Krystal Biotech Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

Krystal Biotech (NASDAQ: KRYS) provided a business update ahead of its J.P. Morgan Healthcare Conference presentation on Jan 12, 2026, reporting preliminary unaudited Q4 2025 VYJUVEK net revenue of $106M–$107M and full‑year 2025 revenue of $388M–$389M. Cash, cash equivalents, and investments were approximately $955M as of Dec 31, 2025. The company raised enrollment for a registrational NK study from 27 to 60 patients, expects top‑line NK data before end of 2026, and plans multiple registrational readouts in 2026. 2026 objectives include additional European launches, expanding distribution to >40 countries, and advancing a pipeline aimed at four marketed rare‑disease medicines by 2030. 2026 non‑GAAP R&D+SG&A guidance: $175M–$195M.

Positive

• Q4 2025 revenue of $106M–$107M
• FY 2025 revenue of $388M–$389M
• Approximately $955M in cash and investments
• Increased NK trial enrollment from 27 to 60 patients
• Multiple registrational readouts expected in 2026

Negative

• Preliminary fourth‑quarter and full‑year results are unaudited and subject to adjustment
• Planned non‑GAAP R&D+SG&A expense of $175M–$195M in 2026

Key Figures

Q4 2025 VYJUVEK revenue: $106–$107 million FY 2025 VYJUVEK revenue: $388–$389 million Cash & investments: $955 million +5 more

8 metrics

Q4 2025 VYJUVEK revenue $106–$107 million Preliminary unaudited net product revenue, 4Q 2025

FY 2025 VYJUVEK revenue $388–$389 million Preliminary unaudited net product revenue, full year 2025

Cash & investments $955 million Cash, cash equivalents, investments as of Dec 31, 2025

KB801 trial size 60 patients Registrational double-masked, randomized, placebo-controlled NK study target

Previous KB801 target 27 patients Original enrollment target for registrational NK study

Marketed rare disease goal 4 medicines Target number of marketed rare disease medicines by end of 2030

Patient treatment goal Over 10,000 patients Worldwide patients targeted by end of 2030

2026 non-GAAP R&D+SG&A $175–$195 million Combined non-GAAP expense guidance for 2026

Market Reality Check

Price: $276.45 Vol: Volume 344,385 is 1.22x t...

normal vol

$276.45 Last Close

Volume Volume 344,385 is 1.22x the 20-day average of 282,870, indicating elevated interest ahead of the update. normal

Technical Shares at $261.41 are trading above the 200-day MA of $171.94 and sit 2.27% below the 52-week high.

Peers on Argus

KRYS gained 5.02% while peers were mixed: MIRM +5.56%, ACLX +2.22%, but ARWR, AC...

KRYS gained 5.02% while peers were mixed: MIRM +5.56%, ACLX +2.22%, but ARWR, ACAD, and MTSR declined modestly. The pattern points to a stock-specific reaction rather than a broad biotech move.

Historical Context

5 past events · Latest: Jan 08 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 08	Clinical data update	Positive	+1.0%	Positive Phase 1 KB407 CF data confirming wild-type CFTR delivery and expression.
Jan 07	Clinical event notice	Neutral	-1.2%	Announcement of upcoming CORAL-1 interim update webcast scheduling details.
Jan 05	Conference participation	Neutral	-0.9%	Notice of planned presentation at 44th J.P. Morgan Healthcare Conference.
Nov 26	Conference participation	Neutral	+0.8%	Participation announcement for Evercore Healthcare Conference investor meetings.
Nov 03	Earnings update	Positive	+0.2%	Strong 3Q 2025 VYJUVEK revenue, high margins, and global launch progress.

Pattern Detected

Recent KRYS news events have produced modest price moves, with positive clinical and earnings updates generally followed by small, aligned gains and conference notices drawing limited reactions.

Recent Company History

Over the last few months, KRYS has reported steady operational and clinical progress. A Q3 2025 earnings release highlighted strong VYJUVEK revenue growth and high gross margins, while multiple conference appearances underscored active investor engagement. Recent KB407 cystic fibrosis updates in early Jan 2026 confirmed successful CFTR delivery with mild-to-moderate safety findings. Against this backdrop, today’s preliminary 2025 revenue, cash balance disclosure, and expanded rare-disease pipeline plans extend the company’s trajectory of commercial execution plus advancing registrational programs.

Market Pulse Summary

This announcement highlighted preliminary 2025 VYJUVEK revenue of $388–$389 million, a solid cash an...

Analysis

This announcement highlighted preliminary 2025 VYJUVEK revenue of $388–$389 million, a solid cash and investment balance of $955 million, and a plan to advance multiple registrational rare-disease programs. KRYS aims for at least four marketed medicines by 2030 and to treat over 10,000 patients while remaining profitable. Investors may focus on upcoming KB803, KB801, KB407, and KB111 readouts, as well as 2026 non-GAAP R&D and SG&A spending of $175–$195 million, as key markers of execution and pipeline value.

Key Terms

hsv-1, platform technology designation, double-masked, randomized, placebo-controlled, +4 more

8 terms

hsv-1 medical

"leaning into our strengths – the strengths of our HSV-1 platform"

Herpes simplex virus type 1 (HSV-1) is a common virus that typically causes cold sores and can remain dormant in the body, like a sleeper agent that hides in nerve cells and sometimes flares up again. It matters to investors because treatments, vaccines, diagnostic tests, or complications linked to HSV-1 can drive revenue, regulatory scrutiny, or clinical trial risk for healthcare and biotech companies, affecting valuations and investment decisions.

platform technology designation regulatory

"a redosable HSV-1 platform with Platform Technology Designation that is well-suited"

A platform technology designation means a company’s core scientific method, software, or manufacturing approach is recognized as a reusable foundation that can support multiple products or applications. For investors, it signals potential for faster product development, lower marginal costs and diversified revenue streams—like a single toolkit that can build many different devices—so the business can scale more efficiently and spread risk across several programs.

double-masked technical

"registrational double-masked, randomized, placebo-controlled study from 27 to 60 patients"

Double-masked describes a clinical study setup where neither the people receiving treatments nor the researchers who administer or assess them know who gets the active therapy versus a placebo or comparison. This reduces conscious or unconscious bias and makes results more reliable for regulators and doctors. For investors, double-masked trials carry more credibility—like a taste test where neither the tasters nor the servers know which sample is which—so positive outcomes and approvals are taken more seriously.

randomized, placebo-controlled technical

"registrational double-masked, randomized, placebo-controlled study from 27 to 60 patients"

A randomized, placebo-controlled trial is a medical study where people are assigned by chance (like flipping a coin) to receive either the experimental treatment or an inactive substitute (a placebo), and neither participants nor often the researchers know who got which. For investors, this design is the gold standard for showing whether a therapy truly works beyond chance or expectation, which reduces uncertainty about regulatory approval, market adoption, and the commercial value of a drug or device.

phase 3 medical

"registrational Phase 3 study evaluating KB803 for the treatment of ocular complications"

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.

double-blind technical

"registrational double-blind, intra-patient randomized, placebo-controlled study evaluating KB111"

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.

non-small cell lung cancer medical

"including programs targeting larger indications such as KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

non-gaap financial

"expects its combined non-GAAP R&D and SG&A expense in 2026 to be between"

Non-GAAP refers to financial measures that companies use to show their earnings or performance without including certain expenses or income that are often added back to give a different picture. It matters because it can make a company's results look better or more favorable, but it may also hide important costs, so investors need to look at both GAAP (official rules) and non-GAAP numbers to get a full understanding.

AI-generated analysis. Not financial advice.

Preliminary 4Q 2025 VYJUVEK net revenue of $106 million to $107 million

Robust clinical pipeline with multibillion dollar opportunities and strong balance sheet for sustained growth

PITTSBURGH, Jan. 11, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced selected preliminary unaudited 2025 financial results, including fourth quarter and full year 2025 VYJUVEK® net product revenue, and outlined the Company’s strategic vision to drive the next stage of growth of its rare disease business. These topics will be discussed during the Company’s presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco tomorrow, Monday, January 12, 2026, at 10:30 am ET / 7:30 am PT.

“2025 was a standout year for Krystal, with the successful launch of VYJUVEK in Europe and Japan setting the foundation for our broader ambitions to build a true global leader in rare disease,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “As we execute on the next stage of our growth story, we will be leaning into our strengths – the strengths of our HSV-1 platform and the strengths of our organization – and focusing in on rare disease indications where we can move quickly and launch truly differentiated and impactful redosable genetic medicines. With multiple potential blockbuster launches in the next four years, as well as a strong growth outlook for VYJUVEK, we are well positioned to execute on this vision and deliver transformational outcomes for patients.”

Preliminary and Unaudited Fourth Quarter and Full Year 2025 Financial Updates

Based on preliminary unaudited financial information, the Company expects net product revenue for VYJUVEK to be between $106 million and $107 million for the fourth quarter of 2025. VYJUVEK net revenue for the full year 2025 is expected to be between $388 million and $389 million.

Cash, cash equivalents, and investments were approximately $955 million as of December 31, 2025.

These preliminary unaudited results are based on management’s initial analysis of operations for the year ended December 31, 2025 and subject to adjustment. The Company will report its full financial results for the fourth quarter and full year 2025 in February 2026.

Rare Disease Strategic Vision and 2026 Corporate Objectives

Over 300 million people around the world are living with rare diseases, many of whom lack adequate therapies. With global rare disease drug development and launch infrastructure and a redosable HSV-1 platform with Platform Technology Designation that is well-suited for gene delivery to high turnover tissues in the skin, lung, and eye, the Company is uniquely positioned to help fill this treatment gap.

To that end, the Company is accelerating and expanding clinical development efforts for its rare disease pipeline of programs:

• KB803 for ocular complications of dystrophic epidermolysis bullosa (DEB)
• KB801 for neurotrophic keratitis (NK)
• KB407 for cystic fibrosis (CF)
• KB111 for Hailey-Hailey disease (HHD)

In support of potential expedited development of KB801 for the treatment of NK, the Company has increased the enrollment target of its ongoing registrational double-masked, randomized, placebo-controlled study from 27 to 60 patients. The Company will provide a detailed update on the registrational study design when it reports its 2025 financial results in February 2026. Top line data from the study is expected before the end of 2026.

The Company’s strategic vision is to have at least four marketed rare disease medicines, inclusive of VYJUVEK, by the end of 2030, treating over 10,000 patients worldwide.

The Company expects to achieve these goals while remaining profitable throughout the period and continuing to invest strategically across its broader preclinical and clinical pipeline, including programs targeting larger indications such as KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer.

To achieve the Company’s broader ambitions in rare disease, the Company’s corporate objectives for 2026 include:

• Launch VYJUVEK in at least one more major European market and expand specialty distributor network to cover over 40 countries
• Report top-line results from its registrational Phase 3 study evaluating KB803 for the treatment of ocular complications of DEB
• Report top-line results from its registrational double-masked, randomized, placebo-controlled study evaluating KB801 for the treatment of NK
• Initiate and complete enrollment in a registrational repeat dose study evaluating KB407 for the treatment of CF
• Dose first patient in registrational double-blind, intra-patient randomized, placebo-controlled study evaluating KB111 in HHD patients
  
  

The Company also expects to report updates for both KB408 and KB707 before the end of the year.

Non-GAAP Research & Development (R&D) and Selling, General & Administrative (SG&A) Expense Guidance for 2026

Based on its current operating plans, the Company expects its combined non-GAAP R&D and SG&A expense in 2026 to be between $175 million and $195 million. Non-GAAP R&D and SG&A expense does not include stock-based compensation.

44^th Annual J.P. Morgan Healthcare Conference Presentation and Webcast

Krish S. Krishnan, Chairman and Chief Executive Officer, and Suma M. Krishnan, President of Research and Development, will highlight these updates and Krystal’s strategic vision in a presentation at the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 10:30 am ET / 7:30 am PT.

A webcast of the presentation will be available here beginning at 10:30 am ET / 7:30 am PT on Monday, January 12, 2026 and will be posted on the Investors section of the Company’s website.

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).

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 selected preliminary and unaudited financial results for 2025; our strategic vision and our 2026 corporate goals; our combined R&D and SG&A expense guidance; and our expectations for our product pipeline, including clinical trial plans, enrollment in clinical trials, and the timing of initiating clinical trials, dosing patients, data read-outs, and regulatory submissions 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 or 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 Measure

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. The Company believes this non-GAAP financial measure is useful to investors as a supplemental measure to evaluate operating performance. 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
Krystal Biotech
spaquette@krystalbio.com

FAQ

What did Krystal Biotech (KRYS) report for Q4 2025 VYJUVEK revenue?

Krystal reported preliminary unaudited Q4 2025 VYJUVEK net revenue of $106M–$107M.

What is Krystal Biotech's full‑year 2025 VYJUVEK revenue guidance?

The company expects full‑year 2025 VYJUVEK net revenue of $388M–$389M (preliminary unaudited).

How much cash did Krystal Biotech (KRYS) have at year‑end 2025?

Cash, cash equivalents, and investments were approximately $955 million as of Dec 31, 2025.

What clinical readouts and trial changes did Krystal announce for 2026?

Krystal increased enrollment in the NK registrational study from 27 to 60 patients and expects top‑line NK data and other registrational readouts before year‑end 2026.

What are Krystal's 2026 expense expectations for investors?

The company expects combined non‑GAAP R&D and SG&A expense of $175M–$195M in 2026 (excludes stock‑based compensation).

What are Krystal Biotech's commercialization goals through 2030?

The company aims to have at least four marketed rare‑disease medicines, including VYJUVEK, treating over 10,000 patients worldwide by end of 2030.