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Krystal Biotech Announces Fourth Quarter and Full Year 2025 Financial and Operating Results

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Krystal Biotech (NASDAQ: KRYS) reported strong 4Q and FY2025 results highlighted by $107.1M in 4Q VYJUVEK revenue and $389.1M for full-year product revenue, with a 94% gross margin. The company ended 2025 with $955.9M in cash and investments and provided FY2026 non-GAAP R&D+SG&A guidance of $175–$195M. Regulatory milestones include FDA RMAT for KB707 (advanced NSCLC) and Fast Track for KB111 (Hailey-Hailey disease). Positive clinical readouts were reported for inhaled KB407 (CF airway transduction 29.4%–42.1%) and multiple registrational study timelines target 2026–2027.

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Positive

  • VYJUVEK revenue of $107.1M in 4Q 2025
  • Full-year product revenue of $389.1M in 2025 (+34% vs prior year)
  • Gross margin of 94% for 4Q and full year 2025
  • Cash and investments totaling $955.9M at year-end 2025
  • FDA RMAT designation granted to KB707 for advanced NSCLC
  • KB111 Fast Track designation granted for Hailey-Hailey disease

Negative

  • Ongoing pricing negotiations in Germany and France could delay European revenue recognition
  • SG&A increased to $146.7M in 2025 from $113.6M in 2024 (material operating cost rise)
  • Non-GAAP FY2026 R&D+SG&A guidance excludes stock-based compensation, creating GAAP expense uncertainty
  • European launch timing dependent on regulatory interactions and pricing outcomes, pacing expansion plans

Market Reaction

+6.31% $293.89 2.0x vol
15m delay 7 alerts
+6.31% Since News
$293.89 Last Price
$270.71 $298.30 Day Range
+$506M Valuation Impact
$8.52B Market Cap
2.0x Rel. Volume

Following this news, KRYS has gained 6.31%, reflecting a notable positive market reaction. Our momentum scanner has triggered 7 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $293.89. This price movement has added approximately $506M to the company's valuation. Trading volume is elevated at 2.0x the average, suggesting notable buying interest.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Q4 2025 VYJUVEK revenue: $107.1M FY 2025 product revenue: $389.1M VYJUVEK revenue since U.S. launch: $730.3M +5 more
8 metrics
Q4 2025 VYJUVEK revenue $107.1M Fourth quarter 2025 net product revenue
FY 2025 product revenue $389.1M Twelve months ended Dec 31, 2025
VYJUVEK revenue since U.S. launch $730.3M Cumulative net product revenue since launch
Cash & investments $955.9M Balance as of Dec 31, 2025
Gross margin 94% Q4 and full year 2025
Q4 2025 net income $51.4M ($1.77 basic EPS) Quarter ended Dec 31, 2025
FY 2025 net income $204.8M ($7.08 basic EPS) Twelve months ended Dec 31, 2025
2026 non-GAAP R&D+SG&A $175.0–$195.0M FY 2026 expense guidance (excludes stock-based comp)

Market Reality Check

Price: $276.45 Vol: Volume 357,325 vs 20-day ...
normal vol
$276.45 Last Close
Volume Volume 357,325 vs 20-day avg 260,105 (relative volume 1.37x). normal
Technical Price 276.45, trading above 200-day MA (184.81) and 6.6% below 52-week high.

Peers on Argus

KRYS is up 2.29% on earnings while peers show mixed moves (e.g., ARWR +4.4%, ACL...

KRYS is up 2.29% on earnings while peers show mixed moves (e.g., ARWR +4.4%, ACLX -1.07%). No momentum-clustered sector move flagged.

Previous Earnings Reports

5 past events · Latest: Nov 03 (Positive)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Nov 03 Q3 2025 earnings Positive +0.2% Strong Q3 VYJUVEK growth, 96% margin, cash build, guidance reaffirmed.
Aug 04 Q2 2025 earnings Positive -14.0% Robust Q2 revenue and margins with Japan approval and global expansion.
May 06 Q1 2025 earnings Positive -14.1% Strong early 2025 revenue, high margins, and multiple upcoming readouts.
Feb 19 FY 2024 earnings Positive +12.4% Q4 and full-year 2024 revenue surge with solid profitability and access.
Nov 04 Q3 2024 earnings Positive -3.1% Strong Q3 2024 revenue and margins with advancing global launch plans.
Pattern Detected

Earnings releases have often seen downside reactions despite positive fundamentals, with 3 prior negative moves vs 2 positive.

Recent Company History

Over the past year, Krystal’s earnings updates have highlighted rapid VYJUVEK revenue growth, expanding global launches, and consistently high gross margins above 90%. Cash and investments have steadily increased, supporting a broad pipeline across respiratory, ophthalmology, dermatology, oncology, and aesthetics. However, share-price reactions to these earnings have been mixed, frequently negative despite constructive metrics. Today’s report continues the theme of strong revenue, profitability, and pipeline progress, building directly on prior quarterly results and guidance updates.

Historical Comparison

-3.7% avg move · Past earnings-day moves averaged -3.73% despite solid metrics. Today’s +2.29% gain represents a rela...
earnings
-3.7%
Average Historical Move earnings

Past earnings-day moves averaged -3.73% despite solid metrics. Today’s +2.29% gain represents a relatively stronger reaction versus prior earnings updates.

Earnings updates show VYJUVEK revenue scaling each quarter, rising cash and investments, and steady advancement of CF, AATD, ocular, oncology, and aesthetics programs.

Market Pulse Summary

The stock is up +6.3% following this news. A strong positive reaction aligns with the company’s demo...
Analysis

The stock is up +6.3% following this news. A strong positive reaction aligns with the company’s demonstrated execution: rising VYJUVEK revenue, high 94% gross margin, and FY 2025 net income of $204.8M. Historically, earnings days averaged a -3.73% move, so a large upside response would mark a break from prior selling pressure. Investors would need to weigh sustainability of growth, expense guidance of $175.0–$195.0M, and pipeline execution risks.

Key Terms

rmat designation, fast track designation, phase 1, phase 3, +4 more
8 terms
rmat designation regulatory
"In February 2026, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to KB707"
A Regenerative Medicine Advanced Therapy (RMAT) designation is a US regulatory status granted by the Food and Drug Administration to experimental cell, gene or tissue-based therapies that treat serious conditions. It gives the developer extra access to regulators and opportunities for faster review, similar to getting a fast-track lane at a government agency; for investors, RMAT can shorten time to market and reduce regulatory risk, which may increase a program’s commercial value and stock impact.
fast track designation regulatory
"FDA granted RMAT to KB707 for the treatment of advanced NSCLC and Fast Track Designation to KB111"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
phase 1 medical
"Phase 1 study evaluating KB407 in patients with CF"
Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.
phase 3 medical
"The Phase 3 registrational IOLITE study is an intra-patient, double-blind, decentralized"
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
open label medical
"Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating inhaled KB707"
Open label is a clinical trial design in which both the participants and the researchers know which treatment or intervention is being given. For investors, this matters because knowledge of the treatment can influence reported effects and side effects—like how seeing a product label can change a shopper’s opinion—so open-label results are useful for safety and real-world experience but are generally viewed as less rigorous evidence of effectiveness than blinded studies.
double-blind medical
"registrational IOLITE study is an intra-patient, double-blind, decentralized, placebo-controlled study"
A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.
placebo-controlled medical
"registrational IOLITE study is an intra-patient, double-blind, decentralized, placebo-controlled study"
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.
rule 10b5-1 trading plan regulatory
"were carried out under a pre-arranged Rule 10b5-1 trading plan that began"
A Rule 10b5-1 trading plan is a pre-arranged schedule that allows company insiders to buy or sell stock at specific times, even if they have inside information. It helps prevent accusations of unfair trading by making these transactions look planned and transparent, rather than sneaky or illegal.

AI-generated analysis. Not financial advice.

$107.1 million in 4Q VYJUVEK revenue and $730.3 million since U.S. launch

FDA granted RMAT to KB707 for the treatment of advanced NSCLC and Fast Track Designation to KB111 for the treatment of HHD

Strong balance sheet, ending the quarter with $955.9 million in cash and investments

PITTSBURGH, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update.

“In 2025, Krystal made meaningful progress on our mission to serve patients with dystrophic epidermolysis bullosa around the world, while continuing to build the global infrastructure required to scale our impact,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “As we work toward our goal of launching multiple products and treating more than 10,000 patients living with rare diseases by the end of 2030, our recent cystic fibrosis readout further reinforces the versatility of our platform in high-turnover epithelial tissues. We believe we are still in the early stages of unlocking the transformational potential of our redosable HSV-1-based gene delivery platform, and we look forward to multiple registrational study readouts ahead across our rare disease pipeline.”

VYJUVEK® (beremagene geperpavec-svdt, or B-VEC)
for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

  • The Company recorded $107.1 million and $389.1 million in VYJUVEK net product revenue for the fourth quarter and full year of 2025, respectively. Gross margin for the fourth quarter and full year of 2025 was 94%.
  • The Company has secured over 660 reimbursement approvals for VYJUVEK in the United States and continues to maintain strong access nationwide.
  • High patient demand is driving steady VYJUVEK uptake since launch in Germany, France and Japan. The Company estimates that over 90 patients have been prescribed VYJUVEK therapy across Germany, France, and Japan.
  • Pricing discussions with German and French reimbursement authorities are ongoing. The Company expects negotiations to continue until at least 2H 2026 in Germany and until at least 2027 in France.
  • The Company is also advancing pricing discussions with the reimbursement authorities in Italy and is currently on track for a potential launch in 2H 2026. The timing of additional European launches will depend on the cadence and outcomes of regulatory interactions and pricing negotiations.
  • In December 2025, VYJUVEK was awarded the Prix Galien France in the Innovative Therapy Medicines category. The Prix Galien is an international awards program created recognizing excellence in scientific innovation that improves the state of human health. Earlier in 2025, VYJUVEK was also awarded the Prix Galien Italia in the Advanced Therapy Medicinal Products category in Italy.
  • In February 2026, the Company executed an agreement with a leading regional specialty distributor to support commercialization of VYJUVEK in Israel. The Company remains on track to achieve its objective of expanding its specialty distributor network to cover over 40 countries by the end of 2026.

Respiratory

KB407 for the treatment of cystic fibrosis (CF)

  • In January 2026, the Company announced a positive clinical update from the highest dose cohort of CORAL-1, the Company’s multi-center, dose escalation Phase 1 study evaluating KB407 in patients with CF, confirming lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407. Airway cell transduction by KB407 was observed in all patients with successful bronchoscopies, irrespective of modulator-status and genetic background, with broad airway distribution and transduction as assessed by CFTR or viral marker immunofluorescence ranging from 29.4% to 42.1% of conducting airway cells. Inhaled KB407 continued to be well tolerated by patients treated at the highest dose, consistent with the safety profile previously reported from lower dose cohorts. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT05504837.
  • The Company is currently engaged in discussions with the United States Food and Drug Administration (FDA) regarding the design of the Company’s proposed repeat dosing study CORAL-3, which is intended to evaluate the safety and efficacy of repeat KB407 administration, including through regular assessments of lung function by spirometry, and to support potential registration. The Company expects to align on the CORAL-3 study design with the FDA and start enrollment in CORAL-3 in 1H 2026. Additional details on the study design will be provided by the time of study initiation.

KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease

  • The Company continues to enroll patients in the repeat dose Cohort 2B of SERPENTINE-1, the Company’s open label dose escalation study evaluating KB408 in adult patients with AATD with a Pi*ZZ or a Pi*ZNull genotype, and expects to report interim data for this cohort in 2026. Cohort 2B is designed to evaluate the safety and tolerability of repeat KB408 dosing at the same dose level that was previously shown to safely deliver SERPINA1 to the lungs of AATD patients after a single dose. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT06049082.

Ophthalmology

KB803 for the treatment and prevention of corneal abrasions in DEB patients

  • Based on the promising clinical safety profile observed to date with both KB803 and KB801, the Company has modified the KB803 dosing regimen in the registrational IOLITE study to maximize convenience for patients and their caregivers while reducing potential impact of human error in eye drop administration in the home setting. The Phase 3 registrational IOLITE study is an intra-patient, double-blind, decentralized, placebo-controlled study with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients. Patients are receiving either KB803 or placebo three times weekly in the home setting with the option of administration by a healthcare professional (HCP), a trained caregiver, or by the patient themselves. Enrollment in IOLITE is ongoing. The Company expects to complete enrollment in 1H 2026 and report top-line results before year end. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT07016750.

KB801 for the treatment of neurotrophic keratitis (NK)

  • To support expedited development of KB801 and facilitate patient or caregiver administration at home, the Company has also updated the protocol of its registrational, randomized, double-masked, multicenter, placebo-controlled study, EMERALD-1, evaluating KB801 for the treatment of NK. Patients are receiving KB801 or placebo control daily with the option of administration by either a HCP, a trained caregiver, or by the patient themselves. The Company expects to enroll approximately 60 patients in the study, randomized 1:1 to KB801 and placebo. Enrollment in EMERALD-1 is ongoing, and the Company expects to announce data before year end. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT06999733.

Dermatology

KB111 for the treatment of Hailey-Hailey disease (HHD)

  • In January 2026, the FDA granted KB111 Fast Track Designation for the treatment of HHD.
  • The Company has initiated development of an HHD-specific evaluation scale necessary for the clinical evaluation of KB111. The Company expects to complete development and validation of the scale in 1H 2026 and initiate a registrational study evaluating KB111 for the treatment of HHD in 2H 2026.

Oncology

Inhaled KB707 for the treatment of non-small cell lung cancer (NSCLC)

  • In February 2026, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to KB707 for the treatment of advanced or metastatic NSCLC. The FDA’s RMAT designation is intended to support and expedite the development of regenerative medicine therapies, including gene therapies such as KB707.
  • The Company is enrolling patients with advanced NSCLC in a dose expansion cohort of KYANITE-1 evaluating inhaled KB707 in combination with chemotherapy. KYANITE-1 is a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating inhaled KB707, either as monotherapy or in combination, in patients with locally advanced or metastatic solid tumors of the lung. The Company expects to report interim efficacy data and potential registrational study plans later this year. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.

Intratumoral KB707 for the treatment of injectable solid tumors

  • The Company continues to follow patients enrolled in OPAL-1, the Company’s Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies. The Company will update its development plans for intratumoral KB707 as additional safety and efficacy data are collected from the study. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT05970497.

Aesthetics

KB304 for the treatment of wrinkles of the décolleté

  • Jeune Aesthetics, Inc. (“Jeune”), a wholly-owned subsidiary of the Company, has aligned with the FDA on Jeune’s validated décolleté-specific photonumeric scale and expects to now initiate a Phase 2 study of its lead program, KB304, in 2027.

Financial Results for the Quarter Ended December 31, 2025:

  • Cash, cash equivalents, and investments totaled $955.9 million as of December 31, 2025.
  • Product revenue, net totaled $107.1 million and $91.1 million for the quarters ended December 31, 2025 and December 31, 2024, respectively.
  • Cost of goods sold totaled $6.6 million and $4.9 million for the quarters ended December 31, 2025 and December 31, 2024, respectively.
  • Research and development expenses for the quarter ended December 31, 2025 were $14.8 million, inclusive of $2.7 million of stock-based compensation, compared to $13.5 million, inclusive of stock-based compensation of $2.3 million for the quarter ended December 31, 2024.
  • Selling, general, and administrative expenses for the quarter ended December 31, 2025 were $41.4 million, inclusive of stock-based compensation of $11.1 million, compared to $31.3 million, inclusive of stock-based compensation of $11.0 million, for the quarter ended December 31, 2024.
  • Net income for the quarter ended December 31, 2025 was $51.4 million, or $1.77 per common share (basic) and $1.70 per common share (diluted). Net income for the quarter ended December 31, 2024 was $45.5 million, or $1.58 per common share (basic) and $1.52 per common share (diluted).

Financial Results for the Twelve Months Ended December 31, 2025:

  • Product revenue, net totaled $389.1 million and $290.5 million for the twelve months ended December 31, 2025 and December 31, 2024, respectively.
  • Cost of goods sold totaled $23.0 million and $20.1 million for the twelve months ended December 31, 2025 and December 31, 2024, respectively.
  • Research and development expenses for the twelve months ended December 31, 2025 were $58.0 million, inclusive of $10.4 million of stock-based compensation, compared to $53.6 million, inclusive of stock-based compensation of $9.2 million for the twelve months ended December 31, 2024.
  • Selling, general, and administrative expenses for the twelve months ended December 31, 2025 were $146.7 million, inclusive of stock-based compensation of $44.1 million, compared to $113.6 million, inclusive of stock-based compensation of $39.9 million, for the twelve months ended December 31, 2024.
  • Net income for the twelve months ended December 31, 2025 was $204.8 million, or $7.08 per common share (basic) and $6.84 per common share (diluted). Net income for the twelve months ended December 31, 2024 was $89.2 million, or $3.12 per common share (basic) and $3.00 per common share (diluted).
  • For additional information on the Company’s financial results for the twelve months ended December 31, 2025, please refer to the Form 10-K filed with the SEC.

Financial Guidance

($ in millions) FY 2026 Guidance
Non-GAAP Research and Development (“R&D”) and Selling, General and Administrative (“SG&A”) expense(1) $175.0 - $195.0

(1) Refer to Non-GAAP Financial Measures section below for additional information. 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 2026 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 in the above. This could materially affect the calculation of forward-looking GAAP combined R&D and SG&A Expense as it is inherently uncertain.

Conference Call

The Company will host an investor webcast on February 17, 2026, at 8:30 am ET.

Investors and the general public can access the live webcast at:
https://www.webcaster5.com/Webcast/Page/3018/53598.

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 genetic medicine 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. VYJUVEK is approved in the United States, Europe, and Japan.

U.S. INDICATION

VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients 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 http://www.fda.gov/medwatch.

Contraindications

None.

Warnings and Precautions

VYJUVEK gel may be applied by a healthcare provider, a caregiver, or the patient.

After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.

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 Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. 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

Statements in this press release about future expectations, plans, and prospects, as well as statements that are not historical facts, including statements about, among other topics, our combined R&D and SG&A expense guidance; our commercial launch of VYJUVEK in the U.S., Europe, and Japan, including our expectations regarding timing of pricing discussions in Germany and France, pricing discussions with the reimbursement authorities in Italy and a potential commercial launch in Italy in 2H 2026, and the potential expansion of the Company’s specialty distributor network; and our expectations for our product pipeline, including our clinical trial plans, enrollment in clinical trials, the timing of development and validation of an HHD-specific evaluation scale, and the timing of initiating clinical trials and data read-outs may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Undue reliance should not be placed on the forward-looking statements in this press release. These statements are not guaranties of future performance and 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 and commercial potential of VYJUVEK or our 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. The Company is providing the information in this press release as of the date hereof and undertakes no duty to update this information unless required by law.

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 expense. 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
spaquette@krystalbio.com     


Condensed Consolidated Balance Sheet Data:

 December 31,
2025
 December 31,
2024
(in thousands)(unaudited)
   
Balance sheet data:     
Cash and cash equivalents$496,304  $344,865 
Short-term investments 331,487   252,652 
Long-term investments 128,066   152,114 
Total assets 1,333,794   1,055,838 
Total liabilities 114,234   109,458 
Total stockholders’ equity$1,219,560  $946,380 
        

Condensed Consolidated Statements of Operations:

 Three Months Ended December 31,  
 2025
 2024 Change
(in thousands, except per share data)(unaudited)  
Revenue      
Product revenue, net$107,105  $91,139  $15,966 
Operating Expenses      
Cost of goods sold 6,592   4,949   1,643 
Research and development 14,794   13,527   1,267 
Selling, general, and administrative 41,449   31,286   10,163 
Litigation settlement        
Total operating expenses 62,835   49,762   13,073 
Income from operations 44,270   41,377   2,893 
Other income      
Interest and other income, net 6,861   7,233   (372)
Income before income taxes 51,131   48,610   2,521 
Income tax benefit (expense) 269   (3,131)  3,400 
Net income$51,400  $45,479  $5,921 
       
Net income per common share:      
Basic$1.77  $1.58   
Diluted$1.70  $1.52   
       
Weighted-average common shares outstanding:      
Basic 29,093   28,755   
Diluted 30,250   29,883   
       

Condensed Consolidated Statements of Operations:

 Twelve Months Ended December 31, 2025  
 2025
 2024 Change
(in thousands, except per share data)(unaudited)  
Revenue      
Product revenue, net$389,130  $290,515  $98,615 
Operating Expenses      
Cost of goods sold 23,049   20,061   2,988 
Research and development 58,045   53,580   4,465 
Selling, general, and administrative 146,741   113,626   33,115 
Litigation settlement    37,500   (37,500)
Total operating expenses 227,835   224,767   3,068 
Income from operations 161,295   65,748   95,547 
Other income      
Interest and other income, net 28,176   29,608   (1,432)
Income before income taxes 189,471   95,356   94,115 
Income tax benefit (expense) 15,360   (6,197)  21,557 
Net income$204,831  $89,159  $115,672 
       
Net income per common share:      
Basic$7.08  $3.12   
Diluted$6.84  $3.00   
       
Weighted-average common shares outstanding:      
Basic 28,944   28,592   
Diluted 29,951   29,740   
       

FAQ

How much revenue did Krystal Biotech (KRYS) report for VYJUVEK in 4Q 2025?

Krystal reported $107.1 million in VYJUVEK net product revenue for 4Q 2025. According to the company, that contributed to $389.1 million of full-year product revenue for 2025, reflecting continued commercial uptake.

What is Krystal Biotech's (KRYS) cash position at December 31, 2025?

Krystal ended 2025 with $955.9 million in cash, cash equivalents and investments. According to the company, this strong balance sheet is intended to fund pipeline development and planned registrational studies.

What regulatory designations did the FDA grant to Krystal Biotech (KRYS) in February 2026?

The FDA granted RMAT to KB707 for advanced NSCLC and Fast Track to KB111 for Hailey-Hailey disease. According to the company, these designations aim to expedite development and regulatory engagement.

What guidance did Krystal Biotech (KRYS) give for FY2026 non-GAAP R&D and SG&A expense?

Krystal provided non-GAAP combined R&D and SG&A guidance of $175.0–$195.0 million for FY2026. According to the company, this range excludes stock-based compensation, which could materially affect GAAP expense calculations.

When does Krystal Biotech (KRYS) expect European launches for VYJUVEK in key markets?

Krystal expects German pricing negotiations to continue into 2H 2026 and French negotiations until at least 2027. According to the company, launch timing for additional European markets will depend on regulatory and pricing outcomes.
Krystal Biotech

NASDAQ:KRYS

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8.02B
26.11M
Biotechnology
Biological Products, (no Diagnostic Substances)
Link
United States
PITTSBURGH