Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a
commercial-stage biotechnology company focused on the discovery,
development and commercialization of genetic medicines to treat
diseases with high unmet medical needs, today reported financial
results and key business updates for the third quarter ended
September 30, 2023.
“The third quarter was highlighted by strong commercial
execution of the VYJUVEK launch, advancement of the oncology
program into the clinic and continued momentum in the CF program,”
said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “With
respect to the VYJUVEK launch, our guiding vision is centered
around optimizing the patient experience, and we have and will
continue to work tirelessly to ensure that each patient’s journey,
with respect to starting on VYJUVEK and staying on it, is smooth,
timely and hassle free.”
VYJUVEK® (beremagene
geperpavec-svdt, or B-VEC)
For the treatment of Dystrophic Epidermolysis Bullosa (DEB)
- The Company received 284 Patient Start Forms from 136 unique
prescribers as of the end of the third quarter of 2023:
- 20% of the start forms were generated from patients with
dominant DEB;
- 33% of the start forms were from patients 10 years of age or
younger; and
- Patient compliance on VYJUVEK is currently tracking at
96%.
- The Company has received positive coverage determinations from
all major commercial national health plans. Optional Medicaid
fee-for-service states initiated coverage in July. The Company
expects to receive positive coverage from most mandatory states in
the fourth quarter of 2023 and the balance in the first quarter of
2024.
- In October, the Company filed for a Marketing Authorization for
B-VEC with the European Medical Agency and anticipates approval in
the EU in the second half of 2024.
- Following acceptance of the open label extension study of B-VEC
by Japan’s Pharmaceuticals and Medical Devices Agency in July 2023,
the Company initiated the extension study and dosed 5 patients.
Following completion of the open label extension study, the Company
intends to file a Japanese New Drug Application for B-VEC for DEB
in the first half of 2024. Details of the trial can be found at
https://rctportal.niph.go.jp/en under JRCT ID jRCT2053230075.
Respiratory
KB407 for the treatment of Cystic Fibrosis (CF)
- Cohort 1 of the Phase 1 (CORAL-1) study has been enrolled and
completed. No severe or serious adverse events were observed in
patients treated in Cohort 1 of the CORAL-1 study. We are working
to initiate Cohort 2 of the CORAL-1 study following safety review
by the Data Monitoring Committee. The CORAL-1 study is a
multi-center, dose-escalation trial of KB407 in patients with CF,
regardless of their underlying genotype. The Company anticipates
announcing data from the Phase 1 study in 2024. Details of the
Phase 1 study can be found at www.clinicaltrials.gov under NCT
identifier NCT05504837.
KB408 for the treatment of Alpha-1 Antitrypsin Deficiency
(AATD)
- In September, the Company announced that the U.S. Food and Drug
Administration (FDA) had cleared the Company’s Investigational New
Drug (IND) application for KB408 for the treatment of AATD and
granted KB408 Orphan Drug Designation. The Company expects to dose
the first patient in a Phase 1 clinical trial (SERPINA-1) in the
first quarter of 2024.
Oncology
KB707 for the treatment of solid tumors
- In October, the first patient was dosed in the Phase 1 (OPAL-1)
study to evaluate intratumoral KB707 in patients with locally
advanced or metastatic solid tumor malignancies. Details of the
study can be found at www.clinicaltrials.gov under NCT identifier
NCT05970497.
- The Company presented preclinical data in multiple oncology
models at the Society for Immunotherapy of Cancer’s annual meeting
on November 3 and 4, 2023. Combinatorial IL-2 and IL-12 expressed
from the Company’s platform technology was shown in one
presentation, to provide a synergistic effect in a melanoma model,
suppressing treated and non-treated tumor outgrowth, enhancing
survival, and eliciting a durable memory response sufficient for
recurrent tumor control. Similarly, the Company presented that
non-invasive inhalation of vector-encoded IL-2 and IL-12 was found
to be both safe and effective in treating lung tumors in a
metastasis model, resulting in long-term survival after single or
repeated cancer cell challenge, suggestive of prolonged adaptive
immunity.
- The Company is on track to file an amendment to the existing
KB707 IND in the fourth quarter of 2023 to allow the Company to
evaluate inhaled KB707 in a clinical trial to treat tumors in a
patient’s lungs. The Company expects to dose the first patient with
inhaled KB707 in the first half of 2024.
- In October, the United States Patent & Trademark Office
issued to the Company U.S. Patent No. 11,779,660 entitled Viral
Vectors for Cancer Therapy.
Dermatology
- The Company remains on track to commence the Phase 2 cohort of
its KB105-02 (JADE-1) trial for the treatment of TGM1-ARCI in 2024
and plans to file an IND application with the FDA and to initiate a
clinical trial of KB104 to treat patients with Netherton Syndrome
in late 2024.
Aesthetics
KB301 for the treatment of aesthetic indications
- In April, Jeune Aesthetics, Inc., a wholly-owned subsidiary of
the Company, announced the dosing of the first subject in the Phase
1, Cohort 3 study of KB301 for the improvement of lateral canthal
lines at rest. The study is on-going, and the Company plans to
announce results from this study in the first half of 2024. Details
of the Phase 1 study can be found at www.clinicaltrials.gov under
NCT identifier NCT04540900.
Business
- In August, the Company sold its Rare Pediatric Disease Priority
Review Voucher (PRV) for $100 million. The Company was awarded the
PRV in connection with the FDA’s accelerated approval of VYJUVEK
for the treatment of DEB for patients 6 months of age and
older.
- In August, the Company began research and development
operations in its second commercial scale CGMP biologics
manufacturing facility, ASTRA, a 155,000 sq. ft. state-of-the-art
CGMP facility with comprehensive end-to-end capabilities.
Financial results for the quarter ended
September 30, 2023:
- Cash, cash
equivalents, and investments totaled $598.6 million on
September 30, 2023.
- The Company recorded its first sales for patients that began
treatment in August 2023 and the resulting product revenues, net
totaled $8.6 million for the quarter ended September 30,
2023.
- Cost of goods sold totaled $223 thousand for the quarter ended
September 30, 2023. Prior to receiving FDA approval for
VYJUVEK in May 2023, costs associated with the manufacturing of
VYJUVEK were expensed as research and development expense. As such,
a portion of the cost of inventory sold during the period was
expensed prior to FDA approval.
- The Company recorded a gain of $100 million for the sale of the
rare pediatric disease Priority Review Voucher.
- Research and development expenses
for the quarter ended September 30, 2023 were $10.6 million,
inclusive of $2.3 million of stock-based compensation, compared to
$11.5 million, inclusive of stock-based compensation of $2.2
million for the quarter ended September 30, 2022.
- Selling, general, and administrative
expenses for the quarter ended September 30, 2023 were $23.7
million, inclusive of stock-based compensation of $6.0 million,
compared to $19.9 million, inclusive of stock-based compensation of
$6.9 million, for the quarter ended September 30, 2022.
- Net income (loss) for the quarters
ended September 30, 2023 and 2022 was $80.7 million and
$(29.9) million, or $2.88 and $(1.17), respectively, per common
share (basic) and $2.79 and $(1.17), respectively per common share
(diluted).
- For additional information on the Company’s financial results
for the quarter ended September 30, 2023, please refer to the
Form 10-Q filed with the SEC.
Financial results for the nine months ended
September 30, 2023:
- The Company recorded
its first sales for patients that began treatment in August 2023
and the resulting product revenues, net totaled $8.6 million for
the nine months ended September 30, 2023.
- Cost of goods sold totaled $223
thousand for the nine months ended September 30, 2023. Prior
to receiving FDA approval for VYJUVEK in May 2023, costs associated
with the manufacturing of VYJUVEK were expensed as research and
development expense. As such, a portion of the cost of inventory
sold during the period was expensed prior to FDA approval.
- The Company recorded a gain of $100 million for the sale of the
rare pediatric disease Priority Review Voucher.
- Research and
development expenses for the nine months ended September 30,
2023 were $35.1 million, inclusive of stock-based compensation of
$7.7 million, compared to $31.7 million, inclusive of stock-based
compensation of $5.5 million for the nine months ended
September 30, 2022.
- Selling, general, and administrative
expenses for the nine months ended September 30, 2023 were
$73.6 million, inclusive of stock-based compensation of $22.4
million, compared to $53.7 million, inclusive of stock-based
compensation of $18.1 million for the nine months ended
September 30, 2022.
- Net income (loss) for the nine
months ended September 30, 2023 and 2022 were $2.2 million and
$(107.9) million, or $0.08 and $(4.24), respectively, per common
share (basic) and $0.08 and $(4.24), respectively, per common share
(diluted).
- For additional information on the Company’s financial results
for the nine months ended September 30, 2023, please refer to
the Form 10-Q filed with the SEC.
Conference Call
Krystal Biotech will host a conference call to discuss its third
quarter 2023 financial results and business highlights today,
November 6, 2023, at 8:30 a.m. ET. To access the live call, please
preregister:
https://www.netroadshow.com/events/login?show=15609a11&confId=57029.
A replay of the conference call will be available on the
Investors section of the Company’s website at
https://www.krystalbio.com for 30 days following the event.
About VYJUVEK
VYJUVEK is a non-invasive, topical, redosable gene therapy
designed to deliver two copies of the COL7A1 gene when applied
directly to DEB wounds. VYJUVEK was designed to treat DEB at the
molecular level by providing the patient’s skin cells the template
to make normal COL7 protein, thereby addressing the fundamental
disease-causing mechanism.
Indication
VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based
gene therapy indicated for the treatment of wounds in patients six
months of age and older with dystrophic epidermolysis bullosa with
mutation(s) in the collagen type VII alpha 1 chain (COL7A1)
gene.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
The most common adverse drug reactions (incidence >5%) were
itching, chills, redness, rash, cough, and runny nose. These are
not all the possible side effects with VYJUVEK. Call your
healthcare provider for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Krystal
Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or
http://www.fda.gov/medwatch.
Contraindications
None.
Warnings and Precautions
VYJUVEK gel must be applied by a healthcare provider.
After treatment, patients and caregivers should be careful not
to touch treated wounds and dressings for 24 hours.
Wash hands and wear protective gloves when changing wound
dressings. Disinfect bandages from the first dressing change with a
virucidal agent, and dispose of the disinfected bandages in a
separate sealed plastic bag in household waste. Dispose of the
subsequent used dressings in a sealed plastic bag in household
waste.
Patients should avoid touching or scratching wound sites or
wound dressings.
In the event of an accidental exposure flush with clean water
for at least 15 minutes.
For more information, see full U.S. Prescribing Information
About Orphan Drug Designation
Orphan Drug Designation is granted by the FDA to investigational
therapies addressing rare medical diseases or conditions that
affect fewer than 200,000 people in the U.S. Orphan drug status
provides benefits to drug developers, including assistance in the
drug development process, tax credits for clinical costs,
exemptions from certain FDA fees and seven years of post-approval
marketing exclusivity.
About Fast Track Designation
Fast Track Designation is designed to facilitate the development
and expedite the review of drugs to treat serious conditions and
treat a serious or unmet medical need, enabling drugs to reach
patients sooner. Clinical programs with Fast Track designation may
benefit from early and frequent communication with the FDA
throughout the regulatory review process, and such clinical
programs may be eligible to apply for Accelerated Approval and
Priority Review if relevant criteria are met.
About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a commercial-stage
biotechnology company focused on the discovery, development and
commercialization of genetic medicines to treat diseases with high
unmet medical needs. VYJUVEK® is the Company’s first commercial
product, the first-ever redosable gene therapy, and the only
medicine approved by the FDA for the treatment of dystrophic
epidermolysis bullosa. The Company is rapidly advancing a robust
preclinical and clinical pipeline of investigational genetic
medicines in respiratory, oncology, dermatology, ophthalmology, and
aesthetics. Krystal Biotech is headquartered in Pittsburgh,
Pennsylvania. For more information, please visit
http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn
and Twitter.
About Jeune Aesthetics,
Inc.
Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal
Biotech, Inc., is a biotechnology company leveraging a clinically
validated gene-delivery platform to develop products to
fundamentally address – and reverse – the biology of aging and/or
damaged skin. For more information, please visit
http://www.jeuneinc.com.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Krystal Biotech, Inc. or Jeune Aesthetics,
Inc., including statements about the Company’s commercial launch of
VYJUVEK, including its expectations regarding positive coverage
determinations; the Company’s anticipation of potential B-VEC
approval in the EU in the second half of 2024; the Company’s
intention to file a Japanese New Drug Application for B-VEC for DEB
in the first half of 2024; the Company’s expectation that it will
announce data from the Phase 1 study of KB407 in 2024; the
Company’s plan to dose the first patient in the Phase 1 clinical
trial of KB408 in the first quarter of 2024; the Company’s plans to
file an amendment to the existing KB707 IND in the fourth quarter
of 2023 and to dose the first patient with inhaled KB707 in a
clinical trial to treat tumors in a patient’s lungs in the first
half of 2024; the Company’s plans to initiate the Phase 2 cohort of
the KB105-02 (JADE-1) trial in 2024; the Company’s plans to file an
IND application and initiate a clinical trial of KB104 in late
2024; the Company’s expectation that it will announce results of
the Phase 1, Cohort 3 study of KB301 for the improvement of lateral
canthal lines at rest in the first half of 2024, and other
statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “target,” “potential,” “likely,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: uncertainties
associated with regulatory review of clinical trials and
applications for marketing approvals, the availability or
commercial potential of VYJUVEK or product candidates, the
sufficiency of cash resources and need for additional financing and
such other important factors as are set forth under the caption
“Risk Factors” in the Company’s annual and quarterly reports on
file with the U.S. Securities and Exchange Commission. In addition,
the forward-looking statements included in this press release
represent the Company’s views as of the date of this press release.
The Company anticipates that subsequent events and developments
will cause its views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, it specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this press release.
CONTACT:Investors and Media:
Meg Dodge
Krystal Biotech
mdodge@krystalbio.com
Consolidated Balance Sheet Data:
(In
thousands) |
September 30,2023 |
|
December 31,2022 |
|
|
(unaudited) |
|
|
|
Balance sheet data: |
|
|
|
|
Cash and cash equivalents |
$ |
373,241 |
|
$ |
161,900 |
|
Short-term investments |
|
188,828 |
|
|
217,271 |
|
Long-term investments |
|
36,548 |
|
|
4,621 |
|
Total assets |
|
790,350 |
|
|
558,450 |
|
Total liabilities |
|
34,402 |
|
|
36,219 |
|
Total stockholders’ equity |
$ |
755,948 |
|
$ |
522,231 |
|
|
|
|
|
|
|
|
Consolidated Statements of Operations:
|
Three Months EndedSeptember
30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Change |
(In thousands, except
shares and per share data) |
(unaudited) |
|
|
Revenue |
|
|
|
|
|
Product revenues, net |
$ |
8,556 |
|
|
$ |
— |
|
|
$ |
8,556 |
|
Expenses |
|
|
|
|
|
Cost of goods sold |
|
223 |
|
|
|
— |
|
|
|
223 |
|
Research and development |
|
10,629 |
|
|
|
11,516 |
|
|
|
(887 |
) |
Selling, general, and administrative |
|
23,697 |
|
|
|
19,935 |
|
|
|
3,762 |
|
Total operating expenses |
|
34,549 |
|
|
|
31,451 |
|
|
|
3,098 |
|
Loss from operations |
|
(25,993 |
) |
|
|
(31,451 |
) |
|
|
5,458 |
|
Other
Income |
|
|
|
|
|
Gain from sale of Priority Review Voucher |
|
100,000 |
|
|
|
— |
|
|
|
100,000 |
|
Interest and other income, net |
|
6,740 |
|
|
|
1,601 |
|
|
|
5,139 |
|
Net income (loss) |
$ |
80,747 |
|
|
$ |
(29,850 |
) |
|
$ |
110,597 |
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
Basic |
$ |
2.88 |
|
|
$ |
(1.17 |
) |
|
|
Diluted |
$ |
2.79 |
|
|
$ |
(1.17 |
) |
|
|
|
|
|
|
|
|
Weighted-average common
sharesoutstanding: |
|
|
|
|
|
Basic |
|
28,042,130 |
|
|
|
25,619,125 |
|
|
|
Diluted |
|
28,892,226 |
|
|
|
25,619,125 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months EndedSeptember
30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Change |
(In thousands, except
shares and per share data) |
(unaudited) |
|
|
Revenue |
|
|
|
|
|
Product revenues, net |
$ |
8,556 |
|
|
$ |
— |
|
|
$ |
8,556 |
|
Expenses |
|
|
|
|
|
Cost of goods sold |
|
223 |
|
|
|
— |
|
|
|
223 |
|
Research and development |
|
35,061 |
|
|
|
31,720 |
|
|
|
3,341 |
|
Selling, general, and administrative |
|
73,637 |
|
|
|
53,705 |
|
|
|
19,932 |
|
Litigation settlement |
|
12,500 |
|
|
|
25,000 |
|
|
|
(12,500 |
) |
Total operating expenses |
|
121,421 |
|
|
|
110,425 |
|
|
|
10,996 |
|
Loss from operations |
|
(112,865 |
) |
|
|
(110,425 |
) |
|
|
(2,440 |
) |
Other
Income |
|
|
|
|
|
Gain from sale of Priority Review Voucher |
|
100,000 |
|
|
|
— |
|
|
|
100,000 |
|
Interest and other income, net |
|
15,105 |
|
|
|
2,502 |
|
|
|
12,603 |
|
Net income (loss) |
$ |
2,240 |
|
|
$ |
(107,923 |
) |
|
$ |
110,163 |
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
Basic |
$ |
0.08 |
|
|
$ |
(4.24 |
) |
|
|
Diluted |
$ |
0.08 |
|
|
$ |
(4.24 |
) |
|
|
|
|
|
|
|
|
Weighted-average common
sharesoutstanding: |
|
|
|
|
|
Basic |
|
26,812,278 |
|
|
|
25,428,097 |
|
|
|
Diluted |
|
27,384,539 |
|
|
|
25,428,097 |
|
|
|
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