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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:78Outperform
Price Target:
$42.00
▲(11.91% Upside)
Harmony Biosciences receives a strong overall stock score due to its robust financial performance, positive technical indicators, and promising corporate developments. The company's strategic initiatives and pipeline advancements further enhance its growth outlook, despite some concerns about potential expenses and competitive challenges.
Positive Factors
Market Potential
The potential market for ZYN-002 is large, with a total addressable market of over $2 billion and no FDA approved treatments currently available.
Pipeline Development
The upcoming data readout for ZYN-002 in Fragile X Syndrome is an important milestone for Harmony Biosciences as it could validate the company's strategy of building its pipeline.
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.
Placebo Response
There is a risk of high placebo response impacting the success of ZYN-002 in Fragile X Syndrome.

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

Harmony Biosciences Holdings Business Overview & Revenue Model

Company DescriptionHarmony 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.
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: |
Next Earnings Date:Nov 04, 2025
Earnings Call Sentiment Positive
The earnings call reflects a strong performance by Harmony Biosciences with significant revenue growth and advancements in their clinical pipeline. The company has a robust pipeline and financial health, although there are some concerns about trade inventory reductions and potential expenses. Overall, the positive aspects significantly outweigh the challenges.
Q2-2025 Updates
Positive Updates
Strong Revenue Growth
Harmony Biosciences reported $200.5 million in net revenue for the second quarter, representing a 16% increase year-over-year.
WAKIX Performance
WAKIX delivered $200.5 million in net sales for the quarter, with a 16% year-over-year growth and an addition of approximately 400 average patients.
Advancements in Clinical Pipeline
The Phase III registrational trial for ZYN002 in Fragile X syndrome completed enrollment, with top-line data expected later in the quarter.
Robust Pipeline and Future Prospects
Harmony has a robust pipeline with 8 innovative assets across 13 development programs, including up to 6 Phase III trials by the end of the year.
Positive Financial Health
Non-GAAP adjusted net income for the quarter was $53.8 million, indicating sustained profitability and financial stability.
Negative Updates
Reduction in Trade Inventories
There was a reduction in trade inventories of a few days as the company headed into the summer months, impacting revenue.
Potential Milestone Expenses
Expected to potentially incur $29 million in milestones for the completion of the Phase III trial for ZYN002 in Fragile X syndrome and other programs.
Challenges in New Market Entries
New market entries such as orexin receptor agonists could pose competitive challenges to WAKIX, although the company is confident in its differentiated position.
Company Guidance
During the Harmony Biosciences Second Quarter 2025 Financial Results Conference Call, the company provided several key metrics and forward-looking statements. Harmony reported $200.5 million in net revenue for Q2 2025, marking a 16% year-over-year increase, primarily driven by the continued growth of WAKIX in the narcolepsy market. The company added approximately 400 average patients during the quarter and reaffirmed their full-year revenue guidance of $820 million to $860 million. Harmony anticipates achieving $1 billion in annual revenue from WAKIX alone. The call also highlighted the advancement of their late-stage pipeline, including the upcoming Phase III trial data for ZYN002 in Fragile X syndrome, expected later in Q3 2025. The company maintains a strong cash position with over $670 million, providing flexibility for strategic business development. Harmony is actively preparing for further growth, with up to six Phase III trials expected by year-end and plans to launch new products or indications annually over the next several years.

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 Price37.53
Price Trends
50DMA
35.19
Positive
100DMA
33.84
Positive
200DMA
34.30
Positive
Market Momentum
MACD
0.64
Positive
RSI
58.48
Neutral
STOCH
47.87
Neutral
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 37.53 is above the 20-day moving average (MA) of 36.50, above the 50-day MA of 35.19, and above the 200-day MA of 34.30, indicating a bullish trend. The MACD of 0.64 indicates Positive momentum. The RSI at 58.48 is Neutral, neither overbought nor oversold. The STOCH value of 47.87 is Neutral, 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
78
Outperform
$2.13B12.1027.58%17.74%59.96%
58
Neutral
$1.86B-57.33%99.50%65.91%
57
Neutral
$2.91B-33.26%-49.51%-44.09%
51
Neutral
$7.90B-0.33-41.69%2.23%23.45%-1.99%
50
Neutral
$2.04B-86.34%30.14%-10.08%
50
Neutral
$1.66B-41.94%-82.90%-155.64%
45
Neutral
$2.23B-39.69%-100.00%1.62%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
HRMY
Harmony Biosciences Holdings
37.53
1.97
5.54%
DNLI
Denali Therapeutics
15.31
-9.94
-39.37%
ARQT
Arcutis Biotherapeutics
15.94
5.11
47.18%
BEAM
Beam Therapeutics
18.76
-5.42
-22.42%
KYMR
Kymera Therapeutics
43.30
-3.30
-7.08%
RXRX
Recursion Pharmaceuticals
4.63
-1.54
-24.96%

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.

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.

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: Sep 03, 2025