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    HRMY
    Earnings call· Jun 2026(Q2 FY26)

    Harmony Biosciences Holdings Q2 FY26 earnings call HRMY

    Aug 4, 2026 Source

    Executive summary

    Harmony Biosciences Q2 FY26 — Record WAKIX Revenue and Promising BP-205 Phase I Data

    Harmony Biosciences reported a defining quarter with record WAKIX revenue, firmly on track to exceed $1 billion for the year, driven by strong patient additions. The company also unveiled encouraging Phase I data for its potential best-in-class orexin-2 agonist, BP-205, with multiple data catalysts expected over the next six months. Harmony maintains a strong balance sheet and is actively pursuing strategic business development opportunities while protecting its pitolisant franchise IP.

    Highlights

    5

    • WAKIX delivered record quarterly net revenue of $261.3 million, up 30% year-over-year and 21% quarter-over-quarter.

    • Reiterated full-year 2026 guidance for WAKIX net revenue of $1 billion to $1.04 billion.

    • BP-205 Phase I SAD study showed a predictable PK profile with potential for once-daily dosing and a favorable safety/tolerability profile, reinforcing its potential as a best-in-class orexin-2 agonist.

    • WAKIX achieved estimated average patients of 8,950, an increase of approximately 450 patients from Q1, the highest Q2 increase in brand history.

    • Ended the quarter with $962.5 million in cash, cash equivalents, and investments, providing significant capacity for strategic business development.

    Concerns

    2

    • Cost of product sold increased to 24.2% of net revenue, up from 19% a year ago, primarily due to new royalties from the Novitium license agreement.

    • Delay in TEMPO study (Prader-Willi syndrome) top-line data to mid-2027 due to limited patient prevalence and specific enrollment criteria.

    Guidance & targets

    13
    CategoryTargetConfidence
    WAKIX Net Revenue
    $1.0 billion to $1.04 billion
    high materiality
    High
    Pitolisant GR PDUFA Date
    April 1, 2027
    medium materiality
    High
    Pitolisant HD Top-line Data (ONSTRIDE 1 & 2)
    2027
    medium materiality
    High
    Pitolisant HD Anticipated PDUFA
    2028
    medium materiality
    High
    TEMPO Study Top-line Data (Prader-Willi syndrome)
    mid-2027
    medium materiality
    Medium
    EPX-100 Top-line Data (ARGUS & LIGHTHOUSE)
    mid-2027
    medium materiality
    High
    EPX-100 Anticipated PDUFA
    2028
    medium materiality
    High
    BP-205 Multiple Ascending Dose (MAD) Data Disclosure
    Q4
    high materiality
    High
    BP-205 Phase Ib Study Initiation
    Q3
    high materiality
    High
    BP-205 Phase Ib Study Top-line Data
    early next year
    high materiality
    High
    BP-205 Phase II Trials Initiation
    mid-2027
    high materiality
    High
    WAKIX Exclusivity
    March 2030
    high materiality
    High
    Pitolisant Franchise Extension
    into the 2040s
    medium materiality
    Medium

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    WAKIX (Pitolisant)
    Record quarterly net revenue driven by strong patient additions and differentiated profile as the only non-scheduled treatment for narcolepsy. Field team expansions and improved reimbursement support contributed to performance.
    Estimated average patients: 8,950Patient additions (QoQ): 450CAGR (last 5 years): 40%Payer coverage: >80% of livesNarcolepsy market penetration: ~20%
    		$261.3 million30%21%—

    Operational metrics

    17
    Cash, cash equivalents and investments
    $962.5 million
    Q2 FY26

    Balance sheet position at the end of the quarter.

    Debt
    $155 million
    Q2 FY26

    Total debt at the end of the quarter.

    Cost of product sold as % of net revenue
    24.2%vs 19% in prior year quarter
    Q2 FY26

    Year-over-year increase primarily driven by new royalties related to the Novitium license agreement.

    Total operating expenses
    $108.8 millionvs $114.2 million in prior year quarter
    Q2 FY26

    Decline primarily driven by a $15 million upfront fee paid to CiRC in Q2 2025 with no corresponding amount in the current year period, partially offset by investments in R&D and WAKIX commercialization.

    Net income
    $75.4 millionvs $39.8 million in prior year quarter
    Q2 FY26

    Reported net income for the quarter.

    Diluted EPS
    $1.28vs $0.68 in prior year quarter
    Q2 FY26

    Reported diluted earnings per share for the quarter.

    Narcolepsy diagnosed patients
    80,000
    Current

    Estimated number of diagnosed narcolepsy patients.

    Narcolepsy undiagnosed individuals
    90,000 to 100,000
    Current

    Estimated number of undiagnosed narcolepsy individuals.

    Total narcolepsy population
    170,000
    Current

    Approximate total narcolepsy population, including diagnosed and undiagnosed.

    Field team expansion
    20%
    Q2 FY26

    Largest expansion and increase in investment in the brand's history; all physicians hired, trained, and deployed.

    BP-205 Half-life
    25 hours
    Phase I SAD study

    Mean half-life observed across dose groups, supporting once-daily dosing.

    BP-205 Tmax
    30 to 75 minutes
    Phase I SAD study

    Rapid absorption observed, pointing to potential for rapid onset of efficacy.

    BP-205 Selectivity (orexin-2 vs orexin-1)
    >600-fold
    Preclinical

    Selectivity for orexin-2 receptors over orexin-1 receptors.

    BP-205 Selectivity (over other receptors)
    >1,000-fold
    Preclinical

    Selectivity over 100 other receptors of interest.

    BP-205 Potency (EC50 orexin-2)
    0.015 nanomolar
    Preclinical

    EC50 at orexin-2 receptor.

    BP-205 Potency (EC50 orexin-1)
    9.01 nanomolar
    Preclinical

    EC50 at orexin-1 receptor.

    BP-205 Margin over orexin-1 at max predicted efficacy dose
    140-fold
    Preclinical

    Predicted margin over orexin-1 receptor at the maximum predicted efficacy dose in humans.

    Industry KPIs

    2
    MetricValueDetails
    EPS revenue guidanceFY26 Net Revenue: $1.0B - $1.04B; FY26 Diluted EPS: Not statedUSD
    Business development capacity deal appetite$963 millionUSD

    Deals & partnerships

    2
    NovitiumLicense agreement for amorphous form of pitolisant

    Supported by an issued patent through 2042. Current efforts are directed towards formulation optimization and ongoing Phase I PK study.

    CiRCUpfront fee payment$15 million

    Upfront fee paid in Q2 2025.

    Risks & headwinds

    3
    Increased cost of product soldQ2 FY26

    24.2% of net revenue in Q2 FY26, up from 19% in prior year quarter.

    Mitigation: Primarily driven by new royalties related to the Novitium license agreement.

    Delay in TEMPO study (Prader-Willi syndrome) top-line dataMid-2027

    Top-line data expected mid-2027 (delayed from prior expectation).

    Mitigation: Due to limited prevalence of PWS patients and specific sleepiness criteria for enrollment. Study designed with FDA input to meet registrational requirements and secure pediatric exclusivity for WAKIX.

    WAKIX IP litigation with AETOngoing, with key event in Q4 FY26

    Bench trial concluded, post-trial briefs public. Closing arguments scheduled for October 22, 2026.

    Mitigation: Harmony is confident in prevailing in both active legal proceedings to maintain exclusivity for WAKIX into March 2030. Also filed a new patent infringement lawsuit against AET Pharma US and Sandoz covering an amorphous form of pitolisant hydrochloride.

    What to watch in Q3 FY26

    4

    BP-205 Multiple Ascending Dose (MAD) data

    Q4 FY26
    CurrentData analysis ongoing
    TargetDisclosure of full data, including target engagement AEs (insomnia, polyuria) and their characteristics.

    Why it matters

    Provides further insight into BP-205's safety, tolerability, and on-target effects, crucial for assessing its best-in-class potential.

    Multiple ascending dose study data analysis is ongoing, and we plan to disclose those data in Q4.

    Q&A highlights

    6

    How do BP-205's short Tmax, long half-life, and high potency translate into a differentiated clinical profile for efficacy and safety, especially compared to BID/split-dose orexin-2 agonists, and its impact on broader CNS indications?

    Kumar Budur explained that short Tmax (30-75 min) suggests rapid onset of efficacy, beneficial for hypersomnolence and ADHD. Long half-life (approx. 25 hours) supports once-daily dosing and sustained wakefulness. High potency allows for low doses across CNS indications. Jeffrey Dayno added that neuropsych drugs with QD dosing typically have 15-25 hour half-lives, similar to WAKIX.

    “The time to maximum concentration was very short, 30 to 75 minutes. And this is a very desirable feature because it results in rapid onset of efficacy.”

    asked by Pete Stavropoulos · answered by Kumar Budur

    2 min read5 chapters

    Detailed Narrative

    01

    WAKIX Commercial Performance

    WAKIX achieved record quarterly net revenue of $261.3 million, representing a 30% year-over-year and 21% quarter-over-quarter increase, keeping the company on track to exceed $1 billion in net revenue for FY26. This strong performance was supported by an estimated 450 new patient additions, bringing the average patient count to 8,950, marking the second-highest quarterly increase in the brand's history. Management attributed this success to WAKIX's differentiated non-scheduled treatment option, broad payer coverage (over 80% of lives), and recent strategic investments in field sales, remote sales, and reimbursement support.

    02

    BP-205 Orexin-2 Agonist Development

    Harmony Biosciences reported encouraging Phase I single ascending dose (SAD) data for BP-205, its potential best-in-class orexin-2 agonist. The study demonstrated a predictable pharmacokinetic (PK) profile with rapid absorption (Tmax 30-75 minutes) and a mean half-life of approximately 25 hours, supporting once-daily dosing. BP-205 also showed a favorable safety and tolerability profile with no serious adverse events. The company expects to disclose multiple ascending dose (MAD) data in Q4 2026 and initiate a Phase Ib study in sleep-deprived healthy volunteers in Q3 2026, with top-line data anticipated in early 2027, providing the first efficacy signals.

    03

    Next-Generation Pitolisant Programs

    The company continues to advance its next-generation pitolisant programs. The pitolisant GR New Drug Application (NDA) was submitted in Q2 2026 and accepted for full review, with a target PDUFA date of April 1, 2027. Pitolisant GR is designed to reduce gastrointestinal adverse events and allow for immediate therapeutic dosing without titration. Additionally, pitolisant HD, an optimized high-dose formulation, is progressing in two Phase III registrational trials (ONSTRIDE 1 for narcolepsy and ONSTRIDE 2 for idiopathic hypersomnia), with top-line data expected in 2027 and anticipated PDUFA in 2028, targeting differentiated labels for fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia.

    04

    Broader Pipeline and IP Strategy

    Harmony's broader pipeline includes the TEMPO study for Prader-Willi syndrome, which now expects top-line data in mid-2027 due to recruitment challenges, though it remains on track to secure pediatric exclusivity for WAKIX. The epilepsy franchise's EPX-100 is in two global Phase III trials (ARGUS for Dravet syndrome and LIGHTHOUSE for Lennox-Gastaut syndrome), with top-line data expected in mid-2027 and anticipated PDUFA in 2028. The company also emphasized its multilayered IP strategy, which supports WAKIX exclusivity until March 2030, with potential extensions for new pitolisant formulations into the 2040s.

    05

    Business Development and Financial Strength

    Harmony Biosciences ended the second quarter with a strong financial position, holding approximately $962.5 million in cash, cash equivalents, and investments. This capital provides significant capacity for strategic business development, with the company prioritizing assets in Phase III, in registration, or already on the market, with revenue potential in the 2028-2032 timeframe. The focus areas include Sleep/Wake, epilepsy, rare orphan CNS, and broader CNS indications, with a strategy to engage in multiple transactions rather than a single large acquisition.

    AI-generated summary of the company’s earnings call. Not investment advice.