Latest news with #WAKIX
Yahoo
4 hours ago
- Business
- Yahoo
Harmony Biosciences Holdings, Inc. (HRMY): A Bull Case Theory
We came across a bullish thesis on Harmony Biosciences Holdings, Inc. (HRMY) on Capital Curiosity's Substack by Taylor Nichols. In this article, we will summarize the bulls' thesis on HRMY. Harmony Biosciences Holdings, Inc. (HRMY)'s share was trading at $35.03 as of 5th June. HRMY's trailing and forward P/E were 13.37 and 9.45 respectively according to Yahoo Finance. Copyright: zneb076 / 123RF Stock Photo Harmony Biosciences stands out as an overlooked gem in the small-cap biotech space, combining strong financials with pipeline potential in a niche therapeutic area. With a $2 billion market cap and a focus on rare neurological diseases, Harmony's flagship drug WAKIX for narcolepsy has underpinned impressive fundamentals—35% revenue CAGR since 2020, 25% net margins, and consistent free cash flow conversion above 30%. Despite these metrics, the stock trades at just 13x earnings and an EV/EBITDA of 7.9x, reflecting investor scepticism largely tied to single-product dependency and unresolved legal risks from 2023 fraud allegations. Still, Harmony boasts over $480 million in cash, negligible debt, and a stable share count, which enhances confidence in long-term shareholder returns. While WAKIX remains the core revenue driver, the company is aggressively diversifying through M&A, including the Zynerba and Epygenix acquisitions, bringing promising assets like ZYN002 for Fragile X Syndrome into the pipeline. Phase 3 data expected in Q3 2025 could catalyze upside, alongside the development of Pitolisant HD and other preclinical candidates. A DCF valuation incorporating conservative assumptions yields share prices between $38 and $62, implying a substantial upside from current levels. Analyst sentiment is bullish, with eight of nine recent ratings being buys and a $51 average price target. Although risks like competition from Jazz Pharmaceuticals, FDA hurdles, and prolonged legal overhang remain, Harmony's profitability, cash strength, and strategic execution offer investors a compelling asymmetrical opportunity. For those seeking exposure to a profitable, underappreciated rare disease player with both pipeline and financial momentum, Harmony merits close attention. Previously, we covered a on Harmony Biosciences by Long-Access-2143 in April 2025, which aligns with Taylor Nichols' analysis. The stock has seen an appreciation of approximately 13% since then. Both highlight WAKIX's strength and undervaluation, while Long-Access-2143 stresses the mispricing post short-seller attack and details a WAKIX-driven DCF, Nichols places more emphasis on pipeline expansion and cash strength. Together, they reinforce Harmony's appeal as a profitable, underappreciated biotech. Harmony Biosciences Holdings, Inc. (HRMY) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 27 hedge fund portfolios held HRMY at the end of the first quarter which was 26 in the previous quarter. While we acknowledge the risk and potential of HRMY as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 days ago
- Business
- Yahoo
Harmony Biosciences settles generic drug litigation, strengthens patent
Harmony Biosciences (HRMY) announced a settlement agreement with Lupin Limited, resolving patent infringement litigation related to Lupin's Abbreviated New Drug Application for a generic version of WAKIX. Under the agreement, Lupin will receive a license to launch its generic product no earlier than January 2030 (or July 2030 with pediatric exclusivity), or earlier under certain circumstances. Harmony asserted multiple patents covering WAKIX, its FDA-approved treatment for excessive daytime sleepiness or cataplexy in adults and pediatric patients with narcolepsy. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on HRMY: Disclaimer & DisclosureReport an Issue Harmony Biosciences Settles Patent Dispute with Lupin Harmony Biosciences assumed with an Outperform at Oppenheimer Harmony Biosciences Holds 2025 Annual Stockholders Meeting Harmony Biosciences price target raised to $48 from $44 at Mizuho Harmony Biosciences Holdings: Strong Market Position and Growth Potential Justify Buy Rating Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
06-05-2025
- Business
- Business Wire
Harmony Biosciences Reports Strong Q1 2025 Financial Results, Highlights Advancement of Its Pipeline and Upcoming Catalysts, and Reaffirms 2025 Revenue Guidance
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced strong year-over-year revenue growth for WAKIX® of 20% in the first quarter 2025, on its way to a potential $1B+ opportunity in narcolepsy alone and poised for additional growth from its next-gen pitolisant development programs. The company has demonstrated four consecutive years of profitability and has grown its cash and investments position to over $600M. 'Building off of our strong foundation of commercial success, we are poised for significant momentum throughout the rest of the year, driven by the upcoming catalysts from our robust, late-stage pipeline,' said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. 'Our next major clinical milestone, topline data readout from our Phase 3 registrational trial of ZYN002 in patients with Fragile X syndrome, the RECONNECT Study, is on track for Q3. A positive readout could put us on a path toward the first ever approved treatment for this patient community. I am proud of the unique profile we have created at Harmony, a profitable, self-funding biotech company, with a robust pipeline, that has the potential to help hundreds of thousands of patients living with unmet medical needs while creating significant, long-term value.' Franchise Highlights Sleep/Wake Franchise WAKIX in Narcolepsy Net Revenue was $184.7 million for Q1 2025 2025 Net Revenue projected between $820 to $860 million The average number of patients on WAKIX increased to approximately 7,200 for Q1 2025 and we exited the quarter with approximately 7,300 patients Pitolisant HD (high-dose) Higher dose and optimized pharmacokinetic profile designed for greater efficacy in narcolepsy; development program to pursue multiple additional indications Phase 3 registrational trial in narcolepsy designed for greater efficacy in excessive daytime sleepiness and cataplexy; also to include endpoint on narcolepsy-related fatigue in pursuit of differentiated label Phase 3 registrational trial in IH to include endpoint on sleep inertia in pursuit of differentiated label On track to initiate Phase 3 registrational trials in both narcolepsy and IH in Q4 2025 with potential PDUFA dates in 2028 Utility patents filed out to 2044 for narcolepsy and IH Pitolisant GR (gastro-resistant) Pivotal bioequivalence study initiated in March 2025 Topline data readout anticipated in Q3 2025 with potential PDUFA date in 2026 Utility patents filed out to 2044 Orexin-2 receptor agonist (BP1.15205) Comprehensive preclinical safety and efficacy data to be presented at SLEEP 2025 (June) Potential to be best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity and safety data, as well as its potential for once-a-day dosing IMPD submission on track for mid-2025; first-in-human study expected to initiate 2H 2025 with clinical data anticipated in 2026 Neurobehavioral Franchise ZYN002 Completed recruitment of Phase 3 registrational trial, the RECONNECT Study, in patients with Fragile X syndrome (FXS); on track for topline data readout in Q3 RECONNECT Study is designed to confirm the positive findings from the prespecified analysis of the primary outcome in the subgroup of patients with complete methylation from the Phase 2/3 CONNECT Study Promising new open-label extension (OLE) data shows benefit in patients with FXS Participants in the OLE trial demonstrated clinically meaningful improvements in behavioral symptoms as measured by the Aberrant Behavior Checklist – Community (ABC-C FXS Irritability) More than 60% of participants achieved clinically meaningful improvement of at least 9 points on the ABC-C FXS Irritability scores out to 3 years Potential to be the first and only approved treatment for patients with FXS; 80,000 patients in the U.S. and Harmony possesses global rights Prepared to initiate Phase 3 registrational trial in 22q11.2 deletion syndrome (22q) in Q4 2025 (pending positive data from the RECONNECT Study) Rare Epilepsy Franchise EPX-100 (clemizole hydrochloride) Most advanced development program in the 5HT2 (serotonin) agonist class Recruitment ongoing for Phase 3 registrational trial in Dravet syndrome (ARGUS Study) with topline data anticipated in 2026 Recruitment ongoing for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated in 2026 EPX-200 (lorcaserin hydrochloride) Proven mechanism of action in developmental and epileptic encephalopathies (DEEs) confirmed via non-clinical and clinical data Currently in IND enabling stage First Quarter 2025 Financial Results Net product revenue for the quarter ended March 31, 2025, was $184.7 million, compared to $154.6 million for the same period in 2024. The 20% growth versus the same period in 2024 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the U.S.) and the broad clinical utility of WAKIX across the approximately 9,000 HCPs that we call on (about 5,000 of whom do not participate in an oxybate REMS program). GAAP net income for the quarter ended March 31, 2025, was $45.6 million, or $0.78 earnings per diluted share, compared to GAAP net income of $38.3 million, or $0.67 earnings per diluted share, for the same period in 2024. Non-GAAP adjusted net income was $60.4 million, or $1.03 earnings per diluted share, for the quarter ended March 31, 2025, compared to Non-GAAP adjusted net income of $50.7 million, or $0.88 per diluted share, for the same period in 2024. Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release. Harmony's operating expenses include the following: Research and Development expenses were $34.5 million in the first quarter of 2025, as compared to $22.2 million for the same quarter in 2024, representing a 56% increase; Sales and Marketing expenses were $30.7 million in the first quarter of 2025, as compared to $27.2 million for the same quarter in 2024, representing a 13% increase; General and Administrative expenses were $31.2 million in the first quarter of 2025, as compared to $25.7 million for the same quarter in 2024, representing a 22% increase; and Total Operating Expenses were $96.5 million in the first quarter of 2025, as compared to $75.1 million for the same quarter in 2024, representing a 29% increase. As of March 31, 2025, Harmony had cash, cash equivalents and investments of $610.2 million, compared to $576.1 million as of December 31, 2024. 2025 Net Product Revenue Guidance Expect full year 2025 net product revenue of $820 million to $860 million. Conference Call Today at 8:30 a.m. ET We are hosting our first quarter 2025 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern Time. The live and replay webcast of the call will be available on the investor relations page of our website To participate in the live call by phone, dial 800-267-6316 (domestic) or 203-518-9783 (international), and reference passcode HRMYQ125. Non-GAAP Financial Measures In addition to our GAAP results, we present certain Non-GAAP measures including Non-GAAP adjusted net income and Non-GAAP adjusted net income per share, which we believe provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate Non-GAAP adjusted net income and Non-GAAP adjusted net income per share may not be identical to the manner in which other companies calculate adjusted net income and adjusted net income per share. We use these Non-GAAP measurements as an aid in monitoring our financial performance from quarter-to-quarter and year-to-year and for benchmarking against comparable companies. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our Non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our Non-GAAP financial measures. About WAKIX® (pitolisant) Tablets WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States. Indications and Usage WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. Important Safety Information Contraindications WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment. Warnings and Precautions WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD). Adverse Reactions In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and greater than placebo) for WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program. Drug Interactions Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half. Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required. H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists. WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment. Use in Specific Populations There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460. The safety and effectiveness of WAKIX have not been established for treatment of excessive daytime sleepiness in pediatric patients less than 6 years of age with narcolepsy. The safety and effectiveness of WAKIX have not been established for treatment of cataplexy in pediatric patients with narcolepsy. WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment. WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR <60 mL/minute/1.73 m 2. Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers. Please see the Full Prescribing Information for WAKIX for more information. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or About Narcolepsy Narcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. About Idiopathic Hypersomnia Idiopathic Hypersomnia (IH) is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. EDS in IH cannot be alleviated by naps, longer sleep or more efficient sleep. People living with IH experience significant EDS along with the symptoms of sleep inertia (prolonged difficulty waking up from sleep) and 'brain fog' (impaired cognition, attention, and alertness). The cause of IH is unknown, but it is likely due to alterations in areas of the brain that stabilize states of sleep and wakefulness. IH is one of the central disorders of hypersomnolence and, like narcolepsy, is a debilitating sleep disorder that can result in significant disruption in daily functioning. About ZYN002 ZYN002 is the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC and formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The product is manufactured through a synthetic process in a cGMP facility and is not extracted from the cannabis plant. ZYN002 does not contain THC, the compound that causes the euphoric effect of cannabis, and has the potential to be a nonscheduled product if approved. Cannabidiol, the active ingredient in ZYN002, has been granted orphan drug designation by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of FXS and for the treatment of 22q. Additionally, ZYN002 has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS. About Fragile X Syndrome Fragile X syndrome (FXS) is a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder. The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability. While the exact prevalence is unknown, upwards of 80,000 patients in the U.S. and 121,000 patients in the European Union and the UK are believed to have FXS, based on FXS prevalence estimates of approximately 1 in 4,000 to 7,000 in males and approximately 1 in 8,000 to 11,000 in females. There is a significant unmet medical need in patients living with FXS as there are currently no FDA-approved treatments for this disorder. FXS is caused by a mutation in FMR1, a gene which modulates a number of systems, including the endocannabinoid system, and most critically, codes for a protein called FMRP. The FMR1 mutation manifests as multiple repeats of a DNA segment, known as the CGG triplet repeat, resulting in deficiency or lack of FMRP. FMRP helps regulate the production of other proteins and plays a role in the development of synapses, which are critical for relaying nerve impulses, and in regulating synaptic plasticity. In people with full mutation of the FMR1 gene, the CGG segment is repeated more than 200 times, and in most cases causes the gene to not function. Methylation of the FMR1 gene also plays a role in determining functionality of the gene. In approximately 60% of patients with FXS, who have complete methylation of the FMR1 gene, no FMRP is produced, resulting in dysregulation of the systems modulated by FMRP. About Clemizole Hydrochloride (EPX-100) EPX-100, clemizole hydrochloride, is under development for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central 5-hydroxytryptamine receptors to modulate serotonin signaling. The drug candidate is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform. DS is caused by a loss of function mutation in the SCN1A gene, and scn1 mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of DS patients. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system. About Dravet Syndrome Dravet syndrome (DS) is a severe and progressive epileptic encephalopathy that begins in infancy and causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and a risk of sudden unexpected death in epilepsy. Approximately 85% of Dravet syndrome cases are caused by de novo loss-of-function (LOF) mutations in a voltage-gated sodium channel gene, SCN1A1. DS has an estimated incidence rate of 1:15,700. About Lennox-Gastaut Syndrome Lennox-Gastaut syndrome (LGS) is a rare and drug-resistant epileptic encephalopathy characterized by onset in children between 3-5 years of age. The underlying cause of LGS is unknown and can be related to a wide range of factors including genetic differences and structural differences in the brain. As a result, patients experience multiple seizure types, including atonic seizures, and developmental, cognitive, and behavioral issues. LGS affects approximately 48,000 patients in the U.S. About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2025 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including ZYN002 and EPX-100; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche ('Bioprojet'); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2025, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES (In thousands, except share and per share data) March 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 488,998 $ 453,001 Investments, short-term 17,955 14,185 Trade receivables, net 105,969 83,033 Inventory, net 6,384 7,198 Prepaid expenses 16,470 13,714 Other current assets 6,916 8,121 Total current assets 642,692 579,252 NONCURRENT ASSETS: Property and equipment, net 1,378 1,257 Restricted cash 270 270 Investments, long-term 103,245 108,874 Intangible assets, net 107,302 113,263 Deferred tax asset 194,709 190,398 Other noncurrent assets 5,939 5,886 Total noncurrent assets 412,843 419,948 TOTAL ASSETS $ 1,055,535 $ 999,200 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Trade payables $ 17,459 $ 13,744 Accrued compensation 7,582 18,776 Accrued expenses 112,701 120,640 Current portion of long-term debt 17,500 16,250 Other current liabilities 19,876 5,672 Total current liabilities 175,118 175,082 NONCURRENT LIABILITIES: Long-term debt, net 158,182 163,016 Other noncurrent liabilities 1,710 1,947 Total noncurrent liabilities 159,892 164,963 TOTAL LIABILITIES 335,010 340,045 COMMITMENTS AND CONTINGENCIES (Note 13) STOCKHOLDERS' EQUITY: Common stock—$0.00001 par value; 500,000,000 shares authorized at March 31, 2025 and December 31, 2024, respectively; 57,393,673 and 57,144,887 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 1 1 Additional paid in capital 672,503 656,872 Accumulated other comprehensive income 245 66 Retained earnings 47,776 2,216 TOTAL STOCKHOLDERS' EQUITY 720,525 659,155 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 1,055,535 $ 999,200 Expand HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES (In thousands except share and per share data) Three Months Ended March 31, March 31, 2025 2024 GAAP net income $ 45,560 $ 38,334 Non-GAAP Adjustments: Non-cash interest expense (1) 166 180 Depreciation 7 163 Amortization (2) 5,961 5,961 Stock-based compensation expense 12,450 10,434 Income tax effect related to non-GAAP adjustments (3) (3,776 ) (4,350 ) Non-GAAP adjusted net income $ 60,368 $ 50,722 GAAP reported net income per diluted share $ 0.78 $ 0.67 Non-GAAP adjusted net income per diluted share $ 1.03 $ 0.88 Weighted average number of shares of common stock used in non-GAAP diluted per share 58,524,566 57,597,627 Expand (1) Includes amortization of deferred finance charges. (2) Includes amortization of intangible asset related to WAKIX. (3) Calculated using the reported effective tax rate for the periods presented less impact of valuation allowance release and discrete items. Expand
Yahoo
05-04-2025
- Business
- Yahoo
Harmony Biosciences Holdings, Inc. (HRMY): A Bull Case Theory
We came across a bullish thesis on Harmony Biosciences Holdings, Inc. (HRMY) on Value Investing Subreddit Page by Long-Access-2143. In this article, we will summarize the bulls' thesis on HRMY. Harmony Biosciences Holdings, Inc. (HRMY)'s share was trading at $30.97 as of April 3rd. HRMY's trailing and forward P/E were 12.34 and 8.72 respectively according to Yahoo Finance. Harmony Biosciences, a commercial-stage pharmaceutical company focused on rare neurological disorders, presents a compelling investment case built on a profitable and differentiated product, strong financial execution, and deep undervaluation. Its flagship product, WAKIX, is an FDA-approved treatment for excessive daytime sleepiness (EDS) and cataplexy in narcolepsy. Uniquely, WAKIX is not a controlled substance, unlike competitors such as Xyrem or Adderall, making it more accessible and safer for patients. The drug's mechanism as a selective H3 receptor antagonist avoids addictive properties, enabling once-daily dosing that improves both patient experience and adherence. At a cost of $165,000 per patient annually—less than some competitors—WAKIX has demonstrated its commercial strength, with 2024 sales growing 23% to $715 million. Harmony's impressive financial profile includes a 35% return on invested capital and 30% free cash flow margins, signaling disciplined capital allocation and strong operating leverage. Despite flat EBITDA and FCF in 2024 due to non-recurring expenses from licensing and M&A activity, margin expansion is expected to resume in 2025 as revenue continues to scale. Yet, Harmony's valuation fails to reflect its quality. The company trades at just 13.2x earnings and 8.7x free cash flow, while its FCF per share more than doubled from $0.60 in Q3 2023 to $1.30 in Q4 2024. This disconnect stems largely from two events. First, a March 2023 short-seller attack caused a temporary drop in the share price, which has yet to recover despite the FDA fully rejecting all related claims and expanding WAKIX's approval to pediatric patients in mid-2024. Second, the failure of the INTUNE study targeting Idiopathic Hypersomnia (IH) weighed on sentiment, though such setbacks are common in biotech. Harmony quickly pivoted to a new approach with Pitolisant High Dose (HD), now advancing to Phase 3 trials. Importantly, none of these headwinds affected core revenue growth or the favorable risk profile of WAKIX. Looking ahead, the upside potential is substantial. Management projects WAKIX sales of $820–$860 million in 2025 and over $1 billion by 2027. More significantly, six Phase 3 programs are expected to be in development by the end of 2025, and the company aims to launch a new product every year through 2030. This could drive total sales to over $3 billion by 2028. Of particular note is ZYN-002, targeting Fragile X Syndrome, which has no current treatment but affects over 80,000 patients. Fast-tracked by the FDA, ZYN-002 could launch as early as 2026 and—with full ownership—would provide high-margin revenue. Additionally, a new gastro-resistant formulation of Pitolisant (GR) is advancing with potential approval by 2026, possibly extending WAKIX exclusivity through 2044. Even excluding pipeline contributions, Harmony's intrinsic value is considerably higher. A conservative DCF model based solely on WAKIX, using management's low-end guidance and a 13.58% WACC, implies a base-case share price of $74.81—well above current levels. Harmony outperforms peers such as Jazz, Takeda, and Avadel in both margins and growth while remaining significantly undervalued. As clinical milestones unfold and investor sentiment corrects, Harmony offers a high-quality, cash-generating asset with clear catalysts for a major rerating. Harmony Biosciences Holdings, Inc. (HRMY) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 26 hedge fund portfolios held HRMY at the end of the fourth quarter which was 25 in the previous quarter. While we acknowledge the risk and potential of HRMY as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than HRMY but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
Associated Press
24-03-2025
- Business
- Associated Press
Harmony Biosciences Names Adam Zaeske as Chief Commercial Officer to Lead the Next Phase of Commercial Growth as Its Portfolio Expands
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the appointment of Adam Zaeske as Executive Vice President and Chief Commercial Officer (CCO), effective March 31, 2025. The company's current CCO, Jeffrey Dierks, is voluntarily stepping down for personal reasons. Zaeske brings 25 years of global leadership across the pharmaceutical industry, building teams and transforming organizations in both the U.S. and Europe. He has broad functional experience spanning commercial strategy and operations, sales, marketing, market access, new product planning and finance. At Harmony, Zaeske will be responsible for leading the company's commercial organization, setting commercial strategy, driving market expansion in the U.S. and abroad, and ensuring strong execution across all brands and geographies. His deep expertise in launching products, including in rare diseases, coupled with his extensive experience in scaling commercial operations and embedding strong capabilities, will be pivotal as Harmony builds on the commercial success of WAKIX ® (pitolisant) and prepares to advance its late-stage pipeline assets toward approvals both in the U.S. and other territories to serve even more patients worldwide. 'I am very excited to welcome Adam to the team as we build upon the commercial success of WAKIX in narcolepsy and prepare for our next phase of growth,' said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. 'As Harmony continues to execute on our growth strategy, Adam's deep commercial expertise, proven leadership across both the US and international markets, and experience launching and growing brands, including in rare diseases, make him the ideal person to lead our Commercial team and drive our next phase of growth. I also want to express my gratitude to Jeffrey Dierks for his contributions in building Harmony's strong commercial foundation and leading the successful launch and commercialization of WAKIX. With this foundation, we remain confident in our 2025 revenue guidance and in WAKIX being a $1B plus opportunity in adult narcolepsy alone.' Zaeske most recently served as Head of Central, South, and Eastern Europe at Takeda Pharmaceuticals, where he managed a $2 billion business spanning 25 countries and nearly 900 employees. Under his leadership, the region delivered three consecutive years of double-digit growth and contributed the largest portion of revenue and growth for Takeda's European and Canadian business. Zaeske has also successfully led commercial organizations in the U.S. and Europe across multiple therapeutic areas, including rare diseases, neuroscience, immunology, hematology, oncology and gastroenterology, ensuring patient access to innovative therapies and driving long-term portfolio growth. Zaeske holds an MBA from Harvard Business School and graduated with honors from the University of Michigan with a degree in Business Administration and Finance. 'I am impressed by the Harmony team, their clarity of purpose in helping people living with rare neurological diseases, and the success of WAKIX in narcolepsy,' said Zaeske. 'I am very excited to be joining the organization at such a pivotal time with the opportunity to expand on that success with the next-generation pitolisant formulations as well as the late-stage products in their robust pipeline as they advance toward commercialization. My experiences in both rare disease and neurology were tremendously rewarding parts of my career, and I look forward to returning to these therapeutic areas and contributing to Harmony's potential to help many more patients who are living with unmet medical needs.' Zaeske's appointment comes as Harmony's portfolio is poised for significant growth, driven by a catalyst-rich pipeline with late-stage assets that have global rights, and strategic initiatives designed to expand its reach of innovative products to patients around the world. About WAKIX ® (pitolisant) Tablets WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States. Indications and Usage WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. Important Safety Information Contraindications WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment. Warnings and Precautions WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD). Adverse Reactions In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and greater than placebo) for WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program. Drug Interactions Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half. Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required. H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists. WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment. Use in Specific Populations There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460. The safety and effectiveness of WAKIX have not been established for treatment of excessive daytime sleepiness in pediatric patients less than 6 years of age with narcolepsy. The safety and effectiveness of WAKIX have not been established for treatment of cataplexy in pediatric patients with narcolepsy. WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment. WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR <60 mL/minute/1.73 m 2. Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers. Please see the Full Prescribing Information for WAKIX for more information. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2024 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche ('Bioprojet'); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe and the significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption 'Risk Factors' in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 'SEC') on February 25, 2025, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. Brennan Doyle 484-539-9700 [email protected] Biosciences Media Contact: Cate McCanless 202-641-6086 SOURCE: Harmony Biosciences Holdings, Inc. Copyright Business Wire 2025. PUB: 03/24/2025 08:05 AM/DISC: 03/24/2025 08:04 AM
