Krystal Biotech, Inc.: Q2 FY2026 earnings call
What management said about Q2 FY2026, from the documents filed with the SEC on 3 August 2026: press release. Guidance figures: 5 kept. The quarter’s numbers.
Key takeaways
- VYJUVEK revenue rose 24%: Global VYJUVEK net product revenue was $119.2 million for the second quarter, up 24% from the prior-year quarter. Cumulative revenue since launch reached $965.9 million. Source
- Net income rose to $54.8 million: Net income was $54.8 million, or $1.79 diluted EPS, against $38.3 million, or $1.29 diluted EPS, a year earlier. Six-month net income was $110.7 million, or $3.62 diluted EPS. Source
- IOLITE readout due 4Q 2026: KB803 IOLITE, a registrational study for corneal abrasions in DEB, was fully enrolled in April. Top-line readout is due 4Q 2026, against the prior plan for results before year end. Source
- KYANITE-1 response rate reported: Interim KYANITE-1 data in late-line NSCLC showed a 31% objective response rate and 75% disease control rate for inhaled KB707 plus pembrolizumab. Updated results are now due 1H 2027. Source
- Italy and Spain launches before year end: Pricing talks in Italy and Spain are progressing. Management continues to expect commercial launches in both countries before year end, against a potential Italian launch in 2H 2026 previously. Source
- Cash and investments reached $1.1 billion: Cash, cash equivalents and investments totaled $1.1 billion at June 30, 2026, against $955.9 million at December 31, 2025. Cash and cash equivalents alone were $427.7 million. Source
“Our second quarter reflects the strength of the Krystal model: a global commercial product that continues to perform, a strong balance sheet, and a pipeline now moving toward multiple registrational readouts,”
Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Non-GAAP combined R&D and SG&A expense Source | FY 2026 | $175.0 - $195.0 million | Kept |
| VYJUVEK pricing in Germany and France Source | until 2H 2026 (Germany); into 2027 (France) | at least 2H 2026 in Germany; into 2027 in France | Kept |
| EMERALD-1 enrollment (KB801) Source | before year end 2026 | approximately 60 patients | Kept |
| IOLITE top-line readout (KB803) Source | 4Q 2026 | 4Q 2026 | Kept |
| KB407 registrational study start Source | 2027 | start in 2027; design alignment with FDA expected 4Q 2026 | |
| KB111 registrational study start Source | 2027 | registrational study start in 2027 | |
| KB408 interim results (AATD lung disease) Source | 2027 | 2027 | |
| KYANITE-1 updated interim results and registrational plans (NSCLC) Source | 1H 2027 | 1H 2027 | |
| KB304 Phase 2 study (aesthetics) Source | 2027 | initiate Phase 2 in 2027 | Kept |
What changed from last quarter
- Guidance kept: The FY 2026 non-GAAP combined R&D and SG&A expense range of $175.0 to $195.0 million is the same as in the prior release. Source
- New: VYJUVEK was approved by the UK Medicines and Healthcare products Regulatory Agency in May. The prior release did not mention a UK approval. Source
- New: A commercial launch in Spain before year end is now expected, in addition to Italy. Source
- New: HALITE-1, an open label study of KB111 for Hailey-Hailey disease, has started enrolling and dosing patients. Source
- New: The intratumoral KB707 study OPAL-1 was expanded to patients with Gorlin syndrome. Source
- New: Multiple marketing authorization applications for VYJUVEK are planned for 2H 2026, including Switzerland and Australia. Source
- New: The KB407 registrational study is on track to start in 2027, after FDA alignment on design expected in 4Q 2026. Source
Revenue and VYJUVEK sales
- VYJUVEK revenue rose 24%: Global VYJUVEK net product revenue was $119.2 million for the second quarter, up 24% from the prior-year quarter. Cumulative revenue since launch reached $965.9 million. Source
- Six-month product revenue higher: Product revenue, net was $235.6 million for the first six months of 2026, against $184.2 million for the same period of 2025. Source
- Gross margin at 95%: Gross margin was 95% for the quarter, against 94% for fourth quarter 2025 in the prior release. Management linked US launch performance to demand and reimbursement access. Source
Costs, margins and profit
- Net income rose to $54.8 million: Net income was $54.8 million, or $1.79 diluted EPS, against $38.3 million, or $1.29 diluted EPS, a year earlier. Six-month net income was $110.7 million, or $3.62 diluted EPS. Source
- Cost of goods sold lower: Cost of goods sold was $6.4 million, against $7.2 million a year earlier, while product revenue rose over the same period. Source
- SG&A expense increased: SG&A expense was $39.9 million, against $35.1 million a year earlier. Stock-based compensation within SG&A was $11.7 million, against $11.5 million. Source
- R&D expense near prior level: R&D expense was $14.5 million, against $14.4 million a year earlier, including $2.5 million of stock-based compensation. Source
“We believe the next 12 to 18 months have the potential to mark an important transition for Krystal from a commercial success story to a multi-product genetic medicines company.”
Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech
Pipeline readouts and trial timing
- IOLITE readout due 4Q 2026: KB803 IOLITE, a registrational study for corneal abrasions in DEB, was fully enrolled in April. Top-line readout is due 4Q 2026, against the prior plan for results before year end. Source
- KYANITE-1 response rate reported: Interim KYANITE-1 data in late-line NSCLC showed a 31% objective response rate and 75% disease control rate for inhaled KB707 plus pembrolizumab. Updated results are now due 1H 2027. Source
- KB111 HALITE-1 started dosing: HALITE-1, a 12-week open label study of KB111 in Hailey-Hailey disease, has begun enrolling and dosing. An FDA meeting is planned after the study completes. Source
- KB407 and KB408 timing: KB407 repeat-dose study expects about five patients and interim results before year end. KB408 interim results moved to 2027, from 2026 in the prior release. Source
European and international launches
- Italy and Spain launches before year end: Pricing talks in Italy and Spain are progressing. Management continues to expect commercial launches in both countries before year end, against a potential Italian launch in 2H 2026 previously. Source
- Germany and France pricing talks continue: Pricing discussions with German and French authorities remain ongoing, expected until at least 2H 2026 in Germany and into 2027 in France. Source
- UK approval and pricing talks: The UK regulator approved VYJUVEK in May. UK pricing discussions are now underway, and the product received a Prix Galien UK award for Best Product for Orphan Disease in June. Source
- Further filings planned 2H 2026: Multiple additional marketing authorization applications for VYJUVEK are expected to be filed in 2H 2026, including in Switzerland and Australia. Source
Reimbursement, prescribers and patient support
- Reimbursement approvals above 730: The company has over 730 reimbursement approvals for VYJUVEK in the US, against over 660 in the February release. Unique prescribers grew to over 640 by end of 2Q 2026. Source
- Label update aids patient support: Patient support initiatives are helping DEB patients use the recent label update and greater administration flexibility within wound care routines. Source
- International demand growing: Management said VYJUVEK continues to gain momentum in its initial launch markets, with growing physician engagement, patient starts and prescription demand. Source
Cash, balance sheet and capital
- Cash and investments reached $1.1 billion: Cash, cash equivalents and investments totaled $1.1 billion at June 30, 2026, against $955.9 million at December 31, 2025. Cash and cash equivalents alone were $427.7 million. Source
- Stockholders’ equity increased: Total stockholders’ equity was $1,359.1 million at June 30, 2026, against $1,219.6 million at December 31, 2025. Total liabilities were $141.5 million. Source
- Diluted share count higher: Weighted-average diluted shares were 30.7 million for the quarter, against 29.7 million a year earlier. Source
Strategy and pipeline breadth
- Pipeline spans eye, lung and skin: Management said the company is advancing rare disease programs across the eye, lung and skin, building on VYJUVEK's experience with the redosable platform. Source
- Respiratory candidates shown preclinically: Early-stage respiratory genetic medicine candidates for primary ciliary dyskinesia were presented with preclinical data in May at the ASGCT 2026 annual meeting. Source
- KB707 scope expanded to Gorlin: After early signals in basal cell carcinoma patients at the lowest intratumoral dose, OPAL-1 was expanded. Three Gorlin syndrome patients are enrolled, with an interim update due later this year. Source
- Aesthetics Phase 2 set for 2027: Jeune Aesthetics, a wholly owned subsidiary, expects to start a Phase 2 study of KB304 for décolleté wrinkles in 2027. Source
Coming up, as management said on 3 August 2026
- IOLITE top-line readout: Top-line data from the KB803 IOLITE study is expected in 4Q 2026. Source
- Italy and Spain launches: Commercial launches in Italy and Spain are expected before year end, with pricing talks progressing. Source
- EMERALD-1 enrollment completion: Enrollment of about 60 patients in EMERALD-1 is expected to complete before year end. Source
- KB407 interim results: Interim results from the KB407 study with about five patients are expected before year end. Source
- KB111 interim results: Interim results from HALITE-1 with about seven patients are expected before year end. Source
- FDA meeting on KB111: A meeting with the FDA is planned after HALITE-1 completes, to discuss results, the scale and study designs. Source
- KYANITE-1 updated results: Updated interim results and potential registrational plans for inhaled KB707 are planned for 1H 2027. Source
- Gorlin syndrome interim update: An interim update on the Gorlin syndrome patients and development plans for intratumoral KB707 are expected later this year. Source
- KB304 Phase 2 start: A Phase 2 study of lead aesthetics program KB304 is expected to start in 2027. Source
- Germany and France pricing talks: Pricing talks with German and French authorities are expected to continue until at least 2H 2026 and into 2027. Source
Figures management reported
| Figure | Reported |
|---|---|
| VYJUVEK net product revenue, 2Q 2026 Source | $119.2 million |
| VYJUVEK cumulative revenue since launch Source | $965.9 million |
| Gross margin, 2Q 2026 Source | 95% |
| Product revenue, net, six months 2026 Source | $235.6 million |
| R&D expense, 2Q 2026 Source | $14.5 million |
| US reimbursement approvals for VYJUVEK Source | over 730 |
| UK regulatory approval of VYJUVEK Source | May 2026 |
| Pipeline readout, KB803 IOLITE top-line Source | 4Q 2026 |
| KYANITE-1 objective response rate, late-line NSCLC Source | 31% |
Risks management discussed
- Regulatory: Reimbursement pricing talks in Germany and France remain ongoing, with the French discussions expected to run into 2027. Source
- Financial: Management said it cannot confidently estimate 2026 stock-based compensation, so GAAP combined R&D and SG&A expense is not guided. Source
Earlier plans management reported on
- On track: Management stated it is on track for VYJUVEK launches in Spain and Italy later this year. Source
- On track: Management stated the IOLITE study is on track for a top-line readout in 4Q 2026. Source
- On track: Management stated the company is on track to initiate the KB407 registrational study in 2027. Source
- Not stated: Management referred to pricing discussions continuing until at least 2H 2026 in Germany and into 2027 in France. Source
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.