OPKO Health, Inc. (NASDAQ:OPK) Q4 2023 Earnings Call Transcript
OPKO Health, Inc. (NASDAQ:OPK) Q4 2023 Earnings Call Transcript February 27, 2024
OPKO Health, Inc. reports earnings inline with expectations. Reported EPS is $-0.09 EPS, expectations were $-0.09. OPKO Health, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good day, and welcome to the OPKO Health Fourth Quarter 2023 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
Yvonne Briggs: 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 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 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 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, 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, will then provide an overview of OPKO's pharmaceutical business as well as BioReference Health. After that, Adam Logal, OPKO's CFO, will review the company's fourth quarter financial results, and then we'll open up the call to questions. Now I'd like to turn the call over to Dr. Frost.
Phil Frost: Good afternoon, and thank you for joining us today. 2023 was a year of significant achievement for OPKO, 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 U.S., 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. ModeX 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 our unique pipeline to commercial realization. Specifically, last March, we announced an exclusive worldwide license and collaboration agreement with Merck to develop ModeX's nanoparticle vaccine candidate against Epstein-Barr virus. We received a sizable upfront payment and are eligible for milestone and royalty payments. In September, ModeX 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 infectious diseases deemed to be public health threats. The BARDA contract included an initial payment to develop multi-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. Sales of RAYALDEE, our 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 RAYALDEE may slow chronic kidney disease progression. Some of you have been asking about my long-time enthusiasm for our once-weekly oxyntomodulin 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 3 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 increase 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, OPKO Iberoamerica, FinTech and EirGen 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 over to Elias.
Elias Zerhouni: Thank you, Phil, and good afternoon, everyone. As Phil mentioned, last year was quite eventful for both of our operating segments of OPKO Health. And NGENLA 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 assisted easing the burden, especially for the pediatric market, and increases medication adherence. NGENLA annual growth is anticipated to be in excess of 12%. But as part of our partnership with Pfizer, OPKO's anti-oral 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 3 clinical trials. Phil also mentioned our success last year in securing collaborations for ModeX 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 1 study of our multi-specific antibodies against known variants of SARS-CoV-2 for the treatment and as well as prevention of COVID-19, which remains a particular threat, especially for immune-compromised 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 MDX-2201, 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 scale royalties on global sales, ranging from single digit to double-digit percentages. This program truly leverages ModeX'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 antigens 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 -enabling studies, and we expect Phase 1 clinical trials to start later this year. To round out our ModeX 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 1 trial and we are moving forward with a more potent next-generation tetra-specific 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, our focus 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 tetra-specific 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 Diagnostics segment via BioReference Health. 2023 was a transition year for our Diagnostics division as we get closer to turning the corner to profitability. As you know, we implemented our REACH initiatives to reduce costs, improve efficiency and enhance productivity. For example, we've reduced our headcount by 8% or 252 headcount in 2023.
In parallel, we're driving growth in various testing segments, including our higher-value specialty segments like oncology, wounds health and urology primarily through our proprietary 4Kscore test. The 4Kscore test volume has continued to perform, and we expect these volumes to continue as the test was included in the 2023 American Urology Association and the NCNN guidelines for early detection of prostate cancer and for follow-up after PSC screening for initial and repeat biopsy risk stratification. In addition, we expect that the recent expansion of insurance coverage will continue to boost those levels this year. GenPath continued to launch innovative 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 accessions -- additional accessions. And we've also signed major oncology groups like the Virginia Oncology -- Oncology Group with 90 oncology which is a component of U.S. Oncology that started in November. So in summary, BioReference Health made great progress last year, and we expect to continue to build 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 Logal to discuss our fourth quarter financial results.
Adam?
Adam Logal: Thank you, Elias. Starting with our Pharmaceuticals 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 RAYALDEE, 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 NGENLA, 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, none 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 ModeX development programs, partially by decreased spending on NGENLA as well as an R&D tax credit for our Irish activities. The resulting operating loss for the quarter ended December 31, 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 4th quarters, respectively.
Moving to our Diagnostics 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 Diagnostics segment included a change in estimated collections as well as approximately $4.7 million of nonrecurring costs related to employee severance and retention programs associated with our efforts to return to profitability. Depreciation and amortization expense were $8.1 million 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 noncash mark-to-market losses related to our investment in GeneDx. I'd like to briefly comment on our balance sheet and the recently completed refinancing of our convertible debt. On December 31, we had two convertible debt issuances that were set to mature in early 2025. Our 4.5% notes, which were held by a number of institutions, and our 5% notes, which were primarily held by Dr. Frost, Dr. Hsiao and a long-term investor of OPKO.
In consultation with our advisors at JPMorgan, 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 OPKO. 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 Pharmaceuticals segment, there are a number of factors that impact our gross profit share payments from Pfizer, including revenue from product sales of GENOTROPIN and NGENLA. Global sales of GENOTROPIN for 2023 as reported by Pfizer were $539 million. Pfizer has not separately reported sales of NGENLA. However, we have observed consistent prescription growth globally for NGENLA as reported by IQVIA and Symphony.
As such, for the full year, we estimate our gross profit share will be between $40 million and $50 million, although we anticipate that a number of scenarios may impact sales of GENOTROPIN and NGENLA globally. We assume a stable foreign exchange rate for our ex U.S. 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 operations 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 Diagnostics 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 core testing volumes with a slight increase in the average per patient collection amount 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 nonrecurring cost that may result from our restructuring activities, we expect our cost 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 million and $130 million, revenue from product sales between $36 million and $40 million; and other revenue between $14 million and $18 million, inclusive of the estimated Pfizer gross profit share payments between $9 million and $11 million. We expect first quarter costs and expenses to be between $235 million and $245 million, including R&D expense between $20 million and $29 million, dependent on the timing for certain CMC activities for our ModeX 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.
Operator: We will now begin the question-and-answer session. [Operator Instructions]. And our first question comes from Jeffrey Cohen of Ladenburg. Please go ahead.
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