Harmony Biosciences Holdings, Inc. ((HRMY)) has held its Q3 earnings call. Read on for the main highlights of the call.
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Harmony Biosciences Holdings, Inc. recently held its earnings call, revealing a strong performance marked by significant revenue growth and an increase in patient numbers. The company showcased a robust cash position and promising advancements in its pipeline. However, challenges were acknowledged, particularly in the Fragile X syndrome study, alongside increased operating expenses.
Record Revenue Growth
Harmony Biosciences reported an impressive $239.5 million in net revenue for the third quarter of 2025, representing a 29% growth compared to the previous year. This substantial increase prompted the company to raise its annual net revenue guidance from a range of $820 million to $860 million, now expecting between $845 million and $865 million.
Strong Patient Adds for WAKIX
The quarter was notable for the highest number of quarterly patient additions for WAKIX since its launch, with an average of 500 new patients. This brought the total number of patients on WAKIX to 8,100 by the end of the third quarter.
Robust Cash Position
The company reported strong cash generation of $106 million, enhancing its balance sheet to a total of $778 million as of September 30, 2025. This robust cash position underscores Harmony’s financial health and ability to support ongoing and future initiatives.
Pipeline Advancements
Significant progress was made in Harmony’s pipeline, with the Investigational New Drug (IND) application for pitolisant HD submitted to the FDA. Additionally, two Phase III trials are on track to commence by the end of the year, with expectations to have five Phase III registrational studies in five distinct indications by year-end.
Fragile X Syndrome Study Setback
The ZYN002 Phase III RECONNECT study in Fragile X syndrome faced a setback as it did not meet its primary endpoint, attributed to a higher-than-expected placebo response. This has led to a pause in the program for 22q deletion syndrome.
Increased Operating Expenses
Operating expenses for the third quarter of 2025 rose to $114.3 million, up from $81.6 million in the same quarter of the previous year. This increase was driven by investments in pipeline advancements and a $15 million milestone payment for the ZYN002 trial.
Forward-Looking Guidance
In its forward-looking guidance, Harmony Biosciences highlighted its strong performance with a 29% year-over-year growth in net revenue, driven by the addition of 500 new patients. The company has raised its full-year net revenue guidance to between $845 million and $865 million. Harmony aims to position WAKIX as a $1 billion-plus blockbuster in narcolepsy while advancing its late-stage pipeline with five ongoing Phase III trials across distinct indications.
In summary, Harmony Biosciences’ earnings call reflected a positive sentiment with strong financial performance and strategic advancements in its pipeline. Despite challenges in the Fragile X syndrome study and increased operating expenses, the company remains optimistic about its future growth prospects and continues to strengthen its position in the market.