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1. Company Snapshot

1.a. Company Description

Harmony Biosciences Holdings, Inc., a commercial-stage pharmaceutical company, develops and commercializes therapies for patients with rare neurological disorders in the United States.Its product, WAKIX is a medication for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.The company was formerly known as Harmony Biosciences II, Inc.


and changed its name to Harmony Biosciences Holdings, Inc.in February 2020.Harmony Biosciences Holdings, Inc.


was incorporated in 2017 and is based in Plymouth Meeting, Pennsylvania.

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1.b. Last Insights on HRMY

Harmony Biosciences Holdings, Inc.'s recent performance was negatively impacted by its Q2 earnings miss, with quarterly earnings of $0.68 per share, falling short of the Zacks Consensus Estimate of $0.78 per share. The company's revenue growth, although 16% year-over-year, was not enough to offset concerns. Additionally, the company's upcoming topline data from its phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome, expected in Q3 2025, has not yet been released, creating uncertainty. (Source: Zacks)

1.c. Company Highlights

2. Harmony Biosciences' Q3 2025 Earnings: A Strong Performance

Harmony Biosciences reported a robust financial performance in Q3 2025, with net revenues reaching $239.5 million, representing a 29% year-over-year growth. The company's earnings per share (EPS) came in at $0.87, slightly below analyst estimates of $0.92. The strong revenue growth was driven by the continued adoption of WAKIX, with an average of 500 patients added during the quarter, resulting in an average of 8,100 patients on WAKIX at the end of Q3. The company's gross margin was not explicitly stated, but the reported net income growth suggests a solid profitability.

Publication Date: Nov -18

📋 Highlights
  • Revenue Growth:: Q3 net revenue reached $239.5 million, up 29% YoY, with full-year guidance raised to $845–$865 million (from prior $820–$860 million).
  • WAKIX Patient Adds:: Achieved 500 average quarterly patient adds, totaling 8,100 patients on therapy, with expectations to reach ~10,000 patients by year-end.
  • Balance Sheet Strength:: Generated $106 million in cash flow, ending Q3 with $778 million in cash, supporting pipeline investments and commercial expansion.
  • Pipeline Catalysts:: 3 Phase III trials ongoing, with 5 expected by year-end, including pitolisant HD/GR formulations and EPX-100 for Dravet and Lennox-Gastaut syndromes.
  • Commercial Momentum:: WAKIX driven by 45% NT1 and 55% NT2 patient mix, with 500 new prescribers added in Q3, fueling 30% YoY growth in its sixth year on market.

Revenue Growth and Guidance

The company's revenue growth is expected to continue, with analysts estimating a 16.0% revenue growth for the next year. Harmony Biosciences has raised its net revenue guidance for the year to $845 million to $865 million, up from the previous guidance of $820 million to $860 million. The company's commercial team has been driving the strong momentum in WAKIX, with adjustments to field sales deployment, call plans, and messaging, as well as securing new payer coverage wins and improving patient support.

Valuation Metrics

To understand what's priced into Harmony Biosciences' stock, we can look at some valuation metrics. The company's Price-to-Sales (P/S) Ratio is 2.53, and the EV/EBITDA ratio is 5.97. These metrics suggest that the stock is trading at a premium, but still within reasonable bounds given the company's growth prospects. The Return on Equity (ROE) is 26.32%, indicating a strong profitability. With a strong balance sheet and a growing cash balance, the company is well-positioned to invest in its pipeline and drive future growth.

Pipeline Progress

Harmony Biosciences is making progress in its pipeline, with multiple Phase III registrational studies ongoing and anticipating up to 5 Phase III registrational studies in 5 distinct indications by the end of the year. The company is also advancing its orexin-2 agonist program, with plans to initiate a Phase I study this quarter. The company's focus on rare CNS disorders and its commitment to using its strong commercial engine to drive growth and value creation are positives for investors.

Outlook

3. NewsRoom

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Harmony Biosciences to Present New Open-Label Extension Data from Phase 3 ARGUS Trial at the 2025 American Epilepsy Society Annual Meeting

Dec -02

Source: businesswire.com

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Boston Partners Takes $19.40 Million Position in Harmony Biosciences Holdings, Inc. $HRMY

Nov -29

Source: defenseworld.net

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Harmony Biosciences Holdings, Inc. $HRMY Shares Bought by American Century Companies Inc.

Nov -29

Source: defenseworld.net

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Harmony Biosciences Announces Positive Results From the Pivotal Bioequivalence Study for Pitolisant Gastro-Resistant Formulation

Nov -24

Source: businesswire.com

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Envestnet Asset Management Inc. Sells 15,944 Shares of Harmony Biosciences Holdings, Inc. $HRMY

Nov -21

Source: defenseworld.net

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Harmony Biosciences Announces Initiation of First-In-Human Study With Potential Best-In-Class Orexin 2 Receptor Agonist (BP1.15205) for Central Disorders of Hypersomnolence

Nov -19

Source: businesswire.com

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Harmony Biosciences Holdings, Inc. (HRMY) Q3 2025 Earnings Call Transcript

Nov -04

Source: seekingalpha.com

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Harmony Biosciences Holdings, Inc. (HRMY) Q3 Earnings Miss Estimates

Nov -04

Source: zacks.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (8.50%)

6. Segments

Pharmaceutical

Expected Growth: 8.5%

Harmony Biosciences Holdings, Inc.'s 8.5% growth in pharmaceuticals is driven by increasing demand for rare disease treatments, strong pipeline of novel therapies, and strategic partnerships. Additionally, growing awareness of sleep disorders and increasing adoption of Wakix, its flagship product, contribute to the segment's growth.

7. Detailed Products

Wakix

A medication used to treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy

Pitolisant

A medication used to treat excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy

Xyrem

A medication used to treat cataplexy and excessive daytime sleepiness in adult patients with narcolepsy

8. Harmony Biosciences Holdings, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Harmony Biosciences Holdings, Inc. operates in a niche market with limited substitutes, reducing the threat of substitutes.

Bargaining Power Of Customers

Harmony Biosciences Holdings, Inc. has a diverse customer base, reducing the bargaining power of individual customers.

Bargaining Power Of Suppliers

Harmony Biosciences Holdings, Inc. relies on a few key suppliers, giving them some bargaining power, but the company's size and scale mitigate this threat.

Threat Of New Entrants

Harmony Biosciences Holdings, Inc. operates in a highly regulated industry with significant barriers to entry, reducing the threat of new entrants.

Intensity Of Rivalry

Harmony Biosciences Holdings, Inc. operates in a competitive industry with several established players, leading to a high intensity of rivalry.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 29.30%
Debt Cost 7.69%
Equity Weight 70.70%
Equity Cost 7.69%
WACC 7.69%
Leverage 41.45%

11. Quality Control: Harmony Biosciences Holdings, Inc. passed 8 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Puma Biotechnology

A-Score: 5.6/10

Value: 7.4

Growth: 6.1

Quality: 8.7

Yield: 0.0

Momentum: 9.5

Volatility: 2.0

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CytomX Therapeutics

A-Score: 5.3/10

Value: 5.7

Growth: 6.2

Quality: 9.8

Yield: 0.0

Momentum: 10.0

Volatility: 0.3

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Harmony Biosciences

A-Score: 5.2/10

Value: 7.0

Growth: 9.4

Quality: 9.0

Yield: 0.0

Momentum: 1.5

Volatility: 4.3

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iTeos Therapeutics

A-Score: 4.6/10

Value: 7.8

Growth: 3.6

Quality: 6.2

Yield: 0.0

Momentum: 6.0

Volatility: 4.3

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Akebia Therapeutics

A-Score: 4.6/10

Value: 4.8

Growth: 5.8

Quality: 5.8

Yield: 0.0

Momentum: 10.0

Volatility: 1.3

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Amylyx Pharmaceuticals

A-Score: 4.3/10

Value: 8.2

Growth: 3.6

Quality: 7.2

Yield: 0.0

Momentum: 5.0

Volatility: 1.7

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

39.83$

Current Price

39.83$

Potential

-0.00%

Expected Cash-Flows