HRMY

A month has gone by since the last earnings report for Harmony Biosciences Holdings, Inc. (HRMY). Shares have added about 12.1% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Harmony Biosciences due for a pullback? Well, first let's take a quick look at its latest earnings report in order to get a better handle on the recent catalysts for Harmony Biosciences Holdings, Inc. before we dive into how investors and analysts have reacted as of late. HRMY Q2 Earnings Beat Estimates on Strong Wakix Sales Harmony Biosciences Holdings reported second-quarter 2026 earnings of $1.28 per share, up from 68 cents in the year-ago quarter. The figure surpassed the Zacks Consensus Estimate of 97 cents. Quarterly revenues rose 30% year over year to $261.28 million and surpassed the Zacks Consensus Estimate of $253 million. Growth was driven by sustained demand for lead drug, Wakix (pitolisant), with the estimated average patient count increasing by 450 sequentially to 8,950. HRMY Q2 Cost Analysis Cost of products sold represented 24.2% of product revenues compared with 19% in the prior-year quarter, primarily due to new royalties tied to the Novitium license agreement. Research and development expenses declined 7.1% to $46.6 million, reflecting the absence of a $15-million CiRC upfront payment recorded a year ago. Sales and marketing expenses increased 13.5% to $34.1 million due to the expansion of field-based teams. General and administrative expenses decreased 17.3% to $28.1 million due to a charge related to an ANDA settlement in the second quarter of 2025. Cash, cash equivalents and investments totaled $962.5 million as of June 30, 2026, up from $882.5 million as of 2025-end. Harmony Pipeline Updates Highlight BP-205 In April 2024, the company expanded into orexin-based therapies through a sublicense agreement with Bioprojet for BP-205, an investigational orexin-2 receptor agonist being developed for narcolepsy and other central nervous system (CNS) disorders. The agreement grants exclusive rights to develop, manufacture and commercialize BP-205 in the United States and Latin America. Harmony reported favorable phase I single-ascending-dose data for BP-205, its orexin-2 receptor agonist. The candidate demonstrated a short time to maximum plasma concentration (30-75 minutes) and a mean half-life of approximately 25 hours, supporting the potential for rapid onset and once-daily dosing. Exposure increased proportionally across the tested doses. BP-205 was generally safe and well tolerated, with no serious or severe treatment-emergent adverse events. Multiple-ascending-dose data in healthy volunteers are expected in the fourth quarter of 2026. Harmony also plans to begin a phase Ib study in sleep-deprived healthy volunteers during the third quarter, with data expected in early 2027. Phase II studies across multiple central nervous system indications are scheduled to begin in mid-2027. HRMY Advances Pitolisant and Epilepsy Assets The FDA accepted the new drug application for pitolisant GR, assigning a target action date of April 1, 2027. The gastro-resistant formulation is designed to reduce gastrointestinal side effects and allow patients to begin treatment at a therapeutic dose without titration. Harmony is pursuing label expansion opportunities for pitolisant beyond narcolepsy, targeting rare neurological disorders such as Prader-Willi syndrome (PWS) and myotonic dystrophy type 1 (DM1). Phase III ONSTRIDE studies of high-dose pitolisant in narcolepsy and idiopathic hypersomnia remain underway, with top-line data expected in 2027. Top-line results are expected in mid-2027. The company is conducting the phase III TEMPO study in PWS, supported by FDA alignment, which has the potential to serve as the registrational trial and support the company’s efforts to seek pediatric exclusivity for pitolisant. The FDA granted Orphan Drug designation to pitolisant for the treatment of PWS in 2024. The company also strengthened its rare epilepsy pipeline by acquiring Epygenix Therapeutics, gaining exclusive rights to develop EPX-100 (clemizole hydrochloride) for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).EPX-100 is being evaluated in the phase III LIGHTHOUSE study for LGS and the ARGUS study for DS. Top-line results from both rare-epilepsy programs are expected in the first half of 2027, with potential regulatory action targeted for 2028. Harmony Reiterates 2026 Revenue Outlook Harmony reaffirmed its 2026 Wakix net revenue guidance of $1 billion to $1.04 billion. Wakix net product revenues rose 21% sequentially in the second quarter, reflecting a rebound from the seasonal market-access headwinds that affected patient starts during the first quarter. Management expects patient growth to continue steadily through the second half of the year, supported by the expanded commercial infrastructure. The average patient increase was the second highest in the product’s seven-year commercial history. Four of the past five quarters generated more than 400 patient additions, indicating steady demand within the narcolepsy market. Management attributed the strong performance to Wakix’s position as the only non-scheduled treatment option for narcolepsy. The product has payer coverage for more than 80% of covered lives and is used both as a standalone therapy and in combination with other narcolepsy therapies. It turns out, estimates revision have trended upward during the past month. At this time, Harmony Biosciences has a great Growth Score of A, though it is lagging a lot on the Momentum Score front with a C. However, the stock has a grade of A on the value side, putting it in the top 20% for value investors. Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Harmony Biosciences has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Harmony Biosciences belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Myriad Genetics (MYGN), has gained 2.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Myriad reported revenues of $190.7 million in the last reported quarter, representing a year-over-year change of -10.5%. EPS of -$0.25 for the same period compares with $0.05 a year ago. For the current quarter, Myriad is expected to post a loss of $0.16 per share, indicating a change of 0% from the year-ago quarter. The Zacks Consensus Estimate has changed -118.2% over the last 30 days. Myriad has a Zacks Rank #5 (Strong Sell) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of B. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report Myriad Genetics, Inc. (MYGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Tuesday, Aug. 4, 2026 at 8:30 a.m. ET Head of Investor Relations - Brennan Doyle President and Chief Executive Officer - Jeffrey Dayno Chief Commercial Officer - Adam Zaeske Chief Medical and Scientific Officer - Kumar Budur Chief Operating Officer - Peter Anastasiou Interim Principal Financial Officer - Steve Mollichella Operator: Good morning, everyone. My name is Bo, and I will be your conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences Second Quarter Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to turn the call over to Mr. Brennan Doyle, Head of Investor Relations. Please go ahead, sir. Brennan Doyle: Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' second quarter 2026 financial results and provide a business update. Before we start, I encourage everyone to go to the Investors section of our website to find the materials that accompany today's discussion, including a reconciliation of our GAAP to non-GAAP financial measures. At this stage of our life cycle, we believe non-GAAP financial results better represent the underlying business performance. Our speakers on today's call are Dr. Jeffrey Dayno, President and CEO; Adam Zaeske, Chief Commercial Officer; Dr. Kumar Budur, Chief Medical and Scientific Officer; Peter Anastasiou, Chief Operating Officer; and Steve Mollichella, Interim Principal Financial Officer. As a reminder, we will be making forward-looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially, and we undertake no obligation to update these statements even if circumstances change. We encourage you to consult the risk factors referenced in our SEC filings for additional details. I would now like to turn the call over to our CEO, Dr. Jeffrey Dayno. Jeff? Jeffrey Dayno: Thank you, Brennan. Good morning, everyone, and thank you for joining us today. This was a defining quarter for Harmony Biosciences on 2 fronts. Commercially, WAKIX delivered record quarterly net revenue of $261.3 million, up 30% year-over-year and up 21% compared to last quarter, signaling a decisive rebound from the seasonal headwinds we discussed on our first quarter earnings call. And importantly, on the R&D front related to our robust pipeline, today, we shared encouraging data from a Phase I single ascending dose or SAD study for BP-205 that reinforces its potential as a best-in-class orexin-2 receptor agonist. Revenue is on track to exceed $1 billion this year, and our opportunity with our orexin-2 agonist BP-205 is coming into focus with multiple data catalysts over the next 6 months. The 2 key messages that I want you to take away from today's call are: first, continued strong growth for WAKIX on track for over $1 billion in net revenue for the year; and second, encouraging Phase I PK data for our potential best-in-class orexin-2 agonist BP-205 with multiple data catalysts coming in the next 6 months. The foundation upon which we continue to grow the business and advance our pipeline remains strong. We are a profitable, self-funding biotech company operating from a position of strength, a proven commercial engine now in its seventh year in the market, a robust pipeline centered around BP-205, our potential best-in-class orexin-2 agonist, a balance sheet with the capacity and a management team with the expertise and conviction to execute on meaningful business development opportunities and a multilayered IP strategy to protect the pitolisant franchise out to 2030. We continue to run the business aligned around our 4 priorities focused on value creation, growing the WAKIX franchise in an evolving market, advancing our robust pipeline, transacting on strategic business development opportunities and protecting our IP estate around the pitolisant franchise. Let me walk you through the highlights for each of these 4 priorities. First, the commercial performance this quarter was outstanding as we continue to grow the WAKIX franchise in an evolving market. Our record quarterly revenue of $261.3 million keeps us firmly on track to achieve more than $1 billion in net revenue in 2026, which is why we are confident in reiterating our full year guidance of $1 billion to $1.04 billion. WAKIX has a compounded annual growth rate of about 40% over the last 5 years, and there continues to be a large market opportunity for WAKIX with about 80,000 patients diagnosed with 90,000 to 100,000 individuals not yet diagnosed. Turning to our pipeline and the focal point for this call, BP-205, our potential best-in-class orexin-2 agonist. Today, we shared encouraging data from a Phase I single ascending dose PK study for BP-205. Kumar will take you through the SAD data results later in the call. BP-205 is designed to deliver a differentiated profile as the most potent of the orexin-2 agonist currently in the clinic with excellent selectivity and now with clinical PK data demonstrating a predictable PK profile with the potential for once-daily dosing, along with a favorable safety tolerability profile. These data strengthen our conviction that BP-205 could be a best-in-class orexin-2 agonist and reinforce our commitment to invest in the BP-205 development program. We will be initiating Phase II trials in the middle of next year to evaluate multiple CNS indications as we believe BP-205 could have broad clinical utility. Next up for BP-205 is top line data from the multiple ascending dose study in Q4 and initiation of a Phase Ib study in sleep-deprived healthy volunteers in the third quarter with top line data readout expected early next year. Kumar will provide more color on BP-205 during his R&D update. One additional comment on BP-205 and our exciting orexin opportunity. We have been leaders in the Sleep/Wake space for almost a decade now and are leveraging our expertise to accelerate our BP-205 development program toward multiple CNS indications and become a leader in the orexin space. In addition to organic growth, we have significant firepower to put forward business development for inorganic growth. With approximately $963 million on the balance sheet, we have the capacity and the conviction to execute on meaningful transactions to drive long-term value. Peter will share more color around our BD strategy later in the call. Additionally, he will provide an update on our multilayered IP strategy and our efforts to protect the WAKIX franchise. We have settled with 6 of the 7 ANDA filers and are confident in the strength of our IP estate, which supports WAKIX exclusivity to March of 2030, inclusive of 6 months of pediatric exclusivity for which we are on track to obtain. In summary, this has been a defining quarter for Harmony Biosciences. We posted record revenue for WAKIX in its seventh year in the market and shared encouraging data for BP-205, which supports its profile as a potential best-in-class orexin-2 agonist. With multiple data catalysts coming for BP-205 over the next 6 months and our focus on business development, Harmony is poised to deliver meaningful long-term value creation as we drive toward delivering innovative treatments for patients living with CNS diseases and unmet medical needs. With that, I will now turn the call over to Adam Zaeske, our Chief Commercial Officer, for a closer look at our Q2 commercial performance. Adam? Adam Zaeske: Thank you, Jeff, and good morning, everyone. The second quarter continued our strong growth and momentum trend. WAKIX delivered $261.3 million in net sales, up 30% year-over-year and up 21% over the first quarter, now in its seventh year on the market and firmly on pace for our full year guidance of $1 billion to $1.04 billion in net revenue. Last quarter, we saw a bit more pronounced seasonal market access headwinds that impact the industry every year, the elevated plan changes, planned switching and premium increases, which can delay patient starts, especially in January. But the underlying fundamentals remained steady and consistent. This quarter, the demand-driven trajectory and patient additions continue. WAKIX achieved estimated average patients of 8,950 or an increase of approximately 450 patients from 1Q. This represents the highest 2Q increase in the history of the brand, the second highest increase all time and with 4 of the last 5 quarters achieving 400-plus patient additions, our growth and performance has never been stronger. What's driving this continued performance is clear. WAKIX owns a highly differentiated position as the only non-scheduled treatment option for narcolepsy patients. With now 7-plus years of clinical experience, health care providers are highly aware of WAKIX and believe in its unique combination of efficacy, safety and tolerability with low drug-drug interactions as well as its broad payer coverage with more than 80% of lives covered. This makes WAKIX a familiar go-to option for any patient with narcolepsy and in any combination with other therapies in a highly polypharmacy market, and this will continue to remain true as the market continues to evolve. Q2 was the first quarter after our field team expansions, which has expanded our presence by roughly 20% across field sales, remote sales and field reimbursement. This represents the largest expansion and increase in investment in the history of the brand. All of those physicians have been hired, trained and fully deployed. We also launched a new online portal, easing the process to prescribe WAKIX for health care providers and office staff. And we implemented changes to our reimbursement support process, which is already showing results with patients able to secure WAKIX faster and with higher success. As a result, we see significant continued growth potential in a total narcolepsy population of approximately 170,000 at diagnosis rates still under 50% and brand penetration of about 20%. Looking ahead, we're excited about our 2 life cycle programs to extend and expand the franchise. Pitolisant GR builds on the WAKIX safety and tolerability profile and enables patients to start at a therapeutic dose. Pitolisant HD offers a new optimized formulation with up to 2x the highest labeled dose of WAKIX, all of the benefits of the GR formulation and potential for differentiated labeling regarding fatigue in narcolepsy and sleep inertia in IH. Finally, our orexin program gives us the opportunity to deliver on the promise of efficacy with a favorable tolerability profile, once-daily dosing and potential use in a broad range of CNS indications. To summarize, we continue to operate from a position of strength. We are on track to achieve more than $1 billion in net sales this year with a pipeline built to extend our leadership in Sleep/Wake for at least the next decade. I'll now turn the call over to our Chief Medical and Scientific Officer, Dr. Kumar Budur. Kumar? Kumar Budur: Thank you, Adam. Good morning, everyone, and thank you for joining us today. We continue to make good progress across all our pipeline programs, including 5 Phase III registrational studies in 5 distinct rare neurological disorders. The headline for R&D this quarter is BP-205, a potential best-in-class orexin-2 receptor agonist. So let me start there. BP-205 is built on novel chemical scaffold that confers unique potency, selectivity and potentially avoids some of the molecular structure-related effects such as hepatic and cardiac toxicity. It is the most potent orexin-2 receptor agonist in clinical development with excellent selectivity for orexin-2 over orexin-1 receptors and over 150 other receptors of interest. The high potency gives us the flexibility to use low doses and to pursue a broad range of CNS indications, including those with no obvious orexin deficiency. Today, we reported data from the single ascending dose portion of our Phase I study in healthy volunteers. In this randomized, double-blind, placebo-controlled study across 9 cohorts in men and women, each participant received a single dose of BP-205 or placebo with doses ranging from 0.2 milligram up to 6 milligrams. In total, 72 healthy volunteers participated in this study. The SAD study in healthy volunteers was designed to characterize pharmacokinetics and safety tolerability profile. Within that scope, the data was very encouraging. Walking through the specific findings, BP-205 showed rapid absorption with a short Tmax in the range of 30 to 75 minutes pointing to the potential for rapid onset of efficacy. We observed a mean half-life of approximately 25 hours across dose group, which supports once-daily dosing and the potential for durable efficacy throughout the day and into the early evening. Exposure was dose proportional Cmax and AUC across all doses, indicating predictable systemic exposures across the ranges tested. We saw no age or gender differences in PK parameters, which supports no dose adjustment for elderly or female patients. Finally and most importantly, BP-205 was generally safe and well tolerated with no serious or severe treatment-emergent adverse events reported, including no cardiovascular, hepatic or visual abnormalities. The most common adverse events were headache, fatigue and diarrhea in approximately 10%, 4% and 3% of the participants, respectively. To our knowledge, we are the first company to share this level of granularity on orexin-2 receptor single ascending dose data, and we are doing so because we have strong conviction in BP-205 having the potential for a best-in-class profile. What comes next? Multiple ascending dose study data analysis is ongoing, and we plan to disclose those data in Q4. The U.S. IND for BP-205 is now open and we'll be initiating our Phase Ib study in sleep-deprived healthy volunteers in Q3 with the top line data expected from this study in early 2027. That study is a one to watch because it will provide the first signals of efficacy for BP-205 and provide a basis for comparison against other orexin agonist. Given the potential for broad utility of this profile, we will be initiating Phase II trials in multiple CNS indications in mid-2027. Turning to our other programs and starting with next-gen pitolisant programs. We submitted the pitolisant GR NDA in the second quarter. The file is accepted for full review with a target PDUFA date of April 1, 2027. Approximately 80% to 90% of patients with narcolepsy experienced GI symptoms as part of the disease and pitolisant GR is designed to reduce the potential for GI AEs while also allowing patients to initiate treatment at a therapeutic dose of 17.8 milligrams without titration, an important clinical differentiation. Pitolisant HD and optimized formulation of pitolisant with GR coating and high dose continues to advance in 2 Phase III registrational trials, ONSTRIDE 1 in narcolepsy and ONSTRIDE 2 in idiopathic hypersomnia with top line data expected in 2027 and anticipate PDUFA in 2028. These programs are pursuing differentiated labels, fatigue in narcolepsy and sleep inertia in IH, symptoms for which there are no currently approved treatments. Utility patents were filed for both pitolisant GR and pitolisant HD with the potential to extend the pitolisant franchise into the 2040s. Moving on, the Phase III registrational study in Prader-Willi syndrome, the TEMPO study is actively recruiting patients and we now expect top line data in mid-2027. The delay in top line data is mainly due to limited prevalence of people living with PWS and also experiencing the level of sleepiness that meets the criteria to enroll in this study. This study is designed with the input from the FDA, not only to meet the registrational requirements but also fulfill the second and last requirement for pediatric exclusivity, which gives us 6 months of additional regulatory exclusivity for WAKIX on the back end of the longest patent. And we remain on track to obtain pediatric exclusivity for WAKIX. We are also advancing the amorphous form of pitolisant license for Novitium, supported by an issued patent through 2042. The current efforts are directed towards formulation optimization and ongoing Phase I PK study. Finally, our epilepsy franchise. EPX-100, our clemizole hydrochloride continues to advance in 2 global Phase III registrational trials, the ARGUS Study in Dravet syndrome and the LIGHTHOUSE Study in Lennox-Gastaut syndrome, with top line data expected in mid-2027 and anticipated PDUFA in 2028. In summary, we are encouraged by the data we shared today for our orexin-2 agonist, BP-205, supporting its potential best-in-class profile and excited about the multiple data catalysts coming within the next 6 months for BP-205. We also continue to make progress on the 5 Phase III registrational clinical trials that we are conducting across our other pipeline programs, which will contribute to additional data catalysts in 2027 and target PDUFA date in 2028. On behalf of Harmony, I want to thank the patients and the families for participating in our clinical trials, along with the investigators and site personnel for their dedication in advancing our clinical trials. I'll now turn the call over to our Chief Operating Officer, Peter Anastasiou. Peter? Peter Anastasiou: Thank you, Kumar. I want to provide a brief update on the final 2 objectives in our value creation strategy, transacting on business development and protecting the pitolisant franchise. In business development, we are primarily focused on assets with revenue potential in the 2028 to 2032 time frame. We are prioritizing products in Phase III, in registration or on the market. We plan to leverage our core competencies and are directing our search and evaluation efforts in Sleep/Wake, epilepsy, rare orphan CNS and broader CNS indications. We are considering a variety of deal types, including M&A and licensing. With approximately $963 million on the balance sheet, we have both the capacity and the conviction to transact. You should not expect that we will allocate all of that capital on one transaction. Instead, we will likely engage in multiple transactions and together, they can be transformative for Harmony. With regard to protecting pitolisant, our IP estate is multilayered across formulations, methods of use and next-generation applications, and it supports WAKIX exclusivity into March 2030, inclusive of 6 months of pediatric exclusivity. There is the potential for Harmony to extend the pitolisant franchise through other formulations into the 2040s via additional patents and applications. With respect to ongoing litigation, we have settled with 6 of the 7 ANDA filers, and we have 2 active legal proceedings with the lone remaining ANDA filer. The first is the ANDA litigation with AET, where we are defending our polymorph 197 patent and the method of use 947 patent. The bench trial has concluded and the post-trial briefs are public. Harmony requested and the judge has called for closing arguments from both sides on October 22 this year. In April, Harmony and Novitium filed a new patent infringement lawsuit against AET Pharma US and its marketing partner, Sandoz, alleging infringement of the 920 patent covering an amorphous form of pitolisant hydrochloride. We are confident that we will prevail in both of these legal proceedings, enabling us to maintain exclusivity for WAKIX into March 2030. I will now turn the call over to our Interim Principal Financial Officer, Steve Mollichella. Steve? Stephen Mollichella: Thank you, Peter, and good morning, everyone. This morning, we issued our second quarter 2026 earnings release and filed our 10-Q, where you will find details of our financial and operating results. We delivered strong financial results that reflect continued demand for WAKIX and our disciplined approach to managing expenses across the business. For the second quarter of 2026, we reported net revenue of $261.3 million compared to $200.5 million in the prior year quarter, representing 30% growth. Performance in the quarter reflects the continued robust demand for WAKIX. Cost of product sold was 24.2% of net revenue compared to 19% 1 year ago. This year-over-year increase was primarily driven by new royalties related to the Novitium license agreement, which we signed in Q1 of this year. We reported total operating expenses of $108.8 million for the second quarter compared to $114.2 million in the prior year quarter. The decline in expenses was primarily driven by the $15 million upfront fee we paid to CiRC in Q2 of 2025, with no corresponding amount in the current year period. This was partially offset by continued investments in R&D and the ongoing commercialization of WAKIX. Net income for the second quarter was $75.4 million or $1.28 per diluted share compared to $39.8 million or $0.68 per diluted share for the prior year period. Finally, we ended the second quarter with $962.5 million of cash, cash equivalents and investments and $155 million in debt. We expect cash flow generation to continue to be strong in the coming quarters. That said, our intent is to deploy our cash towards strategic business development opportunities and to continue to invest in the growth of our pipeline and diversification of our commercial portfolio. And with that, I will turn the call back over to Jeff for his closing remarks. Jeff? Jeffrey Dayno: Thanks, Steve. In closing, this was a defining quarter for Harmony Biosciences, centered around 2 key accomplishments. We delivered record quarterly net revenue for WAKIX and are on track to achieve greater than $1 billion in revenue for the year. And importantly, we took a big step forward in our orexin-2 agonist development program, sharing encouraging Phase I PK data for BP-205, which supports its potential best-in-class differentiated profile. And coming soon, MAD data in Q4 and data from a sleep-deprived healthy volunteer study for BP-205 early next year. We have been leaders in the Sleep/Wake space for almost a decade now and are leveraging our expertise to accelerate our BP-205 development program toward multiple CNS indications and become a leader in the orexin space. We continue to drive the business around our 4 priorities focused on value creation, grow WAKIX in an evolving market, advance our robust late-stage pipeline with our potential best-in-class orexin-2 agonist, BP-205 as the centerpiece of our pipeline with multiple data catalysts coming over the next 6 months, transact on strategic BD opportunities, and lastly, protect the pitolisant franchise based on our multilayered patent estate and robust IP strategy that gives us confidence in defending the WAKIX franchise out to March 2030. We believe that when we execute on these 4 priorities, Harmony is well positioned to bring innovative treatments to patients living with CNS diseases while driving sustained long-term value for shareholders. Thank you for your attention. I will now turn the call back over to the operator for Q&A. Operator? Operator: [Operator Instructions] We'll go first this morning to Pete Stavropoulos at Cantor Fitzgerald. Pete Stavropoulos: Congratulations on the progress. My question is around the clinical program on BP-205. Congrats on the SAD data. Good first step. And I'm curious on how the short Tmax relatively long half-life and high potency could translate into a differentiated clinical profile from both efficacy and safety standpoint, especially compared to other orexin-2 receptor agonists that are either BID or split dose? And how do you think they impact the use in the broader CNS indication? Jeffrey Dayno: Pete, thank you for your question. Yes, with regards to BP-205, we are excited about the emerging clinical profile with the Phase I SAD data. I'll turn to Kumar to provide perspective on short half-life and the rest of the profile and the potential clinical relevance. Kumar Budur: Pete, thanks for the question. So you asked 3 questions, Tmax, half-life and potency. Let's start with Tmax. The time to maximum concentration was very short, 30 to 75 minutes. And this is a very desirable feature because it results in rapid onset of efficacy. And that's especially important when you look at central disorders of hypersomnolence where patients are sleepy. And within central disorders of hypersomnolence, if you look at indications such as idiopathic hypersomnia, for example, who have sleep inertia, again, short Tmax is very helpful. And also beyond central disorders of hypersomnolence, if you look at indications such as ADHD, again, a short Tmax will be very helpful. In terms of half-life, first and foremost, the longer half-life will facilitate QD dosing, which is always preferable from a patient perspective. And in terms of efficacy, it does help sustain wakefulness in the later part of the day and in early part of the evening. And if you look beyond NT1, for example, in NT2, idiopathic hypersomnia and other central disorders, where there is no obvious deficiency of orexin, what we are trying to accomplish there is look at the higher cascade mechanism of orexin receptor agonist and depend on the downstream impact on histamine, norepinephrine, dopamine and serotonin. so having a longer half-life dosing to steady state will be helpful in both hypersomnolence disorders and non-hypersomnolence disorders, the broader central nervous system disorders. Finally, the potency. We have always talked about the importance of potency. In fact, we have been talking about the importance of potency since we first disclosed our in vitro data in October 2024. And we are very impressed with the potency of BP-205. This continues to be the most potent orexin-2 receptor agonist in clinical development. It gives us the flexibility to use low doses across all 3 central disorders of hypersomnolence and by extension, other broad CNS indications as well. Pete Stavropoulos: Just a quick follow-up. How do you -- were you able to confirm target engagement? Do you know if BP-205 is actually activating the orexin-2 receptor in CNS? Kumar Budur: Yes, Pete, great question. Yes, in our single ascending dose study, probably you are referring specifically to insomnia and [ polyuria ], we did not see those [ EAEs ], but it's single ascending dose study, so there is some limitation in extrapolation of the safety and tolerability profile. We are not disclosing our multiple ascending dose data today because the data analysis are still ongoing. But in our multiple ascending dose study, we dosed for 15 days in healthy volunteers. What I can say is we did see some target engagement mechanistic EAEs such as insomnia and polyuria. But this is transient and none of them were either serious or sustained. And we'll disclose full MAD data sets in Q4. Jeffrey Dayno: Yes. Thanks, Kumar. Pete, I just want to add additional -- a few additional comments with regards to the half-life, just frame of reference. I think as you may be aware, neuropsych drugs that in the market that are dosed once-daily typically have half-life in the range of about 15 to 25 hours. So just an important sort of context with regards to the half-life we're reporting today, 25 hours. One interesting analog is actually WAKIX. WAKIX half-life of about 20 hours dosed once-daily in the morning, convenient dosing for patients. So frame of reference with regards to a half-life of 24 hours. And importantly, as Kumar said, maintaining the physiologic tone of the orexin system when dosed to steady state, another important component of the PK profile. Thanks, Pete. Operator: We'll go next now to David Hoang at Deutsche Bank. David Hoang: Congrats on the quarter and the data update today. So first question, I was wondering if you could just comment a little bit on the selectivity of your orexin, BP-205 for the orexin-2 receptor versus orexin-1. I think you have some preclinical data in the presentation and how that might compare against other orexin molecules out there? And maybe just -- if you could just elaborate on the importance of potency versus selectivity. So that's my first question. Jeffrey Dayno: Thanks, David. Let me just a brief comment. I think that comes down to a threshold effect. So a threshold effect with regards to selectivity, after which there's really no incremental benefit. And then Kumar can provide sort of the data behind that. Kumar Budur: Yes, David. In terms of the selectivity, you are probably referring to the in vitro data that is in the slide deck. We have over 600-fold selectivity for orexin-2 receptors over orexin-1 receptors. Potency and selectivity, they go hand in hand. If you look at the half [indiscernible] at orexin-2 receptor, EC50 is 0.015 nanomolar. And for orexin-1 receptor, it's 9.01 nanomolar. So that's over 600-fold selectivity. That's a lot of selectivity. We also look at selectivity over 100 other receptors of interest. And we saw greater than 1,000-fold selectivity over there. Now what it implies from a clinical perspective, based on the preclinical data, we have a predicted maximum therapeutic dose. If you look at that dose, we will have 140-fold margin over the maximum predicted efficacy dose in humans. And typically, in central nervous system disorders, you work with a selectivity of around 20, 30-fold and having 140-fold margin over orexin-1 receptor is pretty good, a lot more selectivity than we will ever need. And if there is ever a concern about EAEs related to orexin-1 receptor agonist, we just disclosed the single ascending dose study, granted that it's single ascending dose study, we actually did not see anything to say that the drug is interacting with orexin-1 receptors. And the same was true with the preliminary MAD safety tolerability data as well. David Hoang: Great. And then my follow-up question pertains to pitolisant HD. I understand the top line data would be next year. Can you just help maybe set some expectations for us? What would you -- what will you present in the top line data for pitolisant HD? And what's your level of confidence in getting a differentiated label? Kumar Budur: Right. David, in terms of the top line data for pitolisant HD, we are on track for top line data for both narcolepsy and idiopathic hypersomnia in 2027 and PDUFA date in 2028. Let me start with narcolepsy. Pitolisant HD is an optimized formulation of pitolisant. So milligram to milligram is just not the same as, for example, WAKIX formulation, also has GR coating and it's higher dose. And we have data to show some linear correlation between exposure and efficacy. So to start with, when it comes to excessive daytime sleepiness, we anticipate to see a larger effect size. And then we will also be pursuing a differentiated label for narcolepsy by targeting symptoms of fatigue. So that's narcolepsy. When it comes to idiopathic hypersomnia, we had disclosed a lot of data from our INTUNE study. So we will not just be targeting excessive daytime sleepiness in idiopathic hypersomnia. We will have a high level of confidence, but we'll also be targeting sleep inertia, a very important symptom in patients with idiopathic hypersomnia for which there are no approved treatments. And again, at last year's SLEEP Meeting, we showed the effectiveness of pitolisant in treating sleep inertia as measured by Sleep Inertia Questionnaire. Jeffrey Dayno: Thanks, Kumar. Operator: We'll go next now to Graig Suvannavejh at Mizuho. Graig Suvannavejh: I wanted to get back to the orexin candidate. And in particular, can you talk more about the novel scaffold you're using for BP-205 and in particular, how different and what is that specific difference versus scaffolds used by other orexin candidates that directly translate or at least you believe directly translate to a potential differentiated profile in both efficacy and safety tolerability? And then I have a follow-up. Jeffrey Dayno: Yes, Graig, thank you for your question. And I'll turn it over to Kumar, but I think that's where the differentiated profile for BP-205 begins with that differentiated scaffold and chemical structure. Kumar, can you provide some more detail around that. Kumar Budur: Yes. Graig, I'm not a medicinal chemist, but I'll try to explain to the best of my ability. When the orexin-2 receptor agonist was being developed, you may remember that there were some EAEs that were caused because of reactive metabolites, for example, liver function test abnormalities. So Teijin from who Bioprojet licensed and we sub-licensed, this drug was designed to stay away some of the molecular structure-related EAEs, especially when it comes to hepatotoxicity and cardiac toxicity. So what we did was instead of going with the typical pyrrolidine sulfonamide bicyclic moieties, which is a typical structure, they stayed away from it. And what it really provides is instead of this 3-dimensional crystal structure, the structure is much more flat, and that is supposed to give us more potency and also help us with some of the structure-related EAEs. And we saw that. We saw that in our preclinical profile, where we showed very high potency. In fact, BP-205 was effective at a dose of 0.03 mg per kg in the narcolepsy transgenic mice model, the lowest dose that was ever used to test. And we saw the same profile in our single ascending dose study in terms of short Tmax, in terms of longer half-life and the safety and tolerability profile to the extent we can extrapolate based on the single ascending dose is very favorable. So overall, very encouraging data, both from a nonclinical perspective and from a limited data that we have on the clinical side. Graig Suvannavejh: Okay. And then I think there are many of us who are excited about the potential for BP-205 to be differentiated. But I think a question that I get often from investors is really relates to kind of developmental time lines and how far you might be behind, say, Takeda or some of the other players. So can you comment on maybe broadly speaking, how we should think about the clinical development program and kind of what's next in terms of time lines? Jeffrey Dayno: Yes. So Graig, I think at a high level, as you can hear today, we are -- have the conviction to move quickly and accelerate the development time line. So while we may not be first to market with regards to NT1 or with regards to NT2 or IH or the other hypersomnias, but importantly, looking at broader CNS indications, as we said, we'll be initiating multiple Phase II trials mid next year. And we believe with our experience, our know-how in the space, we'll be able to accelerate those development programs and potentially be first or second to market in some of the broader indications. So we have that commitment. We have that experience to move the program forward across multiple CNS targets, and we're building that momentum. And as we shared, multiple data catalysts coming over the next 6 months. Peter Anastasiou: And I would just add, Graig, that as we've seen in many therapeutic categories, the first or second asset isn't necessarily the best asset. And so we believe we've shown today some initial clinical data that supports that this is a differentiated profile that can be well set up to be best-in-class, not just in hypersomnolence indications, but importantly, in broader CNS indications where features like the potential for rapid onset of action, potential for once-daily dosing are going to be very important. And so first isn't necessarily best, and we believe that we are developing what's emerging to be the best profile. Jeffrey Dayno: Yes. Thanks, Peter. Excellent. Operator: We go next now to David Amsellem at Piper Sandler. David Amsellem: A couple for me. So I wanted to drill down more on Graig's question on different indications. So we already have a glimpse of potential other indications. There's Alkermes with an ADHD program and also fatigue in MS and Parkinson's program. Obviously, there are other potential indications across mood and cognition, for example. So given the business model, which is focused historically on rare, how are you thinking about these broader indications, particularly in these larger markets that are much more promotion intensive, and your willingness to dive into, say, mood or cognition where you're going to need considerably more commercial infrastructure? So that's number one. And then number two is, sorry if I missed this, but wanted to get a better flavor for your IP estate on BP-205, when the composition IP expires and talk to additional patents that issued or pending. Jeffrey Dayno: Thanks, David, for your question. So let me start, and I'll turn it over to Peter some thoughts. So in terms of the opportunity with BP-205, and we're also working with our partner, Bioprojet on additional orexin-2 compounds. So there's a backup and then additional compounds based on novel chemical scaffold that we talked about. So I think that now we are looking at optionality. So we're looking at optionality as we advance the program with regards to, obviously, the hypersomnias and some of those programs are further ahead, but the broader CNS indications that you alluded to, I think there is a lot of activity in the space around some of the targets, you mentioned ADHD, MS fatigue, et cetera. So we actually have worked with our partner, Bioprojet, on some preclinical models and emerging evidence in what potentially could be the best of those targets with regards to preclinical proof-of-concept. So we are looking broadly with optionality and accelerating the development program opportunity, realizing that in indications in the orphan rare space, there's one opportunity there and then other orexin-2 compounds to go broader with a different commercial model. And I'll turn it over to Peter, any additional comments. Peter Anastasiou: The only thing I would add is on your question about appetite. The appetite is strong, and I think it is based on the foundation that we just talked about that this asset has the potential to be effective in both Sleep/Wake indications and the broader indications. And in particular, that's where the potency, I think, really helps us, because many of those broader indications are not indications where there's orexin deficiency. And so having the most potent asset, I think, sets us up well from an efficacy perspective. And in terms of your question on appetite for investment commercially, et cetera, certainly, Adam can chime in. But we have that appetite as well. Many of us have significant experience in many of those categories. Even though the organization doesn't have experience in those categories, many of us within the organization do. And we, I think, have clearly established with the fact that we're on track to achieve $1 billion in revenue that we have the commercial wherewithal. So to be able to scale up from that very strong commercial footprint we already have to take advantage of opportunities in these broader markets is something we're prepared to do and quite confident we can do. David Amsellem: IP. Peter Anastasiou: And then you asked about IP. The IP goes to 2043 with the potential for additional patent term extensions on top of that. David Amsellem: And the composition patent expiry, is that 2043? Isn't it earlier? Peter Anastasiou: No, that's 2043, with again, the potential for patent term extension add-ons. Operator: We go next now to Ami Fadia at Needham & Company. Ami Fadia: Maybe a follow-up to the last couple of questions. As you think about sort of navigating the competitive landscape with this first orexin asset, BP-205, and some of the backup compounds that you talked about, how would you think about prioritizing either rare indications versus the larger markets with your first sort of initial program? Because I would assume that [ you'd want in ] each of the different markets and appropriately develop each asset catered to a different market. So maybe if you could sort of talk about how -- maybe your current thoughts around how you're prioritizing around those. And then maybe if I could squeeze in a question on WAKIX. With the strong patient adds that we saw this quarter, if you could comment on how you anticipate the cadence of patient adds in the remainder of the year? Jeffrey Dayno: Ami, thanks for your questions. With regards to the first one and prioritizing, I think it's a combination of multiple factors. I think as Peter alluded to, we have the ability and the conviction to pursue multiple CNS indications, both the hypersomnias and these broader CNS indications, understanding in terms of price point of an orphan rare indications such as narcolepsy and IH. So I think it's a combination of timing. But again, we feel first to market may not be best. So there's still opportunity in hypersomnias off of the strong foundation and the strong base and business that we've built in that space with WAKIX, but also excited about the broader CNS indications, accelerating those efforts, multiple Phase II trials beginning mid next year and then investing in those Phase II studies, letting the data inform our opportunities going forward. And as Peter alluded to, with the commercial experience to broaden that footprint, broaden that effort, towards those opportunities. So I think we've got optionality, multiple opportunities in both the hypersomnias, broader CNS indications and are moving the program forward to generate data covering both of those areas to inform our decisions on Phase III development and eventual commercialization. Adam Zaeske: And I can speak to patient adds. Ami, good to hear from you. So we are very pleased with the performance we saw in 2Q, achieved 8,950 average patients, that's up 450 in the quarter. That is the second highest quarterly increase in the 7-year history of the brand. So very, very strong. And we've now seen 4 of the last 5 quarters actually achieving 400-plus patient adds. So the momentum is there. We're carrying that into Q3, and we'd expect that growth to continue through the end of the year, similar to what we've seen in prior years for WAKIX, very steady growth, very steady momentum, and we expect that growth to continue. Hence, confirming full year guidance at $1 billion plus in net sales, $1 billion to $1.04 billion for the year. Thanks for the question. Operator: We'll go next now to Patrick Trucchio with H.C. Wainwright. Luis Santos: Congrats on the progress. This is Luis in for Patrick. I'm curious about the next steps for the BP-205 program. So what efficacy data would give you confidence to advance to Phase II? What are the key gating items? Is there a minimum threshold that the FDA requires? What would be a go/no-go decision for you? Jeffrey Dayno: Luis, thanks for the question. So I think the next steps, and then I'll hand it over to Kumar. So as we said, multiple data catalysts coming over the next 6 months, the MAD data that will read out in the fourth quarter, importantly, initiation of the sleep-deprived healthy volunteer study this quarter, data early '27. Obviously, the mechanism of action is proven. So with regards to -- we anticipate a strong outcome in the sleep-deprived healthy volunteer study. The opportunity is also demonstrating at lower clinical doses, at lower clinical doses, which could provide a very good risk benefit profile, similar to what Kumar alluded to in the preclinical model at the lowest doses, demonstrating sustained wakefulness. So that is the opportunity with regard to the sleep-deprived healthy volunteer data. And then from there, Kumar, additional thoughts. Kumar Budur: Yes. Sure. Luis, thanks for this question. Just building on what Jeff mentioned, the sleep-deprived healthy volunteer study, that's when we will see the first signals for efficacy. We anticipate strong and sustained response from the sleep-deprived healthy volunteer study, and that is based on the profile that we saw in our nonclinical studies and also the early profile, the PK profile that we are seeing in our single ascending dose study. In terms of your question regarding go/no-go gating decisions, those kind of things, as Jeff was alluding to, in NT1, the mechanism of action is established. There is orexin deficiency, you get an orexin-2 receptor agonist and you see efficacy. But beyond that, that's where the profile of BP-205 becomes extremely important in terms of potency, in terms of selectivity, in terms of half-life and also the safety and tolerability profile, the initial safety and tolerability profile that we shared today. We believe all of these features are -- continue to support our belief that BP-205 is a best-in-class orexin-2 receptor agonist that will be helpful not just for central disorders of hypersomnolence, but beyond that, including many other broader central nervous system disorders. Jeffrey Dayno: Thanks, Kumar. Operator: We'll go next now to Jason Gerberry with Bank of America. Unknown Analyst: This is [ Chi ] on for Jason. I have a question on BP-205 and a follow-up as well. I'm curious, can you talk about the shape of the PK curve? Should investors interpret the rapid Tmax as a high Cmax as well or peak concentration? Or does the PK curve have a flat peak-to-trough profile? And then I have a follow-up after this. Kumar Budur: Yes. Thank you. Thank you for the question. We haven't disclosed all the data because typically, we disclose the full data set at a scientific meeting. But to your point in terms of Tmax and Cmax, is Tmax that's when we saw the maximum concentration of BP-205 and the Tmax varied in the range of 30 to 75 minutes. Unknown Analyst: Okay. And my follow-up question is on the extended half-life relative to other clinical programs or other clinical orexin clinical programs. And I think those programs seem to have roughly around 10 hours of half-life or less. So I'm curious, do you think you've thread the needle between having a long enough half-life for a once-daily dosing and also having exposure level low enough at nighttime? Can you talk about dosing strategy to mitigate insomnia and early insight from the Phase I MAD portion given you have talked about insomnia and polyuria as signal of target engagement earlier on the call? Kumar Budur: Yes. Good question. In terms of half-life, look, we don't know the half-life or the exact half-life of the other programs because no one has shared the data in a comprehensive way like what we are doing in our SAD study. So I can only comment on BP-205. The terminal half-life that we saw in the single ascending dose study was approximately 25 hours. If you look at the drugs that are administered once a day, for example, the half-life ranges anywhere between 14 to 20-plus hours. I just mentioned earlier, the half-life of pitolisant is 20 hours, and it's dosed once a day. So based on what we know about the PK profiles of the drugs that are dosed once a day, we are confident that this profile fits QD dosing, which is preferable from a patient perspective. And it will also help to sustain wakefulness in the afternoon and in the early part of the evening. In your -- to your question about the long half-life and potential for EAEs, I mentioned earlier in our single ascending dose study, we did not see insomnia or polyuria that are some of the mechanistic target engagement-related EAEs. But in our MAD study, where we did dose for 15 days in healthy volunteers, we did see some insomnia and polyuria, but neither of them were neither severe nor sustained. So the emerging profile that we are seeing is very much supportive of QD dosing, helping the patients through the day and without necessarily carrying the effect into night, resulting in undesirable EAEs. Operator: We'll go next now to Danielle Brill with Truist. Danielle Brill Bongero: Maybe a bit of a follow-up to the prior one. So you've confirmed insomnia and polyuria in your MAD study and understanding you're not giving numbers today, but just wondering if you could maybe provide some directional color ahead of the data. Specifically wondering if investors should expect incidence rates to track similarly to peers in the 50% to 60% range, whether we should expect a dose response? And understanding there were transient events, did these resolve despite continued dosing? Or did they fade over time as tolerance improved? And should we -- what should we expect in terms of discontinuation? Kumar Budur: Danielle, thanks for the question. All great questions. But at this point in time, those data are still being analyzed, and we plan to provide a comprehensive MAD data in the fourth quarter of this year. I can't comment anything beyond than what I already said, which is, yes, we did see insomnia, we did see some polyuria, these were transient, not sustained or severe. Danielle Brill Bongero: Okay. Maybe as a follow-up, could you frame -- you talked a lot about how metrics that would support the best-in-class profile of BP-205. Could you frame on the safety front, how you would define a best-in-class profile? Kumar Budur: All right. So from a safety perspective, there are things that are class-related that we expect based on the mechanism of action. And there are things that are off target depending on the chemical structure of the compound, right? From a class-related EAEs, I already mentioned what I can mention on this call, which is from a single ascending dose study perspective, we did not see cardiovascular, hepatic or visual disturbances. Specifically mentioning just because based on the development program from other sponsors, we have seen in the past some hepatotoxicity and some visual disturbances. In terms of off-target effects, we already talked about the selectivity, 600-fold selectivity over orexin-1 receptor agonist. And we already talked about the potency and the efficacy. Ultimately, what it comes down to is the product profile, the product profile based on efficacy, safety and tolerability and ease of use. Based on the data that we have as of today, the nonclinical and early clinical, high potency, longer half-life, short Tmax, seeing some on-target engagement EAEs, transient, not sustained, not severe, no off-target effects and once-a-day dosing. We are actually very, very confident with the emerging product profile for BP-205. Jeffrey Dayno: Thanks, Kumar. Yes. So I think, Danielle, just to add, overall benefit risk based on efficacy, safety, tolerability, as Kumar said, and also the opportunity with BP-205 are lower clinical doses given its potency, both in NT1 and other disorders that don't have orexin deficiency. So that opportunity in terms of threading the needle, if you will, of a favorable benefit risk profile is what we are working towards and what BP-205 is designed to deliver. So more data to come, but excited about the emerging profile and our opportunity in the broader orexin space. Operator: Thank you. Ladies and gentlemen, that's all the time we have for questions this morning. Dr. Dayno, I'd like to turn things back to you, sir, for any closing comments. Jeffrey Dayno: Thanks, operator. My thanks to all of you for being on the call today, for your interest in Harmony Biosciences and our opportunities ahead. Again, strong commercial performance this quarter and excited about our opportunity, BP-205 and in the orexin space. Thank you, and have a great day. Operator: Thank you, Dr. Dayno. This does conclude today's Harmony Biosciences second quarter 2026 financial results conference call. You may now disconnect your line, and have a wonderful day, everyone. Before you buy stock in Harmony Biosciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Harmony Biosciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Harmony Biosciences (HRMY) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

ANI Pharmaceuticals ANIP reported second-quarter 2026 adjusted EPS of $2.21, beating the Zacks Consensus Estimate of $2.01. The reported figure rose 23% year over year, driven by higher sales during the quarter. Quarterly revenues totaled $266 million, up 26% from the year-ago period. The metric also beat the Zacks Consensus Estimate of $262.7 million. The quarter reflected solid execution across the portfolio, led by continued momentum for Purified Cortrophin Gel and contributions from a newly monetized intellectual property licensing arrangement. Rare Disease revenues totaled $135.8 million, up 31% year over year but below the Zacks Consensus Estimate of $141 million. Cortrophin Gel revenues of $117.1 million missed the Zacks Consensus Estimate of $120.4 million. Still, the metric rose 43.5%, primarily driven by existing specialties, including nephrology, neurology, ophthalmology, pulmonology and rheumatology. ANIP shares fell more than 5% on Friday following the results announcement, likely reflecting investor concerns over lower-than-expected Cortrophin sales despite the broader earnings and revenue beat. These concerns were further amplified after management lowered its full-year outlook for the drug. Year to date, the stock has lost 1% against the industry’s 5% growth. Image Source: Zacks Investment Research Iluvien revenues declined 16% year over year to $18.7 million, missing the Zacks Consensus Estimate of $20.7 million, mainly due to the timing of international shipments. The company also reported $17.7 million in brand royalties and other revenues during the second quarter, comprising $9.7 million in royalties on sales of pitolisant-based products and $8 million tied to work completed toward certain development milestones under its Harmony Biosciences HRMY licensing agreement. By contrast, Brands' revenues declined 10.5% year over year to $11.8 million as demand normalized for certain products. In January, the company’s Novitium subsidiary entered into an agreement with Harmony Biosciences, under which ANIP out-licensed intellectual property related to pitolisant, marketed by HRMY under the brand name Wakix. The agreement generated a $15 million upfront license fee and includes low single-digit royalties on sales of pitolisant-based products. It provides for an additional $10 million in development milestones that management expects to be achieved in the second and third quarters of 2026. Generic pharmaceutical product revenues increased 10% year over year to $99.1 million, exceeding the Zacks Consensus Estimate of $96.9 million. Growth reflected new product launches, continued strength from a partnered generic introduced in the third quarter of 2025 and commercial and operational outperformance. ANIP has launched 12 generic products so far in 2026 and expects to launch at least 15 during the full year. The company also maintained its position as the second-ranked player in overall Competitive Generic Therapy (CGT) filings. Adjusted gross margin contracted to 62.6% from 64.9% in the year-ago quarter. The decline primarily reflected higher sales of royalty-bearing products, including Cortrophin Gel and a partnered generic, along with the non-recurrence of prior-year Prucalopride revenues. Adjusted selling, general and administrative expenses increased 20% to $80.7 million, reflecting spending on the Cortrophin gout expansion and broader investments supporting business growth. Adjusted research and development expenses declined 11% to $14.1 million. The company reaffirmed its 2026 total revenue guidance of $1.08-$1.14 billion and adjusted EBITDA outlook of $285-$300 million. Adjusted earnings are still projected between $9.19 and $9.69 per share. However, ANIP lowered its full-year 2026 Cortrophin Gel revenue outlook to $520-$540 million from the previous guidance of $540-$575 million. Management said the revision principally accounts for first-half results, while expectations for the second half remain largely intact. The new range still represents 50-55% growth from 2025. Despite the lowered guidance, management remained optimistic about Cortrophin sales for the remainder of the year. It expects third-quarter revenues of $143-$153 million, followed by further sequential growth in the fourth quarter as the gout sales force contributes more meaningfully. The company maintained the outlook for Iluvien revenues in the range of $78-$83 million. ANIP's gout-focused Cortrophin commercial expansion was fully operational by the end of June. More than 95% of the new sales representatives generated multiple patient cases, while more than a third of prescribers initiated at least two cases. Demand was balanced between primary care physicians and podiatrists. Management said momentum in existing specialties continued into the third quarter, with July recording the highest number of new patient cases initiated. Ophthalmology volumes also doubled year over year during the second quarter. The stock currently has a Zacks Rank #4 (Sell). ANI Pharmaceuticals, Inc. price | ANI Pharmaceuticals, Inc. Quote A better-ranked stock in the biotech sector is Liquidia Corporation LQDA, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 162% so far this year. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Puma Biotechnology PBYI reported second-quarter 2026 adjusted earnings of 19 cents per share, beating the Zacks Consensus Estimate of 10 cents. In the year-ago quarter, the company had reported adjusted earnings of 15 cents per share. Total revenues for the quarter were $56.5 million, which beat the Zacks Consensus Estimate of $53 million. Revenues increased 7.8% year over year, driven by higher net product sales. Total revenues comprised net product sales of Nerlynx (neratinib), PBYI’s only marketed drug in the United States, and royalty revenues. Nerlynx is indicated for the treatment of early-stage HER2-positive breast cancer. Year to date, shares of Puma Biotechnology have rallied 36.5% compared with the industry’s 4.4% growth. Image Source: Zacks Investment Research Product revenues from Nerlynx totaled $53.6 million in the second quarter, up about 9% year over year. This metric beat our model estimate of $50.9 million. Royalty revenues declined 9.4% year over year to $2.9 million. Selling, general and administrative (SG&A) expenses (excluding stock-based compensation expense) declined 4.1% year over year to $16.3 million. Research and development (R&D) expenses (excluding stock-based compensation expense) totaled $18.2 million, up 22.1% year over year, reflecting higher costs associated with clinical studies on alisertib along with higher internal R&D expenses. As of June 30, 2026, PBYI had cash, cash equivalents, restricted cash and investment securities of $93.9 million compared with $101.5 million as of March 31, 2026. Puma Biotechnology raised its financial guidance for 2026. For full-year 2026, total revenues are expected to be in the range of $224-$231 million compared with the previous projection of $222-$229 million. The Zacks Consensus Estimate for the metric is pegged at $224.5 million. Net product revenues are projected to be in the range of $205-$209 million versus the earlier expectation of $202-$206 million. Meanwhile, royalty revenues are expected to be to range from $19 million to $22 million, down from the previous expectation of $20–$23 million. The company expects to generate net income of $17-$20 million compared with the earlier projection of $16-$19 million for 2026. For the third quarter of 2026, the company expects net product revenues to be between $54 million and $56 million and royalty revenues in the range of $2 million to $3 million. Total revenues are expected to be between $56 million and $59 million. The company anticipates reporting a net income of approximately $2 million to $3.5 million for the quarter. Puma Biotechnology in-licensed global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022. It is developing alisertib for hormone receptor-positive breast cancer as well as small-cell lung cancer (SCLC). The company is conducting a phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Updated data from the study are expected in the fourth quarter of 2026. PBYI is conducting ALISCA-Lung1, a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive-stage SCLC. The company plans to expand enrollment in both these studies in the second half of 2026. Puma Biotechnology plans to initiate enrollment in the phase I/II ALISCA-Lung2 study of alisertib in combination with paclitaxel for the treatment of patients with extensive-stage SCLC in the third quarter of 2026. Puma Biotechnology, Inc. price-consensus-eps-surprise-chart | Puma Biotechnology, Inc. Quote Puma Biotechnology currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy) and Altimmune ALT, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share estimates for Harmony Biosciences have increased from $3.20 to $3.33 for 2026. Over the same period, estimates for earnings per share increased from $3.64 to $3.92 for 2027. HRMY shares have risen 3.5% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and beat in the remaining one, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 60 days, estimates for Altimmune’s 2026 loss per share have narrowed from 69 cents to 64 cents. Over the same period, loss estimates for 2027 have also improved from 73 cents to 64 cents. ALT shares have declined 16.7% year to date. Altimmune’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 15.81%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report Altimmune, Inc. (ALT) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Intellia Therapeutics NTLA incurred a second-quarter 2026 loss of 80 cents per share, in line with the Zacks Consensus Estimate. The loss narrowed 18.4% from the loss of 98 cents per share in the year-ago quarter. Intellia’s total revenues currently comprise only collaboration revenues. The company reported revenues of $7.7 million, which missed the Zacks Consensus Estimate of $15 million. Revenues declined 46.2% year over year, reflecting lower collaboration revenues from Regeneron Pharmaceuticals REGN. Research and development expenses declined 14.9% year over year to $82.6 million. The decrease was due to lower external costs related to Intellia’s lead development programs, lonvo-z and nex-z, and lower stock-based compensation, partly offset by higher employee-related expenses due to increased headcount. General and administrative expenses increased 39% year over year to $37.8 million. The increase was primarily driven by costs associated with the ongoing buildout of Intellia's commercial infrastructure, higher legal expenses and stock-based compensation. As of June 30, 2026, Intellia had cash, cash equivalents and marketable securities worth $628.4 million compared with $517.2 million as of March 31, 2026. Following the completion of an underwritten public offering of common stock in April, which generated approximately $195 million in net proceeds, the company expects its existing cash resources to fund operations at least into 2028 and well beyond the anticipated U.S. commercial launch of lonvo-z for hereditary angioedema (HAE) in the first half of 2027. Year to date, shares of NTLA have surged 25% compared with the industry’s 3.6% growth. Image Source: Zacks Investment Research Intellia continued to advance lonvoguran ziclumeran (lonvo-z) for HAE. The phase III HAELO study met its primary endpoint and all key secondary endpoints, with a one-time infusion reducing attacks by 87% compared with placebo over the six-month efficacy evaluation period. NTLA expects the FDA to accept its biologics license application for lonvo-z to treat HAE in the second half of 2026. If approved, Intellia plans a U.S. commercial launch in the first half of 2027 and has been building its field medical, reimbursement and strategic accounts teams ahead of that potential launch. Intellia is developing nexiguran ziclumeran (nex-z) with Regeneron for transthyretin (ATTR) amyloidosis. Both phase III studies of nex-z, MAGNITUDE in ATTR cardiomyopathy and MAGNITUDE-2 in hereditary ATTR amyloidosis with polyneuropathy, were previously placed on clinical hold by the FDA. Earlier this year, the FDA lifted the clinical holds on both studies, following which enrollment and dosing resumed in both studies in the first quarter of 2026. NTLA remains on track to complete enrollment in MAGNITUDE-2 in the second half of 2026. Management said screening activity is accelerating globally. The MAGNITUDE study has enrolled well over 650 patients. Working with Regeneron and external experts, Intellia analyzed more than 600 patient samples across nex-z clinical studies. The analysis found that the highest observed liver transaminase elevations occurred in patients carrying one specific HLA allele. About 12% of the analyzed samples carried the allele, while most carriers did not experience severe transaminase elevations. Intellia has incorporated HLA typing into both ongoing phase III nex-z studies and is providing the information to investigators and patients during screening or before crossover. Intellia Therapeutics, Inc. price-consensus-eps-surprise-chart | Intellia Therapeutics, Inc. Quote Intellia currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33, while estimates for 2027 have increased from $3.64 to $3.92 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Ocugen OCGN reported a second-quarter 2026 loss of 7 cents per share, which was wider than the Zacks Consensus Estimate as well as the year-ago loss of 5 cents. Higher research and development spending weighed on results. Revenues rose 8.4% year over year to $1.5 million and slightly beat the Zacks Consensus Estimate of $1.4 million. The company’s top line currently comprises only collaboration revenues. Total operating expenses increased 18.2% year over year to $17.9 million. Research and development expenses rose 27.2% to $10.7 million, while general and administrative expenses increased 7.0% to $7.2 million. Cash, cash equivalents and restricted cash totaled $100.4 million as of June 30, 2026, up from $32.2 million as of March 31. The increase followed the closing of $130.0 million of 6.75% convertible senior notes due 2034, which generated about $112.5 million in net proceeds. Ocugen used about $32.7 million of those proceeds to fully retire its Avenue Capital loan and eliminate 12.25% interest-rate debt. Management expects the financing to extend the cash runway into 2028, supporting the company’s late-stage clinical programs and planned regulatory submissions. Ocugen’s shares declined 3% on Wednesday after the results were announced. Year to date, shares of OCGN have declined 8.2% compared with the industry’s 3.5% decline. Image Source: Zacks Investment Research Ocugen is advancing its ophthalmology gene therapy pipeline, targeting three biologics license application (BLA) submissions by 2028. The first half of 2027 is expected to be catalyst-rich, with late-stage top-line data anticipated for OCU400 and OCU410ST. Enrollment has been completed in a phase III liMeliGhT study on lead modifier gene therapy candidate, OCU400, to treat Retinitis pigmentosa, or RP, a rare genetic disorder that can lead to vision loss and blindness. Top-line data from the phase III study is expected in the first quarter of 2027. Management said the FDA feedback keeps the rolling BLA pathway tied to the top-line data, with completion of the filing targeted for the second quarter of 2027 and potential approval in the fourth quarter as a treatment option for early- to late-stage RP. OCU410ST is being developed as a one-time gene therapy for the treatment of Stargardt disease, a rare inherited retinal disorder. In April 2026, the company completed enrollment and dosing in the phase II/III GARDian3 pivotal confirmatory study on OCU410ST for Stargardt disease. Management expects an interim outcome decision for the first 50% of subjects at eight months in the third quarter of 2026. Top-line data are anticipated in the second quarter of 2027, with a BLA submission planned for mid-2027. The FDA cleared the phase III ArMaDa3 registrational study of Ocugen’s another important candidate, OCU410, for geographic atrophy, an advanced stage of dry age-related macular degeneration. Ocugen plans to initiate the global phase III study by September. The program is supported by positive 12-month phase II data showing a statistically significant 31% reduction in geographic atrophy lesion growth at the optimal dose in the target lesion-size population. BLA and Marketing Authorization Application filings are targeted for 2028. Ocugen currently carries a Zacks Rank #3 (Hold). Ocugen, Inc. price-consensus-chart | Ocugen, Inc. Quote Some better-ranked stocks in the biotech sector are Repligen RGEN, Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 2.7% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33. Over the same period, EPS estimates for 2027 have surged from $3.64 to $3.92. HRMY shares are up 3.6% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters, while beating in just one, with the average negative surprise being 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ocugen, Inc. (OCGN) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Immunocore Holdings plc IMCR incurred a loss of 2 cents per share in the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 1 cent per share. In the year-ago quarter, the company had incurred a loss of 20 cents per share. Second-quarter revenues were $115.9 million, increasing 18.3% year over year, mainly on higher volumes of its sole marketed drug, Kimmtrak (tebentafusp-tebn), in the United States and international regions. The top line beat the Zacks Consensus Estimate of $114 million. Immunocore's top line solely comprised worldwide net product sales of Kimmtrak. Year to date, shares of Immunocore have lost 0.6% against the industry’s rise of 4.4%. Image Source: Zacks Investment Research Kimmtrak generated $74.9 million in U.S. sales, $34.1 million in Europe and $6.9 million across international regions during the second quarter. U.S. quarterly sales rose 17% year over year, while combined Europe and international sales increased 21% on higher demand. Management noted that U.S. second-quarter sales included roughly $6 million of distributor inventory stocking, which is expected to create a headwind in the third quarter. Excluding this stocking effect, underlying sequential quarterly growth was 3%. Kimmtrak has been launched in more than 30 countries globally. The drug continues to be the standard of care in all major markets where it is launched. Research and development expenses increased around 7.2% year over year to $73.9 million in the second quarter. The increase primarily reflected advancement of clinical programs, including three phase III studies. Selling, general and administrative expenses rose 2.6% year over year to $43.9 million. As of June 30, 2026, Immunocore had cash, cash equivalents and marketable securities worth $880.2 million compared with $844.9 million as of March 31, 2026. The registrational phase III TEBE-AM study is evaluating Kimmtrak as monotherapy and in combination with Keytruda (pembrolizumab) versus a control arm in previously treated advanced cutaneous melanoma. The primary endpoint of the study is overall survival. Enrollment in the phase III TEBE-AM study is nearing the target of 540 patients. Top-line data from the same can be announced as early as the end of 2026. Meanwhile, the EORTC-sponsored phase III ATOM study in high-risk adjuvant uveal melanoma continues to expand its site footprint and is now enrolling patients in the United States. Beyond Kimmtrak, Immunocore is advancing a diversified pipeline of ImmTAC candidates across multiple oncology indications. Brenetafusp is the company’s lead PRAME-A02 ImmTAC bispecific candidate.  The registrational phase III PRISM-MEL-301 study is evaluating brenetafusp in combination with Opdivo (nivolumab) for treating first-line advanced cutaneous melanoma. The candidate is also being investigated in early-to-mid-stage studies both as monotherapy and as combination therapy in multiple tumor types, including ovarian cancer and non-small cell lung cancer. Immunocore is also progressing in earlier-stage programs targeting colorectal cancer and other gastrointestinal cancers as well as certain infectious diseases and autoimmune diseases using its proprietary T-cell receptor platform. Immunocore Holdings PLC Sponsored ADR price-consensus-eps-surprise-chart | Immunocore Holdings PLC Sponsored ADR Quote Immunocore currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.62, while estimates for 2027 have increased from $3.64 to $4.07 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 2.7% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

BioMarin Pharmaceutical BMRN reported second-quarter 2026 adjusted earnings of $1.20 per share, which beat the Zacks Consensus Estimate of 96 cents. However, the bottom line declined 16.7% year over year from $1.44. Total revenues were $989.7 million, up 20% year over year, beating the Zacks Consensus Estimate of $922 million. Growth was driven by new Amicus-acquired products, Voxzogo patient additions and stronger Palynziq demand. Shares of BioMarin were up 4.4% in after-market trading on Thursday following the earnings announcement. The positive stock reaction came as both earnings and revenues topped expectations and management raised key elements of its 2026 financial guidance. Year to date, BMRN stock has gained 3.4% compared with the industry’s 3.6% growth. Image Source: Zacks Investment Research Net product revenues totaled nearly $984.4 million, up about 21% year over year, driven by higher revenues from the company’s Metabolic Conditions drugs, as well as Voxzogo. Voxzogo generated $253 million in sales, up 14% year over year from $221 million. Sales also beat the Zacks Consensus Estimate of $238.2 million. The number of children treated globally increased more than 20% year over year. BioMarin said about 90% of U.S. children treated with Voxzogo remained on therapy through the end of July after a competing product entered the market. More than half of new U.S. patient starts during the quarter were children under two years of age. Metabolic Conditions revenues totaled $695 million, up 25% year over year. The portfolio now comprises seven therapies, including Galafold and Pombiliti-Opfolda, which were added following the Amicus acquisition. Palynziq sales jumped 27% to $135 million, topping the Zacks Consensus Estimate of $112.7 million. Naglazyme revenues rose 5% to $135 million, which also came above the consensus estimate of $125.9 million. Brineura sales increased 4% to $51 million. Vimizim revenues fell 10% to $194 million, reflecting the timing of large government orders outside the United States. Sales missed the Zacks Consensus Estimate of $205.8 million. Aldurazyme sales declined 21% to $44 million due to timing of order fulfillment to Sanofi SNY. Galafold contributed $106 million following the Amicus acquisition. BioMarin said the therapy maintained broad-based patient growth, supported by increased diagnosis and patient identification. The Sanofi-related Aldurazyme order timing was a separate headwind within the portfolio. BioMarin signed a collaboration agreement with Sanofi’s subsidiary, Genzyme, for Aldurazyme. SNY, through Genzyme, is BMRN’s sole customer for Aldurazyme. The Sanofi subsidiary is responsible for marketing and selling Aldurazyme to third parties. Kuvan generated $24 million in second-quarter sales, down 11% from $27 million a year earlier. Roctavian revenues were $12 million, up 33% year over year from $9 million. Royalty and other revenues were $5.3 million compared with $12.4 million in the year-ago quarter. BioMarin raised its 2026 total revenue guidance to $3.875-$3.925 billion from $3.825-$3.925 billion. Metabolic Conditions revenue guidance was maintained at $2.725-$2.775 billion. Voxzogo revenue guidance was increased to $1-$1.05 billion from $975-$1.025 billion. Other revenues are expected to be in the range of $100-$125 million in 2026, unchanged from the previous guidance. Adjusted earnings guidance was raised to $4.90-$5.10 per share from $4.85-$5.05. BioMarin submitted a supplemental new drug application (NDA) to the FDA seeking approval of Voxzogo for hypochondroplasia after the phase III CANOPY-HCH-3 study met its primary endpoint. The company expects to provide an update on the application status with its third-quarter earnings update. The FDA also accepted BioMarin's supplemental NDA for full approval of Voxzogo in children with achondroplasia, with a Feb. 28, 2027, target action date. Meanwhile, the company discontinued BMN 401 after the ENERGY 3 study failed to meet one of its two co-primary endpoints for the treatment of ENPP1 deficiency. A data update from the phase II/III study of BMN 333 for achondroplasia is expected in 2027. In the second quarter, the European Commission approved Palynziq for adolescents aged 12 years and older with phenylketonuria (PKU). The label expansion broadens access to Palynziq, which enables patients with PKU to achieve physiologic phenylalanine levels while reducing dietary restrictions, regardless of disease severity. BioMarin Pharmaceutical Inc. price-consensus-eps-surprise-chart | BioMarin Pharmaceutical Inc. Quote BioMarin's quarter showed broad commercial momentum, with Voxzogo growth and the newly acquired Galafold contribution supporting a strong revenue beat. Palynziq and Naglazyme also exceeded expectations, while Vimizim and Aldurazyme faced order-timing pressure. The raised outlook adds to the positive read-through from the quarter, though product-level volatility remains evident. In particular, Aldurazyme's decline reflected order fulfillment timing to Sanofi, making SNY-related ordering an important factor to watch alongside competitive dynamics in Voxzogo. BioMarin currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33, while estimates for 2027 have increased from $3.64 to $3.92 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Insmed INSM reported an adjusted loss of 52 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 69 cents. The adjusted figure excluded a non-cash gain of $99.8 million tied to a change in the fair value of contingent consideration liabilities. Including this item, the reported loss was 6 cents per share. The company had incurred a loss of $1.70 per share in the year-ago quarter. Quarterly revenues soared 296% year over year to $425.5 million, entirely from the sales of its two marketed products. The reported figure beat the Zacks Consensus Estimate of $389.7 million. Shares of Insmed jumped 34% yesterday following the earnings announcement. The stock's upside was driven by strong organic patient uptake of Brinsupri during the quarter, prompting management to significantly raise its sales guidance. Year to date, the stock has lost 24% against the industry’s nearly 4% growth. Image Source: Zacks Investment Research Insmed currently has two marketed drugs, Arikayce and Brinsupri, in its portfolio. While Arikayce is approved to treat refractory mycobacterium avium complex (MAC) lung disease in adults with limited or no treatment options, Brinsupri is approved for non-cystic fibrosis bronchiectasis (NCFB). Sales of Arikayce rose 8% year over year to $116.3 million, driven by strong growth across ex-U.S. markets. The metric also beat the Zacks Consensus Estimate of $113.9 million. This was the third full quarter in which Insmed generated revenues from Brinsupri sales since its approval in August 2025. The drug contributed $309.2 million to the top line during the quarter, up from $207.9 million in the previous quarter. The reported figure also surpassed the Zacks Consensus Estimate of $275.8 million. Around 7,000 new patients started Brinsupri during the quarter, ahead of management's prior expectation of approximately 6,300. Importantly, management stated that all these patient starts represented organic demand, with no contribution from the "ready and waiting" patient pool — those who were already aware of the drug before approval and began treatment quickly once it became available. Insmed expects roughly 7,000 new patient starts per quarter through the remainder of 2026. Management also noted favorable payer access for Brinsupri, with an approximately 90% approval rate and approvals taking less than a week for most patients. Persistence and other patient-use metrics remained at or ahead of Insmed's internal benchmarks, supporting confidence in the growth trajectory. Research and development expenses rose 18.5% year over year to $210 million. The increase was primarily caused by higher employee-related costs and increased clinical development expenses. Selling, general and administrative expenses climbed 60% year over year to $247.5 million. Higher professional fees, external costs and employee-related expenses associated with Brinsupri commercial activities led to the increase. As of June 30, 2026, Insmed had cash, cash equivalents and marketable securities of around $1.2 billion, in line with the previous quarter’s level. Following the stronger-than-expected launch, Insmed raised its 2026 Brinsupri revenue guidance to $1.25-$1.40 billion from its previous expectation of at least $1 billion. The company also increased its estimated global peak sales for Brinsupri to more than $7 billion from the previous guidance of over $5 billion. Management cited expectations for growth in the addressable bronchiectasis market through improved diagnosis and greater disease awareness. Insmed maintained its 2026 Arikayce revenue guidance at $450-$470 million. The company continues to expect to reach cash-flow positivity in 2027 without raising additional capital. Last month, Insmed submitted a regulatory filing with the FDA seeking to expand Arikayce's use to newly diagnosed patients with MAC lung disease. The company also plans discussions with Japanese regulators later this year to support a potential label expansion in Japan. Insmed continues to advance its investigational treprostinil palmitil inhalation powder (TPIP) program across multiple pulmonary indications. The company is currently enrolling patients in separate late-stage studies for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). The company remains on track to initiate two additional late-stage TPIP studies, one in progressive pulmonary fibrosis (PPF) in the second half of 2026 and another in idiopathic pulmonary fibrosis (IPF) in the first half of 2027. Like Brinsupri, Insmed raised its peak sales estimate for TPIP to more than $6 billion from the previous guidance of over $2 billion. This reflects increased confidence following encouraging clinical data and the expansion of the program into additional indications. Insmed currently carries a Zacks Rank #3 (Hold). Insmed, Inc. price | Insmed, Inc. Quote Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share (EPS) estimates for Harmony Biosciences have risen from $3.20 to $3.33 for 2026. Over the same period, EPS estimates have increased from $3.64 to $3.87 for 2027. HRMY shares have risen about 4% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and met on one occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 159% so far this year. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Insmed, Inc. (INSM) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Harmony Biosciences Holdings, Inc. recently reported second-quarter 2026 results showing net income of US$75.43 million, up from US$39.78 million a year earlier, with basic earnings per share from continuing operations rising to US$1.30 from US$0.69. Alongside these stronger earnings, the company reported progress across its neurology pipeline and clinical trials for rare neurological diseases, which could influence how investors view the balance between its current cash-generating products and longer-term development assets. We'll now examine how Harmony's sharp year-over-year earnings improvement and advancing neurology pipeline reshape its investment narrative for long-term investors. Explore 26 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research. To own Harmony Biosciences, you need to believe WAKIX can keep funding the business while the neurology pipeline gradually broadens the company’s revenue base. The sharp Q2 2026 earnings jump strengthens the near term story, but it does not remove the key risk that Harmony still leans heavily on a single drug as competition and patent timelines come into clearer focus. The Q2 2026 earnings release is the most relevant recent announcement here, as it highlights robust profitability alongside continued progress in rare neurology trials. That combination ties directly into the main catalyst for the stock: whether Harmony can convert today’s WAKIX driven cash flows into a more diversified portfolio that reduces concentration risk over time. Yet, beneath these stronger results, one risk investors should be aware of is that Harmony’s heavy reliance on WAKIX leaves it vulnerable if... Read the full narrative on Harmony Biosciences Holdings (it's free!) Harmony Biosciences Holdings' narrative projects $1.2 billion revenue and $333.5 million earnings by 2028. This requires 17.0% yearly revenue growth and about a $152.6 million earnings increase from $180.9 million today. Uncover how Harmony Biosciences Holdings' forecasts yield a $47.30 fair value, a 23% upside to its current price. Some of the lowest ranked analysts were assuming Harmony’s revenue could shrink about 5 percent a year and earnings fall to around US$97.8 million, which contrasts sharply with the current profitability and highlights how differently you and other investors might view the same WAKIX dependency risk and the impact of fresh trial data on future expectations. Explore 4 other fair value estimates on Harmony Biosciences Holdings - why the stock might be worth just $46.10! Don't just follow the ticker - dig into the data and build a conviction that's truly your own. A great starting point for your Harmony Biosciences Holdings research is our analysis highlighting 4 key rewards that could impact your investment decision. Our free Harmony Biosciences Holdings research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Harmony Biosciences Holdings' overall financial health at a glance. Early movers are already taking notice. See the stocks they're targeting before they've flown the coop: Find 49 companies with promising cash flow potential yet trading below their fair value. We've uncovered the 8 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. Uncover the next big thing with 20 elite penny stocks that balance risk and reward. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include HRMY. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Editas Medicine EDIT incurred a loss of 15 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 30 cents. The company had reported a loss of 63 cents per share in the year-ago quarter. Collaboration and other research and development revenues totaled approximately $11.9 million, comfortably surpassing the Zacks Consensus Estimate of $2 million. Revenues were $3.6 million in the year-ago quarter. The increase reflected deferred revenues recognized following the expiration of certain rights under the company’s collaboration with Bristol Myers. Research and development expenses increased 25% year over year to $20.2 million in the second quarter of 2026. The increase was primarily related to higher external expenses supporting ongoing research and preclinical work for EDIT-401. General and administrative expenses declined 10% to $11.6 million from $12.9 million in the year-ago quarter. The decrease was due to lower employee-related expenses and reduced professional services costs following the workforce reduction and discontinuation of the reni-cel program. Editas recorded a restructuring and impairment benefit of $1.3 million in the reported quarter. This compared favorably with restructuring and impairment charges of $26.1 million in the second quarter of 2025. The benefit reflected favorable adjustments to previously estimated contract costs associated with the discontinuation of the reni-cel program. Editas had cash, cash equivalents and investments worth $211.6 million as of June 30, 2026, compared with $123.6 million as of March 31, 2026. The company expects its existing cash position to fund operating and capital needs into the second half of 2028. Year to date, shares of Editas have soared 34.1% compared with the industry’s 2.5% growth. Image Source: Zacks Investment Research Editas has no approved products in its portfolio at present. Therefore, progress with its gene-editing pipeline, particularly lead candidate EDIT-401, remains the company’s primary focus. EDIT-401 is an experimental, one-time in vivo gene-editing therapy targeting the LDLR gene. The candidate is being developed for patients with heterozygous familial hypercholesterolemia, an inherited disorder associated with elevated LDL cholesterol and increased cardiovascular risk. Editas presented new preclinical findings for EDIT-401 at several scientific conferences. A single dose of the candidate produced mean reductions of approximately 90% or more in LDL cholesterol, lipoprotein(a) and apolipoprotein B in non-human primates. The reductions were rapid and dose-dependent. A mean LDL cholesterol reduction of at least 90% remained durable for approximately six months. The company also reported no adverse clinical observations in non-human primates receiving a single dose of 1.5 milligrams per kilogram. Editas remains on track to submit a Clinical Trial Notification in Australia in August 2026. The filing is intended to support the initiation of a phase I/II study evaluating EDIT-401 in patients with heterozygous familial hypercholesterolemia. The study will assess the safety, tolerability and efficacy of a single dose of EDIT-401. Its first part will use a single ascending dose, open-label design. Editas has selected four clinical study sites across Australia and New Zealand. The company expects to provide an EDIT-401 data update in the first quarter of 2027. It also plans to complete enrollment in the dose-finding portion of the phase I/II study and report top-line results in 2027. Editas Medicine, Inc. price-consensus-eps-surprise-chart | Editas Medicine, Inc. Quote Editas currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33, while estimates for 2027 have increased from $3.64 to $3.87 during the same time. HRMY shares have gained 2.2% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 3.2% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 158.4% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Editas Medicine, Inc. (EDIT) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). 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ADMA Biologics, Inc. ADMA reported second-quarter 2026 earnings of 16 cents per share, which matched the Zacks Consensus Estimate and rose from 14 cents in the year-ago quarter. Revenues grew 2.0% year over year to $124.4 million but missed the Zacks Consensus Estimate of $126.0 million. ADMA Biologics markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases. The company’s top line currently comprises sales of three FDA-approved products — Bivigam (an Intravenous Immune Globulin [“IVIG”] product to treat primary humoral immunodeficiency), Asceniv (to treat primary immunodeficiency disease or PIDD) and Nabi-HB (to treat and provide enhanced immunity against the hepatitis B virus). Strong Asceniv growth and margin expansion were partly offset by a sharp year-over-year decline in Bivigam sales. ADMA Biologics Inc price-consensus-eps-surprise-chart | ADMA Biologics Inc Quote Asceniv revenues increased 23.5% year over year to $102.9 million. The product accounted for most of ADMA’s quarterly revenues and remained the company’s principal growth driver amid competitive pressure across the broader U.S. immune globulin market. Management stated that Asceniv utilization strengthened progressively during the quarter. June produced the strongest sequential month-over-month utilization growth since the first half of 2024, supported by new patient starts, broader prescriber engagement and higher patient utilization. Bivigam revenues plunged 48.5% year over year to $19.4 million. Increased supply, aggressive discounting and competitive pricing continued to pressure the standard immune globulin market. However, Bivigam revenues improved sequentially. Management said demand stabilized during the second quarter and expects the product’s current run rate to remain sustainable, though the company is not incorporating a meaningful recovery into its guidance. Gross profit increased to $86.3 million from $67.2 million in the prior-year period. Gross margin expanded to 69% from 55%, reflecting a greater contribution from the higher-margin Asceniv product and benefits from the yield-enhanced manufacturing process approved in 2025. The shift in revenue mix supported substantial earnings leverage despite modest top-line growth. Research and development expenses climbed to $6.0 million from $1.0 million a year earlier, primarily due to investments in the SG-001 development program. Management expects quarterly R&D spending to remain near the second-quarter level, with another increase anticipated in the fourth quarter. Selling, general and administrative expenses rose to $26.7 million from $22.2 million recorded a year earlier, mainly due to higher employee-related expenses, increased software maintenance costs, greater legal and consulting fees, and investments in strategic growth initiatives. ADMA reiterated its 2026 revenue guidance of $530-$560 million. The company continues to expect adjusted net income in the band of $170-$200 million and adjusted EBITDA in the $265-$300 million range. The outlook assumes persistent competitive dynamics and pricing pressure in the standard immune globulin market. Asceniv is expected to remain the main driver of revenue growth, profitability and cash generation, with management forecasting upper-20% to low-30% revenue growth for the product in 2026. ADMA ended the quarter with $136.0 million in cash and cash equivalents. The company repurchased approximately 7.1 million shares during the quarter. Year-to-date repurchases totaled about 13.8 million shares, representing 5.3% of outstanding common stock as of June 30, 2026. ADMA remains on track to complete at least $200 million of share repurchases during 2026. ADMA continued progressing SG-001, its hyperimmune globulin program targeting S. pneumoniae. ADMA expects to submit a pre-investigational new drug meeting package to the FDA by the end of 2026 and believes the candidate could address a $300-$500 million annual revenue opportunity if approved. ADMA’s performance in the second quarter was mixed, with earnings matching expectations but revenues missing the same as the company grapples with challenges in the IG market. The stock is down in pre-market trading. Year to date, shares of ADMA have plunged 49.2% against the industry’s growth of 2.6%. Image Source: Zacks Investment Research Per management, increased supply and pricing competition continues to weigh on the standard IG market. Nonetheless, demand for Asceniv remains strong. Management believes Asceniv remains in the early stages of penetrating the later-line refractory primary immunodeficiency market and represents a key long-term growth driver for ADMA (supported by a differentiated, patented supply and manufacturing platform). ADMA currently has a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Liquidia Corporation LQDA and Novavax NVAX, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share (EPS) have risen from $3.20 to $3.33, while those for 2027 EPS have increased from $3.64 to $3.87 during the same time. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased from $2.97 to $3.02, while those for 2027 EPS have improved from $4.81 to $5.31. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 60 days, estimates for Novavax’s 2026 loss per share have remained unchanged at 20 cents. Over the same period, loss per share estimates for 2027 have narrowed from 26 cents to 25 cents. Novavax’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 305.24%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ADMA Biologics Inc (ADMA) : Free Stock Analysis Report Novavax, Inc. (NVAX) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research