Opko Health, Inc.

your telephone keypad to withdraw yourself from the question queue. Press star, then two. 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 Opco Health 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 can 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 4th, 2022. 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 Chief Executive Officer, will open the call. Dr. Elias Zerhouni, Vice Chairman and President of Opco, will then provide an overview of Opco's pharmaceutical business. Dr. John Cohen will discuss bioreference laboratories, and after that, Adam Vogel, Opco's CFO, will review the company's second quarter financial results, then will 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 OpcoHealth 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 MODX, was appointed president of OPCO 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 nine years. Along with Elias, the MODX team of outstanding scientists bring significant expertise to advance both MODEX and OPCO proprietary pipelines through the clinic. Elias will provide further details on the pharmaceutical business momentarily. Pfizer, a commercial partner for Anginilic or Simetragan, has launched a weekly injectable growth hormone product in Japan and other countries, including Germany, Canada, and Australia. Pfizer believes clinicians and 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 NGINLA to patients globally as soon as possible. Semaphore Holdings announced the closing of their acquisition of GeneDx for $150 million before adjustments, plus 80 million shares of Semaphore common stock. Subject to revenue milestones, ICO may receive an additional $150 million over the next two 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 three trial of auxinthamonduin 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 UPCO 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 John will discuss by references quarterly results and initiatives. Elias?

Thank you, Phil, and good afternoon, everyone. The Monex team and I are very excited to be a part of UPCO and to be able to advance our leading-edge technology platform while building upon Opco's strong foundational work. As Phil said, the transition is going extremely well and the integration of our team with Opco's team is going extremely well. By way of background, MODX 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 MODX 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 MODX and they're continuing their important work here at Opco. I'm proud to say that we have attracted a top management team with significant experience in academia, government, industry, and we're in the initial stages of integrating the team into Opco as we make progress with the MODX pipeline while understanding and prioritizing Opco's technologies and pipeline as well. At this time, I'd like to provide you with a bit more background on MODX's two fundamental platforms, First is our proprietary STAR technology platform. STAR was designed to allow us to go beyond three targets and up to a total of six. 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 systems optimize functionality and manufacturing simplicity, which is typically a difficult feat for multispecifics. Our pipeline using the STAR technology comprises therapies for infectious disease and oncology. In infectious diseases, we already have experience with a tri-specific candidate developed with our Sanofi technology when we were in the breakthrough lab in phase one for treating HIV. that's supported by NIH, as well as two preclinical QUADRI-specific candidates also targeting HIV. In addition, we have used our own STAR technology to develop several SARS-CoV-2 molecules, COVID-2, in late preclinical stages, partially funded by DARPA, with the potential of controlling, actually, the emergence of variants of concern. In oncology, we have two targets focused on hard-to-treat solid tumors and one target, one 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 one 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 OPCO. It has gone extremely well and believe the combination of the two companies It's really the potential to provide meaningful benefit to patients and significant value to shareholders. So now let me turn it over to John Cohen, who will speak about BioReference Laboratory. John?

Thanks, Elias, and good afternoon, everyone. The second quarter was challenging due to rapidly declining COVID business, while our base business rate of recovery was slowing. We had 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 increase 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 touched 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 very well, with revenue of 3% over prior year, and up 8% sequentially from Q1 of 2022. Our next generation sequencing Oncocyte portfolio is up 9% versus the prior year. In addition, we have added three 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 West Chester 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 four pinnacle leadership structure, including the Chief Operating Officer, the Chief Commercial Officer, the Chief Strategy Officer, and President of Scarlett 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 two 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 environments 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 six 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 for HEDIS and STAR ratings with key health plans leveraging Scarlet Health. The heated star ratings are widely used tools to measure, improve, and compare healthcare 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 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 Scarlett 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 Scarlett to close gaps in care for value-based contracting. Teladoc Health publicly announced our collaboration to increase Scarlett availability to Teladoc's millions of the primary 360 members based on the pilot program with Scarlett, 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, John. We had a transformative second quarter with the closing of two significant deals and the transitioning of our file reference 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 Opco common stock. The fair value of these shares issued at closing were approximately $219 million. And we recorded approximately $195 million as non-amortizing, in-process research and development, as well as $66 million of goodwill. The details of this transaction can be found in our Form 10Q. 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 Ingenla 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 Ingenla. In addition, we are earning royalties on commercial sales of Ingenla 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 Ingenla is launched in two additional major markets in Europe, we will begin earning a gross profit share in the European region as well. On April 29th, we closed our transaction with Semaphore with their acquiring GDX for $150 million in gross cash at closing in 80 million shares of SEMA IV 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 GDX, 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 Semaphore's common stock price at each reporting period will be marked to market as other income and expense. As of June 30th, we recorded a non-cash other expense of $71.2 million related to the decline in Semaphore's stock price post-closing. As a reminder, we are eligible to receive up to an additional $150 million in cash or Semaphore shares upon the achievement of certain revenue targets for GeneDx during 2022 and 2023. Moving to operating results, our diagnostic 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 John 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 into 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 six 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 employees. 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 diagnostic segment was $57.5 million compared to operating income of $30 million for the comparable period of 2021. Moving to our pharmaceutical 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 Rialdi, which compares to $35.7 million for the 2021 period, which included $5 million of Rialdi's 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 Vengenla 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 SOMA TROGEN, amortization of intangible assets increased to $16.7 million from $5 million, reflecting the reclassification of IPR&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 non-cash mark-to-market adjustment or declines in the price of Semaphore's common stock, resulting in a loss of $101.7 million or 14 cents per diluted share for the quarter, compared to a net loss of 16.2 or 3 cents 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 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 six months of the year. We have not assumed any new surge in COVID testing for the remainder of 2022, and as such, expect our core clinical laboratory business to remain consistent with our second quarter volumes. We have made adjustments to reflect the accounting treatment for the MODX acquisition and the disposition of GNDX, including the $15 million gain previously mentioned. We have not forecasted any mark-to-market adjustments in the Semaphore common stock we hold, which is recorded in other income and expense, but does not impact our operating results. At June 30th, our carrying value of Semaphore's common stock was approximately $102 million. With that, overall, we expect revenue for 2022 to be between $950 and $1 billion, including revenue from services of $700 to $750 million, revenue from products of $140 to $150 million, and other revenue of $100 to $110 million. We expect costs and expenses to be between $1.1 billion and $1.2 billion, which reflect various assumptions of testing volume. Operating results include approximately $100 million of non-cash depreciation and amortization expense, as well as an expectation of research and development expense of $74 to $80 million. Thank you all. Operator, would you please open the call for questions?

We'll now begin the question and answer session. If you'd like to join the question queue, the instructions are to press star, then 1. If you're using a speakerphone, you may need to pick up your handset before pressing the keys. To remove yourself from the question queue, press star, then two. We'll pause momentarily to assemble the roster. And our first question comes from Maury Raycroft with Jefferies.

Please go ahead. Hi, this is Kevin Strang on for Maury. Thanks for taking my questions. First question was just on for COVID-19 testing. Could you say what percentage of testing at this point is done within the 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?

Yeah, so I would say this is John. 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 has really dramatically gone away. So most people are doing home testing or we're 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, is 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. So 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 I think that's the big unknown as we go into the fall.

So, yeah, 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 There is some upside if what John 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% to 5% of those volumes now as we exited Q2 and it's been consistent through July. So pretty significant fall off in overall COVID testing in our business today.

Great. Thank you both. And then just another question on the MODEX pipeline. It was 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. Thanks.

Thank you, Kevin. On the MODX 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 three molecules, two 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 two 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. 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 we're looking forward to that.

Great, thank you very much.

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 UPGO 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 MODX 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 MODX team. First, Dr. Gary Nabel. He's the director of the R&D program at MODX. He's the president and CEO of the operation. He's a founding director of the Vaccine Research Center at the NIH. And then he was a chief science officer at Sanofi. Brilliant career in academics, government, industry. Dr. Betsy Nabel, professor at Harvard, president of the Brigham and Women's Hospital, director of the Heart, Lung, and Blood Institute, tremendous leader. Dr. John Mescola, 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 MODX and the people and the projects, we have every reason to feel good about Opco. I'll leave you with that thought in mind. See you next time.

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