Harmony Biosciences Holdings HRMY

Harmony Biosciences Holdings shares investor presentation

Item 2.02 Reports results, Item 7.01 Investor disclosure

Form
8-K
Filed
Importance
Major
  1. Investor presentation posted on November 4, 2026
  2. Presentation includes forward-looking statements

Written from the 8-K on EDGAR. Check the filing before you rely on it.

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The reading, claim by claim

  1. The filing includes a press release and an investor presentation.
  2. The press release states that WAKIX net revenue in Q3 was $269 million, with 400 net patient adds.
  3. The company reiterated its full-year guidance of $1.0 billion to $1.04 billion.

3 of 3 claims matched the filing text.

From the filing

Item 2.02. Results of Operations and Financial Condition.

Item 2.02. Results of Operations and Financial Condition.

On November 4, 2026, Harmony Biosciences Holdings, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K1 and is incorporated herein by reference.

Item 7.01. Regulation FD Disclosure.

Item 7.01. Regulation FD Disclosure.

On November 4, 2026, the Company posted an investor presentation to its website at ttps://ir.harmonybiosciences.com (the "Investor Presentation"). A copy of the Investor Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K1 and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others.

The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company's Securities and Exchange Commission ("SEC") filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Investor Presentation speaks only as of the date of this Current Report on Form 8-K. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Investor Presentation, although it may do so from time to time. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. In addition, the exhibit furnished herewith contains statements intended as "forward-looking statements" that are subject to the cautionary statements about forward-looking statements set forth in such exhibit. By furnishing the information contained in the Investor Presentation, the Company makes no admission as to the materiality of any information in the Investor Presentation that is required to be disclosed solely by reason of Regulation FD.

This Current Report on Form 8-K and its contents (including Exhibits 99.1 and 99.2) are furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act

Item 9.01. Financial Statements and Exhibits.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1*

Press release issued by the Company, dated November 4, 2026.

99.2*

Investor Presentation, dated November 4, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

*

This Exhibit is furnished herewith and will not be deemed "filed" for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

HARMONY BIOSCIENCES HOLDINGS, INC.

Date: November 4, 2026

By:

/s/ Stephen Mollichella

Stephen Mollichella

Senior Vice President, Controller and Interim Principal Financial Officer

Harmony Biosciences Reports Q3 Financial Results

On Track to Achieve More Than $1 Billion WAKIX Net

Revenue and Announces Strong Multiple-Ascending Dose Data for Its Orexin Agonist BP-205, Supporting Potential Best-in-Class Profile

WAKIX ® Net Revenue in Q3 of $269 Million; Driven by Strong Demand with 400 Net Patient Adds in the Quarter2; Reiterates Full Year Guidance of $1.0B to $1.04B3

Repeated Once-Daily Dosing with BP-205 in Multiple-Ascending Dose Study Reinforces Favorable Safety, Tolerability and Pharmacokinetic Profile Observed in Single-Ascending Dose Study

Results from Phase 1b Study in Sleep-Deprived Healthy Volunteers for BP-205 Remain on Track for Q1 2027; Phase 2 Studies in Multiple CNS Indications Expected to Initiate by Mid-2027 Pitolisant GR NDA Under FDA Review, PDUFA Date April 1, 2027; Pitolisant HD Phase 3 Topline Data in 2027, Target PDUFA Date in 2028

Multi-Layered IP Strategy Across Active Legal Proceedings Reinforces Confidence in W

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