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The call conveyed multiple major positive developments: first commercial launch with encouraging early uptake and revenue, EU approval and imminent German launch, positive pivotal Acacia HCM topline results that could expand aficamtin to nonobstructive HCM, and continued pipeline progress and regulatory filings. Offsetting these positives are meaningful launch and operating costs (SG&A up sharply), continued cash burn, incomplete payer access early in launch, and notable safety observations in Acacia HCM (higher incidence of LVEF decline and a small number of serious heart failure events) that will require regulatory and prescriber scrutiny. On balance, the transformative commercial and clinical milestones materially outweigh the near-term financial and safety challenges described on the call.
Cytokinetics maintained full‑year 2026 financial guidance with GAAP combined R&D and SG&A of $830–$870 million (including $120–$130 million of stock‑based compensation; excluding stock‑based comp $700–$750 million), reported approximately $1.1 billion in cash and investments (down ~$144 million in the quarter) and said it will update guidance following Acacia HCM; operational and regulatory timing included a MAPLE HCM PDUFA of 11/14/2026, planned German MYCorzo launch in Q2 2026, potential Health Canada decision in 2H 2026, completion of CEDAR‑HCM adolescent enrollment in Q4 2026, continued COMET‑HS enrollment through 2026, AMBER‑HFpEF cohort‑1 enrollment completion in 2H 2026, and initiation of a second Phase‑1 for CK‑089. The company also reiterated commercial targets and access timelines—Medicare parity expected in Q2, 50% commercial lives by early Q3 and parity by end‑Q4—and highlighted early launch metrics: Q1 net product revenue of $4.8M (~nine weeks), >275 HCPs prescribing in Q1 (>425 through April), ~680 patients prescribed by end‑Q1 (1,100 through April), average 2.4 scripts per HCP (2.6 for high‑volume prescribers), estimated new‑to‑brand Q1 exit share >30%, >1,400 REMS certifications, >2,100 patient community enrollments, >70% of dispensed patients on paid prescriptions with conversion in <2 weeks.
Launched MYCorzo in the U.S. (available to patients Jan 27). Recorded $4.8 million in net product revenue in Q1 (approx. nine weeks of commercial sales); over 70% of dispensed patients on a paid prescription and average conversion to paid in <2 weeks.
By end of Q1 ~275 unique HCPs prescribed MYCorzo (50%+ from high-volume prescribers); through April >425 HCPs prescribing. Average prescriptions per HCP: 2.4 overall / 2.6 for high-volume prescribers. Internal estimate of new-to-brand Q1 exit share >30%. Over 1,400 HCPs REMS-certified and >2,100 enrolled in the patient community; ~680 patients prescribed by end of Q1 rising to ~1,100 through April.
European Commission approved MYCorzo in February; German commercial launch planned in Q2 2026. Six HTA dossiers submitted with five more expected this quarter; MAA submitted to Swissmedic; Canadian decision expected in H2 2026.
Acacia HCM met both dual primary endpoints: KCCQ improvement LS mean difference 3.0 points (11.4 vs 8.4; p=0.021) and peak VO2 LS mean difference 0.67 mL/kg/min (0.64 increase vs -0.03; p=0.003). Statistically significant secondary endpoint improvements (NYHA class, composite ventilatory efficiency/peak VO2, NT-proBNP). No new safety signals identified overall. Company plans regulatory discussions and potential sNDA submission.
sNDA for MAPLE HCM accepted for filing by FDA with PDUFA date 11/14/2026; MAA submitted for oHCM in Switzerland; marketing application under review in Canada; Sanofi partner progressing potential approvals in Hong Kong and Taiwan.
Recorded $11.9 million milestone under the Bayer license agreement tied to first U.S. commercial sale. Collaboration revenue $2.6M in Q1 vs $1.6M in Q1 2025 (+62.5%).
Ongoing global programs: CAMELLIA-HCM (Japan), CEDAR-HCM (pediatric; adolescent cohort enrollment expected complete by end of 2026), COMET-HS enrollment progressing (omicamtiv program), and AMBER-HFpEF cohort 1 enrollment expanded (expect completion in 2H 2026). Afibcamtin received orphan designation in Japan for nHCM and pediatric oHCM.
Maintained full-year 2026 GAAP combined R&D and SG&A guidance of $830M-$870M (excluding stock comp $700M-$750M). Ended Q1 with approximately $1.1 billion in cash and investments.
Thank you for standing by, and welcome to the Cytokinetics, Incorporated Q1 2026 earnings conference call. This call is being recorded, and all participants are in a listen-only mode. There will be no question and answer session after the company's prepared remarks. I would now like to turn the call over to Diane Weiser, Cytokinetics, Incorporated’s Senior Vice President of Corporate Affairs. Please go ahead.
Good afternoon, and thanks for joining us on the call today. Robert I. Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew M. Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYCorzo in the United States and readiness in Europe. Fady Ibraham Malik, EVP of R&D, will address the results from Acacia HCM. Stuart Kupfer, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development programs. Sung H.
Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. And finally, Robert I. Blum will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today’s discussion will include forward-looking statements that are subject to risks and uncertainties. Please refer to our SEC filings for a discussion of these factors. I will now turn the call over to Robert I. Blum.
2026 has been a remarkable period for Cytokinetics, Incorporated and one that I believe reflects the emerging promise of what we have been building here for over 25 years. Most notably, we launched MYCorzo, our first a...