KRYSTAL BIOTECH, INC. – 10-Q – MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of
operations should be read together with the unaudited condensed consolidated
financial statements and related notes included in Item 1 of Part I of this
Quarterly Report on Form 10-Q and with the audited financial statements and the
related notes included in our Annual Report on Form 10-K for the fiscal year
ended
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains "forward-looking statements" within
the meaning of Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities Exchange Act of 1934, as
amended, or the Exchange Act. Forward-looking statements include all statements
that are not historical facts and can be identified by terms such as
"anticipate," "believe," "continue," "could," "estimate," "expect," "intend,"
"may," "plan," "potential," "predict," "project," "seek," "should," "target,"
"will," "would," or similar expressions and the negatives of those terms. These
statements relate to future events or to our future operating or financial
performance and involve known and unknown risks, uncertainties and other factors
that may cause our actual results, performance or achievements to be materially
different from any future results, performances or achievements expressed or
implied by the forward-looking statements. Some of such factors include, but are
not limited to:
•the initiation, timing, cost, progress and results, of our research and
development activities, preclinical studies and clinical trials for B-VEC
(previously "KB103" and now known as VyjuvekTM), KB105, KB104, KB407, KB408,
KB301, KB303, and any other product candidates;
•the continuing impact that the COVID-19 pandemic and measures implemented to
prevent its spread may have on our business operations, access to capital,
research and development activities, and preclinical and clinical trials for our
product candidates;
•the timing, scope or results of regulatory filings and approvals, including
timing of final
regulatory approval of our product candidates;
•our ability to achieve certain accelerated or orphan drug designations from the
FDA;
•changes in our estimates regarding the potential market opportunity for B-VEC,
KB105, KB104, KB407, KB408, KB301, KB303 and any other product candidates;
•our ability to raise capital to fund our operations;
•increased costs associated with our research and development programs for our
product candidates;
•our general and administrative expenses;
•risks related to our ability to successfully develop and commercialize our
product candidates, including B-VEC, KB105, KB104, KB407, KB408, KB301, KB303
and our other product candidates;
•our ability to identify and develop new product candidates;
•our ability to identify, recruit and retain key personnel;
•risks related to our marketing and manufacturing capabilities and strategy;
•our business model and strategic plans for our business, product candidates and
technology;
•the cost of building a medical affairs and commercial organization, including a
sales force in anticipation of commercialization of B-VEC and any additional
product candidates;
•the rate and degree of market acceptance and clinical utility of our product
candidates and gene therapy, in general;
•our competitive position and the success of competing therapies;
•our intellectual property position and our ability to protect and enforce our
intellectual property;
•our financial performance;
•our ability to establish and maintain collaborations or obtain additional
funding;
•our estimates regarding expenses, future revenue, capital requirements and
needs for or ability to obtain additional financing;
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•our ability to successfully avoid or resolve any litigation, intellectual
property or other claims, that may be brought against us;
•global economic conditions, including the recent rise in inflation; and
•the impact of changes in laws and regulations.
Forward-looking statements are subject to a number of risks, uncertainties and
assumptions, including those described in "Risk Factors" in our Annual Report on
Form 10-K for the fiscal year ended
make with the
and rapidly changing environment, and new risks emerge from time to time. It is
not possible for our management to predict all risks, nor can we assess the
impact of all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those
contained in any forward-looking statements we may make. In light of these
risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this Quarterly Report on Form 10-Q may not occur and
actual results could differ materially and adversely from those anticipated or
implied in the forward-looking statements. Given these uncertainties, you should
not place undue reliance on these forward-looking statements. Also,
forward-looking statements represent our management's beliefs and assumptions
only as of the date of this Quarterly Report. You should read this Quarterly
Report completely and with the understanding that our actual future results may
be materially different from what we expect.
Except as required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons actual results
could differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the future.
Throughout this Form 10-Q, unless the context requires otherwise, all references
to "Krystal," "the Company," we," "our," "us" or similar terms refer to
Biotech, Inc.
Overview
We are a clinical stage biotechnology company leading the field of redosable
gene delivery. Using our patented platform that is based on engineered 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 encoded effector to treat or prevent disease. We formulate
our vectors for non-invasive or minimally invasive routes of administration at a
healthcare professional's office or potentially in the patient's home by a
healthcare professional. Our goal is to develop easy-to-use medicines to
dramatically improve the lives of patients living with rare diseases and chronic
conditions. Our innovative technology platform is supported by in-house,
commercial scale cGMP manufacturing capabilities.
21
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Our Product Candidates
The following table summarizes information regarding our product candidates in
various stages of clinical and preclinical development:
[[Image Removed: krys-20220630_g1.jpg]]
There can be no assurance that the upcoming milestones will be met on the
expected timeline or at all.
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Pipeline Highlights and Recent Developments
B-VEC is a topical gel containing our novel vector designed to deliver two
copies of the COL7A1 transgene for the treatment of dystrophic epidermolysis
bullosa ("dystrophic EB"), a serious rare skin disease caused by missing or
mutated type VII collagen protein. Our randomized, double-blind,
placebo-controlled GEM-3 pivotal study was designed to evaluate topical B-VEC as
compared to placebo in dystrophic EB patients. Following public announcement of
topline data from the GEM-3 study trial on
detailed results at the 2022
2 study of B-VEC were published in Nature Medicine. In 2Q 2021, we began
enrolling patients into an open label extension ("OLE") study, including
patients who participated in the Phase 3 study, as well as new participants who
meet all enrollment criteria. Based on the feedback from the FDA following their
review of our human factors validation study report, we announced on
2022
opportunity to be dosed in their homes by a healthcare professional.
On
approval of B-VEC for the treatment of patients with dystrophic EB, and we
expect to file a Marketing Authorization Application with the
Agency
approved or the ultimate timing of any approval from either agency.
KB407 is an inhaled (nebulized) formulation of our novel vector designed to
deliver two copies of the full-length cystic fibrosis transmembrane conductance
regulator ("CFTR") transgene for the treatment of cystic fibrosis, a serious
rare lung disease caused by missing or mutated CFTR gene. On
announced that the FDA had accepted our KB407 Investigational New Drug ("IND")
application, and we plan to initiate a Phase 1 clinical study ("CORAL-1/US
study") of inhaled KB407 in patients with cystic fibrosis ("CF") in the
2H 2022. Previously, on
Human Research Ethics Committee
1 clinical study ("CORAL-1/AU study") of inhaled KB407 in patients with CF. We
have begun screening patients for enrollment in the CORAL-1/AU study and plan to
initiate dosing in 2H22.
KB105 is a topical gel containing our novel vector designed to deliver two
copies of the TGM1 transgene for the treatment of TGM1-deficient autosomal
recessive congenital ichthyosis ("TGM1-ARCI"), a serious rare skin disorder
caused by missing or mutated TGM1 protein. A randomized, placebo-controlled
Phase 1/2 study is ongoing. On
patient dosed in the trial, showing repeat topical KB105 dosing continued to be
well tolerated with no adverse events or evidence of immune response. We plan to
resume dosing in the KB105 Phase 1/2 study later this year.
KB104 is a topical gel formulation of our novel vector designed to deliver two
copies of the SPINK5 transgene for the treatment of Netherton Syndrome, a
debilitating autosomal recessive skin disorder caused by missing or mutated
SPINK5 protein. We expect to initiate a Phase 1 clinical study in 2022.
We have several other product candidates in various stages of preclinical
development as reflected in the chart above.
We are also leveraging the ability of our platform to deliver proteins of
interest to cells in the skin in the context of aesthetic medicine via our
wholly-owned subsidiary
of Jeune's lead product candidate and its status is as follows:
KB301 is a solution formulation of our novel vector for intradermal injection
designed to deliver two copies of the COL3A1 transgene to address signs of aging
or damaged skin caused by declining levels of, or damaged proteins within the
extracellular matrix, including type III collagen. On
announced positive proof-of-concept efficacy data from Cohort 2 of the PEARL-1
study of KB301. In Q2 2022, subjects from the PEARL-1 Cohort 2 trial were
enrolled in a durability trial to evaluate duration of treatment effect,
reduction of the unevenness in placebo treated sites, and long term safety
monitoring. We anticipate announcing data from the durability trial in 2H 2022
and initiating a Phase 2 trial in 4Q 2022 or early 2023.
Jeune has several other aesthetic medicine product candidates in various stages
of preclinical development as reflected in the chart above.
23
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COVID-19 Update
To date the impact of the COVID-19 pandemic on our business and clinical trials
in the
the pandemic on our business and operations, including our supply chain and
preclinical and clinical trial activities. Outside of the
experienced pandemic-related delays in clinical trial initiation in
and we will continue to closely monitor the impact that future pandemic
developments have on this and our other clinical trials, going forward. For
additional information regarding the impact of the coronavirus pandemic, please
see "Risk Factor - Business interruptions resulting from the COVID-19 outbreak
or similar public health crises could cause a disruption of the development
efforts of our product candidates and adversely impact our business." in our
Annual Report on Form 10-K for the fiscal year ended
Financial Overview
Revenue
We currently have no approved products for commercial marketing or sale and have
not generated any revenue from the sale of products or other sources to date. In
the future, we may generate revenue from product sales, royalties on product
sales, or license fees, milestones, or other upfront payments if we enter into
any collaborations or license agreements. We expect that our future revenue will
fluctuate from quarter to quarter for many reasons, including the uncertain
timing and amount of any such sales.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred to advance
our preclinical and clinical candidates, which include:
•expenses incurred under agreements with contract manufacturing organizations,
consultants and other vendors that conduct our preclinical activities;
•costs of acquiring, developing and manufacturing clinical trial materials and
lab supplies;
•facility costs, depreciation and other expenses, which include direct expenses
for rent and maintenance of facilities and other supplies; and
•payroll related expenses, including stock-based compensation expense.
We expense internal research and development costs to operations as incurred. We
expense third party costs for research and development activities, such as the
manufacturing of preclinical and clinical materials, based on an evaluation of
the progress to completion of specific tasks such as manufacturing of drug
substance, fill/finish and stability testing, which is provided to us by our
vendors.
We expect our research and development expenses will increase as we continue the
manufacturing of preclinical and clinical materials and manage the clinical
trials of, and seek regulatory approval for, our product candidates and expand
our product portfolio. In the near term, we expect that our research and
development expenses will increase as we continue our open label extension study
for B-VEC, resume dosing with KB105 Phase 1/2 clinical trial, initiate a Phase 2
trial for KB301, initiate a Phase 1 trial for KB407, initiate a Phase 1 trial
for KB104, and incur preclinical expenses for our other product candidates. Due
to the numerous risks and uncertainties associated with product development, we
cannot determine with certainty the duration, costs and timing of clinical
trials, and, as a result, the actual costs to complete clinical trials may
exceed the expected costs.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and other
related costs, including stock-based compensation for personnel in our
executive, commercial, business development and other administrative functions.
General and administrative expenses also include professional fees associated
with corporate and intellectual property-related legal expenses, consulting and
accounting services, facility-related costs and expenses associated with
obtaining and maintaining patents. Other general and administrative costs
include travel expenses.
We anticipate that our general and administrative expenses will increase in the
future to support the continued research and development of our product
candidates and to operate as a public company. These increases will likely
include increased
24
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costs for insurance, costs related to the hiring of additional personnel and
payments to outside consultants, lawyers and accountants, among other expenses.
Additionally, we anticipate that we will increase our salary and personnel costs
and other expenses as a result of our preparation for commercial operations.
ASTRA Capital Expenditures
On
to house our second cGMP facility, ASTRA. We are currently in the process of
constructing the interior build-out of this facility and we have entered into a
contract with Whiting-Turner who manages the construction of ASTRA. Further, we
have entered into various non-cancellable purchase agreements for long-lead
materials to help avoid potential schedule disruptions or material shortages.
These contracts typically call for the payment of fees for services or materials
upon the achievement of certain milestones. We expect to continue to incur
significant capital expenditures related to ASTRA as we construct and validate
this facility, which is expected to be completed in 2022.
Interest Income
Interest income consists primarily of income earned from our cash, cash
equivalents and investments.
Interest Expense
Interest expense consists primarily of non-cash interest expense recognized to
accrete the build to suit financial obligation to a balance that equaled the
cash consideration that was paid upon the close of the purchase of ASTRA.
Critical Accounting Policies, Significant Judgments and Estimates
There have been no significant changes during the three and six months ended
estimates as disclosed in our management's discussion and analysis of financial
condition and results of operations included in our Annual Report on Form 10-K
for the year ended
25
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Results of Operations
Three Months Ended
Three Months Ended June 30,
2022 2021 Change
(In thousands) (unaudited)
Expenses
Research and development $ 10,890 $ 6,594 $ 4,296
General and administrative 17,863 9,799 8,064
Total operating expenses 28,753 16,393 12,360
Loss from operations (28,753) (16,393) (12,360)
Other Income (Expense)
Interest and other income, net 645 30 615
Net loss $ (28,108) $ (16,363) $ (11,745)
Research and Development Expenses
Research and development expenses increased
ended
research and development expenses were due to an increase in preclinical,
clinical and pre-commercial manufacturing activities of
related expenses of
headcount to support overall growth, and includes a
stock-based compensation, outsourced research and development activities of
thousand
due to software related costs and rent.
General and Administrative Expenses
General and administrative expenses increased
ended
general and administrative spending was due largely to increases in payroll
related expenses of approximately
increase in headcount in our executive, commercial, business development and
other administrative functions to support overall growth, and includes a
million
of approximately
related costs of
travel related activities of
expenses. These increases were offset by a net decrease in legal and
professional fees of approximately
insurance proceeds.
Other Income (Expense)
Interest and other income for the three months ended
dividend income earned from our cash, cash equivalents and investments.
26
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Six Months Ended
Six Months Ended June 30,
2022 2021 Change
(In thousands) (unaudited)
Expenses
Research and development $ 20,204 $ 12,795 $ 7,409
General and administrative 33,771 17,951 15,820
Litigation settlement 25,000 - 25,000
Total operating expenses 78,975 30,746 48,229
Loss from operations (78,975) (30,746) (48,229)
Other Income (Expense)
Interest and other income, net 902 64 838
Interest expense - (1,492) 1,492
Net loss $ (78,073) $ (32,174) $ (45,899)
Research and Development Expenses
Research and development expenses increased
and development expenses were due to an increase in preclinical, clinical and
pre-commercial manufacturing activities of
expenses of
headcount to support overall growth, and includes a
stock-based compensation, outsourced research and development activities of
thousand
due to software related costs and rent. These increases were partially offset by
a decrease in travel related activities of approximately
General and Administrative Expenses
General and administrative expenses increased
ended
general and administrative spending was due largely to increases in payroll
related expenses of approximately
an increase in headcount in our executive, commercial, business development and
other administrative functions to support overall growth, and includes a
million
of approximately
related costs of
travel related activities of
conference expenses. These increases were offset by a net decrease in legal and
professional fees of approximately
insurance proceeds.
Litigation settlement
Litigation settlement for the six months ended
million
with
consolidated financial statements included in this Form 10-Q for more
information.
Other Income (Expense)
Interest and other income for the six months ended
dividend income earned from our cash, cash equivalents and investments.
Interest expense for the six months ended
for the build to suit lease liability during the six months ended
to a balance that equaled the purchase consideration for ASTRA.
27
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Liquidity and Capital Resources
Overview
At
was approximately
operating losses. Our net losses were
three and six months ended
proceeds raised from our previous public and private securities offerings and
our ability to issue additional shares under our current ATM program, the
Company believes that our cash, cash equivalents and short-term investments as
of
at least 12 months from the filing date of this Form 10-Q.
As the Company continues to incur losses, a transition to profitability is
dependent upon the successful development, approval and commercialization of our
product candidates and the achievement of a level of revenues adequate to
support the Company's cost structure. Furthermore, we expect to incur increasing
costs associated with satisfying regulatory and quality standards, maintaining
product and clinical trials, and furthering our efforts around our current and
future product candidates. The Company may never achieve profitability, and
unless and until it does, the Company will continue to need to raise additional
capital or obtain financing from other sources.
Costs related to clinical trials can be unpredictable and therefore there can be
no guarantee that we will have sufficient capital to fund our continued clinical
studies of B-VEC, KB105, KB301 or our planned preclinical studies for our other
product candidates, or our operations. Further, we do not expect to generate any
product revenues until 4Q 2022, at the earliest, assuming we receive marketing
approval for B-VEC on the schedule we currently contemplate. While we are in the
process of building out our internal vector manufacturing capacity, some of our
manufacturing activities will be contracted out to third parties. Additionally,
we currently utilize third-party contract research organizations to carry out
some of our clinical development activities. As we seek to obtain regulatory
approval for any of our product candidates, we expect to continue to incur
significant commercialization expenses as we prepare for product sales,
marketing, manufacturing, and distribution. Furthermore, pursuant to our
settlement agreement with
upon the approval of our first product by the FDA, followed by three additional
total cumulative sales,
million
to conduct pivotal clinical trials for, seek marketing approval for or
commercially launch B-VEC, KB105, KB301 or any other product candidate.
Accordingly, to obtain marketing approval for and to commercialize these or any
other product candidates, we may be required to obtain further funding through
public or private equity offerings, debt financings, collaboration and licensing
arrangements or other sources. Adequate additional financing may not be
available to us on acceptable terms, if at all. Our failure to raise capital
when needed could have a negative effect on our financial condition and our
ability to pursue our business strategy.
Operating Capital Requirements
Our primary uses of capital are, and we expect will continue to be for the near
future, compensation and related expenses, manufacturing costs for preclinical
and clinical materials, third party clinical trial research and development
services, laboratory and related supplies, clinical costs, legal and other
regulatory expenses, payments of settlement amounts to
overhead costs. In order to complete the process of obtaining regulatory
approval for any of our product candidates and to build the sales,
manufacturing, marketing and distribution infrastructure that we believe will be
necessary to commercialize our product candidates, if approved, we may require
substantial additional funding.
We have based our projections of operating capital requirements on assumptions
that may prove to be incorrect, and we may use all of our available capital
resources sooner than we expect. Because of the numerous risks and uncertainties
associated with research, development and commercialization of pharmaceutical
products, we are unable to estimate the exact amount of our operating capital
requirements. Our future funding requirements will depend on many factors,
including, but not limited to:
•the timeline and cost of our OLE study for B-VEC;
•the progress, timing and costs of our ongoing Phase 1/2 clinical trials for
KB105;
•the progress, results and costs of our Phase 2 clinical trials for KB301;
•the progress, timing and costs of manufacturing of B-VEC;
•the continued development and the filing of an IND application for future
product candidates;
•the initiation, scope, progress, timing, costs and results of drug discovery,
laboratory testing, manufacturing, preclinical studies and clinical trials for
any other product candidates that we may pursue in the future, if any;
28
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•the costs of maintaining our own commercial-scale cGMP manufacturing
facilities;
•the outcome, timing and costs of seeking regulatory approvals;
•the costs associated with the manufacturing process development and evaluation
of third-party manufacturers;
•the extent to which the costs of our product candidates, if approved, will be
paid by health maintenance, managed care, pharmacy benefit and similar
healthcare management organizations, or will be reimbursed by government
authorities, private health coverage insurers and other third-party payors;
•the costs of commercialization activities for our current and future product
candidates if we receive marketing approval for such product candidates we may
develop, including the costs and timing of establishing product sales, medical
affairs, marketing, distribution and manufacturing capabilities;
•subject to receipt of marketing approval, if any, revenue received from
commercial sale of our current and future product candidates;
•the terms and timing of any future collaborations, licensing, consulting or
other arrangements that we may establish;
•the amount and timing of any payments we may be required to make, or that we
may receive, in connection with the licensing, filing, prosecution, maintenance,
defense and enforcement of any patents or other intellectual property rights,
including milestone and royalty payments and patent prosecution fees that we are
obligated to pay pursuant to our license agreements;
•our current license agreements remaining in effect and our achievement of
milestones under those agreements;
•our ability to establish and maintain collaborations and licenses on favorable
terms, if at all; and
•the extent to which we acquire or in-license other product candidates and
technologies.
We may need to obtain substantial additional funding in order to receive
regulatory approval and to commercialize our product candidates. To the extent
that we raise additional capital through the sale of common stock, convertible
securities or other equity securities, the ownership interests of our existing
stockholders may be materially diluted and the terms of these securities could
include liquidation or other preferences that could adversely affect the rights
of our existing stockholders. In addition, debt financing, if available, would
result in increased fixed payment obligations and may involve agreements that
include restrictive covenants that limit our ability to take specific actions,
such as incurring additional debt, making capital expenditures or declaring
dividends, that could adversely affect our ability to conduct our business. If
we are unable to raise capital when needed or on attractive terms, we could be
forced to significantly delay, scale back or discontinue the development or
commercialization of our product candidates, seek collaborators at an earlier
stage than otherwise would be desirable or on terms that are less favorable than
might otherwise be available, and relinquish or license, potentially on
unfavorable terms, our rights to our product candidates that we otherwise would
seek to develop or commercialize ourselves.
Sources and Uses of Cash
The following table summarizes our sources and uses of cash for the six months
ended
Six Months Ended June 30,
2022 2021
(unaudited)
Net cash used in operating activities $ (58,552) $ (19,783)
Net cash used in investing activities (94,132) (63,064)
Net cash provided by financing activities 30,158 144,105
Net increase (decrease) in cash $ (122,526) $ 61,258
Operating Activities
Net cash used in operating activities for the six months ended
for non-cash items primarily comprised of depreciation and amortization and
stock-based compensation expense of
operating assets and liabilities of approximately
29
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Net cash used in operating activities for the six months ended
for non-cash items primarily comprised of depreciation and amortization and
stock-based compensation expense of approximately
interest expense of
liabilities of approximately
Investing Activities
Net cash used in investing activities for the six months ended
build-out of our ASTRA facility, leasehold improvement of new office space, and
purchases of computer and laboratory equipment,
of short-term and long-term investments, partially offset by proceeds of
Net cash used in investing activities for the six months ended
build-out of our ASTRA facility, leasehold improvement of new office space, and
purchases of computer and laboratory equipment,
short-term and long-term investments, partially offset by proceeds of
Financing Activities
Net cash provided by financing activities for the six months ended
was
from our ATM Program and exercises of stock options and offset by
used for the employee tax withholding payment for settlement of vested
restricted stock awards.
During the six months ended
shares of common stock at a weighted average price of
proceeds of
of approximately
For the six months ended
Net cash provided by financing activities for the three months ended
2021
received from our ATM Program, a public offering, and exercises of stock
options, partially offset by
building.
On
of its common stock at
offering were
commissions of approximately
approximately
During the six months ended
Company issued 262,500 shares of common stock at a weighted average price of
discounts and commissions of approximately
incurred
For the six months ended
thousand
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in the rules and
regulations of the
Contractual Obligations
There have been no material changes to our contractual obligations as previously
disclosed in our Annual Report on Form 10-K for the fiscal year ended
31, 2021
our condensed consolidated financial statements on this Form 10-Q.
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