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Harmony Biosciences Holdings (HRMY)
NASDAQ:HRMY
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Harmony Biosciences Holdings
(NASDAQ:HRMY)
73Outperform
Positive Factors
Clinical Trials
Top-line data from RECONNECT are expected to support the first FDA approval for any treatment targeting the behavioral symptoms of FXS.
Financial Performance
HRMY is seen as a profitable, commercial-stage company with a deep pipeline, a strong balance sheet, and excellent visibility on the catalyst calendar through 2027/2028.
Product Development
The announcement of a patent settlement with a first generic challenger sets a 2030 generic Wakix launch, which is seen as a positive development for HRMY.
Negative Factors
Clinical Development Risk
Risks include clinical development risk tied to pitolisant GR, pitolisant HD, ZYN002, and EPX100.
Revenue Expectations
Last month's setback for pitolisant for idiopathic hypersomnia/IH still stings, leading to reset revenue expectations for HRMY.
Harmony Biosciences Holdings (HRMY) vs. S&P 500 (SPY)
Market Cap
$1.67B
Dividend YieldN/A
Average Volume (3M)731.79K
Price to Earnings (P/E)11.6
Beta (1Y)1.58
Revenue Growth22.80%
EPS Growth18.12%
CountryUS
Employees268
SectorHealthcare
Sector Strength71
IndustryBiotechnology
Share Statistics
EPS (TTM)2.51
Shares Outstanding57,386,690
10 Day Avg. Volume810,725
30 Day Avg. Volume731,789
Financial Highlights & Ratios
PEG Ratio0.64
Price to Book (P/B)N/A
Price to Sales (P/S)2.83
Price to Cash Flow (P/CF)6.70
P/FCF Ratio6.40
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$54.00Price Target Upside82.86% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
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 core product, Wakix (pitolisant), which is a first-in-class medication used to address excessive daytime sleepiness associated with narcolepsy. The company earns money by marketing and distributing Wakix to healthcare providers and institutions, who then prescribe it to patients. Harmony Biosciences benefits from exclusivity agreements and patents that limit competition, allowing it to capitalize on its innovative product within a niche market. Additionally, the company may engage in strategic partnerships and collaborations to enhance its product offerings and expand its market reach, although these are not the primary sources of revenue.
Harmony Biosciences Holdings Financial Statement Overview
Summary
Harmony Biosciences exhibits strong financial health with impressive revenue growth, high profitability margins, and a solid balance sheet with low leverage. Cash flow management is efficient, though future free cash flow trends should be monitored.Income Statement
Harmony Biosciences has demonstrated strong growth with a Revenue Growth Rate of 22.8% from 2023 to 2024, indicating robust expansion. The Gross Profit Margin of 78.06% and Net Profit Margin of 20.36% for 2024 reflect excellent profitability. The EBIT margin has slightly decreased from the previous year, but the consistent EBITDA margin signifies operational efficiency.85
Very Positive
Balance Sheet
The company maintains a solid financial position with a Debt-to-Equity Ratio of 0.025, showcasing low leverage risk. The ROE of 22.06% indicates strong returns to shareholders. The Equity Ratio of 65.97% suggests a stable capital structure. However, the increase in total debt, albeit small, should be monitored.78
Positive
Cash Flow
Harmony Biosciences has shown a slight decline in Free Cash Flow Growth Rate. However, the Operating Cash Flow to Net Income Ratio of 1.51 highlights strong cash generation relative to net income. The Free Cash Flow to Net Income Ratio remains robust, underscoring efficient cash flow management.82
Very Positive
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 714.73M | 582.02M | 437.86M | 305.44M | 159.74M | Gross Profit |
| 557.92M | 460.79M | 354.37M | 249.92M | 132.00M | EBIT |
| 190.83M | 192.03M | 120.19M | 68.70M | 3.68M | EBITDA |
| 233.41M | 221.51M | 143.57M | 106.37M | 1.51M | Net Income Common Stockholders |
| 145.49M | 128.85M | 181.47M | 34.60M | -51.86M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 467.19M | 353.46M | 323.12M | 234.31M | 228.63M | Total Assets |
| 999.20M | 811.45M | 673.87M | 433.44M | 427.07M | Total Debt |
| 16.25M | 193.57M | 191.65M | 191.98M | 194.25M | Net Debt |
| -436.75M | -118.09M | -52.14M | -42.33M | -34.38M | Total Liabilities |
| 340.05M | 344.46M | 271.03M | 246.94M | 329.89M | Stockholders Equity |
| 659.15M | 466.99M | 402.84M | 186.51M | 97.18M |
| Cash Flow | Free Cash Flow | |||
| 218.67M | 219.07M | 104.29M | -1.74M | -4.99M | Operating Cash Flow |
| 219.82M | 219.39M | 144.47M | 98.56M | -2.98M | Investing Cash Flow |
| -67.48M | -46.44M | -141.83M | -100.30M | -2.00M | Financing Cash Flow |
| -11.00M | -105.55M | 6.84M | 7.42M | 209.16M |
Harmony Biosciences Holdings Technical Analysis
Negative
29.53
Price Trends
34.11
Negative
34.64
Negative
34.79
Negative
Market Momentum
-1.50
Positive
35.74
Neutral
41.76
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For HRMY, the sentiment is Negative. The current price of 29.53 is below the 20-day moving average (MA) of 31.90, below the 50-day MA of 34.11, and below the 200-day MA of 34.79, indicating a bearish trend. The MACD of -1.50 indicates Positive momentum. The RSI at 35.74 is Neutral, neither overbought nor oversold. The STOCH value of 41.76 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 (50)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
73 Outperform | $1.67B | 11.62 | 25.84% | ― | 22.80% | 18.12% | |
57 Neutral | $1.49B | ― | -113.76% | ― | 229.74% | 70.23% | |
50 Neutral | $1.65B | ― | -36.38% | ― | -40.11% | -17.79% | |
50 Neutral | $5.52B | 2.98 | -43.78% | 2.78% | 16.94% | 3.55% | |
45 Neutral | $2.21B | ― | -61.89% | ― | 32.00% | -6.86% | |
41 Neutral | $1.93B | ― | -37.40% | ― | -100.00% | -144.79% | |
39 Underperform | $1.70B | ― | -43.94% | ― | -83.18% | -144.95% |
* Healthcare Sector Average
Performance Comparison
HRMY
Harmony Biosciences Holdings
28.75
-1.03
-3.46%
DNLI
Denali Therapeutics
13.17
-4.17
-24.05%
ARQT
Arcutis Biotherapeutics
13.19
3.09
30.59%
BEAM
Beam Therapeutics
17.28
-8.42
-32.76%
KYMR
Kymera Therapeutics
25.43
-8.50
-25.05%
RXRX
Recursion Pharmaceuticals
5.64
-1.93
-25.50%
Harmony Biosciences Holdings Earnings Call Summary
Earnings Call Date: Feb 25, 2025 | % Change Since: -13.60% | Next Earnings Date: May 6, 2025
Earnings Call Sentiment Positive
The earnings call reflected a strong performance in terms of revenue growth and patient base expansion for Harmony Biosciences. Significant advancements in their pipeline, including multiple ongoing and upcoming Phase 3 trials, highlight a solid strategy for future growth. However, the rejection of the Pitolisant sNDA and challenges in clinical trials for idiopathic hypersomnia present notable setbacks. Despite these challenges, the company's financial stability and strategic moves, such as the generic settlement, contribute to an overall positive outlook.Highlights
Strong Revenue Growth
Harmony Biosciences reported net product revenues of $714.7 million in 2024, representing a 23% growth year-over-year. Q4 alone generated $201.3 million, reflecting continued growth of WAKIX in narcolepsy.
Expansion of Patient Base
The average number of patients on WAKIX increased to approximately 7,100 in Q4, marking a sequential increase of about 300 patients. This growth was supported by an expanding prescriber base and favorable market access.
Pipeline Advancements
There are four Phase 3 Registrational Trials ongoing, with two more expected to start by the end of the year. These trials cover a range of indications, including narcolepsy, idiopathic hypersomnia, Fragile X Syndrome, and epilepsy.
Financial Stability
Harmony ended 2024 with $576.1 million in cash and cash equivalents, highlighting strong cash generation of approximately $219.8 million from operations in 2024.
Generic Settlement
Harmony announced its first generic settlement agreement with Novagen Pharma, allowing the sale of a generic product beginning January 2030, reinforcing the strength of Harmony's intellectual property.
Lowlights
Pitolisant sNDA Submission Rejected
The FDA issued a Refusal to File (RTF) letter for the supplemental new drug application (sNDA) for Pitolisant in idiopathic hypersomnia due to unmet primary endpoints in the Phase 3 INTUNE study.
Challenges in IH Clinical Trials
The INTUNE study did not meet its primary endpoint during the randomized withdrawal phase, presenting a challenge in advancing Pitolisant for idiopathic hypersomnia.
Competitive Landscape
There is significant competition for patients in clinical trials for narcolepsy and idiopathic hypersomnia, which may impact recruitment and trial timelines.
Company Guidance
During the Harmony Biosciences Fourth Quarter and Full Year 2024 Financial Results Conference Call, the company provided guidance for 2025, expecting net revenue between $820 million and $860 million, reflecting continued growth from their flagship product, WAKIX. In 2024, WAKIX achieved net product revenues of $714.7 million, marking a 23% growth year-over-year. The company highlighted their success in increasing average patients on WAKIX to approximately 7,100 in Q4, with a significant increase in prescribers. The call also covered strategic pipeline developments, including the initiation of Phase 3 trials for their pitolisant HD formulation in Q4 2025, targeting a PDUFA date in 2028. Harmony plans to expand their leadership in the CNS space by advancing late-stage programs and pursuing pediatric exclusivity for pitolisant, potentially extending its regulatory exclusivity by six months. They also announced a settlement agreement with Novagen Pharma regarding generic competition, reinforcing their strong intellectual property estate.Harmony Biosciences Holdings Corporate Events
Executive/Board Changes
Harmony Biosciences Appoints Ron Philip to Board
Positive
Apr 3, 2025
On April 2, 2025, Harmony Biosciences appointed Ron Philip to its Board of Directors, filling a vacancy left by Jack Bech Nielsen’s resignation in June 2024. Philip, who brings extensive experience from his roles at Orbital Therapeutics and Spark Therapeutics, will serve on the Audit and Nominating and Corporate Governance Committees. His appointment is expected to support Harmony’s growth and pipeline expansion, aligning with the company’s focus on innovative therapies for rare neurological diseases.
Executive/Board ChangesBusiness Operations and Strategy
Harmony Biosciences Appoints New Chief Commercial Officer
Neutral
Mar 24, 2025
On March 24, 2025, Harmony Biosciences announced the departure of Jeffrey Dierks as Chief Commercial Officer, effective March 31, 2025, and the appointment of Adam Zaeske as his successor. Zaeske, with over 25 years of experience in the pharmaceutical industry, is expected to lead the company’s commercial strategy and expansion efforts, building on the success of WAKIX and advancing Harmony’s late-stage pipeline assets.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.