Prepared remarks
Good day, and welcome to the OPKO Health Second Quarter 2026 Business Highlights and Financial Results Conference Call. Please note this event is being recorded. I would now like to turn the conference over to Ms. Vivian Cervantes of Investor Relations. Please go ahead, ma'am.
Thank you. Good afternoon, everyone. This is Vivian Cervantes with Alliance Advisors IR. Thank you all for joining us on today's call to discuss OPKO Health's financial results for the second quarter 2026. 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 are subject to risks and uncertainties that could materially affect the company's 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, 2025. Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, July 27, 2026. 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. Regarding the format of today's call, Dr. Phillip Frost, Chairman and Chief Executive Officer, will provide opening remarks. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of OPKO's Therapeutics segment as well as BioReference Health. After that, Adam Logal, OPKO's CFO, will review the company's second quarter financial results and discuss OPKO's financial outlook. And then we will open 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. During the second quarter, we made meaningful progress in improving operating efficiency and profitability and in advancing our product pipeline. ModeX continues to move forward with its present portfolio of five clinical trial programs in oncology, immunology and vaccines, each with the potential to deliver first and best-in-class medicines. We initiated a Phase I/IIa clinical safety and efficacy study in the U.S. of our GLP-1 glucagon candidate, and we plan to enroll 44 healthy volunteers and presumed MASH patients to assess single-dose tolerability and pharmacokinetics. OPKO Biologics is making progress with its human growth hormone antagonist to treat acromegaly, its GLP-2 program for patients with short bowel syndrome and its oral PTH to treat hypoparathyroidism. NGENLA, our growth hormone product, partnered with Pfizer, continues to increase market penetration as we advance label expansion clinical trials. I'm pleased that we ended the second quarter with a strong cash position and a solid balance sheet that continues to fund our R&D portfolio at a meaningful level, while also returning capital to shareholders through our ongoing stock repurchase program. With that brief overview, I'll turn the call over to Elias. Elias?
Sorry, I was on mute, and thank you, everyone, for joining us today. And thank you, Phil. Let me take this opportunity to highlight continued advancements in our pipeline, targeting important unmet clinical needs across large markets. First, in immuno-oncology and immunology. I'll start with ModeX, where we now have five assets in the clinic and expect a sixth program, our in vivo CAR-T asset, to begin first-in-human clinical trials by the end of this year or in early 2027. Our collaboration with Merck for MDX2201 focused on the vaccine against Epstein-Barr virus, commonly known as the cause of infectious mononucleosis but also associated with several cancers and immune-related conditions such as multiple sclerosis, continues to advance. The program, fully funded by Merck, is in the late stages of data analysis of its completed Phase I trial. We continue to expect Merck to have the data to inform the Phase II design by the end of this year with a potential progression to a Phase II clinical study next year. MDX2001, our lead immuno-oncology candidate for solid tumors, including head and neck, esophageal, pancreatic, lung and prostate cancers, continues to advance in Phase I and is expected to conclude dose escalation and regimen optimization by Q3 or early Q4 2026. We then expect early data to be presented at a medical conference in late 2026 or early 2027, and we're underway with initiatives to enable subcutaneous formulations. A differentiated tetra-specific design, MDX2001 combines dual tumor antigen targeting Trop2 and c-Met with dual T-cell activation, CD3 and CD28, to enhance immune engagement and potentially deliver deeper, more durable responses than conventional T-cell engagers. Now MDX2003, our next-generation T-cell specific directed to CD19 and CD20 on tumor cells and CD3 and CD28 on T cells, is an engager-expander designed to harness and amplify the body's immune system by precisely connecting T cells to B-cell cancers, driving enhanced T cell activation and expansion to enable sustained antitumor responses. MDX2003 has entered its Phase I clinical trial and is enrolling patients. In parallel, we are also evaluating the optimal path to explore autoimmune indications for MDX2003. MDX2004, our first-in-class trispecific, which is a CD3, CD28 and 4-1BB ligand immune modulator antibody fusion molecule engineered to rejuvenate exhausted T cells and other immune cells, primarily in heavily pretreated cancer patients, is enrolling patients in Phase I. We expect to announce preliminary data in 2027. And finally, MDX2301, our fifth ModeX program in the clinic, fully funded by BARDA, is a multi-specific COVID-19 antibody that has been shown to be active against all prior and current circulating variants of the virus aimed at the prevention of COVID-19, primarily in high-risk immunocompromised patients. We're completing enrollment of its Phase I clinical trials in the third quarter of this year with early results to be presented at medical meetings later this year or early 2027, which will inform the next development stages. In addition to COVID multi-specific antibodies, BARDA is also supporting our multi-specific influenza program, which targets conserved regions of hemagglutinin to enable broad coverage across influenza A and B strains, and we're currently conducting pre-IND work for this program. We're also excited by our continued progress toward advancing our sixth ModeX asset, MDX3001, into clinical trials following the successful completion of all preclinical studies. Unlike traditional CAR-T therapy, we believe our in vivo CAR-T program is highly differentiated as it leverages our multi-specific antibody expertise and platform with targeted lipid nanoparticles seeking to generate engineered T cells directly inside the patient by delivering the CAR payload to the right immune cells in the body, which we can select due to our multi-specific technology. We are now in IND-enabling studies and expect to begin clinical studies by the end of 2026 or early 2027, potentially in cancer and autoimmunity indications. In May, MDX3001 data was presented at the American Society of Gene and Cell Therapy, demonstrating in vivo CAR T cell generation with B-cell depletion in blood and lymphoid tissues, including spleen, bone marrow and lymph nodes. Activity was confirmed in both humanized mouse and nonhuman primate models. Now turning to research conducted with our partners. We're pleased to note continued progress with our collaboration with Regeneron, which combines their extensive library of clinically validated monoclonal antibody binders with our modular multi-specific architecture across immunology, oncology and metabolic diseases. We remain focused on advancing four initial discovery programs with Regeneron using the ModeX platforms to rapidly generate and optimize multi-specific antibody candidates with the potential to expand into additional targets over time. Regeneron is responsible for funding preclinical, clinical and commercial development of selected assets, while OPKO is eligible for research, development, regulatory and commercial milestones that could exceed $1 billion as well as tiered royalties on global sales up to the low double digits. We have also advanced the development of the once-weekly dual GLP-1 glucagon agonist, OPK-88006. The Phase I/IIa randomized double-blind, placebo-controlled clinical trial is open to enrolling participants in the U.S. The first part of the trial is to evaluate the pharmacokinetic and tolerability of OPK-88006 at three levels of ascending doses in healthy volunteers. The Phase IIa portion of the trial will evaluate the safety and effectiveness of OPK-88006 administered once weekly for 16 weeks in participants with presumed MASH or Metabolic Dysfunction Associated Steatohepatitis. We're also steadily advancing programs in OPKO Biologics. Our parathyroid hormone program in collaboration with Entera Bio, as a first-in-class oral long-acting PTH tablet for hypoparathyroidism, which is structured under a 50-50 economic arrangement, reported excellent preclinical results at the recent Endocrine Society conference. The data showed that the tablet was well tolerated, no safety concern identified, and calcemic effects were consistent with those reported for clinically validated injectable PTH replacement therapies for hypoparathyroidism. Ongoing studies are advancing this program towards first-in-human clinical evaluation with an intention to file an IND later this year. Our long-acting human growth hormone antagonist program, known as OPK8801001, designed to treat patients with acromegaly, is expected to advance to clinical trials at the end of 2026 based on the results presented at ENDO last month. With OPK8801001, we envision a once-weekly injection that could significantly improve upon the current standard of care, which requires daily injections. NGENLA, our long-acting human growth hormone commercialized by our partner Pfizer, continues to progress commercially according to plan. In addition, clinical label expansion studies are underway, building on the pediatric growth hormone deficiency label to further expand both market access and geographic reach. Currently approved and commercialized in over 50 markets, the NGENLA long-acting pediatric growth hormone deficiency product is contributing meaningfully to recurrent cash flow. Turning to our international pharmaceutical businesses. Our Iberoamerica business continues to grow with sustainable profitability as we focus on accelerating top-line growth and driving further operating efficiencies. Further, RAYALDEE, our innovative vitamin D product, continues to perform to plan and is contributing nicely to our operating cash flows. For the quarter, global pharmaceutical product sales grew about 7% year-to-date as of June 30 of this year due to favorable demand trends as well as foreign currency tailwinds. Now I'd like to turn finally to our clinical diagnostics business. As previously announced, following the sale of select oncology and oncology-related clinical testing assets to Labcorp in 2025, we received $192.5 million payment at closing, along with an additional $18.4 million earn-out payment received in the second quarter of 2026. We continue to strengthen BioReference's core diagnostics platform by leveraging our regional clinical lab operations and national specialty testing franchise with a proprietary 4Kscore test, serving as a key driver of growth. We continue to see the 4Kscore test as a unique high-value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating urologists and primary care physicians about its clinical utility. Therefore, as we operate with a more efficient footprint and an expanding menu of higher-margin services, we're progressing towards achieving breakeven and positioning the business for sustainable profitability. In summary, we're encouraged by steady advancements in our ModeX portfolio, which is fully engaged in clinical development in our biologics portfolio and partner programs while generating nondilutive revenue and more profitable growth and cash flow from our global pharmaceutical business and BioReference Health. With that, I'll turn the call over to Adam to review our financial results and outlook. Adam?
Thank you, Elias. We ended the quarter with a strong cash position with over $300 million in cash, cash equivalents and restricted cash, which is more than sufficient to fund our ongoing operations and development plans while continuing to return capital to our shareholders through our share buyback program. During the quarter, we repurchased 9.7 million shares for approximately $13 million. We have approximately $94 million authorized to repurchase additional shares of our common stock. Let's move to the financial performance of our Diagnostics business. Revenue for Q2 2026 was $74.5 million, including $6.2 million from our 4Kscore Test. Revenue in Q2 2025 was $101.1 million, with the year-over-year decline expected due to the sale of our oncology customer account to Labcorp. In the transaction that closed in September 2025, revenue from our retained business declined approximately $1.7 million versus the prior year, principally due to test mix changes as we continue to see the impact of shifting certain unprofitable but higher-priced esoteric testing to our strategic partners. Total costs and expenses were $69.8 million, down from $119.3 million last year, reflecting the September 2025 Labcorp transaction as well as an $18.1 million gain from the receipt of the final earn-out payment from the transaction, which offset operating expenses as well as the continued efforts to rationalize our cost structure to align with our more focused geographic footprint and test offerings. Our diagnostic operating income was $4.8 million compared to an operating loss of $18.2 million in Q2 2025. Depreciation and amortization came in at $3.9 million for the second quarter of 2026, down from $4.9 million in 2025. As Elias mentioned, we remain focused on achieving breakeven and operating profitability for this business. During the second quarter, the team executed on its overall plan that had several operational headwinds resulting in slightly higher costs and expenses principally in employee benefit costs and professional fees. With continued execution, we anticipate achieving these profitability objectives in 2026. Turning to our Pharmaceutical business. Revenue was $89 million in Q2 compared to $55.7 million in the prior year, with improvements across all revenue sources. Revenue from product sales increased to $42.9 million, up from $40.7 million, reflecting higher sales volumes in our international operations and foreign exchange tailwinds during the 2026 quarter, along with improved RAYALDEE gross-to-net benefits, which were partially offset by the timing of delivery of certain products within our CDMO business. As we continue to focus on the profitability of RAYALDEE, the gross-to-net improvements we began to realize last year have resulted in meaningful cash flow from operations in 2026, while maintaining overall revenue levels. RAYALDEE contributed $8.1 million of revenue during Q2 2026 compared to $7.2 million last year. Our Pfizer gross profit share was $6.4 million for the quarter, an increase from 2025's $6.1 million. Pfizer's progress in the global commercialization of NGENLA continues to show consistent growth while the market transitions away from daily growth hormone products. BARDA funding was $5 million for the second quarter of 2026 compared to $6.5 million a year ago, reflecting the start of our clinical trial program under this collaboration, while the 2025 period included higher levels of CMC activities in our infectious disease antibody programs. Finally, the overall increase was driven by $29.4 million in revenue recognized from Series A-2 preferred shares that we received in connection with our partnership with Nicoya for the commercialization of RAYALDEE in the Greater China market. As a result, IP and transfer of other revenue was $46.1 million in Q2 2026 compared to 2025's $15 million. Costs and expenses for our Pharmaceutical business were $88.2 million, increasing from 2025's $84.4 million, reflecting meaningful investments in our R&D programs. For R&D, for Q2 2026, spending totaled $32.7 million, up from $29.8 million in the 2025 quarter, which reflects the increased levels of activities related to our early-stage clinical trials. Our pharmaceutical operating income was $8.8 million in Q2 2026 compared to last year's operating loss of $28.7 million. Depreciation and amortization expense was $18.5 million, which is slightly higher than 2025's $18.1 million. For our consolidated financial results, total revenues for Q2 2026 were $163.6 million compared to $156.8 million in the second quarter of 2025. Consolidated operating loss for Q2 2026 was $7 million, which improved from 2025's $60 million operating loss. Our net loss for Q2 2026 was $8.4 million or $0.01 per share, which improved from 2025's net loss of $148.4 million or $0.19 per share. The 2025 period included $91.7 million of expense related to the exchange of our convertible notes. Looking forward to our outlook for the third quarter of 2026, we expect revenue to be $131 million to $142 million, with revenue from services of $75 million to $78 million, which reflects several assumptions around testing volumes and reimbursement pricing mix. We expect pharmaceutical product revenue of $40 million to $44 million, and we expect IP and other revenue to be between $16 million and $20 million, including Pfizer profit share of $8 million to $10 million. Total costs and expenses for Q3 are expected to come in between $180 million and $190 million with our expanding investments in R&D to come in between $34 million and $38 million, which is partially offset by $5 million to $7 million in BARDA and other collaboration funding. Depreciation and amortization expense of approximately $22 million. And moving to our outlook for the full year 2026, we're adjusting our full year guidance to reflect several of the transactions and trends. For the year, we now expect an increase to our previously issued guidance with total revenue now expected to be between $560 million and $585 million, with revenue from services contributing $296 million to $306 million and pharmaceutical product revenue of $164 million to $174 million, while other revenue from our partner collaboration agreements is expected to be between $100 million to $105 million, including profit share from Pfizer of $34 million to $37 million. We've reduced our total cost and expenses to now be in the range of $710 million to $740 million, which excludes any future one-time items. Our full year investment in R&D is expected to be between $125 million and $135 million, offset by funding from BARDA of $18 million to $22 million as well as reimbursement from Regeneron under our collaboration agreement. Depreciation and amortization expense is expected to be approximately $95 million. This concludes our prepared remarks. Operator, let's open the call for questions.
Questions and answers
Our first question for today will come from Brian Cheng with JPMorgan.
This is Sarah on for Brian. Just two questions from us. The first question being, how do you think about target and indication selection for your first in vivo CAR-T program in the clinic? And then what type of collaboration with pharma will you be looking for? And the second question is for the 88006 molecule. What do you need to see to justify moving into a larger MASH study: weight loss, liver biomarkers, tolerability, dose frequency, anything like that?
Let me take the second one, and then Gary Nabel can handle the first one about the in vivo CAR-T program. What we're doing is showing that this molecule has a competitive profile to any other competitors. There are a couple of competitors out there, and so that's what we want to demonstrate in Phase I and Phase IIa, both in normal volunteers at the dose tolerance of three dose levels and then in the subsequent phase study in patients with MASH. When we study those patients, we're not going to have biopsies to start with. We're going to have a combination of factors that are known to correlate with the presence and degree of MASH, including fatty liver and biomarkers that are typical of MASH at different stages, and then see what the difference will be between entrance into the trial and exit at 16 weeks. So the first step is to validate that this molecule can be competitive as a once-weekly therapy for both the weight loss as well as improvements in the status of MASH as determined by biomarkers. Based on that, we will decide whether we go to a full-fledged Phase II to prove tolerability and efficacy of the drug. Gary, do you want to take the question about indication selection and partnerships for the in vivo CAR-T program?
Yes. I think you mean MDX3001 for the in vivo CAR-T program. For MDX3001, our initial thought is that we would pursue studies in autoimmune disease. There, the targeting we would be looking for would be B cells. We would be looking to deplete normal B cells in patients who have autoimmune disease and look across a diverse range of autoimmune diseases. The CD19 CAR that's encoded by the mRNA in the antibody-targeted LNP would be the mechanism by which we would achieve that. We have convincing preclinical data, both in nonhuman primate models and in humanized mouse models, that those cells can be depleted in both the blood and in tissues. We would hope to be doing the same in patients late this year or early next year when we have completed production. In terms of partners, we are actively looking to partner with big pharma. What we're looking for in a partnership is someone who can help us move the product into the clinic in patients who would benefit from the treatment. This would require, first and foremost, interest and expertise in the area of autoimmune disease. Also, this technology is applicable to a wide range of clinical targets, including oncology and some antiviral applications and a variety of inflammatory conditions. So we'd be looking to partners who have expertise both commercially and scientifically and medically in terms of understanding the pharmacokinetics, the dose-response relationships and the regulatory pathways in those indications. We are having discussions but are at the early phases of those discussions presently.
The next question will come from Edward Tenthoff with Piper Sandler.
I'm really excited to hear about all the progress with the pipeline and, in particular, excited about the in vivo CAR-T; I think that could be really differentiated. I wanted to ask about the MDX2001 data. It looks like maybe that data was pushed out to the first half of 2027. Can you give us a sense of what's going on with enrollment there? Is there one indication that's enrolling more patients? How many are you intending to enroll altogether in that Phase I study?
The initial studies with MDX2001 were performed to demonstrate safety, pharmacokinetics and immunogenicity. For the very first part of those studies, we were taking all comers regardless of where we thought the drug might eventually be useful in the clinic. This was mostly to get into a range where we could expect to see efficacy. At the point where we think we're starting to get efficacy, that's when we will switch into the specific tumor targets. To date, we've enrolled 39 patients in MDX2001. The data we're looking at lead us to think we are getting to ranges where we're seeing biologic effects in vivo. We are now thinking more actively about recruiting patients who have tumors that we think are more likely to respond to immunotherapy. There's a list of about 13 different malignancies that bear Trop-2 and c-Met. For various reasons, we are starting to narrow down ones where we think it would be more likely to see a response. Non-small cell lung cancer would be high on that list. We think perhaps some types of renal carcinomas would be high on that list. There is a possibility that other solid tumors like ovarian might be worth exploring. We will focus our next efforts on those. We also are planning to look at subcutaneous injection, which might allow us to go to a higher dose with good tolerability and is more patient-friendly. Regarding how many more patients, it's hard to know because we're at the signal-seeking stage. It's more likely to be in the tens, a multiple of 10, not multiples of 100, but we'll follow the data.
The next question will come from Kevin DeGeeter with Ladenburg Thalmann.
On MDX2003, can you walk us through the strategy with regard to potential timing of the Phase I data? And I think you called out autoimmune for potential development moving forward post-Phase I. How are you thinking about prioritization in oncology versus autoimmune and maybe the clinical strategy in the autoimmune space for MDX2003?
Gary, you're going to take that one.
For MDX2003, our initial indications are in the area of B-cell lymphomas. That's because there is clinical proof of concept in that space. What we bring to the table with our molecule is that in addition to CD20, which is in successful products like glofitamab, we also can include CD19 so that the problem of immune escape, which is seen frequently with those molecules, can be addressed. We think we're following a path that is significantly de-risked by prior clinical data. We will move as quickly as we can through dose escalation initially intravenously and then through subcutaneous routes, which could follow and be patient-friendly. That will be our first priority. Regarding autoimmunity, we remain interested. The initial safety data from the oncology studies will help us find a dose that is safe and likely to be effective in autoimmune disease. We're also open to the possibility of using another form of the molecule, one optimized for oncology and another for autoimmunity, but that still builds on the same basic premise. Short answer: oncology first, autoimmune second, and we will get to a therapeutic dose as quickly as we can without compromising patient safety.
The next question will come from Yale Jen with Laidlaw & Company.
I just want to go back to OPK-88006 in terms of MASH. What severity or what level of patients do you initially contemplate; F2 to F4 or any specific F3 or F4 level? Any comments or thoughts on that?
No, we're definitely looking at F2 and F3 to start, as determined by a composite biomarker panel that has been validated and is being used more. Informed by that, we'll decide whether we go to F3-F4, which is where the most unmet need is, and/or include F2 as well. Right now, we need to get fundamental information about behavior of this molecule in both normal volunteers and MASH patients, more favoring F3. Recruitment can be challenging because many studies are ongoing, so we will focus on F2 and F3, which is easier to enroll.
Maybe one more follow-up on the same molecule: over the longer term, would you consider OPK-88006 as a monotherapy, or do you think that could be used in combination with another drug?
That's a great question. It goes to why we picked a GLP-1 glucagon dual agonist. There are competitors and different mechanisms under development, including thyroid hormone beta receptor approaches and FGF21-targeting programs. FGF21 is a validated target. Glucagon is upstream of FGF21, and we've shown that our molecule increases levels of FGF21 triggered by glucagon in addition to the direct effects of glucagon itself. We believe there is synergy within the molecule rather than by combining two separate drugs. We will measure FGF21 levels before and after treatment to demonstrate activation of that pathway, and preclinical studies suggest our drug has significant effect on the FGF21 pathway compared to other GLP-1 glucagon molecules.
Thanks for the answers, and congrats on the progress.
Our next question will come from Michael Petusky with Barrington Research.
On 4Kscore, you have expressed hopes that things could open up with primary care doctors and payer policy advancements. Can you speak to your expectations around any of that impacting the second half, or is that more of a 2027, 2028 story? Can you talk about near-term and longer-term expectations around 4K?
For 4K, we're still pending confirmations from Medicare before actively pursuing broader market opportunities. Reimbursement broadly continues to go well, and there's opportunity for improvement, but until we hear definitively on CMS approvals for changing Medicare requirements, we'll be cautious in the primary care space. We think there's a large opportunity, with double-digit growth potential from volume and reimbursement improvement, and it should be a significant tailwind once that comes through. At this stage, it has not, so we would expect this to be more of a 2027 and beyond impact.
Okay. And on the lab business: the reduction in your estimate for costs and expenses, is a meaningful part of that coming out of the lab? Can you speak to where that reduction is primarily coming from?
It is coming out of the diagnostics business and is mostly tied to the earn-out payment we received from Labcorp on the second closing that happened in May. Beyond that, we have some modest decreases coming, but the majority of the reduction came from the gain offset related to that earn-out.
In addition, we focused on increasing productivity on multiple vectors. One is reduction in headcount: we're now in the low 1,400s; two years ago we were at 3,300. That reduction relates to both efficiency efforts and the divestment of non-core businesses. Second, operationally, we reduced costs by not performing certain esoteric tests that are expensive and not in high demand and partnered with specialists who can deliver them at lower cost. Third, we reorganized our patient service center footprint, resulting in reduced logistical costs. We are also using our resources more efficiently, participating as a lab for clinical trials and monetizing leftover samples for analyses that pharma companies and CROs need for large-scale population data. Those are the vectors we're using in addition to operational efficiencies.
Could I sneak one more quick one in around profit share? It feels like you guys are tracking behind guidance, but you maintained guidance. I'm curious about the level of visibility and confidence for the full year expectation.
NGENLA performance for the first half of the year was within guidance, and we feel the full year guidance remains intact. Each year the gross profit share resets on January 1, and as the year progresses, the percentages and amounts increase depending on NGENLA's share compared to GENOTROPIN and the growth of the overall franchise. The cyclical nature of that weighs on the second half each year. We're pleased with Pfizer's progress and feel the gross profit share is on track to the first half guide, and we expect the full year to come in within the $34 million to $37 million guide.
Our next question will come from Yi Chen with H.C. Wainwright & Company.
I noticed core diagnostic revenue had a small drop from Q2 '25 to Q2 '26, and your guidance for full year 2026 service revenue had a small drop compared to guidance given during the first quarter. Can you give us additional color as to whether the diagnostic performance is meeting your expectations?
A couple of things drove the change. It was primarily driven by a few lines of business that are taking a little longer to mature; when we looked at the first half of the year and the mix coming through the core business, those new revenue verticals were taking more time than expected. They're not significant revenue drivers in 2026 but did cause a slight adjustment down. 4K is also slightly behind our expectations as we had expected some positive movement on the Novitas decision that hasn't come through yet. On the pharmaceutical side, we increased the product revenue guide: RAYALDEE is ahead of expectations and operations in Spain, Mexico and Chile remain strong with improvements expected in our CDMO business in Ireland. Those are the main drivers behind the movements in the guide.
Regarding OPK8801001, you mentioned it showed 20-fold greater growth hormone receptor antagonism. Does that translate to lower dosing frequency or better tolerability, and how does that affect your clinical development strategy?
Yes. That's our aim. Current antagonists are given daily by injection. This molecule is designed to be once weekly. Based on the data presented, it appears to be more efficacious, and we believe once-weekly dosing will be an advantage. We expect it to offer a more convenient therapy with potentially fewer safety issues compared to daily injection therapy, and we have significant hope for this product.
This will conclude our question-and-answer session. I would like to turn the conference back over to Dr. Phillip Frost for any closing remarks. Please go ahead.
Thanks for your questions, and above all, thanks for your interest in OPKO. We look forward to speaking with you again at the end of the third quarter. Have a good evening.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.