Krystal Biotech

Krystal Biotech, Inc. is a clinical-stage biotechnology company, which focuses on the development of redosable gene therapies to improve the lives of patients living with rare diseases. The firm developed a proprietary gene delivery platform that enables off-the-shelf treatments for serious rare diseases with significant unmet need, initially in the areas of dermatology and respiratory diseases. Its platform consists of a patented, engineered viral vector derived from the herpes simplex virus type 1 that is optimized for local and repeat gene transfer to epithelial cells, and initially using its platform to develop treatments for rare or orphan monogenic diseases caused by the absence of or a mutation in a single gene. It is also involved in leveraging its platform to develop novel therapies to treat more prevalent conditions, and also focuses on developing treatments for use in the setting of aesthetic skin conditions. The company was founded by Suma M. Krishnan on April 15, 2016 and is headquartered in Pittsburgh, PA.

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Krystal Biotech reports robust Q3 earnings and eyes global expansion

Krystal Biotech's Q3 performance showcased positive earnings and high patient conversion rates.
Despite challenges in patient source diversity and conversion cycle, the company remains well-positioned.
Opportunities lie in global expansion, pipeline advancement, and leadership enhancements.
Overall, Krystal Biotech's strong financials and patient compliance bode well for future growth.

Krystal Biotech excels with VYJUVEK, eyes global expansion

Krystal Biotech's VYJUVEK shows strong performance and market potential
Balanced financials and strategic clinical trials position for future growth
Challenges include competitive landscape shifts and global expansion execution
Opportunities lie in market expansion, pipeline advancements, and partnerships

Krystal Biotech excels in Q1 2024, eyes global expansion

Krystal Biotech's strong performance in Q1 2024 reflects continued growth and execution.
The company's focus on compliance, pipeline advancements, and global expansion positions it well.
Challenges in conversion time and reimbursement delays require strategic mitigation.
Opportunities in European and Japanese markets, patient education, and new product data.

Krystal Biotech excels in Q2 2024, eyes global expansion

Krystal Biotech's Q2 2024 performance reflects strong revenue growth, profitability, and operational efficiency, positioning the company well for future success.
The company's focus on patient demand, compliance, and global expansion highlights its strategic priorities and growth trajectory.
While facing challenges in manufacturing expansion and clinical data readouts, Krystal Biotech has opportunities to drive revenue growth and market expansion through strategic initiatives.

Krystal Biotech excels in Q3 with VYJUVEK success and global expansion plans

Krystal Biotech's Q3 performance reflects strong revenue growth, profitability, and strategic advancements in product development and market access.
While facing challenges related to compliance, market dynamics, and competitive landscape, the company is well-positioned for international expansion and future growth.
By capitalizing on strengths in commercial strategies, pipeline progress, and revenue diversification, Krystal Biotech can navigate challenges and seize opportunities for sustained success.

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Krystal Biotech, Inc. engages in developing and commercializing pharmaceutical products. It offers the product, VYJUVEK. The company was founded by Krish S. Krishnan and Suma M. Krishnan on April 15, 2016 and is headquartered in Pittsburgh, PA.

Krystal Biotech, Inc. (KRYS) came out with quarterly earnings of $0.30 per share, beating the Zacks Consensus Estimate of a loss of $0.52 per share. This compares to loss of $1.25 per share a year ago.

Krystal Biotech, Inc. (KRYS) Tops Q4 Earnings and Revenue Estimates

•  Net product revenue of $42.1M in 4Q and $50.7M for the year •  New England Journal of Medicine publication of the use of B-VEC eyedrop formulation •  Reached alignment with FDA to enable approval of B-VEC eyedrop formulation for the treatment of lesions in the eye of DEB patients •  First patient dosed in Phase 1 KB408 trial for the treatment of AATD; five active clinical trials in 2024 •  Strong balance sheet, closing the year with $594.1M in cash and investments PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today reported financial results and key business updates for the fourth quarter and year ending December 31, 2023.

Krystal Biotech Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

PITTSBURGH, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, will report its fourth quarter and full year 2023 financial results on Monday, February 26, 2024, prior to the open of U.S. markets. Subsequently, at 8:30 am ET, the Company will host a webcast to discuss the financial results and provide a business update.

Krystal Biotech to Report Fourth Quarter and Full Year 2023 Financial Results on February 26, 2024

• FDA clears IND and Phase 1 (KYANITE-1) clinical trial expected to be initiated in 1H 2024 PITTSBURGH, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy. “The lung is often the predominant site of metastasis for many different cancers, most of which have limited or no standard of care immunotherapy treatment options” said Daniel Johnson, MD, Director of the Center for Innovative Cancer Therapies at the Ochsner MD Anderson Cancer Center Medical Center in New Orleans, LA.

Krystal Biotech Receives FDA Fast Track Designation for Inhaled Oncology Candidate KB707 to Treat Solid Tumors of the Lung

• Initial clinical data suggest the potential of B-VEC to treat lesions in the eye of DEB patients and additional applications of Krystal's HSV-1 platform to treat ocular diseases

Krystal Biotech Announces Publication in the New England Journal of Medicine on the Application of B-VEC to Treat Ocular Complications in Patient with Dystrophic Epidermolysis Bullosa

PITTSBURGH, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the Guggenheim 6th Annual Biotechnology Conference, which takes place in New York on February 7-8.

Krystal Biotech to Present at Guggenheim 6th Annual Biotechnology Conference

PITTSBURGH, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J3401) for VYJUVEK® (beremagene geperpavec-svdt), the first U.S. Food and Drug Administration-approved treatment for dystrophic epidermolysis bullosa (DEB). The J-code for VYJUVEK became effective on January 1, 2024.

Krystal Biotech Receives Permanent J-code (J3401) for VYJUVEK®

Krystal Biotech, Inc. (KRYS) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Krystal Biotech, Inc. (KRYS) Moves to Buy: Rationale Behind the Upgrade

PITTSBURGH, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).

Krystal Biotech Receives Orphan Drug Designation from the Japanese MHLW for Beremagene Geperpavec-svdt (B-VEC)

Krystal Biotech's Vyjuvek shows strong early sales for DEB treatment, indicating market acceptance and revenue potential. Financially, Krystal is robust with $598.5M in liquid assets and a low risk of near-term financing needs. Market sentiment is mixed; Krystal's market cap reflects confidence, but insider selling and high short interest suggest caution.

Krystal Biotech's Vyjuvek Impresses Early On, Bolsters Prospects

The mean of analysts' price targets for Krystal Biotech, Inc. (KRYS) points to a 42.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts See a 42.55% Upside in Krystal Biotech, Inc. (KRYS): Can the Stock Really Move This High?

PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company's Marketing Authorization Application (MAA) to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review. A CHMP opinion is anticipated in the second half of 2024.

Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa

Krystal Biotech's recent approval is the only game in town, but it has a small addressable market. The biotech is developing other therapies, with most still in the early stages.

This Stock Has Quadrupled in 5 Years. Can It Do It Again?

PITTSBURGH, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the Company will participate in the Stifel 2023 Healthcare Conference in New York.

Krystal Biotech to Present at the Stifel 2023 Healthcare Conference

Krystal Biotech Inc. (NASDAQ:KRYS ) Q3 2023 Earnings Conference Call November 6, 2023 8:30 AM ET Company Participants Meg Dodge - VP, Investor Relations & Corporate Communications Krish Krishnan - Chairman & Chief Executive Officer Suma Krishnan - President, Research & Development Kathryn Romano - EVP & Chief Accounting Officer Conference Call Participants Robert Finke - Guggenheim Partners Alec Stranahan - Bank of America Merrill Lynch Ritu Baral - Cowen Carly Kenselaar - Citigroup Dae Gon Ha - Stifel Tim Lugo - William Blair Gavin Clark-Gartner - Evercore ISI Operator Thank you for standing by and welcome to the Krystal Biotech Third Quarter 2023 Earnings Conference Call. As a reminder today's conference call is being recorded.

Krystal Biotech Inc. (KRYS) Q3 2023 Earnings Call Transcript

•   284 VYJUVEK Patient Start Forms and $8.6 million in VYJUVEK U.S. net product revenue as of the end of the third quarter •   Cohort 1 completed in Phase 1 clinical trial of KB407 for the treatment of CF •   First patient dosed in Phase 1 Clinical Trial of KB707 in patients with locally advanced or metastatic solid tumor malignancies •   IND cleared for KB408 for the treatment of AATD •   Strong balance sheet, closing the quarter with $598.6 million in cash, cash equivalents and investments PITTSBURGH, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today reported financial results and key business updates for the third quarter ended September 30, 2023. “The third quarter was highlighted by strong commercial execution of the VYJUVEK launch, advancement of the oncology program into the clinic and continued momentum in the CF program,” said Krish S.

Krystal Biotech Announces Third Quarter 2023 Financial Results and Provides Business Update

PITTSBURGH, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, will report its third quarter 2023 financial results on Monday, November 6, 2023, prior to the open of U.S. markets. Subsequently, at 8:30 am ET, the Company will host an investor conference call to discuss the financial results and provide a business update.

Krystal Biotech to Report Third Quarter 2023 Financial Results on November 6, 2023

PITTSBURGH, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the Company will participate in the Chardan 7th Annual Genetic Medicines Conference in New York.

Krystal Biotech to Present at the Chardan 7th Annual Genetic Medicines Conference

Krystal Biotech, Inc. received FDA approval of Vyjuvek, for the treatment of patients with dystrophic epidermolysis bullosa in May of 2023. FDA IND clearance of KB408 for the treatment of patients with antitrypsin deficiency given; Phase 1 study expected to begin Q1 of 2024. The market size for AATD treatment is expected to reach $3.48 billion in 2031.

Krystal Biotech: FDA Approval Of Vyjuvek And Further Pipeline Enhancement

• Orphan Drug Designation Granted to KB408 PITTSBURGH, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug Application (IND) for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).

Krystal Biotech Announces FDA Clearance of Investigational New Drug Application for KB408 for the Treatment of Type 1 Alpha-1 Antitrypsin Deficiency

PITTSBURGH, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the Company will participate in the Morgan Stanley 21st Annual Global Healthcare Conference in New York.

Krystal Biotech to Present at the Morgan Stanley 21st Annual Global Healthcare Conference

PITTSBURGH, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).

Krystal Biotech Announces Orphan Drug Designation Granted to KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency

Krystal (KRYS) announces the sale of its priority review voucher for a consideration of $100 million. The stock of the company rises 5.2% on the news.

Krystal (KRYS) Up 5% on Sale of FDA's Priority Review Voucher

PITTSBURGH, Aug. 21, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (NASDAQ: KRYS) (the “Company”), a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced that it has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million.

Krystal Biotech Announces Sale of Priority Review Voucher for $100 Million

• VYJUVEK™ approved in the U.S. as the first and only topical redosable gene therapy for the treatment of dystrophic epidermolysis bullosa

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