KRYS

A month has gone by since the last earnings report for Amgen (AMGN). Shares have added about 8.6% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Amgen due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Amgen reported second-quarter 2026 adjusted earnings of $6.29 per share, up 4% year over year. Earnings beat the Zacks Consensus Estimate of $5.60 as higher revenues were partially offset by higher operating costs and higher taxes.Total revenues increased 10% to $10.1 billion and surpassed the consensus estimate of $9.44 billion.Total product sales increased 9% year over year to $9.54 billion, driven by higher volumes.Other revenues were $517 million in the quarter, up 26.7% year over year.Broad-based volume growth across Repatha, Evenity, Tezspire, Uplizna and oncology products more than offset biosimilar erosion for Prolia and Xgeva and weakness in mature brands like Otezla and Enbrel. New biosimilar products are also contributing to sales growth.  Twenty-two products achieved double-digit sales growth in the quarter.Amgen’s key growth drivers, which include Repatha, Evenity, Tezspire and oncology and rare disease drugs, as well as biosimilar products, rose 26% year over year in the second quarter. These key growth drivers represented almost 70% of Amgen’s total product sales. Repatha sales surged 37% year over year to $953 million, exceeding the Zacks Consensus Estimate of $907 million. The increase was driven by volume growth. New-to-brand prescriptions in the United States rose more than 50%, supported by increased use in secondary prevention and high-risk primary prevention patients.Evenity sales climbed 38% to $714 million, driven by solid volume growth. Evenity sales beat the Zacks Consensus Estimate of $636 million. Prolia sales declined 32% to $759 million but exceeded the estimate of $728 million as multiple biosimilars affected volumes and pricing. Xgeva revenues fell 34% to $352 million, slightly missing the consensus mark of $356 million.Patents for Prolia and Xgeva expired in 2025. Sales of these best-selling drugs are eroding significantly in 2026 as several biosimilars have been launched globally with more biosimilars expected.Inflammation and Oncology Drugs’ Mix PerformanceTezspire sales rose 42% year over year to $486 million, marginally exceeding the Zacks Consensus Estimate of $483 million. Demand increased in severe uncontrolled asthma, while the uptake of its new indication of chronic rhinosinusitis with nasal polyps was encouraging.Otezla sales declined 21% to $491 million, missing the consensus estimate of $562 million, due to lower pricing and volume.Enbrel revenues decreased 4% to $580 million due to lower selling prices (including the impact from increased 340B program mix and Medicare Part D redesign), partially offset by favorable changes to estimated sales deductions. Enbrel sales topped the estimate of $466 million.Nplate sales rose 17% year over year to $430 million. In oncology, Blincyto sales increased 23% to $472 million, surpassing the consensus estimate of $457 million. Growth reflected broader prescribing in U.S. academic and community settings and strong international demand. Kyprolis recorded sales of $314 million, down 17% year over year, due to lower volumes.  Vectibix revenues came in at $338.0 million, up 11% year over year. Lumakras/Lumykras sales rose 23% year over year to $111 million.New cancer drug Imdelltra’s sales rose 11.6% sequentially to $288 million, supported by increased adoption in second-line small-cell lung cancer. In oncology biosimilars, sales of Mvasi were $153 million in the quarter, down 20% year over year, due to lower selling prices and lower volume. Amgen’s rare-disease portfolio generated $1.6 billion in quarterly revenues, up 21%, supported by international expansion, additional indications and pricing.Uplizna revenues increased 90% year over year to $335 million, beating the Zacks Consensus Estimate of $306 million. Performance reflected sustained momentum across its three approved indications, aided by broader physician adoption and the drug’s twice-yearly maintenance dosing.On the conference call, Amgen said that growth continues for Uplizna in IgG4-related while uptake for Uplizna in generalized myasthenia gravis or gMG is increasing across both bio-naive and switch patients.Tepezza sales advanced 14% to $576 million, driven by higher volumes and pricing. On the call, the company mentioned that uptake in Japan following last year's launch remains strong. The company has launched Tepezza in 13 countries and expects to launch it in six additional markets in the near term.Krystexxa revenues rose 15% to $400 million driven by higher pricing, partially offset by lower inventory levels. Tavneos sales increased 36% to $150 million driven by volume growth.Ultra-rare products generated revenues of $149.0 million in the quarter, down 19% year over year. Total biosimilar sales were $855 million in the quarter, up 29% year over year.Sales of Wezlana were $61 million, compared with $47 million in the previous quarter, entirely from ex-U.S. markets. Pavblu generated sales of $287 million in the quarter, up 2.5% sequentially, driven by increased adoption among retina specialists. Sales of Amjevita/Amgevita were $155 million in the quarter, up 17% year over year. Total sales of established products, which include Aranesp, Parsabiv and Neulasta, increased 19% year over year in the second quarter to $632 million. Adjusted operating margin declined 0.5 percentage points year over year to 48.4% in the second quarter.Adjusted operating expenses increased 11% to $5.44 billion. R&D expenses rose 10% year over year to $1.85 billion, reflecting higher spending on late-stage clinical programs, particularly MariTide. SG&A expenses increased 4% to $1.72 billion, mainly due to higher general and administrative expenses and increased commercial product-related spending.The adjusted tax rate was 15.6% in the quarter, up 1.4 points from the year-ago quarter. Amgen raised its financial outlook for 2026 for the second time this year.Amgen raised its total revenue guidance for 2026 to a range of $38.2 billion to $39.4 billion. The company previously expected revenues between $37.1 billion and $38.5 billion.Adjusted earnings guidance was increased to $22.30-$23.50 per share from the prior range of $21.70-$23.10. The improved outlook reflects strong first-half execution and continued momentum across the company’s key growth products.Other revenues are expected to be approximately $1.9 billion compared with the prior expectation of being in the range of $1.7 billion to $1.8 billion in 2026.Adjusted R&D is expected to increase in a high single-digit range year over year in 2026. Amgen expects a meaningful sequential increase in operating expenses in the third quarter.Adjusted operating margin is expected to be roughly 45% to 46% for 2026.The adjusted tax rate is expected to be in the range of 15.0% to 16.5%. Capital expenditures are expected to be approximately $2.6 billion.Share repurchases are expected not to exceed $3 billion in 2026. Amgen announced that it will discontinue further development of AMG 513, while its ongoing phase I obesity study will continue until all enrolled participants complete the study. In the past month, investors have witnessed a downward trend in estimates review. Currently, Amgen has a nice Growth Score of B, though it is lagging a bit on the Momentum Score front with a C. Following the exact same course, the stock was allocated a score of C on the value side, putting it in the middle 20% for value investors. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Amgen has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Amgen is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Krystal Biotech, Inc. (KRYS), a stock from the same industry, has gained 13.3%. The company reported its results for the quarter ended June 2026 more than a month ago. Krystal Biotech reported revenues of $119.22 million in the last reported quarter, representing a year-over-year change of +24.1%. EPS of $1.79 for the same period compares with $1.29 a year ago. Krystal Biotech is expected to post earnings of $1.91 per share for the current quarter, representing a year-over-year change of -28.2%. Over the last 30 days, the Zacks Consensus Estimate has changed +0.8%. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Krystal Biotech. Also, the stock has a VGM Score of D. 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 Amgen Inc. (AMGN) : Free Stock Analysis Report Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

A month has gone by since the last earnings report for Krystal Biotech, Inc. (KRYS). Shares have added about 12% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Krystal Biotech due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important catalysts. Krystal Q2 Earnings & Sales Beat Estimates, Pipeline in Focus Krystal reported second-quarter 2026 earnings per share (EPS) of $1.79, which surpassed the Zacks Consensus Estimate of $1.70. The company recorded an EPS of $1.29 in the year-ago quarter.Revenues of $119.2 million rose 24.14% year over year in the reported quarter, marginally beating the Zacks Consensus Estimate of $119 million. Revenues came in solely from Vyjuvek sales. Q2 Results in Detail The top line comprises product revenues from Krystal’s only marketed drug, Vyjuvek.Krystal generated $119.2 million in product revenues from Vyjuvek, up from $96 million in the year-ago quarter, driven by strong patient uptake.The gross margin in the reported quarter was 95%.Research and development (R&D) expenses were approximately $14.5 million, including stock-based compensation and where roughly consistent with the prior-year quarter. Selling, general and administrative (SG&A) expenses totaled $39.9 million, including stock-based compensation, up 13.6% from the year-ago level. This increase was primarily due to increased headcount and marketing costs to support the global launches of Vyjuvek.As of June 30, 2026, cash, cash equivalents and investments totaled $1.1 billion compared with approximately $1 billion as of March 31, 2026. KRYS’ 2026 Guidance Krystal reiterated its non-GAAP combined R&D and SG&A expense guidance of $175 million to $195 million for full-year 2026. Since the earnings release, investors have witnessed a upward trend in estimates review. At this time, Krystal Biotech has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock has a grade of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of D. 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. Notably, Krystal Biotech has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Krystal Biotech belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Astrazeneca (AZN), has gained 4.4% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Astrazeneca reported revenues of $15.38 billion in the last reported quarter, representing a year-over-year change of +6.4%. EPS of $2.63 for the same period compares with $2.18 a year ago. For the current quarter, Astrazeneca is expected to post earnings of $2.60 per share, indicating a change of +9.2% from the year-ago quarter. The Zacks Consensus Estimate has changed -1.3% over the last 30 days. Astrazeneca has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. 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 Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Monday, Aug. 3, 2026 at 11 a.m. ET Senior Vice President of Corporate Development - Stephane Paquette Chairman and Chief Executive Officer - Krish Krishnan President of Research and Development - Suma Krishnan Executive Vice President and General Manager for Europe - Laurent Goux Senior Vice President and Head of U.S. Commercial - Christine Wilson Chief Accounting Officer - Kate Romano Operator: Thank you for standing by, and welcome to the Krystal Biotech 2Q 2026 Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Senior Vice President of Corporate Development. Please begin. Stephane Paquette: Good morning, and thank you all for joining today's call. Earlier today, we released our financial results for the second quarter of 2026. The press release is available on our website at www.krystalbio.com. We also filed our earnings 8-K and 10-Q with the SEC earlier today. Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer; Suma Krishnan, President of Research and Development; Laurent Goux, Executive Vice President and General Manager for Europe, Christine Wilson, Senior Vice President and Head of U.S. Commercial; and Kate Romano, Chief Accounting Officer. This conference call will and our responses to questions may contain forward-looking statements. You are cautioned not to rely on these forward-looking statements, which are based on current expectations using information available as of the date of this call and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties and other factors can be found in our SEC filings. With that, I will turn the call over to Krish. Krish Krishnan: Good morning, and thank you for joining us. We were focused on execution in Q2, making solid progress across both our commercial and clinical programs. Internationally, strong underlying demand and high patient excitement underpin our launch. We're working diligently to meet that demand and broaden access for DEB patients around the world. We're advancing pricing and reimbursement discussions in Germany, France, Italy, Spain and the U.K., while working through the country-specific requirements associated with each launch. In the United States, demand continues to grow, supported by our increasing focus on reaching patients and physicians in the community setting. Laurent and Christine will provide additional detail on our commercial performance and international launch progress. Our clinical pipeline is also advancing across multiple important programs. We currently have 2 registrational studies underway, our study in neurotrophic keratitis and our study of ocular lesions in patients with dystrophic epidermolysis bullosa. In addition, our repeat dose studies in cystic fibrosis and Hailey-Hailey disease are progressing. And assuming supportive data, we believe both programs have the potential to advance into registrational development in 2027. We're also making great progress with our KB707 program in oncology. Our inhaled 707 formulation for the treatment of NSCLC is on track for a registrational study next year. And we are now evaluating our intratumoral KB707 formulation in Gorlin syndrome, a rare skin indication that fits in well with our therapeutic focus and growing commercial footprint. Suma will provide a more comprehensive update on our clinical programs shortly. Finally, we remain in a very strong financial position. Our continued financial strength reflects both the growing performance of our commercial business and the operating discipline we have maintained over the past 12 quarters. This allows us to invest confidently in global expansion and pipeline development while continuing to manage the business responsibly. With that, let's get into the details. Laurent? Laurent Goux: Thank you, Krish. We are very encouraged by the recent progress in our VYJUVEK launch. Commercial momentum across Europe and Japan is strong and building, supported by growing physician familiarity, high engagement from leading treatment centers and sustained interest across the dystrophic epidermolysis bullosa community. In July, Krystal had a strong presence at the third World Congress on Rare Skin Diseases in France, including a well-attended symposium. This was another important step in building awareness and advancing our ambition to establish VYJUVEK as an essential treatment for DEB patients. Demand is high in France, Germany and Japan and driving growth in both treated patients and treatment volumes. This growth also reflects the excellent work of our country teams as they navigate the access and operational dynamics unique to each market. In Germany, for example, the care landscape is fragmented and only a limited proportion of DEB patients are routinely seen at established [indiscernible] centers. Our team is, therefore, engaging a broader network of physicians and supporting patients in continuing treatment at home. In France, VYJUVEK is available through the early access pathway where administration is currently concentrated in hospital settings due to the requirement associated with its GMO classification. Our team is working closely with centers to facilitate access and treatment continuity while exploring solutions that could support home administration over time. And in Japan, an important nuance is the requirement for intensive prescription renewal, which can put a heavy burden on patients in the first year of launch. We are working closely with prescribers and patients to ensure all stakeholders understand the importance of consistent weekly administration and minimize potential disruptions. Turning to revenues. Reported revenue in Europe and Japan was broadly flat in the quarter, primarily due to a reserve provision related to the ongoing pricing process in Germany. This does not change our assessment of the underlying launch trajectory or our confidence in the longer-term opportunity across Europe and worldwide as we continue to grow patient and treatment volumes in our overseas markets. Turning to market access. Pricing and reimbursement work continue across the EU. In Germany, Italy and Spain, we continue to expect key outcomes before the end of 2026, subject to each country's process. In France, formal pricing and reimbursement discussions are expected to progress into 2027. Our engagement with authorities remains constructive, and we believe VYJUVEK's clinical evidence and potential value to patients provide a strong foundation for these discussions. In the United Kingdom, we also achieved 2 important milestones. On May 15, the MHRA granted marketing authorization for VYJUVEK, making it the first genetic medicine approved in the U.K. for DEB. This was followed in June by VYJUVEK receiving the 2026 Prix Galien UK Award for Best Product for Orphan Disease. This is the third Prix Galien for VYJUVEK following similar recognitions in France and Italy last year. Together, these milestones reinforce the strength of the evidence supporting VYJUVEK and its significance for patients and families living with DEB. Our ultimate objective is sustainable patient access. NICE's appraisal in the U.K. remains ongoing, and our team is engaging constructively to address NICE's questions and showcase the transformational benefit achievable with VYJUVEK. Finally, we are planning multiple additional regulatory submissions in the coming months, including Switzerland and Australia, representing another step towards bringing VYJUVEK to more DEB patients globally. Overall, we are pleased with the momentum across our international business. We remain focused on disciplined execution, navigating market-specific challenges, securing sustainable reimbursement and converting strong physician engagement and patient demand into durable patient-centered access. With that, I will hand the call over to Christine. Christine Wilson: Thank you, Laurent. I am pleased to report another strong quarter of commercial performance. U.S. net revenue was $91.6 million for the quarter. Our field team continues to perform exceptionally well as we extend our reach deeper into the community and across the country. Working in close partnership with health care providers nationwide, they are filling education gaps, raising awareness and helping us reach more patients through the DEB community. To that end, I am also very happy to report that we have achieved more than 730 U.S. reimbursement approvals for VYJUVEK. We have now surpassed our initial penetration target of 60% and have no plans of stopping there. With a strong pace of approvals over the last year and a growing prescriber base, we expect continued penetration of the diagnosed DEB patient pool in the quarters to come. In addition to driving new patient starts, we continue to strengthen our patient engagement efforts to help patients and caregivers successfully incorporate VYJUVEK into their long-term wound care routines. Based on ongoing feedback from the DEB community, we know that virtual education and peer-to-peer connection remain preferred ways to access information and support. As a result, we continue to invest in scalable community-driven programs that educate, engage and empower patients through their treatment journey. During the second quarter, we partnered with debra of America to host a virtual education webinar focused on recent VYJUVEK label updates and practical bandaging techniques presented by our Krystal Connect team. The program was developed in direct response to questions from the patient community as treatment needs continue to evolve. As more patients achieve complete wound closure in larger wound areas and transition to managing smaller or more anatomically challenging wounds, including the scalp, ears and other sensitive locations, the educational needs of patients and caregivers continue to change. The webinar attracted more than 100 live attendees and remain available on demand, extending its impact across the DEB community. Our VYJUVEK Voices program continues to provide peer-to-peer education and support by connecting patients and caregivers with trained ambassadors who share firsthand experience, practical insights and ongoing encouragement through the treatment journey. During the quarter, we also launched VYJUVEK Connections, a virtual discussion series that brings together patients, caregivers and VYJUVEK ambassadors to discuss topics selected by the community. These sessions foster meaningful peer engagement while addressing the real-world questions that arise as patients gain experience with therapy. Collectively, these initiatives support patients as they adopt greater self-administration at home following our recent label expansion and further integrate VYJUVEK into their long-term treatment routines. These programs also provide Krystal with valuable real-world insights into the evolving needs of the DEB community, enabling us to continuously refine and strengthen our patient engagement strategy. Just a few weeks ago, we were also proud to serve as a diamond sponsor of the debra of America Care Conference, one of the largest gatherings of the EB community. The conference provided an important opportunity to engage directly with patients, caregivers, health care professionals and advocacy leaders. These interactions not only strengthen our connection with the community, but also allow us to see firsthand the meaningful impact VYJUVEK continues to have on patients' lives. These advancements, combined with our continued investment in patient support, education and community engagement further strengthen our reach and impact as we establish VYJUVEK as the long-term standard of care for patients living with DEB. I will now hand the call off to Suma to share pipeline highlights. Suma Krishnan: Thank you, Christine, and good morning, everyone. I'm happy to share today's update on our progress. Thanks to the tireless commitment of our team, we are rapidly approaching 2 registrational study readouts in the front of the eye. These readouts have exciting implications both for the patients we aim to serve as well as our platform. Due to the rapid cell turnover and protein clearance, the front of the eye has historically been a difficult-to-shoot target with gene therapies and biologics. Our HSV-1 vectors, which we easily and repeatedly administered as an eye drop, are uniquely positioned to fill this treatment gap. In sentinel patient cases, repeat dosing of our vectors has been well tolerated and delivered profound clinical improvement, underscoring the therapeutic potential of our HSV-1-based approach. With our registrational programs for KB803 and KB801 nearing readouts, we are on the cusp of validating that potential. Our registrational IOLITE study evaluating KB803 in DEB patients was fully enrolled in April and is on track for a readout later this year. On success, we expect to move rapidly to BLA submission, leveraging the extensive CMC work already completed for VYJUVEK. Our registrational EMERALD-1 study evaluating KB801 in NK patients is also progressing well. We expect to complete enrollment before year-end. And given the short 8-week primary endpoint, we expect a readout soon thereafter. Our KB407 and KB111 programs are advancing on similar time lines to deliver clinical data this year and registrational study starts in 2027. Dosing is underway in our open-label single-arm study, evaluating the safety of repeat dose KB407 in patients with cystic fibrosis who are either ineligible or refractory to modulator therapy. We expect to enroll approximately 5 patients and report interim results before year-end. We are also working with the FDA, the Cystic Fibrosis Foundation and the CF Therapeutic Development Network Coordinating Center or TDN on our innovative registrational study design. We are making good progress on the details of our design and statistical analysis plan. We expect study design alignment later this year and registrational study start in 2027. Dosing is also underway in our open-label single-arm study evaluating the safety of repeat dose KB111 in patients with Hailey-Hailey disease. We expect to enroll approximately 7 patients and report interim results before year-end. We have completed development of our HHD assessment scale and validations are now underway. Altogether, we are on track to discuss our repeat dosing safety results, scale and study design with the FDA before the end of the year, again, enabling a registrational study start in 2027. We look forward to sharing clinical updates on both programs in the coming months as we work to deliver meaningful benefits to the tens of thousands of patients with untreated cystic fibrosis or Hailey-Hailey disease. In addition to our work in rare disease, we continue to advance our broader pipeline, which leverages the flexibility of HSV-1 to target more common diseases of the lung, skin and eye. The most advanced of these programs in our inhaled KB707 program for the treatment of non-small cell lung cancer or NSCLC. Inhaled KB707 is currently under investigation in our Phase I/II dose escalation and expansion study KYANITE-1. Last year, we disclosed the inhaled KB707, a monotherapy achieved 36% response rate in heavily treated late-line NSCLC patients. Inhaled KB707 was also generally well tolerated with a safety profile amenable to outpatient management. At ASCO this year, we provided a clinical update on our dose expansion cohort evaluating KB707 in combination with pembrolizumab. We again saw strong response in late-line NSCLC patients with an objective response rate of 31% and encouraging durability. Responses were achieved in a diverse array of tumor types, including those with driver mutation, squamous histology and low PD-L1 expression. The combination regimen was also well tolerated, a positive indicator for KB707 combination potential with checkpoint inhibitors and immunotherapies more broadly. We expect to complete enrollment in our final dose expansion cohort evaluating inhaled KB707 in combination with chemotherapy later this year. Once data from this cohort is available, we expect to have full information needed to finalize and initiate a registrational study in second-line NSCLC expected in 2027. We are also moving intratumoral KB707 forward. Building on early signals of efficacy in patients with basal cell carcinoma from our Phase I/II OPAL-1 study, we expanded the scope of OPAL-1 to evaluate intratumoral KB707 in patients with Gorlin syndrome. Gorlin syndrome is a rare genetic disease, which imposes a heavy burden on patients, dramatically increasing the risk of developing basal cell carcinomas. Patients with Gorlin syndrome can suffer from hundreds of BCCs over their lifetimes, requiring frequent and potential disfiguring surgeries. There is no specific therapy approved for Gorlin and as a result, there exists a clear and urgent need for a safe and effective therapy that reduces BCC burden for these patients. We have now enrolled 3 patients with Gorlin syndrome and expect to provide a clinical update on these patients as well as our development plan in Gorlin later this year. With multiple registrational study readouts and starts upcoming as well as growing momentum in our oncology pipeline, we are uniquely positioned to deliver transformational impact to patients. This is in addition to our ongoing work on alpha-1 antitrypsin lung disease, [indiscernible] and earlier-stage preclinical programs. We look forward to sharing many updates in the months ahead. With that, I'll hand the call over to Kate. Kathryn Romano: Thank you, Suma, and good morning, everyone. I'll now provide some highlights from our second quarter financial results as reported in our press release and 10-Q filing earlier today. Net revenue from global sales of VYJUVEK was $119.2 million for the quarter, which included sales from our commercial launches in Europe and Japan as compared to $96 million or a 24% increase from the second quarter of 2025. Note that this quarter also included a full quarter of accrued pricing for Germany as we started our pricing negotiations mid last quarter, which contributed to reduced quarter-over-quarter net European revenue despite growth in related vial sales. Cost of goods sold for the quarter was $6.4 million compared to $7.2 million in the prior year second quarter. Gross margin for the quarter was 95%, improved from 93% in the second quarter of 2025. R&D expenses for the quarter were $14.5 million, which was essentially flat to the prior year of $14.4 million. G&A expenses were $39.9 million compared to $35.1 million in the prior year. This $4.8 million increase was primarily due to increased head count and related compensation expense as well as commercial costs related to global sales of VYJUVEK. Operating expenses for the quarter included noncash stock-based compensation of $14.2 million compared to $14.1 million in the second quarter of last year. Net income for the quarter was $54.8 million, which represented $1.85 per basic and $1.79 per diluted share. This marks an increase compared to the prior year second quarter net income of $38.3 million and EPS of $1.33 per basic and $1.29 per diluted share. I'll also note that the guidance we previously issued relating to non-GAAP operating expenses remains unchanged. We continue to expect to incur in the range of $175 million to $195 million in non-GAAP R&D and SG&A expenses for the full year of 2026. And finally, we continue to further strengthen our cash and investments foundation, now exceeding $1.1 billion in overall cash and investments. We remain committed to thoughtfully and efficiently deploying our capital as we execute on our upcoming pipeline milestones and continued global commercial strategy. And with that, I'd like to turn the call back over to Krish. Krish Krishnan: Thanks, Kate. To summarize, on the commercial side, we're working through typical overseas launch dynamics, including accruals and pricing negotiations as we build the foundation to sustain our launch for years to come. We're confident that the work we're doing this year will put us in a position to provide access to thousands of patients worldwide and provide a clear path for VYJUVEK to reach its full commercial potential. On the clinical side, we're focused on completing the ongoing registrational trials and initiating at least 2 more registrational trials in 2027. When we do that in the next 12 to 18 months, Krystal has the potential to transition from a commercial success story into a multiproduct genetic medicines company. Thank you, and we're now ready to answer questions. Operator: [Operator Instructions] Your first question for today is from Roger Song with Jefferies. Jiale Song: Great. Congrats for the quarter. Maybe one for commercial, one for pipeline. For the commercial side, seeing the European sales down a little bit from the first quarter, understanding some pricing dynamic. Can you just give us some color around the demand side and then maybe the compliance between Germany and France, that would be very helpful. And then on the pipeline, Hailey-Hailey seems very interesting indication, underappreciated right now. So given you will have Phase I data by year-end, so how should we -- what should we expect from that data readout? And then also, what's the current thinking about the epidemiology and then overall market opportunity for Hailey-Hailey? Krish Krishnan: Roger, thanks for the question. Laurent, do you want to take a first stab at the European question? Laurent Goux: Yes. As we said earlier, the market dynamics are pretty strong. We have been -- we're facing a strong growth in both patient inclusion and volume. And the overall revenues, the full quarter of the German reserve for the future... Krish Krishnan: Laurent, do you want to make any comment on demand because there was a question on demand. Laurent Goux: I mean, the demand is strong. Yes, we still [indiscernible] over 180 patients have been treated in Western Europe and Japan so far. So we are -- but as we are expanding in more centers and countries, it is more and more difficult to have a precise estimation in Europe. So that's why we might not have explicitly given the number. Krish Krishnan: And I will add, Roger, just to close on that. I think compliance in the early days of launch in any country tends to be really good as we start off treating severe patients. So your comment on -- your question on compliance in Germany and France, we see pretty good strong compliance, similar to what we saw in the U.S. Suma? Suma Krishnan: I can take the Hailey-Hailey. Hailey-Hailey is an interesting disease. I mean, again, underappreciated, not well studied. There's not a lot of information in the literature or -- but this is -- the beauty of this is we have done a natural history study. It's been 5 months. We have over 60 to 70 patients already enrolled in this natural history because we use these patients to understand the disease. We've been collecting data over the past 4 to 5 months. So we have extensive knowledge and understanding now about the disease, its cycle time and all of that good stuff. And we've also used these patients to obviously validate our scale. So we -- as you can tell, we are nearing the end of the scale validation. We feel pretty confident like now we understand the disease and what the endpoints we should go after. We have also put together scientific experts and KOLs in the space together to develop the scale and also to the endpoint. So the Phase I study is basically what we learned from the natural history. So we have already -- most of the patients already -- everybody is excited to be part of this trial. So we have no problem enrolling. We have already got patients on the study and started dosing them. So we will, again, through imaging and investigators evaluation over 3 months, just like we did with VYJUVEK, pretty similar. Again, it's going to be a gel. And we have learned a lot from VYJUVEK, how to administer, how to have these patients maintain the treatment and use the right bandages. So it's very useful. It is very easy for us to take the VYJUVEK experience into Hailey-Hailey. And I think very -- in the 3 months, we will look at treated versus nontreated. We'll also have biopsy these patients at baseline and see some sort of correction of the treated areas. So I think we will have enough data for us to basically then sit with the agency and let them know what the endpoints are because the FDA has no idea. So we are going to let them know based on our data that we generated, we're going to propose the endpoints. And we expect to start registrational trial early next year. As I said, we have over 60 to 70 patients already in our natural history, and we continue to -- new patients continue to enroll into that study. Operator: Your next question is from Alec Stranahan with Bank of America. Alec Stranahan: Good to see all the progress in the quarter. I guess, first, maybe on NK. Could you talk a bit about the patient treated with KB801 that had a complete closure? Is this patients still being followed? And I guess, how does their disease stage or demographic compared to the population that's being enrolled in EMERALD-1? And then on CF, just on the 5-patient follow-up study, could you maybe just remind us what kind of functional metrics the study is designed to show? Or is it maybe more around the dosing PK side? Just hoping to link the CFTR expression to improve lung function, but possible this is maybe something we see more with the pivotal study. Krish Krishnan: Alec, before Suma gets into the comment on NK patients, I want to say, look, it was a legal requirement that made us disclose that one patient data stemming from some of the patent disclosures that ensued as we were supporting the patent with clinical information. We have always said and expressed to not have the investment community read too much into a single patient data. I mean the data was fantastic on a single patient, but it is a one patient data and the new study that we are working on is a different design. And so with that, I'll turn it over to Suma. Suma Krishnan: Correct. Okay. This patient, again, was chronic -- had chronic wounding in the eye. I mean, from his records. We treated it -- treated the patient. Obviously, you can see that there was complete closure, and we monitored this patient over a couple of weeks after, and we see durability of that wound healing. And the patient is -- I mean, we are done with this patient because that study got closed out. And in the past, we've explained why we changed the dosing regimen because it made more sense to give daily. It's just enough for -- not only for compliance and it makes sense when you're administering them into the eye. These are older patients to maximize the dose, and there was no safety concerns. So again, very similar population. We want to make sure that we get patients that have chronic wound healing because that's important because if you want to separate from placebo, you want to treat those patients that when you express NGF, you're going to see that the better effect or the efficacy from that drug when we compare to placebo. We're very excited because we opened this trial up globally. We have filed our CTA and we have identified several sites across EU. We want to expand it because we think we want to go for a global trial, just like we did with VYJUVEK and hope to get approval just if everything is successful, not just in the U.S. but globally. So that's the intent for the MTA study. Krish Krishnan: On the CF. Suma Krishnan: Sorry, on the CF, again, as we have said earlier in our previous calls, the intent of this study is, I mean, as per our discussions, which is ongoing with the FDA, the FDA wanted to see some repeat dosing data in these patients. So we have enrolled and dosed patients already. We expect to enroll 5 patients. And this is going to be a weekly repeat dosing study. They come in monthly, and we check for FEV1 and other safety outcomes. So it's going to be a measurement of FEV1 over 6 months, every month, the patient comes in. And hopefully, by 6 months, we'll have data on what's with repeat dosing and what's the improvement in these patients. And again, remember, we are enrolling really sick patients. These patients have very low FEV1. They have no other options. So the null patients and patients that have no other option today. So it's a very sick patient population with high demand. Operator: Your next question for today is from Yigal Nochomovitz with Citigroup. Yigal Nochomovitz: I'm just wondering if you could be perhaps a little more specific with respect to the progress in Germany in terms of the quarter-over-quarter vial growth, demand growth relative to the accrual process and what the headwind is on the accrual given that starting in 2Q, I believe there was an accrual throughout the quarter. And then on NK, if you could just clarify, it sounds like you're going to finish enrollment before the end of the year and then 8 weeks to the endpoint, but it appears [indiscernible] I'm correct that the data will be likely in early '27? Or could it still be in this year? Krish Krishnan: Laurent, do you want to take the German question? Laurent Goux: Yes. We don't provide country-by-country details for number of patients and revenues, but German -- the dynamic in terms of patient inclusion and vial increase is very solid in Germany. Krish Krishnan: And Yigal, on the accrual process, look, we are expecting at this moment to complete negotiations in Q3, pricing negotiations in Germany. And assuming successful completion of the negotiation, the impact of accrual, I mean, our whole objective is to be conservative in the accrual and get it over with once the pricing is established in Germany. So we did experience some accrual in the first half of Q1, completely in Q2 and maybe a partial in Q3. And hopefully, by the time Q4 comes around, we'll be back to an actual net revenue number in Germany. On NK, Suma? Suma Krishnan: Yes. NK, again, as I mentioned, we are going globally. So our -- I mean, as I said, we're getting all the sites activated in EU countries and regions because we want to do one global filing. So yes, we expect -- I mean, we are targeting and getting all of it enrolled by end of the year. So potentially '27 by the -- early '27 by the time we clean the database and announce data. But again, keep in mind, I mean, the thing is the CMC, right? I mean if we have still -- that's just objective. We have the platform technology. We have all the stuff ready to go. So once data is out, I think we -- all of -- I mean, in an entirety, I think we'll be ready to file the BLA. Operator: Your next question is from Ritu Baral with TD Cowen. Ritu Baral: Suma, I just want to clarify on NK enrollment. Are you pushing out the enrollment completion and the data just slightly in order to -- for the sake of the European patients. I wanted to just ask how enrollment rate was going overall as far as a reflection of the interest in the therapy. And also, are you upsizing the trial at all to include these European patients? And then my second question was a commercial question just on VYJUVEK in the U.S. In your remarks, you mentioned -- Krish, you mentioned that you were going more to the community setting. What opportunity -- what commercial opportunity or patient number opportunity is left in the community setting for DEB? Is it mostly dominant DEB? And what sort of market research trends have you seen to sort of drive that interest? Suma Krishnan: So I'll take the NK study. I mean, obviously, it makes sense for us to go global to file in Europe. And obviously, in Europe, there is -- OXERVATE is not available. So there is a need for these patients -- I mean it will be hopefully, when we talk to all of the KOLs in Europe, they all want to participate because there's nothing for these patients. So obviously, we want to take advantage of that. So we can speed up some of the enrollment with adding more patients in Europe that are willing to get -- there's a need. So that's the intent. So again, I mean, we are not upsizing the study trial. It's just -- we want to do global filing. We want to increase recruitment with keeping the study design the same and the number the same. And the intent is to get a global filing. Krish Krishnan: And Ritu, we presently expect enrollment to be done year-end as we've been saying. On the commercial side, Christine, do you want to take a shot? Christine Wilson: Sure. I'd be happy to. So yes, we continue to believe there's opportunity in the community setting. While we've made a lot of great progress on finding these patients wherever they may be located across the U.S. and as mentioned, we have surpassed our initial penetration target of 60% of the diagnosed patient population. We're continuing to see opportunities and finding opportunities, which supports the demand growth that you're continuing to see. In addition, you asked about the DDEB population. We're continuing to see patients come in that are both RDEB and DDEB. As you can imagine, as the launch has gone on, we're seeing the DDEB patient population grow as they sit more on that mild-to-moderate spectrum, but we're still also seeing RDEB patients coming in. So it is still a healthy split of the opportunity that's being found in that community setting? Krish Krishnan: Yes. And Ritu, in terms of overall, I don't think there's any change. There's about 1,200 identified patients. That's the initial target. Once we get close to that number, we're going to expand our efforts to go after the 3,000 or so, the majority of whom probably are undiagnosed. But if you look at the number of reimbursement approvals we're able to generate every quarter, that shows there is still a healthy demand left, like we're not in any kind of like stable mode. It is true that most of the new patients coming into the drug tend to be more moderate to mild than super severe. But that said, demand continues to be really strong, like somewhere between 35 and 50 reimbursement approvals. We keep hitting on that almost every quarter. Operator: Your next question for today is from Lachlan Hanbury-Brown with William Blair. Lachlan Hanbury-Brown: Maybe a couple on access. I think over the past couple of weeks, we've seen headlines out of Germany that they're sort of passing some reforms on drug pricing or health insurance. I know your negotiations are ongoing and this new law is still very early, but is there any thoughts on your side on how, if at all, that could impact either the negotiations or the ultimate outcome there? And then in the U.S., maybe somewhat similar, but wondering how the sort of negotiations on pricing and coverage and access is going through the PBMs, the at-home administration, given that's sort of earlier in the launch of that than the original ACP-administered product? Krish Krishnan: I'll answer the U.S. quickly and turn it to Laurent to talk about Germany. Look, in the U.S., since the beginning of the launch, we've had really good access. We really haven't had any substantive issue with regard to access to date to really talk about. We do have some wrinkle on the early part of January every year as people transition insurances. But in terms of pricing, in terms of rebates, we've had a very productive relationship with payers and payers in general. And Laurent, on the German side, do you have any comments on the question? Laurent Goux: I mean, each market has its own pricing and reimbursement framework and specificities. So the outcome will naturally vary from one country to another, but our focus is definitely on achieving sustainable reimbursement that reflects VYJUVEK's clinical value, the high unmet medical need in the countries while being able to provide access to an expanding group of patients, yet keeping it consistent with international reference pricing framework. So yes, the news, things are evolving in Germany, but we are very aware of it and negotiations are very constructive. Operator: Your next question for today is from Debjit Chattopadhyay with Guggenheim Securities. Debjit Chattopadhyay: I have a couple. So the first one on NK. Our channel checks seems to suggest patients who have undergone prior corneal surgeries or any vision correction procedures might be at risk for NK. If that's correct, how are you thinking about the commercial opportunity? And the second question, the ocular DEB program will read out prior to NK. How are you thinking about the read-through from DEB to NK? Krish Krishnan: Yes, Debjit, thanks for the question on the NK market opportunity and you're flagging the prospect of maybe a higher incidence rate of NK associated with surgery. It's certainly something we're looking at. I mean we look collectively across the claims data, some of which we disclosed and OXERVATE's performance. I mean, it's clear the number of patients being diagnosed and treated annually with NK has increased dramatically. I mean, some of this is likely awareness, but it does also point to some potential incident forces that we are investigating. I mean, I think quite clearly, the trends both on the claims side and the sales data, the recent sales data for OXERVATE point to NK being a large and growing market in the United States. And then as Suma alluded to, underserved disease worldwide. So plenty of opportunity here for us on 801. Suma Krishnan: I think the advantage for 801 is our CMC. I mean, if you look -- I mean, we have optimized cost of goods, all of that. With regard to [indiscernible] completely different, right? I mean if you look at NK, it's very similar to open wounds and [indiscernible]. I mean you need to make sure they are chronic, you treat them, you have to then look for complete wound healing. So it's mechanistically you have -- because you have to have an open wound and then you treat the wounds in the eye and complete closure. Whereas for 803, it's very different. It's prophylactic. There is no ophthalmologist involved in the study. It's purely a patient-reported outcome. I mean, so we have patients in our natural history study. We look at number of events. And then we treat them -- I mean, prophylactically administer and it's a patient-reported outcome. So the patients evaluate and say, hey, on a scale of 5, they measure it. Do I feel I have pain? Do I have abrasion? So it's very patient-reported outcome, apples and oranges. Whereas for NK, it's a physician -- you have to take the pictures of the images, independent lab. They have to show that the wound is completely closed. And so again, very different. The 2 endpoints are different, evaluation is different. So read-through from one to the other either way may not -- it's not the right thing to do. Debjit Chattopadhyay: If I may follow up with one more. When we did our channel checks, the physicians are also reporting a huge influx of Dompe sales reps, which is obviously being reflected in the OXERVATE sales numbers. So assuming a successful outcome of the study, how are you thinking about sales force in 2027 prepping for a launch later on, so you can address the market opportunity there? Krish Krishnan: Yes. Debjit, I think it's a little early for us to be getting into Phase IV plans. Certainly, I mean, yes, we recognize that there is a significant unmet need and patient opportunity here. And I think certainly on success of EMERALD-1, if it is successful, we would be looking to assume a dominant position in the United States and worldwide, and we do everything we could to achieve that. Operator: Your next question is from Kalpit Patel with Wolfe Research. Kalpit Patel: For the ocular DEB program, can you remind us if that also includes global patients, like you're planning for the NK program? And then one for the NK program itself. Can you comment on what the screening to enrollment rates are and what the demand looks like for the trial itself? And then finally, for the Germany question or Europe question, on a gross prepricing accrual basis, can you give us any color if European VYJUVEK sales increased sequentially? And if so, by approximately how much? Krish Krishnan: Suma, you want to quickly talk about... Suma Krishnan: I mean for the eye study, it's not a global study because I think patient-reported outcomes are not very well accepted by Europe. So we have to first show this in the U.S., at least we were able to negotiate that with the agency. So it's just right now that it is just focused on the U.S. It's a U.S.-based study. And then based on the outcome, then we will open up discussions with -- because, again, because of the patient-reported outcome as the endpoint. Unlike NK, it's a well-defined physician imaging, it's well recognized and it's accepted by Europe and rest of the world. So that's the main difference between the 2 trials. And with regarding to enrollment, I mean, we are -- as I said, we are really picking up enrollment at the moment because we have got most of our sites up and running. We are almost in the process of getting Europe sites up and coming. So enrollment, we expect to continue -- the pace is going to continue to increase. Krish Krishnan: On the Germany question, the answer is yes. We try not to quantify these things because then it becomes a perpetual question that we are held responsible to. But I will say it will be -- it's in the double digits. Operator: Thank you. We have reached the end of the question-and-answer session and today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation. Ever feel like you missed the boat in buying the most successful stocks? Then you’ll want to hear this. On rare occasions, our expert team of analysts issues a “Double Down” stock recommendation for companies that they think are about to pop. If you’re worried you’ve already missed your chance to invest, now is the best time to buy before it’s too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you’d have $581,599!* Apple: if you invested $1,000 when we doubled down in 2008, you’d have $59,719!* Netflix: if you invested $1,000 when we doubled down in 2004, you’d have $399,832!* Right now, we’re issuing “Double Down” alerts for three incredible companies, available when you join Stock Advisor, and there may not be another chance like this anytime soon. See the 3 stocks » *Stock Advisor returns as of August 3, 2026 This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. 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 positions in and recommends Krystal Biotech. The Motley Fool has a disclosure policy. Krystal Biotech (KRYS) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Krystal Biotech KRYS reported second-quarter 2026 earnings per share (EPS) of $1.79, which surpassed the Zacks Consensus Estimate of $1.70. The company recorded an EPS of $1.29 in the year-ago quarter. Revenues of $119.2 million rose 24.14% year over year in the reported quarter, marginally beating the Zacks Consensus Estimate of $119 million. Revenues came in solely from Vyjuvek sales. The FDA approved Krystal’s lead drug, Vyjuvek, the first-ever revocable gene therapy, in 2023 for the treatment of patients aged six months or older with dystrophic epidermolysis bullosa (DEB), a rare and severe monogenic disease that affects the skin and mucosal tissues. The drug has been approved by the FDA for the treatment of DEB patients from birth, with authorization for at-home administration by patients or their caregivers. The company secured more than 730 reimbursement approvals for Vyjuvek in the United States, supporting nationwide access. Internationally, robust patient demand continues to drive steady uptake following the launches in Germany, France and Japan, with more than 180 patients prescribed the therapy across these markets. In May, Vyjuvek got approval in the United Kingdom for the treatment of DEB patients since birth. Despite earnings beat, shares of KRYS were down nearly 8.4% on Monday. Year to date, shares of KRYS have risen 26.8% compared with the industry’s 2.8% growth. Image Source: Zacks Investment Research The top line comprises product revenues from Krystal’s only marketed drug, Vyjuvek. Krystal generated $119.2 million in product revenues from Vyjuvek, up from $96 million in the year-ago quarter, driven by strong patient uptake. The gross margin in the reported quarter was 95%. Research and development (R&D) expenses were approximately $14.5 million, including stock-based compensation, roughly consistent with the prior-year quarter. Selling, general and administrative (SG&A) expenses totaled $39.9 million, including stock-based compensation, up 13.6% from the year-ago level. This increase was primarily due to increased headcount and marketing costs to support the global launches of Vyjuvek. As of June 30, 2026, cash, cash equivalents and investments totaled $1.1 billion compared with approximately $1 billion as of March 31, 2026. Krystal reiterated its non-GAAP combined R&D and SG&A expense guidance of $175 million to $195 million for full-year 2026. For Vyjuvek, the company is advancing pricing and reimbursement negotiations across Europe, targeting commercial launches in Italy and Spain by the end of 2026. Krystal is also advancing a robust clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics. On the respiratory front, the company has two candidates in its pipeline, KB407 and KB408. The company is evaluating KB407 for the treatment of cystic fibrosis (CF). Based on its discussions with the FDA, Krystal has initiated an open-label study to test repeat-dose KB407 in CF patients who cannot use or benefit from existing therapies. Patient enrollment is ongoing, and initial study data are anticipated by the end of the year. Concurrently, Krystal is collaborating with the FDA and the Cystic Fibrosis Foundation on an innovative registrational study design that may use real-world patient data to support evaluation of KB407’s treatment effect. It plans to finalize and share the study design following FDA alignment in the fourth quarter of 2026, with the registrational study expected to begin in 2027. KB408 is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease. Enrollment is ongoing in repeat-dose Cohort 2B of the SERPENTINE-1 study, with interim results expected in 2027. In the ophthalmology space, another candidate, KB803, is being evaluated in IOLITE, a phase III randomized, placebo-controlled crossover study for the treatment and prevention of corneal abrasions in DEB patients. Patient enrollment has been completed, with top-line data anticipated in the fourth quarter of 2026. Krystal is also evaluating KB801 for the treatment of patients with neurotrophic keratitis (NK). A registrational, randomized, double-masked, placebo-controlled study, EMERALD-1, is evaluating the safety and tolerability of topical ocular administration of KB801 in patients with NK. Patient enrollment is ongoing. On the oncology front, Krystal has a promising candidate, KB707, which is being developed for the treatment of non-small cell lung cancer (NSCLC). Krystal is evaluating inhaled KB707 as monotherapy and in combination with other therapies in patients with advanced NSCLC. In May, the company announced interim data from a dose-expansion cohort of its phase I/II KYANITE-1 study, which showed that KB707 combined with Keytruda (pembrolizumab) was well tolerated and demonstrated encouraging anti-tumor activity, while earlier monotherapy data also showed promising efficacy. The company is on track to complete patient enrollment in the final dose-expansion cohort of the KYANITE-1 study, evaluating KB707 in combination with chemotherapy by the end of 2026. Updated interim clinical data, along with potential registrational study plans, are expected in the first half of 2027. In the aesthetics space, the company’s wholly owned subsidiary, Jeune Aesthetics, is currently developing KB304 for the treatment of wrinkles of the décolleté. The company expects to initiate a mid-stage study in 2027. Krystal Biotech, Inc. price-consensus-eps-surprise-chart | Krystal Biotech, Inc. Quote Krystal 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 Neurocrine Biosciences NBIX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 90 days, earnings per share estimates for Harmony Biosciences have decreased from $3.34 to $3.30 for 2026. Over the same period, estimates for earnings per share increased from $3.79 to $3.87 for 2027. HRMY shares have lost 4.9% year to date. Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%. Over the past 90 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $5.31 from $2.91. LQDA shares have gained 143.1% 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 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.04 to $9.09. Over the same period, EPS estimates for 2027 have increased from $9.54 to $10.81. NBIX shares have gained 17.2% year to date. Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 13.57%. 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 Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report Neurocrine Biosciences, Inc. (NBIX) : 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

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Commercial momentum for VYJUVEK is driven by strong underlying demand in Europe and Japan, despite reported revenue being impacted by a reserve provision for German pricing negotiations. U.S. performance remains robust with net revenue of $91.6 million, supported by a field team successfully extending reach into community settings and surpassing a 60% penetration target of diagnosed patients. International growth is navigating market-specific operational dynamics, such as GMO classification requirements in France and intensive prescription renewal cycles in Japan. Management is pivoting U.S. patient engagement toward virtual education and peer-to-peer support to address evolving needs as patients transition to managing smaller, anatomically challenging wounds. The company's financial position, with over $1.1 billion in cash, is being leveraged to transition from a single-product success to a multiproduct genetic medicines company through disciplined R&D investment. Strategic positioning in the front-of-the-eye market utilizes the HSV-1 platform's unique ability to handle rapid cell turnover and protein clearance through repeat-dose eye drops. Management expects to complete enrollment for the registrational EMERALD-1 study in neurotrophic keratitis by year-end 2026, with a data readout anticipated in early 2027. Registrational study starts for cystic fibrosis (KB407) and Hailey-Hailey disease (KB111) are targeted for 2027, contingent on supportive interim data expected before the end of 2026. The oncology program is on track to initiate a registrational study for inhaled KB707 in second-line non-small cell lung cancer in 2027 following completion of combination cohorts. Pricing and reimbursement outcomes in Germany, Italy, and Spain are expected before the end of 2026, while French negotiations are projected to extend into 2027. Regulatory expansion continues with planned submissions for VYJUVEK in Switzerland and Australia in the coming months to broaden global patient access. A reserve provision related to ongoing pricing negotiations in Germany resulted in broadly flat international revenue despite growth in patient and treatment volumes. The U.S. market is seeing a shift in patient mix toward more moderate-to-mild DDEB cases as the launch matures and penetrates the initial severe patient pool. Operational challenges in France persist due to GMO classification, which currently concentrates treatment in hospital settings rather than home administration. Management flagged that the ocular DEB study (KB803) relies on patient-reported outcomes, which may face different regulatory hurdles in Europe compared to the U.S. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed that underlying demand remains strong with over 180 patients treated in Western Europe and Japan, and vial sales grew by double digits sequentially. The revenue dip was purely accounting-driven by the conservative accrual for German pricing, which is expected to resolve by Q4 2026 once negotiations conclude. The EMERALD-1 study was expanded to include European sites to support a global filing strategy, as there is high unmet need and no OXERVATE availability in certain regions. Management noted that while enrollment should finish by year-end, the data readout will likely occur in early 2027 due to database cleaning timelines. Krystal has enrolled 60-70 patients in a natural history study to define endpoints for this under-researched disease, as the FDA currently has no established guidance for it. The company intends to use its VYJUVEK experience in gel administration and bandaging to accelerate the registrational trial start in early 2027. Demand remains healthy with 35-50 new reimbursement approvals per quarter, even as the focus shifts toward the 1,200 identified patients in community settings. While the initial launch captured severe RDEB patients, the current growth is increasingly coming from DDEB patients who sit on the mild-to-moderate spectrum.

This article first appeared on GuruFocus. Net Revenue: $119.2 million from global sales of VYJUVEK, a 24% increase from $96 million in Q2 2025. US Net Revenue: $91.6 million for the quarter. Cost of Goods Sold: $6.4 million, down from $7.2 million in the prior year quarter. Gross Margin: 95%, improved from 93% in Q2 2025. R&D Expenses: $14.5 million, essentially flat compared to $14.4 million in the prior year. G&A Expenses: $39.9 million, up from $35.1 million in the prior year, driven by increased headcount and commercial costs. Stock-Based Compensation: $14.2 million in operating expenses, compared to $14.1 million in Q2 2025. Net Income: $54.8 million, or $1.85 per basic and $1.79 per diluted share, up from $38.3 million and $1.33/$1.29 per share in Q2 2025. Cash and Investments: Exceeded $1.1 billion. US Reimbursement Approvals: Surpassed 730 approvals for VYJUVEK, exceeding the initial penetration target of 60%. Full-Year 2026 Guidance: Non-GAAP R&D and SG&A expenses expected to be in the range of $175 million to $195 million. Warning! GuruFocus has detected 4 Warning Sign with SBH. Is KRYS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 03, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Krystal Biotech Inc (NASDAQ:KRYS) reported strong US commercial performance with $91.6 million in net revenue for Q2 2026, contributing to a 24% year-over-year increase in total global sales. The company surpassed its initial US patient penetration target of 60%, achieving more than 730 reimbursement approvals for VYJUVEK, indicating sustained demand and market expansion. Krystal Biotech Inc (NASDAQ:KRYS) maintains a robust financial position with over $1.1 billion in cash and investments, enabling continued investment in global expansion and pipeline development. The clinical pipeline is advancing with two registrational studies underway (KB803 for ocular lesions in DEB and KB801 for neurotrophic keratitis), with KB803 fully enrolled and on track for a readout later this year. The oncology program, inhaled KB707 for NSCLC, showed promising results with a 31% objective response rate in combination with pembrolizumab, and is on track for a registrational study in 2027. International expansion is progressing with marketing authorization granted in the UK and multiple regulatory submissions planned in Switzerland and Australia, alongside ongoing pricing and reimbursement discussions in key EU markets. European and Japanese revenue was broadly flat in Q2 2026 due to a reserve provision related to ongoing pricing negotiations in Germany, creating a near-term financial headwind. The pricing and reimbursement process in Germany is expected to continue into Q3 2026, with the company accruing revenue conservatively, which may continue to impact reported net revenue. In France, formal pricing and reimbursement discussions are not expected to progress until 2027, delaying potential revenue recognition and market access in that country. The NK registrational study (KB801) enrollment completion has been pushed to year-end 2026, with data readout expected in early 2027, slightly later than previously anticipated. The ocular DEB study (KB803) is US-only due to challenges with patient-reported outcomes acceptance in Europe, potentially limiting the initial global market opportunity for this indication. International launch dynamics, including fragmented care landscapes in Germany and intensive prescription renewal requirements in Japan, pose operational challenges that could affect treatment continuity and patient compliance. Q: Can you provide more color on the demand side and compliance in Germany and France, given the European sales were down slightly quarter-over-quarter due to pricing dynamics?A: Laurent Goux, EVP & Head of International, stated that market dynamics are strong with robust growth in both patient inclusion and volume. Over 180 patients have been treated in Western Europe and Japan so far. The revenue decline was primarily due to a full quarter of accrued pricing for Germany as negotiations began. Compliance in Germany and France is strong and similar to what was seen in the US during the early launch phase. Q: Regarding the KB407 cystic fibrosis program, what functional metrics is the five-patient repeat-dose study designed to show, and how does this link to the registrational study design?A: Suma Krishnan, President of R&D, explained that the study involves weekly repeat dosing with monthly patient visits to measure FEV1 and safety outcomes over six months. The trial is enrolling very sick patients with low FEV1 who are ineligible or refractory to modulator therapy. The data will inform discussions with the FDA on the registrational study design, which is expected to start in 2027. Q: Can you clarify the enrollment timeline for the KB801 neurotrophic keratitis (NK) registrational study and whether the data readout will occur in 2026 or 2027?A: Suma Krishnan confirmed that the study is expanding globally with sites being activated in EU countries to support a global filing. Enrollment is expected to complete by year-end, with a data readout potentially in early 2027 after database cleaning. The company is leveraging its existing CMC platform to move rapidly toward a BLA submission following the readout. Q: What is the commercial opportunity in the community setting for VYJUVEK in the US, and is the patient mix shifting toward dominant DEB?A: Christine Wilson, SVP & Head of US Commercial, noted that the company has surpassed its initial penetration target of 60% of the diagnosed patient population and continues to find new opportunities. The patient mix includes both RDEB and DDEB patients, with a growing proportion of DDEB patients on the mild-to-moderate spectrum. Krish Krishnan added that the initial target is approximately 1,200 identified patients, with plans to expand efforts to reach the broader undiagnosed population of around 3,000 patients. Q: How might recent German drug pricing reforms impact the ongoing pricing and reimbursement negotiations for VYJUVEK?A: Laurent Goux acknowledged that each market has its own pricing framework and outcomes will vary by country. The company's focus is on achieving sustainable reimbursement that reflects VYJUVEK's clinical value and the high unmet medical need, while remaining consistent with international reference pricing. Negotiations in Germany are described as constructive, and the company is aware of the evolving regulatory landscape. Q: Given the potential for a higher incidence of neurotrophic keratitis (NK) associated with corneal surgeries, how are you thinking about the commercial opportunity for KB801?A: Stephane Paquette, SVP of Corporate Development, noted that claims data and Oxervate's sales performance indicate the number of patients diagnosed and treated annually with NK has increased dramatically. This points to potential incident forces that the company is investigating, and the market is large and growing in the US and underserved worldwide, presenting a significant opportunity for KB801. Q: How should investors interpret the read-through from the ocular DEB program (KB803) to the NK program (KB801), given the different endpoints?A: Suma Krishnan clarified that the two programs are mechanistically different. NK is similar to open wound healing requiring physician-assessed complete closure, while ocular DEB is prophylactic and relies on patient-reported outcomes. The endpoints, evaluation methods, and mechanisms are distinct, so drawing direct read-throughs between the two is not appropriate. Q: Can you provide an update on the intratumoral KB707 program in Gorlin Syndrome and what data we should expect by year-end?A: Suma Krishnan stated that three patients with Gorlin Syndrome have been enrolled, and the company expects to provide a clinical update on these patients as well as the development plan later this year. The program leverages the company's natural history study and validated assessment scales to inform endpoints for a potential registrational study. Q: Did European vial sales increase sequentially in Q2, and can you quantify the growth despite the German pricing accrual?A: Krish Krishnan confirmed that European vial sales did increase sequentially, but declined to provide a specific quantification to avoid ongoing scrutiny. He noted the growth was in the double digits, reflecting strong underlying demand despite the accounting headwinds from the German pricing process. Q: How are you preparing for a potential KB801 launch in 2027, given the competitive landscape and the influx of sales representatives from competitors?A: Stephane Paquette stated it is too early to discuss Phase 4 launch plans. However, he emphasized that on success of the Emerald One study, the company would aim to assume a dominant position in the US NK market and do everything possible to achieve that goal. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Krystal Biotech, Inc. (KRYS) came out with quarterly earnings of $1.79 per share, beating the Zacks Consensus Estimate of $1.7 per share. This compares to earnings of $1.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.29%. A quarter ago, it was expected that this company would post earnings of $1.45 per share when it actually produced earnings of $1.83, delivering a surprise of +26.21%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Krystal Biotech, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $119.22 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 0.14%. This compares to year-ago revenues of $96.04 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Krystal Biotech shares have added about 38.4% since the beginning of the year versus the S&P 500's gain of 9.4%. While Krystal Biotech has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Krystal Biotech was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.89 on $126.5 million in revenues for the coming quarter and $7.31 on $500.9 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. RenovoRx, Inc. (RNXT), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 12. This company is expected to post quarterly loss of $0.08 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. RenovoRx, Inc.'s revenues are expected to be $0.73 million, up 72.6% from the year-ago quarter. 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 Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report RenovoRx, Inc. (RNXT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in Krystal Biotech, Inc.? Here are five stocks we like better. VYJUVEK sales and earnings increased: Second-quarter revenue rose 24% year over year to $119.2 million, including $91.6 million in U.S. sales, while net income reached $54.8 million. Krystal ended the quarter with more than $1.1 billion in cash and investments and maintained its 2026 expense outlook. U.S. access continues expanding, while international revenue was affected by Germany: The company has secured more than 730 U.S. reimbursement approvals and is expanding outreach to community settings and potentially undiagnosed patients. European and Japanese revenue was held broadly flat by a German pricing reserve, with negotiations expected to conclude in the third quarter. Multiple pipeline milestones are approaching: The IOLITE study of KB803 is expected to report later this year, while KB801’s EMERALD-1 study could produce data in early 2027. Repeat-dose studies in cystic fibrosis and Hailey-Hailey disease are also expected to yield interim results this year, supporting planned registrational trials in 2027. 3 Biotech Firms With Major Potential Catalysts in the Coming Months Krystal Biotech (NASDAQ:KRYS) reported second-quarter 2026 net revenue of $119.2 million from global sales of VYJUVEK, up 24% from $96 million in the prior-year period, as the company expanded treatment access for patients with dystrophic epidermolysis bullosa, or DEB, in the United States and overseas. Net income rose to $54.8 million, or $1.79 per diluted share, from $38.3 million, or $1.29 per diluted share, a year earlier. The company ended the quarter with more than $1.1 billion in cash and investments and maintained its full-year 2026 non-GAAP R&D and SG&A expense outlook of $175 million to $195 million. → Lost in Space: Why Aerospace Valuations Are Plummeting Right Now Pharma Fire Sale: 3 Stocks the RSI Says You Shouldn’t Ignore Christine Wilson, Krystal’s senior vice president and head of U.S. commercial, said U.S. net revenue totaled $91.6 million during the quarter. The company has achieved more than 730 U.S. reimbursement approvals for VYJUVEK and has surpassed its initial goal of reaching 60% of diagnosed DEB patients, she said. Krystal is expanding its outreach beyond specialized treatment centers and into community settings, where it expects to find additional patients. Chairman and CEO Krish Krishnan said the company continues to target roughly 1,200 identified U.S. patients and may eventually broaden its efforts toward an estimated 3,000 patients, many of whom may be undiagnosed. → MarketBeat Week in Review – 07/27- 07/31 Krystal Clear: Krystal Biotech Clears Resistance in Good Volume Management said demand remains healthy, with approximately 35 to 50 reimbursement approvals per quarter. Krishnan said newer patients initiating treatment tend to be more moderate to mild cases, although both recessive DEB and dominant DEB patients continue to enter treatment. Wilson also highlighted patient-support initiatives intended to help patients and caregivers incorporate VYJUVEK into ongoing wound-care routines, particularly as more patients use the therapy at home following the product’s label expansion. Those programs include virtual education events, peer-to-peer ambassador support through VYJUVEK Voices, and a new virtual discussion series called VYJUVEK Connections. → GE HealthCare Stock Climbs on Vital Diagnostics Demand Laurent Goux, executive vice president and general manager for Europe, said physician engagement and patient demand were strong in Europe and Japan. More than 180 patients have been treated across Western Europe and Japan, according to management. Reported revenue in Europe and Japan was broadly flat sequentially because of a reserve provision associated with Germany’s ongoing pricing process. Kate Romano, Krystal’s chief accounting officer, said the second quarter included a full quarter of accrued pricing in Germany, which reduced reported European net revenue even as related vial sales increased. During the question-and-answer session, Krishnan said German demand and vial growth were in the double digits on a pre-accrual basis, though the company did not provide a precise figure. He said Krystal expects to complete German pricing negotiations in the third quarter, subject to a successful outcome, and hopes the accrual effect will largely be resolved by the fourth quarter. Goux said the company expects pricing and reimbursement outcomes in Germany, Italy and Spain before the end of 2026, subject to country-specific processes. Formal pricing and reimbursement talks in France are expected to extend into 2027. In the United Kingdom, VYJUVEK received marketing authorization from the Medicines and Healthcare products Regulatory Agency in May, while a National Institute for Health and Care Excellence appraisal remains ongoing. Krystal also plans regulatory submissions in Switzerland and Australia in coming months. Goux said France, Germany and Japan have shown strong demand, although each market presents operational differences, including fragmented care in Germany, hospital-based administration requirements in France and prescription-renewal demands in Japan. President of Research and Development Suma Krishnan said the company is approaching two registrational study readouts involving front-of-the-eye diseases. The IOLITE study of KB803 for ocular lesions in DEB patients was fully enrolled in April, with a readout expected later this year. If successful, the company expects to move quickly toward a biologics license application, leveraging manufacturing work completed for VYJUVEK. The KB803 study is U.S.-based because it uses patient-reported outcomes as its primary endpoint. Meanwhile, the EMERALD-1 study of KB801 in neurotrophic keratitis, or NK, is expected to complete enrollment before year-end. With an eight-week primary endpoint, management said data could be available in early 2027 after database cleaning. Krystal is adding European sites to support a global filing strategy but said it is not increasing the study’s planned enrollment. Management described NK as a large and growing market based on claims trends and sales of an existing treatment, while noting that the disease remains underserved internationally. Krishnan cautioned investors against placing too much weight on previously disclosed results from one KB801 patient, saying the ongoing registrational study uses a different design. Krystal is also conducting repeat-dose studies of KB407 for cystic fibrosis and KB111 for Hailey-Hailey disease. The company expects to enroll approximately five cystic fibrosis patients and seven Hailey-Hailey patients, with interim results from both programs anticipated before year-end. For KB407, the study will evaluate repeat weekly dosing in patients who are ineligible for or refractory to modulator therapy, including monthly assessments of lung function such as FEV1 over six months. Krystal expects to align with the FDA on a registrational cystic fibrosis study design later this year and begin that trial in 2027. For KB111, Krystal has enrolled more than 60 to 70 patients in a natural-history study and is validating an assessment scale for Hailey-Hailey disease. The company expects to discuss repeat-dose safety data, the scale and a registrational design with the FDA before year-end, targeting a registrational study start in 2027. In oncology, Krystal said inhaled KB707 remains on track for a registrational study in second-line non-small cell lung cancer in 2027. The company expects to complete enrollment later this year in its final dose-expansion cohort evaluating KB707 with chemotherapy. It also enrolled three patients with Gorlin syndrome in an expansion of its intratumoral KB707 study and expects to provide an update later this year. Krishnan said the company aims to complete current registrational trials and begin at least two additional registrational studies in 2027, potentially supporting its transition into a multi-product genetic medicines company. Krystal Biotech, Inc is a clinical-stage biotechnology company focused on developing gene therapies for rare dermatological diseases. Headquartered in Pittsburgh, Pennsylvania, the company applies proprietary viral vector delivery technology to enable topical administration of corrective genes directly to the skin. By targeting the underlying genetic causes of inherited skin disorders, Krystal Biotech seeks to address areas of high unmet medical need with potentially transformative treatments. The company's lead product candidate, KB103, is designed to deliver a functional COL7A1 gene to patients with dystrophic epidermolysis bullosa (DEB), a severe and often debilitating blistering condition. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Krystal Biotech Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

The market expects Harmony Biosciences Holdings, Inc. (HRMY) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 4. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly earnings of $0.97 per share in its upcoming report, which represents a year-over-year change of +42.7%. Revenues are expected to be $252.54 million, up 26% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 0.76% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Harmony Biosciences, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +14.14%. On the other hand, the stock currently carries a Zacks Rank of #1. So, this combination indicates that Harmony Biosciences will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Harmony Biosciences would post earnings of $0.76 per share when it actually produced earnings of $0.55, delivering a surprise of -27.63%. The company has not been able to beat consensus EPS estimates in any of the last four quarters. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Harmony Biosciences appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Krystal Biotech, Inc. (KRYS), is soon expected to post earnings of $1.7 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +31.8%. This quarter's revenue is expected to be $119.05 million, up 24% from the year-ago quarter. The consensus EPS estimate for Krystal Biotech has been revised 6.4% lower over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +3.33%. This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that Krystal Biotech will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. 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 Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research