Harmony Biosciences(HRMY)

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Harmony Biosciences(HRMY) - 2024 Q1 - Quarterly Results
2024-04-30 11:45
[Q1 2024 Business and Financial Highlights](index=1&type=section&id=Q1%202024%20Business%20and%20Financial%20Highlights) Harmony Biosciences reported strong Q1 2024 results, with WAKIX® net revenue up 30% to $154.6 million, and expanded its portfolio Q1 2024 Key Financial Metrics | Metric | Q1 2024 | YoY Growth | Source | | :--- | :--- | :--- | :--- | | WAKIX® Net Revenue | $154.6 million | ~30% | WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year | | GAAP Net Income | $38.3 million | 30% | GAAP net income for the quarter ended March 31, 2024, was $38.3 million... compared to GAAP net income of $29.5 million... for the same period in 2023. | | GAAP Diluted EPS | $0.67 | 39.6% | $0.67 per diluted share, compared to... $0.48 per diluted share, for the same period in 2023. | | Non-GAAP Adj. Net Income | $50.7 million | 26.4% | Non-GAAP adjusted net income was $50.7 million... compared to Non-GAAP adjusted net income of $40.1 million... for the same period in 2023. | | Non-GAAP Adj. Diluted EPS | $0.88 | 33.3% | $0.88 per diluted share... compared to... $0.66 per diluted share, for the same period in 2023. | - The company has accelerated its growth strategy by adding a rare epilepsy franchise, now possessing three late-stage orphan/rare CNS franchises, each with potential peak sales opportunities of **$1 billion to $2 billion**[3](index=3&type=chunk)[4](index=4&type=chunk) - Harmony expects its pipeline to deliver at least one new product or indication launch **every year for the next five years**, with revenue potential extending **beyond 2040**[4](index=4&type=chunk) [Key Franchise Updates](index=3&type=section&id=Key%20Franchise%20Updates) Harmony updated its three CNS franchises, noting WAKIX growth, ZYN002 progress, and a new Rare Epilepsy franchise [Sleep/Wake Franchise](index=3&type=section&id=Sleep%2FWake%20Franchise) The Sleep/Wake franchise saw WAKIX® revenue up 30%, advancing its pipeline with an IH sNDA and new assets - WAKIX® net revenue was **$154.6 million** in Q1 2024, a **30% increase YoY**, with the average number of patients growing to approximately **6,300**[5](index=5&type=chunk) - A supplemental New Drug Application (sNDA) for pitolisant in Idiopathic Hypersomnia (IH) is planned for the **second half of 2024**[1](index=1&type=chunk)[5](index=5&type=chunk) - Positive pharmacokinetic data was reported for the next-generation pitolisant formulation (NG1), with a PDUFA date expected in **2026** and potential patent protection out to **2044**[1](index=1&type=chunk)[5](index=5&type=chunk) - Licensed TPM-1116, a highly potent oral orexin-2 receptor agonist, to strengthen the sleep/wake portfolio. An IND is expected to be filed by **mid-2025**[6](index=6&type=chunk) [Neurobehavioral Franchise](index=4&type=section&id=Neurobehavioral%20Franchise) The Neurobehavioral franchise is advancing ZYN002, with FXS Phase 3 trial enrollment completing Q1 2025 - Patient enrollment in the Phase 3 RECONNECT trial for ZYN002 in Fragile X syndrome (FXS) is expected to be completed in **Q1 2025**, with topline data expected **mid-2025**[10](index=10&type=chunk) - Intellectual property protection for ZYN002 in FXS is secured out to **2040**[10](index=10&type=chunk) [Rare Epilepsy Franchise](index=4&type=section&id=Rare%20Epilepsy%20Franchise) Harmony established a new Rare Epilepsy franchise via Epygenix acquisition, advancing EPX-100 for Dravet and LGS - Acquired Epygenix Therapeutics, establishing a new rare epilepsy franchise[1](index=1&type=chunk)[10](index=10&type=chunk) - Lead product EPX-100 (clemizole) is in a pivotal trial for Dravet syndrome (DS) with data expected in **2026**. A Phase 3 trial for Lennox-Gastaut syndrome (LGS) is planned for **H2 2024**[10](index=10&type=chunk) - EPX-100 has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for both DS and LGS[10](index=10&type=chunk) [Q1 2024 Financial Performance](index=4&type=section&id=Q1%202024%20Financial%20Performance) Harmony Biosciences reported Q1 2024 net product revenue of $154.6 million, GAAP net income of $38.3 million [Key Financial Metrics](index=4&type=section&id=Key%20Financial%20Metrics) Q1 2024 net product revenue was $154.6 million, GAAP net income $38.3 million, and cash $453.6 million Q1 2024 vs Q1 2023 Financial Summary | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Product Revenue | $154.6 million | $119.1 million | | GAAP Net Income | $38.3 million | $29.5 million | | GAAP Diluted EPS | $0.67 | $0.48 | | Non-GAAP Adj. Net Income | $50.7 million | $40.1 million | | Non-GAAP Adj. Diluted EPS | $0.88 | $0.66 | Q1 2024 Operating Expenses (YoY) | Expense Category | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Research & Development | $22.2 million | $13.3 million | +67% | | Sales & Marketing | $27.2 million | $22.6 million | +21% | | General & Administrative | $25.7 million | $22.1 million | +16% | | **Total Operating Expenses** | **$75.1 million** | **$57.9 million** | **+30%** | - As of March 31, 2024, cash, cash equivalents, and investments totaled **$453.6 million**, an increase from **$425.6 million** at the end of 2023[12](index=12&type=chunk) [Consolidated Statements of Operations](index=13&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2024 consolidated operations show net product revenue of $154.6 million, gross profit of $127.1 million Q1 2024 Statement of Operations (in thousands) | Line Item | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net product revenue | $154,615 | $119,126 | | Gross profit | $127,131 | $98,346 | | Total operating expenses | $75,098 | $57,923 | | Operating income | $52,033 | $40,423 | | Net income | $38,334 | $29,485 | | Diluted EPS | $0.67 | $0.48 | [Consolidated Balance Sheets](index=14&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2024, total assets were $847.0 million, liabilities $331.6 million, and equity $515.4 million Balance Sheet Summary (in thousands) | Account | March 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $332,981 | $311,660 | | Total current assets | $479,503 | $451,070 | | **Total Assets** | **$846,985** | **$811,448** | | Total current liabilities | $154,253 | $163,781 | | **Total Liabilities** | **$331,591** | **$344,456** | | **Total Stockholders' Equity** | **$515,394** | **$466,992** | [Reconciliation of GAAP to Non-GAAP Financial Results](index=15&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Results) Q1 2024 GAAP net income was $38.3 million, adjusted to non-GAAP net income of $50.7 million Q1 2024 GAAP to Non-GAAP Reconciliation (in thousands) | Line Item | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | **GAAP net income** | **$38,334** | **$29,485** | | Amortization | $5,961 | $5,961 | | Stock-based compensation | $10,434 | $6,561 | | Other adjustments (net of tax) | ($4,027) | ($1,270) | | **Non-GAAP adjusted net income** | **$50,722** | **$40,738** | | GAAP diluted EPS | $0.67 | $0.48 | | Non-GAAP adjusted diluted EPS | $0.88 | $0.67 | [2024 Outlook and Corporate Updates](index=5&type=section&id=2024%20Outlook%20and%20Corporate%20Updates) Harmony reiterated 2024 net product revenue guidance of $700-720 million and $150 million for share repurchase - The company reiterates its full-year 2024 net product revenue guidance of **$700 million to $720 million**[2](index=2&type=chunk)[13](index=13&type=chunk) - As of March 31, 2024, **$150 million** remains authorized for the company's share repurchase program[14](index=14&type=chunk) [Product and Pipeline Overview](index=6&type=section&id=Product%20and%20Pipeline%20Overview) Harmony's key products and pipeline include WAKIX® for narcolepsy, ZYN002 for FXS/22q, and EPX-100 for epilepsy [WAKIX® (pitolisant) and Target Indications](index=6&type=section&id=WAKIX%C2%AE%20%28pitolisant%29%20and%20Target%20Indications) WAKIX® (pitolisant) is a first-in-class H₃ receptor antagonist for narcolepsy, also studied for IH and PWS - WAKIX is a first-in-class selective histamine 3 (H₃) receptor antagonist/inverse agonist approved for excessive daytime sleepiness or cataplexy in adult narcolepsy patients[19](index=19&type=chunk) - Narcolepsy is a rare neurological disease affecting approximately **170,000 Americans**, primarily characterized by excessive daytime sleepiness (EDS) and cataplexy[32](index=32&type=chunk) - The pipeline includes expanding WAKIX's use to Idiopathic Hypersomnia (IH) and Prader-Willi Syndrome (PWS), both rare disorders involving EDS[33](index=33&type=chunk)[34](index=34&type=chunk) [ZYN002 and Target Indications](index=9&type=section&id=ZYN002%20and%20Target%20Indications) ZYN002 is a synthetic, THC-free cannabidiol gel developed for Fragile X and 22q syndromes - ZYN002 is a synthetic, THC-free cannabidiol in a transdermal gel formulation[35](index=35&type=chunk) - It is being developed for Fragile X syndrome (FXS), which affects up to **80,000 patients** in the U.S., and 22q11.2 deletion syndrome (22q), affecting a similar number[36](index=36&type=chunk)[39](index=39&type=chunk) [EPX-100 (clemizole) and Target Indications](index=10&type=section&id=EPX-100%20%28clemizole%29%20and%20Target%20Indications) EPX-100 (clemizole) is an oral drug targeting serotonin receptors for Dravet and LGS - EPX-100 (clemizole hydrochloride) is an oral drug candidate that targets central 5-hydroxytryptamine (serotonin) receptors[40](index=40&type=chunk) - It is under development for Dravet syndrome (DS), which has an incidence of **~1:15,700**, and Lennox-Gastaut syndrome (LGS), which affects approximately **48,000 patients** in the U.S[41](index=41&type=chunk)[42](index=42&type=chunk) [WAKIX® Important Safety Information](index=6&type=section&id=WAKIX%C2%AE%20Important%20Safety%20Information) WAKIX® safety notes contraindications for hypersensitivity or hepatic impairment, QT prolongation, and common adverse reactions - WAKIX is contraindicated in patients with severe hepatic impairment or known hypersensitivity to pitolisant[21](index=21&type=chunk) - A primary warning is that WAKIX prolongs the QT interval; it should be avoided in patients with known QT prolongation or with other risk factors for torsade de pointes[22](index=22&type=chunk)[23](index=23&type=chunk) - The most common adverse reactions (≥5% and twice placebo) in clinical trials were **insomnia (6%)**, **nausea (6%)**, and **anxiety (5%)**[25](index=25&type=chunk) - WAKIX may reduce the effectiveness of hormonal contraceptives; an alternative non-hormonal method is recommended during and for 21 days after treatment[27](index=27&type=chunk)[28](index=28&type=chunk)
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
Newsfilter· 2024-04-30 11:05
WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia Planned for Second Half 2024 On Track Toward Pediatric Exclusivity to Extend WAKIX Exclusivity to September 2030: Pediatric Narcolepsy sNDA PDUFA Date of June 21, 2024; PWS Phase 3 TEMPO Study Initiated in March 2024 Pitolisant Franchise Revenue Potential Extended Beyond 2040 With Next-Generation Formulations; Reports Positive Pharma ...
Wolf Popper LLP Continues its Investigation on Behalf of Investors in Harmony Biosciences Holdings, Inc.
Newsfilter· 2024-04-25 11:00
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 ...
HARMONY BIOSCIENCES TO REPORT FIRST QUARTER 2024 FINANCIAL RESULTS ON APRIL 30, 2024
Prnewswire· 2024-04-16 12:05
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 ...
HARMONY BIOSCIENCES ANNOUNCES EXCLUSIVE AGREEMENT TO DEVELOP AND COMMERCIALIZE TPM-1116, A HIGHLY POTENT AND SELECTIVE ORAL OREXIN-2 RECEPTOR AGONIST
Prnewswire· 2024-04-11 12:05
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(HRMY) - 2023 Q4 - Earnings Call Transcript
2024-02-22 18:32
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 ...
Harmony Biosciences(HRMY) - 2023 Q4 - Annual Report
2024-02-22 13:00
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 ...
Harmony Biosciences(HRMY) - 2023 Q3 - Earnings Call Presentation
2023-11-01 11:15
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. ...
Harmony Biosciences(HRMY) - 2023 Q3 - Quarterly Report
2023-10-31 12:00
[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)
Harmony Biosciences(HRMY) - 2023 Q2 - Earnings Call Presentation
2023-08-01 19:04
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 ...