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, 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; 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.
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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-20220331_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 ("COL7"). 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
the EMA in 2H 2022. On
the Phase 1 and 2 study of B-VEC were published in Nature Medicine. During 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
the GEM-3 OLE, the opportunity to be dosed in their homes by a healthcare
professional.
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 2 study later this year.
KB407 is an inhaled (nebulized) formulation of our novel vector designed to
deliver two copies of the full-length CFTR transgene for the treatment of cystic
fibrosis, a serious rare lung disease caused by missing or mutated cystic
fibrosis transmembrane conductance regulator ("CFTR") protein. On
2021
in patients with cystic fibrosis, and trial initiation is anticipated in 2Q
2022. We plan to submit an IND and initiate a Phase 1 trial in the
2022.
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 key 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. A Phase 1 study is currently
ongoing. On
from Cohort 2 of the PEARL-1 study of KB301. We plan to initiate 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.
Business Highlights and Recent Developments
•On
from the Board of Directors to accept the position as Chief Business Officer
with the Company and
of Directors to fill the vacancy.
•On
litigation filed by
23
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COVID-19 Update
The COVID-19 pandemic has prompted governments and businesses across the globe
to take unprecedented measures, such as restrictions on travel and business
operations, temporary closures of businesses, and quarantines. For example, in
an effort to slow the spread of the virus, The
where the Company's primary offices, laboratory and manufacturing spaces are
located, enacted stay-at-home orders, and sweeping restrictions to travel were
initiated by corporations and governments. Although these restrictions have been
lifted, it is not known at this time whether they will be reestablished or the
extent to which the Company will be impacted. The degree of the pandemic's
effect on the Company's clinical, operational and financial performance will
depend on future developments, including additional protective measures that may
be implemented by governmental authorities or the Company to protect its
employees, or by investigators, caregivers or patients to minimize exposure, all
of which are uncertain and difficult to predict. To date the impact of the
pandemic on our business and clinical trials in the
the increased vaccination rates in the
assess the potential impact of the pandemic on our business and operations,
including our supply chain and preclinical and clinical trial activities.
Outside of the
trial initiation in
rapidly evolving situation. 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 payments and 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
("OLE") study for B-VEC, resume dosing with KB105 Phase 2 clinical trial,
initiate Phase 2 trial for KB301, initiate Phase 1 trial for KB407, 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
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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 stock-based compensation and 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, if and when we believe a regulatory approval of
our first product candidate appears likely, 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 will manage 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 months ended
2022
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 March 31,
2022 2021 Change
(In thousands) (unaudited)
Expenses
Research and development $ 9,314 $ 6,201 $ 3,113
General and administrative 15,908 8,152 7,756
Litigation settlement 25,000 - 25,000
Total operating expenses 50,222 14,353 35,869
Loss from operations (50,222) (14,353) (35,869)
Other Income (Expense)
Interest and other income, net 257 33 224
Interest expense - (1,492) 1,492
Net loss $ (49,965) $ (15,812) $ (34,153)
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 an
stock-based compensation, and other research and development expenses of
thousand
partially offset by a decrease in travel related activities of approximately
General and Administrative Expenses
General and administrative expenses increased
ended
Higher general and administrative spending was due largely to increases in
payroll related expenses of approximately
driven by an increase in headcount to personnel in our executive, commercial,
business development and other administrative functions to support overall
growth, and includes a
commercial preparedness expenses of approximately
costs of
development costs of
thousand
decrease in legal and professional fees of approximately
includes
Litigation settlement
Litigation settlement expenses increased
consisted of the settlement of litigation with
Proceedings" in Note 6 of the notes to condensed consolidated financial
statements included in this Form 10-Q for more information.
Other Income (Expense)
Interest and other income for the three months ended
dividend income earned from our cash, cash equivalents and investments.
Interest expense for the three months ended
for the build to suit lease liability during the three months ended
2021
26
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Liquidity and Capital Resources
Overview
At
was approximately
operating losses. Our net losses were
three months ended
had an accumulated deficit of
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
sufficient to allow the Company to fund operations for 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 operating as a public company, meeting financial controls,
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
our clinical development activities. As we seek to obtain regulatory approval
for any of our product candidates, we expect to incur significant
commercialization expenses as we prepare for product sales, marketing,
manufacturing, and distribution. 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 and general 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 will 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 on 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;
•the costs of maintaining our own commercial-scale cGMP manufacturing
facilities;
•the outcome, timing and costs of seeking regulatory approvals;
27
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•the costs associated with the manufacturing process development and evaluation
of third-party manufacturers;
•the costs of future activities, including product sales, medical affairs,
marketing, manufacturing and distribution, in the event we receive marketing
approval for our current and future product candidates;
•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 (in thousands):
Three Months Ended March 31,
2022 2021
(unaudited)
Net cash used in operating activities $ (15,493) $ (9,654)
Net cash used in investing activities (55,908) (747)
Net cash provided (used in) by financing activities (542) 144,304
Net increase (decrease) in cash $ (71,943) $ 133,903
Operating Activities
Net cash used in operating activities for the three months ended
was
adjusted for non-cash items primarily of depreciation and amortization and
stock-based compensation expense of
liabilities of approximately
legal settlement of
28
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Net cash used in operating activities for the three months ended
was
for non-cash items primarily of depreciation and amortization and stock-based
compensation expense of approximately
expense of
approximately
Investing Activities
Net cash used in investing activities for the three months ended
was
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 three months ended
was
build-out of our ASTRA facility, leasehold improvement of new office space, and
purchase of computer and laboratory equipment, partially offset by proceeds of
Financing Activities
Net cash used by financing activities for the three months ended
was
from exercises of stock options and offset by
employee tax withholding payment for settlement of vested restricted stock
awards.
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 three months ended
Company issued 262,500 shares of common stock at a weighted average price of
discounts and commissions of approximately
incurred
For the three 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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