5/7/2026

speaker
Operator
Operator

Hello and welcome to the GenMAP's first quarter 2026 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GenMAP is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that GenMap may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on GenMap going forward. Please refer to our website for more information on GenMap and our privacy policy. I would like to hand the conference over to our first speaker today, Jan van der Winkel. Please go ahead.

speaker
Jan van der Winkel
Chief Executive Officer

Hello, and welcome to our financial results call for the first quarter of 2026. With me today is our Chief Financial Officer, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tai Yamadi, and our Chief Development Officer, Judith Klimowski. As noted, we will be making forward-looking statements, so please keep that in mind. Let's move to the first quarter highlights. In Q1, 2026, we continue to deliver strong financial performance and make focused progress against our strategic priorities. We grew total revenue by 25%, reflecting continued momentum across our portfolio. And importantly, we continue to invest with discipline in our medicines, in our pipeline, and in our future growth, fully aligned with our capital allocation priorities. Even with these strategic investments, we grew operating profits. The quarter was also marked by progress in our mission to bring innovative medicines to patients. There are a few highlights I would like to mention. At Kinley-Courtain, to build positive momentum, we were very pleased to see the hospitalization recommendation removed from the third-line plus relapsed or refractory diffused large B-cell lymphoma label, and we are on track with the integration of mirrors. And we are approaching this with the same focus and discipline that we brought to Profound Bio. Finally, the breadth, depth, and potential of RINA-S continues to increase. The data we presented at STO in April further supported the promise of RINA-S, including in combination with the standard of care therapies such as Bevacizumab. We are also making significant progress with our development plan, as you can see on the next slide. We anticipate starting two new Phase III trials for RNA-S in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers. These include a Phase III chemoreplacement trial in platinum-sensitive ovarian cancer, and the first frontline trial for RNA-S in endometrial cancer. And we continue to explore new opportunities for RNA-S outside gynecological oncology with a phase two trial seeking, with a phase two signal-seeking basket trial in advanced gastrointestinal cancers. Finally, I'm pleased to share an update on the ongoing phase three trial in second-line plus platinum-resistant ovarian cancer on the next slide. Because recruitment has been much faster than expected, the Phase III RAINFALL-02 trial has now completed enrollment. This important milestone brings forward the pivotal Phase III data for ARENA-S in platinum-resistant cancer into 2026. This reflects strong investigator engagement, the significant unmet medical needs in this and the strength of our execution on one of our highest priority late-stage programs. So we can now look forward to two data sets in the second half of this year for reNA-S in platinum-resistant ovarian cancer, and the opportunity for broader global regulatory filings earlier than anticipated. For both p2-centimab and epkinley, we are maintaining our guidance on the timing of data, as you see here. So the key takeaway is that 2026 continues to be a very catalyst-rich year for GenMob, with readouts that have the potential to support important launches in 2027 to bring our antibody medicines to many more patients. With that, I'm very pleased to hand you over to Brad for a review of the recent commercial performance for our Kinley and TIFTAC. Brad.

speaker
Brad Bailey
Chief Commercial Officer

Thanks, Jan. Our proprietary portfolio is off to a strong start here in 2026. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Momentum for TIBDAC and Deb Kinley reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake, and ultimately reach more patients. This performance, combined with our work this year to advance our portfolio, and expand our footprint to reach patients in more markets, positions as well to deliver on our growth ambitions in 2026 and beyond. In the quarter, Epkinley continued to gain notable traction as the only bispecific approved in DOBCL and FL indications. Looking globally, Epkinley grew 52% year-over-year, reaching $137 million in sales. In the U.S., Epkinley continued to expand across both academic and community settings, and this growth reinforces Epkinley's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems. The recent approval of fixed duration Epkinley plus R-square and Second Line FL has been a growth driver for the brand and contributed positively to Epkinley's growth in the quarter. The recent approval of In the quarter, we're seeing physicians increasingly use this chemo-free combination in academic and community sites, supported by unprecedented data demonstrating powerful efficacy and proven safety with seamless subcutaneous administration. Looking ahead, we expect adoption in the community to continue to expand across both FL and the OBCL, bringing up Kenley-based therapies closer to where patients live. And in March, the FDA revised the label for epikinley and third-line plus VOBCL to remove the recommendation for 24-hour hospitalization following the first full dose. Now the label advises physicians to assess whether outpatient monitoring for hospitalization is appropriate following the first full dose. We do expect this will further broaden use in the community and in the outpatient setting. Beyond the U.S., performance remains strong. In Japan, Epkinley continues to stand out as the only bispecific approved in both third-line plus LBCL and FL with continued year-over-year growth. The FL launch is building positively on the brand's success in large B-cell lymphoma, supported by strong field execution and ongoing site activation. In other markets, through our partner AbbVie, Epkinley continues to grow with approvals in more than 65 countries, which most have dual indications. For the remainder of 2026, we're focused on maximizing our first mover advantage in second line FL in the US, while preparing for expected approvals in this setting in Europe and Japan later this year, and in early lines of DLBCL in the future. As we look ahead, our priority is to accelerate development, including in combination and across early lines of therapy, to continue to build on the already strong clinical data demonstrating Epkinley's versatility, and ultimately, established at McKinley as the core therapy in B-cell malignancies. Turning now to TIBDAC, which is the global standard of care in recurrent or metastatic cervical cancer. TIBDAC grew 18% year-over-year, reaching $39 million in sales in the quarter. This reflects both the significant need for therapies that improve survival for women with advanced cervical cancer and our ability to effectively scale commercialization across markets. In the U.S., the brand delivered steady performance and continues to lead the market, a position that has held since launch nearly five years ago. Outside the U.S., we're seeing encouraging progress in newer launch markets. In both Japan and Europe, where we lead commercialization directly, growth is being driven by strong field execution and expanding site activation. We also made meaningful progress expanding patient access this quarter. In the U.K., TIPDAC launched in February through private prescribing and payer channels, and we're actively engaging NICE and SMC to secure broader availability. At the same time, building upon our work in the UK and our established presence in Germany, we're actively preparing for additional launches, with infrastructure and teams being established across key European markets, including France, Italy, and Spain. Given the significant unmet need in advanced cervical cancer, we look forward to the impact TIBDAC can make for more patients as additional markets gain approval and reimbursement. And more broadly, we're building a strong, scalable presence in gynecologic oncology with a meaningful opportunity to expand our impact over time, particularly with RHNA-S in the future. To wrap up, our Q1 performance positions us well to sustain momentum in 2026. With continued performance and expanding portfolio, we're well positioned to successfully evolve our business and grow through the decade, supported by the strength of our science, including three potential blockbuster assets with F. kinley, RHNA-S, and ptosimptomab, and our proven ability to scale commercialization and successfully launch in markets where we can drive the greatest impact for patients. Overall, we're very pleased with the start to the year and expect 2026 to be another strong year for GemMap.

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