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 interest
rates; 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 biotechnology company focused on developing and commercializing genetic
medicines for patients with rare diseases. 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.
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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-20220930_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
Dermatology
Beremagene geperpavec ("B-VEC"), our lead product candidate 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"
or "DEB"). DEB is a group of heritable skin diseases characterized by skin
fragility, blister formation, milia, and scarring that affects approximately
10,000 patients worldwide. In
Application ("BLA") with the
approval of B-VEC for the treatment of patients with dystrophic EB with a
request for six-month priority review. In
and granted priority review with a Prescription Drug User Fee Act target date of
priority name for B-VEC) was acceptable to the FDA. In
received a positive opinion from the
Committee on the Pediatric Investigation Plan for B-VEC for the treatment of DEB
with no additional studies required. We also plan to submit a market
authorization application, or MAA, to the
in Q4 2022. We have exclusive, worldwide commercialization rights for B-VEC.
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. In
patient dosed in the trial, showing repeat topical KB105 dosing continued to be
well tolerated with no adverse events or evidence of immune response. Faced with
competing priorities during the BLA review cycle and initiation of the cystic
fibrosis clinical program, the Company anticipates patient dosing in the ongoing
Phase 1/2 clinical trial of KB105 for the treatment of TGM1-deficient autosomal
recessive congenital ichthyosis in 1H 2023. Details of the Phase 1/2 study can
be found at www.clinicaltrials.gov under NCT identifier NCT04047732.
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 the first half
of 2023.
Respiratory
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. In
announced that the FDA had accepted our KB407 Investigational New Drug ("IND")
application. We plan to initiate a Phase 1 clinical study ("CORAL-1/US study")
of inhaled KB407 in patients with cystic fibrosis ("CF") in the
fourth quarter of 2022. Details of the Phase 1 study can be found at
www.clinicaltrials.gov under NCT identifier NCT05095246. Previously, in
in
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 the fourth
quarter of 2022.
Aesthetics
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
product candidate, KB301, is a 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. Details of the Phase 1 study can be found at
www.clinicaltrials.gov under NCT identifier NCT04540900. 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 Q4 2022. The Company intends to start a Phase 2 clinical
study (PEARL-2) for the treatment of wrinkles and improvements in skin quality
attributes in 1H 2023 following agreement with the FDA on measurement of primary
efficacy endpoints.
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Jeune has several other aesthetic medicine product candidates in various stages
of preclinical development as reflected in the chart above.
Business Highlights and Recent Developments
•In
that the FDA does not plan to hold an Advisory Committee meeting and has not
identified a need for Risk Evaluation and Mitigation Strategies (REMS) for this
application.
•In
purpose of establishing operations in
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
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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 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 the facility,
which is expected to be completed in 1H 2023.
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 nine months ended
and 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
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Results of Operations
Three Months Ended
Three Months Ended September 30,
2022 2021 Change
(In thousands) (unaudited)
Expenses
Research and development $ 11,516 $ 6,080 $ 5,436
General and administrative 19,935 9,572 10,363
Total operating expenses 31,451 15,652 15,799
Loss from operations (31,451) (15,652) (15,799)
Other Income (Expense)
Interest and other income, net 1,601 63 1,538
Net loss $ (29,850) $ (15,589) $ (14,261)
Research and Development Expenses
Research and development expenses increased
ended
Higher research and development expenses were due to increased preclinical,
clinical and pre-commercial manufacturing activities of
payroll related expenses of
increase in headcount to support overall growth, and includes a
increase in stock-based compensation, an increase in outsourced research and
development activities of
development expenses of
and regulatory fees, and software related costs.
General and Administrative Expenses
General and administrative expenses increased
ended
2021
payroll related expenses of approximately
driven by an increase in headcount in our executive, commercial, and other
administrative functions to support overall growth, and includes a
increase in stock-based compensation, increased commercial preparedness expenses
of approximately
of a decreased legal and professional fees of
in litigation proceeds of approximately
settlement of the
increased other administrative expenses of
increased utilities, taxes, and IT costs. These increases were offset by a net
decrease in business development costs of
software related costs of
Other Income (Expense)
Interest and other income for the three months ended
was
dividend income earned from our cash, cash equivalents and investments. The
increase in interest and dividend income is the result of increased investment
activity and increased interest rates.
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Nine Months Ended
Nine Months Ended September 30,
2022 2021 Change
(In thousands) (unaudited)
Expenses
Research and development $ 31,720 $ 18,875 $ 12,845
General and administrative 53,705 27,524 26,181
Litigation settlement 25,000 - 25,000
Total operating expenses 110,425 46,399 64,026
Loss from operations (110,425) (46,399) (64,026)
Other Income (Expense)
Interest and other income, net 2,502 127 2,375
Interest expense - (1,492) 1,492
Net loss $ (107,923) $ (47,764) $ (60,159)
Research and Development Expenses
Research and development expenses increased
ended
Higher research and development expenses were due to an increase in preclinical,
clinical and pre-commercial manufacturing activities of
payroll related expenses of
increase in headcount to support overall growth, and includes a
increase in stock-based compensation, increased outsourced research and
development activities of
development expenses of approximately
related costs and rent and depreciation.
General and Administrative Expenses
General and administrative expenses increased
ended
2021
payroll related expenses of approximately
driven by an increase in headcount in our executive, commercial, business
development and other administrative functions to support overall growth, and
includes a
preparedness expenses of approximately
software related costs of
expenses. These increases were offset by a net decrease of
consists of a decrease in legal and professional fees of
an increase in litigation proceeds of approximately
to the settlement of the
Litigation settlement
Litigation settlement for the nine months ended
litigation with
condensed consolidated financial statements included in this Form 10-Q for more
information.
Other Income (Expense)
Interest and other income for the nine months ended
was
dividend income earned from our cash, cash equivalents and investments. The
increase in interest and dividend income is the result of increased investment
activity and increased interest rates.
Interest expense for the nine months ended
and
obligation for the build to suit lease liability during the nine months ended
ASTRA.
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Liquidity and Capital Resources
Overview
At
balance was approximately
incurred operating losses. Our net losses were
for the three and nine months ended
million
2021
ability to issue additional shares under our current ATM program, we believe
that our cash, cash equivalents and short-term investments as of
2022
from the filing date of this Form 10-Q.
As we continue 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 our
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. We may never achieve profitability, and unless and until we do, we
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 clinical and preclinical studies
for our other product candidates, or our operations. Further, we do not expect
to generate any product revenues until 1Q 2023, 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 manufacturing and commercialization expenses as
we prepare for product sales, marketing, commercial manufacturing, packaging,
labeling and distribution. Furthermore, pursuant to our settlement agreement
with
our first product by the FDA, followed by three additional
contingent milestone payments upon reaching
sales,
cumulative sales. Our funds may not be sufficient to enable us 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 nine months
ended
Nine Months Ended September 30,
2022 2021
(unaudited)
Net cash used in operating activities (78,240) (27,038)
Net cash used in investing activities (108,875) (100,230)
Net cash provided by financing activities 32,278 145,613
Net increase (decrease) in cash $ (154,837) $ 18,345
Operating Activities
Net cash used in operating activities for the nine months ended
2022
adjusted for non-cash items primarily comprised of depreciation and amortization
and stock-based compensation expense of
in operating assets and liabilities of approximately
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Net cash used in operating activities for the nine months ended
2021
adjusted for non-cash items primarily comprised of depreciation and amortization
and stock-based compensation expense of approximately
suit interest expense of
and liabilities of approximately
Investing Activities
Net cash used in investing activities for the nine months ended
2022
on the build-out of our ASTRA facility, leasehold improvement of new office
space, and purchases of computer and laboratory equipment,
purchase of short-term and long-term investments, partially offset by proceeds
of
Net cash used in investing activities for the nine months ended
2021
on the build-out of our ASTRA facility, leasehold improvement of new office
space, and purchases of computer and laboratory equipment,
purchase of short-term and long-term investments, partially offset by proceeds
of
Financing Activities
Net cash provided by financing activities for the nine months ended
offset by
settlement of vested restricted stock awards.
During the nine months ended
shares of common stock at a weighted average price of
proceeds of
of approximately
For the nine months ended
Net cash provided by financing activities for the nine months ended
of stock options, partially offset by
ASTRA building.
On
common stock at
approximately
During the nine months ended
issued 262,500 shares of common stock at a weighted average price of
share for net proceeds of
and commissions of approximately
of other offering expenses related to the ATM Program.
For the nine months ended
million
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