Opko Health (OPK) Q1 2019 Earnings Call Transcript

Opko Health (OPK -0.81%)
Q1 2019 Earnings Call
May. 07, 2019, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Welcome to the OPKO Health conference call. [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 -- Investor Relations

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 -- Chairman and Chief Executive Officer

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 three and four 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: only RAYALDEE is able to accomplish this.

An accompanying editorial emphasized the importance of our data. The recently expanded renal sales force is fired up. Last week's sales were a solid 10% higher than the high for any week before, and of course, we hope the trend will continue. We can't promise, but it's a step in a good direction.

We're still selling 4K. Our urology sales team has been expanded to handle 4K, as well as our full line of other urology tests. And remember, approximately 50% of men with an elevated PSA are below Medicare age and not affected by the LCD. On the other hand, we have submitted a request for reconsideration of the LCD and are also busy preparing an application for the FDA to approve the 4Kscore test.

As for BioReference, Jon Cohen, its new CEO, will tell you why he's feeling good about its future. Now as to our R&D program. As I said, we're spending what for us is a lot of money, but I think it's being well spent. The course of the final phase of our once-a-week growth hormone program have accelerated, and we should complete our multinational Phase 3 trial in August.

We remain optimistic about its outcome. We've now begun to expand our referenced use of our technology that prolongs drug action on another group of rare diseases. We've been at it for some time, but recently, we've seen that although still at early stages, they have the potential, by virtue of being better than currently available products, to be very valuable assets. Their development can move relatively fast and at comparatively low costs.

We'll keep you posted. And with that, I pass you on to Steve Rubin.

Steve Rubin -- Executive Vice President

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 five 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 healthcare 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 -- Executive Chairman of BioReference Laboratories

Thank you, Steve. I was asked to comment on my first four 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 six 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 seven 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 three pillars: patient engagement, specific physician expertise and strategic partnerships. On the patient pillar, we have launched our patient portal for patients to register, pay their bills, see their results, track trends and get information about their tests. We will also have some more interesting announcements through Q3 and Q4 relative to several other patient-specific initiatives as we aggressively push to improve the overall patient experience. On the physician pillar, we remain committed to the areas where BioReference and GeneDx have been leaders, with specific expertise in women's health, urology, oncology, servicing diverse communities and, of course, genetics, including all of the components of the genetic landscape, such as inherited cancer, somatic cancer and rare diseases.

In terms of genetic testing, GeneDx continues to grow at, as Steve stated, 17% year over year for Q1. GeneDx has the deepest menu for rare diseases in the world. I would remind you that there are now 7,000 known rare diseases and approximately 8% to 10% of the population have a genetic disorder, which means approximately 30 million Americans have an identifiable genetic variation that could impact on their health. The third pillar is the strategic partnerships where we have put in place a vigorous structure to specifically address this growing part of the market.

Within a short time frame, we have developed a very vigorous pipeline of deals in various stages of the proposal process. And in Q1, we have already closed several deals. Overall, I remain incredibly optimistic about the future growth trajectory of both BioReference and GeneDx. Steve, back to you.

Steve Rubin -- Executive Vice President

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 healthcare 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 six 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 among 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 2 trial with a higher-strength RAYALDEE in patients with stage five 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 one of three 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 4 study designed to demonstrate that RAYALDEE is superior to commonly used competitive therapies: paricalcitol or Zemplar, immediate-release calcifediol or Hidroferol and cholecalciferol or vitamin D3. Initial data readout started in late Q1 2019, with final data expected to be available by the end of this year. The early data suggest that RAYALDEE is the only therapy which can reliably raise and maintain serum total 25-hydroxyvitamin D levels at sufficiently high levels to control elevated parathyroid hormone in patients with stage three or four CKD.

A Phase 3 study with RAYALDEE in pediatric patients, this is a post-market requirement, is our next study. And final protocol has been submitted to FDA, and the study will start in the U.S. as soon as the protocol is approved by the FDA, likely in Q2 of this year. A Phase 2 study with RAYALDEE for SHPT associated with vitamin D insufficiency in bariatric surgery patients is also being planned.

The protocol has been finalized and resubmitted to FDA, and that study is expected to start in Q3. Finally, a Phase 2 study with RAYALDEE for SHPT and vitamin D insufficiency in anephric patients or patients with no kidneys is being planned. The final protocol has been submitted to FDA. This study is expected to start in Q3 2019, and the point of this study is to -- conclusively to demonstrate that RAYALDEE can be activated outside of the kidney.

Turning to our metabolic and endocrinology pipeline. We have several late-stage programs under way or nearing initiation. I'll start with our long-acting human growth hormone product, Somatrogon or hGH-CTP. Now as you know, Somatrogon is partnered with Pfizer for worldwide commercialization.

We are approaching conclusion of our pivotal non-inferiority study comparing a single-weekly injection of Somatrogon for 12 months with daily injections of GENOTROPIN. This 225-patient study uses the pen device and formulation intended for commercial launch. We are hopeful that the outcomes will support a dosing change from daily to weekly administration and positively impact the quality of life for children with growth hormone deficiency. The last patient, last injection of this study will be the end of August, and we expect to announce top-line data from this study in Q4 of this year.

Last summer, we began a pediatric registration study in Japan to assess pharmacokinetics and compare efficacy of weekly Somatrogon to daily GENOTROPIN in 44 prepubertal growth hormone-deficient subjects. We completed enrollment in this 12-month study in early 2019. Over 95% of the patients who were eligible to enter the open-label extension study are continuing in the second year study with Somatrogon as the sole treatment. We are expanding our rare and necrology disease pipeline by utilizing our existing platform technologies: the CTP, which is used for Somatrogon; and reverse PEG, to identify lead candidates where long-acting therapeutic drugs would have significant benefits to patients.

We plan to bring at least three additional product candidates into development. Our products under development include MOD-12104, which is a long-acting CTP-hGH antagonist for the treatment of acromegaly; MOD-1501, a long-acting GLP-2 peptide for the treatment of small bowel syndrome; and MOD-1301, a long-acting CTP IGF-1 for the treatment of growth failure associated with severe primary insulin-like growth factor one deficiency. Each of these development targets represents a significant market opportunity, a relatively clear and fast regulatory pathway to market and an existing standard of care that we believe can be greatly improved by application of our technology. Turning to OPK88003, our oxyntomodulin product.

In early February, we reported that our Phase 2b dose escalation trial for this once-weekly GLP-1/glucagon dual-agonist oxyntomdulin for the treatment of type two diabetes and obesity was complete. In March, we reported top-line data from the modified intent to treat population, and then in April, we reported further data from the Per Protocol population. This study included 110 type two diabetics with an inadequate glucose control with metformin and/or diet and exercise and evaluated HbA1c, weight loss and safety over 30 weeks. Patients were randomized to OPK88003 or placebo, with the OPK88003-treated arm starting with 20 milligrams for four weeks, then 40 milligrams for four weeks and finally, our target dose of 70 milligrams for 22 weeks.

The modified intent to treat population included patients who received at least one dose of drug and had one post-baseline evaluation. This analysis showed that OPK88003 met the primary objective with a statistically significant lowering of hemoglobin A1c after 30 weeks of treatment versus placebo, as well as statistically significant weight loss versus placebo, which was a key secondary endpoint. In the Per Protocol population, which includes all patients who received OPK88003 for at least 26 weeks of the 30-week trial, the decrease in HbA1c and the increase in weight loss were even more pronounced. Similarly, other efficacy parameters improved in the Per Protocol population, such as percentage of patients achieving less than 6.5% HbA1c, the percentage of patients achieving weight loss greater than 5% and the decrease in serum triglycerides.

We are pleased with the result of this trial and believe OPK88003 has the potential to compete favorably with other drugs in the market or under development. We plan to further evaluate OPK88003 in a Phase 3 clinical program in type two diabetes and obesity, as well as in other promising indications such as NASH. With respect to OPK88004, our once-daily oral selective androgen receptor modulator or SARM, we are planning an additional exploratory Phase 2 clinical study to assess OPK88004 in prostate cancer patients treated with androgen deprivation therapy. We expect to finalize and submit the protocol to the FDA later this year.

With that overview, let me turn the call over to Adam for a discussion of our first-quarter financial performance.

Adam Logal -- Chief Financial Officer

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 three 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 three 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 J.P. Morgan 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. Operators?

Questions & Answers:

Operator

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

Unknown speaker

Hi. This is Mitchell on for Maury, and thank you for taking our questions. 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?

Steve Rubin -- Executive Vice President

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.

Unknown speaker

OK. 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 -- Chief Financial Officer

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.

Unknown speaker

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 -- Chief Financial Officer

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, etc. 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.

Unknown speaker

OK. Great. 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 -- Laidlaw and Company -- Analyst

Good afternoon. Thanks for taking the question. Two questions here. No.

1 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?

Steve Rubin -- Executive Vice President

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 -- Laidlaw and Company -- Analyst

OK. 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?

Steve Rubin -- Executive Vice President

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 -- Laidlaw and Company -- Analyst

OK. 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 3 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?

Steve Rubin -- Executive Vice President

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 seven 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 seven players in the market and down to two, potentially three, we feel pretty good about it. We've got a great partner in Pfizer as the No.

2 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 -- Laidlaw and Company -- Analyst

OK. Great. Thanks a lot and appreciate the update. 

Steve Rubin -- Executive Vice President

You're welcome.

Operator

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

Phillip Frost -- Chairman and Chief Executive Officer

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

[Operator signoff] 

Duration: 43 minutes

Call participants:

Miriam Miller -- Investor Relations

Phillip Frost -- Chairman and Chief Executive Officer

Steve Rubin -- Executive Vice President

Jon Cohen -- Executive Chairman of BioReference Laboratories

Adam Logal -- Chief Financial Officer

Unknown speaker

Yale Jen -- Laidlaw and Company -- Analyst

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