Record Quarterly Product Sales and Strong YoY Growth
Product sales and royalty revenue were $24.3M in Q1 2026, representing a 73% year-over-year increase (Q1 2025 product sales $14.0M). Total revenue for the quarter increased 40% to $24.3M versus $17.3M in Q1 2025.
Raised Full-Year Revenue Guidance
Management raised 2026 revenue guidance to exceed $120M (previous guidance $110M), reflecting stronger-than-expected early 2026 trends across the portfolio and contributions from new launches.
Two Major Product Launches (DESMODA and HEMANGEOL)
Launched DESMODA (first/only FDA‑approved desmopressin oral solution) and HEMANGEOL (only FDA‑approved treatment for infantile hemangiomas). DESMODA launch reception strong with potential peak sales estimated at $30M–$50M; HEMANGEOL expected to meaningfully contribute beginning in Q3 and could be the largest product in 2027.
Profitability and Margin Progress
Adjusted EBITDA was $5.7M (24% of revenue) in Q1 2026 versus $3.7M (21%) a year ago (+$2.0M, ~+54%). Management expects full-year adjusted EBITDA margin >30% and is targeting a 50% adjusted EBITDA margin by 2028.
Gross Profit and Margin Targets
Gross profit rose to $14.7M (+49% YoY from $9.9M). Adjusted gross profit was $16.2M (67% of revenue); company reiterates expectation of at least 70% adjusted gross margin for full-year 2026 and 75%–80% in coming years. HEMANGEOL and DESMODA are expected to have above‑average gross margins.
R&D Pipeline Progress and High‑Value Opportunities
Key R&D milestones: FDA cleared INCRELEX label harmonization study (to start H2 2026) — harmonization could expand the U.S. market ~5x; ET‑700 pilot study initiated with topline in H2 2026 and potential >$100M peak sales; KHINDIVI bioequivalence dosing wrapping up with potential supplemental filing in Q3 2026 and approval in Q2 2027; Amglidia IND filed with NDA planned for Q4 2026 (U.S. launch potential in 2027).
Operational Scalability and Cost Discipline
Revenue grew 73% while GAAP G&A increased only 14% (22% on a non‑GAAP basis). Management highlighted that much of the G&A increase was due to loss of orphan PDUFA exemption fees rather than discretionary spend increases, citing scalability of the rare disease commercialization model.
Solid Cash Generation and Improved Financing Terms
Generated $7.4M cash from operations in Q1, paid $14M for the HEMANGEOL acquisition, and finished the quarter with $19.7M cash on hand. Amended $30M credit facility lowered interest by ~200 bps; management expects cash balance to grow during 2026 and to have capacity for accretive product acquisitions.