7/28/2026

speaker
Operator
Conference Operator

Greetings and welcome to the Insight Second Quarter 2026 Earnings Conference Call and Webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow a formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad, and we ask you please limit yourselves to one question and then return to the queue. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star 0. It's now my pleasure to turn the call over to Alexis Smith, Vice President, Head of Investor Relations. Please go ahead, Alexis.

speaker
Alexis Smith
Vice President, Head of Investor Relations

Thank you and good morning. Welcome to Insight's second quarter 2026 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of our website to find the press release, related financial tables, and slides that follow today's discussion. On today's call, I'm joined by Bill, Pablo, and Suki, who will deliver our prepared remarks. Steven, Dave, and Mohamed will also be available for Q&A. I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I'll now hand the call over to Bill.

speaker
Bill
Chief Executive Officer

Thank you, Alexis, and good morning everyone. At the start of the year, we laid out a plan to move Insight from an alliance on a cornerstone product to a company with multiple growth drivers. Six months in, This transition is well underway and we've made tangible progress. We've strengthened the core business, delivered key regulatory milestones, de-risked and advanced our pipeline to late stage development, and added a novel phase three hematology asset through business development. Let me expand on each. First, our business continues to perform above expectations. Total net sales growth was driven by increased demand and higher net sales across every product. Jackify remains foundational to the company and delivered another strong quarter. Keeping this product healthy is a strategic priority because it serves as a funding vehicle for the pipeline and new product launches. At the same time, our core business, excluding Jackify, continues to grow and is solidly on track to reach three to four billion dollars in net sales by 2030. Importantly, this growth is not dependent on a single asset, but is supported by multiple products and near term launches. We have the commercial capabilities, resources, infrastructure, and management team required to execute successfully. The opportunity here is not simply the value of each individual product, but our ability to launch and scale multiple products in parallel. This capability will be a key driver of Insight's next phase of growth. Second, we achieved several of the key regulatory milestones we identified at the beginning of the year, including the approval and launch of JackifyXR, as well as the positive CHMP opinion of Opsalura in moderate AD with the final European Commission decision and signature expected in the third quarter. In addition, regulatory reviews for Povacitinib and HS and Monjuvian first-line DLBCL are underway with anticipated approvals and launches through early 2027. Third, we moved multiple assets into late stage development. We launched phase three studies for 989 and second line ET, 734 and PDAC, and 890 and CRC. We also have a catalyst for its second half of the year with 10 data readouts across nearly all assets in our clinical pipeline, including data from our registration trials for Opsalura, NHS, and porvacitinib and PN. As these programs advance, we are gaining greater visibility into the potential shape of our growth profile beyond 2029. We also strengthened our hematology portfolio through business development. The Vega transaction added latarsabart, a potentially transformative treatment for von Willebrand's disease in phase three development, and a potential new growth driver for the company. Latarsabart expands our most important therapeutic franchise, offers an attractive risk-reward profile, and the transaction was structured to preserve balance sheet flexibility. It checked all the boxes we look for in business development and is a textbook example of a type of deal that makes sense for Insight. Taken together, Insight is no longer dependent on one asset, catalyst or blockbuster. We now have a solid core business, a series of near-term launches and a more mature late-stage pipeline supporting multiple avenues for future growth. Operationally, we're a stronger organization than we were a year ago. Our focus right now is execution, turning phase three studies into approvals and approvals into successful launches. Turning to the quarter, total revenue in the second quarter of 26 was $1.67 billion, up 38% year over year. Total net sales in the second quarter were $1.49 billion, representing 40% growth year over year. The increase was driven by continued demand across the portfolio and by a one-time non-cash benefit from the CMS settlement. Excluding this benefit, total net sales increased 17%. This growth was broad-based with every marketed product growing year-over-year in both the U.S. and international markets. Jackify sales in the second quarter were $817 million, up 7% year-over-year. Prescription demand for Jackify increased 9% across all indications, MF, PV, and GVHD. with PV being the largest growth driver. New patient starts remain strong, the prescriber base is stable, and formulary coverage is broad, providing an important foundation for the Jackify XR launch. A few comments on XR. The launch has two parts, coverage and adoption. On coverage, we're on track to achieve our year-end formulary goal of 50 to 70%, supported by recent wins at ESI, CVS, Optum, and more than 10 regional plans. On adoption, we expect physician adoption to build gradually through the remainder of 2026 as coverage expands and physicians gain experience with XR, with acceleration expected throughout 2027. Commercially, XR generated 10 million in sales in the second quarter, which primarily consists of initial inventory build, We expect XR sales to approach $40 to $50 million for the full year, which is captured in our full year Jackify guidance. Sales for our core business, excluding Jackify, were $671 million, up 127% year over year, excluding the one-time Opsalura benefit. Sales grew 44%. This business is becoming an increasingly important part of how we transition Insight through the LOE period and for long-term growth. Opsalor remains the largest contributor of business outside of Jackify, generating $450 million in second quarter sales. This includes $204 million of net product sales and a one-time non-cash benefit of $246 related to our agreement with CMS and the reversal of previously accrued balances associated with the resolution of Medicaid rebate litigation. In the U.S., sales excluding the one-time benefit were $161 million, an increase of 22% versus the second quarter of 2025. Demand here remains strong, with prescriptions increasing 26% year-over-year, which outpaced the overall market, which grew 21%. New patient starts also remain strong, with Opsalura capturing 46% of branded topical NBRX volume, a leading indicator of future growth and business health. The resolution of the CMS matter improves the economics of the business, resulting in a favorable change to our average selling price and gross to net profile. It effectively offsets some of the investment we made to expand and maintain formulary access at the beginning of the year. As a result, prescription growth should translate more efficiently into net sales growth going forward. That said, we continue to view the pricing and reimbursement environment as dynamic, and so maintaining broad access and a disciplined gross to net profile remains a priority. Opsalura is in a stronger position today than it was a year ago. Demand is robust and access is broad. And while we're encouraged by this momentum, this is not a business we can put on autopilot. Sustaining growth will require effective commercial execution and continued focus on the access and pricing dynamics that support growth. Internationally, Opsalura sales were $43 million in the second quarter, up 34% year over year. Growth remains robust in Vitiligo where we see strong demand across markets. We remain on track for potential approval and launch of Opsalura for moderate atopic dermatitis in Europe during the third quarter. We expect modest revenue contribution in 2026 with momentum building through 27 as additional countries launch and reimbursement expands. We continue to view the international expansion of Opsalura as an important long-term growth driver for the franchise with the potential to deliver two to three times the international sales today. Finally, in hematology and oncology, net sales grew 69% to $222 million. Nictimbo, Monjuvi, Zainez were the biggest contributors to growth in the quarter. Nictimbo net sales were 60 million in the second quarter of 26, representing a 67% increase versus the prior year. The performance was entirely volume growth based. More than 300 new patients initiating therapy during the quarter, and more than 1,200 patients treated. We currently hold approximately one third of the third line plus market. Monjuvi net sales were 54 million in the second quarter, up 72% year over year. Growth was primarily driven by uptake in follicular lymphoma in international markets, including the recent approval and launch in Japan in the second quarter. Monjuvi is expected to have three sources of growth, relapse refractory, DLBCL, follicular lymphoma and potentially Firstline DLBCL. We expect the existing indications to remain incremental contributors while Firstline DLBCL has the potential to become the largest growth driver for the franchise over time. Finally, Zyna's net sales were 50 million in the second quarter, a four times increase year over year with rapid and robust adoption in SEAC across markets. In the U.S., Zyna is becoming the leading prescribed regimen with over a 40% share in Firstline SEAC in just 12 months post-launch. Now I'll turn the call over to Pablo.

Disclaimer

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