Key Takeaways Vyjuvek is now approved for DEB patients from birth, with self-administration at home allowed.Vyjuvek posted $184.2M in 1H25 sales, with growth expected from the U.S., EU, and Japan labels.KRYS prioritizes oncology candidate KB707, with an FDA end-of-phase II meeting set for October.Krystal Biotech, Inc.’s (KRYS) lead drug Vyjuvek is a non-invasive, topical, redosable gene therapy approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa (DEB).Kryst ...

Key Takeaways Krystal Biotech gained FDA approval to expand Vyjuvek's label to DEB patients from birth.The update allows at-home administration and flexibility in managing wound dressings.Approvals in Europe and Japan, plus U.S. growth, are expected to boost Vyjuvek sales.Krystal Biotech (KRYS) announced that the FDA has approved a label update of its marketed product, Vyjuvek (beremagene geperpavec-svdt), to include dystrophic epidermolysis bullosa ("DEB") patients from birth.Shares of Krystal Biotech were ...

Core Viewpoint - The stock market is expected to see a shift from large-cap dominance to a focus on high-growth midcap stocks in the latter part of 2025, with potential changes in interest rates and inflation impacting investor sentiment [2][27]. Group 1: Stock Recommendations - Five stocks are highlighted for September 2025, characterized by optimistic outlooks, positive cash flow, and manageable debt levels [3]. - The stocks are ranked by market capitalization, with detailed metrics provided for each [3]. Group 2: Monday.com Ltd. (MNDY) - Expected EPS growth for Monday.com is over 25%, with a price target upside above 35% [4]. - The stock price is currently $193, with an expected EPS of $0.62 for 2024 and a projected growth of 550.4% this year [5]. - The company has a positive free cash flow and a debt/free cash flow ratio under 2, indicating strong financial health [4]. Group 3: Wix.com Ltd. (WIX) - Wix.com has a strong buy rating from eight analysts, with an average price target of $214.84 and a consensus EPS target of $6.92 for 2025, up from $2.36 in 2024 [11]. - The company has seen free cash flow grow from $32 million in 2022 to $488 million in 2024, driven by increased demand for its services [11]. Group 4: Dolby Laboratories (DLB) - Dolby has a strong buy rating from two analysts, with an average price target of $102.25 and a consensus EPS target of $4 for fiscal 2025, up from $2.69 in fiscal 2024 [14]. - The company reported $68 million in operating cash flow in the last quarter and has $777 million in cash and investments on its balance sheet [15]. Group 5: Krystal Biotech (KRYS) - Krystal Biotech is rated a strong buy by seven analysts, with an average price target of $204.90 and a consensus EPS target of $5.06 for 2025, up from around $3 in 2024 [20]. - The company estimates a global market opportunity for its product Vyjuvek exceeding $1 billion, with plans for expansion into various markets [21]. Group 6: Harmony Biosciences Holdings (HRMY) - Harmony Biosciences has a strong buy rating from five analysts, with an average price target of $55.33 and a consensus EPS expectation of $3.21 for 2025, up from $2.51 in 2024 [24]. - The company's flagship product, Wakix, generated $714.7 million in sales for 2024, reflecting a 20% annual gain [25].

Core Viewpoint - Krystal Biotech, Inc. has shown a positive performance with an 8.5% increase in shares since the last earnings report, outperforming the S&P 500, but faces concerns regarding future revenue guidance [1][2]. Financial Performance - The company reported Q2 2025 earnings per share (EPS) of $1.29, exceeding the Zacks Consensus Estimate of $1.08, and up from $0.93 in the same quarter last year [3]. - Revenues reached $96 million, a 36.6% year-over-year increase, surpassing the Zacks Consensus Estimate of $91 million, with all revenues derived from Vyjuvek sales [3]. - Despite strong quarterly results, shares fell by 14% due to soft guidance for third-quarter revenues [4]. Product Developments - Vyjuvek, the first-ever revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in 2023 and has secured over 575 reimbursement approvals in the U.S. as of July [5]. - The European Commission approved Vyjuvek for treating DEB-related wounds, with launches planned in Germany and France in Q3 and Q4 respectively [7]. - Vyjuvek was also approved in Japan for DEB treatment, with a target launch before the end of 2025 [7]. Research and Development - Research and development expenses were $14.4 million, down 7.5% year-over-year, while selling, general, and administrative expenses rose to $35.2 million, a 27.2% increase from the previous year [6]. - The company is evaluating KB407 for cystic fibrosis, with four patients enrolled in a study, and expects interim data before year-end [8]. - KB408 is being assessed for alpha-1 antitrypsin deficiency, with positive results reported in a patient from a dose escalation study [9]. Pipeline Progress - Krystal Biotech is advancing multiple candidates, including KB801 for neurotrophic keratitis and KB707 for solid tumors, with ongoing enrollment in various studies [11][12]. - Jeune Aesthetics, a subsidiary, reported positive results for KB304 in treating décolleté wrinkles, leading to its progression into phase II studies [13][14]. Market Outlook - Since the earnings release, there has been a downward trend in estimates, with a consensus estimate shift of -16.13% [15]. - The stock has an average Growth Score of C, a Momentum Score of F, and a Value Score of D, resulting in an aggregate VGM Score of F [16]. - Krystal Biotech holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [17][18].

Core Insights - Krystal Biotech reported Q2 2025 EPS of $1.29, exceeding the Zacks Consensus Estimate of $1.08, and up from $0.93 in the same quarter last year [1][8] - Revenues reached $96 million, a 36.6% increase year over year, surpassing the Zacks Consensus Estimate of $91 million, driven solely by Vyjuvek sales [1][8] - Despite strong quarterly results, shares fell 14% due to soft guidance for Q3 revenues [2][17] Financial Performance - Gross margin for the reported quarter was 93% [5] - Research and development expenses were $14.4 million, down 7.5% year over year [5] - Selling, general and administrative expenses increased by 27.2% to $35.2 million, attributed to higher professional services fees [5] - As of June 30, 2025, cash, cash equivalents, and investments totaled $820.8 million, up from $765.3 million as of March 31, 2025 [6] Product Developments - Vyjuvek, the first revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in 2023 and has over 575 reimbursement approvals in the U.S. as of July [4][9] - The European Commission approved Vyjuvek for DEB treatment, with launches planned in Germany and France in Q3 and Q4 respectively [9] - Vyjuvek was also approved in Japan for DEB treatment, with a target launch before the end of 2025 [9] Pipeline Progress - Krystal Biotech is advancing multiple gene therapy candidates, including KB407 for cystic fibrosis and KB408 for alpha-1 antitrypsin deficiency, with ongoing clinical trials [10][11] - Enrollment is ongoing for various studies, including EMERALD-1 for KB801 and KYANITE-1 for inhaled KB707 [13][14] - Jeune Aesthetics, a subsidiary, is developing KB304 for aesthetic treatments, with positive results from the PEARL-2 study leading to progression into phase II [15][16] Market Outlook - Despite a strong Q2 performance, revenues are expected to decline in Q3 due to seasonal trends, but growth is anticipated to resume in Q4 [17]

Company Overview - Krystal Biotech (KRYS) announced the dosing of the first patient in a phase I/II study for its eye drop KB801, aimed at treating neurotrophic keratitis (NK), a rare corneal disease [1][7] - KB801 is a redosable gene therapy designed to enhance nerve growth factor (NGF) production in the eye, promoting corneal healing and preventing complications associated with NK [2][8] Market Context - NK affects an estimated 10 to 50 individuals per 100,000, with increasing awareness and diagnosis in the U.S.; claims for NK reached approximately 68,000 in 2024, up from 31,000 in 2020 [3] - Year-to-date, KRYS shares have declined by 5%, while the industry has seen a 2% decline [6] Clinical Development - The EMERALD-1 study is a double-masked, placebo-controlled trial evaluating the safety and tolerability of KB801 in up to 27 adults with NK [7][8] - This study represents a significant step towards providing a simple eye drop treatment option for patients with NK [8] Other Developments - In addition to KB801, Krystal Biotech is also advancing its phase III IOLITE study for KB803, another investigational eye drop treatment for corneal abrasions in dystrophic epidermolysis bullosa (DEB) [9] - The company's only marketed product, Vyjuvek, is FDA-approved for treating DEB in patients aged six months and older [10]

Core Viewpoint - The healthcare sector is highlighted as a critical area in the stock market, driven by the need for innovative therapies and medical technologies to address an aging population and rising chronic diseases. There are ten under-the-radar healthcare stocks identified as potential investment opportunities. Group 1: Company Highlights - **Certara**: Positioned to benefit from AI-driven transformations in medicine, providing bio-simulation software that accelerates drug development, with over 90% of novel drugs approved by the FDA since 2014 utilizing its technology [3][4]. - **Beam Therapeutics**: A clinical-stage biotech focusing on precision gene editing therapies for genetic diseases, with its lead candidate in phase 1/2 trials for sickle cell disease, showing promise for long-term growth [5][6]. - **Inspire Medical Systems**: Develops implantable devices for obstructive sleep apnea, reporting a 23% year-over-year revenue increase to $201 million, indicating strong market demand [8]. - **Insulet**: Specializes in tubeless insulin pump technology, targeting a revenue growth of 19% to 22% by 2025, with significant expansion opportunities in international markets [9]. - **Krystal Biotech**: Focuses on rare skin diseases, with its gene therapy expected to generate approximately $400 million in revenue this year, reinforcing its market position [10]. - **LifeMD**: Operates a telehealth platform with a 49% year-over-year revenue increase, driven by a partnership with Novo Nordisk, indicating potential for further growth [11]. - **Option Care Health**: Leading provider of home infusion services, positioned to benefit from the shift towards personalized healthcare [12]. - **Tempus AI**: Utilizes AI for precision medicine, projecting over 80% revenue growth this year to about $1.3 billion, highlighting its expansive data ecosystem [13]. - **TransMedics Group**: Innovates in organ transplantation with its FDA-approved Organ Care System, projecting a 30% revenue growth this year [14][15]. - **Veeva Systems**: Offers cloud-based software for life sciences, serving over 1,000 customers and positioned to capitalize on the industry's digital transformation [16].

Industry Overview - The field of genomics has rapidly evolved over the past decade, focusing on the complete set of genes and their interactions rather than individual genes [1] - Genomics is pivotal for developing targeted therapies, leading to a revolutionary era in genetic medicine, attracting significant attention from pharmaceutical and biotech companies [2] Technological Innovations - Synthetic biology, which applies engineering principles to biology, has emerged as a key concept within genomics, aiding in drug discovery, disease detection, and gene editing [3] - The cost, accuracy, and time required to map an individual's genome have drastically reduced, enhancing the spotlight on genomics companies [4] Market Potential - The genomics market is projected to reach $157.47 billion by 2033, while the global synthetic biology market was valued at $16.22 billion in 2024, with a projected CAGR of 17.30% from 2025 to 2030 [6] Company Highlights - MeiraGTx Holdings plc is focused on genetic medicine with a pipeline addressing conditions like Parkinson's disease and retinal dystrophy, showing promising efficacy data [8][9] - Beam Therapeutics is advancing base editing programs for genetic diseases, with FDA orphan drug designation for its BEAM-101 treatment for sickle cell disease [12][13] - Krystal Biotech received FDA approval for Vyjuvek, the first gene therapy for dystrophic epidermolysis bullosa, and is advancing a pipeline in various therapeutic areas [14][15]

Company Overview - Krystal Biotech's shares increased by 4.2% following the announcement of dosing the first patient in a late-stage study for KB803, aimed at treating and preventing corneal abrasions in dystrophic epidermolysis bullosa (DEB) [1][5] - The company's only marketed product, Vyjuvek, is FDA-approved for DEB patients aged six months or older, known as B-VEC outside the U.S. [2] Disease Context - DEB is a rare, severe monogenic disease affecting skin and mucosal tissues, with over 25% of patients experiencing eye complications. There are no corrective treatments available, leading to reliance on wound management and occasional surgery. Approximately 750 individuals in the U.S. and 2,000 globally are affected [3][6]. Study Details - The phase III IOLITE study will enroll 16 DEB patients, administering either placebo or KB803 eye drops for 12 weeks, followed by a switch for another 12 weeks. The study is decentralized, allowing home dosing by healthcare professionals [7][8]. - The primary endpoint is to measure the change in average monthly days with corneal abrasion symptoms in patients receiving KB803 compared to placebo, with safety and secondary efficacy data collected throughout the 24-week study [8]. Previous Efficacy Evidence - KB803 (B-VEC) previously demonstrated efficacy in a compassionate use case, leading to full corneal healing and significant visual acuity improvement in a DEB patient after eye surgery [9].

Company Overview - Krystal Biotech, Inc. (KRYS) shares increased by 4.2% to close at $143.67, with trading volume significantly higher than usual, reflecting a 10.3% gain over the past four weeks [1][2] Product Development - The stock price surge followed the initiation of patient dosing in the phase III IOLITE study for KB803 eye drops, targeting DEB-related corneal damage, which is a next-generation version of the approved gene therapy Vyjuvek [2] - KB803 addresses a rare patient population lacking corrective treatments, and the decentralized, at-home study design, along with prior compassionate use data showing strong efficacy, has bolstered investor confidence [2] Financial Performance Expectations - The company is projected to report quarterly earnings of $1.31 per share, reflecting a year-over-year increase of 52.3%, with revenues expected to reach $102.5 million, up 45.9% from the previous year [3] - The consensus EPS estimate for the quarter has remained stable over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Krystal Biotech is categorized under the Zacks Medical - Biomedical and Genetics industry, where Coherus Oncology (CHRS) also operates, having closed 5.6% higher at $0.77, but with a -3.9% return over the past month [5] - Coherus Oncology's consensus EPS estimate for the upcoming report is -$0.25, representing a significant year-over-year decline of 78.6% [6]