Adam Logal
Analyst · Ladenburg
Thank you, Elias, and good afternoon, everyone. As both Phil and Elias mentioned, the LabCorp agreement was announced on October 15 and is a defining step for OPKO. I'll start with the deal terms, then explain what it means for how we report our results and then turn to the quarter. The LabCorp will acquire select assets of BioReference for approximately $722 million in cash at closing. That cash is subject to an adjustment based on the revenue of the business leading up to closing. And OPKO is eligible to receive royalty payments of up to $150 million based on 4Kscore revenue over the next 10 years. The assets include our clinical and women's health testing, urology and corrections businesses as well as more than 80 patient service centers and finally, our FDA-approved 4Kscore test. As Elias mentioned, closing is subject to regulatory approvals and customary closing conditions. For shareholders, this does 2 things. It completes the repositioning of OPKO that we began in 2022 when we sold GeneDx and acquired ModeX, leaving a focused company built around our Global Products and Innovative Biotech. It provides substantial capital to fund the pipeline Elias just walked us through, and it also changes how we present our numbers. So let me cover that first. On September 30, our Board approved a plan to sell substantially all of our remaining BioReference operations to LabCorp. And as a result, BioReference is now classified as a held-for-sale asset and is presented as discontinued operations for all periods with all prior periods being recast. In practical terms, the results I'll walk through today reflect only the business OPKO will keep after closing. We now report those continuing operations through 2 segments: Global Products and Innovative Biotech, with unallocated corporate costs shown separately. This matches how our executive team evaluates performance, allocates resources and manages the business. Global Products include our commercial pharmaceutical operations, OPKO Iberia America, our pharmaceutical businesses in Spain, Chile and Mexico; Eirgen, our specialty manufacturing business in Ireland and Rayaldee. Our Innovative Biotech segment includes our intellectual property assets, royalty interest, strategic collaborations and development programs, including ModeX, NGENLA, Economics and our biologics platform. Until the transaction closes, BioReference will continue to operate as usual and will report its results in discontinued operations each quarter. So turning to the quarter. Revenue from continuing operations grew 16% in the third quarter compared with the third quarter of 2025. Both product revenue and licensing, collaboration and other revenue came in ahead of our expectations, led by OPKO Iberia America, Rayaldee and our Mazdutide royalties. We have also strengthened our balance sheet with $125 million of nondilutive financing from Healthcare Royalty while continuing to repurchase shares of our common stock. Consolidated revenue was $65.4 million for the third quarter of 2026 compared with $56.4 million in the third quarter of 2025. Our Global Product segment generated a total revenue of $48.4 million in the third quarter of 2026, with product revenue growing 11% to $41.8 million, led by OPKO Iberia America and the continued growth of Rayaldee. Licensing, collaboration and other revenue of $6.6 million was driven by $5.8 million of Mazdutide royalties from Lilly through Innovent's commercialization of Mazdutide in China. Global Products segment costs and expenses were $42.4 million compared with $40.6 million in the prior year quarter, resulting in operating income of $6 million compared with an operating loss of $1.2 million for the third quarter of 2025. Our Innovative Biotech segment generated total revenue of $17 million, all from licensing, collaboration and other revenue, including Pfizer gross profit share of $8.7 million compared to $8.8 million in the third quarter of 2025. In the quarter, gross profit share faced a headwind in the U.S. market where Genotropin had a negative gross to net impact due to the utilization of certain government programs. Pfizer continues to make progress with the global commercialization of NGENLA with meaningful contributions of growth from in the European, Japanese and U.S. regions. Weekly growth hormone therapies continue to gain share as the market moves away from daily injections and NGENLA remains well positioned to benefit from that shift. The segment also included BARDA funding of $7.5 million during Q3 2026 compared with $8.2 million in 2025. The decrease reflects our move from CMC activities in the prior quarter to the clinical phase of the program, which Elias outlined. Our Regeneron collaboration generated revenue of approximately $800,000. Our Innovative Biotech segment costs and expenses were $43.8 million compared with $39.5 million in the prior year quarter, reflecting increased activity in our early-stage clinical programs. Its operating loss was $26.8 million compared with $22.5 million in the third quarter of 2025, with the difference coming from our increased investments in our research and development activities. On a consolidated basis, R&D expense was $32.2 million compared with $29.8 million and depreciation and amortization expense was $18.9 million compared with $18 million in the prior year quarter. Our consolidated operating loss was $31.4 million compared with $33.6 million in the third quarter of 2025. Moving to our balance sheet. We ended the quarter with $403.2 million in cash, cash equivalents and restricted cash, which is more than enough to fund our operations and development plans while we continue to return capital to our shareholders. As I mentioned, in August, we expanded our relationship with Healthcare Royalty Partners by issuing an additional $125 million of secured notes, which are secured by our Mazdutide royalty interest. The notes mature in 2044 and total payments are capped at 1.5x the amount funded. Once the cap is reached, OPKO keeps the future royalty economics, which gives us nondilutive capital today while preserving meaningful long-term upside in the Mazdutide franchise. During the third quarter of 2026, we repurchased approximately 7.2 million shares for $10.6 million with an average price of $1.48 per share, and we have approximately $84.3 million remaining under our current authorization. Now I'll turn to our outlook. And given our exit from Diagnostics and the pending LabCorp transaction, we're withdrawing our consolidated full year guidance for total revenue and costs. After closing, we'd expect to enter into a transition services agreement or TSA with LabCorp to support the transition of the business which we expect to continue for approximately 1 year after closing. And we expect the total costs and expenses related to the sale of BioReference to be approximately $125 million, which will record between the fourth quarter of 2026 and through the completion of the TSA. As the timing of the closing becomes more clear, we'll provide more detail on the expected results of operations for discontinued operations as well as our anticipated gain that is expected upon closing. For the fourth quarter, we expect total revenue from continuing operations of $62 million to $72 million, including product revenue of $41 million to $46 licensing, collaboration and other revenue of $21 million to $27 million, including Pfizer gross profit share of $12.5 million to $15 million; and finally, BARDA funding of approximately $3 million to $5 million. We expect our total costs and expenses from continuing operations to be between $100 million and $105 million, including R&D expense of $32 million to $35 million. Depreciation and amortization expense is expected to be approximately $19 million and our loss from discontinued operations of approximately $40 million or approximately $0.05 per share. This reflects BioReference's operating loss expected during the quarter, employee retention costs and costs related to the anticipation reduction in the useful life of certain assets -- for the full year, we're updating our guidance for continuing operations. Our business has some seasonality, and we expect the fourth quarter to benefit from the improved gross to net on NGENLA. We expect our total revenue from continuing operations for the year to be approximately $268 million to $278 million, including product revenue of $164 million to $169 million. We expect licensing, collaboration and other revenue of $105 million to $110 million, including Pfizer's gross profit share of $34 million to $37 million and total BARDA funding of $20 million to $22 million. We expect full year cost and expenses from continuing operations of $390 million to $395 million, including R&D expense of $125 million to $130 -- we expect depreciation and amortization expense of approximately $75 million. That concludes our prepared remarks. Operator, would you please open the call for questions?