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Harmony Biosciences Holdings (HRMY)
NASDAQ:HRMY
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Harmony Biosciences Holdings (HRMY) AI Stock Analysis

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HRMY

Harmony Biosciences Holdings

(NASDAQ:HRMY)

Rating:81Outperform
Price Target:
$40.00
▲(9.56% Upside)
Harmony Biosciences receives a strong overall score driven by its robust financial performance, attractive valuation, and positive corporate developments. The company's solid financials and strategic initiatives in pipeline advancement and patent protection position it well for future growth, despite moderate technical indicators and some regulatory uncertainties.
Positive Factors
Pipeline Development
Topline data from the Phase 3 RECONNECT trial in Fragile X syndrome remains on track and, if positive, could support the first FDA-approved therapy for FXS, representing a potential inflection point in a severely underserved patient population.
Revenue Growth
WAKIX continues to deliver resilient growth, with 16% year-over-year revenue expansion and steady prescriber penetration across both REMS and non-REMS segments.
Negative Factors
Earnings Miss
HRMY reported a top-line miss, with Wakix revenue of $200.5mn below estimates.
Investor Expectations
Investor expectations are low for Harmony Biosciences due to a history of failures, gel formulation issues, and an unproven mechanism of action.

Harmony Biosciences Holdings (HRMY) vs. SPDR S&P 500 ETF (SPY)

Harmony Biosciences Holdings Business Overview & Revenue Model

Company DescriptionHarmony Biosciences Holdings, Inc. is a pharmaceutical company focused on developing and commercializing innovative therapies for patients with rare neurological disorders. The company is primarily engaged in the healthcare sector, with its core product being WAKIX (pitolisant), a novel treatment for excessive daytime sleepiness in adults with narcolepsy.
How the Company Makes MoneyHarmony Biosciences generates revenue primarily through the sales of its pharmaceutical product, WAKIX. The company makes money by marketing and selling WAKIX to healthcare providers, hospitals, and pharmacies, which then distribute the medication to patients. Key revenue streams include direct sales of the drug in the United States, and the company may also engage in strategic partnerships or licensing agreements to expand its product reach and maximize its market potential. Factors contributing to its earnings include the drug's efficacy, market demand for treatments addressing narcolepsy, and the company's ability to navigate the regulatory landscape to maintain product approvals and explore additional indications for WAKIX.

Harmony Biosciences Holdings Earnings Call Summary

Earnings Call Date:Jul 31, 2025
(Q2-2025)
|
% Change Since: 2.90%|
Next Earnings Date:Nov 04, 2025
Earnings Call Sentiment Positive
The earnings call presented a generally positive outlook, highlighting strong revenue growth and significant advancements in the company's pipeline. Although there were some concerns regarding inventory fluctuations and potential regulatory challenges, the company's robust financial position and strategic collaborations suggest continued growth and innovation.
Q2-2025 Updates
Positive Updates
Strong Revenue Growth
Harmony Biosciences reported $200.5 million in second quarter net revenue, representing a 16% increase year-over-year, continuing a 4-year streak of profitability.
Pipeline Advancements
The Phase III registrational trial for ZYN002 in Fragile X syndrome completed enrollment, with top-line data expected later this quarter. The company also plans to initiate Phase III trials for pitolisant HD in narcolepsy and idiopathic hypersomnia in Q4 2025.
Expansion and Collaboration
Harmony entered a research collaboration with Circ Biosciences to develop novel regenerative cellular therapies, aligning with their pipeline focus on refractory epilepsy and treatment-resistant narcolepsy.
Financial Strength
Strong cash generation from operations ($79 million) and a cash position of over $670 million provide financial flexibility for strategic business development.
Negative Updates
Inventory Fluctuations
The quarter saw a reduction in trade inventories by a few days as the company headed into the summer months, which affected net revenue figures.
Regulatory Uncertainty
While optimistic, the company faces potential regulatory hurdles for ZYN002 as it is based on a novel mechanism and targets a population with no currently approved treatments.
Company Guidance
During the Harmony Biosciences second quarter 2025 financial results conference call, the company reported a net revenue of $200.5 million, reflecting a 16% year-over-year increase. The number of average patients using WAKIX, their key product for narcolepsy, grew by approximately 400 during the quarter. The company reaffirmed their full-year revenue guidance of $820 million to $860 million and expressed confidence in achieving over $1 billion in annual revenue from WAKIX alone by the time of its loss of exclusivity in 2030. Harmony is also advancing its pipeline, with a focus on the upcoming Phase III RECONNECT study for ZYN002 in Fragile X syndrome, which has completed enrollment and is expected to deliver top-line data later in the quarter. The company is also working on next-generation formulations of pitolisant, expected to initiate Phase III trials in the fourth quarter of 2025. Harmony's financial performance remains strong, with a non-GAAP adjusted net income of $53.8 million for the quarter and a robust cash position, enabling strategic business development and pipeline expansion opportunities.

Harmony Biosciences Holdings Financial Statement Overview

Summary
Harmony Biosciences exhibits strong financial performance with robust revenue growth, high profitability margins, and a solid balance sheet with low leverage. The company's cash flow generation is healthy, supporting its operational and strategic initiatives. Overall, the financial statements indicate a well-managed company with a positive growth outlook in the biotechnology industry.
Income Statement
85
Very Positive
Harmony Biosciences has demonstrated strong revenue growth with a TTM increase of 3.72% and a consistent upward trajectory over the past years. The company maintains robust profitability with a gross profit margin of 78.34% and a net profit margin of 23.42% in the TTM. EBIT and EBITDA margins are also healthy at 24.32% and 32.88%, respectively, indicating efficient operational management. The consistent growth and strong margins reflect a solid financial performance in the biotechnology sector.
Balance Sheet
80
Positive
The balance sheet shows a strong equity position with a low debt-to-equity ratio of 0.024 in the TTM, indicating minimal leverage and financial risk. Return on equity is impressive at 26.32%, showcasing effective use of shareholder funds to generate profits. The equity ratio stands at 69.76%, highlighting a stable financial structure. Overall, the balance sheet reflects financial stability and prudent management of resources.
Cash Flow
78
Positive
Cash flow analysis reveals a positive trend with a free cash flow growth rate of 16.87% in the TTM, indicating improved cash generation capabilities. The operating cash flow to net income ratio is 1.44, suggesting strong cash conversion from earnings. The free cash flow to net income ratio is nearly 1, reflecting efficient cash management. While cash flow metrics are strong, continued monitoring of cash flow sustainability is advisable.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue772.53M714.73M582.02M437.86M305.44M159.74M
Gross Profit605.19M557.92M460.79M354.37M249.92M132.00M
EBITDA265.05M233.41M221.51M143.57M106.37M1.51M
Net Income180.90M145.49M128.85M181.47M34.60M-51.86M
Balance Sheet
Total Assets1.11B999.20M811.45M673.87M433.44M427.07M
Cash, Cash Equivalents and Short-Term Investments565.27M467.19M353.46M323.12M234.31M228.63M
Total Debt172.09M179.27M193.57M191.65M191.98M194.25M
Total Liabilities334.93M340.05M344.46M271.03M246.94M329.89M
Stockholders Equity773.08M659.15M466.99M402.84M186.51M97.18M
Cash Flow
Free Cash Flow258.73M218.67M219.07M104.29M-1.74M-4.99M
Operating Cash Flow259.38M219.82M219.39M144.47M98.56M-2.98M
Investing Cash Flow-23.67M-67.48M-46.44M-141.83M-100.30M-2.00M
Financing Cash Flow-6.95M-11.00M-105.55M6.84M7.42M209.16M

Harmony Biosciences Holdings Technical Analysis

Technical Analysis Sentiment
Positive
Last Price36.51
Price Trends
50DMA
34.32
Positive
100DMA
33.12
Positive
200DMA
34.15
Positive
Market Momentum
MACD
0.36
Negative
RSI
59.64
Neutral
STOCH
91.57
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For HRMY, the sentiment is Positive. The current price of 36.51 is above the 20-day moving average (MA) of 35.59, above the 50-day MA of 34.32, and above the 200-day MA of 34.15, indicating a bullish trend. The MACD of 0.36 indicates Negative momentum. The RSI at 59.64 is Neutral, neither overbought nor oversold. The STOCH value of 91.57 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for HRMY.

Harmony Biosciences Holdings Risk Analysis

Harmony Biosciences Holdings disclosed 67 risk factors in its most recent earnings report. Harmony Biosciences Holdings reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Harmony Biosciences Holdings Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
81
Outperform
$2.04B11.8227.58%17.74%59.96%
53
Neutral
$1.92B-57.33%99.50%65.91%
53
Neutral
$2.85B-33.26%-49.51%-44.09%
51
Neutral
$7.44B-0.20-46.00%2.27%22.80%-2.27%
47
Neutral
$2.35B-86.34%30.14%-10.08%
45
Neutral
$2.11B-39.69%-100.00%1.62%
41
Neutral
$1.71B-41.94%-82.90%-155.64%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
HRMY
Harmony Biosciences Holdings
36.51
1.57
4.49%
DNLI
Denali Therapeutics
14.46
-8.56
-37.19%
ARQT
Arcutis Biotherapeutics
15.98
7.49
88.22%
BEAM
Beam Therapeutics
17.63
-6.80
-27.83%
KYMR
Kymera Therapeutics
41.55
-2.25
-5.14%
RXRX
Recursion Pharmaceuticals
5.64
-1.10
-16.32%

Harmony Biosciences Holdings Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Harmony Biosciences Reveals Promising Preclinical Data for BP1.15205
Positive
Jun 11, 2025

On June 11, 2025, Harmony Biosciences announced new preclinical data for BP1.15205, a promising orexin 2 receptor agonist, showing significant wake-promoting and cataplexy-suppressing effects in narcolepsy type 1 mouse models. The company plans to begin human trials in the latter half of 2025, with results expected in 2026, potentially enhancing its position in the sleep-wake disorder treatment market.

The most recent analyst rating on (HRMY) stock is a Sell with a $32.00 price target. To see the full list of analyst forecasts on Harmony Biosciences Holdings stock, see the HRMY Stock Forecast page.

Legal ProceedingsBusiness Operations and Strategy
Harmony Biosciences Settles Patent Dispute with Lupin
Positive
Jun 5, 2025

On June 5, 2025, Harmony Biosciences announced a settlement with Lupin Limited regarding patent infringement litigation over Lupin’s generic version of WAKIX® (pitolisant hydrochloride). The agreement allows Lupin to launch its generic product no earlier than January 2030, reinforcing Harmony’s patent position and protecting its intellectual property. This settlement highlights Harmony’s commitment to defending its innovations in sleep/wake therapeutics and strengthens its market position as it continues to develop next-generation formulations of pitolisant.

The most recent analyst rating on (HRMY) stock is a Buy with a $61.00 price target. To see the full list of analyst forecasts on Harmony Biosciences Holdings stock, see the HRMY Stock Forecast page.

Shareholder Meetings
Harmony Biosciences Holds 2025 Annual Stockholders Meeting
Neutral
May 15, 2025

On May 15, 2025, Harmony Biosciences Holdings conducted its 2025 Annual Meeting of Stockholders, where two key proposals were voted on. The election of three Class II directors was confirmed, and the appointment of Deloitte & Touche LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was ratified, indicating stable governance and continuity in financial oversight for the company.

The most recent analyst rating on (HRMY) stock is a Sell with a $32.00 price target. To see the full list of analyst forecasts on Harmony Biosciences Holdings stock, see the HRMY Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Aug 12, 2025