Harmony Biosciences Q4 Earnings Call Highlights

4 weeks ago 2

MarketBeat

Tue, February 24, 2026 astatine 10:47 AM CST 8 min read

Harmony Biosciences logo

Harmony Biosciences logo
  • Harmony reported beardown WAKIX momentum with Q4 nett merchandise gross of $243.8 million, full-year WAKIX income of $868.5 million, astir 8,500 mean patients, and reiterated guidance of $1.0 billion–$1.04 billion successful WAKIX nett gross for 2026 (blockbuster status).

  • The institution has settled with six of 7 ANDA filers and said generic introduction would hap nary sooner than March 2030 if pediatric exclusivity is granted (otherwise September 2029), with a tribunal enactment successful spot done February 2027.

  • Harmony is advancing lifecycle and pipeline programs—pitolisant GR NDA connected way for Q2 2026 (PDUFA Q1 2027), pitolisant HD top-line information expected successful 2027 (potential PDUFA 2028), and EPX-100 Phase 3 epilepsy readouts expected H1 2027—supported by a currency presumption of $882.5 million.

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Harmony Biosciences (NASDAQ:HRMY) reported fourth-quarter and full-year 2025 results highlighting continued maturation for WAKIX and an expanding late-stage cardinal tense strategy (CNS) pipeline. Management said sustained request for WAKIX, caller pediatric statement expansion, and ongoing lifecycle initiatives presumption the institution to scope “blockbuster” gross successful 2026, portion currency procreation is backing a wide acceptable of Phase 3 programs and concern improvement efforts.

CEO Dr. Jeffrey Dayno said Harmony delivered $243.8 million successful fourth-quarter nett merchandise revenue, up from $201.3 million successful the prior-year period, driven by “continued beardown demand” for WAKIX. Management noted the 4th marked the third consecutive quarter with astir 400-plus mean diligent adds, bringing the franchise to astir 8,500 mean patients connected WAKIX.

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For the afloat year, Harmony reported $868.5 million successful WAKIX nett merchandise revenue, which absorption said represented beardown year-over-year maturation and extended the company’s tally to six consecutive years of gross maturation and profitability.

Looking ahead, the institution reiterated guidance for 2026 WAKIX nett gross of $1.0 cardinal to $1.04 billion, which absorption characterized arsenic achieving blockbuster presumption for the archetypal clip successful franchise history. CFO Sandeep Kapadia cautioned that first-quarter 2026 gross is expected to amusement emblematic manufacture seasonality, including higher gross-to-net deductions tied to security resets and higher copay obligations, on with imaginable commercialized inventory drawdowns.

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