OPKO Health Inc (OPK) 2022 Q2 法說會逐字稿

Good day, and welcome to the OPKO Health Second Quarter 2022 Financial Results Conference Call. (Operator Instructions) Please also note, this event is being recorded. And now I'd like to turn the conference over to Yvonne Briggs. Please go ahead.

Thank you, operator. 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 second quarter of 2022.

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, 2021, and its subsequently filed SEC reports.

The conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 4, 2022. 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. Dr. Elias Zerhouni, Vice Chairman and President of OPKO, will then provide an overview of OPKO's pharmaceutical business. Dr. Jon Cohen will discuss BioReference Laboratories. And after that, Adam Logal, OPKO's CFO, will review the company's second quarter financial results, then we'll open up the call to questions.

Now I'd like to turn the call over to Dr. Frost.

Good afternoon, and thank you for joining today's call to discuss our second quarter financial results and business progress.

Last quarter, we announced the acquisition of ModeX Therapeutics, a biotechnology company focused on developing unique, advanced multi-specific immunotherapies for cancer and infectious diseases. I'm really pleased to say that the integration of ModeX into OPKO Health is proceeding smoothly. We continue to be very enthusiastic about their transformative platform technology, which we believe has the potential to provide better outcomes for patients. These multi-specific antibody technologies and vaccine programs are differentiated from the competition and have garnered significant interest from potential big pharma partners for various applications. We look forward to keeping you apprised of our progress.

As I mentioned on our last call, Dr. Elias Zerhouni, the Co-Founder and Chairman of ModeX, was appointed President of OPKO and has joined the company's Board of Directors as Vice Chairman. Dr. Zerhouni is a former Director of the National Institutes of Health and has significant experience in industry as the Head of Global Research and Development for Sanofi for 9 years. Along with Elias, the ModeX team of outstanding scientists bring significant expertise to advance both ModeX and OPKO proprietary pipelines through the clinic. Elias will provide further details on the pharmaceutical business momentarily.

Pfizer, our commercial partner for NGENLA or somatrogon, has launched a weekly injectable growth hormone product in Japan and other countries, including Germany, Canada and Australia. Pfizer believes clinicians of patients will welcome a once-weekly injection therapy versus daily injections, the standard of care for more than 30 years. In the U.S., we continue to work with Pfizer on resolving the FDA's comments regarding the BLA submission. Pfizer remains fully committed to bringing NGENLA to patients globally as soon as possible.

In May, Sema4 Holdings announced the closing of their acquisition of GeneDx for $150 million before adjustments plus 80 million shares of Sema4 common stock. Subject to revenue milestones, OPKO may receive an additional $150 million over the next 2 years, payable in either cash or stock. We look forward to the progress of the combined company.

LeaderMed, our joint venture partner in China, is gearing up to commence a Phase III trial of oxyntomodulin for the treatment of obesity and type 2 diabetes, now scheduled to begin in early 2023. Also, LeaderMed is preparing to start a clinical trial of our Factor VII-CTP, a novel long-acting coagulation factor to treat hemophilia. The data from both trials will be available for OPKO to seek regulatory approval in countries outside of China.

With that brief overview, I'd like to turn the call over to Elias, and then Jon will discuss BioReferences' quarterly results and initiatives. Elias?

Thank you, Phil, and good afternoon, everyone. The ModeX team and I are very excited to be a part of OPKO and to be able to advance our leading-edge technology platform, while building upon OPKO's strong foundational work. As Phil said, the transition is going extremely well and the integration of our team with OPKO's team is going extremely well.

By way of background, ModeX Therapeutics, I should say that in 2012, Dr. Gary Nabel and I initiated a breakthrough laboratory within Sanofi with a mission to explore technologies and concepts focusing on various applications, including oncology, infectious diseases and vaccine. But our underlying thesis was that future therapies needed to comprise smarter molecules designed to attack multiple points in the disease pathway. And over the subsequent years, we advanced several multi-specific drug candidates into the clinic.

And in 2020, we founded ModeX and in-licensed the technology from Sanofi that we had developed in our breakthrough lab to further develop our ideas and the next generation of multifunctional therapeutics. And given the important prospects of this technology and the excitement about the potential of this technology, most of the experienced Sanofi team joined us at ModeX, and they're continuing their important work here at OPKO. I'm proud to say that we have attracted the top management team with significant experience in academia, government, industry. And we're in the initial stages of integrating the team into OPKO as we make progress with the ModeX pipeline, while understanding and prioritizing OPKO's technologies and pipeline as well.

At this time, I'd like to provide you with a bit more background on ModeX's 2 fundamental platforms. First is our proprietary STAR technology platform. STAR was designed to allow us to go beyond 3 targets and up to a total of 6. And that means that we can create multifunctional molecule in a plug and play platform that is much more flexible and functional than previously available.

On top of that, we own the intellectual property that supports the technology and our system's optimized functionality and manufacturing simplicity, which is typically a difficult feat for multi-specifics. A pipeline using the STAR technology comprises therapies for infectious disease and oncology. In infectious diseases, we already have experience with a trispecific candidate developed with our Sanofi technology when we were in the breakthrough lab in Phase I for treating HIV, that's supported by NIH, as well as 2 preclinical quadrispecific candidates, also targeting HIV.

In addition, we have used our own STAR technology to develop several SARS-CoV-2 molecules in late preclinical stages, partially funded by DARPA, with the potential of controlling actually the emergence of variants of concern. In oncology, we have 2 targets focused on hard-to-treat solid tumors, and 1 target -- 1 molecule focused on liquid tumors. And these programs in oncology are all in the preclinical stage, nearing the IND stage. And hopefully, we'll be reporting on them as we advance.

Our second platform focuses on vaccines and utilizes a ferritin platform. Ferritin is a necessary protein for all cells as it brings iron for their metabolism. However, it's a protein that can self-assemble in a way that makes a particle that can be used, in fact, to carry antigens on its surface in a scalable and cost-effective manner, which can essentially become the base of multiple vaccines, and that's what we have done. And we know that this platform is safe, as it has been through Phase I clinical trials with the NIH.

And our first application for this technology is targeting EBV, or the Epstein-Barr virus. It's the virus that is responsible for mononucleosis, which also can lead to multiple cancers, but also has been found to probably be the cause of multiple sclerosis recently. That application is in the preclinical stage. As mentioned by Dr. Frost, we're currently in exploration of interest and discussions with several pharma companies for potential partnerships surrounding this platform.

So we look forward to providing further details regarding our multi-specific technology platforms and products in the near future. As I mentioned, we're excited to be part of OPKO. It has gone extremely well and believe the combination of the 2 companies is really the potential to provide meaningful benefit to patients and significant value to shareholders.

So now let me turn it over to Jon Cohen, who will speak about BioReference Laboratories. Jon?

Thanks, Elias, and good afternoon, everyone. The second quarter was challenging due to a rapidly declining COVID business, while our base business rate of recovery was slowing. We have built up resources and capabilities in response to the Omicron spike and have had to reset our cost structure and strategic focus as the demand for testing fell as rapidly as it had risen.

In order to return to our margin profile and increased growth, we are focused on a three-pronged strategy. Number one, we will continue to execute our Reach initiative of cost reduction that we started in January of this year. This initiative has now reduced costs by over $40 million this year, and our intention is to take out an additional $100 million in costs by the end of the year.

We now have over 100 work streams that touch every part of the organization to ensure an aggressive program to align costs with our go-forward plan. Significant costs related to the infrastructure we have built to deliver on our highly successful COVID testing program over the last few years touch every single part of the organization.

As you remember, at the peak of COVID, we had nearly 8,000 employees at BioReference. And by the end of the July -- this July, our employee count has now been reduced to 3,600 employees, including reductions of approximately 700 associates in June and July.

Number two, we will aggressively pursue revenue opportunities with our investments in oncology, women's health, urology and ventures, all which have near-term growth opportunities. We are evaluating new offerings in the GYN space to launch in Q3 and Q4 of this year. And oncology continues to perform (technical difficulty) over prior year and up 8% sequentially from Q1 of 2022.

Our next-generation sequencing OnkoSight portfolio is up 9% versus the prior year. In addition, we have added 3 leading academic medical center oncology centers as a result of our strength in somatic cancer testing.

Ventures continues to perform well as we have added several new ACOs, urgent care centers and hospital reference contracts during the quarter. Our relationship with the Westchester Health System continues to grow with added hospitals, reference work, genetic services and outpatient services.

Number three, we are changing our organizational structure to be more efficient and aligned with how we move the business forward in a post-COVID environment. Along those lines, we have created a new 4 pinnacle leadership structure, including the Chief Operating Officer, the Chief Commercial Officer, the Chief Strategy Officer and the President of Scarlet and Digital Services. This moves us away from the highly complex structure we had built to deliver COVID testing to literally hundreds of clients.

Over the 2 years, we performed over 23 million lab-based PCR COVID tests and several million point-of-care tests and, at the peak, had the capacity to perform 100,000 PCR tests a day. This was accomplished while maintaining a structure for the existing business and specialty verticals. As expected, our COVID volume continued to decrease throughout the quarter. During the second quarter, we performed 1 million COVID-19 tests compared to 2.1 million performed in Q1 of 2022 and 3 million tests performed in Q2 of 2021. Despite the testing environment having moved predominantly to home rapid testing, there is still significant interest in some sectors to continue lab-based PCR surveillance testing.

Moving on to the payers. Our commercial payer strategy continues to be successful with the renewal of our preferred lab network agreement with UnitedHealthcare for the fourth consecutive year. We have access to over 74 million lives through preferred status with UnitedHealthcare, Aetna and Oscar Health.

In the first 6 months of 2022, we added 11 million additional lives through local and regional agreements. As of today, we have 85 million lives covered by Scarlet Health, with ongoing discussions with most health plans. In addition, we have launched several gaps in care programs through HEDIS and Star Ratings with key health plans leveraging Scarlet Health. The HEDIS Star Ratings are widely used tools to measure, improve and compare health care effectiveness, quality and outcomes.

Finally, let me update you on Scarlet Health, our mobile alternative to traditional laboratory specimen collection in which we have been making significant investments. Scarlet is now available to more than 150 million homes across the U.S., has a lifetime Net Promoter Score of 92 and a client retention rate of over -- of 100%. These are important metrics as it validates the value of our existing customers and is a great way to drive growth.

We continue to see significant demand for Scarlet Health Services across our different commercial verticals, including oncology, women's health, urology and the core business. Strategic venture clients, including health systems and large medical groups, are utilizing Scarlet to close gaps in care for value-based contracting.

Teladoc Health publicly announced our collaboration to increase Scarlet availability to Teladoc's millions of primary -- the primary 360 members based on the pilot program with Scarlet, which increased Teladoc's completion lab orders by 22.5%. Our other national contracts include Oscar Health and Optum's virtual primary care network.

And now let me turn it over to our CFO, Adam.

Thank you, Jon. We had a transformative second quarter with the closing of 2 significant deals and the transitioning of our BioReference business to adapt to an endemic COVID.

As you know, we closed on the acquisition of ModeX this quarter and issued approximately 90 million shares of OPKO common stock. The fair value of these shares issued at closing were approximately $219 million, and we have recorded approximately $195 million as nonamortizing in process, research and development as well as $66 million of goodwill. The details of this transaction can be found in our Form 10-Q.

Pfizer, our partner for our long-acting growth hormone, recently launched NGENLA in Japan, Germany and other countries, which triggered $85 million in milestone payments. The commercial launch in Japan commenced our gross profit sharing for the hGH franchise in the Japanese region as defined in our agreement with Pfizer. This gross profit share includes sales of NGENLA as well as Pfizer's GENOTROPIN. Japan is one of the largest markets for hGH in the world and represents a significant commercial opportunity for NGENLA.

In addition, we are earning royalties on commercial sales of NGENLA for markets that have been launched by Pfizer, including Germany, which is also one of the largest pharmaceutical markets in Europe. Once pricing is approved and NGENLA is launched in 2 additional major markets in Europe, we will begin earning a gross profit share in the European region as well.

On April 29, we closed our transaction with Sema4, with their acquiring GeneDx for $150 million in gross cash at closing and 80 million shares of Sema4 stock. After considering transaction expenses, working capital adjustments and a $13.4 million cash escrow, net proceeds at closing were approximately $116 million. We recorded a $15 million gain on the disposition of GeneDx, which is included in our operating results. In addition, the 80 million shares we received were recorded at fair value on closing, and fluctuations in Sema4's common stock price at each reporting period will be mark-to-market as other income and expense.

As of June 30, we recorded a noncash other expense of $71.2 million related to the decline in Sema4's stock price post closing. As a reminder, we are eligible to receive up to an additional $150 million in cash or Sema4 shares upon the achievement of certain revenue targets for GeneDx during 2022 and 2023.

Moving to operating results. Our diagnostics segment reported revenue of $186.8 million compared to $397.2 million for the 2021 period. This decline reflects decreased COVID testing levels, as the broad testing market has shifted to rapid at-home testing. As Jon highlighted, we performed approximately 1 million COVID diagnostic tests this quarter, down sequentially from Q1 2022 where we performed more than 2 million COVID diagnostic tests and down compared to the approximately 3 million tests performed in the second quarter of 2021.

In addition, during the quarter, a significant shift continued in point of care from lab-based PCR COVID testing within our business lines, which comes at a higher cost to serve and lower margin profile, which impacted negatively overall gross margins and operating margins. Throughout the first 6 months of the year, with an accelerating pace throughout the second quarter, we have reduced our employee count and related payroll by more than 38% and are approaching pre-pandemic levels for employee count.

Further, we are reducing, delaying or eliminating our longer term commercial initiatives, including initiatives around Scarlet Health and our digital health platforms, while we bring the remainder of our cost structure in line with our expected volumes. When looking at our base business in total, despite the strong rebound we saw during the first quarter of this year, our second quarter volumes flattened and, as a result, have negatively impacted overall gross and operating margins. As a result, our operating loss for our diagnostics segment was $57.5 million compared to operating income of $30 million for the comparable period of 2021.

Moving to our pharmaceuticals segment. We reported revenues of $123.1 million for the second quarter compared to $45.2 million for the 2021 period. Revenue from product sales in the second quarter increased to $35.9 million, which included $6.2 million of revenue from RAYALDEE, which compares to $35.7 million for the 2021 period, which included $5 million of RAYALDEE revenue.

With respect to revenue from the transfer of intellectual property, we reported $87.2 million for the 2022 period compared to $9.5 million from a year ago. This increase reflects milestone payments for the launch of NGENLA in Europe and Japan.

Operating income from our pharmaceutical segment was $55.4 million for the second quarter of 2022, while the comparable period of 2021 reported an operating loss of $13.7 million. Overall research and development expense for the second quarter of '22 was consistent with the 2021 period at $14.8 million. With the approval of somatrogon, amortization of intangible assets increased to $16.7 million from $5 million, reflecting the reclassification of IP R&D to an amortizing intangible asset.

Turning to the consolidated financial results of the second quarter. We reported an operating loss of $10.7 million compared to operating income of $5.6 million in the 2021 period. Net loss for the second quarter of 2022 includes the $71.2 million noncash mark-to-market adjustment for declines in the price of Sema4's common stock, resulting in a loss of $101.7 million, or $0.14 per diluted share, for the quarter compared to a net loss of $16.2 million, or $0.03 per diluted share, for the 2021 period. We remain in a strong financial position as a result of our overall cash of $210 million on our balance sheet, along with an additional $53 million of availability under our credit facility with JPMorgan.

As we look at the remainder of 2022, we have updated our assumptions to the following: we anticipate performing between $3.3 million and $3.5 million COVID, PCR, point of care and antibody tests during the year, including the 3.1 million tests performed during the first 6 months of the year. We have not assumed any new surge in COVID testing for the remainder of 2022 and, as such, expect our third quarter laboratory business to remain consistent with our second quarter volumes.

We have made adjustments to reflect the accounting treatment for the ModeX acquisition and the disposition of GeneDx, including the $15 million gain previously mentioned. We have not forecasted any mark-to-market adjustments in the Sema4 common stock we hold, which is recorded in other income and expense, but does not impact our operating results. At June 30, our carrying value of Sema4's common stock was approximately $102 million.

With that, overall, we expect revenue for 2022 to be between $950 million and $1 billion, including revenue from services of $700 million to $750 million, revenue from products of $140 million to $150 million and other revenue of $100 million to $110 million. We expect costs and expenses to be between $1.1 billion and $1.2 billion, which will reflect various assumptions of testing volume. Operating results include approximately $100 million of noncash depreciation and amortization expense as well as an expectation of research and development expense of $74 million to $80 million.

Thank you all. And operator, would you please open the call for questions?

(Operator Instructions) And our first question comes from Maury Raycroft with Jefferies.

This is Kevin Strang on for Maury. First question was just on for COVID-19 testing. Could you say what percentage of testing at this point is done within surveillance contracts? And how durable you think these contracts are over the next few quarters? And then how this fits into the refocusing strategy that you mentioned in terms of reducing margins?

Yes. So I -- this is Jon. The majority of the COVID testing is now through the surveillance contracts. Once the Omicron came back down, the testing of the general public or people going to their physicians to get testing or health systems is really dramatically gone way. So most people are doing home testing or were doing surveillance testing for multiple contracts.

As we enter -- as we exit the summer into the fall, one of the bigger questions is going to be, which we're dealing with now, how much school testing we will continue to do, although I can tell you that there has been some recent uptick in multiple school systems around the country who are desiring a solution for the fall, because what's happening is not all kids are getting vaccinated.

So the school systems are trying to figure out how they're going to implement a testing protocol that's both safe and reliable but, at the same time, addresses the issues about kids not being vaccinated. So that -- I think that's the big unknown as we go into the fall.

So -- yes -- Kevin, it's Adam. Just to touch on that. So we haven't -- as you heard in the volumes in my guidance, we haven't projected any significant contracts to come through. So there is some upside if what Jon just mentioned does actually translate into some overall business.

But I think if you were to look at the volumes in the first month of the year, we're down around 3% -- 3% to 5% of those volumes now as we exited Q2 and have gone -- and it's been consistent through July. So pretty significant falloff in overall COVID testing in our business today.

Great. And then just another question on the ModeX pipeline. It's mentioned that you might look to partner out for EBV. Could you just clarify maybe if that's for the whole ferritin platform or just for EBV in particular? And then just maybe if there is one particular oncology asset that you wanted to talk about that you're most excited about? And finally, whether or not we would get an R&D Day at some point.

Thank you, Kevin. On the ModeX pipeline, actually, we have interest beyond EBV. And so our conversations with major pharmaceutical companies are really related to the platform. Because we had advanced EBV quite a bit in our prior work at Sanofi, obviously, that's the most mature asset, but there are other targets, which I cannot disclose to you at this point, that are interesting and have pharmaceutical companies interested in working with us on a partnership with that.

In oncology, basically, we have 3 molecules, 2 with a double targeting of tumors. I can't tell you what the binders are, but the technology is one of T-cell engaging with the engagement arm being CD3, CD28. The other 2 targets are really focused on specific cancers where the targets are known to be expressed. And that's the quadrispecific format, which is entering IND studies as we speak.

And yes, indeed, I love R&D Days. If we can find a good time, we'll be happy to do that. As I said initially, the fall would be a good period of time to do that. So looking forward to that.

We have no further questions. So this concludes our question-and-answer session. I'll turn the conference back over to Dr. Frost for any closing remarks.

Thank you. So in closing, I would like to just say that as I look at OPKO now, I can only observe that this is a new day for the company. And why do I say that? It's because the addition of ModeX to our company brings with it an additional array of talent that can only be positive and good for the company. I'll mention specifically a few people among the many who are part of the ModeX team.

First, Dr. Gary Nabel. He is the Director of the R&D program at ModeX. He is the President and CEO of Operations. He's a Founding Director of the Vaccine Research Center at the NIH, and then he was the Chief Science Officer at Sanofi. Brilliant career in academics, government industry.

Dr. Betsy Nabel, Professor at Harvard; President of the Brigham & Women's Hospital; Director of the Heart, Lung and Blood Institute. Tremendous leader.

Dr. John Mascola, most recently, the Director of Vaccine Research at the NIH. He was the one who was directly responsible for the development of a large part of the COVID program.

So with talent like that, and as I look at them, only one word comes to mind, and that's success. And I truly believe that as we move on with the other things going on in the company, with the addition of ModeX and the people and the projects, we have every reason to feel good about OPKO.

I'll leave you with that thought in mind. See you next time.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.