Other Information.
−Removed: Not applicable.
+Added: On May 1, 2023, the Company’s Board of Directors appointed Dr.
+Added: Kumar Budur as the Company’s new Chief Medical Officer following the appointment of Dr.
+Added: Jeffrey Dayno as the Company’s President and Chief Executive Officer on April 24, 2023.
+Added: Budur has served in the role of SVP & Head of Clinical Development with the Company since March 21, 2022.
+Added: Prior to joining Harmony Biosciences, Dr.
+Added: Budur spent 6 years at each of AbbVie Inc.
+Added: and Takeda Pharmaceutical Company, respectively.
+Added: A nationally recognized expert in Research and Development, he has overseen programs ranging from late discovery, early clinical development to late clinical development, and post-marketing studies.
+Added: He has experience in progressing small molecules, biologics, and drug-device combinations through various stages of development.
+Added: Budur was involved with four New Drug Applications (NDAs) and was the lead for the registration of clinical trials, submission, and approval processes of two NDAs.
+Added: Budur was trained at Cambridge University in the UK and Cleveland Clinic in the US and completed his residency in Psychiatry and fellowships in Neurophysiology and Sleep Medicine.
+Added: He is Board Certified in Psychiatry and Sleep Medicine and holds a master’s degree in clinical research from Case Western Reserve University.
+Added: Budur has published over 45 original research papers in peer reviewed journals, edited four books, and chaired National and International seminars and symposiums.
Incorporated by Reference
4 unchanged sentences
August 21, 2020
−Removed: License and Commercialization Agreement dated July 31, 2022, by and between Bioprojet Societe Civile de Recherche and Harmony Biosciences, LLC.
−Removed: Amendment No.
−Removed: 1 to Credit Agreement, dated as of August 2, 2022, among Harmony Biosciences, Inc., as Borrower, Harmony Biosciences, LLC, as Guarantor, the Guarantors from time to time party thereto, the Lenders from time to time party thereto, and Wilmington Trust National Association, as Administrative Agent.
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
4 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
−Removed: The following financial statements from the Company ’ s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2022 formatted in Inline XBRL:
+Added: The following financial statements from the Company ’ s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023 formatted in Inline XBRL:
(i) Balance Sheets, (ii) Statements of Operations, (iii) Statements of Stockholders ’ Equity and (vi) Notes to Financial Statements, tagged as blocks of text and including detailed tags.
7 unchanged sentences
HARMONY BIOSCIENCES HOLDINGS, INC.
+Added: /s/ Jeffrey M.
President, Chief Executive Officer and Director (principal executive officer)
−Removed: November 1, 2022
/s/ Sandip Kapadia
1 unchanged sentence
Chief Financial Officer (principal financial officer)
−Removed: November 1, 2022
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.