Investors interested in Medical - Biomedical and Genetics stocks are likely familiar with Harmony Biosciences Holdings, Inc. (HRMY) and Techne (TECH) . But which of these two stocks offers value investors a better bang for their buck right now? We'll need to take a closer look.We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The proven Zacks Rank emphasizes companies with positive estimat ...

Financial Performance - Harmony Biosciences reported Q1 2024 net product revenue of $154.6 million, a 30% increase compared to $119.1 million in Q1 2023[8, 53] - The company's Non-GAAP adjusted net income for Q1 2024 was $50.7 million, a 25% increase from $40.7 million in Q1 2023[62] - Harmony Biosciences has cash, cash equivalents, and investments totaling $453.6 million[53] - The company reiterates its 2024 net revenue guidance of $700-$720 million[68] WAKIX Growth and Potential - WAKIX is considered a potential $1 billion+ net revenue opportunity in adult narcolepsy alone[5, 7] - The average number of patients on WAKIX is approximately 6,300 and growing[11, 39] - WAKIX sales have shown durable growth into year five, with a 30% year-over-year increase[9, 52] Pipeline and Development - The company plans to submit an sNDA for Idiopathic Hypersomnia (IH) in the second half of 2024[5, 15] - A PDUFA date is set in 2026 for Next-Gen Formulation 1 (NG1)[5, 45] - Topline data for ZYN002 in the Phase 3 RECONNECT study for Fragile X syndrome (FXS) is expected in mid-2025[5, 43] - Topline data for clemizole hydrochloride (EPX-100) in a pivotal registrational trial for Dravet syndrome (DS) is expected in 2026[6, 27]

Product Development and Approvals - As of March 31, 2024, the average number of patients on WAKIX was approximately 6,300, with over 80% of all insured lives in the U.S. having secured formulary access[120] - WAKIX was approved by the FDA for the treatment of cataplexy in adult patients with narcolepsy in October 2020, contributing to favorable access for patients[120] - The FDA granted orphan drug designation for pitolisant in the treatment of idiopathic hypersomnia in September 2023 and fast track designation in November 2023[107] - The Phase 3 registrational trial, TEMPO study, for Prader-Willi Syndrome was initiated in March 2024, with FDA alignment on the protocol received in October 2023[112] - The company is developing two new formulations of pitolisant, NG1 and NG2, with clinical studies initiated in Q4 2023 and data from NG1 expected to support further development[112] - The FDA granted priority review for the pediatric narcolepsy supplemental NDA, with a target action date set for June 21, 2024[110] - The primary endpoint of the INTUNE study for idiopathic hypersomnia did not meet statistical significance, but favorable numerical trends were observed, leading to a planned supplemental NDA submission in H2 2024[107] Financial Performance - Net product revenue increased by $35.5 million, or 29.8%, for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to a 28.3% increase in units shipped and a 7% price increase[143] - Cost of product sales increased by $6.7 million, or 32.3%, for the three months ended March 31, 2024, with cost of product sales as a percentage of net product revenue at 17.8%[144] - Research and development expenses increased by $8.9 million, or 67.0%, for the three months ended March 31, 2024, driven by increased costs for clinical development and regulatory work associated with pitolisant and ZYN002[146] - Sales and marketing expenses increased by $4.7 million, or 20.6%, for the three months ended March 31, 2024, primarily due to increased patient engagement and marketing activities[147] - General and administrative expenses increased by $3.6 million, or 16.4%, for the three months ended March 31, 2024, mainly due to higher stock compensation and legal fees[148] - Net income for the three months ended March 31, 2024, was $38.3 million, compared to $29.5 million for the same period in 2023[142] Cash and Debt Management - As of March 31, 2024, the company had cash, cash equivalents, and investments of $453.6 million, with outstanding debt of $192.5 million[152] - The effective tax rate for the three months ended March 31, 2024, was 26.0%, compared to 22.0% for the same period in 2023, influenced by prior year tax benefits[151] - The company entered into a five-year senior secured term loan agreement totaling $185.0 million in July 2023[154] - An incremental term loan of $15.0 million was added in September 2023, with identical terms to the original loan[155] - The repayment schedule includes quarterly principal payments starting at $3.8 million, increasing to $5.0 million by December 2025, with a final payment of $115.0 million due in July 2028[156] - As of March 31, 2024, the company had $192.5 million in borrowings outstanding, with interest rates based on a senior secured net leverage ratio[177] Strategic Acquisitions and Agreements - The company completed the acquisition of Zynerba Pharmaceuticals in October 2023, focusing on innovative transdermal cannabidiol therapies for orphan neuropsychiatric disorders[113] - Topline data from the pivotal Phase 3 RECONNECT study for Zynerba's ZYN002 is anticipated in mid-2025, with patent protection until 2038[113] - A share repurchase program was approved in October 2023, allowing for up to $200.0 million in repurchases, with $150.0 million remaining as of March 31, 2024[158] - The company completed a tender offer to acquire Zynerba for $60.0 million, plus contingent value rights potentially worth up to $2.5444 per share[160] - An asset purchase agreement for HBS-102 was made for $3.5 million, with additional milestone payments totaling up to $174.0 million[161] - A sublicense agreement for an orexin-2 receptor agonist was established, involving an upfront fee of $25.5 million and potential milestone payments of up to $367.5 million[162] Cash Flow Activities - Net cash provided by operating activities for Q1 2024 was $31.1 million, down from $42.6 million in Q1 2023[165][166] - Net cash used in investing activities increased to $6.2 million in Q1 2024 from $1.8 million in Q1 2023[168][169]

[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)

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 ...

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 ...