Shares of Harmony Biosciences Holdings, Inc. (HRMY) have gained 13.4% over the past four weeks to close the last trading session at $32.66, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $43.38 indicates a potential upside of 32.8%. While the consensus price target is a much-coveted metric for investors, solely banking on this metric to make an investment decision may not be wi ...

One stock to keep an eye on is Harmony Biosciences (HRMY) . HRMY is currently sporting a Zacks Rank of #2 (Buy) and an A for Value. Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks. Value investors also love the P/S ratio, which is calculated by simply dividing a stock's price with the company's s ...

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Use in Specific Populations WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is recommended in patients with moderate hepatic impairment. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800- FDA-1088 or www.fda.gov/medwatch. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements con ...

PLYMOUTH MEETING, Pa., June 5, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) presented data from its Phase 2 signal detection study showing that pitolisant reduced excessive daytime sleepiness (EDS) and fatigue in adults with Myotonic dystrophy Type 1 (DM1). "More than 80 percent of DM1 patients experience EDS and fatigue, which patient-reported outcomes research has shown to be nearly as debilitating as the primary symptoms of DM1, namely myotonia and muscle weakness,"1 said Kumar Budur, M.D., M. ...

Luis Sanay, CFA 445-235-8386 [email protected] Harmony Biosciences Media Contact: PLYMOUTH MEETING, Pa., May 28, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, FL on Monday, June 10, 2024, at 9:20 a.m. ET. A webcast of the fireside chat will be available on the investor page of Harmony's website at https://ir.harmon ...

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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]