OPKO Health, Inc. (OPK) CEO Dr. Phillip Frost on Q3 2019 Results - Earnings Call Transcript

Nov. 05, 2019 10:10 PM ETOPKO Health, Inc. (OPK)2 Likes
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OPKO Health, Inc. (NASDAQ:OPK) Q3 2019 Results Conference Call November 5, 2019 4:30 PM ET

Company Participants

Miriam Miller - LHA IR

Dr. Phillip Frost - Chairman and CEO

Steve Rubin - EVP

Jon Cohen - SVP, OPKO Health and Executive Chairman, BioReference Laboratories

Adam Logal - CFO

Tony Cruz - President, Transition Therapeutics

Jane Hsiao - CTO and Vice Chairman

Conference Call Participants

Maury Raycroft - Jefferies

Ted Tenthoff - Piper Jaffray


Welcome to the OPKO Health Third Quarter Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded today, November 5, 2019.

I would now like to turn the conference over to 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 facts 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 filings with the SEC. Importantly, this conference call contains time sensitive information that is accurate only as of the date of the live broadcast, November 5, 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 for the call. Dr. Phillip Frost, Chairman and Chief Executive Officer will open the call; then, Steve Rubin OPKO’s Executive Vice President will provide a business update and pipeline review; and Dr. Jon Cohen will discuss BioReference Laboratories. After that Adam Logal OPKO’s CFO will review the Company’s third quarter financial results. And then, we’ll open the call to questions.

Now, let me turn the call over to Dr. Frost.

Dr. Phillip Frost

Good afternoon, and thank you for joining the call today.

We’ve had an eventful quarter with important progress across several business units. I’ll start by saying, we’re pleased to announce jointly with Pfizer, positive topline results from our pediatric global Phase 3 trial comparing once weekly somatrogon to once daily GENOTROPIN. Steve will share more detail about the data later in the call, but I want to say that we’re optimistic about the potential of somatrogon to positively impact the lives of children with growth hormone deficiency, as well as their families.

It’s clear that once weekly dosing is a more acceptable way to manage the condition and improve compliance. We’re grateful to the healthcare professionals and patients who participated in this trial and clinical trial sites around the world. We also appreciate the support we’ve received from our partner, Pfizer, over the past five years. And we look forward to the presentation of detailed data in an upcoming scientific conference.

BioReference Laboratories continues to progress under the leadership of Jon Cohen and Geoff Monk. Recently, we received a new proposed local coverage determination from Novitas for the 4kscore test. The final coverage determination is still pending. But, if issued, it will once again provide reimbursement for Medicare patients who meet specific criteria. It’s been a long road for the 4kscore test, but our conviction of the potential importance of this test and the diagnostic paradigm for caring for prostate cancer is solid. And we appreciate the support of physicians and patients who have continued to champion the value of the 4kscore test.

Our drug RAYALDEE continued to boost sales in the third quarter. Total prescriptions reported by increased 83% this quarter compared with the 2018 quarter. And again, Steve will get into the sales numbers in a little more detail. But, I want to point out that we continued to increase RAYALDEE revenue and prescriber penetration quarter-over-quarter, making crucial progress in product adoption.

I’m going to turn the call over to Steve now to expand on these themes. Steve?

Steve Rubin

Thanks, Phil. Good afternoon, everyone. And thank you for joining us today.

As Phil indicated, it’s been an eventful quarter. We achieved progress across multiple programs and reached important milestones, particularly on the somatrogon project. We were very pleased with results in our global Phase 3 trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency. The trial successfully met its primary endpoint of non-inferiority to GENOTROPIN injected daily with respect to height velocity after 12 months.

Various sensitivity analyses show that weekly somatrogon was consistently higher and non-inferior to daily GENOTROPIN with respect to height velocity. Key secondary endpoints were also achieved. Change in height standard deviation scores or SDS at six and 12 months were higher in somatrogon compared to GENOTROPIN. At six months, change in height velocity was also higher with somatrogon compared to GENOTROPIN. These common measures of growth are employed in the clinical setting to measure the potential level of catchup growth that children may experience relative to height per age and gender match peers.

Finally, as to safety, somatrogon was generally well-tolerated and comfortable to GENOTROPIN dosed daily with respect to the type, number and severity of adverse events. We are concluding immunogenicity testing and analysis of additional data and we look forward to presentation of the full results of the study at our future scientific meeting.

Recall that we have over four years of safety and efficacy data in growth hormone deficiency, pediatric patients from our Phase 2 extension study, in children with growth hormone deficiency. 48 children with growth hormone deficiencies that completed the main Phase 2 study continued an open label expansion or OLE Phase 2 study.

40 subjects are still continuing in the OLE study with the GLP, the pen device using the same dose 0.66 milligrams per kg per week as used in the Phase 3 study. Safety and tolerability data from the OLE study remain comparable to those obtained with the early growth hormone treatment. Mean annualized height velocity over three years in the OLE study shows that long-term somatrogon treatment resulted in sustained growth.

Height SDS value showed height normalization over time. Important to note IGF-1 and IGF binding protein 3 levels remained within the normal range with the ongoing Somatrogon therapy. No other long-acting growth hormone therapy under development has safety and the efficacy data for as long as we have with somatrogon.

I also would like to highlight that our Phase 3 trial was global with over 80 clinical sites across more than 20 countries including parts of Asia and Latin America. The global enrolment including our separate ongoing study in Japan is part of a strategy that provides Pfizer the ability to seek global approval and global commercialization of somatrogon.

It is important to note that the purpose of growth hormone replacing therapy for pediatric growth hormone deficiency is to provide a level of growth hormones to children similar to the level that would have occurred naturally, had they not had growth hormone deficiency. We developed our once weekly somatrogon with that concept in mind, to mimic the activity of the growth hormone therapies that have been safely and effectively used on a daily basis in children for over 24 years. We believe we have demonstrated that objective through our Phase 3 trial which compared our once weekly somatrogon to once a day GENOTROPIN. If you give a child greater levels of growth hormone, they may grow taller, but that could also result in higher than normal levels of IGF-1 with its attendant potential safety issues. For this reason, with long-acting formulations administered once weekly, IGF-1 SDS is used as a biomarker to evaluate efficacy and safety of hGH replacement and mean IGF-1 SDS level are used to guide clinical decisions making on dosing.

Patients with sustained mean IGF-1 SDS levels of greater than 2 may require a dose reduction. In the previous Phase 2 pediatric trial, somatrogon demonstrated that mean IGF-1 SDS levels occurred at 96 hours post dose in pediatric GHD patients and that less than 2% of the patients had IGF-1 SGS levels greater than 2.

In our Phase 3 study, we observed similar results with somatrogon when mean IGF-1 SD levels were estimated using a pharmacokinetic-pharamcodynamic model. These data suggest that weekly somatrogon dosing results in patients maintaining IGF-1 SDS levels within a normal range over the 12-month three treatment period. And in-depth analysis of the IGF-1 SDS levels and other study outcome data is expected to be submitted for presentation at the Endocrinology Conference in March of 2020.

Based on these results, we anticipate that Pfizer will submit the biologics license application to the FDA and a marketing authorization application in Europe for somatrogon in the second half of 2020. The pediatric registration study in Japan comparing our weekly somatrogon to daily GENOTROPIN continues to progress with over 65% of subjects already having completed 12 months of treatment and entered the open-label extension. We expect top line data readout for that study in the second half of next year.

Touching briefly on our other therapeutics pipeline projects, we also expect to advance our long-acting rare disease platform, moving several compounds designed to offer advantages over existing medicines into the clinic. These include our long-acting GLP-2 compound for short bowel syndrome, our hGH antagonist CTP for acromegaly and our IGF-1 CTP for growth failure associated with severe primary insulin-like growth factor deficiency.

A briefly update on our SARM or OPK88004. In previous studies, our SARM was showed to increase lean body mass and physical function without altering PSA levels in aging males. In collaboration with Dr. Shalender Bhasin and his colleagues at Harvard Medical School with support from the NIH, we have just completed a six-month Phase 2 trial with approximately 114 patients. This trial is examining the efficacy and safety of our SARM, given improving patients symptoms of androgen deficiencies such as sexual function, lean body mass and physical strength and dysfunction endemic prostate cancer we have undergone radical prostatectomy.

In this study, to-date, we have not observed any safety issues related to treatment with our SARM, such as increased PSA or liver enzyme levels. We expect top-line efficacy data by the end of this year. The safety data with our SARM has been compelling. And with this new data, we are considering a late stage clinical trial evaluating our SARM for the treatment of sarcopenia associated physical strength dysfunction in end-stage renal disease patients on dialysis.

Turning now to our pharmaceutical business. Let me start the RAYALDEE. From a commercial perspective, RAYALDEE numbers for the quarter break down as follows. Total prescriptions of RAYALDEE in Q3 as reported by IQVIA increased 83% compared with Q3 2018 and show continual sequential growth with a 14% increase compared with Q2 of this year. New patient starts increased 9% in Q3 versus Q2. Since launch, there has been a total of approximately 13,600 patients on RAYALDEE. As of Q3, over 2,400 patients have written a prescription for RAYALDEE of which 229 or nearly 10% were new prescribers in Q3.

We ended Q3 2019 with approximately 83% of patients having access to RAYALDEE without prior authorization or other restrictions. After assistance, most patients pay a nominal amount out of pocket for RAYALDEE.

Turning now to our clinical development programs, starting with renal. Last September, we initiated a global Phase 2 trial with a higher strength RAYALDEE in patients with the stage five, chronic kidney disease and vitamin D insufficiency, who require regular dialysis. The study is progressing well and is proceeding the two successive cohorts. 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 to be studied in the second, larger cohort.

Treatment of the first cohort is expected to be completed in mid-2020. An interim data readout for this first cohort is expected in Q1 2020. Final data will be available in the second half of 2020. Costs of this study are being shared with Vifor Fresenius Japan Tobacco.

Other ongoing and upcoming clinical studies for RAYALDEE include, an ongoing 80-patient open label Phase 4 study designed to demonstrate that RAYALDEE is superior to commonly used competitive therapies, namely paricalcitol or Zemplar, immediate release calcifediol or Hidroferol and high dose cholecalciferol or vitamin D3.

The enrollment is more than 60% complete and full enrollment is expected near the end of 2019 or in early 2020. Initial top-line data are anticipated in Q2 of 2020. And we also have a Phase 3 study with RAYALDEE in pediatric patients as part of a post-marketing requirement, which is expected to start in Q1 2020. The final protocol for this study was approved by the FDA in Q2 of 2019.

With that overview, let me turn the call over to Jon Cohen for discussion of our diagnostic business. Jon?

Jon Cohen

Thanks, Steve, and good afternoon, everyone.

I’m pleased to report that BioReference Laboratories continues to make progress towards its goal to improve both, top line and bottom line results. When I first spoke with you six months ago, we committed to improving BRL’s performance with a plan to improve operational efficiencies, increase access to health plans, improve billing operations, identify and implement opportunistic cost cutting measures, and increasing testing volume and revenue growth through a focused commercial strategy. We continue to execute against this plan and are making measurable progress. We have recently recruited new leaders for women’s health and cancer services and are moving aggressively to pursue a focused strategy in these areas of our expertise.

In addition, our plan to develop a vigorous process to identify and pursue new strategic partnerships to deliver large books of business is beginning to bear fruit. From a numbers perspective, BRL posted sequential quarter growth in revenues. BRL again met its revenue targets for the quarter, and we continue to see growth and improved efficiency from the laboratory. The third quarter is a second full quarter in which 4kscore was not covered by Medicare. Despite this issue, we processed nearly 18,000 4kscores for the quarter.

As previously discussed in, late June, we announced that the Medicare administrative contractor with jurisdiction over New Jersey issued a new proposed local coverage determination for the 4kscore. Under this newly issued proposal by Novitas, Medicare would reimburse the test for patients who need to define coverage criteria.

With regard to GeneDx, this quarter saw volume increases of 6% compared to the 2018 third quarter. As was the case in Q2, institutional hospital and health system based ordering was especially strong with a 21% year-over-year accession growth. GeneDx continues to leverage strong relationships with leading children’s hospitals and academic centers throughout the country to drive increases in growth and revenue. We’ve also appointed a new commercial leader for GeneDx sales force with the goal of restructuring the sales force to provide a more focused strategy to address this rapidly evolving market.

In addition, we’re seeing significant interest in the portfolio of tests offered by GeneDx, as several new payer contracts were signed in the past quarter. GeneDx has also increased its focus on advanced bioinformatics techniques to provide further test differentiation as well as improved efficiency. GeneDx continues to impact the risk assessment and diagnostic paradigm for illness and disease. As an example, in the third quarter, the medical journal JAMA Oncology published data from GeneDx study addressing cancer risk estimates in patients with pathogenic variants in the gene CDH1 for gastric cancer.

These results will directly impact patients with the rare form of hereditary stomach cancer by providing a more personalized risk assessment and allowing for better informed decision making.

With that overview, let me turn it over to Adam for a discussion of our third quarter financial performance. Adam?

Adam Logal

Thank you, Jon.

Before I go into the detailed numbers, I want to reiterate what Steve and John have mentioned. We are pleased with the progress that we have made within our overall financial performance. Our laboratory business is beginning to benefit from the structural changes we have made in its operations. Geoff and his team continue to improve the overall cost structure. And overall, we saw a decrease of approximately $17 million in the cost of service and SG&A within that business line, compared to the third quarter of 2018. The sequential revenue and margin improvements do not include these associated contributions from the 4kscore test, as Jon mentioned.

A final positive coverage decision could immediately contribute to increased margins and sequential revenue growth. The reimbursement environment is a challenging one. However, with the team we have in place, we believe we are positioned for continued improvement in the financial results.

Turning to RAYALDEE, the third quarter saw the benefit of robust revenue growth in both units and dollars in comparison to the 2018 period as well as sequentially. Our long-term strategy has been to use the cash flow from our commercial businesses to fund our investments in research and development.

Now, I’ll go into more of the detailed historical results before providing fourth quarter guidance. Net revenues were $228.8 million for the third quarter of 2019, compared to $249.8 million for the 2018 period. Revenue from services for the three months ended September 30, 2019 were $181.1 million compared to $202.3 million for the 2018 period. Consistent with the first half of the year, revenue from services has been impacted by challenges within the payer environment, specifically the compounding of the PAMA rate decreases along with prior authorization requirements and enhanced denial rates on both our clinical laboratory testing as well as our genomic testing.

While we saw a slight decline in testing volumes in the clinical laboratory, the increase in volumes within our genetic testing as well as overall improvement in our revenue cycle have stabilized our revenue from services on a sequential basis.

Revenue from product sales during the three months ended September 30th were $26.2 million compared to $25.4 million for the comparable period of 2018. Revenue from RAYALDEE was $7.4 million during the quarter compared to $5.8 million for the comparable 2018 period. Year-over-year unit growth of RAYALDEE was partially offset by a decrease in net price as a result of increased utilization by patients covered by Medicare Part D and increased discounting in the utilization of our copay card program. We believe that the impact of gross to net declines have stabilized, and future revenue growth will more closely reflect unit growth as we work to minimize discounting for RAYALDEE. We expect to see the benefits of improved gross-to-net during future periods.

Moving to cost and expenses. We continue to make significant investments in our R&D projects where we recorded $30 million for the third quarter of 2019 compared to $30 million for 2018. Offsetting R&D expense was approximately $3 million of research and development tax credits related to our Irish operations. Our biggest R&D spend was attributable to our pediatric trial within our hGH-CTP long-acting growth hormone product. As you know, we successfully completed our pivotal Phase 3 study for hGH-CTP in August and announced positive results in October. While we continue to make R&D investments in this program, the largest spend is now behind us.

As I previously mentioned, we continue to make improvements in our cost structure within our laboratory business to partially offset the decline in reimbursement rates. The foundation of improved operating efficiencies that Geoff and his team have established within our laboratory business, position us for profitable growth going forward.

Despite our increased investment in the commercial organization of RAYALDEE, SG&A overall declined approximately $4 million compared to the 2018 period. A decline in market values of several of our strategic investments had a negative impact on our net loss for the quarter, resulting in $13.5 million of other expense. For the comparable period of 2018, net loss benefited from an income tax benefit recording during that period of $11.6 million. As a result, our net loss during the third quarter of 2019 was $62 million or $0.11 per share compared to a net loss of $27.7 million, or $0.05 per share for the comparable period of 2018.

Looking forward to the fourth quarter of 2019, we expect revenue from services to be between $165 million and $175 million which excludes any revenue from this 4kscore from Medicare beneficiaries. The revenue range provided is based on a mix of volume and reimbursement assumption, and it compares to $183 million for the fourth quarter of 2018.

Turning to product revenue, we expect the fourth quarter to come in between $25 million and $29 million, including revenue from RAYALDEE to be between $8 million and $9 million, while the revenue from the transfer of intellectual property are expected to be between $16 million and $18 million. RAYALDEE continues to grow in units. And now, we expect revenues to more closely aligned with that strong unit growth.

Looking at anticipated expenses for the fourth quarter, we expect costs and expenses to be between $265 million and $275 million, including research and development expense of $28 million to $31 million. Based on these ranges, we expect our operating loss during the fourth quarter to be between $42 million and $69 million, which includes approximately $25 million of non-cash, depreciation and amortization.

Our cash position at September 30th was $64 million. And with $70 million of net proceeds from our underwritten public offering, we will continue to invest in our R&D programs throughout 2020 as Steve mentioned. However, expense rationalization and capital allocation will remain a top priority as we continue into 2020. Given the guidance, we anticipate utilizing $40 million of cash during the fourth quarter.

As we look into 2014, we have expectations for improved cash contributions and financial performance within our diagnostic and RAYALDEE commercial businesses, both of which are important for our continued investments in R&D.

With that, I’ll open the call for questions. Operator?

Question-and-Answer Session


[Operator instructions] Your first question comes from the line of Maury Raycroft with Jefferies.

Maury Raycroft

Hi, everyone. Good afternoon and thanks for taking my questions, and congrats on the progress on the progress too. So, first question is for the somatrogon pediatric growth hormone study. Just wondering if you could talk more about when patients came in for the IGF-1 measures, the importance of timing and getting that IGF-1 measure. And do you have any perspective on how you’re IGF-1 data compares to the Ascendis’ TransCon data?

Tony Cruz

Hi, Maury, it’s Tony Cruz. To interpret the IGF-1 SDS, you need to understand patient [indiscernible] analyzed, because as you know when you take a weekly therapy, the IGF-1 in our case, the Phase 2 data was indicated and also it’s consistent in the Phase 3 that after 48 hours it peaks. And then, at the average or the mean IGF-1 SDS occurs around 96 hours. And yes, patients tend to have it analyzed at various time points. So, what you do is you evaluate those patients and normalize it to 96 hours to properly interpret the data that. That’s what we did.

Now, just to give you some background in the Phase 2 data. In the Phase 2, we had very good IGF-1 SDS level where I think there was only one patient that was above 2, for example, in that patient population, in the first year of treatment. Now, we haven’t obviously released the data yet, because we’re planning to present it at the ENDO meetings and that will be analyzed in depth at that meeting.

Maury Raycroft

Got it. And any perspective on how that compares to competitor weekly growth hormone data out there? And just wondering also…

Tony Cruz

Yes, I agree. It’s a little bit difficult, because we know what our data is. And we haven’t -- but generally speaking, our data for the Phase 3 was similar to Phase 2, and when we do further analysis, not identical but similar. And in terms of Ascendis data, they had -- they measured day five plus or minus one day -- or day six plus or minus one day -- sorry, five to seven, I think it was five to seven, but their percentage of IGF-1 was higher, but it’s hard to understand or correlate with our data.

Maury Raycroft

Got it. And it’s interesting, and just wondering if FDA would eventually normalize the Ascendis in the Pfizer OPKO datasets for IGF-1 when they’re reviewing data and the filings? Do you have any perspective into that?

Tony Cruz

The mean IGF-1 SDS levels is what’s used to make medical decisions about dosing. And so, if you are going to do an analysis, I think you’d have to convert all the data to the mean value, mean IGF-1 SDS value, I think, that would be likely. I know, we’re doing that in preparation for the FDA and also for the -- especially also for the European regulatory body.

Maury Raycroft

Got it. Okay. And then, for the Phase 3, just wondering if you can give a breakdown on geographies, and where patients came from and how this could have affected data in both arms of the study? And any perspective on how this compares to Ascendis Phase 3 as well?

Tony Cruz

We had strategically brought in additional countries, particularly from Asia, where we wanted to achieve approximately 10% of the patients from Korea as part of the criteria to meet that number of patients to be able to receive approval there or to apply there for approval. We also wanted to have approximately 15% to 20% of Latino patient population in our study. So, we have a large population from South America and Mexico, Chile, Colombia and so forth. And so, that is a little bit different than I think what Ascendis. In addition, we had patients approximately 10% -- over 10%, maybe 12% from India, which again, is a different population I think then they had, and then the rest is always the East and Western Europe and North America, where the remaining population of patients came from, which is more in similar to what Ascendis did.

Steve Rubin

Maury, I think, a telling factor is the way -- the difference in patient growth, if you want to compare our studies that you really can’t it. So, the GENOTROPIN for the Ascendis study, which is the same -- we used GENOTROPIN in ours, grew almost a full centimeter taller in their study than they did in ours. And obviously that’s the same drug. So, it just shows when you have a range of populations in a different genetics, some population grow taller than others, so you can’t really compare the trials. Now no one did a head to head for one. And two, as I mentioned in my remarks, the goal isn’t to increase the height, the goal is to match the height that they would have achieved in nature, or to match the height in the daily. And I think we achieved that.

Maury Raycroft

That’s helpful. And then, the other question I had on the study was just -- actually, if you can provide any more perspective on advisors plans to file for approval and their plans for introducing somatrogon on top of GENOTROPIN. Do you think they’re going to push GENOTROPIN in the same way or could that program sort of turn over to the weekly option with somatrogon?

Steve Rubin

Well, I think Pfizer’s goal is to grab a different market share. There’s over seven players in the daily growth hormone market today. It’s a fairly split-on market. I mean, Pfizer, I think is number two or number three, or maybe even dropped a little bit, but fairly close towards the top with Novo being the highest. And so, clearly if you go down from 7 to 1, 2 or 3, your goal is to grab additional market share. So, they’re heavily incentivized to do just that, so to go out and promote somatrogon.

Maury Raycroft

Okay. And any perspective into filings and timelines for filing for approval?

Adam Logal

So, we believe it will be second half, we’re hoping in this next summer.

Maury Raycroft

Got it. Okay. And then, separately on RAYALDEE. Just a quick question there for the Phase 2 in CKD 5 hemodialysis patients. What are the plans to use the data from that study? And then, also, from the head to head data that we’re expect in 2Q, what are the plans to use those data sets to expand the RAYALDEE label? I guess, what are next steps and what else would you have to do get the label expansion?

Steve Rubin

So, for the Phase 2, and dialysis patients, sort of two points. One is, we’re obviously picking the dosage. And to some degree, it’s a little bit of proof of concept to show that our product, which is a pro-hormone still will work in the patients with very little of any kidney function. So, that will serve two functions. One, assuming successful, we’ll roll into a Phase 2, the second part of our cohort of our Phase 2, but it will also help us drive sales of our existing stage 3 and 4 chronic kidney disease are the current reality that’s on market because there remain skepticism that our salesmen have to overcome in the field like why would it work any different than nutritional vitamin D if you no kidney function, because it’s a pro hormone.

Now, we -- based upon our study for RAYALDEE in stage 3 and 4, we have a high level of confidence because of the exact same dosage levels for stage 3 and 4. In other words, stage 4 having a higher -- less kidney function than a 3, we got the exact same results. And with the lower PTH, at the same levels and safely increase levels of vitamin D. So, that will be a useful tool for our existing sales team on stage 3 and 4. But more importantly, that will allow us to roll into the stage, second cohort stage 2 and then probably a subsequent Phase 3. Now, we power that or design that second cohort to we believe be able to allow to argue with FDA that will count as one of our Phase 3s. Maybe we could -- depending on the quality of the data, maybe that will even suffice. If not, we would have an additional Phase 3 to get it on label, and we would expect that to be a six-month trial, not too dissimilar from what we did for RAYALDEE itself.

Now, the head to head is really a large part driven by our European partner, Vifor, for pricing. So, to achieve premium pricing over the existing therapeutics, you need to show that you’re superior drug. So, that’s the purpose of that trial. So, so assuming that that is accessible in the head to head, then it will us to tell Vifor to ask for a premium pricing in the European market.

Dr. Phillip Frost

Just to clarify, it is -- primarily, the kidney is involved in activating the vitamin D to the active form. And it’s something that occurs only in the kidney. And the fact that as Steve pointed out, we got the same results irrespective of to what extent the kidney was not functional shows that there must be extra renal production of the active form 2. And that’s the uniqueness of our product. And it lends itself to being converted to the active form even outside of the kidney.

Maury Raycroft

Got it. That’s very helpful. Okay. Thank you for taking my questions. And I’ll hop back in the queue.


Your next question comes from the line of Ted Tenthoff with Piper Jaffray.

Ted Tenthoff

Just a quick question if I may on the status of some somatrogon in Japan, and when we could expect data and sort of what you see as steps towards filing in that territory? Thank you.

Steve Rubin

So, for Japan, it’s about six months behind. So, we expect about sometime to finish the trial middle of next year and then hopefully submit [Indiscernible] about six to eight months later.

Jane Hsiao

We say the top-line data will be available end of next year. From filing point of view, PMDA, Japanese health authority has specifically asked to see the switching data. So, our submission will now occur in 2020, a little bit later.

Ted Tenthoff

Okay. Thank you very much.

Steve Rubin

The switching data is going on now, as we’ve enrolled 66 -- 65% have rolled on to somatrogon.

Dr. Phillip Frost

And that market is important to us, because Pfizer has a significant part of the market now and we expect that they will continue to lead once they have once a week product.

Jane Hsiao

Pricing is…

Ted Tenthoff


Dr. Phillip Frost

I don’t know whether you heard that, but Dr. Hsiao said that the pricing is exceptionally good in Japan also.

Ted Tenthoff

Great. Thank you for that.


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

Dr. Phillip Frost

I just want to thank everybody for participating, and let you all know that we look forward to meeting with you by phone next year at the end of our first -- at the end of the year to give you our yearly results, and of course then again at the end of the first quarter. So, we look forward to that. And happy holidays between now and then. Thank you.


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

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