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Krystal Biotech, Inc.

For the period ended Mar 31, 2026. Filed May 4, 2026.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 4, 2026

KRYS$303.06+0.7%Stored close · as of Nov 9, 2026

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Notes to Condensed Consolidated Financial Statements (unaudited)

Notes to Condensed Consolidated Financial Statements

  1. Organization

Krystal Biotech, Inc. (together with its wholly-owned subsidiaries, the “Company,” or “we” or other similar pronouns), a Delaware C-corporation, is a fully integrated, global, commercial-stage biotechnology company. We are focused on the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Using our patented gene therapy technology platform that is based on engineered herpes simplex virus-1 (“HSV-1”), we create vectors that efficiently deliver therapeutic transgenes to cells of interest in multiple organ systems. The cell’s own machinery then transcribes and translates the transgene to treat the disease. Our vectors are amenable to formulation for non-invasive or minimally invasive routes of administration at a healthcare professional’s office or in the patient’s home. Our innovative technology platform is supported by two in-house, commercial scale Current Good Manufacturing Practice (“CGMP”) manufacturing facilities.

Liquidity

As of March 31, 2026, the Company had a retained earnings balance of $80.1 million. Our operating profitability is dependent upon the continued successful commercialization of VYJUVEK, our U.S. Food and Drug Administration (“FDA”), European Commission (“EC”), and Japan’s Ministry of Health, Labour, and Welfare (“MHLW”) approved product, as well as successful development, approval and commercialization of our product candidates. Management intends to fund future operations through its on hand cash and cash equivalents and revenue generated from the sale of VYJUVEK, and may also seek additional capital through arrangements with strategic partners, the sale of equity, debt financings or other sources.

The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, the failure of product candidates in clinical and preclinical studies, the development of competing product candidates or other technological innovations by competitors, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to commercialize product candidates. The Company expects to incur significant costs in connection with, among other things, advancing its product pipeline, expanding its commercialization capabilities, and complying with EU post-authorization regulatory requirements and EU member state-specific pricing, reimbursement, and market access activities. The Company believes that its cash and cash equivalents and short-term investments of approximately $823.4 million as of March 31, 2026 will be sufficient to allow the Company to fund its planned operations for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.

  1. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). In the opinion of management, all adjustments, which consist of all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods presented, are reflected in the interim condensed consolidated financial statements. All intercompany balances and transactions have been eliminated in consolidation.

Certain prior period amounts have been reclassified to conform to the current period presentation. The reclassified amounts have no impact on the Company’s previously reported financial position or results of operations.

The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “2025 10-K”), as filed with the U.S. Securities and Exchange Commission (“SEC”) on February 17, 2026.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors and applies significant judgment in developing the estimates and assumptions that are used in the preparation of these financial statements. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates in the period these variances become known. Estimates are used in the following areas, among others: variable consideration associated with revenue recognition, stock-based compensation expense, accrued expenses, and income taxes.

Summary of Significant Accounting Policies

See Note 2 to our consolidated financial statements included in the 2025 10-K. There were no material changes to the Company’s significant accounting policies during the three months ended March 31, 2026.

Recently Issued Accounting Pronouncements, Not Yet Adopted

There were no accounting pronouncements issued or adopted during the three months ended March 31, 2026 that had or are expected to have a material impact on the Company’s condensed consolidated financial statements.

In November 2024, the Financial Accounting Standards Board (“FASB”) issued ASU 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This standard calls for enhanced disclosures about components of expense captions on the face of the income statement. This standard will be effective for fiscal years beginning after December 15, 2026, with the option to apply it retrospectively. Early adoption is allowed. Currently, the Company is assessing the potential impact of this guidance on its consolidated financial statement disclosures.

In December 2025, the FASB issued ASU 2025-11 Interim Reporting (Topic 270): Narrow-Scope Improvements. This standard clarifies current interim reporting requirements on Topic 270 and introduces a disclosure principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. This standard will be effective for fiscal years beginning after December 15, 2027, with the option to apply it retrospectively. Early adoption is allowed. Currently, the Company is assessing the potential impact of this guidance on its condensed consolidated financial statement disclosures.

  1. Product Revenue, Accounts Receivable and Reserves for Product Sales

The Company’s product revenue, net of sales discounts and allowances totaled $116.4 million and $88.2 million for the three months ended March 31, 2026 and March 31, 2025, respectively. Product revenue by significant geographic region is as follows:

Three Months Ended March 31,
20262025
United States$87,489$88,183
Europe20,677—
Japan8,191—
Total product revenue, net$116,357$88,183

The Company’s accounts receivable, net balance relating to VYJUVEK sales was $127.0 million as of March 31, 2026 and $127.4 million as of December 31, 2025. Accounts receivable, net from the Company’s customers who individually accounted for 10% or more of accounts receivable, net consisted of the following:

Percent of Accounts Receivable, Net
March 31,2026December 31,2025
Customer A62%66%
Customer B13%14%

All other single customers represent less than 10% of outstanding accounts receivable, net in the applicable period.

The following table summarizes changes in allowances and discounts for the three months ended March 31, 2026:

(in thousands)RebatesPrompt PayOther AccrualsTotal
Balance as of December 31, 2025$61,905$5,834$378$68,117
Provisions22,3353,3496025,744
Payments/Credits(8,399)(3,845)(278)(12,522)
Balance as of March 31, 2026$75,841$5,338$160$81,339

Rebates are included in accrued rebates and other long-term liabilities on the condensed consolidated balance sheets. Other long-term liabilities are comprised of $5.1 million and $3.7 million of long-term accrued rebates as of March 31, 2026 and December 31, 2025, respectively. Prompt pay discount is recorded as an allowance against accounts receivable, net on the condensed consolidated balance sheets. Other accruals are included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. Provisions for rebates, prompt pay discounts and other accruals are recorded reductions to product revenue, net on the condensed consolidated statements of operations and comprehensive income.

  1. Net Income Per Share Attributable to Common Stockholders

Basic net income per share attributable to common stockholders is calculated by dividing net income attributable to common stockholders by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net income per share attributable to common stockholders is computed by dividing the net income by the weighted-average number of shares of common stock and common stock equivalents outstanding for the period. Common stock equivalents consist of common stock issuable upon (1) exercise of stock options and (2) vesting of restricted stock awards, restricted stock units and performance-based restricted stock units (collectively, “restricted stock”).

For the three months ended March 31, 2026 and 2025, respectively, there were 376 thousand and 413 thousand common stock equivalents outstanding in the form of stock options and 50 thousand and 48 thousand in unvested restricted stock, that have each been excluded from the calculation of diluted net income per common share as their effect would be anti-dilutive.

Three Months Ended March 31,
(in thousands, except per share data)20262025
Numerator:
Net income$55,932$35,733
Denominator:
Weighted-average basic common shares29,28828,815
Dilutive effect of stock options and unvested restricted stock1,2191,056
Weighted-average diluted common shares30,50729,871
Net income per common share—basic$1.91$1.24
Net income per common share—diluted$1.83$1.20
  1. Fair Value Instruments

The following tables show the Company’s cash and cash equivalents and available-for-sale securities by significant investment category as of March 31, 2026 and December 31, 2025:

March 31, 2026
(in thousands)Amortized CostGross Unrealized GainsGross Unrealized (Losses)Aggregate Fair ValueCash and Cash EquivalentsShort-term Marketable Securities(1)Long-term Marketable Securities(2)
Level 1:
Cash and cash equivalents$501,313$—$—$501,313$501,313$—$—
Subtotal501,313——501,313501,313——
Level 2:
Corporate bonds229,575125(348)229,352—147,36981,983
U.S. government agency securities286,398165(338)286,225—174,723111,502
Subtotal515,973290(686)515,577—322,092193,485
Total$1,017,286$290$(686)$1,016,890$501,313$322,092$193,485
December 31, 2025
(in thousands)Amortized CostGross Unrealized GainsGross Unrealized (Losses)Aggregate Fair ValueCash and Cash EquivalentsShort-term Marketable Securities(1)Long-term Marketable Securities(2)
Level 1:
Cash and cash equivalents$496,304$—$—$496,304$496,304$—$—
Subtotal496,304——496,304496,304——
Level 2:
Commercial paper12,8872(1)12,888—12,888—
Corporate bonds211,268535(6)211,797—142,80168,996
U.S. government agency securities234,216653(1)234,868—175,79859,070
Subtotal458,3711,190(8)459,553—331,487128,066
Total$954,675$1,190$(8)$955,857$496,304$331,487$128,066

(1)The Company’s short-term marketable securities mature inone year or less.

(2)The Company’s long-term marketable securities mature betweenone andtwo years.

  1. Balance Sheet Components

Inventory

Inventory consisted of the following:

(in thousands)March 31,2026December 31,2025
Raw materials$15,173$15,938
Work-in-process15,11515,224
Finished goods12,3589,313
Inventory$42,646$40,475

Property and Equipment, Net

Property and equipment, net consisted of the following:

(in thousands)March 31,2026December 31,2025
Building and building improvements$109,256$109,242
Manufacturing equipment30,20229,279
Leasehold improvements27,22727,227
Construction in progress12,3418,108
Laboratory equipment3,5213,490
Computer equipment and software2,6162,559
Furniture and fixtures2,1912,152
Total property and equipment187,354182,057
Accumulated depreciation(33,772)(31,281)
Property and equipment, net$153,582$150,776

Depreciation expense was $1.5 million and $1.4 million for the three months ended March 31, 2026 and 2025, respectively. Depreciation expense capitalized into inventory was $1.0 million for the three months ended March 31, 2026 and 2025.

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following as of March 31, 2026 and December 31, 2025:

(in thousands)March 31,2026December 31,2025
Accrued taxes$13,110$10,919
Accrued payroll and benefits4,93811,457
Accrued professional fees4,3475,936
Accrued preclinical and clinical expenses3,8014,667
Other current liabilities3,1763,579
Accrued inventory1,0401,005
Accrued construction in progress7842,189
Accrued expenses and other current liabilities$31,196$39,752
  1. Commitments and Contingencies

Agreements with Contract Manufacturing Organizations and Contract Research Organizations

The Company enters into various agreements in the normal course of business with Contract Manufacturing Organizations (“CMOs”), Contract Research Organizations (“CROs”) and other third parties for preclinical research studies, clinical trials and testing and manufacturing services. The agreements with CMOs primarily relate to the manufacturing of our sterile gel that is mixed with in-house produced vectors as part of the final drug product for VYJUVEK. Agreements with third parties may also include research and development consulting activities, clinical-trial agreements, testing of our clinical-stage, pre-commercial and commercial stage products and/or storage, packaging and labeling. The Company is obligated to make milestone payments under certain of these contracts. The Company incurred research and development expenses related to commitments under these agreements of $2.5 million for the three months ended March 31, 2026 and $2.2 million for the three months ended March 31, 2025.

Legal Proceedings

In the ordinary course of business, the Company may be subject from time to time to various proceedings, lawsuits, disputes, or claims. In accordance with FASB ASC Topic 450, Contingencies (“ASC 450”), the Company accrues a liability for legal contingencies when it is probable that a liability has been incurred, and the amount of the loss can be reasonably estimated. If there is at least a reasonable possibility that a loss may be incurred, ASC 450 requires disclosure of a loss contingency.

In the first quarter of 2025, the Company and certain of its employees received subpoenas from the U.S. Department of Justice requesting that the Company produce certain documents regarding its sponsored genetic testing program relating to

VYJUVEK and commercial practices relating thereto. The Company is cooperating and providing information in response to the subpoenas. It is not possible to estimate the amount of any loss or range of possible loss that might result from this inquiry, and because the final outcome cannot be predicted with certainty, unfavorable or unexpected developments or outcomes could result in a material impact to the Company’s results of operations.

On September 18, 2025, a stockholder filed a derivative complaint in the Court of Chancery of the state of Delaware naming the Company’s directors as defendants and the Company as a nominal defendant. The complaint alleged claims for breach of fiduciary duty, unjust enrichment, and waste of corporate assets based on allegedly excessive non-employee director compensation in each of 2021 through 2024. The parties have reached an agreement in principle on settlement terms but must still negotiate and execute a definitive settlement agreement, which will be filed with the Delaware Court of Chancery and is subject to court approval upon the conclusion of a settlement hearing concerning the fairness of the terms of the proposed settlement. If approved, the Company will adopt, implement, and maintain certain corporate governance reforms for a period offive (5) years. The Company has recorded a liability for an estimated amount of the settlement. The estimated amount of settlement is not material to the condensed consolidated financial statements.

  1. Leases

As of March 31, 2026, future minimum commitments under the Company’s operating leases with lease terms in excess of 12 months were as follows:

(in thousands)Operating Leases
2026 (remaining nine months)$1,417
20271,919
20281,954
20291,990
20302,016
Thereafter7,279
Future minimum operating lease payments16,575
Less: Interest(7,463)
Present value of lease liability$9,112

As of March 31, 2026 and December 31, 2025, the Company’s weighted-average remaining lease term for operating leases was 10.0 years and 10.1 years, respectively, and the Company’s weighted-average discount rate for operating leases was 9.7% as of March 31, 2026 and December 31, 2025.

The components of the Company’s lease expense are as follows:

Three Months Ended March 31,
(in thousands)20262025
Operating lease expense$411$426
Variable lease expense6364
Total lease expense$474$490
  1. Stock-Based Compensation

In 2017, the Company adopted the 2017 IPO Stock Incentive Plan (“Plan”), which governs the issuance of equity awards to employees, certain non-employee consultants, and directors. Initially, the Company reserved 900 thousand shares for issuance under the Plan with an initial sublimit for incentive stock options of 900 thousand shares. On an annual basis, the amount of shares available for issuance under the Plan increases by an amount equal tofour percent of the total outstanding shares as of the last day of the preceding calendar year. The sublimit of incentive stock options is not subject to the increase. The Company has historically granted stock options, restricted stock awards (“RSAs”), restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”) to certain employees.

Shares of common stock remaining available for grant under the Plan were approximately 1.6 million as of March 31, 2026.

Stock Options

The following table summarizes the Company’s stock option activity for the three months ended March 31, 2026:

Stock Options OutstandingWeighted-Average Exercise PriceWeighted-Average Remaining Contractual Life(in years)Aggregate Intrinsic Value(1)(in thousands)
Outstanding as of December 31, 20252,030,417$99.456.8$298,662
Granted275,500$275.37
Exercised(145,130)$44.79
Cancelled or forfeited(53,605)$156.67
Outstanding as of March 31, 20262,107,182$124.767.0$286,111
Exercisable as of March 31, 20261,268,779$82.985.8$222,474

(1)Aggregate intrinsic value represents the difference between the closing stock price of our common stock on December 31, 2025 and March 31, 2026 and the exercise price of outstanding in-the-money options on the respective date.

The following table summarizes the Company’s stock option activity for the three months ended March 31, 2025:

Stock Options OutstandingWeighted-Average Exercise PriceWeighted-Average Remaining Contractual Life(in years)Aggregate Intrinsic Value(1)(in thousands)
Outstanding as of December 31, 20242,049,063$82.697.3$156,404
Granted255,773$176.00
Exercised(17,123)$85.39
Cancelled or forfeited(25,240)$107.01
Outstanding as of March 31, 20252,262,473$92.947.4$198,813
Exercisable as of March 31, 20251,168,812$69.136.4$130,018

(1)Aggregate intrinsic value represents the difference between the closing stock price of our Common Stock on December 31, 2024 and March 31, 2025 and the exercise price of outstanding in-the-money options on the respective date.

The total intrinsic value (the amount by which the fair market value exceeds the exercise price) of stock options exercised was $32.1 million and $1.4 million during the three months ended March 31, 2026 and 2025, respectively.

The weighted-average grant-date fair value per share of options granted to employees and directors was $175.20 and $116.88 during the three months ended March 31, 2026 and 2025, respectively.

There was $92.8 million of unrecognized stock-based compensation expense related to employees’ and directors’ options that is expected to be recognized over a weighted-average period of 3.2 years as of March 31, 2026.

Restricted Stock Units

The following table summarizes the Company’s RSU activity:

Three Months Ended March 31,
20262025
Number of SharesWeighted-Average Grant Date Fair ValueNumber of SharesWeighted-Average Grant Date Fair Value
Non-vested RSUs, beginning of period331,574$152.97308,096$135.22
Granted96,322$275.64130,556$179.25
Vested(105,767)$143.50(84,097)$129.56
Forfeited(11,945)$156.52(5,798)$154.56
Non-vested RSUs, end of period310,184$194.16348,757$152.75

There was $58.1 million of unrecognized stock-based compensation expense related to employees’ RSU awards that is expected to be recognized over a weighted-average period of 3.1 years as of March 31, 2026.

Performance-Based Restricted Stock Units

The following table summarizes the Company’s PSU activity:

Three Months Ended March 31,
20262025
Number of SharesWeighted-Average Grant Date Fair ValueNumber of SharesWeighted-Average Grant Date Fair Value
Non-vested PSUs, beginning of period56,250$159.47137,500$145.37
Granted43,536$275.64—$—
Vested(56,250)$159.47(81,250)$135.61
Forfeited—$——$—
Non-vested PSUs, end of period43,536$275.6456,250$159.47

PSUs granted during the period are subject to regulatory performance-based vesting conditions, as determined by the Compensation Committee of the Company’s Board of Directors, and vest on a three year cliff basis upon satisfaction of such conditions.

There was $11.6 million of unrecognized stock-based compensation expense related to employees’ PSU awards that is expected to be recognized over a weighted-average period of 2.9 years as of March 31, 2026.

Stock-Based Compensation Expense, Net

The Company recorded stock-based compensation expense, net related to its stock options and restricted stock in the condensed consolidated statements of operations and comprehensive income for the three months ended March 31, 2026 and 2025 as follows:

Three Months Ended March 31,
(in thousands)20262025
Research and development2,1772,469
Selling, general and administrative11,43211,009
Total stock-based compensation$13,609$13,478

The Company capitalized stock-based compensation associated with the allocation of labor costs related to work performed to manufacture VYJUVEK of $0.8 million and $1.0 million for the three months ended March 31, 2026 and 2025, respectively, into inventory.

  1. Income Taxes

The Company recorded an income tax expense of $5.5 million for the three months ended March 31, 2026. The tax expense for interim periods is calculated using an estimate of the annual effective tax rate, adjusted for discrete items. If there are any changes to the estimated annual effective tax rate, the Company will make a cumulative adjustment to the income tax provision in the period the change becomes known. The Company recorded an income tax expense of $7.9 million for the three months ended March 31, 2025.

We monitor the realizability of our deferred tax assets taking into consideration all relevant factors at each reporting period. As of March 31, 2026, except for certain state net operating loss carryforward and tax credit carryforward, we do not have valuation allowance against deferred tax assets. We continue to maintain a full valuation allowance against certain state attributes as of March 31, 2026, because we concluded they are not more likely than not to be realized as we expect certain state attribute generation in future years to exceed our ability to use these deferred tax assets.

We are subject to income taxes in the U.S. and in many foreign jurisdictions. Significant judgment is required in determining our provision for income taxes, our deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets that are not more likely than not to be realized. The determination of the realizability of deferred tax assets requires significant judgment in assessing the likelihood of future tax consequences. The Company previously maintained a full valuation allowance against its U.S. federal and state deferred tax assets due to historical cumulative losses and uncertainty regarding the realization of such assets. The Company will continue to evaluate all available evidence each reporting period and may adjust the valuation allowance in future periods if estimates of future taxable income or other relevant factors change.

  1. Segment Information

The Company operates asone operating segment, which is focused on the discovery, development, manufacturing and commercialization of genetic medicines to treat diseases with high unmet medical needs. The Company’s chief operating decision maker (“CODM”), our chief executive officer, utilizes financial information presented on a consolidated basis to manage and allocate resources. The CODM uses consolidated gross margin, operating margin, net income and total research and development expenses by product candidate or program to assess performance, forecast future financial results and to allocate resources.

The following table presents selected financial information with respect to the Company’s single operating segment for the three months ended March 31, 2026, and 2025:

Three Months Ended
(in thousands)March 31, 2026March 31, 2025
Product revenue, net$116,357$88,183
Cost of goods sold6,3235,028
Gross margin95%94%
B-VEC5471,973
KB11199227
KB3043242
KB407762349
KB408143298
KB7072,4322,738
KB801787454
KB8031,142486
Other research programs736692
Other research and development costs (1)7,7876,997
Total research and development15,33114,256
Selling, general and administrative41,01432,647
Income from operations$53,689$36,252
Other income
Interest and other income, net7,7537,345
Income before income taxes$61,442$43,597
Income tax expense(5,510)(7,864)
Net income$55,932$35,733

(1)Includes stock-based compensation, other manufacturing expenses related to our product candidates and other unallocated expenses which largely relates to depreciation and other facilities and equipment related costs.

  1. Subsequent Events

The Company evaluates events or transactions that occur after the balance sheet date, but prior to the issuance of the financial statements, to identify matters that require recognition or disclosure. The Company concluded that no subsequent events have occurred, that would require recognition or disclosure in the condensed consolidated financial statements.

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