NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Wolf Popper LLP is continuing to investigate potential securities fraud claims on behalf of purchasers of Harmony Biosciences Holdings, Inc. ("Harmony") common stock (NASDAQ:HRMY). Harmony is a commercial and clinical stage drug company that focuses on therapies for patients with rare neurological diseases. Before the market opened on March 28, 2023, Scorpion Capital published a short seller report headlined "The Latest Price-Gouging Ploy By The Grifter Who Inspi ...

PLYMOUTH MEETING, Pa., April 16, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report first quarter 2024 financial results on Tuesday, April 30, 2024, before the open of the U.S. financial markets. Harmony will host a conference call and live webcast on April 30, 2024, at 8:30 a.m. ET to discuss the results.To participate in the call, please dial (800) 579-2543 (domestic) or +1 (785) 424-1789 (international), and reference passcode HRMYQ124. It is recomm ...

PLYMOUTH MEETING, Pa., April 11, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. TPM-1116 represents a new chemical series of OX2R agonists with the potential for a best-in-class clinical profile. Narcolepsy and other ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q4 2023 Results Conference Call February 22, 2024 8:30 AM ET Company Participants Luis Sanay - Head of Investor Relations Jeffrey Dayno - President and CEO Jeffrey Dierks - Chief Commercial Officer Kumar Budur - Chief Medical Officer Sandip Kapadia - Chief Financial Officer and Chief Administrative Officer Conference Call Participants Ami Fadia - Needham & Company Charles Duncan - Cantor Fitzgerald Francois Brisebois - Oppenheimer David Amsellem - Piper Sandl ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Delaware 82-2279923 630 W. Germantown Pike, Suite 215, Plymouth Meeting, PA 19462 (Address of principal executive offices) (Zip Code) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANG ...

October 31, 2023 This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management's understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accuracy and completeness of such information cannot be assured. ...

[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited financial statements detail its financial position, performance, and cash flows as of Q3 2023 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to $777.8 million, driven by increased cash, while stockholders' equity rose to $481.3 million Balance Sheet Highlights (In thousands) | Balance Sheet Highlights (In thousands) | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $324,603 | $243,784 | | Total current assets | $462,998 | $400,285 | | Total Assets | $777,766 | $673,870 | | **Liabilities & Equity** | | | | Total current liabilities | $112,408 | $78,884 | | Long-term debt, net | $182,131 | $189,647 | | Total Liabilities | $296,434 | $271,032 | | Total Stockholders' Equity | $481,332 | $402,838 | [Condensed Consolidated Statements of Operations and Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) Q3 2023 net product revenues grew 36.7% YoY to $160.3 million, resulting in a net income of $38.5 million Income Statement Highlights (In thousands, except EPS) | Income Statement Highlights (In thousands, except EPS) | Q3 2023 | Q3 2022 | YoY Change | | :--- | :--- | :--- | :--- | | Net product revenues | $160,268 | $117,206 | +36.7% | | Gross profit | $127,972 | $94,247 | +35.8% | | Operating income | $64,509 | $11,901 | +442.0% | | Net income | $38,461 | $87,943 | -56.3% | | Diluted EPS | $0.63 | $1.44 | -56.3% | - The significant decrease in Q3 2023 net income compared to Q3 2022 is primarily due to a **one-time income tax benefit of $79.98 million in Q3 2022** related to the release of a valuation allowance on deferred tax assets[10](index=10&type=chunk)[139](index=139&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash from operations increased 21% to $142.7 million, offset by cash used for financing and investing activities Cash Flow Summary (In thousands) | Cash Flow Summary (In thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $142,722 | $117,788 | | Net cash used in investing activities | ($10,374) | ($94,937) | | Net cash (used in) provided by financing activities | ($52,029) | $4,183 | | **Net increase in cash** | **$80,319** | **$27,034** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key events include a $200 million debt refinancing, a $125 million share repurchase program, and the Zynerba acquisition - In July and September 2023, the company entered into a new five-year senior secured term loan facility for an aggregate principal amount of **$200 million**[53](index=53&type=chunk)[54](index=54&type=chunk) - The company extinguished its Blackstone Credit Agreement, resulting in a **loss on debt extinguishment of $9.8 million** for the third quarter of 2023[60](index=60&type=chunk)[137](index=137&type=chunk) - On August 1, 2023, the Board approved a **$125 million share repurchase program**, and during Q3 2023, the company repurchased 1.44 million shares for **$50.0 million**[70](index=70&type=chunk) - Subsequent to the quarter end, on October 10, 2023, the company completed the acquisition of Zynerba Pharmaceuticals for an aggregate consideration of **$60 million** plus contingent value rights (CVRs)[91](index=91&type=chunk)[92](index=92&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes strong Q3 revenue growth, clinical pipeline progress, the Zynerba acquisition, and capital allocation [Company Overview and Pipeline Development](index=33&type=section&id=Company%20Overview%20and%20Pipeline%20Development) The company advances its pipeline for rare neurological diseases through new indications for WAKIX and strategic acquisitions - The company's **Phase 3 INTUNE study** of pitolisant in adult patients with Idiopathic Hypersomnia (IH) **did not meet its primary endpoint**, but showed favorable trends[104](index=104&type=chunk) - Harmony received FDA alignment on the protocol for its **Phase 3 TEMPO study** in patients with Prader-Willi Syndrome (PWS) and expects to initiate the study in **Q1 2024**[104](index=104&type=chunk) - Topline results from the Phase 2 proof-of-concept trial of pitolisant in adult patients with Myotonic Dystrophy (DM1) are expected in **Q4 2023**[104](index=104&type=chunk) - On October 10, 2023, the company completed the acquisition of Zynerba Pharmaceuticals, adding **Zygel**, a pivotal Phase 3 candidate for Fragile X Syndrome, to its pipeline[108](index=108&type=chunk) [Commercial Performance](index=35&type=section&id=Commercial%20Performance) WAKIX commercial growth continues with an average of 5,800 patients and broad market access covering over 80% of insured lives - The average number of patients on WAKIX was approximately **5,800** for the three months ended September 30, 2023[112](index=112&type=chunk) - As of September 30, 2023, the company has secured formulary access for WAKIX for **more than 80% of all insured lives** (Commercial, Medicare, and Medicaid) in the U.S[112](index=112&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) Q3 revenue grew 36.7% from higher volume and pricing, while R&D expenses decreased due to a prior-year licensing fee Operating Results Comparison (In thousands) | Operating Results Comparison (In thousands) | Q3 2023 | Q3 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Net product revenues | $160,268 | $117,206 | +36.7% | | Cost of product sales | $32,296 | $22,959 | +40.7% | | Research and development | $17,499 | $40,548 | -56.8% | | Sales and marketing | $23,418 | $20,467 | +14.4% | | General and administrative | $22,546 | $21,331 | +5.7% | | Operating income | $64,509 | $11,901 | +442.0% | - The increase in net product revenues for Q3 2023 was primarily due to a **28.2% increase in the number of units shipped** and the net impact of a **7.0% price increase** that occurred in January 2023[131](index=131&type=chunk)[132](index=132&type=chunk) - The decrease in R&D expenses for Q3 2023 was primarily driven by a **$30 million licensing fee incurred in Q3 2022**, partially offset by increased clinical development work[134](index=134&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity at $438.6 million while executing debt refinancing and $50 million in share repurchases - The company held **$438.6 million in cash, cash equivalents, restricted cash, and investments** as of September 30, 2023[140](index=140&type=chunk) - In Q3 2023, the company entered into a new five-year TLA Credit Agreement for **$200 million** and used the proceeds to extinguish the previous Blackstone Credit Agreement[145](index=145&type=chunk)[146](index=146&type=chunk)[150](index=150&type=chunk) - During Q3 2023, the company repurchased **1,439,792 shares** of common stock for an aggregate cost of **$50.0 million**[151](index=151&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure from its investment portfolio and variable-rate debt - The company's primary market risk exposure is to interest rate fluctuations affecting its investment portfolio and its **$200.0 million in variable-rate debt** tied to Term SOFR[170](index=170&type=chunk)[171](index=171&type=chunk) - Management concluded that an immediate **10% change in market interest rates would not materially impact** the fair value of its investment portfolio or its debt-related obligations[170](index=170&type=chunk)[173](index=173&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - The principal executive officer and principal financial officer concluded that the company's **disclosure controls and procedures were effective** as of the end of the period[176](index=176&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[177](index=177&type=chunk) [Part II. Other Information](index=53&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings that would adversely affect its business - As of the filing date, management believes there are **no pending claims or actions** against the company that could have a material adverse effect on its business[180](index=180&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) This report references previously disclosed risk factors from the 2022 Form 10-K with no material updates - The company directs investors to review the risk factors detailed in its **2022 Form 10-K**, stating they could materially affect the business[181](index=181&type=chunk) [Issuer Purchases of Equity Securities](index=55&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company repurchased 1.44 million shares for $50 million in Q3 2023, with $75 million remaining under the program Share Repurchase Activity (Q3 2023) | Share Repurchase Activity (Q3 2023) | Total Shares Purchased | Weighted Avg. Price Paid | Approx. Value of Shares Purchased ($ thousands) | | :--- | :--- | :--- | :--- | | August 2023 | 764,800 | $32.81 | $25,093 | | September 2023 | 674,992 | $36.90 | $24,907 | | **Total** | **1,439,792** | **$34.73** | **$50,000** | - On August 1, 2023, the Board of Directors approved a share repurchase program for up to **$125.0 million**[185](index=185&type=chunk) - As of September 30, 2023, approximately **$75.0 million remained available** for repurchase under the program[183](index=183&type=chunk)

Q2 2023 Financial and Business Update 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 financial position, business strategy and plans and objectives of management for future operations, should be considered forward-looking statements. Forward-looking ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q2 2023 Earnings Conference Call August 1, 2023 8:30 AM ET Company Participants Luis Sanay - Head, Investor Relations Dr. Jeffrey Dayno - President and CEO Jeffrey Dierks - Chief Commercial Officer Dr. Kumar Budur - Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Alex Sklar - Raymond James David Amsellem - Piper Sandler Francois Brisebois - Oppenheimer Graig Suvannavejh - Mizuho Securities Jason Gerberry - Bank of A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Table of Contents ☒ 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: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or othe ...