were more competitors, several more competitors going after a long-acting. And many have dropped out and for starters, and it failed the most recent failure. So now we're down to, that I'm aware of, Ascendis, Novo and us. So there's 7 players in the market of a $3.5 billion market today. All those products are identical. So we always expected -- we never expected to be the only player on the market, so there's plenty of room for everyone. And again, you can do the simple math, so there -- with 7 players in the market and down to 2, potentially 3, we feel pretty good about it. We've got a great partner in Pfizer as the number two product -- daily product on the market today. They've got a great team. And the timing with Ascendis, we actually feel that our submission should be right about the same time as theirs. So it's -- we're pretty excited about the potential.

[Yale Jen:]

Okay, great. Thanks a lot and appreciate the update.

[Steven Rubin:]

You’re welcome.

[Operator:]

There are no further questions at this time. Please proceed with your presentation or any closing remarks.

[Phillip Frost:]

We'd just like to conclude by thanking everyone for participating. And if you have any burning questions, feel free to call us at the company, and we'll try to address them.

[Operator:]

Ladies and gentlemen, that concludes your conference call for today. We thank you for your participation and ask that you please disconnect your lines.+