• Krystal Biotech, Inc. reported financial results and business updates for Q2 2024.
• The company reported significant growth in its VYJUVEK U.S. operations.
• The company is a biotech company that produces pharmaceuticals.
• Krystal Biotech, Inc. reports significant growth in its VYJUVEK U.S. product line.
• The company's revenue from Q2 2024 was $27.8 billion.
• The company's US market share is $19.4 billion.
• Krystal Biotech, Inc. is a biotech company with a focus on biopharmaceutical.
• The company's products are used in the U.S. market.
• Krystal Biotech, Inc. is a biotech company focused Jeune Aesthetics recorded $70.3 million in VYJUVEK net product revenue for Q2 2024, an increase of 55.3% compared to the first quarter of 2024.
• The company has secured over 400 reimbursement approvals.
• ANCORIS received GMP certification from the European Medicines Agency (EMA).
• High patient compliance with weekly treatment while on drug continued at 90% as of the end of the quarter.
• The company is on track to report interim data from the study in 4Q 2024.
• Jeune Aesthetics completed enrollment in Cohorts 3 and 4 of the Phase 1 PEARL-1 study.
• The Company reported that selling, general, and administrative expenses for the six months ended June 30, 2024 were $53.7 million.
PITTSBURGH, Aug. 05, 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 second quarter ending June 30, 2024.
“We are pleased to report another strong quarter for Krystal, headlined by significant growth in our VYJUVEK U.S. commercial launch and steady progress across our clinical-stage pipeline,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “The rapid growth in VYJUVEK net product revenue, up over 55% compared to the first quarter of 2024 and now totaling over $166 million since launch, is a reflection of the robust and sustained demand for VYJUVEK among the DEB patient community, the clinical benefits and correspondingly high compliance that come from a fundamentally corrective therapy, and strong execution by our commercial team. As we enter into the second year of the VYJUVEK launch, and with market authorizations in Europe and Japan either under review or planned for submission later this year, we see significant potential to drive further VYJUVEK growth both in the U.S. and overseas. At the same time, we continue to rapidly advance our deep clinical pipeline of genetic medicines and are looking forward to a wave of clinical data readouts starting later this quarter.”
VYJUVEK® for the treatment of Dystrophic Epidermolysis Bullosa (DEB)
Respiratory
KB407 for the treatment of cystic fibrosis (CF)
KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease
Ophthalmology
B-VEC eyedrops for ocular complications of DEB
Pipeline expansion
Oncology
Inhaled KB707 for the treatment of solid tumors of the lung
Intratumoral KB707 for the treatment of injectable solid tumors
Aesthetics
KB301 for the treatment of aesthetic indications
Dermatology
The Company has resumed efforts in KB105 for the treatment of lamellar ichthyosis and expects to commence the Phase 2 portion of JADE-1 trial in pediatric patients in 1H 2025.
Financial Results for the Quarter Ended June 30, 2024:
Financial Results for the Six Months Ended June 30, 2024:
Financial Guidance
For the year ending December 31, 2024, we continue to anticipate approximately $150 million to $175 million of Non-GAAP Research and Development (“R&D”) and Selling, General and Administrative (“SG&A”) expense. Non-GAAP combined R&D and SG&A expense guidance does not include stock-based compensation as we are currently unable to confidently estimate Full Year 2024 stock-based compensation expense. As such, we have not provided a reconciliation from forecasted non-GAAP to forecasted GAAP combined R&D and SG&A Expense. This could materially affect the calculation of forward-looking GAAP combined R&D and SG&A Expense as it is inherently uncertain. Refer to Non-GAAP Financial Measures section below for additional information.
Conference Call
The Company will host an investor webcast on August 5, 2024, at 8:30 am ET.
Investors and the general public can access the live webcast at: https://www.webcaster4.com/Webcast/Page/3018/50830
For those unable to listen to the live conference call, a replay will be available for 30 days on the Investors section of the Company’s website at www.krystalbio.com.
About VYJUVEK
VYJUVEK is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.
Indication
VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patients six months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or https://www.fda.gov/apology_objects/abuse-detection-apology.html.
Contraindications
None.
Warnings and Precautions
VYJUVEK gel must be applied by a healthcare provider.
After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours.
Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.
Patients should avoid touching or scratching wound sites or wound dressings.
In the event of an accidental exposure flush with clean water for at least 15 minutes.
For more information, see full U.S. Prescribing Information.
About Rare Pediatric Disease Designation
The FDA grants Rare Pediatric Disease Designations for serious or life-threatening diseases with manifestations in individuals aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application or biologics license application for a product for the prevention or treatment of a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for any subsequent marketing application, and may be sold or transferred.
About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK® is the Company’s first commercial product, the first-ever redosable gene therapy, and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).
About Jeune Aesthetics, Inc.
Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., is a biotechnology company leveraging a clinically validated gene delivery platform to develop products to fundamentally address – and reverse – the biology of aging and/or damaged skin. For more information, please visit http://www.jeuneinc.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc. or Jeune Aesthetics, Inc., including statements about the Company’s commercial launch of VYJUVEK in the United States; the Company’s beliefs about potential marketing authorizations in Europe and Japan, including timing of filings; the Company’s expectation regarding the timing of initiating the third and final cohort of its CORAL-1 study evaluating KB407 in patients with cystic fibrosis; the Company’s expectation that it will report interim data in 4Q 2024 from its SERPENTINE-1 clinical study evaluating KB408 for the treatment of AATD; the Company’s plans to initiate its study of B-VEC eyedrops to treat ocular complications of DEB in 4Q 2024; the Company’s expectation that it will report interim data in 4Q 2024 from its OPAL-1 clinical study evaluating KB707 for the treatment of injectable solid tumors; Jeune Aesthetics’ plans to announce results in 3Q 2024 of Cohort 3 and Cohort 4 of its PEARL-1 clinical study to evaluate KB301; the Company’s expectation that it will commence the Phase 2 portion of its JADE-1 clinical study in pediatric patients in 1H 2025 to evaluate KB105 for the treatment of lamellar ichthyosis; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the availability or commercial potential of VYJUVEK or product candidates; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Non-GAAP Financial Measures
This press release includes forward-looking combined R&D and SG&A expense guidance that is not required by, or presented in accordance with, U.S. GAAP and should not be considered as an alternative to R&D and SG&A expense or any other performance measure derived in accordance with GAAP. The Company defines non-GAAP combined R&D and SG&A expense as GAAP combined R&D and SG&A expense excluding stock-based compensation. The Company cautions investors that amounts presented in accordance with its definition of non-GAAP combined R&D and SG&A expense may not be comparable to similar measures disclosed by competitors because not all companies calculate this non-GAAP financial measure in the same manner. The Company presents this non-GAAP financial measure because it considers this measure to be an important supplemental measure and believes it is frequently used by securities analysts, investors, and other interested parties in the evaluation of companies in the Company’s industry. Management believes that investors’ understanding of the Company’s performance is enhanced by including this forward-looking non-GAAP financial measure as a reasonable basis for comparing the Company’s ongoing results of operations. Management uses this non-GAAP financial measure for planning purposes, including the preparation of the Company’s internal annual operating budget and financial projections; to evaluate the performance and effectiveness of the Company’s operational strategies; and to evaluate the Company’s capacity to expand its business. This non-GAAP financial measure has limitations as an analytical tool, and should not be considered in isolation, or as an alternative to, or a substitute for R&D and SG&A expense or other financial statement data presented in accordance with GAAP in the Company’s consolidated financial statements. The Company has not provided a quantitative reconciliation of forecasted non-GAAP combined R&D and SG&A expense to forecasted GAAP combined R&D and SG&A expense because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP combined R&D and SG&A expense, is inherently uncertain and depends on various factors, some of which are outside of the Company’s control.
CONTACT
Investors and Media:
Stéphane Paquette, PhD
Krystal Biotech
This email address is being protected from spambots. You need JavaScript enabled to view it.
Condensed Consolidated Balance Sheet Data:
June 30, 2024 | December 31, 2023 | ||||||
(in thousands) | (unaudited) | ||||||
Balance sheet data: | |||||||
Cash and cash equivalents | $ | 345,786 | $ | 358,328 | |||
Short-term investments | 213,826 | 173,850 | |||||
Long-term investments | 69,292 | 61,954 | |||||
Total assets | 917,658 | 818,355 | |||||
Total liabilities | 78,765 | 39,714 | |||||
Total stockholders’ equity | $ | 838,893 | $ | 778,641 | |||
Condensed Consolidated Statements of Operations:
Three Months Ended June 30, | |||||||||||
2024 | 2023 | Change | |||||||||
(in thousands, except per share data) | (unaudited) | ||||||||||
Revenue | |||||||||||
Product revenue, net | $ | 70,284 | $ | — | $ | 70,284 | |||||
Expenses | |||||||||||
Cost of goods sold | 6,009 | — | 6,009 | ||||||||
Research and development | 15,583 | 12,144 | 3,439 | ||||||||
Selling, general, and administrative | 27,626 | 25,904 | 1,722 | ||||||||
Litigation settlement | 12,500 | — | 12,500 | ||||||||
Total operating expenses | 61,718 | 38,048 | 23,670 | ||||||||
Income (loss) from operations | 8,566 | (38,048 | ) | 46,614 | |||||||
Other income | |||||||||||
Interest and other income, net | 7,479 | 4,838 | 2,641 | ||||||||
Income (loss) before income taxes | 16,045 | (33,210 | ) | 49,255 | |||||||
Income tax expense | (477 | ) | — | (477 | ) | ||||||
Net income (loss) | $ | 15,568 | $ | (33,210 | ) | $ | 48,778 | ||||
Net income (loss) per common share: | |||||||||||
Basic | $ | 0.54 | $ | (1.25 | ) | ||||||
Diluted | $ | 0.53 | $ | (1.25 | ) | ||||||
Weighted-average common shares outstanding: | |||||||||||
Basic | 28,598 | 26,657 | |||||||||
Diluted | 29,637 | 26,657 |
Six Months Ended June 30, | |||||||||||
2024 | 2023 | Change | |||||||||
(in thousands, except per share data) | (unaudited) | ||||||||||
Revenue | |||||||||||
Product revenue, net | $ | 115,535 | $ | — | $ | 115,535 | |||||
Expenses | |||||||||||
Cost of goods sold | 8,428 | — | 8,428 | ||||||||
Research and development | 26,539 | 24,432 | 2,107 | ||||||||
Selling, general, and administrative | 53,685 | 49,939 | 3,746 | ||||||||
Litigation settlement | 25,000 | 12,500 | 12,500 | ||||||||
Total operating expenses | 113,652 | 86,871 | 26,781 | ||||||||
Income (loss) from operations | 1,883 | (86,871 | ) | 88,754 | |||||||
Other income | |||||||||||
Interest and other income, net | 15,095 | 8,364 | 6,731 | ||||||||
Income (loss) before income taxes | 16,978 | (78,507 | ) | 95,485 | |||||||
Income tax expense | (477 | ) | — | (477 | ) | ||||||
Net income (loss) | $ | 16,501 | $ | (78,507 | ) | $ | 95,008 | ||||
Net income (loss) per common share: | |||||||||||
Basic | $ | 0.58 | $ | (3.00 | ) | ||||||
Diluted | $ | 0.56 | $ | (3.00 | ) | ||||||
Weighted-average common shares outstanding: | |||||||||||
Basic | 28,446 | 26,187 | |||||||||
Diluted | 29,504 | 26,187 |
Last Trade: | US$177.11 |
Daily Change: | 1.18 0.67 |
Daily Volume: | 120,467 |
Market Cap: | US$5.090B |
May 06, 2024 February 26, 2024 February 13, 2024 |
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