Opko Health, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to OpcoHealth's Second Quarter 2020 Financial Results Conference. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during that session, you will need to press star 1 on your telephone. Please see advice at today's conference may be recorded. If you require any further assistance, please press star NCL. I will now hand the conference over to Yvonne Briggs with LHA Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss Opco's health financial results for the second quarter of 2020. 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, 2019, 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, July 30th, 2020. Except as required by law, OPCO 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. Philip Frost, Chairman and CEO, will open the call, then Steven Rubin, Opco's Executive Vice President, will provide a business update and pipeline review, and then Dr. John Cohen will discuss bioreference laboratories. After that, Adam Logel, Opco's CFO, will review the company's second quarter financial results, and then we'll open up the call to questions. Now let me turn the call over to Dr. Frost.

Good afternoon, and thanks for joining the call today. We continue to contend with the COVID-19 pandemic As our business meets with both challenges and opportunities, I'm proud to say that BioReference Laboratories has further solidified its leadership position with COVID-19 testing for both the public and private sectors. Our management team and employees have done an outstanding job to meet the ever increasing demand for testing to help manage the pandemic and its rapid spread. Given these successful efforts to provide quality results, Within reasonable turnaround times, BioReference has been chosen to provide testing services by the CDC, various states, cities, and large healthcare systems, as well as several high-visibility professional sports organizations. As you would expect, BRL's base clinical testing business has been impacted by the reduction in the number of physician office visits and the postponement of elective medical procedures. However, With the easing of restrictions, starting in May, we began to see some recovery in our base testing services. Regardless, COVID-19 testing has more than offset this decline and was a strong contributor to our second quarter growth and profitability. As we look to the third quarter, with daily case numbers continuing to increase, we foresee strong demand for COVID-19 tests. Notwithstanding the pandemic, we've made progress with our pharmaceutical business. We're on track for Pfizer to submit a BLA for our human growth hormone product to the FDA this fall. In addition, we reported favorable top line results for the Sumetragon phase 3 trial in Japan in children with growth hormone deficiency, showing non-inferiority to the current standard of daily injections. Regarding Rialdi, Sales growth was impacted by restrictions put in place to manage the pandemic. Nevertheless, reality sales continue to make progress, and also the number of prescriptions and number of prescribers. Because of a unique action of vitamin D to produce a potent antimicrobial peptide in humans, we believe reality may be helpful in treating patients with COVID-19. and are pleased that the FDA recently authorized a Phase II trial, which we hope to begin soon. Finally, in recognition of the important contributions to OPCO in its role as viral reference laboratories, John Cohen was recently appointed to the OPCO Board of Directors. Welcome, John. So with that, I will now turn the call over to Steve Rubin to further discuss our business unit. Thank you, Phil.

Good afternoon, everyone, and thank you for joining us today. Overall, we are very pleased with the company's progress across all our business units, especially at Bioreference Laboratories, which has seen increased revenues as a result of the ongoing pandemic. Still, certain aspects of our business continue to be impacted by COVID-19. As discussed on our last call, Two abstracts regarding the somatrogen global phase 3 pediatric trial were presented at EndoOnline 2020 by Dr. Sherry Diehl, the study's principal investigator. Dr. Diehl presented data demonstrating that once-weekly somatrogen treatment met its endpoint of non-inferiority when compared to daily genotropin with regard to height velocity and height standard deviation score, or SDS. Importantly, Dr. Diehl presented new data demonstrating that 95% of patients had mean IGF-1 SDS levels within the normal range. IGF-1 SDS is used as a biomarker for efficacy and safety of human growth hormone replacement therapy. The extensive IGF-1 data obtained during this phase three study permits physicians to prescribe somatrogon for their patient with confidence. In the U.S., we expect Pfizer to submit the biologics license application to the FDA this upcoming fall. In Europe, our open-label study demonstrating benefit and compliance with reduced treatment burden will be completed later this quarter, enabling Pfizer to submit a marketing authorization application with the EMA in Europe early next year. Last month, we were pleased to announce positive top-line results for the pediatric growth hormone study in Japan. the Japanese phase three clinical study of somatrogon met its primary and secondary objectives. The study demonstrated that the efficacy and safety of somatrogon administered weekly was comparable to genotropin administered once daily as measured by annual height velocity in treatment-naive Japanese pre-pubertal children with poor hormone deficiency. Both height velocity and height SDS were higher in the somatrogon treatment group after 12 months of treatment. The efficacy and safety findings in the Japanese study were consistent with the results previously reported in the global phase three study. We anticipate the regulatory filing to be submitted with the Japanese authorities in the first half of 2021. Now I'd like to turn to our commercial pharmaceutical business, starting with reality. The reality numbers for the quarter break down as follows. Total prescriptions for reality in Q2 2020, as reported by QVIA, increased approximately 45% compared with Q2 2019 and showed a 1% increase compared with Q1 of 2020. Fortunately, sales around did not decrease with the onset of the pandemic. However, prescriptions growth essentially halted in Q2 due to both the decline in patient visits to doctors' offices and the widespread inability of so many of our sales reps to meet with physicians in their offices. As a direct result of COVID-19, new patient starts decreased by almost 33% in Q2 versus Q1. Since launch, over 20,500 patients have had reality prescribed by nearly 3,200 physicians. Approximately 200 physicians, or about 6% of the total number of prescribers, were new reality prescribers in Q2. Our partner, V4 Percentius, expects to soon receive, under a decentralized marketing authorization application, European approvals for reality in all countries in which the application was filed, and to launch the product as soon as possible thereafter. In an effort to combat COVID-19 with multiple strategies, we announced in June that the FDA had authorized Opco to initiate a Phase II trial with reality as a treatment for patients with mild to moderate COVID-19. This authorization follows from the publication of numerous independent studies reporting a correlation between vitamin D status and COVID-19 risk and severity. The operating trial is a randomized, double-blind, placebo-controlled study in approximately 160 subjects, including many with Stage III or IV chronic kidney disease. A result from Fair Health analyzing private insurance data found that CKD and kidney failure were the most common comorbidities among patients hospitalized with COVID-19. Enrolled subjects will be treated daily for four weeks and monitored after treatment for another two weeks. Subjects assigned to the reality treatment arm will receive a loading dose of 300 micrograms on each of the first three days of treatment. followed by a maintenance dose of 60 micrograms for the remaining 24 days. There are two primary efficacy endpoints, time to resolution of COVID-19 symptoms and consistent attainment of serum total 25 hydroxy vitamin D levels greater than or equal to 50 nanograms per mil during the last week of treatment. The study is expected to begin in rolling subjects later this quarter. During our Q1 call, we discussed progress with our clinical studies designed to expand the indications for reality. Interim results from our Phase 4 clinical trial comparing reality with three common treatment regimens for secondary hyperparathyroidism in adult patients with Stage 3 or 4 CKD and vitamin D insufficiency show that a daily dose of 60 micrograms of reality was the only treatment that reliably raised serum total 25-hydroxyvitamin D the range of 50 to 100 nanograms per mil, a level required to effectively suppress elevated plasma intact parathyroid hormone in CKD patients. Due to pandemic-related safety concerns and given that 86% of the subjects had already completed treatment, we ended the study early. Final results from the trial are expected by the end of the fourth quarter. We continue to advance our phase two clinical trial, exploring the safety and efficacy of a high strength formulation of reality as a new treatment for secondary hyperparathyroidism in adult patients with stage five CKD requiring regular hemodialysis and vitamin D insufficiency. Due to the ongoing pandemic, enrollment was slower than expected, but it is now complete. We expect final top line data in the first quarter of 2021. Now, let me turn the call over to John Cohen to discuss our bioreference lab business. John?

Thanks, Steve, and good afternoon, everybody. Let me begin by discussing the broader bioreference clinical business. As physicians and hospitals began to get back to business, we have seen a return of our base business to about 80% of our pre-COVID volumes. We've had a strong uptick in our hospital reference business from new client relationships we established as a result of providing COVID testing. The Westchester Hospital deal is making excellent progress as we continue to fully operationalize that relationship. We have also developed some new women's health relationships and are seeing increased new business as a result of our focus in the oncology space. As urology offices began to open, we have seen a return of our 4K business. As you know, Medicare coverage for 4K score resumed on January 1st of this year with the new local coverage determination by Novitas. Earlier this month, we were pleased that Medicare granted a favorable decision on our appeal for reimbursement of nearly all of our 14,000 tests performed for Medicare beneficiaries in 2019 before the LCD went into effect. Adam will discuss this later. We have seen the same return in business with GeneDx. we are currently utilizing the GDX laboratory to give us increased capacity for COVID testing. Since the beginning of the pandemic, BioReference Laboratories has been committed to offering high quality testing services with efficient turnaround times. As I mentioned in our last call, we were able to pivot our laboratory operations to scale up PCR molecular testing on several different platforms to diagnose COVID-19. Shortly thereafter, We started offering serology testing for COVID-19 antibodies to indicate prior exposure to the disease. We continue to see a huge demand for COVID testing across all segments of the economy. We have provided COVID-19 testing to the general public through our relationships with multiple states and cities, multiple drive-thrus around the country, urgent care centers, and in our partnerships with both Rite Aid and CVS at almost 500 different locations. We continue to support our existing physician client base, FQHCs, prisons, health systems, unions, nursing homes, and multiple types of employers. We are providing COVID-19 testing to large employers, including several highly visible sports franchises, including the NFL, the NBA, and Major League Soccer. In addition, we have contracted with several colleges and universities to provide testing of students as they return to school this fall. Recently, the CDC awarded BioReference an indefinite delivery indefinite quantity contract to provide antibody testing to determine COVID-19 seroprevalence across the country. We will provide results with key demographic information and analysis in collaboration with the CDC for the next four months. During the second quarter, we agreed to divert significant resources for nursing home employees due to the crisis in New York. We tested approximately 225,000 employees over four weeks from over 350 nursing homes. Although this volume increased our turnaround time during that time, we have been able to return our average turnaround time to 72 hours. We are still prioritizing tests for hospital patients, first responders, healthcare workers, and all those on the frontline of patient care. To date, we have performed about 3.2 million COVID-19 molecular tests. We have a current capacity of over 50,000 tests per day with plans to scale to 100,000 tests per day over the next several coming weeks. We introduced pooling of samples several weeks ago and are evaluating additional emerging technologies to further increase our capacity and types of offerings. Since our COVID-19 antibody serology testing offering began in late April, we have performed more than 400,000 tests measuring the SARS-CoV-2 specific antibody levels. The laboratory has a significant capacity to perform antibody testing. Although we have not experienced the demand for serology tests in comparison to viral testing, We see increased interest in these tests as the research evolves around risks for reinfection and the role of antibody testing that may play relative to vaccinations. The pandemic and the role of diagnostic testing has put the diagnostic industry front and center in the minds of the American public. Not a day goes by when testing is not the focus of some major news story. Our response to the crisis has significantly increased awareness of bioreferencing as a national brand. We are seeing the results of this recognition in several other parts of our business as multiple other opportunities have begun to emerge that will help us continue to grow the top and bottom line over the long term. I will now turn the call over to our CFO, Adam.

Thank you, John. Phil, Steve, and John covered many of the highlights that have resulted in a strong financial quarter for us. The rapid and lasting response to the COVID pandemic that BioReference team has mounted has resulted in consolidated operating and net profit for the quarter. As John mentioned in his remarks, to date we have performed over 3.2 million COVID-19 PCR tests, including 2.2 million tests performed during the second quarter. Average reimbursement for this testing was in the low the mid $60 per test each month during the quarter and through July, we have seen increasing demand and have increased our capacity for testing. As John mentioned, we have capacity to perform over 50,000 tests per day and continue to expand that capacity. Our daily testing volumes have been limited by availability of reagents and consumables used with the various testing machines that run these tests. We are using emerging technologies such as pooling of samples to help expand our testing capacity. Moving to our second quarter financial performance, I'll start with our diagnostic segment. We reported revenues from services of $251 million compared to $178.5 million for the 2019 period. The increase in net revenue was driven by the execution of our COVID-19 testing strategy. Combining our routine testing business and our COVID testing business, volumes overall increased over 46% compared to historical levels. As stay at home orders were issued, we saw a significant decline in our routine and genetic testing businesses beginning in early March, continuing throughout the quarter, resulting in overall decline of our routine and clinical testing, clinical and genetic testing of 46%. We continue to see week-over-week return of our routine and clinical and genetic testing volumes, and through July, have seen those volumes return to more than 80 percent of historical levels for our routine clinical business and 90 percent for our genetic testing volumes. As a result of the increase in testing volumes and revenues, as well as the effectiveness of the cost control measures put in place over the last two years, the diagnostic segment reported operating income of $40.9 million in comparison to an operating loss of $28 million an overall improvement of $68.9 million compared to the 2019 period. The second quarter of 2020 benefited from two items in addition to the COVID-19 testing. First, we received a $6.2 million grant under the CARES Act, which was recorded as other revenue. And second, as John mentioned, we successfully appealed over 14,000 Medicare claims previously denied for the 4K score, and recorded $10.9 million of incremental revenue related to that successful appeal. Overall costs and expenses increased by $9.8 million compared to 2019 expenses, reflecting increased costs of revenue due to the 46 percent increase in overall volume. Selling, general, and administrative expenses decreased $4.6 million compared to the 2019 period as a result of the cost control programs I previously mentioned. Moving to our pharmaceutical segment, we reported revenues of $44 million for the second quarter of 2020, compared to $47.9 million for the 2019 period. Revenue from product sales in the second quarter of 2020 increased to $29.4 million, including $8.6 billion of revenue from Rialdi compared to $28.7 million in the second quarter of 2019, which included $5.7 million of revenue from Royalty. As Steve mentioned, Royalty volumes remain strong, posting approximately 18.4 thousand prescriptions during the second quarter. However, the growth of Royalty has been negatively impacted by the stay-at-home orders and physician offices restricting product sales representatives from making sales calls. When looking at revenue for the transfer of intellectual property, we reported $14.7 million in revenue for the 2020 period compared to $19.2 million a year ago, reflecting the completion of our SOMATROGEN Phase III clinical trial. As a reminder, we had been amortizing our upfront payment from Pfizer over the development period of SOMATROGEN and have now fully amortized that upfront payment. Loss from operations of our pharmaceutical segment decreased by $2.6 million to $6 million for the second quarter of 2020. Overall, research and development expense for the second quarter of 2020 was $14.1 million in comparison to $25 million for the 19 period, reflecting reduced spending on our somatrogen development program. On a consolidated basis, the second quarter of 2020 had an operating profit of $27.2 million, a significant improvement of $74.4 million over 2019's operating loss of $47.3 million. Consolidated revenues for the second quarter of $301.2 million reflect an increase of $74.8 million over 2019's $226.4 million. Our net income for the second quarter of 2020 was $33.7 million, or 5 cents per diluted share, compared to a net loss of $59.8 million, or 10 cents per share, for the 2019 period. Our second quarter net income included other income of $18 million related to the mark-to-market activity of our strategic investments, which were partially offset by increased tax expense in our international tax jurisdictions. As we look forward to the remainder of 2020, we see significant opportunity to continue to generate operating profits, revenue growth compared to 2019 levels. For the third quarter of 2020, we have built the following assumptions into our forecast. COVID-19 testing on a full quarter basis will fluctuate between 45 and 55,000 tests per day combining both PCR testing and antibody testing. Should we develop additional PCR testing capacity through the expansion of the supply chain, greater testing volume for the quarter could increase our revenue significantly beyond our guidance. Should demand decrease for PCR tests or antibody testing, we could see revenue come in lower than anticipated, However, based on July's volumes, which have been higher than any month before, we consider this unlikely. We assume continued improvement in our base business for both routine and clinical and genetic testing, resulting in a return to historical levels in both lines of testing. Should routine office visits or elective surgeries again be suspended because of increased COVID-19 infection rates, our revenue expectations could be negatively impacted. With that, overall, we expect revenue for the third quarter of 2020 to be between $360 to $380 million, including revenue from services of $325 to $350 million, revenue from products of $25 to $33 million, and other revenue of $6 to $8 million. We expect costs and expenses to increase to $340 to $360 million, resulting in an operating of profit of $20 to $30 million at various points in the revenue and expense assumptions. Operating profit includes approximately $22 million of non-cash depreciation and amortization expense, as well as an expectation of an increase in overall research and development expense to $21 to $25 million, increasing over the second quarter's levels. We provided We will provide further guidance on the fourth quarter during our third quarter conference call later this year. Given the remaining opportunity and uncertainty of COVID testing, we believe there's significant upside for the remainder of the year. However, should COVID testing decline, we believe our base business is well positioned to organically grow in the near term because of the significant relationships our bio reference team have established before COVID testing began and which have accelerated over the last five months. Our cash balance as of June 30th was $21.6 million. We also have approximately $15 million of availability of our line of credit with JPMorgan and $100 million under our line of credit with Dr. Frost, which remains unutilized. The combination of cash on hand, the lines of credit, and our strong financial performance at BioReference, for which we anticipate generating cash flow from operations for the remainder of 2020, provides us with a strong balance sheet. With that, I'll open the call for questions. Operator?

Marie Raycroft, your line is open.

Hi, everyone. Hi. Thanks for taking my questions, and congrats on the update today. To start off, so you mentioned you anticipate 45,000 to 55,000 COVID tests per day, and that's a mix of PCR and antibody tests. I'm just wondering if you think that that's going to be for 3Q or potentially for the rest of the year, or what are your thoughts on the longer-term perspective for this?

Hey, Maury. So I'll start and then let John kind of chime in here. So we've looked at where July has come in, which, as I mentioned, demand continues to build rapidly. you know, day over day or week over week. But, you know, the supply chain constraints that we've been faced with have limited our ability to really expand our testing capacity. So I think as that supply chain opens up and we're able to obtain more and more reagents and consumables, I think that opportunity will expand. As well as infection rates allow for us to pool samples the lower the infection rate, the higher the ability it is and benefit there is for us to pool our samples, we could expand our testing capacity as well. So I think as we looked at it, as we saw that, the 45 to 55 in Q3 with the potential for that number to increase significantly. John, I don't know if you have any additional comments to that.

Yeah, I just think the demand, as you can imagine, has been, uh, it continues to be enormous at every single sector across the economy. So it's, uh, uh, it's mostly like Adam referred as how much of that, and we continue to increase. Um, I do think that, uh, some of the technology advancements, uh, will certainly improve our capacity. Um, the, uh, That's one issue, the demand side being there. The only, I don't really see any other limitation. The serology side you asked about continues to be level. There is some increasing demand beginning to occur on the serology side relative to, certainly because of the CDC win that we talked about and some other issues. But I think that The 45 to 55 is about right for where we see July coming in, but there can be significant uptick on that based on some of these other issues.

I think we should point out that, in fact, we've tried to modulate the demand to a certain extent because what we don't want is to develop a backlog that will result in a delay in delivering results. the fact that we've been able to do a pretty good job in this area has stood us in good stead in terms of getting new business and enhancing our reputation in general. So whereas we would like to do lots and lots more, we're trying to take into consideration what the reasonable capacity is and work in those terms within that framework.

Got it. Yeah, it's all very helpful. And I'm also wondering if you've fine-tuned your views on a plan for return to work and school, and will the antibody testing, I guess, could you get more of the partnership contracts for the antibody testing, and could those types of contracts be announced over the next couple months? And then what are your views on additional PCR partnerships as well? I guess, could we expect more of those partnerships in the next couple months?

Yeah, so absolutely. And as Phil says, we are being incredibly sensitive to our 72-hour turnaround time right now for all of the, I guess, obvious reasons. But if you look at employers, however you want to divide them up into healthcare, meaning biotech, food service, professional services, manufacturing, hospitality, and then under entertainment, the sports franchises, movies, casinos, etc. We have been in discussions with most parts of the U.S. economy. We have, as I mentioned in my comments, we've already signed on several colleges and universities. We are also talking to both public and private schools in addition. So those are all coming and will be announced. There has been a mix of contracts with the employers where some want PCR only and some want antibody and PCR. I would say that there is some other evolving interest in antibodies, as I've referred to before, which if that occurs, we'll make announcements around.

Got it. Thank you very much for taking my questions.

Thank you. And ladies and gentlemen, to ask a question, you will need to press star one on your telephone. Our next question is from Dana Flanders with Guggenheim. Please go ahead.

Great. Thank you for the questions. I guess my first is for John. And just on your comments on pooling. Can you just elaborate on that a little bit and just talk about what your kind of current and expected use of pooling is, you know, over the next couple months here and just what that exactly means for capacity expansion? Does the 50,000 tests per day capacity you have now, does that include pooling or is pooling kind of an additional upside on the capacity side? And then just my second follow-up question. I know a big goal of yours has been to improve kind of the profitability of the business. And we certainly saw some nice progress before COVID hit. And I know testing, the COVID testing has certainly helped on that side as well. Can you just frame, you know, how we should think about the profitability of bioreference labs and this incremental testing revenue? I mean, as testing increases, Do you have a fairly fixed cost base, or does the cost increase as well with revenues? Thank you.

Hey, Dana, thanks for the questions, and I'll try to answer a couple of them quickly and then turn it over to John. So, you know, the overall profitability profile for bioreference, you know, we have talked about it for some time where we expect its EBITDA margins overall to continue to improve and overall margins continue to improve. with the goals of in the medium term excluding COVID to have gotten into the high single digits to low double digits. We've made good progress leading up to COVID. As we sit here today and looking at 2020's financial results, it's going to be very difficult for us to parse the COVID business apart from the base business, given the substantial declines in that routine business. and offset, more than offset by the substantial increases related to COVID. So, you know, we think the profitability levels that we saw in Q2 are going to be sustainable as long as COVID sticks around with the base business really starting to build and build momentum around, you know, some of the things that John mentioned between the Westchester and other business development opportunities that are coming to light. So I think the profitability profile should continue to improve and could even accelerate as we continue through this year into next year. I'll just mention on the capacity numbers, the guidance that we gave of 45 to 55 really takes everything into account that we know, but as John mentioned, we have line of sight to bring that capacity up to 100,000 tests per day. I think, you know, that does include the ability to pool and some assumptions that we built around our ability to pool effectively based on those infection rates. So maybe, John, you want to address any of those as well.

So on the pooling, you know, each pooling that you do has to be approved, has to be validated and approved on each separate platform. So as we march through our our different platforms were moving towards more pooling on the platforms. And then of course the, you know, the issue is it has to be in low prevalent areas. And that actually means also you can do it by certain client types where if you're doing more of a screening program, you know, that pooling will be, will be highly effective. I think what I get, you know, too, too deep, but the, the capacity numbers, um, are taken into consideration how we view the platforms running relative to their efficiency numbers and reagent supplies. So, yes, we say $45,000 to $55,000. That's taking into consideration a bunch of other factors that we've learned as we've gotten into this business for the last five months. So what I mean by that is Our true capacity, which we may have mentioned or have talked about on different interviews, is actually higher. But when we consider what we now know as reagent supply and what we now know is how well these platforms run, modulate that capacity to more of a realistic number than what the actual specific capacity could be. I don't want to make it any more complicated than that. So there's all those factors that we take into consideration. you know, account when we report these numbers to you.

Okay, got it. Very helpful. Thank you.

Thank you. And as a reminder, to get in the queue, just press star then 1. Our next question is from with Lake Law and Company. Please go ahead.

Good afternoon and congrats on a very good quarter. Just a quick, several quick ones. First, in the diagnostic side, you mentioned about the constraint, the reagent constraint. In your due diligence, do you feel that will be sort of alleviated more going forward, or that still will be a similar situation? Also, what's the average cost for the serology test you performed?

I do believe that the supply chain is not just reagents. It's multiple different factors, multiple different parts of a test kit that comes to us. For instance, on one of the platforms, there's actually 17 different parts of a reagent kit that we get, which includes the reagents. It's plates, it's plastic pipette tips, there's all sorts of other parts of the equipment that we get in when we run these. And then we're running four different platforms, as you've heard me talk about. So the supply chain on all of the platforms are different. So it's not just one versus the other. So that's the first thing. The second is our understanding and our discussions with the platform manufacturers is we do believe by the third quarter, limitations that we're seeing up until now will begin to lift. That's what we're being told. So I do think that there will be some loosening of the supply chain side starting somewhere around September, maybe into October.

Okay, great.

In terms of the serology, I mean, it's public. The Medicare serology reimbursement now is a little over $40, and that's a work. That's what Medicare will be paying, and that's what we assume the rest of the payers will be paying.

Okay, that's very helpful. And maybe just two brief questions. First one is, in terms of Pfizer's going to file later this year, do you anticipate, for instance, approval maybe in the second half of next year? And if that's the scenario, would that be the co-profit sharing program would start roughly in that time. And maybe just last question here is that you got earning this quarter. Do you anticipate this financial performance will continue for remaining of the year or it's too difficult to tell at this moment? And thanks.

Well, two points. I'll let Adam take the latter part of financial, but as he mentioned his remarks, he did, you know, forecast a continuing growth throughout the year. But, um, For growth hormone, yes. So we basically assume 12 months from submission. And that puts us in the second half of next year, as you stated. And yes, the profit share begins upon approval of pediatrics.

So yeah, I'll just kind of supplement what Steve said on the guidance. I guided an operating profit on a consolidated basis for the third quarter of $20 to $30 million. You know, we see that continuing as long as the COVID testing remains as robust as it has been. And, you know, I think as John mentioned, it seems like it will continue. You know, on the profit share, Steve mentioned, you know, we'll have a significant milestone that we receive upon the approval in the U.S. And then in the U.S. region, we'll start to have that gross profit share commence with Pfizer at that time.

Okay, great. Thanks a lot. I really appreciate it and congrats.

Thank you. And our next question is from Ted Kent Hall with Piper Sandler. Please go ahead.

Great. Thank you very much for taking the question and congrats on just a fantastic quarter. Really amazing how everything's coming together. Kind of a just personal interest question first. In terms of the pooling, it's a really interesting concept to me and I hadn't even considered that, but What is the kind of localized infection rate? Is it that, how you sort of trigger when you can pool, or how does that actually, how does pooling sort of go into effect? Really interesting.

It should be less than 5% in the overall infection rate, because whether we're pooling 1 to 3, 1 to 4, whatever that number is, you have to... If your infection rate is higher than 1 in 20, then you begin to bump up against that your pooling will be ineffective because too many people in that pool will become positive. It means you have to rerun them. So it's essentially very good for low incidence, large screenings.

Yeah, it makes a lot of sense. Great. And, yeah, I actually think you guys did a great job just walking through everything. And I appreciate all the detail that you provided. So thanks and congrats on a great quarter.

Thanks, Ted.

Thank you. And this concludes our Q&A session for today. I will turn the call back to Dr. Philip Frost for his final remarks.

Thank you all for participating. And we look forward to meeting with you at the end of the next quarter. In the meantime, stay safe. and stay far away as possible from other people. Thank you.

Thank you. Thank you.

Thank you, ladies and gentlemen, for participating in today's program. You may now disconnect. Have a wonderful day.