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The call conveyed a strongly positive commercial and clinical momentum: a landmark FDA approval in FSGS, record demand and an 88% YoY increase in FILSPARI sales, encouraging pipeline progress (HARMONY restart with 2027 readout expectation), and improved non-GAAP profitability. Offsetting these positives are significant near-term cost increases (R&D and SG&A), higher royalty expense due to accounting changes, a continuing GAAP net loss, and some short-term revenue recognition/timing headwinds and education needs with physicians and payers. Overall, the positives (major approval, large sales growth, record demand, and clear runway to advance the pipeline) outweigh the near-term financial and operational challenges.
Management guided to continued strong demand for FILSPARI and a faster, larger FSGS launch, citing 993 new patient start forms in Q1, ~88% year‑over‑year FILSPARI growth to $105.2M (total U.S. net product sales $124.5M; total revenue $127.2M), and established payer access (~97% pathway to access); they estimate >100,000 U.S. patients eligible across IgA nephropathy and FSGS (>30,000 FSGS patients) and a ~$3 billion potential peak sales opportunity. They reiterated near‑term commercial and R&D investment plans (Q1 R&D $57.1M / non‑GAAP $51.5M; SG&A $80.3M / non‑GAAP $69.3M; royalty expense $24.8M), reported Q1 net loss $37.1M ($0.40/share) versus prior $41.2M ($0.47), non‑GAAP net income $4.1M ($0.05), and a balance sheet with cash, equivalents, marketable securities and receivables of ~ $352M (cash ~$264.7M). For the pipeline, they dosed the first new patient in Phase III HARMONY (pegtibatinase) with top‑line results expected in 2027, cited a 67.1% mean tHcy reduction at 2.5 mg/kg in COMPOSE and maintenance <100 µmol, and noted DUPLEX/PROTECT data (proteinuria ~1.5 g/g at DUPLEX end; complete remission <0.3 g/g in PROTECT linked to eGFR decline <1 mL/min/yr) supporting their outlook.
FILSPARI received full FDA approval for FSGS (April 13), becoming the first and only approved medicine for this rare disease; company estimates >30,000 U.S. patients currently eligible in FSGS and >100,000 total U.S. patients eligible across IgA nephropathy and FSGS, supporting a modeled ~$3 billion potential peak sales opportunity.
Record commercial demand with 993 new patient start forms in Q1 and U.S. FILSPARI net product sales of $105.2 million, an ~88% year-over-year increase despite typical Q1 insurance resets, gross-to-net dynamics, and fewer revenue shipping weeks.
Total U.S. net product sales were $124.5 million and total revenue was $127.2 million in Q1 2026; Thiola/Thiola EC contributed $19.3 million and licensing/collaboration revenue was $2.7 million.
On a non-GAAP adjusted basis the company reported net income of $4.1 million, or $0.05 per share, versus a non-GAAP net loss of $16.9 million (−$0.19) in Q1 2025 — a material improvement in underlying profitability.
Dosed the first new patient in the pivotal Phase III HARMONY study of pegtibatinase for classical homocystinuria after enrollment restart; top-line HARMONY results are expected in 2027 and the program targets an estimated 7,000–10,000 addressable HCU patients globally.
New publications and data (CJASN, PROTECT) reinforce FILSPARI’s efficacy: PROTECT showed patients reaching proteinuria <0.3 g/g had eGFR decline <1 mL/min/yr; DUPLEX data showed sustained proteinuria reductions to ~1.5 g/g and CJASN publication demonstrated consistent efficacy/safety in genetic FSGS. These data support strong physician adoption and persistence.
As of March 31, 2026 the company reported cash, cash equivalents, marketable securities and receivables of ~ $352 million (cash balance reported ~$264.7M with a $25M Mirum milestone received in April), supporting near-term operations and pipeline investment.
Hello, and welcome to Travere Therapeutics, Inc.’s first quarter 2026 financial results conference call. Today’s call is being recorded. At this time, I would like to turn the conference call over to Nivi Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.
Thank you, Operator. Good afternoon, and welcome to Travere Therapeutics, Inc.’s first quarter 2026 financial results and corporate update call. Thank you all for joining. Today’s call will be led by Eric M. Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Jula Inrig, our Chief Medical Officer, Peter Heerma, our Chief Commercial Officer, and Christopher Cline, our Chief Financial Officer. William E. Rote, our Chief Research Officer, will join us for the Q&A.
Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statements. Please see the forward-looking statement disclaimer on the company’s press release issued earlier today, as well as the Risk Factors section in our Forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the da...