Opko Health (OPK) Q1 2021 Earnings Call Transcript

Opko Health (OPK -2.44%)
Q1 2021 Earnings Call
Apr 28, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, and thank you for standing by, and welcome to the OPKO Health Inc. first-quarter 2021 financial results conference call. [Operator instructions] Please be advised that today's conference call is being recorded. [Operator instructions] I would now like to hand the conference over to your speaker today, Ms.

Yvonne Briggs. Thank you. Please go ahead.

Yvonne Briggs -- Investor Relations

Thank you, operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss OPKO Health's financial results for the first quarter of 2021. 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 SEC filings, including the annual report on Form 10-K for the year ended December 31, 2020, and in subsequently filed SEC reports. Importantly, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, today, April 28, 2021. 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 today's call.

Dr. Phillip Frost, chairman and chief executive officer, will open the call; and Steve Rubin, OPKO's executive vice president, will provide a business update and pipeline review. And then Dr. Jon Cohen will discuss BioReference Laboratories.

After that, Adam Logal, OPKO's CFO, will review the company's first-quarter financial results, and then we'll open up the call for questions. Now, I'd like to turn the call over to Dr. Frost.

Phillip Frost -- Chairman and Chief Executive officer

Good afternoon, and thank you for joining the call today. I'm happy to share our first-quarter results with you. Revenues, earnings, and cash flow from operations were strong. BioReference Laboratories continues to be recognized as a national leader in COVID testing as demonstrated by recently announced high-profile professional sports and school contracts.

COVID-19 PCR testing volume remained strong during the first quarter even with a significant decline in cases nationwide. As the country starts to emerge from the pandemic, we're seeing an overall shift from diagnosis to surveillance, and we are seeing BRL's routine business improving toward historical levels. While we anticipate that COVID-19 test volumes for the general public for diagnostic purposes may decline, there is still strong interest in BRL's COVID-19 capabilities for large-scale screening and ability to provide customized solutions across a broad spectrum of customer requirements. BRL consistently tries to differentiate itself from other laboratories.

You will hear Jon Cohen tell you a been a novel program to make it easier for patients to have blood drawn. This is part of a bigger vision to have our laboratory interact more directly with healthcare providers such as telemedicine and large physician groups to achieve better patient outcomes. Our pharmaceutical business continues to advance nicely. The European regulatory submission was recently announced for somatrogon, our long-acting human growth hormone.

This is in addition to previously announced submissions in the U.S. and Japan. To create further awareness of this important drug candidate, earlier in the quarter, we participated in several endocrinology conferences to highlight somatrogon's clinical data profile. Rayaldee's prescription sales growth continue to be impacted by the pandemic.

As COVID-19-related limitations lessen, we expect Rayaldee to return to pre-pandemic levels and to resume its previous growth trajectory. The COVID-19 trial is ongoing. Too early for optimism, but literature data support the notion that sufficiently elevated vitamin D levels, help prevent more severe forms of infection, and Rayaldee is quite efficient in raising vitamin D levels. This would be important in the general population, but even more so for chronic kidney disease patients who tend to have more unfavorable outcomes.

As you may know, OPKO has a small but excellent unit, OPKO Iberoamerica with business units in Chile, Mexico, and Spain. Under the leadership of its General Manager, Hans Berner, it continues to grow in revenues and profits. OPKO's pharmaceutical chemical business in Israel, although quite small, also continues to do well. I will now turn the call over to Steve Rubin, who will further -- provide further discussion on our pharmaceutical business.

Steve?

Steve Rubin -- Executive Vice President

Thanks, Phil. Good afternoon, everyone, and thank you for joining us today. As Phil mentioned, we are quite pleased with our strong first-quarter financial results and continued profitability. BioReference Laboratories continues to secure COVID-19 testing contracts, and its core testing business is trending back to normal levels.

In addition, we are also generally pleased with the advancement of OPKO's pharmaceutical businesses. Global regulatory progress with somatrogon continues to be made by our commercial partner, Pfizer. Somatrogon is our long-acting recombinant human growth hormone that is intended to be administered once weekly in the treatment of pediatric patients with growth hormone deficiency or GHD. In February, the European Medicines Agency validated for review the marketing authorization application.

Pfizer expects a decision from the European Commission in 2022. In addition, we previously announced that the U.S. FDA accepted for filing initial biologics license application for somatrogon with a target PDUFA action date in October 2021 and that a new drug application was submitted in Japan. Under our agreement with Pfizer, OPKO is eligible to receive up to $275 million upon the achievement of certain regulatory and pricing milestones.

In addition, upon launch, we are entitled to regional, tiered gross profit sharing on sales of both somatrogon and Pfizer's daily GHD drug, Genotropin. During February and March, we participated in two endocrinology conferences, including ENDO 2021, the Endocrine Society's 2021 Annual Meeting, and at ICE 2021, the 19th International Congress of Endocrinology Annual Meeting. We are pleased to have somatrogon clinical trial data presented to generate further awareness of our drug. Collectively, the various studies presented provided a breadth and depth of data for somatrogon that demonstrate its efficacy and safety for an expansive number of patients over the long term.

The presentations, posters, and abstracts from these conferences can be viewed on our website. We are also participating in the 2021 Pediatric Endocrine Society Virtual Annual Meeting, which is being held today through May 3. Now, I'd like to turn to our commercial pharmaceutical business, starting with Rayaldee. Rayaldee numbers for the quarter break down as follows.

Total prescriptions for Rayaldee in Q1 2021 as reported by IQVIA were approximately 12,300, representing a decrease of approximately 33% compared with Q1 2020 and a decrease of approximately 18% compared to Q4 of 2020. As in recent quarters, the Rayaldee sales force continues to contend with the impact of COVID-19 on in-person access to physicians, as well as a decline in patient business to physicians' offices. New patient starts decreased by 10% in Q1 versus Q4. Since the product was launched, nearly 25,200 patients have had Rayaldee prescribed by approximately 3,600 physicians.

Approximately 170 physicians or nearly 5% of the total number of prescribers were new Rayaldee prescribers in Q1. We anticipate that sales of Rayaldee will start to rebound as COVID-19 vaccinations become more available and infections decline. To mitigate the impact of the ongoing pandemic, we are continuously training our sales force in virtual selling techniques, boosting our marketing efforts, channels through social media platforms, and redeploying sales personnel to geographies with lower infection rates. We are pleased to announce today that phase 2a results with Rayaldee as a new treatment for SHPT in hemodialysis patients fully confirm the previously reported interim data, cohort 1 of this phase 2 clinical trial, exploring the safety and efficacy of a high-strength formulation of Rayaldee in adults with SHPT, vitamin D insufficiency and stage 5 CKD, who require regular hemodialysis was completed in February 2021.

This phase 2 trial is being conducted in two successive cohorts. The first of which involved 44 patients from multiple U.S. dialysis centers treated in a randomized, open-label fashion with either Rayaldee or placebo for 26 weeks. Top-line results from 44 subjects comprised of 33 on Rayaldee and 11 on placebo demonstrated that Rayaldee was well tolerated at a dose of 900 micrograms a week and activated to calcitriol, the active hormone, despite the lack of functional kidneys and decreased intact parathyroid hormone levels versus placebo.

The full analysis of the final data is under way and will be reviewed with both the FDA and OPKO's development partners. Our phase 2 trial with Rayaldee as a treatment for COVID-19 outpatients is now over 70% enrolled, is ongoing at 10 U.S. sites, many of which are located in areas that are experiencing high sustained SARS-CoV2 infection rates. Total enrollment of approximately 160 patients is planned.

Patients are being screened for possible inclusion if they have symptoms consistent with mild to moderate COVID-19 and are excluded if they are either asymptomatic or exhibit oxygen saturation below 94%. The primary efficacy endpoints include raising and maintaining serum total 25-hydroxy vitamin D within the range of 50 to 100 nanograms per ml, and time to resolution of COVID-19 symptoms. A self-reported each day by subjects using a questionnaire designed and validated to evaluate in clinical trials of presence, severity, and duration of symptoms associated with viral infections. Top-line data from this randomized double-blind, placebo-controlled trial are expected in the third quarter.

If sufficiently positive, they will form the basis for an immediate request to FDA for emergency use authorization. We continue to advance our earlier-stage programs with a focus on our long-acting platform technologies in rare diseases. Two of our most advanced compounds are our long-acting recombinant, Factor VII compound for the treatment and prevention of bleeding episodes in patients with hemophilia A or B with inhibitors of Factor VIII or Factor IX and our long-acting GLP-2 analog for the treatment of short bowel syndrome. We are continuing to progress discussions to partner our Factor VII program.

Preclinical studies in a rat model using our GLP-2 analog demonstrated strong efficacy and prolonged activity on the intestine. Preliminary monkey data from the four-week toxicity program demonstrated a plateauing of increased intestinal weight with the lowest dose and a sustained effect over the recovery period of 28 days. We are planning to extend the monkey study to determine more precisely the effect of a lower dose range. The human studies are expected to begin in early 2022.

Now, let me turn the call over to Jon Cohen to discuss our BioReference Lab's business. Jon?

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

Thanks, Steve, and good afternoon, everyone. BioReference's core clinical laboratory business continues to make progress to return toward 2019 levels as more physicians' offices reopen, our salespeople are allowed back into the offices and patients feel more comfortable with in-person visits. Many of our existing clinical accounts have rebounded through Q1, while at the same time, we have added new business in women's health in oncology. Although oncology practice patient visits are still at 80% to 90% of pre-COVID levels, our liquid tumor hematology offering continues to thrive and has bounced back to pre-COVID levels, and our solid tumor offering is almost at pre-COVID levels.

In addition, our somatic genomics offerings has nearly doubled in Q1 versus Q1 of 2020. Our larger accounts, including large medical groups, FQHCs, ACOs, and health systems are also seeing increases in in-patient visits month-over-month. We expect these improving trends to continue throughout the year as vaccines are administered and the number of COVID cases decreases. Our volume exiting Q1 is now down 7% versus prior year.

Our payer relations team continues to make remarkable progress, increasing our access across the country as 10 new health plans will be added within the next 30 to 60 days. Our investment in the hospital reference business and in a sales force to deliver on that business is beginning to pay off with several new reference accounts having been added this quarter. In addition, we are expanding our partnerships with several large physician groups in managing their physician office laboratories. At GeneDx, in the first quarter, our genetic testing volume grew over 10%, driven by our industry-leading exome testing offerings.

There is a substantial interest in our genome offering across our existing client base, driven by our recently launched rapid genome offering. In January, we also partnered with Tempus, a leading precision medicine company, to combine a customized hereditary cancer panel with our somatic cancer offering as a way to expand our commercial reach without investing in a broader commercial organization. Finally, our adult neurology testing is growing as a result of our recently launched ataxia testing offering. While reimbursement headwinds continue to impact revenue growth, we expect the accelerating growth in volumes to result in this business to be a growth contributor as the year progresses.

In January, we formally launched Scarlet Health, an in-home diagnostic service to expand digital health access. Scarlet brings diagnostic services to patients' homes, offices, or other preferred locations, delivering on-demand, safe, and convenient diagnostic experience for patients. Scarlet has been designed to be similar to tools that consumers use daily in order to provide a convenient, ease-of-use, innovative, flexible mobile alternative to the traditional patient service center experience. We believe that a significant part of the future of healthcare is at home.

Our plan is to make in-home healthcare real for millions of Americans by bringing diagnostic services directly to the patient. Now, let me turn my attention to COVID. Since the start of the pandemic, we have now performed 14.4 million COVID-19 PCR tests. In the first quarter, we performed approximately 4.3 million COVID-19 tests, compared to 4.7 million tests performed in the fourth quarter.

We are averaging about 40,000 to 50,000 tests a day. BioReference continues to provide COVID-19 solutions to meet testing needs of numerous customer verticals, including physicians, health systems, long-term facilities, governments, schools, employers, professional sports teams, entertainment venues, and the general public through our retail pharmacy chain relationships with Rite Aid and CVS at over 1,500 locations around the country. BioReference remains the laboratory of choice for professional sports leagues as we expand our ongoing relationship with the NFL, NBA, Major League Soccer, National Hockey League, and now, Major League Baseball, which we kicked off in April on opening day. I'm thrilled to announce today a COVID-19 testing agreement with the Women's NBA league to support all players of staff for their 25th season.

Across the sports portfolio, we performed approximately 1 million COVID-19 tests, including 150,000 point-of-care tests in Q1. We provide customized solutions to 200 professional sports clubs across 40 cities with perhaps the most experienced on-site services organization in the country. In Q1, BioReference successfully supported a large-scale testing program for the Super Bowl in Tampa, the Women's and Men's Big East Basketball Championship in March, U.S. soccer national teams, the USA swimming team, and the USGA and multiple universities.

We are performing fan testing at several stadiums and arenas around the country through our growing point-of-care testing capabilities, which includes both point-of-care PCR and antigen testing. Speaking of point-of-care rapid testing, we continue to rapidly expand our delivery of COVID-19 point-of-care testing. We have performed more than 270,000 COVID point-of-care tests, including 200,000 rapid PCR tests using the Mesa Accula. We use point-of-care PCR for multiple sports leagues at over 400-plus testing sites with 3,000 point-of-care devices.

We performed a large-scale arena testing at Madison Square Garden in New York and the Chase Center in San Francisco. As I mentioned on our last call, point-of-care devices are expected to play a larger role in COVID testing with the shift in demand from screening with timely results. We have validated multiple point-of-care platforms and have developed proprietary software to deliver the result -- deliver the report result in a timely fashion in order to provide customized solutions for many different industries. In March, we announced the expansion of our COVID-19 school testing program to support a return to in-person classroom instruction around the country.

We are working with two of the three largest school systems in the country, New York City and Chicago, by providing testing services for over 1,400 schools, testing nearly 300 schools every day. To date, we have performed almost 500,000 individual tests on public school students, principals, and teachers. We expect to announce expansion of our school testing programs to at least four more school districts in the next several weeks. In February, we announced a unique program in partnership with New York State to provide COVID-19 rapid testing to help reopen the New York State economy.

The New York Forward rapid testing program is designed to provide New Yorkers and those visiting with inexpensive and rapid COVID-19 testing. The New York Forward program is a collaboration with The Empire State Development Corporation, The Real Estate Board of New York, REBNY, the city's leading real estate trade association, and CVS Pharmacy. To date, we now have 31 of these retail locations open. Using a mobile device or a computer, an individual can schedule a rapid COVID-19 test, pay in advance using a cashless experience, get tested, and receive the results within 30 minutes or less, sent by a secure email, allowing them to show proof of a negative COVID-19 result.

As cases have decreased and vaccination has increased, we are seeing a shift from diagnostic testing to screening and surveillance. In anticipation of this trend, BioReference strategically positioned itself several months ago by adding specific point-of-care personnel, developing specific point-of-care workflow for high-throughput events, and developing customary -- custom proprietary software to schedule and report of six different point-of-care platforms. As a result, we're able to address simple and complex surveillance programs across multiple different venues. We continue to see a significant demand for testing for travel, hospitality, employer return to work programs, and large venue events in addition to the sports testing and school testing we already mentioned.

We believe that many of these entities will continue their surveillance and screening programs through the end of 2021 and in many cases, through the first half of 2022. Our custom solutions utilizing both lab-based PCR and point-of-care test has positioned us as to maintain our position as the nation's leading provider of large-scale COVID screening programs. In addition, our improved business -- base business and strengthening our specialty testing services should continue to bolster our performance throughout the year. And now, let me turn it over to our CFO, Adam.

Adam Logal -- Chief Financial Officer

Thank you, Jon. We began 2021 by delivering solid operating performance across all of our operations, resulting in consolidated operating profit for the fourth straight quarter. Our diagnostics segment reported revenue from services of $507 million, compared to $170 million for the 2020 period. The increase in net revenue was driven by the continued execution of our COVID-19 testing strategy.

Combining our routine testing business and our COVID testing business, volumes overall increased more than 158% compared to historical levels. Our routine clinical testing, however, as Jon mentioned, was 7% lower compared to the 2020 period. While our genetic testing volumes were 10% higher compared to the 2020 period. The diagnostics segment reported operating income of $67 million, compared to an operating loss of $18 million, an improvement of $85 million over the 2020 period.

Selling, general, and administrative expenses, along with research and development expense decreased as a percentage of revenue from 33%, down to 18% of revenue, reflecting operating leverage improvements. Total cost and expenses increased by $251 million, compared to 2020, including increased cost of revenue of $216.5 million due to the increase in testing volumes. Moving to our pharmaceuticals segment. We reported revenues of $38.2 million for the first quarter of 2021, compared to $40.6 million for the 2020 period.

Revenue from product sales in the first quarter increased slightly to $33.9 million, which included $5.8 million of revenue from Rayaldee, compared to $31.1 million in the first quarter of 2020, inclusive of $9.9 million of revenue from Rayaldee. Rayaldee has continued to be negatively impacted by physician office restrictions, keeping product sales representatives for making sales calls. Revenue from the transfer of intellectual property, we reported $4.3 million of revenue for the 2021 period compared $9.6 million from a year ago, reflecting the completion of our somatrogon phase 3 clinical trial. Loss from operations of our pharmaceutical segment was $19.2 million for the first quarter of 2021, compared to $14.1 million for the 2020 period.

Overall, research and development expense for the first quarter was $15.8 million, compared to $18.6 million for the 2020 period, again, reflecting reduced spending on our somatrogon development program. On a consolidated basis, the first quarter of 2021 had an operating profit of $38.4 million, a significant improvement of $79.2 million over 2020's operating loss of $40.8 million. Our net income for the first quarter was $31.1 million or $0.05 per diluted share, compared to a net loss of $59.1 million or $0.09 per share for the 2020 period. Our cash balance as of March 31, was $89.5 million, and we have approximately $164 million under -- of availability under our lines of credit.

The combination of our cash on hand and the lines of credit provide us with a strong balance sheet and adequate capital resources. As we look into the second quarter of 2021, we see continued opportunity to generate operating profit and cash flow. Given the uncertainty of testing demand for COVID-19, we again are limiting our forward-looking guidance to the second quarter. For the second quarter of 2021, we have built the following assumptions into our forecast.

We anticipate performing between 3 million and 4 million COVID-19 PCR point-of-care and antibody tests during the quarter. As Jon mentioned, we have capacity well in excess of these levels should demand for testing increase. Our revenue could expand beyond our guidance. So far, this quarter, we have already performed over 1 million COVID tests.

So our guidance reflects a range for testing demand from our physician and general public channels while testing from our schools, sports, entertainment, and employer channels are expected to remain or grow from their current levels. We assume our base business for routine clinical testing will remain at current levels, which are overall in the mid- to high single digits behind our base year of 2019. We anticipate Rayaldee sales to remain behind 2020 until our sales force is able to fully return to their promotional activities. With that, overall, we expect revenue for the second quarter of '21 to be between $420 million and $490 million, including revenue from services of $385 million to $450 million.

Revenue from products of $30 million to $34 million and other revenue of $4 million to $6 million. We expect costs and expenses to be between $415 million to $485 million, resulting in an operating profit of $5 million to $15 million at various points between the revenue and expense assumptions. As Jon mentioned, we're making significant investments into our commercial organization, which are reflected at those costs. Operating profit excludes approximately $20 million of non-cash depreciation and amortization expense, as well as an expectation of research and development expense of $18 million to $22 million.

With that, I'll turn the call over to the operator for questions.

Questions & Answers:

Operator

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

Maury Raycroft -- Jefferies -- Analyst

Great. First question I had was just on COVID-19 testing. So there was some discussion around OPKO getting named as one of the four designation testing centers for the U.S. government.

And I think that decision was supposed to be made yesterday. Just checking if there's a status update on that.

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

Yeah. Hi. It's Jon. So that decision has been delayed by the government until May 14 or 15.

But yes, we have submitted, and we were asked to submit as one of the finalists. But the answer is we won't know anything until May -- it looks like May 14 or 15. They've delayed all decisions until then.

Maury Raycroft -- Jefferies -- Analyst

Got it. Makes sense. And then now that we've been into COVID for a couple of quarters, probably difficult to predict too much going forward. But just wondering if you have any line of sight into optimizing capacity and cost and expenses that could potentially benefit the bottom line maybe in 3Q or 4Q?

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

I'm sorry. Go ahead.

Steve Rubin -- Executive Vice President

I was just going to say, Jon, please add. So we're obviously paying pretty close attention to the level of investment that we have. Obviously, the testing demand is declining. So you could imagine that we're starting to scale back some of our operations.

However, it is remaining fairly robust. So there's not a significant amount of cuts that we could do to bring those costs in line, but it is absolutely something that we'll continue to manage appropriately. I don't know, Jon, if you had any specifics there.

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

No, that's right. It's -- no, that's exactly right. We're trying to manage it. Most of the cost, quite honestly, is on the staff side.

It's not on the equipment, and some of it is on the supply side on the reagent side. But right now, we're managing it as tight as we can given the fluctuations in what's going on day to day, but we are acutely aware and are keeping a very close eye on it.

Maury Raycroft -- Jefferies -- Analyst

Got it. That's helpful. And then last question is just on somatrogon. So your PDUFA is scheduled for October 2021, and then the Ascendis PDUFA scheduled for June.

I'm just wondering if you've gotten any indication from FDA that the timing on the somatrogon decision could get accelerated based on the Ascendis timeline, if there's been any informal feedback on that.

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

No, we've had no feedback on that point.

Maury Raycroft -- Jefferies -- Analyst

OK. Any thoughts on if that's a possibility, I guess?

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

Anything is possible. We're continuing with the expectation that the PDUFA date will remain the approval date in October.

Maury Raycroft -- Jefferies -- Analyst

OK. Thank you for taking my question.

Operator

Your next question comes from the line of Dana Flanders from Guggenheim. Your line is now open.

Dana Flanders -- Guggenheim Partners -- Analyst

Great. Thank you very much for the questions. My first one, I was hoping you could help me understand -- better understand just the services revenue number this quarter. And I ask because it looks like your testing volumes came in at the lower end of guidance, but your reported revenues -- service revenues came in at above the high end of the guidance.

And so I'm wondering if that was better reimbursement on the testing side or if there was something else that maybe I'm missing.

Steve Rubin -- Executive Vice President

Yes. So, Dana, what we've seen is, and we've talked about this a little bit before is a lot of the testing volume has shifted away from the state and local government testing that was done and move to some of the higher revenue line items or higher price per test line items with some of our non-government business. So it's a shift and an increase in the overall reimbursement that you're seeing come through to have that impact.

Dana Flanders -- Guggenheim Partners -- Analyst

OK. OK. Got it. And I guess, along those lines, just I appreciate the color on the volume you're getting on the sports channel side.

Wondering if there are other kind of nontraditional channels that you are focused on where you see a big future opportunity that maybe you haven't tapped yet?

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

Yes. So I mentioned a little bit. So if you look at the different verticals, the -- and this is related to what everybody's referring to as screening/surveillance. So the bigger ones are travel and hospitality.

There's obviously an enormous amount of funding available for school testing, which we are -- I still believe probably the largest -- has the largest amount of public-school testing in the country currently, which were -- I mentioned we're adding on. And then there's the, I'll call them, a large venue. And it's not just the Garden, Barclays, Chase Center, etc., but there's also large venue events that are looking for testing, particularly screening testing as they unfold in the fall, and that could be all sorts of different concerts and races, etc. So we see a fairly significant demand for those kind of events.

And I would say the last of the large verticals is how employers deal with bringing their employees back to work. So a lot of discussions around that because that's also falling in the screening/surveillance category.

Dana Flanders -- Guggenheim Partners -- Analyst

OK. OK. That's helpful. And maybe just my last one.

Just wondering on your broader kind of R&D efforts and pipeline with hGH kind of nearing the finish line, how are you thinking about kind of the internal assets you have? And if there are internal ones that you're excited about and going to start to prioritize or if kind of BD in-licensing could also be something you consider as you think about moving the pipeline forward. Thanks.

Tony Cruz -- Chief Executive Officer, Transition Therapeutics

Well, there's -- this is Tony Cruz. The focus right now still is in finishing the growth hormone and also initiating a second indication in pediatrics in another indication or a basket of indications with Pfizer. So there is quite a bit of focus still on the growth hormone as it progresses and also potentially getting the -- ready the data and the analysis if necessary for potential indication application. So there is still an ongoing -- in terms of the pipeline, as Steve has indicated, the Factor VII is a molecule that looks promising in the phase 1 data that we did and the phase 2a data.

We are looking at starting a synthesis in a development plan for that. And the other one is the GLP-2 where we did an animal tox study where we're looking to optimize this molecule because it looks very potent compared to some of the competitors that are currently in once weekly, as well as compared to Gattex. So those two look promising and moving forward. We do have additional molecules that we could move forward, but these are the two that we really are focusing at this time.

Dana Flanders -- Guggenheim Partners -- Analyst

OK. Thanks for the color.

Operator

Your next question comes from the line of Edward Tenthoff from Piper Sandler. Your line is open.

Edward Tenthoff -- Piper Sandler -- Analyst

Thanks, guys, and congrats on a nice quarter. So a lot of the questions I had were answered, but I wanted to sort of pick up just in terms of prep work, both ahead of the PDUFA date, as well as commercial launch. Again, appreciating that a lot of that is in the hands of Pfizer. Is there anything in particular that you guys are involved with? Just any color you can kind of share with respect to preparation for the launch? Thank you.

Tony Cruz -- Chief Executive Officer, Transition Therapeutics

No. As per the agreement, Pfizer is responsible for all commercialization activities. I mean, we do have regular meetings, discussing what they're doing. But in terms of our actively participating, we don't.

Where we're participating is in continuing development and continuing to present data in different meetings to make sure that the awareness has continued. But I think most of it really is still in the development ongoing. As you know, we had large trials that were completed, but the ongoing open-label extensions are ongoing, and we're still gathering data from that. So there's very close activity.

The last is obviously associated with these submissions. There's a continuous report between the company and the FDA or other regulatory agencies to answer their questions. And so a lot of the focus with Pfizer is really taking this to approval.

Edward Tenthoff -- Piper Sandler -- Analyst

Excellent. Thank you so much.

Operator

Your next question comes from the line of Yale Jen from Laidlaw and Company. Your line is now open.

Yale Jen -- Laidlaw & Company

Good afternoon and congrats on the quarter. My first question is that going forward, do you anticipate the breakdown for the COVID test between PCR and serological test changes, or pretty much, it stays relatively same sort of ratio?

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

Yeah. It's a good question. And quite honestly, I don't think anybody knows yet what will happen for the antibody testing or quantitative antibodies for both people who have the vaccine or the disease. A little bit of that will be dependent on the government or government's regulatory oversight in either here and international relative to showing proof of vaccine and/or possible antibodies, but that's conjecture right now.

Nobody knows which way it's going to happen -- it's going to occur. But it just depends on who will require one on validation. So otherwise, I don't think anybody's got that answer.

Yale Jen -- Laidlaw & Company

OK. Maybe two quick ones. In terms of -- you just mentioned that it seems that you are getting a higher price test being done that's why your revenue increases. Do you anticipate this trend going forward into next quarter, maybe further into the second half of this year in terms of getting a higher price test then?

Steve Rubin -- Executive Vice President

Yeah. So, Yale, I don't think there's going to be another large step-up. The school and some of the surveillance testing that Jon was talking about, those come at a slightly lower price than where our average is coming in today. But I think it really does depend on a lot of the general public demand for testing and how that continues to evolve.

I do think that the government sites have mostly shifted from testing to vaccinations. So most of those contracts are going to continue to wind down. But as the broader testing from the general public continues or if we're able to expand some of our sports and leisure franchises, some of those come with higher price points. So it really does depend on the mix, but I think the general public demand is the biggest unknown there.

Yale Jen -- Laidlaw & Company

OK. Maybe the last question that -- I think this is for Jon, that you mentioned there will be 10 more health plan to be consigned over the next, I guess, 60 days. Just overall, what's the coverage life in total for those plans? Thanks.

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

I don't have it in front of me -- if you're asking me for the number of lives, I'd have to get back to you to tell you what the impact will be. So we'd have to circle back to tell you exactly how -- yes. No, I don't know exactly how many lives that represents.

Yale Jen -- Laidlaw & Company

OK, great. Thanks. I appreciate it.

Operator

I am showing no further questions at this time. I would now like to turn the conference back to Dr. Frost.

Phillip Frost -- Chairman and Chief Executive officer

Well, if there are no more questions, I'd like to thank everybody for participating and tell you that we look forward to meeting with you again after the next quarter's results are ready. Thank you.

Operator

[Operator signoff]

Duration: 46 minutes

Call participants:

Yvonne Briggs -- Investor Relations

Phillip Frost -- Chairman and Chief Executive officer

Steve Rubin -- Executive Vice President

Jon Cohen -- Director and Executive Chairman, BioReference Laboratories

Adam Logal -- Chief Financial Officer

Maury Raycroft -- Jefferies -- Analyst

Dana Flanders -- Guggenheim Partners -- Analyst

Tony Cruz -- Chief Executive Officer, Transition Therapeutics

Edward Tenthoff -- Piper Sandler -- Analyst

Yale Jen -- Laidlaw & Company

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