Core Insights - Zacks Premium offers tools for investors to enhance their stock market strategies and confidence [1] - The Zacks Style Scores are designed to help investors select stocks with the highest potential to outperform the market in the short term [2] Zacks Style Scores Overview - The Style Scores categorize stocks into four types: Value Score, Growth Score, Momentum Score, and VGM Score, each focusing on different investment strategies [3][4][5][6] - Value Score identifies undervalued stocks using financial ratios [3] - Growth Score assesses a company's future growth potential based on earnings and sales [4] - Momentum Score tracks price trends to capitalize on upward or downward movements [5] - VGM Score combines all three styles to provide a comprehensive evaluation of stocks [6] Zacks Rank and Performance - The Zacks Rank is a proprietary model that uses earnings estimate revisions to identify strong investment opportunities [7] - Stocks rated 1 (Strong Buy) have historically achieved an average annual return of +25.41%, significantly outperforming the S&P 500 [8] - Investors are encouraged to focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal returns [9] Stock Highlight: Krystal Biotech, Inc. (KRYS) - Krystal Biotech is a biotechnology company focused on genetic medicines for unmet medical needs [11] - KRYS holds a Zacks Rank of 2 (Buy) and a VGM Score of B, with a Momentum Style Score of A [11] - The stock has increased by 21.4% in the past four weeks, indicating strong momentum [11] - Recent upward revisions in earnings estimates for fiscal 2025 have raised the consensus estimate to $6.64 per share, reflecting a positive outlook [12]

Core Viewpoint - Krystal Biotech, Inc. (KRYS) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily based on a company's changing earnings picture, with the Zacks Consensus Estimate tracking EPS estimates from sell-side analysts [2]. - The recent upgrade reflects an upward trend in earnings estimates, which is correlated with near-term stock price movements [3][5]. Impact of Institutional Investors - Changes in earnings estimates significantly influence institutional investors' valuation models, leading to buying or selling actions that affect stock prices [5]. - The rising earnings estimates for Krystal Biotech suggest an improvement in the company's underlying business, likely resulting in increased stock prices as investors respond positively [6]. Earnings Estimate Revisions - Empirical research supports a strong correlation between earnings estimate revisions and near-term stock movements, making tracking these revisions beneficial for investment decisions [7]. - The Zacks Rank system effectively utilizes earnings estimate revisions to classify stocks, with a proven track record of performance [8]. Specific Earnings Projections - Krystal Biotech is projected to earn $5.62 per share for the fiscal year ending December 2025, reflecting a year-over-year increase of 87.3% [9]. - Over the past three months, the Zacks Consensus Estimate for Krystal Biotech has increased by 3.1%, indicating growing analyst confidence [9]. Zacks Rating System Overview - The Zacks rating system maintains a balanced distribution of 'buy' and 'sell' ratings across its universe of over 4000 stocks, with only the top 20% receiving favorable ratings [10][11]. - The upgrade to Zacks Rank 2 positions Krystal Biotech among the top 20% of stocks in terms of earnings estimate revisions, suggesting potential for market-beating returns in the near term [11].

Group 1 - Brendan completed a Ph.D. at Stanford University in organic synthesis in 2009 [1] - He worked for Merck from 2009 to 2013 and has experience in biotech startups such as Theravance and Aspira [1] - Brendan is a co-founder of 1200 Pharma, which spun out of Caltech and received significant investment in the 8 figures [1] Group 2 - Brendan remains an avid investor focused on market trends, particularly in biotechnology stocks [1]

Core Viewpoint - Krystal Biotech reported strong earnings per share for Q4 2024, driven by the growing traction of its gene therapy product, Vyjuvek, despite missing revenue expectations [1][2]. Financial Performance - Q4 2024 earnings per share were $1.52, exceeding the Zacks Consensus Estimate of $1.29, compared to $0.30 in the same quarter last year [1] - Total revenues for Q4 2024 were $91.1 million, falling short of the Zacks Consensus Estimate of $97 million, with revenues solely from Vyjuvek sales, up from $42.1 million in the year-ago quarter [2] - For the full year 2024, total revenues reached $290.5 million, slightly below the Zacks Consensus Estimate of $292.1 million, compared to $50.7 million in 2023 [8] - Full-year earnings per share were $3, surpassing the Zacks Consensus Estimate of $2.9, compared to $0.39 in the previous year [8] Product Development and Market Access - Vyjuvek, approved by the FDA in 2023, is the first revocable gene therapy for treating dystrophic epidermolysis bullosa (DEB) [3] - As of February 2025, Krystal Biotech secured over 510 reimbursement approvals for Vyjuvek in the U.S., achieving positive access determinations for 97% of lives covered under commercial and Medicaid plans [4] - The gross margin for the reported quarter was 95%, with patient adherence to weekly treatment at 85% as of the end of 2024 [4] Research and Development - Research and development expenses for Q4 2024 were $13.5 million, a 19% increase year over year, while selling, general, and administrative expenses totaled $31.3 million, up 26% from the previous year [7] - The company is advancing a robust pipeline of investigational genetic medicines across various fields, including respiratory, oncology, dermatology, and aesthetics [10][11][12][13][14][15][16] Market Reaction - Despite mixed earnings results, Krystal Biotech's shares rose by 12.4% following the announcement, attributed to record revenue growth from Vyjuvek sales [5] - Over the past three months, shares of Krystal Biotech have decreased by 3.4%, while the industry has seen a growth of 0.8% [5]

Financial Data and Key Metrics Changes - For the year 2024, net income per share was $3.12, up from $0.40 per share in 2023, marking the sixth consecutive quarter of positive EPS and fourth straight quarter of sequential earnings growth [10] - Net revenue for VYJUVEK in Q4 was $91.1 million, bringing total revenue for 2024 to $290.5 million, with gross margins consistent with prior quarters [12][46] - The company ended Q4 with $344.9 million in cash on hand and $749.6 million in total cash plus short-term and long-term investments, reflecting a quarterly growth of about $55 million [49] Business Line Data and Key Metrics Changes - VYJUVEK's U.S. launch is progressing well, tracking in the top tier of rare disease launches, with strong early signs of efficacy [7] - Jeune Aesthetics reported strong Phase 1 data for KB301, with plans to start a Phase 2 study later in 2025, achieving $341 million in net revenue within 18 months of launch [11] Market Data and Key Metrics Changes - The U.S. market for VYJUVEK has seen over 500 reimbursement approvals, with a strong access landscape continuing into 2025 [14] - The company expects to launch VYJUVEK in the EU and Japan, with over 1,000 identified deaf patients in Germany and France [30][72] Company Strategy and Development Direction - The company aims to successfully launch VYJUVEK in the EU and Japan, translate early efficacy signs into strong results across cystic fibrosis and alpha-1 antitrypsin programs, and prepare for the anticipated launch of B-VEC for treating lesions in the eye of DEB patients [8][9] - The company is committed to treating DEB globally and is progressing its second product, KB803, for ocular complications associated with DEB [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a global peak sales estimate of over $1 billion for VYJUVEK, emphasizing the strong patient benefits and compliance rates observed [51][56] - The company is aware of potential competition in the DEB market but believes the value proposition of VYJUVEK will maintain its market share [90][91] Other Important Information - Research and development expenses for Q4 were $13.5 million, driven by increased clinical trial-related costs and manufacturing costs for pipeline candidates [47] - Selling, general, and administrative expenses for Q4 were $31.3 million, reflecting increased personnel-related costs and VYJUVEK sales and marketing costs [47] Q&A Session Summary Question: Was there any year-end stocking in Q4 for VYJUVEK? - Management confirmed there was no substantial difference in Q4 compared to previous quarters regarding stocking or inventory [61][62] Question: How is enrollment going for the CF study? - Enrollment in Cohort 3 has begun, and it is progressing well with several active sites [64][66] Question: What are the expectations for Europe in the second half of the year? - Approximately 600 patients are identified in Germany and 400 in France, with pricing strategies discussed for both markets [72][73] Question: Can you quantify the impact of the annual cap on VYJUVEK in 2024? - About 8% of commercial patients have been on the cap consistently since the beginning [102] Question: What is the update on the regulatory process? - The delay in the CHMP decision was due to the need for a favorable label, which has now been achieved [88]

Product Launch and Revenue - VYJUVEK, the first FDA approved treatment for dystrophic epidermolysis bullosa (DEB), was launched in the U.S. in August 2023, with reported net product revenue of $341.2 million since launch[30]. - The company estimates over 3,000 DEB patients in the U.S., with 1,200 identified at launch through analytics and pre-launch activities[30]. - As of February 2025, the company secured positive coverage decisions from plans covering over 97% of commercial and Medicaid lives for VYJUVEK[31]. - The FDA approved VYJUVEK on May 19, 2023, and issued a Rare Pediatric Disease Priority Review Voucher (PRV), which was sold for $100 million in Q3 2023[34]. Clinical Trials and Studies - The company initiated Phase 1 testing of B-VEC in May 2018, with positive interim results announced in October 2018 and further positive results from the complete Phase 1/2 study published in Nature Medicine in March 2022[39]. - The GEM-3 trial for topical B-VEC enrolled 31 participants and showed positive results, with full results published in December 2022[40]. - The OLE study enrolled 47 participants, with no new safety concerns noted, and concluded in Q3 2023[41]. - The Japan OLE study was initiated and completed enrollment, with all four patients achieving complete wound closure at six months[42]. - KB407, a gene therapy for cystic fibrosis, has been dosed in the Phase 1 CORAL-1 study, with interim safety data showing mild to moderate adverse events[54]. - KB408 for AATD received FDA ODD designation, with successful gene delivery and AAT expression observed in the SERPENTINE-1 study[59][60]. - KB707 is an immunotherapy targeting solid tumors, utilizing a vector platform for sustained cytokine expression in the tumor microenvironment[64]. - In the KYANITE-1 study, inhaled KB707 demonstrated an objective response rate (ORR) of 27% and a disease control rate (DCR) of 73% in patients with advanced non-small cell lung cancer (NSCLC)[69]. - The initial clinical update for inhaled KB707 included safety data for 37 patients, with no Grade 4 or 5 adverse events observed[69]. - The OPAL-1 study for intratumoral KB707 began dosing patients in October 2023, with ongoing evaluations for safety and efficacy[71]. - Initial Phase 2 data for KB105 showed improvement on the Investigator's Global Assessment (IGA) scale, with maximum effects observed in high-dose treatment areas[76]. - The PEARL-1 trial for KB301, targeting aesthetic skin conditions, demonstrated positive proof-of-concept efficacy and safety data in March 2022[86]. - Enrollment in the KYANITE-1 and OPAL-1 studies is ongoing, with additional dose expansion cohorts being evaluated[70][71]. - KB301 showed positive interim safety and efficacy results in two new cohorts, with 94% of subjects in the décolleté region reporting increased satisfaction with wrinkle appearance[88]. - The company expects to complete the development of a décolleté-specific evaluation scale and dose the first subject in a Phase 2 study in the second half of 2025[88]. - KB304 is currently in a Phase 1 study with 21 subjects expected to be enrolled, randomized 2:1 to KB304 or placebo, with top-line results anticipated in the second half of 2025[92]. Manufacturing and Facilities - The company has established in-house CGMP manufacturing facilities to support the production of its gene therapy products[26]. - The company built in-house CGMP facilities, with the first facility, ANCORIS, producing VYJUVEK for commercial sales and receiving FDA and EMA certifications[95][96]. - The second commercial scale CGMP facility, ASTRA, was completed and qualified in 2023, adding significant capacity to support the growing pipeline[96]. - The proprietary manufacturing process for VYJUVEK ensures reproducible production of multiple commercial and clinical batches in a six-week cycle time frame[102]. Intellectual Property and Patent Strategy - The company actively seeks patent protection for its product candidates and proprietary technologies, evaluating its patent portfolio continuously[113][114]. - The technology platform VYJUVEK is primarily protected by composition of matter and methods of use patents, with key patents expiring on December 28, 2036[117]. - The company holds multiple patents for its product candidates, including U.S. patent 9,877,990 for compositions comprising HSV vectors, which is set to expire on December 28, 2036[119]. - Patent term extensions may be available under the Hatch-Waxman Act, allowing for up to 5 years of additional protection beyond the standard 20-year term[116]. - The company has a diverse patent portfolio across multiple regions, including patents in Japan, Australia, and Europe, all expiring in 2036[118]. - The company holds multiple patents related to pharmaceutical compositions for improving skin condition, with expiration dates set for April 26, 2039[127]. Regulatory and Compliance - The FDA regulates the company's biologic products, including gene therapy, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act[130]. - The process for obtaining FDA marketing authorization involves extensive preclinical testing, IND application submission, and clinical trials[134]. - Clinical trials are conducted in three phases, with Phase 3 trials being pivotal for FDA approval, involving a larger patient population[139]. - The FDA requires annual progress reports detailing clinical trial results to ensure ongoing compliance and safety monitoring[140]. - The company must adhere to additional standards for gene therapy trials, including long-term monitoring of subjects for delayed adverse effects[141]. - User fees are associated with BLA submissions under the Prescription Drug User Fee Act, which are adjusted annually[142]. - The FDA imposes rigorous post-approval requirements, including compliance with CGMP regulations and reporting of adverse effects[159]. - Non-compliance with regulatory requirements can lead to marketing restrictions or product withdrawal, along with potential civil or criminal sanctions[160]. - The FDA's Rare Pediatric Disease Priority Review Voucher program allows sponsors to apply for priority review of subsequent marketing applications for different products[158]. Market and Competitive Landscape - The commercial success of VYJUVEK is critical for the company's near-term prospects and future growth[179]. - The company faces significant competition from other firms developing alternative therapies, which may have greater resources and faster regulatory approval timelines[187]. - The Biologics Price Competition and Innovation Act (BPCIA) allows for an abbreviated approval pathway for biosimilars, potentially impacting the exclusivity of VYJUVEK[184]. - The company has established several wholly-owned subsidiaries in Europe and Japan to support the commercialization of VYJUVEK and its product pipeline[176]. Financial and Operational Risks - The healthcare reform initiatives in the U.S. may affect drug pricing and reimbursement, impacting the company's revenue potential[170]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the cost-effectiveness of its products to secure third-party reimbursement[168]. - The company faces potential litigation regarding patent rights, which could limit demand and pricing for VYJUVEK and future product candidates[189]. - Product liability lawsuits could lead to substantial liabilities, impacting the commercialization of VYJUVEK and other product candidates[190]. - Negative publicity regarding product safety could adversely affect financial condition and operational results[191]. - The company may need to increase product liability insurance coverage, which is becoming increasingly expensive[192]. - Public perception and regulatory scrutiny of gene therapy could hinder commercialization and regulatory approval of VYJUVEK[193]. - The company has experienced significant growth in personnel and infrastructure, which may pose management challenges[198]. - Retaining key employees and scientific advisors is critical for achieving research and commercialization objectives[199]. - Legislative changes, such as the IRA, could impact the company's ability to profitably sell VYJUVEK and other product candidates[207]. - The company is evaluating the uncertain effects of the IRA on its business operations and financial condition[208]. - Heightened governmental scrutiny over drug pricing could lead to regulatory changes affecting the company's market strategies[209]. Compliance with Healthcare Laws - The company is subject to various federal and state healthcare fraud and abuse laws, which could result in substantial penalties if not complied with[211]. - The federal Anti-Kickback Statute prohibits remuneration for the purchase or recommendation of items reimbursable under federal healthcare programs, impacting sales and marketing practices[212]. - Non-compliance with healthcare laws may lead to civil and criminal penalties, damages, fines, and exclusion from government healthcare programs[213]. - The company faces significant costs to ensure compliance with healthcare laws, which may affect financial operations and reputation[215]. Environmental and Safety Regulations - Environmental, health, and safety laws impose liabilities that could materially affect the company's business and financial condition[217]. - The company does not carry specific biological or hazardous waste insurance, increasing potential liability from contamination or injury[218]. - Future healthcare reforms may impose more rigorous coverage criteria and downward pressure on product pricing, impacting revenue generation[210]. - The company may incur substantial costs to comply with increasingly stringent environmental regulations, which could impair research and development efforts[218]. - Legal challenges related to compliance could divert management's attention and incur significant legal expenses[216]. - The company’s operations involve hazardous materials, and any resulting contamination could lead to liabilities exceeding available resources[217].

Financial Performance - Fourth quarter revenues increased 116% to $91.1 million compared to the fourth quarter of 2023 [1] - Full year revenues increased 473% to $290.5 million compared to 2023 [1] - Net income for the fourth quarter was $45.5 million, or $1.58 per common share (basic) [20] - Net income for the full year was $89.2 million, or $3.12 per common share (basic) [20] - Gross margin for the fourth quarter was 95% [7] Business Developments - The Company received full sanctioning of the KB407 Phase 1 protocol from the Cystic Fibrosis Foundation Therapeutic Development Network [1][8] - The Company has secured over 510 reimbursement approvals for VYJUVEK in the U.S. [7] - The Company is focused on executing the global launch of VYJUVEK and advancing multiple clinical stage programs in 2025 [2] Clinical Pipeline - VYJUVEK is indicated for the treatment of Dystrophic Epidermolysis Bullosa (DEB) [3][22] - The Company has enrolled approximately 50 DEB patients in a natural history study for KB803, with a Phase 3 study expected to commence in 1H 2025 [5] - KB407 is being evaluated in a Phase 1 study for cystic fibrosis, with interim data expected in mid-2025 [8][9] - KB408 for alpha-1 antitrypsin deficiency has shown promising initial data, with results from expanded cohorts expected in 2H 2025 [9] - Inhaled KB707 for lung tumors has shown an objective response rate of 27% in advanced non-small cell lung cancer patients [11] Financial Guidance - The Company projects non-GAAP combined R&D and SG&A expenses for FY 2025 to be between $150 million and $175 million [18]

Core Points - Krystal Biotech, Inc. will report its fourth quarter and full year 2024 financial results on February 19, 2025, before U.S. market opens [1] - A conference call and webcast will be hosted by the company's management at 8:30 am ET on the same day to discuss the financial results and provide a business update [1] Company Overview - Krystal Biotech, Inc. is a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines for diseases with high unmet medical needs [3] - The company's first commercial product, VYJUVEK®, is the first-ever redosable gene therapy and the first FDA-approved medicine for treating dystrophic epidermolysis bullosa [3] - The company is advancing a robust pipeline of investigational genetic medicines across various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [3]

Group 1 - The stock of Krystal Biotech, Inc. (KRYS) is experiencing significant attention due to high implied volatility in the options market, particularly for the Feb. 21, 2025 $100 Call option [1] - Implied volatility indicates the market's expectation of future price movement, suggesting that investors anticipate a significant change in the stock's price, potentially due to an upcoming event [2] - Krystal Biotech currently holds a Zacks Rank 4 (Hold) in the Medical - Biomedical and Genetics industry, which is in the top 31% of the Zacks Industry Rank, with no changes in earnings estimates from analysts over the last 60 days [3] Group 2 - The high implied volatility surrounding Krystal Biotech may indicate a developing trading opportunity, as options traders often seek to sell premium on such options to capture decay, hoping the stock does not move as much as expected by expiration [4]

PITTSBURGH, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) leveraging Krystal’s clinically validated gene-delivery platform to fundamentally address and reverse the biology of aging skin, announced today the appointment of Nishant Saxena as Chief Financial Officer (CFO), effective January 15, 2025. Mr. Saxena has over 20 years of experience in finance, strategy, capital markets, mergers and acquisitions, and c ...