Opko Health, Inc.

Good day and welcome to the Opco Health fourth quarter 2023 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now 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's financial results for the fourth quarter of 2023. 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 severely 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 2023, and in subsequently filed SEC reports. This conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 27, 2024. 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, will then provide an overview of Opco's pharmaceutical business, as well as bioreference health. After that, Adam Logo, Opco's CFO, will review the company's fourth quarter financial results, and 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 us today. 2023 was a year of significant achievement for Opco, and we expect continued progress in 2024. In 2023, NGENLA, our long-acting growth hormone therapy, was approved by the FDA for sale in the US, the largest growth hormone market in the world. Pfizer, our global commercial partner, has now launched NGENLA in over 40 markets worldwide, And we're optimistic about Pfizer's ability to convert users to the weekly injection from the daily to further penetrate this growing $5.5 billion market. MODX made great strides last year, in particular in executing its strategy to secure important collaborations to advance its multi-specific biologics platform into the clinic. These collaborations provide non-dilutive funding to advance a unique pipeline to commercial realization. Specifically, last March, we announced an exclusive worldwide license and collaboration agreement with Merck to develop MODX's nanoparticle vaccine candidate against Epstein-Barr virus. We received a sizable upfront payment and are eligible for milestone and royalty payments. In September, MODX was awarded a contract from the Biomedical Advanced Research and Development Authority, known as BARDA, to develop novel multi-specific antibodies against viruses that cause specific antibodies to treat and prevent COVID-19. And additional funding may be available to develop multi-specific antibodies targeting other viral pathogens, such as influenza. Elias will provide more detail on those programs. Stands of reality are drug to treat chronic kidney disease patients with elevated parathyroid hormone and low vitamin D levels. grew 13% last year, and we're expecting further progress this year. We're gathering data which indicate that reality may slow chronic kidney disease progression. Some of you have been asking about my long-time enthusiasm for our once-weekly auxinthamodulin product to treat type 2 diabetes and obesity. You'll remember that we had completed a successful phase 2 trial achieving significant weight loss, lowering of serum cholesterol and triglycerides, and lowered A1C levels. We delayed a Phase III trial when other products appeared which provided greater weight loss. Noting the great commercial success of these products, we decided to have a closer look at ours. The polyethylene glycol PEG added to our base peptide to increase its half-life is large and bulky, and increased the viscosity of the injection, which limited the maximum dose administered, which is related to the amount of weight loss. We have now found a substitute for PEG, which makes our molecule size similar to those on the market. With guarded optimism, we're in early stages of preclinical evaluation of this product. Switching to our international business, APCOA Iberoamerica, Finetec, and Ergen are all doing well. Turning to BioReference Health, our team has worked hard to improve our cost structure and enhance revenue. In addition to our expense reduction efforts, BioReference has been aiming to drive growth in higher value segments with new tests, larger customers, and better insurance reimbursement. We are laser focused on returning this segment to profitability in the near term, and again, Elias will provide more detail. With that overview, I'll turn it over to Elias.

Thank you, Phil, and good afternoon, everyone. As Phil mentioned, last year was quite eventful for both of our operating segments of Covel. And Gila launches in all major global markets, as mentioned by Phil, is progressing well, and we believe this drug is well-positioned for significant growth. This next-generation long-acting therapy is administered once a week and not daily and assists in easing the burden especially for the pediatric market, and increases medication adherence. And again, annual growth is anticipated to be in excess of 12%. But as part of our partnership with Pfizer, Upco is entitled to an additional $100 million in milestone payments associated with approvals for an adult indication for growth hormone deficiency and additional pediatric indications. These are global registration strategies underway for the adult application and other pediatric indications, which are currently in phase three clinical trials. Phil also mentioned our success last year in securing collaborations for MODX Therapeutics with BARDA and Merck. Most recently with BARDA, we secured an initial $59 million grant to fund R&D and clinical evaluation through a phase one study of our multi-specific antibodies against known variants of SARS-CoV-2 for the treatment as well as prevention of COVID-19, which remains a particular threat, especially for immunocompromised patients. Additional funding of up to $109 million, based upon the achievement of certain milestones in the first phase, may be available from BARDA to develop more multispecific antibodies targeting other viral pathogens, such as influenza. And as part of the research program, Gene-based delivery methods for the multispecific antibodies will be developed using mRNA or DNA vectors to supplement the body's natural protein production processes and hopefully provide BARDA with a platform that can be used very quickly for any emerging threat. In addition, we announced the collaboration with Merck to develop MDX2201, which is our Epstein-Barr virus multivalent nanoparticle vaccine. We received a $50 million upfront payment for the license of this vaccine, with a potential $872.5 million in development and commercial milestones and scaled royalties on global sales, ranging from single digit to double digit percentages. This program truly leverages MODEC's nanoparticle-based vaccine platform, which enables simultaneous immunization against several major EBV proteins, in this case four major EBV proteins, but the platform itself has the potential to in fact address multiple integers against multiple viral diseases. The market opportunity here is quite large as the Epstein-Barr virus affects up to 95% of the global adult population during their lifetime. Moreover, there are over 260,000 cancer cases annually caused by EBV, along with an association between multiple sclerosis and this virus. We're working with Merck on IND-enabled studies, and we expect phase one clinical trials to start later this year. To round out our MODX pipeline, we have partnered with the NIH to develop an antiviral multispecific antibody focused on the treatment and prevention of HIV. We've had success. with our first-generation candidate in the phase one trial, and we are moving forward with a more potent next-generation tetraspecific antibody versus the previous tri-specific one. We believe there is an unmet need for a therapy that can provide long-acting protection and treatment for patients who require options beyond small molecule-based therapies. And lastly, our immuno-oncology programs are focused on hard-to-treat solid tumors as well as liquid tumors such as leukemias and lymphomas. Our multispecific antibody candidates can simultaneously target several tumor antigens and enable better control of immune system activation. Our tetraspecific laser program to treat solid tumors is expected to enter the clinic the first half of this year. Now, I'd like to turn to a review of our diagnostic segment, bioreference health. 2023 was a transition year for our diagnostic division as we get closer to turning the corner to profitability. As you know, we implemented our REACH initiative to reduce costs, improve efficiency, and enhance productivity. For example, we've reduced our headcount by 8% or 252 headcount into 2023. In parallel, we're driving growth in various testing segments including our higher-value specialty segments like oncology, women's health, and the neurology, primarily through our proprietary 4K score test. The 4K score test volume has continued to perform, and we expect these volumes to continue as the test was included in the 2023 American Neurology Association and the NCNN guidelines for early detection of prostate cancer and for follow-up after PSA screening and for initial and repeat biopsy risk stratification. In addition, we expect that the recent expansion of insurance coverage will continue to bolster levels this year. GENPATH continued to launch innovating testing, including an expanded hematologic malignancy panel and introducing several new tests in the market that will sustain growth of the GENPATH oncology products. Other advances have been made over the 2023 year. For example, we have signed over 300 new accounts in the fourth quarter of 2023 with over 40,000 additional accessions. And we've also signed major oncology groups like the Virginia Oncology Group with 90 oncologists, which is a component of US Oncology that started in November. So in summary, BioReference Health made great progress last year, and we expect to continue to build on these achievements in 2024. We narrowed our operating loss sequentially, and through both expense reduction and revenue growth, we continue to feel confident that these efforts will further improve financial metrics and return this segment to profitability in the next few years. I will now turn the call over to Adam Hogan to discuss our fourth quarter financial results.

Thank you, Elias. Starting with our pharmaceutical segment, revenue increased to $57.7 million for the fourth quarter of 2023 from $46 million for the comparable period of 2022. Revenue from products, including our international pharmaceutical businesses and reality, increased by $5.1 million, reflecting from improvements in the number of prescriptions and in overall net price. Further, revenue increased as a result of gross profit share payments from Pfizer due to the global launch of Ingenla, resulting in $12.2 million of revenue during the quarter. The fourth quarter revenue includes a catch-up payment for the U.S. market related to the third quarter of $3.1 million. As I mentioned last quarter, the U.S. launch occurred mid-August, and Pfizer was delayed in reporting our gross profit share amounts, and as a result, and were included in our third quarter results. Costs and expenses were $73.8 million for the fourth quarter of 2023 compared to $68 million for the 2022 period. Research and development expenses for the fourth quarter of 23 were $18.7 million compared to $16.6 million for the comparable period of 2022. This increase reflects activities for our MODX development programs partially offset by decreased spending on NGINLA as well as an R&D tax credit for our Irish activities. The resulting operating loss for the quarter ended December 31st, 2023 was $16 million, a $6 million improvement from the operating loss of $22 million for the fourth quarter of 2022. Amortization expenses related to intangible assets were $16.4 million and $16.5 million for the 2023 and 2022 fourth quarters, respectively. Moving to our diagnostic segment, We reported revenue for Q4 2023 of $124.2 million, compared with $139.4 million for the 2022 period. This decline primarily reflects lower COVID testing of $7.1 million, as well as a change to our estimated collections of $8.1 million, partially offset by increased testing volumes. Costs and expenses increased to $166.4 million for the fourth quarter of 2023, from $162.5 million for the 2022 period. Operating loss for our diagnostic segment included a change in estimated collections, as well as approximately $4.7 million of non-recurring costs related to employee severance and retention programs associated with our efforts to return to profitability. Depreciation and amortization expense were $8.1 and $8.7 million for the 2023 and 2022 periods, respectively. Turning to our consolidated financial results, for the fourth quarter of 2023, we reported an operating loss of $69.1 million compared to an operating loss of $55.3 million for the 2022 quarter. Net loss for the fourth quarter of 2023 was $66.5 million, or $0.09 per share, which compares with a net loss of $85.2 million, or $0.11 per share, for the 2022 quarter, reflecting lower non-cash mark-to-market losses related to our investment in GNDX. I'd like to briefly comment on our balance sheet and the recently completed refinancing of our convertible debt. On December 31st, we had two convertible debt issuances that were set to mature in early 2025. Our 4.5 percent notes, which were held by a number of institutions, and our 5 percent notes, which were primarily held by Dr. Frost, Dr. Hsiao, and a long-term investor of Opco. In consultation with our advisors at J.P. Morgan, we chose to issue new five-year notes, reducing our coupon interest rate to 3.75% and took advantage of the strong demand from institutional investors to raise a total of $230 million. We used the proceeds to buy back the outstanding 4.5% notes and the 55 million shares of our common stock, and we added approximately $25 million in cash to our balance sheet. Our 5% note holders exchanged their principal and accrued interest of approximately $71.1 million into notes with identical financial terms as the 3.75% note holders. This refinancing strengthened our balance sheet, reduced the number of shares outstanding, and provided the company with additional cash to fund our ongoing development activities. The offering was oversubscribed and brought in an impressive group of new prominent investors to Opco. During 2024, we anticipate receipt of additional non-dilutive cash payments under our existing collaborations with Merck, BARDA, and other potential transactions as the year progresses. As we look ahead, we're providing the following financial guidance with the following assumptions. For our pharmaceutical segment, there are a number of factors that impact our gross profit share payments from Pfizer, including revenue from product sales of genotropin and angela. Global sales of genotropin for 2023, as reported by Pfizer, were $539 million. Pfizer has not separately reported sales of angela. However, we have observed consistent prescription growth globally for angela, as reported by IQVIA and Symphony. As such, for the full year, we estimate our gross profit share will be between $40 and $50 million, although we anticipate that a number of scenarios may impact sales of genotropin and angina globally. We assume a stable foreign exchange rate for our ex-US pharmaceutical businesses, which will allow for continued and profitable growth. R&D expenses for the first quarter of 2024 will reflect higher activities related to our MODEX programs, including CMC and efforts related to the initiation of our first immuno-oncology clinical trial. Those increased activities will be partially funded through our BARDA agreement and partially offset by lower R&D costs related to the wind down of our clinical operation for the ongoing open-label pediatric extension study for NGENLA, which we expect to substantially complete by the end of the first quarter. For our diagnostic segment, as Elias outlined, we are diligently working to align the business to achieve cash flow breakeven by the middle of 2024 and profitability by the end of the year. This work includes consolidating our geographic footprint and rationalizing our test offerings. As a result, we expect our client mix to improve and cost structure to appropriately support our go-forward strategy. During this transition phase, we expect consistent quarter testing volumes with a slight increase in the average per patient collection amounts due to our revenue cycle management initiatives, partially offset by volume impact due to several weather events that occurred during the first quarter already. Before considering any non-recurring costs that may result from our restructuring activities, we expect our costs and expenses to decline sequentially by $7 million to approximately $159 million. As a result, we expect the following for the first quarter of 2024. Total revenues between $180 million and $185 million, revenue from services between $126 and $130 million, revenue from product sales between $36 and $40 million, and other revenue between $14 and $18 million, inclusive of the estimated Pfizer gross profit share payments between $9 and $11 million. We expect first quarter costs and expenses to be between $235 and $245 million, including R&D expense between $20 and $29 million, dependent on the timing for certain CMC activities for our MODX programs, and depreciation and amortization expense of $26 million. That concludes our prepared remarks, and thank you for your attention. Operator, let's open the call for questions.

We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. And our first question comes from Jeffrey Cohen of Ladenburg. Please go ahead.

Good afternoon, everyone. Thanks for taking our questions. I guess first, Adam, could you just recap on your finances with regard to the 4.5% and 5% instruments out there? So currently then, Share count is down toward approximately 700, and then what would the appropriate cash and debt levels be if one were estimated pro forma?

Yeah, so we ended the year with $95 million in cash, so if you pro forma in the additional $25 million, that would put us right at about $120 million in cash on a pro forma basis. The total convertible notes were just over $300 million, so just right at $300 million in principle. And you got the share count right.

OK, perfect. Could one of you discuss a little bit about the press release with regard to the Alibaba global platform in China and talk about perhaps some of the products that you're planning on offering and what we should expect as far as the status during 24?

The products involved are made by our Irish company, and I'm sorry, by our Spanish company, and are primarily nutritional products for animals, for which there appears to be a large market in China. And it is just beginning, so there's not much else to say about it.

OK, got it. And then lastly for us, Could you provide any commentary on general and daily going to weekly and what you've learned or what Pfizer's learned perhaps, you know, versus what's anticipated as far as costs and transference of patients from one to the other and new patients and how that may look over the coming year?

I'll start off. Jeff, so, you know, I think what we've seen, you know, in the markets that are the most mature from Pfizer where they launched initially is, you know, good steady growth in the conversion is happening broadly. I think, you know, with one of the competitors launching a bit earlier in the U.S. market, we've seen that conversion happen, you know, similar to what we've seen globally. We expect that to continue and accelerate as Pfizer enters the market as well as if Novo eventually enters the market with their long-acting products. So the conversions are happening, and we expect those to accelerate over the next 18 to 24 months.

Okay, perfect. And lastly, on reality, it sounds like you're expecting growth, and it looks like Q4 had some strong growth. Could you identify for us where that may be coming from, either demographically or geographically or pricing-wise and what we should expect for that.

So Charlie's here.

You want to go ahead and... Yeah, happy to do that. So we're seeing growth for a number of reasons with the reality brand. First is the obvious passing of the adverse effects of the pandemic, which slowed the ability of our sales force to get into clinics and promote the brand. and it also slowed the ability of patients to get into the clinics to get prescriptions. That seems to have abated as of the beginning of Q2 of last year. In addition, our sales force is much more adept now at moving the product into areas of business that have low copays. This would include the Medicaid sector. This includes the low-income subsidy Medicare Part D patients, and it also includes the commercial patients who have zero co-pay. So these are the main drivers of the growth in the business.

Okay, got it. It seems like it's on a nice trajectory post-COVID currently. Okay, I think that does it for us. Thanks for taking all the questions.

Thanks, Seth.

The next question comes from Laurie Raycroft of Jefferies. Please go ahead.

Hi, thanks for taking our questions. I was wondering if you can talk more about timing and next steps for Angela label expansions for the adult setting and additional pediatric indications.

Yeah, quickly. The adult indication, basically we're in the process with Pfizer, obviously, to put our application to the FDA. And as I mentioned in my comments, we're towards the end of phase three for the pediatric education. So timing-wise, you know, probably the end of the year, beginning of next year for the adult, and probably fairly next year for the pediatrics if everything goes well.

Got it. Okay. And then for profit share with Pfizer, just wanted to make sure I heard this correctly, that the guidance for 2024 is 40 to 50 million. Is that right? And wondering if there are more details you can provide on the profit share currently and how that will change as, in general, it takes more market share from genotropin. And what would a peak profit share percent look like?

Sure. So the 40 to 50, you're correct, is the full year guide. based on the information we know today, right? So Pfizer doesn't separately forecast out in general or genotropin sales. So we're using our internal models to calculate what we anticipate the franchise revenues to be globally. And then we apply the various tables that we have to come up with our estimated calculations. So, you know, we've got some conservatism built into that with some uncertainty on the daily portion for genotropin and you know, modest growth rates that we would expect for NGEMLA. So you've got the 40 to 50 right. So in the fourth quarter, if you take out the third quarter catch-up, you know, we had about $9 million in gross profit share payments. So when you think about that modest growth that we're forecasting in the gross profit share, you can see what that math kind of looks like overall. You know, when we look out at peak, when you look at the growth hormone franchise as a whole, so the combination of Ingenla and Genotropin, you know, when the product is at its peak where we think the peak could be, and I think, you know, Pfizer has stated what they think the total market potential is for Ingenla, you know, it's a substantial increase substantial revenue stream, we've estimated an effective royalty rate to be in the mid-20s on that franchise. So at peak, it's a pretty substantial cash flow, as we would expect to see the growth from now until we hit that peak.

Got it. That's helpful. And maybe last question, just on Oxford Modulin. If you could talk about timelines for the new formulation and What would a clinical development path look like there, and is this something you're going to keep in-house or partner out, and does LeaderMed have any rights to this program?

I think with respect to both of those questions, it's early. We'll get back to you as soon as we have something more definitive to talk about.

Understood. Okay, thanks for taking my questions.

Thanks, Maureen.

Question comes from Edward Tenthoff of Piper Sandler. Please go ahead.

Great. Good evening, everyone. So two quick questions that I made. Firstly, just at a high level with respect to Engenla versus SkyDrove, what are the differences that Pfizer is pushing in terms of marketing? Or is it really just a land grab at this point where they're going to the genotropin clients and converting them over? and, you know, basically trying to get into as many other accounts as possible. And then the second question really for Phil, high level as bioreference in the diagnostic business returns to break even, is the plan here still to keep that as part of OPCO or potentially to monetize it how you have for some of the other diagnostic segments slash products? You know, do you ultimately see this business being farmed and diagnostic going forward? Thanks.

Well, for those of you who know me, you realize that first and foremost, we will always do what's in the best interest of the shareholders in terms of creating value. So, at a particular point in time, one approach seems advisable, we'll certainly consider it seriously. I don't want to be more specific than that right now, but it's clear that we have an asset on our books that is at the moment losing money, although we're very optimistic about turning that around, that has inherent value as an asset, and so we're very mindful of that, be assured.

Yeah, thank you. And then on the competition and sort of, you know, a little bit more on the marketing in the long-acting or weekly human growth loop. Thank you.

Yeah, so obviously Pfizer is leading the charge on the commercial efforts. So where we think that they are going to be very successful is, you know, in the near term is where they're alone in the market, right? So when you think about the Japanese market, which is a substantial market for the growth hormone space where they're by themselves currently, they've had, you know, meaningful market share penetration and continued growth. And, you know, there's a number of other countries where they're by themselves. They've done a great job marketing throughout Europe as well and forcing the conversion or suggesting the conversion there as well. In the U.S. market, they've got access commercially to a strong number of plans. We think they're well-positioned with their team to go ahead and take substantial share in the U.S. as well. As far as how they're going to go about that, I think that's a question for Pfizer to answer. Okay, great.

Thank you, guys.

The next question comes from Yi Chen of HC Wainwright & Co. Please go ahead. Yi, your line is open. Are you muted on your end?

Hello?

Hey, we can hear you now.

Oh, sorry about that. So regarding the storefront on Alibaba, can you talk about the potential market size that, you know, that Upco can target and what is the potential revenue contribution in 2024 and How is the current economic environment could affect your market prospects in China? Thank you.

You know, this is a product line that is very successful as sold by our Spanish unit. They manufacture the products, develop the products, and have done so well that they're beginning to expand into France, as a matter of fact, and have every intention to continue to expand geographically. We were approached by a company that has a partnership with Alibaba and thinking that because of the tremendous interest in pet animals now in China and because such products as we have are successful, that we might be willing to let them distribute them through Alibaba in China. And we said, why not? And that's where we are now. It's just getting launched, so it's too early to say much more about the market size for our products as sold by Alibaba. It's a wait-and-see situation.

So it's strictly animal health products, right? There are no human products off of this stuff. Sorry?

So there's a combination of human health and veterinary products that will eventually go on the platform. Right. All right, thank you.

This concludes our question and answer session. I would like to turn the conference back over to Dr. Philip Frost for any closing remarks.

Well, we'd like to certainly thank you for participating in today's session, and we hope you'll be with us again when we report the first quarter results. Thank you.

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