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SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Harmony Biosciences Holdings, Inc.
SEC Filings (Chronological Order)
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| May 14, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 14, 2026 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Empl |
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| May 7, 2026 |
Copyright © 2026 Harmony Biosciences. All rights reserved. Q1 2026 Financial Results and Business Update May 7, 2026 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-l |
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| May 7, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2026 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 |
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| May 7, 2026 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS Q1 FINANCIAL RESULTS AND CONFIRMS 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION; REINFORCES 2026 STRATEGIC PRIORITIES WAKIX® Net Revenue Grew 17% to $215.4 Million for First Quarter 2026; On Track for Full Year 2026 Net Revenues over $1 Billion Continue to Vigorously Protect WAKIX IP into 2030; Filed Suit Against AET Pharma/Sandoz Regarding Infringement of A |
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| May 7, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 7, 2026 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emplo |
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| April 14, 2026 |
HARMONY BIOSCIENCES MANAGEMENT, INC. EXECUTIVE EMPLOYMENT AGREEMENT Exhibit 10.2 HARMONY BIOSCIENCES MANAGEMENT, INC. EXECUTIVE EMPLOYMENT AGREEMENT THIS EXECUTIVE EMPLOYMENT AGREEMENT (the “Agreement”), effective as of April 14, 2026 (the “Effective Date”), is made by and between Harmony Biosciences Management, Inc., a Delaware corporation (the “Company”), and Glenn Reicin (the “Executive”). W I T N E S S E T H: WHEREAS, the Company and the Executive mutually des |
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| April 14, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 14, 2026 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| April 14, 2026 |
Exhibit 10.1 SEPARATION AGREEMENT This Separation Agreement (this “Agreement”) is entered into by and between Sandip Kapadia (“Executive”) and Harmony Biosciences Holdings, Inc. and Harmony Biosciences Management, Inc. (together the “Company”), effective as of April 13, 2026 (the “Effective Date”). 1.Separation. Executive shall remain employed by the Company as the Company’s Executive Vice Preside |
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| April 14, 2026 |
Exhibit 99.1 Harmony Biosciences APPOINTS Glenn Reicin as Chief Financial Officer COMPANY REITERATES ITS 2026 NET REVENUE GUIDANCE of OVER $1 BILLION In WAKIX SALES PLYMOUTH MEETING, Pa., April 14, 2026 /Business Wire/ — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the appointment of Glenn Reicin as Chief Financial Officer, effective immediately, supporting Harmony’s continu |
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| April 3, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐Preliminary Proxy Statement ☐Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐Definitive Proxy Statemen |
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| April 3, 2026 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐Preliminary Proxy Statement ☐Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒Definit |
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| April 3, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BI |
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| April 2, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 31, 2026 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| April 2, 2026 |
Exhibit 99.1 Harmony Biosciences Strengthens Executive Team with NEW Appointment and ANNOUNCES Additions TO ITS bOARD Appointments support Harmony’s next phase of growth and long-term value creation PLYMOUTH MEETING, Pa., April 2, 2026 /Business Wire/ — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the appointment of Peter Anastasiou as Chief Operating Officer and updates to i |
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| April 2, 2026 |
HARMONY BIOSCIENCES MANAGEMENT, INC. EXECUTIVE EMPLOYMENT AGREEMENT Exhibit 10.1 HARMONY BIOSCIENCES MANAGEMENT, INC. EXECUTIVE EMPLOYMENT AGREEMENT THIS EXECUTIVE EMPLOYMENT AGREEMENT (the “Agreement”), effective as of April 2, 2026 (the “Effective Date”), is made by and between Harmony Biosciences Management, Inc., a Delaware corporation (the “Company”), and Peter Anastasiou (the “Executive”). W I T N E S S E T H: WHEREAS, the Company and the Executive mutually |
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| February 24, 2026 |
Subsidiaries of Harmony Biosciences Holdings, Inc. Exhibit 21.1 Subsidiaries of Harmony Biosciences Holdings, Inc. Subsidiary Jurisdiction Harmony Biosciences, LLC Delaware, USA Harmony Biosciences Management, Inc. Delaware, USA Zynerba Pharmaceuticals Pty Ltd Australia Epygenix Therapeutics, Inc. Wyoming, USA |
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| February 24, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001- |
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| February 24, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): February 24, 2026 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| February 24, 2026 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG 2025 FINANCIAL RESULTS AND REITERATES 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION WAKIX 2025 Net Revenue of $868.5 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy Recently Completed Settlements with 3 Additional Generic Filers Toward Goal of Securing WAKIX Franchise Pitolisant GR NDA Su |
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| February 24, 2026 |
Copyright © 2026 Harmony Biosciences. All rights reserved. Q4 & FY 2025 Financial Results & Business Update February 24, 2026 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered |
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| February 24, 2026 |
HARMONY BIOSCIENCES HOLDINGS, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION Exhibit 97.1 HARMONY BIOSCIENCES HOLDINGS, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION Harmony Biosciences Holdings, Inc. (the “Company”) has adopted this Policy for Recovery of Erroneously Awarded Compensation (the “Policy”), effective as of October 2, 2023 (the “Effective Date”). Capitalized terms used in this Policy but not otherwise defined herein are defined in Section 11. 1. |
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| January 12, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 12, 2026 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| January 12, 2026 |
Exhibit 99.1 HARMONY BIOSCIENCES GUIDES TO OVER $1 BILLION IN WAKIX® REVENUE IN 2026; ADVANCING ROBUST LATE-STAGE PIPELINE WITH POTENTIAL FOR LONG- TERM VALUE CREATION WAKIX 2025 Preliminary Net Revenue of ~$868 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy On Track to Extend the Pitolisant Franchise into the 2040s With Next Gen Pito |
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| January 12, 2026 |
Exhibit 99.2 Copyright © 2026 Harmony Biosciences. All rights reserved. 44th Annual J.P. Morgan Healthcare Conference JEFFREY M. DAYNO, MD January 13,2026 | San Francisco Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matt |
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| November 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 4, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| November 4, 2025 |
Exhibit 99.2 Copyright © 2024 Harmony Biosciences. All rights reserved. Q3 2025 Financial Results & Business Update November 4 , 2025 Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release th |
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| November 4, 2025 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG Q3 2025 FINANCIAL RESULTS; RECENTLY RAISED 2025 REVENUE GUIDANCE TO $845-$865M WAKIX® (pitolisant) Franchise Delivers Net Revenue of $239M in Q3 2025 (+29% YoY Growth) Record Increase in Average Number of Patients of Approximately 500 to Achieve 8,100 Average Patients in Q3 2025 Strong Cash Generation of $106M with $778M On Balance Sheet at end of Q |
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| November 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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| October 23, 2025 |
HARMONY BIOSCIENCES PREANNOUNCES STRONG Q3 2025 WAKIX PERFORMANCE; RAISES 2025 REVENUE GUIDANCE Exhibit 99.1 HARMONY BIOSCIENCES PREANNOUNCES STRONG Q3 2025 WAKIX PERFORMANCE; RAISES 2025 REVENUE GUIDANCE PLYMOUTH MEETING, Pa., October 23, 2025 /Business Wire/ - Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced preliminary results for Q3 2025, highlighted by the following: ● WAKIX® (pitolisant) franchise delivered net revenue of approximately $239M in Q3 2025, representing 2 |
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| October 23, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 23, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| September 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 24, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IR |
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| September 24, 2025 |
HARMONY BIOSCIENCES PROVIDES UPDATE FROM ITS PHASE 3 RECONNECT STUDY OF ZYN002 IN FRAGILE X SYNDROME Exhibit 99.1 HARMONY BIOSCIENCES PROVIDES UPDATE FROM ITS PHASE 3 RECONNECT STUDY OF ZYN002 IN FRAGILE X SYNDROME PLYMOUTH MEETING, Pa., September 24, 2025 - Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS). The RECONNECT Study did not meet the primary endpo |
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| August 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 5, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| August 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 00 |
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| August 5, 2025 |
Exhibit 99.2 Copyright © 2024 Harmony Biosciences. All rights reserved. Q2 2025 Financial Results & Business Update August 5, 2025 Exhibit 99.2 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact sh |
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| August 5, 2025 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG Q2 2025 FINANCIAL RESULTS AND REAFFIRMS 2025 REVENUE GUIDANCE; ON TRACK TO ANNOUNCE FRAGILE X TOPLINE DATA FROM PHASE 3 REGISTRATIONAL TRIAL IN Q3 2025 ● WAKIX® (pitolisant) Franchise Continues Strong Growth with Net Revenue of $200.5M for Q2 2025 (+16% YoY Growth); Increases Average Patients by 400 to Achieve 7,600 Average Patients in Q2 2025 ● Pha |
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| June 11, 2025 |
Exhibit 99.1 Harmony Biosciences Presents Preclinical Data Demonstrating Significant Wake-Promoting and Cataplexy-Suppressing Effects of BP1.15205 in Narcolepsy at SLEEP 2025 BP1.15205 is a potentially best-in-class OX2R agonist being investigated in narcolepsy and other central disorders of hypersomnolence A first-in-human study is planned to start in 2H 2025; topline clinical data is anticipate |
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| June 11, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 11, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emp |
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| June 5, 2025 |
HARMONY BIOSCIENCES STRENGTHENS PATENT POSITION WITH FAVORABLE SETTLEMENT IN ANDA LITIGATION Exhibit 99.1 HARMONY BIOSCIENCES STRENGTHENS PATENT POSITION WITH FAVORABLE SETTLEMENT IN ANDA LITIGATION PLYMOUTH MEETING, Pa., June 5, 2025 /Business Wire/ — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of |
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| June 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 5, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Empl |
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| May 15, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 15, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Empl |
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| May 6, 2025 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG Q1 2025 FINANCIAL RESULTS, HIGHLIGHTS ADVANCEMENT OF ITS PIPELINE AND UPCOMING CATALYSTS, AND REAFFIRMS 2025 REVENUE GUIDANCE WAKIX® (pitolisant) Net Revenue of $184.7 Million for First Quarter 2025; Representing 20% Growth Year-over-Year; Reiterates Guidance of $820-$860M Net Income Grew 19% Year-over-Year, Building on Four Consecutive Years of Pro |
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| May 6, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 6, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emplo |
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| May 6, 2025 |
Copyright © 2025 Harmony Biosciences. All rights reserved. Q1 2025 Financial Results & Business Update May 6, 2025 Exhibit 99.2 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be consider |
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| May 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 |
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| April 15, 2025 |
April 15, 2025 Sandip Kapadia Chief Financial Officer Harmony Biosciences Holdings, Inc. |
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| April 9, 2025 |
April 9, 2025 Eric Atallah United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| April 4, 2025 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by R |
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| April 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy St |
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| April 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ց ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR տ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BI |
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| April 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 2, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emp |
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| April 3, 2025 |
HARMONY BIOSCIENCES APPOINTS BIOTECH LEADER RON PHILIP TO ITS BOARD OF DIRECTORS Exhibit 99.1 HARMONY BIOSCIENCES APPOINTS BIOTECH LEADER RON PHILIP TO ITS BOARD OF DIRECTORS PLYMOUTH MEETING, Pa., Apr. 3, 2025 - Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the appointment of Ron Philip to the Company's Board of Directors. Ron Philip is the President and Chief Executive Officer of Orbital Therapeutics. Ron has 30 years of experience building companies, le |
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| March 28, 2025 |
March 28, 2025 Sandip Kapadia Chief Financial Officer Harmony Biosciences Holdings, Inc. |
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| March 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 20, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| March 24, 2025 |
Exhibit 10.1 SEPARATION AGREEMENT This Separation Agreement (this “Agreement”) is entered into by and between Jeffrey Dierks (“Executive”) and Harmony Biosciences Holdings, Inc., Harmony Biosciences, LLC and Harmony Biosciences Management, Inc. (together the “Company”), effective as of March 20, 2025 (the “Effective Date”). 1. Transition and Separation. (a) Executive shall remain employed by the |
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| March 24, 2025 |
Exhibit 99.1 HARMONY BIOSCIENCES NAMES ADAM ZAESKE AS CHIEF COMMERCIAL OFFICER TO LEAD THE NEXT PHASE OF COMMERCIAL GROWTH AS ITS PORTFOLIO EXPANDS PLYMOUTH MEETING, Pa., March 24, 2025 /Business Wire/ — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the appointment of Adam Zaeske as Executive Vice President and Chief Commercial Officer (CCO), effective March 31, 2025. The com |
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| February 25, 2025 |
Calculation of Filing Fee Tables S-8 Harmony Biosciences Holdings, Inc. Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee 1 Equity Common Stock, $0.00001 par value per share 457(a) 2,285,795 $ 34.85 $ 79,659,955.75 0.0001531 $ 12 |
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| February 25, 2025 |
List of Subsidiaries of Harmony Biosciences Holdings, Inc. Exhibit 21.1 Subsidiaries of Harmony Biosciences Holdings, Inc. Subsidiary Jurisdiction Harmony Biosciences, LLC Delaware, USA Harmony Biosciences Management, Inc. Delaware, USA Zynerba Pharmaceuticals Pty Ltd Australia Epygenix Therapeutics, Inc. Wyoming, USA |
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| February 25, 2025 |
Exhibit 19.1 HARMONY BIOSCIENCES HOLDINGS, INC. INSIDER TRADING compliance POLICY CONTENTS Page I. SUMMARY 1 II. STATEMENT OF POLICIES PROHIBITING INSIDER TRADING 1 III. EXPLANATION OF INSIDER TRADING 2 IV. STATEMENT OF PROCEDURES PREVENTING INSIDER TRADING 6 V. ADDITIONAL PROHIBITED TRANSACTIONS 9 VI. RULE 10b5-1 TRADING PLANS, SECTION 16 AND RULE 144 11 VII. EXECUTION AND RETURN OF CERTIFICATION |
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| February 25, 2025 |
Policy Relating to Recovery of Erroneously Awarded Compensation Exhibit 97.1 HARMONY BIOSCIENCES HOLDINGS, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION Harmony Biosciences Holdings, Inc. (the “Company”) has adopted this Policy for Recovery of Erroneously Awarded Compensation (the “Policy”), effective as of October 2, 2023 (the “Effective Date”). Capitalized terms used in this Policy but not otherwise defined herein are defined in Section 11. 1. |
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| February 25, 2025 |
Calculation of Filing Fee Tables. Calculation of Filing Fee Tables S-3 Harmony Biosciences Holdings, Inc. Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial |
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| February 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001- |
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| February 25, 2025 |
As filed with the Securities and Exchange Commission on February 25, 2025 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on February 25, 2025 Registration No. |
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| February 25, 2025 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG 2024 FINANCIAL RESULTS AND REITERATES 2025 NET REVENUE GUIDANCE; HIGHLIGHTS 2025 CATALYSTS IN SLEEP/WAKE AND FRAGILE X SYNDROME DEVELOPMENT PROGRAMS WAKIX® (pitolisant) Net Revenue of $201.3 Million for Fourth Quarter and $714.7 Million for Full Year 2024; Representing Growth of 23% in Year-Five on the Market 2025 WAKIX Net Revenue Guidance Between |
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| February 25, 2025 |
Exhibit 1.2 HARMONY BIOSCIENCES HOLDINGS, INC. Shares of Common Stock ($0.00001 par value per share) SALES AGREEMENT February 25, 2025 LEERINK PARTNERS LLC 1301 Avenue of the Americas, 5th Floor New York, New York 10019 CANTOR FITZGERALD & CO. 110 E. 59th Street, 6th Floor New York, New York 10022 Ladies and Gentlemen: Harmony Biosciences Holdings, Inc., a Delaware corporation (the “Company”), con |
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| February 25, 2025 |
Exhibit 99.2 Copyright © 2025 Harmony Biosciences. All rights reserved. Q4 & FY 2024 Financial Results & Business Update February 25, 2025 Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, incl |
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| February 25, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): February 25, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| February 25, 2025 |
As filed with the United States Securities and Exchange Commission on February 25, 2025 As filed with the United States Securities and Exchange Commission on February 25, 2025 Registration No. |
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| February 12, 2025 |
EX-1 2 ea023057701ex-1harmony.htm JOINT FILER AGREEMENT Exhibit 1 Joint Filer Agreement The undersigned hereby agree and acknowledge that the statement containing the information required by Schedule 13G/A, to which this agreement is attached as an exhibit, is filed on behalf of each of them, and any amendments or supplements to the Schedule 13G/A shall also be filed on behalf of each of them. Dat |
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| February 5, 2025 |
EX-24 2 PowerOfAttorney.txt EXHIBIT 24: POWER OF ATTORNEY POWER OF ATTORNEY The undersigned, BlackRock, Inc., a corporation duly organized under the laws of the State of Delaware, United States (the "Company"), does hereby make, constitute and appoint each of Eric Andruczyk, Richard Cundiff, R. Andrew Dickson, III, Spencer Fleming, Laura Hildner, David Maryles, Christopher Meade, Charles Park, Jam |
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| February 5, 2025 |
EX-99 3 ITEM7.txt EXHIBIT 99: ITEM 7 BlackRock Advisors, LLC Aperio Group, LLC BlackRock (Netherlands) B.V. BlackRock Fund Advisors* BlackRock Institutional Trust Company, National Association BlackRock Asset Management Ireland Limited BlackRock Financial Management, Inc. BlackRock Japan Co., Ltd. BlackRock Asset Management Schweiz AG BlackRock Investment Management, LLC BlackRock Investment Manag |
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| January 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 13, 2025 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| January 13, 2025 |
Exhibit 99.2 Copyright © 2025 Harmony Biosciences. All rights reserved. 4 3 r d Annual JP Morgan Healthcare Conference JEFFREY M. DAYNO, MD January 15, 2025 | San Francisco Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in |
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| January 13, 2025 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG 2024 REVENUES, PROVIDES 2025 REVENUE GUIDANCE AND HIGHLIGHTS KEY PIPELINE CATALYSTS WAKIX® (pitolisant) Preliminary Net Revenue of ~$201 Million for Fourth Quarter and ~$714 Million for Full Year 2024; Representing Growth of ~23% in Year-Five of Launch 2025 WAKIX Net Revenue Guidance Between $820 - $860 Million; On Track to a Potential $1 Billion+ Op |
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| November 1, 2024 |
Exhibit 1.1 Harmony Biosciences Holdings, Inc. 8,000,000 Shares of Common Stock Underwriting Agreement October 30, 2024 J.P. Morgan Securities LLC As representative of the several Underwriters named in Schedule I hereto, c/o J.P. Morgan Securities LLC 383 Madison Avenue New York, New York 10179 Ladies and Gentlemen: Certain stockholders listed on Schedule II hereto (the “Selling Stockholders”) of |
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| November 1, 2024 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 30, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction of incorporation) |
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| October 31, 2024 |
Table 1: Newly Registered and Carry Forward Securities Calculation of Filing Fee Tables S-3 Harmony Biosciences Holdings, Inc. Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial |
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| October 31, 2024 |
TABLE OF CONTENTS Filed pursuant to Rule 424(b)(7) Registration Number 333-260905 PROSPECTUS SUPPLEMENT (To Prospectus dated November 9, 2021) 8,000,000 Shares Common Stock The selling shareholders identified in this prospectus supplement are selling up to an aggregate of 8,000,000 shares of Harmony Biosciences Holdings, Inc. |
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| October 29, 2024 |
Exhibit 99.2 Copyright © 2024 Harmony Biosciences. All rights reserved. Q3 2024 Financial Results and Business Updates October 29, 2024 Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, includi |
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| October 29, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 29, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| October 29, 2024 |
TABLE OF CONTENTS The information in this prospectus supplement is not complete and may be changed. |
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| October 29, 2024 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2024 FINANCIAL RESULTS AND HIGHLIGHTS CATALYST-RICH, LATE-STAGE PIPELINE POISED TO DELIVER ONE OR MORE NEW LAUNCHES EVERY YEAR OVER NEXT FIVE YEARS WAKIX (pitolisant) Net Revenue of $186.0 Million for Third Quarter 2024; Surpassed $2B in Cumulative Net Revenue in Less Than Five Years On Track to Submit sNDA for Pitolisant in Idiopathic |
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| October 29, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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| October 1, 2024 |
Exhibit 99.2 HARMONY BIOSCIENCES HIGHLIGHTS NEW DATA, ROBUST LATE-STAGE PIPELINE WITH NEAR-TERM VALUE CREATION OPPORTUNITIES AND ITS BOLD NEW VISION AT INVESTOR DAY BP1.15205 Data Indicates Potential Best-In-Class Orexin-2 Agonist Based on Highest Potency New Data Shows Clinically Meaningful Sustained Efficacy of Pitolisant in Patients with Idiopathic Hypersomnia in Long-Term Extension Study; On T |
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| October 1, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 1, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS E |
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| October 1, 2024 |
Exhibit 99.1 Copyright © 2024 Harmony Biosciences. All rights reserved. INVESTOR DAY 2024 October 1, 2024 | New York City Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements |
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| August 6, 2024 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG SECOND QUARTER 2024 FINANCIAL RESULTS AND ADVANCES PITOLISANT HIGH-DOSE PROGRAM TOWARD EXPECTED PDUFA DATE IN 2028 WAKIX® (pitolisant) Net Revenue of $172.8 Million for Second Quarter 2024; ~29% Growth Year-over-Year Next Generation Pitolisant High-Dose (HD) Program Advances Based on Pilot Pharmacokinetic (PK) Data with PDUFA Date Expected in 2028 t |
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| August 6, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 6, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| August 6, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 00 |
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| August 6, 2024 |
Exhibit 99.2 Q2 2024 Financial Results August 6, 2024 Tara Living with narcolepsy Taking WAKIX since 2020 Exhibit 99.2 2 Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Ha |
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| July 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 27, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emp |
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| May 29, 2024 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 29, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Empl |
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| May 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 1, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emplo |
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| May 3, 2024 |
Employment Letter between Harmony Biosciences, LLC, and Kumar Budur, as amended. Exbibit 10.1 Revised March 1, 2022 Dr. Kumar Budur 701 South Wells Street #2103 Chicago, IL 60607 Dear Kumar: On behalf of Harmony Biosciences, LLC (“Harmony Biosciences” or the “Company”), I am pleased to extend an offer of employment with the Company as Senior Vice President and Head of Clinical Development. Except for business travel on behalf of the Company, you will be a remote employee and |
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| April 30, 2024 |
AMENDMENT NO. 1 TO LICENSE AND COMMERCIALIZATION AGREEMENT This Amendment No. 1, dated as of April 6, 2024 (this “First Amendment”), to the License and Commercialization Agreement, dated as of July 31, 2022, (the “Agreement”), is entered into between Bioprojet Société Civile de Recherche, an independent (privately) owned research company organized under the laws of France and having its principal |
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| April 30, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 30, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| April 30, 2024 |
AMENDMENT NO. 2 TO LICENSE AND COMMERCIALIZATION AGREEMENT This Amendment No. 2, dated as of April 6, 2024 (this “Second Amendment”), to the License and Commercialization Agreement, dated as of July 28, 2017, and amended on August 27, 2018 (the “First Amendment”, collectively the “Agreement”), is entered into between Bioprojet Société Civile de Recherche, an independent (privately) owned research |
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| April 30, 2024 |
Q1 2024 Financial Results April 30, 2024 Exhibit 99.2 2 Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.’s (the “Company”) future financi |
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| April 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 |
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| April 30, 2024 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG FIRST QUARTER FINANCIAL RESULTS AND ACCELERATION OF ITS GROWTH STRATEGY; ADVANCES PITOLISANT FRANCHISE TO EXTEND REVENUE POTENTIAL BEYOND 2040; STRENGHTENS SLEEP/WAKE LEADERSHIP AND DIVERSIFIES INTO RARE EPILEPSY WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for |
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| April 11, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy St |
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| April 11, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A (Amendment No.1) (Mark One) ց ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR տ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 |
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| April 11, 2024 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 6, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emp |
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| April 11, 2024 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ D |
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| February 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A (Amendment No.1) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A (Amendment No.1) (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001 |
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| February 22, 2024 |
Policy Relating to Recovery of Erroneously Awarded Compensation Exhibit 97.1 HARMONY BIOSCIENCES HOLDINGS, INC. POLICY FOR RECOVERY OF ERRONEOUSLY AWARDED COMPENSATION Harmony Biosciences Holdings, Inc. (the “Company”) has adopted this Policy for Recovery of Erroneously Awarded Compensation (the “Policy”), effective as of October 2, 2023 (the “Effective Date”). Capitalized terms used in this Policy but not otherwise defined herein are defined in Section 11. 1. |
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| February 22, 2024 |
Exhibit 107 Calculation of Filing Fee Table Form S-8 (Form Type) Harmony Biosciences Holdings, Inc. |
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| February 22, 2024 |
Q4 and Full Year 2023 Financial and Business Update February 22, 2024 Exhibit 99.2 Forward-Looking Statements 2 This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.’s ( |
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| February 22, 2024 |
List of Subsidiaries of Harmony Biosciences Holdings, Inc. Exhibit 21.1 Subsidiaries of Harmony Biosciences Holdings, Inc. Subsidiary Jurisdiction Harmony Biosciences, LLC Delaware, USA Zynerba Pharmaceuticals, Inc. Delaware, USA Zynerba Pharmaceuticals Pty Ltd Australia |
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| February 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): February 22, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| February 22, 2024 |
As filed with the United States Securities and Exchange Commission on February 22, 2024 As filed with the United States Securities and Exchange Commission on February 22, 2024 Registration No. |
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| February 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001- |
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| February 22, 2024 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX® (pitolisant) Net Revenue of $168.4 Million for Fourth Quarter and $582.0 Million for Full Year 2023; Representing Growth of ~31% and ~33%, Respectively U.S. Food and Drug Administration (FDA) Granted Priority Review for WAKIX in Pediatric Narcolepsy; PDUFA Date of June 21, 2024 |
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| February 13, 2024 |
SC 13G/A 1 d778408dsc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 3)* Harmony Biosciences Holdings, Inc (Name of Issuer) Common Stock, $0.00001 par value per share (Title of Class of Securities) 413197 104 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this S |
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| February 13, 2024 |
EX-99.1 2 d778408dex991.htm EX-99.1 Exhibit 99.1 Joint Filer Agreement The undersigned hereby agree and acknowledge that the statement containing the information required by Schedule 13G/A, to which this agreement is attached as an exhibit, is filed on behalf of each of them, and any amendments or supplements to the Schedule 13G/A shall also be filed on behalf of each of them. Dated: February 13, |
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| February 13, 2024 |
HRMY / Harmony Biosciences Holdings, Inc. / VANGUARD GROUP INC - SCHEDULE 13G/A Passive Investment SC 13G/A 1 tv01076-harmonybiosciencesho.htm SCHEDULE 13G/A SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 1)* Name of issuer: Harmony Biosciences Holdings Inc Title of Class of Securities: Common Stock CUSIP Number: 413197104 Date of Event Which Requires Filing of this Statement: December 29, 2023 Check the appropria |
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| February 9, 2024 |
HRMY / Harmony Biosciences Holdings, Inc. / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.5 HARMONY BIOSCIENCES HOLDINGS INC COMMON STOCK Cusip #413197104 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #413197104 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 5,275,851 Item 6: 0 Item 7: 5,276,825 Item |
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| January 24, 2024 |
HRMY / Harmony Biosciences Holdings, Inc. / BlackRock Inc. Passive Investment SC 13G/A 1 us4131971040012424.txt us4131971040012424.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: 3) Harmony Biosciences Holdings, Inc. - (Name of Issuer) Common Stock - (Title of Class of Securities) 413197104 - (CUSIP Number) December 31, 2023 - (Date of Event Which Requires Filing of this Statement) Check the |
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| January 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 8, 2024 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS E |
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| January 8, 2024 |
Exhibit 99.1 HARMONY BIOSCIENCES PRELIMINARY UNAUDITED FOURTH QUARTER AND FULL YEAR 2023 NET PRODUCT REVENUE INCREASES MORE THAN 30 PERCENT; PROVIDES 2024 NET PRODUCT REVENUE GUIDANCE WAKIX® (pitolisant) Preliminary Net Revenue of ~$168 Million for Fourth Quarter and ~$582 Million for Full Year 2023; Representing Growth of ~31% and ~33%, Respectively Average Number of Patients on WAKIX Increased |
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| December 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No.1) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 10, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdictio |
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| December 7, 2023 |
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION Exhibit 99.3 UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION On October 10, 2023, Harmony Biosciences Holdings, Inc. (the “Company” or “Harmony”) completed the previously announced acquisition (“Transaction”) of Zynerba Pharmaceuticals, Inc. (“Zynerba”), pursuant to an Agreement and Plan of Merger, dated as of August 14, 2023, and amended on October 4, 2023 (the “Merger Agreement”), |
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| December 7, 2023 |
Zynerba Pharmaceuticals, Inc. Consolidated Financial Statements TABLE OF CONTENTS Exhibit 99.1 Zynerba Pharmaceuticals, Inc. Consolidated Financial Statements TABLE OF CONTENTS The following financial statements are filed as a part of this Annual Report on Form 10-K: Consolidated Financial Statements Report of Independent Registered Public Accounting Firm 1 Consolidated Balance Sheets as of December 31, 2022 and 2021 3 Consolidated Statements of Operations for the years ended D |
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| December 7, 2023 |
Exhibit 99.2 ZYNERBA PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS AS OF AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2023 Table of Contents Page Consolidated Balance Sheets (Unaudited) 1 Consolidated Statements of Operations (Unaudited) 2 Consolidated Statements of Stockholders’ Equity (Unaudited) 3 Consolidated Statements of Cash Flows (Unaudited) 5 Notes to Consolidated Financial Statements |
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| November 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 5, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| November 8, 2023 |
HARMONY BIOSCIENCES APPOINTS PETER Anastasiou To Its Board of Directors Exhibit 99.1 HARMONY BIOSCIENCES APPOINTS PETER Anastasiou To Its Board of Directors PLYMOUTH MEETING, PA, November 8, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the appointment of Peter Anastasiou to th |
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| October 31, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2023 FINANCIAL RESULTS Continued Strong Growth with WAKIX® (pitolisant) Net Revenue of $160.3 Million for Third Quarter 2023; Increased ~37% Year-over-Year Average Number of Patients on WAKIX Increased by ~350 Sequentially to ~5,800 for Third Quarter 2023 Remain Committed and Continue to Pursue Idiopathic Hypersomnia Indication; Next S |
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| October 31, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 31, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| October 31, 2023 |
Exhibit 99.2 Q3 2023 Financial and Business Update October 31, 2023 Exhibit 99.2 Forward-Looking Statements 2 This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.’s (th |
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| October 31, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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| October 13, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES ANNOUNCES TOPLINE DATA FROM PHASE 3 INTUNE STUDY EVALUATING PITOLISANT IN PATIENTS WITH IDIOPATHIC HYPERSOMNIA Pitolisant demonstrated clinically meaningful benefit in patients completing the initial open label phase Although primary outcome for excessive daytime sleepiness (EDS) between pitolisant and placebo did not reach statistical significance in the randomiz |
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| October 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 13, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| October 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 10, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| October 11, 2023 |
Exhibit (a)(5)(C) HARMONY BIOSCIENCES COMPLETES ACQUISITION OF ZYNERBA PHARMACEUTICALS AND EXPANDS PIPELINE New product in development diversifies portfolio to drive long-term growth Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs Zygel™ in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study in 22q11. |
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| October 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 4) Zynerba Pharmaceuticals, Inc. (Name of Subject Company (Issuer)) Xylophone Acquisition Corp. a wholly owned subsidiary of Harmony Biosciences Holdings, Inc. (Names of Filing Persons (identifying status |
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| October 11, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES COMPLETES ACQUISITION OF ZYNERBA PHARMACEUTICALS AND EXPANDS PIPELINE New product in development diversifies portfolio to drive long-term growth Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs Zygel™ in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study i |
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| October 6, 2023 |
HRMY / Harmony Biosciences Holdings Inc / BlackRock Inc. Passive Investment SC 13G/A 1 us4131971040100523.txt us4131971040100523.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: 2) Harmony Biosciences Holdings, Inc. - (Name of Issuer) Common Stock - (Title of Class of Securities) 413197104 - (CUSIP Number) September 30, 2023 - (Date of Event Which Requires Filing of this Statement) Check th |
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| October 5, 2023 |
Exhibit (a)(1)(G) Notice of Guaranteed Delivery to Tender of Shares of Common Stock Of ZYNERBA PHARMACEUTICALS, INC. |
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| October 5, 2023 |
Restricted Stock Unit Award Agreement dated October 4, 2023 with Sandip Kapadia Exhibit 10.1 HARMONY BIOSCIENCES HOLDINGS, INC. 2020 INCENTIVE AWARD PLAN RESTRICTED STOCK Unit Grant Notice Harmony Biosciences Holdings, Inc., a Delaware corporation (the “Company”), has granted to the participant listed below (“Participant”) the Restricted Stock Units (the “RSUs”) described in this Restricted Stock Unit Grant Notice (this “Grant Notice”), subject to the terms and conditions of |
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| October 5, 2023 |
Restricted Stock Unit Award Agreement dated October 4, 2023 with Jeffrey Dierks Exhibit 10.2 HARMONY BIOSCIENCES HOLDINGS, INC. 2020 INCENTIVE AWARD PLAN RESTRICTED STOCK Unit Grant Notice Harmony Biosciences Holdings, Inc., a Delaware corporation (the “Company”), has granted to the participant listed below (“Participant”) the Restricted Stock Units (the “RSUs”) described in this Restricted Stock Unit Grant Notice (this “Grant Notice”), subject to the terms and conditions of |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 30, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IR |
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| October 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 3) Zynerba Pharmaceuticals, Inc. (Name of Subject Company (Issuer)) Xylophone Acquisition Corp. a wholly owned subsidiary of Harmony Biosciences Holdings, Inc. (Names of Filing Persons (identifying statu |
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| October 5, 2023 |
AMENDMENT NO. 1 AGREEMENT AND PLAN OF MERGER Exhibit (d)(5) EXECUTION VERSION AMENDMENT NO. 1 TO AGREEMENT AND PLAN OF MERGER This AMENDMENT NO. 1 (this “Amendment”) dated as of October 4, 2023, to the Agreement and Plan of Merger, dated as of August 14, 2023 (the “Agreement”), by and among: Harmony Biosciences Holdings, Inc., a Delaware corporation (“Parent”); Xylophone Acquisition Corp., a Delaware corporation and a wholly owned subsidiary |
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| October 4, 2023 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 28, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IR |
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| September 27, 2023 |
HARMONY BIOSCIENCES ANNOUNCES EXTENSION OF TENDER OFFER TO ACQUIRE ZYNERBA PHARMACEUTICALS, INC. Exhibit 99.(a)(5)(B) HARMONY BIOSCIENCES ANNOUNCES EXTENSION OF TENDER OFFER TO ACQUIRE ZYNERBA PHARMACEUTICALS, INC. PLYMOUTH MEETING, Pa, September 27, 2023 — In connection with the previously announced merger agreement, Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), today announced that Xylophone Acquisition Corp., a wholly owned subsidiary of Harmony, has extended the expiratio |
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| September 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 2) Zynerba Pharmaceuticals, Inc. (Name of Subject Company (Issuer)) Xylophone Acquisition Corp. a wholly owned subsidiary of Harmony Biosciences Holdings, Inc. (Names of Filing Persons (identifying statu |
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| September 25, 2023 |
Exhibit 10.1 Execution Version FIRST INCREMENTAL AMENDMENT This FIRST INCREMENTAL AMENDMENT (this “First Incremental Amendment”), dated as of September 21, 2023, is entered into among HARMONY BIOSCIENCES HOLDINGS, INC., a Delaware corporation (the “Borrower”), each of the Subsidiary Guarantors party hereto, the Incremental Lenders (as defined below) and JPMOrgan CHASE BANK, N.A., as administrative |
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| September 25, 2023 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 21, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IR |
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| September 14, 2023 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 14, 2023 (August 14, 2023) HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State |
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| September 14, 2023 |
September 14, 2023 Mr. David Plattner U.S. Securities and Exchange Commission Division of Corporation Finance Office of Mergers & Acquisitions 100 F Street, N.E. Washington, D.C. 20549 Re: Zynerba Pharmaceuticals, Inc. SC TO-T filed August 28, 2023 Filed by Harmony Biosciences Holdings, Inc. File No. 005-88971 Mr. Plattner: This letter responds to the comments of the staff (the “Staff”) of the U.S |
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| September 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1) Zynerba Pharmaceuticals, Inc. (Name of Subject Company (Issuer)) Xylophone Acquisition Corp. a wholly owned subsidiary of Harmony Biosciences Holdings, Inc. (Names of Filing Persons (identifying statu |
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| September 14, 2023 |
Exhibit 2.1 EXECUTION VERSION AGREEMENT AND PLAN OF MERGER by and among HARMONY BIOSCIENCES HOLDINGS, INC., XYLOPHONE ACQUISITION CORP. and ZYNERBA PHARMACEUTICALS, INC. Dated as of August 14, 2023 TABLE OF CONTENTS ARTICLE 1 DEFINITIONS 2 Section 1.1. Definitions 2 ARTICLE 2 THE OFFER 13 Section 2.1. Tender Offer 13 Section 2.2. Actions of Parent and Merger Sub. 16 Section 2.3. Actions of the Com |
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| September 13, 2023 |
United States securities and exchange commission logo September 13, 2023 Sandip Kapadia Chief Financial Officer Harmony Biosciences Holdings, Inc. |
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| September 12, 2023 |
Eric Atallah and Tara Harkins United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| August 31, 2023 |
United States securities and exchange commission logo August 31, 2023 Sandip Kapadia Chief Financial Officer Harmony Biosciences Holdings, Inc. |
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| August 28, 2023 |
Exhibit (a)(1)(D) Offer to Purchase All Outstanding Shares of Common Stock of ZYNERBA PHARMACEUTICALS, INC. |
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| August 28, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Schedule TO Zynerba Pharmaceuticals, Inc. |
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| August 28, 2023 |
CONFIDENTIALITY AND NONDISCLOSURE AGREEMENT Exhibit (d)(4) CONFIDENTIALITY AND NONDISCLOSURE AGREEMENT THIS CONFIDENTIALITYANDNONDISCLOSURE AGREEMENT (this“Agreement”) is entered into as of this 17th day of November, 2021, by and between Harmony Biosciences, LLC “Harmony”), a Delaware limited liability company, and Zynerba Pharmaceuticals, Inc. |
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| August 28, 2023 |
Exhibit (a)(1)(C) Offer to Purchase All Outstanding Shares of Common Stock of ZYNERBA PHARMACEUTICALS, INC. |
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| August 28, 2023 |
FORM OF CONTINGENT VALUE RIGHTS AGREEMENT Exhibit (d)(2) FORM OF CONTINGENT VALUE RIGHTS AGREEMENT THIS CONTINGENT VALUE RIGHTS AGREEMENT, dated as of [●], 2023 (this “Agreement”), is entered into by and between Harmony Biosciences Holdings, Inc. |
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| August 28, 2023 |
Exhibit (a)(1)(F) This announcement is neither an offer to purchase nor a solicitation of an offer to sell Shares (as defined below). |
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| August 28, 2023 |
Exhibit (a)(1)(B) LETTER OF TRANSMITTAL to Tender Shares of Common Stock of ZYNERBA PHARMACEUTICALS, INC. |
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| August 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Zynerba Pharmaceuticals, Inc. (Name of Subject Company (Issuer)) Xylophone Acquisition Corp. a wholly owned subsidiary of Harmony Biosciences Holdings, Inc. (Names of Filing Persons (Offerors)) Common Stock, $0.001 par |
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| August 28, 2023 |
Exhibit (a)(1)(A) Offer to Purchase All Outstanding Shares of Common Stock of ZYNERBA PHARMACEUTICALS, INC. |
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| August 24, 2023 |
ZYNE / Zynerba Pharmaceuticals Inc / Harmony Biosciences Holdings, Inc. - SC 13D Activist Investment SC 13D 1 brhc20057945sc13d.htm SC 13D UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 ZYNERBA PHARMACEUTICALS, INC. (Name of Issuer) Common Stock, par value $0.001 (Title of Class of Securities) 98986X109 (CUSIP Number) Christian Ulrich General Counsel and Corporate Secretary Harmony Biosciences Holdings, Inc. 630 W. Ge |
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| August 24, 2023 |
EX-99.3 2 brhc20057945ex99-3.htm EXHIBIT 99.3 Exhibit 99.3 JOINT FILING AGREEMENT The undersigned hereby agree that they are filing this statement jointly pursuant to Rule 13d-1(k)(1). Each of them is responsible for the timely filing of such Schedule 13D and any amendments thereto, and for the completeness and accuracy of the information concerning such person contained therein; but none of them |
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| August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 14, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS E |
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| August 14, 2023 |
Exhibit 99.2 Harmony Biosciences Proposed Acquisition of Zynerba Pharmaceuticals, Inc. Conference Call August 14, 2023 Corporate Speakers • Luis Sanay; Harmony Biosciences; Head of Investor Relations • Jeffrey Dayno; Harmony Biosciences; President and Chief Executive Officer • Sandip Kapadia; Harmony Biosciences; Chief Financial Officer • Kumar Budur; Harmony Biosciences; Chief Medical Officer Par |
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| August 14, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES TO ACQUIRE ZYNERBA PHARMACEUTICALS, INC. Acquisition expands pipeline and diversifies portfolio to drive long-term growth Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs Lead asset in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study in 22q11.2 deletion |
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| August 14, 2023 |
Exhibit 99.2 HARMONY BIOSCIENCES TO ACQUIRE ZYNERBA PHARMACEUTICALS, INC. Acquisition expands pipeline and diversifies portfolio to drive long-term growth Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs Lead asset in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study in 22q11.2 deletion |
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| August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 14, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS E |
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| August 14, 2023 |
Exhibit 99.1 Execution Version TENDER AND SUPPORT AGREEMENT This Tender and Support Agreement (this “Agreement”) is entered into as of August 14, 2023, by and among Harmony Biosciences Holdings, Inc., a Delaware corporation (“Parent”), Xylophone Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”), and [●] (“Stockholder”). Recitals A.Parent, Merger Sub a |
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| August 14, 2023 |
Exhibit 2.1 EXECUTION VERSION AGREEMENT AND PLAN OF MERGER by and among HARMONY BIOSCIENCES HOLDINGS, INC., XYLOPHONE ACQUISITION CORP. and ZYNERBA PHARMACEUTICALS, INC. Dated as of August 14, 2023 NO AGREEMENT, ORAL OR WRITTEN, REGARDING OR RELATING TO ANY OF THE MATTERS COVERED BY THIS DOCUMENT HAS BEEN ENTERED INTO BETWEEN THE PARTIES. THIS DOCUMENT IS INTENDED SOLELY TO FACILITATE DISCUSSIONS |
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| August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Zynerba Pharmaceuticals, Inc. (Name of Subject Company (Issuer)) Xylophone Acquisition Corp. a wholly owned subsidiary of Harmony Biosciences Holdings, Inc. (Names of Filing Persons (Offerors)) Common Stock, $0.001 par |
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| August 14, 2023 |
Exhibit 99.1 Execution Version TENDER AND SUPPORT AGREEMENT This Tender and Support Agreement (this “Agreement”) is entered into as of August 14, 2023, by and among Harmony Biosciences Holdings, Inc., a Delaware corporation (“Parent”), Xylophone Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”), and [●] (“Stockholder”). Recitals A.Parent, Merger Sub a |
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| August 14, 2023 |
Exhibit 2.1 EXECUTION VERSION AGREEMENT AND PLAN OF MERGER by and among HARMONY BIOSCIENCES HOLDINGS, INC., XYLOPHONE ACQUISITION CORP. and ZYNERBA PHARMACEUTICALS, INC. Dated as of August 14, 2023 NO AGREEMENT, ORAL OR WRITTEN, REGARDING OR RELATING TO ANY OF THE MATTERS COVERED BY THIS DOCUMENT HAS BEEN ENTERED INTO BETWEEN THE PARTIES. THIS DOCUMENT IS INTENDED SOLELY TO FACILITATE DISCUSSIONS |
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| August 14, 2023 |
Press release issued by the Company dated August 14, 2023 Exhibit 99.2 HARMONY BIOSCIENCES TO ACQUIRE ZYNERBA PHARMACEUTICALS, INC. Acquisition expands pipeline and diversifies portfolio to drive long-term growth Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs Lead asset in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study in 22q11.2 deletion |
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| August 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 00 |
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| August 1, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX® (pitolisant) Net Revenue Increased ~25% Year-over-Year to $134.2 Million for Second Quarter 2023 Average Number of Patients on WAKIX Increased by ~350 Sequentially to ~5,450 for Second Quarter 2023 Exited Second Quarter 2023 With ~5,600 Patients on WAKIX Completed Enrollment in Phase 3 Idiop |
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| August 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 1, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| August 1, 2023 |
Exhibit 99.2 Q2 2023 Financial and Business Update August 1, 2023 Exhibit 99.2 Forward-Looking Statements 2 This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.’s (the |
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| July 27, 2023 |
Exhibit 10.3 EXECUTION VERSION PLEDGE AND SECURITY AGREEMENT THIS PLEDGE AND SECURITY AGREEMENT (as the same may be amended, restated, supplemented or otherwise modified from time to time, this “Security Agreement”) is entered into as of July 26, 2023 by and among HARMONY BIOSCIENCES HOLDINGS, INC., a Delaware corporation (the “Borrower”), each of the Subsidiaries (as defined in the Credit Agreeme |
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| July 27, 2023 |
Exhibit 10.1 EXECUTION VERSION CREDIT AGREEMENT dated as of July 26, 2023 among HARMONY BIOSCIENCES HOLDINGS, INC., as Borrower The Lenders Party Hereto JPMORGAN CHASE BANK, N.A. as Administrative Agent and JPMORGAN CHASE BANK, N.A., as Bookrunner and Lead Arranger TABLE OF CONTENTS Page Article I Definitions1 Section 1.01 Defined Terms1 Section 1.02 Classification of Loans and Borrowings45 Sec |
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| July 27, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES ENTERS INTO $185 MILLION TERM LOAN FACILITY Financing further strengthens balance sheet Use of net proceeds and existing cash to repay existing debt Reduces annual interest expense by approximately $6 million PLYMOUTH MEETING, Pa., JULY 27, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and co |
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| July 27, 2023 |
Exhibit 10.2 EXECUTION VERSION GUARANTY THIS GUARANTY (as the same may be amended, restated, supplemented or otherwise modified from time to time, this “Guaranty”) is made as of July 26, 2023 by and among each of the Subsidiaries of HARMONY BIOSCIENCES HOLDINGS, INC., a Delaware corporation (the “Borrower”), listed on the signature pages hereto (each an “Initial Guarantor”) and those additional Ma |
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| July 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 26, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emp |
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| May 31, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 24, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| May 26, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 25, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Empl |
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| May 2, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX® (pitolisant) Net Revenue Increased ~40% Year-over-Year to $119.1 Million for First Quarter 2023 Average Number of Patients on WAKIX Increased ~1,200 Year-over-Year to ~5,100 for First Quarter 2023 Exited First Quarter 2023 With ~5,200 Patients on WAKIX WAKIX Surpassed $1 Billion in Cumulative |
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| May 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 2, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Emplo |
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| May 2, 2023 |
As filed with the United States Securities and Exchange Commission on May 2, 2023 As filed with the United States Securities and Exchange Commission on May 2, 2023 Registration No. |
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| May 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 |
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| May 2, 2023 |
Exhibit 99.2 Q1 2023 Financial and Business Update May 2, 2023 Exhibit 99.2 Forward Looking Statements 2 This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.’s (the “Co |
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| May 2, 2023 |
Exhibit 107 Calculation of Filing Fee Table Form S-8 (Form Type) Harmony Biosciences Holdings, Inc. |
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| April 24, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES ANNOUNCES JEFFREY M. DAYNO, M.D. APPOINTED PRESIDENT & CHIEF EXECUTIVE OFFICER Dr. Dayno joins Harmony Biosciences Board of Directors PLYMOUTH MEETING, Pa., April 24, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare |
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| April 24, 2023 |
Exhibit 10.1 -1- HARMONY BIOSCIENCES, LLC EXECUTIVE EMPLOYMENT AGREEMENT THIS EXECUTIVE EMPLOYMENT AGREEMENT (the “Agreement”), effective as of April 24, 2023 (the “Effective Date”), is made by and between Harmony Biosciences, LLC a Delaware limited liability company (the “Company”), and Jeffrey M. Dayno, M.D. (the “Executive”). W I T N E S S E T H: WHEREAS, the Executive currently serves as the i |
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| April 24, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 24, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| April 14, 2023 |
2022 Annual Report Our Growth StoryAt Harmony Biosciences, we are driven by our shared conviction that innovative science translates into therapeutic possibilities, that focusing on real-world results can take new therapies from the clinic to the medicine cabinet, and that this can provide value for not only patients, but for all our stakeholders. |
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| April 14, 2023 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ D |
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| April 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy St |
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| March 29, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 29, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| March 29, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES ANNOUNCES ACCELERATED TIMELINE FOR PHASE 3 INTUNE STUDY IN IDIOPATHIC HYPERSOMNIA Strong momentum in Phase 3 trial; enrollment ahead of schedule Expects to complete enrollment in the second quarter of 2023, just over one year from trial initiation Anticipates topline data in the fourth quarter of 2023 PLYMOUTH MEETING, PA, March 29, 2023 — Harmony Biosciences Hol |
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| March 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 10, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| February 21, 2023 |
Exhibit 10.12.2 HARMONY BIOSCIENCES HOLDINGS, INC. January 23, 2023 Jeffrey M. Dayno, M.D. [email protected] Re:Interim President and Chief Executive Officer Role Dear Mr. Dayno: As you know, on January 6, 2023, the Board of Directors (the “Board”) of Harmony Biosciences Holdings, Inc. (the “Company”) appointed you as Interim President and Chief Executive Officer of the Company (the “A |
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| February 21, 2023 |
List of Subsidiaries of Harmony Biosciences Holdings, Inc. Exhibit 21.1 Subsidiaries of Harmony Biosciences Holdings, Inc. Subsidiary Jurisdiction Harmony Biosciences, LLC Delaware |
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| February 21, 2023 |
Exhibit 99.2 Q4 & Full Year 2022 Financial and Business Update February 21, 2023 Exhibit 99.2 Forward Looking Statements 2 This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holding |
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| February 21, 2023 |
Exhibit 10.3 AMENDMENT TO THE HARMONY BIOSCIENCES HOLDINGS, INC. 2020 INCENTIVE AWARD PLAN THIS AMENDMENT (the “Amendment”) to the Harmony Biosciences Holdings, Inc. 2020 Incentive Award Plan (the “Plan”), is made and adopted by the Board of Directors (the “Board”) of Harmony Biosciences Holdings, Inc. (the “Company”), effective as of March 24, 2022 (the “Effective Date”). All capitalized terms us |
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| February 21, 2023 |
Exhibit 10.7.2 HARMONY BIOSCIENCES HOLDINGS, INC. ACKNOWLEDGMENT AND RELEASE AGREEMENT January 20, 2023 John Jacobs [REDACTED] Dear John, As you know, Harmony Biosciences Holdings, Inc. (the “Company”) previously granted to you the awards of stock options (the “Options”) set forth on Exhibit A hereto under and pursuant to the Company’s Amended and Restated Equity Incentive Plan (the “Plan”) and th |
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| February 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001- |
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| February 21, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX® (pitolisant) Net Revenue Increased ~41% Year-over-Year to $128.3 Million for Fourth Quarter 2022; ~43% to $437.9 Million for Full Year 2022 Achieved Net Income of $181.5 Million for Full Year 2022 Average Number of Patients on WAKIX Increased to ~4,900 Continued Strong Momentum |
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| February 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): February 21, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| February 14, 2023 |
SC 13G/A 1 tm235913d3sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* Harmony Biosciences Holdings, Inc. (Name of Issuer) Common Stock, par value $0.00001 per share (Title of Class of Securities) 413197104 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this |
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| February 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* Harmony Biosciences Holdings, Inc. (Name of Issuer) Common Stock, par value $0.00001 per share (Title of Class of Securities) 413197104 (CUSIP Number) December 31, 2022 (Date of Event which Requires Filing of this Statement) Check the appropriate box t |
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| February 13, 2023 |
SC 13G/A 1 d435240dsc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* Harmony Biosciences Holdings, Inc (Name of Issuer) Common Stock, $0.00001 par value per share (Title of Class of Securities) 413197 104 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this S |
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| February 13, 2023 |
EX-99.1 2 d435240dex991.htm EX-99.1 Exhibit 99.1 Joint Filer Agreement The undersigned hereby agree and acknowledge that the statement containing the information required by Schedule 13G/A, to which this agreement is attached as an exhibit, is filed on behalf of each of them, and any amendments or supplements to the Schedule 13G/A shall also be filed on behalf of each of them. Dated: February 14, |
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| February 9, 2023 |
HRMY / Harmony Biosciences Holdings Inc / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.4 HARMONY BIOSCIENCES HOLDINGS INC COMMON STOCK Cusip #413197104 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #413197104 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 5,582,031 Item 6: 0 Item 7: 5,582,728 Item |
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| February 9, 2023 |
HRMY / Harmony Biosciences Holdings Inc / VANGUARD GROUP INC - SCHEDULE 13G Passive Investment SC 13G 1 tv01040-harmonybiosciencesho.htm SCHEDULE 13G SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 Name of issuer: Harmony Biosciences Holdings Inc. Title of Class of Securities: Common Stock CUSIP Number: 413197104 Date of Event Which Requires Filing of this Statement: December 30, 2022 Check the appropriate box to designate the |
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| February 3, 2023 |
HRMY / Harmony Biosciences Holdings Inc / BlackRock Inc. Passive Investment us4131971040020323.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: 1) Harmony Biosciences Holdings, Inc. - (Name of Issuer) Common Stock - (Title of Class of Securities) 413197104 - (CUSIP Number) December 31, 2022 - (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the |
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| January 23, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 5, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| January 23, 2023 |
Exhibit 10.1 US-DOCS\138339073.5 HARMONY BIOSCIENCES HOLDINGS, INC. January 23, 2023 Jeffrey M. Dayno, M.D. [email protected] Re: Interim President and Chief Executive Officer Role Dear Mr. Dayno: As you know, on January 6, 2023, the Board of Directors (the “Board”) of Harmony Biosciences Holdings, Inc. (the “Company”) appointed you as Interim President and Chief Executive Officer of t |
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| January 23, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 17, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| January 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 5, 2023 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction of incorporation) |
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| January 6, 2023 |
Exhibit 99.1 HARMONY BIOSCIENCES APPOINTS JEFFREY DAYNO, MD AS INTERIM CEO AND EXPANDS ROLE OF JEFF ARONIN TO EXECUTIVE CHAIRMAN PLYMOUTH MEETING, PA, January 6, 2023 ? Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced |
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| November 1, 2022 |
Exhibit 10.2 Execution Version AMENDMENT NO. 1 TO CREDIT AGREEMENT THIS AMENDMENT NO. 1 TO CREDIT AGREEMENT, dated as of August 2, 2022 (this “Amendment”), is by and among HARMONY BIOSCIENCES HOLDINGS, INC., a Delaware corporation (the “Borrower”), its wholly owned subsidiary, HARMONY BIOSCIENCES, LLC, a Delaware limited liability company (“Harmony”), as the sole initial Guarantor and the Lenders |
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| November 1, 2022 |
Exhibit 99.2 Harmony Biosciences Q3 2022 Financial and Business Update November 1, 2022 Exhibit 99.2 Legal Disclaimer 2 This presentation includes forward ‐ looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings |
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| November 1, 2022 |
Exhibit 10.1 Certain identified information has been omitted from this document because it is not material and would be competitively harmful if publicly disclosed, and has been marked with “[***]” to indicate where omissions have been made. LICENSE AND COMMERCIALIZATION AGREEMENT THIS LICENSE AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of July 31, 2022 (“Signing Date”) is entered into |
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| November 1, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 1, 2022 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS |
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| November 1, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Numbe |
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| November 1, 2022 |
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX® (pitolisant) Net Revenue of $117.2 Million for Third Quarter 2022 Increase of ~45% vs. the Same Period in 2021 Average Number of Patients on WAKIX Increased to ~4,600 Prader-Willi Syndrome (PWS) Phase 2 Proof-Of-Concept Study Topline Data Showed Positive Signal in Treating Excessive Daytime S |
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| October 3, 2022 |
? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ? FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? Date of report (Date of earliest event reported): September 28, 2022 ? HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) ? ? ? ? Delaware 001-39450 82-2279923 (State or other jurisdiction |
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| September 28, 2022 |
Submission of Matters to a Vote of Security Holders ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ? FORM 8-K/A Amendment No. 1 CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? Date of report (Date of earliest event reported): May 20, 2022 ? HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) ? ? ? ? Delaware 001-39450 82-2279923 (State or other |
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| August 2, 2022 |
?Exhibit 99.1 ? HARMONY BIOSCIENCES REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX? (pitolisant) Net Revenue of $107.0 Million for Second Quarter 2022 Increase of 45% vs. the Same Period in 2021 ? Average Number of Patients on WAKIX Increased to ~4,300 ? Signs New Agreement with Bioprojet Focused on Developing Innovative Therapeutics Based on Pitolisant, Expanding Harmony |
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| August 2, 2022 |
Exhibit 99.2 Harmony Biosciences Q2 2022 Financial and Business Update August 2, 2022 Exhibit 99.2 Legal Disclaimer 2 This presentation includes forward ? looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, |
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| August 2, 2022 |
AMENDMENT TO THE HARMONY BIOSCIENCES HOLDINGS, INC. 2020 INCENTIVE AWARD PLAN Exhibit 10.1 ? AMENDMENT TO THE HARMONY BIOSCIENCES HOLDINGS, INC. 2020 INCENTIVE AWARD PLAN THIS AMENDMENT (the ?Amendment?) to the Harmony Biosciences Holdings, Inc. 2020 Incentive Award Plan (the ?Plan?), is made and adopted by the Board of Directors (the ?Board?) of Harmony Biosciences Holdings, Inc. (the ?Company?), effective as of March 24, 2022 (the ?Effective Date?). All capitalized terms |
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| August 2, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| August 2, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 2, 2022 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39450 82-2279923 (State or other jurisdiction (Commission (IRS Em |
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| May 23, 2022 |
Submission of Matters to a Vote of Security Holders ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ? FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? Date of report (Date of earliest event reported): May 20, 2022 ? HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) ? ? ? ? Delaware 001-39450 82-2279923 (State or other jurisdiction (Comm |
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| May 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| May 3, 2022 |
Exhibit 99.2 Harmony Biosciences Q1 2022 Financial and Business Update May 3, 2022 ([KLELW Legal Disclaimer 2 This presentation includes forward?looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.? |
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| May 3, 2022 |
?Exhibit 99.1 ? HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX? (pitolisant) Net Revenue of $85.3 Million for First Quarter 2022 Increase of 43% vs. the Same Period in 2021 ? WAKIX Surpasses $500 Million in Cumulative Net Revenue Since Launch ? Initiated Phase 3 Clinical Trial in Patients with Idiopathic Hypersomnia ? Conference Call and Webcast to be H |
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| May 3, 2022 |
Amendment to the Harmony Biosciences Holdings, Inc. 2020 Incentive Award Plan. Exhibit 10.1 ? AMENDMENT TO THE HARMONY BIOSCIENCES HOLDINGS, INC. 2020 INCENTIVE AWARD PLAN THIS AMENDMENT (the ?Amendment?) to the Harmony Biosciences Holdings, Inc. 2020 Incentive Award Plan (the ?Plan?), is made and adopted by the Board of Directors (the ?Board?) of Harmony Biosciences Holdings, Inc. (the ?Company?), effective as of March 24, 2022 (the ?Effective Date?). All capitalized terms |
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| May 3, 2022 |
? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ? FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? Date of report (Date of earliest event reported): May 3, 2022 ? HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) ? ? ? ? Delaware 001-39450 82-2279923 (State or other jurisdiction (Commi |
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| April 8, 2022 |
DEFA14A 1 ny20002758x2defa14a.htm DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted |
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| April 8, 2022 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ? ? ? Filed by a Party other than the Registrant ?? Check the appropriate box: ?? Preliminary Proxy Statement ?? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
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| February 28, 2022 |
? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ? FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? Date of report (Date of earliest event reported): February 28, 2022 ? HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) ? ? ? ? Delaware 001-39450 82-2279923 (State or other jurisdiction |
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| February 28, 2022 |
Exhibit 99.2 Harmony Biosciences Q4 2021 Financial and Business Update February 28, 2022 Exhibit 99.2 Legal Disclaimer 2 This presentation includes forward ? looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holding |
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| February 28, 2022 |
?Exhibit 99.1 ? HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX? (pitolisant) Net Revenue Increased 62% Year-over-Year to $91.2 Million for Fourth Quarter 2021 and 91% to $305.4 Million for Full Year ? Achieved First Full Year of Profitability and Net income was $22.7 Million for the Fourth Quarter 2021 ? Average Number of Patients on WAKI |
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| February 28, 2022 |
List of Subsidiaries of Harmony Biosciences Holdings, Inc. Exhibit 21.1 ? ? ? ? ? ? ? Subsidiaries of Harmony Biosciences Holdings, Inc. Subsidiary Jurisdiction ? ? ? ? ? ? ? Harmony Biosciences, LLC Delaware ? ? |
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| February 28, 2022 |
?Exhibit 107 Calculation of Filing Fee Table ? Form S-8 (Form Type) ? Harmony Biosciences Holdings, Inc. |
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| February 28, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
