Krystal Biotech Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress
February 27 2023 - 7:00AM
Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), a
biotechnology company focused on developing and commercializing
genetic medicines, today reported financial results and key
operational updates for the fourth quarter and year ending December
31, 2022.
“In 2022, we were focused on advancing B-VEC toward
approval and getting commercially prepared for a potential launch
this year, and I thank the entire Krystal team for their dedication
and perseverance in helping us achieve our objectives,” said Krish
S. Krishnan, Chairman and CEO of Krystal Biotech, Inc. He added,
“Our focus in 2023 will be on advancing our pipeline and
demonstrating the breadth of our gene delivery platform. We plan to
have ASTRA, our second manufacturing facility, operational early
this year which will enable us to advance our pipeline products in
a timely manner.”
Dermatology
B-VEC (beremagene geperpavec) for Dystrophic
Epidermolysis Bullosa (DEB)
- On January 5, 2023, the Company was
notified by the U.S. Food & Drug Administration (FDA) that the
Prescription Drug User Fee Act (PDUFA) date for the Company’s
Biologics License Application (BLA) for B-VEC for the treatment of
patients with DEB, will be May 19, 2023 and that proposed labeling
discussions would begin no later than April 20, 2023. All clinical
and manufacturing inspections conducted by the FDA as part of the
BLA review process are now successfully complete.
- In December 2022, the results of the
B-VEC pivotal Phase 3 GEM-3 trial were published in the New England
Journal of Medicine (NEJM). The GEM-3 trial was a randomized,
double-blind, intra-patient, placebo-controlled, multi-center study
designed to evaluate the efficacy and safety of B-VEC for the
treatment of DEB. Two editorials were also published in the same
issue of NEJM on the GEM-3 trial.
- The Company submitted a request for
Marketing Authorization Application (MAA) with the European
Medicines Agency (EMA) in November 2022 for B-VEC for the treatment
of DEB in patients 6 months and older. The Company was informed by
the EMA in January 2023 to modify the PIP waiver request to include
patients between birth and 6 months. The Company is modifying the
application so that the MAA procedure can officially start in the
second half of 2023 with an approval expected in early 2024.
Rare Dermatological Pipeline
- The Company expects to initiate dosing
in the Phase 2 cohort of its KB105-02 (JADE-1) trial in the first
half of 2023. The Phase 2 cohort will enroll both pediatric and
adult patients with TGM1 deficient autosomal recessive congenital
ichthyosis for assessment of KB105 safety and efficacy. Details of
the Phase 1/2 study can be found at
www.clinicaltrials.gov under NCT identifier NCT04047732.
- The Company plans to file an
investigational new drug application (IND) for KB104 for the
treatment of Netherton Syndrome in 2023.
Respiratory
KB407 for the treatment of Cystic Fibrosis (CF)
- The Company announced in August 2022,
that the FDA had accepted its IND application to evaluate KB407 in
a clinical trial to treat patients with CF. The Company is working
closely with the Therapeutics Development Network of the Cystic
Fibrosis Foundation to validate its clinical protocol and plans to
initiate a Phase 1 dose ranging clinical (CORAL-1) trial in the US
in the first half of 2023 to assess safety and preliminary
efficacy. Details of the Phase 1 study can be found at
www.clinicaltrials.gov under NCT identifier NCT05095246. The
Company is presently screening patients for enrollment in a Phase 1
clinical trial in Australia to study safety and determine frequency
of dosing application.
- In November 2022, the Company
presented new preclinical data at the North American Cystic
Fibrosis Conference, including assessments of KB407 biodistribution
in the lungs of non-human primates following inhaled delivery.
KB408 for the treatment of Alpha-1 Antitrypsin
Deficiency (AATD)
- The Company is completing preclinical
and manufacturing activities for KB408 and expects to initiate a
Phase 1 clinical trial for the treatment of AATD in the second half
of 2023.
Aesthetics
KB301 for the treatment of Aesthetic
Indications
- In November 2022, the Company
announced up to nine months of durability results from the
extension cohort of KB301 Phase 1 (PEARL-1) study in patients aged
55 to 76. Details of the PEARL-1 study can be found at
www.clinicaltrials.gov under NCT identifier NCT04540900.
- The Company plans to initiate a Phase
2 (PEARL-2) study for the treatment of fine lines in 2023 following
completion of a smaller proof-of-concept study in lateral canthal
lines.
Fourth Quarter and Full Year 2022
Financial Results:
- Cash, cash equivalents, and
investments totaled $383.8 million on December 31, 2022.
- Research and development expenses for
the fourth quarter ended December 31, 2022 were $10.7 million,
compared to $9.0 million for the fourth quarter 2021, and $42.5
million for the year ended December 31, 2022, compared to
$27.9 million for the year ended December 31, 2021.
- General and administrative expenses
for the fourth quarter ended December 31, 2022 were $24.0
million, compared to $12.9 million for the fourth quarter 2021, and
$77.7 million for the year ended December 31, 2022, compared
to $40.4 million for the year ended December 31, 2021.
- Net losses for the quarters ended
December 31, 2022 and 2021 were $32.1 million and $21.8
million, or $(1.25) and $(0.94) respectively, per common share
(basic and diluted). Net losses for the years ended
December 31, 2022 and 2021 were $140.0 million and $69.6
million, or $(5.49) and $(3.13), respectively, per common share
(basic and diluted).
- For additional information on the
Company’s financial results for the year ended December 31,
2022, please refer to the Form 10-K filed with the Securities and
Exchange Commission.
About Krystal Biotech, Inc.Krystal
Biotech, Inc. (NASDAQ: KRYS) is a biotechnology company focused on
developing and commercializing genetic medicines for patients with
rare diseases. The Company’s wide-ranging pipeline is based on its
proprietary redosable HSV vector. Headquartered in Pittsburgh,
Pennsylvania, the Company is led by an experienced management team,
is fully-integrated and has core capabilities in viral vector
design, vector optimization, gene therapy manufacturing and
commercialization. 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.,
including statements about the B-VEC PDUFA date of May 19, 2023;
our focus in 2023 on advancing our pipeline and demonstrating the
breadth of our gene delivery platform; our plans to have our second
manufacturing facility operational; the timing of the Company’s EMA
marketing authorization application for B-VEC; our expectations
regarding initiating dosing in the Phase 2 cohort of our KB105-02
(JADE-1) trial; our plans to file an investigational new drug
application for KB104; our plan to initiate a Phase 1 dose ranging
clinical (CORAL-1) trial for KB407 in the US in the first half of
2023; our plans to initiate a Phase 1 clinical trial for KB408 for
the treatment of AATD; our plans for the commencement of a Phase 2
study of KB301; 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 product candidates
including B-VEC, 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 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 release.
CONTACT:Investors and
Media:Meg DodgeKrystal Biotechmdodge@krystalbio.com
Condensed Balance Sheet: |
|
(In thousands) |
December 31,2022 |
|
December 31,2021 |
|
Balance sheet data: |
|
|
|
|
Cash and cash equivalents |
$ |
161,900 |
|
$ |
341,246 |
|
Short-term investments |
|
217,271 |
|
|
96,850 |
|
Long-term investments |
|
4,621 |
|
|
64,371 |
|
Total assets |
|
558,450 |
|
|
626,295 |
|
Total liabilities |
|
36,219 |
|
|
32,719 |
|
Total stockholders’ equity |
$ |
522,231 |
|
$ |
593,576 |
|
Consolidated Statement of Operations: |
|
|
Three Months Ended December 31, |
|
|
(In thousands, except shares and per share
data) |
2022 |
|
|
2021 |
|
|
Change |
Expenses |
|
|
|
|
|
|
|
Research and development |
$ |
10,741 |
|
|
$ |
9,010 |
|
|
$ |
1,731 |
|
General and administrative |
|
24,030 |
|
|
|
12,867 |
|
|
|
11,163 |
|
Total operating expenses |
|
34,771 |
|
|
|
21,877 |
|
|
|
12,894 |
|
Loss from operations |
|
(34,771 |
) |
|
|
(21,877 |
) |
|
|
(12,894 |
) |
Other Income (Expense) |
|
|
|
|
Interest and other income, net |
|
2,719 |
|
|
|
71 |
|
|
|
2,648 |
|
Net loss |
$ |
(32,052 |
) |
|
$ |
(21,806 |
) |
|
$ |
(10,246 |
) |
|
|
|
|
|
|
|
|
Net loss per common share: Basic and diluted |
$ |
(1.25 |
) |
|
$ |
(0.94 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: Basic and
diluted |
|
25,680,520 |
|
|
|
23,096,530 |
|
|
|
|
Years Ended December 31, |
|
|
(In thousands, except shares and per share
data) |
2022 |
|
2021 |
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
42,461 |
|
|
$ |
27,884 |
|
|
$ |
14,577 |
|
General and administrative |
|
77,735 |
|
|
|
40,391 |
|
|
|
37,344 |
|
Litigation settlement |
|
25,000 |
|
|
|
— |
|
|
|
25,000 |
|
Total operating expenses |
|
145,196 |
|
|
|
68,275 |
|
|
|
76,921 |
|
Loss from operations |
|
(145,196 |
) |
|
|
(68,275 |
) |
|
|
(76,921 |
) |
Other Income (Expense) |
|
|
|
|
|
Interest and other income, net |
|
5,221 |
|
|
|
197 |
|
|
|
5,024 |
|
Interest expense |
|
— |
|
|
|
(1,492 |
) |
|
|
1,492 |
|
Total other income (expense) |
|
5,221 |
|
|
|
(1,295 |
) |
|
|
6,516 |
|
Net loss |
$ |
(139,975 |
) |
|
$ |
(69,570 |
) |
|
$ |
(70,405 |
) |
|
|
|
|
|
|
Net loss per common share: Basic and diluted |
$ |
(5.49 |
) |
|
$ |
(3.13 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: Basic and
diluted |
|
25,491,721 |
|
|
|
22,196,846 |
|
|
|
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