Item 2. Management’s Discussion and Analysis
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2022 (the “Form 10-K”), as filed with the
Securities and Exchange Commission (the “SEC”).
Unless
the context otherwise requires, references herein to “we”, “us”, and “our”, and to the “Company”
or “PAVmed” are to PAVmed Inc. and its subsidiaries, including its majority-owned subsidiaries, including Lucid Diagnostics
Inc. (“Lucid Diagnostics” or “Lucid”) and Veris Health Inc. (“Veris Health” or “Veris”).
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q (this “Form 10-Q”) including the following discussion and analysis of our unaudited condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are
not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important
factors that may affect our actual results include:
● our
limited operating history;
● our
financial performance, including our ability to generate revenue;
● our
ability to obtain regulatory approval for the commercialization of our products;
● the
ability of our products to achieve market acceptance;
● our
success in retaining or recruiting, or changes required in, our officers, key employees or
directors;
● our
potential ability to obtain additional financing when and if needed;
● our
ability to protect our intellectual property;
● our
ability to complete strategic acquisitions;
● our
ability to manage growth and integrate acquired operations;
● the
potential liquidity and trading of our securities;
● our
regulatory and operational risks;
● cybersecurity
risks;
● risks
related to the COVID-19 pandemic; and
● our
estimates regarding expenses, future revenue, capital requirements and needs for additional
financing.
In
addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
joint ventures or investments we may make.
We
may not actually achieve the plans, intentions, and/or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. You should read this Form 10-Q and the documents we have filed as exhibits to this
Form 10-Q and the Form 10-K completely and with the understanding our actual future results may be materially different from what we
expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events
or otherwise, except as required by applicable law.
Overview
PAVmed
is a diversified commercial-stage medical technology operating in the medical device, diagnostics, and digital health sectors, including
through its majority-owned subsidiaries Lucid Diagnostics, a commercial-stage cancer prevention diagnostics company, and Veris Health,
a private digital health company focused on enhanced personalized cancer care. Our current central focus is on the commercialization
of Lucid Diagnostics’s EsoGuard and Veris Health’s Veris Cancer Care Platform. As resources permit, we will continue to explore
internal and external innovations that fulfill our project selection criteria without limiting ourselves to any target specialty or condition.
More broadly, we strive to maintain balance within our pipeline with shorter-term, lower-risk projects with the prospect for rapid commercialization
and revenue generation supporting development of longer-term projects. At the same time, we are continuously re-assessing each project’s
long-term commercial potential relative to other projects in our pipeline, accelerating or decelerating the project and reallocating
resources accordingly.
The
Company operates in one segment as a medical technology company, with the following lines of business: Diagnostics, Medical Devices and
Digital Health. See Part I, Item 1, “Business,” in the Form 10-K for a summary of each of our key products within these sectors,
including in particular EsoGuard and the Veris Cancer Care Platform, currently our two leading products.
24
Recent
Developments
Business
PAVmed
Strategic Business Update
In
January 2023, PAVmed launched a strategic initiative designed to maximize cash runway and protect long-term shareholder interests through
adjustments in near-term strategic priorities and associated resource allocation. The Company is currently focusing substantially all
of its resources and near-term efforts on the commercialization of Lucid’s and Veris’ products.
Status
of Lucid Clinical Trials
Lucid
is currently seeking to accelerate its collection of clinical utility data through a range of trials that can be efficiently executed.
These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the approximately 400
San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event (in
respect of which we expect to publish results in the first half of 2023) ; a virtual-patient randomized controlled trial with intended
recruitment of at least 100 physician participants (in respect of which we expect to publish results
this year) ; a Lucid-sponsored multi-center, prospective, observational study with 500 patients; and a Lucid-sponsored registry
at existing Lucid Test Centers, whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed consent
and contribute data about their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey. Both Lucid-sponsored
observational/registry studies expect to have preliminary results and/or interim analysis before the end of 2023.
LucidDx
Labs Laboratory Operations Update
On
February 14, 2023, Lucid and its subsidiary, LucidDx Labs, entered into an agreement (the “MSA Termination Agreement”) with
RDx, pursuant to which the parties mutually agreed to terminate the management service agreement between them (the “MSA-RDx”)
without cause. The termination was effective as of February 10, 2023. Until the termination of the MSA-RDx, RDx had provided certain
testing and related services for our laboratory in accordance with the terms of the MSA-RDx. In anticipation of the termination of the
MSA-RDx, however, Lucid accelerated the development of internal resources necessary to operate its laboratory entirely on its own. Accordingly,
we believe that termination of the MSA-RDx will improve the efficiency of the performance of the EsoGuard assay.
Among
other things, the MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the MSA-RDx
and the related asset purchase agreement (the “APA-RDx”) to $0.7 million (from the $3.4 million that would otherwise have
been payable under the MSA-RDx and APA-RDX, if the MSA-RDx had remained in effect through the balance of its stated term), resulting
in a net savings to Lucid of $2.7 million. The payment was satisfied through the issuance of 553,436 shares of Lucid’s common stock
on February 25, 2023. Lucid was not required to make any cash payments in connection with the termination.
#CheckYourFoodTube
Events
In
January 2023, Lucid completed its first #CheckYourFoodTube Precancer Testing Event, with the San Antonio Fire Department (the “SAFD”)
during Firefighter Cancer Awareness Month as designated by the International Association of Fire Fighters (IAFF). A total of 391 members
who were deemed to be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed
by our clinical personnel using EsoCheck. Firefighters with suspected esophageal precancer based on a positive EsoGuard result were identified,
including some less than 40 years of age, and will undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines,
to prevent progression to esophageal cancer.
Since
then, two additional screening events have been hosted with the SAFD, and similar events have been held with fire departments in Athens,
GA, Barnstable, MA, Gainesville, FL, and Orange County, CA. These events, which Lucid continues to expand across the country, are an
extension of Lucid’s expanding satellite Lucid Test Center (“sLTC”) program, which brings Lucid precancer testing directly
to patients—at their physician’s office and now at large testing day events.
Launch
of Direct Contracting Strategic Initiative
In
March 2023, Lucid launched a Direct Contracting Strategic Initiative (DCSI) to engage directly with large Administrative Services Only
(ASO) self-insured employers, unions and other entities, seeking to replicate the successes of other cancer screening diagnostic companies
that have deployed similar strategies.
Veris
Health Commercialization Update
In
December 2022 Veris Health, PAVmed’s digital health subsidiary, commercially launched its Veris Cancer Care Platform™ by
executing its first commercial contract with New Jersey Cancer Care, PA (“NJCC”), an oncology practice and member of the
prestigious Quality Cancer Care Alliance. In February 2023, the Veris Cancer Care Platform went live following successful onboarding
of the first cohort of cancer patients and their clinicians at NJCC. Enrolled patients received a VerisBox™ and began connecting
their Bluetooth-enabled health care devices to transmit real-time physiologic data to the cloud-based Veris Cancer Care Platform clinician
portal. The patients also began reporting symptoms and quality-of-life parameters through the Veris Cancer Care Platform patient smartphone
app, which became available for patients on the Apple App Store and Google Play. The cloud-based clinician portal was concurrently integrated
into the oncology practice and the cancer care team began using it to review physiologic and clinical data and other remote patient monitoring
(“RPM”) services.
25
NASDAQ
Notice
On
December 29, 2022, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30
consecutive business days (through December 28, 2022), the closing bid price of the Company’s common stock had been below the minimum
of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter
stated that the Company would be afforded 180 calendar days (until June 27, 2023) to regain compliance. In order to regain compliance,
the closing bid price of the Company’s common stock must be at least $1 for a minimum of ten consecutive business days. During
the special meeting (“Special Meeting”) of shareholders held on March 31, 2023, the shareholders approved a proposal to amend
the Company’s Certificate of Incorporation, to effect, at any time prior to the one-year anniversary date of the Special Meeting,
(i) a reverse split of the Company’s outstanding shares of common stock at a specific ratio, ranging from 1-for-5 to 1-for-15,
to be determined by the board of directors of the Company in its sole discretion, and (ii) an associated reduction in the number of shares
of common stock the Company is authorized to issue, from 250,000,000 shares to 50,000,000 shares. The Company has not yet determined
the specific ratio of the reverse split or the timing of the reverse split and authorized capital reduction, or whether the Company will
effect the reverse split and authorized capital reduction at all. However, the Company may effectuate the reverse split, if necessary,
as part of its effort to regain compliance with the Nasdaq minimum bid price requirement.
Financing
Lucid
Diagnostics Inc. - ATM Facility
In
November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common
stock that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor Fitzgerald
& Co. (“Cantor”). In the three months ended March 31, 2023, Lucid Diagnostics sold 230,068 shares through their
at-the-market equity facility for net proceeds of approximately $0.3 million, after payment of 3% commissions.
Lucid
Diagnostics - Series A Preferred Stock Offering
On
March 7, 2023, Lucid issued 13,625 shares of newly designated Lucid Series A Convertible Preferred Stock (the “Lucid Series A Preferred
Stock”). Each share of the Lucid Series A Preferred Stock has a stated value of $1,000 and a conversion price of $1.394. The Lucid
Series A Preferred Stock is convertible into shares of Lucid’s common stock at any time at the option of the holder from and after
the six-month anniversary of its issuance, and automatically converts into shares of Lucid’s common stock on the second anniversary
of its issuance. The terms of the Lucid Series A Preferred Stock also include a preference on liquidation and a right to receive dividends
equal to 20% of the number of shares of Lucid common stock into which such Lucid Series A Preferred Stock is convertible, payable on
each of the one-year and two-year anniversary of the issuance date. The Lucid Series A Preferred Stock is a non-voting security, other
than with respect to limited matters related to changes in terms of the Lucid Series A Preferred Stock. The aggregate gross proceeds
from the sale of shares in such offering were $13.625 million.
Lucid
Diagnostics - Securities Purchase Agreement - March 13, 2023 - Senior Secured Convertible Note - March 21, 2023
Effective
as of March 13, 2023, Lucid Diagnostics entered into a Securities Purchase Agreement (“Lucid SPA”) with an accredited institutional
investor (“Investor”, “Lender”, and /or “Holder”), pursuant to which Lucid Diagnostics agreed to
sell, and the Investor agreed to purchase a Senior Secured Convertible Note with a face value principal of $11.1 million (the “Lucid
March 2023 Senior Convertible Note”). Lucid Diagnostics issued the Lucid March 2023 Senior Convertible Note on March 21, 2023 pursuant
to the Lucid SPA. The Lucid March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee
and offering costs.
The
Lucid March 2023 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per
share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,
recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance.
The principal and interest on the Lucid March 2023 Senior Convertible Note is convertible into or otherwise payable in shares of Lucid
Diagnostics’ common stock (subject to the satisfaction of certain customary equity conditions and except for interest payable prior
to September 21, 2023).
Under
the Lucid March 2023 Senior Convertible Note, Lucid Diagnostics is subject to certain customary affirmative and negative covenants
regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the
payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness,
and transactions with affiliates, among other customary matters. Under the Lucid March 2023 Senior Convertible Note, Lucid
Diagnostics is also subject to financial covenants requiring that (i) the amount of its available cash equal or exceed $5.0 million
at all times, (ii) the ratio of (a) the outstanding principal amount of the notes issued under the Lucid SPA, accrued and unpaid
interest thereon and accrued and unpaid late charges as of the last day of any fiscal quarter commencing with September 30, 2023 to
(b) Lucid Diagnostics’ average market capitalization over the prior ten trading days, not exceed 30%, and (iii) that Lucid
Diagnostics’ market capitalization shall at no time be less than $30 million.
26
Results
of Operations
Overview
Revenue
The
Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of
such consideration to be probable to the extent that it is unconstrained. Additionally, in the three months ended March 31, 2022, revenue
was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Lucid Diagnostics Inc. and
ResearchDx Inc. (“RDx”), a CLIA certified commercial laboratory service provider. On February 25, 2022, the EsoGuard Commercialization
Agreement was terminated upon the execution of the APA-RDx.
Cost
of revenue
Cost
of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of
test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests
in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due
to costs being incurred in one period that relate to revenues recognized in a later period.
We
expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
patient compliance rates, payor mix, the levels of reimbursement, and payment patterns of payors and patients.
The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of: a royalty
fee incurred under the Amended CWRU License Agreement (as defined in Note 4, Related Party Transactions , to our accompanying unaudited
condensed consolidated financial statements); the cost of EsoCheck devices and EsoGuard mailers (cell sample shipping costs) distributed
to medical practitioners locations and the Lucid Test Centers; and Lucid Test Centers operating expenses, including rent expense and
supplies.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well
as advertising and promotion expenses. We anticipate our sales and marketing expenses will increase in the future, to the extent we expand
our commercial sales and marketing operations as resources permit.
General
and administrative expenses
General
and administrative expenses consist primarily of salaries and related costs for personnel, travel expenses, facility-related costs, professional
fees, accounting and legal services, employees involved in third-party payor reimbursement contract negotiations and consultants and
expenses associated with obtaining and maintaining patents within our intellectual property portfolio.
We
anticipate our general and administrative expenses will increase in the future as and to the extent our business operations grow. We
also anticipate continued expenses related to being a public company, including audit, legal, regulatory, and tax-related services associated
with maintaining compliance as a public company, insurance premiums and investor relations costs.
Research
and development expenses
Research
and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred
for the research and development of our products, including:
● consulting
costs charged to us by various external contract research organizations we contract with
to conduct clinical and preclinical studies and engineering design and development;
● salary
and benefit costs associated with our chief medical officer and engineering personnel;
● costs
associated with regulatory filings;
● patent
license fees;
● cost
of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
● product
design engineering studies; and
● rental
expense for facilities maintained solely for research and development purposes.
Our
current research and development activities, including our clinical trials, are focused principally on the acceleration of EsoGuard
and Veris Cancer Care Platform commercialization. We will resume research and development activities with respect to other products
in our pipeline as well as applicable new technologies, as resources permit.
Other
Income and Expense, net
Other
income and expense, net, consists principally of changes in fair value of our convertible notes and losses on extinguishment of debt
upon repayment of such convertible notes.
27
Results
of Operations - continued
Presentation
of Dollar Amounts
All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars
in millions, except for per share amounts.
Three
months ended March 31, 2023 as compared to three months ended March 31, 2022
Revenue
In
the three months ended March 31, 2023, revenue was $0.4 million as compared to $0.2 million for the corresponding period in the
prior year. The $0.2 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA
laboratory, as compared to revenue from the EsoGuard Commercialization Agreement with RDx, in the prior year period, which was terminated
on February 25, 2022 as Lucid Diagnostics transitioned to its own laboratory operations.
Cost
of revenue
In
the three months ended March 31, 2023, cost of revenue was approximately $1.3 million as compared to $0.4 million for the corresponding
period in the prior year. The $0.9 million increase principally related to:
● approximately
$0.4 million increase in laboratory facility and operations costs;
● approximately
$0.3 million increase in EsoCheck and EsoGuard supplies usage costs; and
● approximately
$0.2 million increase in compensation related costs as a result of an increase in headcount.
Sales
and marketing expenses
In
the three months ended March 31, 2023, sales and marketing costs were approximately $4.5 million as compared to $3.9 million for
the corresponding period in the prior year. The net increase of $0.6 million was principally related to:
● approximately
$1.4 million increase in compensation related costs principally as a result of an increase
in headcount;
● approximately
$0.6 million decrease in consulting and outside professional services; and
● approximately
$0.2 million decrease in stock based compensation from RSA and stock option grants to Lucid
and PAVmed employees and non-employees.
General
and administrative expenses
In
the three months ended March 31, 2023, general and administrative costs were approximately $10.0 million as compared to $9.5 million
for the corresponding period in the prior year. The net increase of $0.5 million was principally related to:
● approximately
$0.9 million increase in third-party professional services related to legal services, accounting
and audit services, outsourced information technology services, investor relations expenses,
and public company expenses;
● approximately
$0.7 million increase in compensation related costs principally as a result of an increase
in headcount;
● approximately
$0.6 million decrease in general business expenses related to favorable renewal of corporate
insurance policies;
● approximately
$0.4 million decrease in stock based compensation from RSA and stock option grants to Lucid
and PAVmed employees and non-employees; and
● approximately
$0.1 million decrease in facility related expenses.
Research
and development expenses
In
the three months ended March 31, 2023, research and development costs were approximately $4.4 million as compared to $5.9 million
for the corresponding period in the prior year. The net decrease of $1.5 million was principally related to:
● approximately
$2.7 million decrease in development costs, particularly in clinical trial activities and
outside professional and consulting fees primarily with respect to CarpX, EsoCure, and NextFlo;
● approximately
$0.6 million increase in compensation related costs and related to expanded clinical and
engineering staff;
● approximately
$0.4 million increase related to clinical activities performed by CWRU; and
● approximately
$0.2 million increase in stock based compensation from RSA and stock option grants to Lucid
and PAVmed employees and non-employees.
As
mentioned above, above we have paused research and development with respect to CarpX, EsoCure and PortIO. Until such time as resources
permit, we expect to devote substantially all of our research and development efforts to EsoGuard, EsoCheck and the Veris Cancer Care
Platform.
Amortization
of Acquired Intangible Assets
In
the three months ended March 31, 2023, the amortization of acquired intangible assets was approximately $0.5 million as compared
to $0.1 million for the corresponding period in the prior year. The net increase was principally related to the purchase of laboratory
licenses and certifications and laboratory information management software in three months ended March 31, 2022.
28
Results
of Operations - continued
The
three months ended March 31, 2023 as compared to the three months ended March 31, 2022 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In
the three months ended March 31, 2023, the non-cash expense recognized for the change in the fair value of our convertible notes
was approximately $1.0 million, related to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note, and the
Lucid March 2023 Senior Convertible Note. The April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note, and the
Lucid March 2023 Senior Convertible Note were initially measured at their issue-date estimated fair value and subsequently remeasured
at estimated fair value as of the reporting period date. The Company initially recognized an aggregate of $4.3 million of fair value
non-cash expense on the issue dates. This initial recognition was partially offset by an aggregate of $2.0 million of decreases in fair
value upon remeasurements through March 31, 2023. There were no similar non-cash expenses recognized in the three months ended March
31, 2022.
Loss
on Issue and Offering Costs - Senior Secured Convertible Note
In
the three months ended March 31, 2023, in connection with the issue of the Lucid March 2023 Senior Convertible Notes, we recognized
a total of approximately $1.2 million of lender fees and offering costs paid by us. There were no similar lender fees or offering costs
paid in the three months ended March 31, 2022.
Loss
on Debt Extinguishment
In
the three months ended March 31, 2023, a debt extinguishment loss in the aggregate of approximately $0.5 million was recognized
in connection with our April 2022 Senior Convertible Note as discussed below.
● In
the three months ended March 31, 2023, approximately $1.5 million of principal repayments
along with less than $0.1 million of interest expense thereon, were settled through the issuance
of 4,330,643 shares of common stock of the Company, with such shares having a fair value
of approximately $2.0 million (with such fair value measured as the respective conversion
date quoted closing price of the common stock of the Company). The conversions resulted in
a debt extinguishment loss of $0.5 million in the three months ended March 31, 2023.
There
were no similar debt extinguishment losses in the three months ended March 31, 2022.
See
Note 11 , Debt , to the Financial Statements, for additional information with respect to the April 2022 Senior Convertible Note,
the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note.
29
Liquidity
and Capital Resources
Our
current operational activities are principally focused on the commercialization of EsoGuard and the Veris Cancer Care Platform, and,
as resources permit, our development activities would be focused on pursuing FDA approval and clearance of other lead products in our
product portfolio pipeline. Our ability to generate revenue depends upon successfully advancing the commercialization of EsoGuard and
the Veris Cancer Care Platform while, as resources permit, also completing the development and the necessary regulatory approvals of
our other products and services. There are no assurances, however, we will be able to obtain an adequate level of financial resources
required for the short-term or long-term commercialization and development of our products and services.
We
have financed our operations principally through the public and private issuances of our common stock, preferred stock, common stock
purchase warrants, and debt. We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic and
medical device companies that devote substantially all of their efforts to the commercialization of their initial product and services
and ongoing R&D and clinical trials. We experienced a net loss before noncontrolling interests of approximately $22.2 million and
used approximately $16.3 million of cash in operations for the three months ended March 31, 2023. Financing activities provided $24.8 million of cash during the three months ended March 31, 2023. We ended the quarter with cash on-hand
of $49.3 million as of March 31, 2023. We expect to continue to experience
recurring losses and negative cash flows from operations, and will continue to fund our operations with debt and/or equity financing
transactions. Notwithstanding, however, with the cash on-hand as of the date hereof and the other debt and equity committed
sources of financing described below, we expect to be able to fund our future operations for the one year period from the date of the
issue of the our unaudited condensed consolidated Financial Statements, as included herein this Form 10-Q.
Issue
of Shares of Our Common Stock
During
the three months ended March 31, 2023
● We
issued 573,229 shares of our common stock for proceeds of approximately $0.2 million under
the PAVmed Employee Stock Purchase Plan (“ESPP”), as such plan is discussed in
Note 12, Stock-Based Compensation, to the Financial Statements.
● We
issued 1,081,997 shares of our common stock for net proceeds of approximately $0.6 million, after payment of 3% commissions, from
the sale of shares through PAVmed’s at-the-market equity facility through Cantor. See below for more information.
Securities
Purchase Agreement - March 31, 2022 - Senior Secured Convertible Notes - April 4, 2022 and September 8, 2022
Effective
as of March 31, 2022, we entered into the SPA with the Investor, pursuant to which we agreed to sell, and the Investor agreed to purchase
an aggregate of $50.0 million face value principal of Senior Secured Convertible Notes. The SPA provided for the sale of the initial
Senior Secured Convertible Note with a face value principal of $27.5 million, which closed on April 4, 2022 (referred to as the “April
2022 Senior Convertible Note”). The SPA also provided for sales of additional Senior Secured Convertible Notes in one or more additional
closings (upon the satisfaction of certain conditions), with an aggregate face value principal of up to an additional $22.5 million.
The April 2022 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per
share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,
recapitalization or other similar transaction), and a contractual maturity date of April 4, 2024. The April 2022 Senior Convertible Note
may be converted into or otherwise paid in shares of our common stock as described in Note 11, Debt. The April 2022 Senior Convertible
Note proceeds were $24.4 million after deducting a $2.5 million lender fee and the Company’s offering costs of approximately $0.6
million, inclusive primarily of $0.5 million placement agent fees.
On
September 8, 2022, we completed an additional closing under the SPA, in which we sold to the Investor an additional Senior Secured Convertible
Note with a face value principal of $11.25 million (referred to as the “September 2022 Senior Convertible Note”). The September
2022 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the
Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization
or other similar transaction), and a contractual maturity date of September 6, 2024. The September 2022 Senior Convertible Note may be
converted into or otherwise paid in shares of our common stock as described in Note 11, Debt. The September 2022 Senior Convertible Note
proceeds were $10.0 million after deducting a $1.0 million lender fee and the Company’s total offering costs of approximately $0.2
million, inclusive primarily of placement agent fees.
30
Liquidity
and Capital Resources - continued
Under
the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and the SPA, we are subject to certain customary affirmative
and negative covenants regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making
of investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other
indebtedness, and transactions with affiliates, among other customary matters. We also are subject to financial covenants requiring that
(i) the amount of our available cash equal or exceed $8.0 million at all times, (ii) the ratio of (a) the outstanding principal amount
of the notes issued under the SPA, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) our average market
capitalization over the prior ten trading days, not exceed 30% (except that such maximum percentage was 50% for the period from September
8, 2022 through March 5, 2023) (the “Debt to Market Cap Ratio Test”), and (iii) that our market capitalization shall at no
time be less than $75 million (the “Market Cap Test” and, together with the Debt to Market Cap Ratio Test, the “Financial
Tests”). From time to time from and after September 8, 2022 through March 12, 2023, the Company was not in compliance with the
Financial Tests. As of March 12, 2023, the Investor agreed to waive any such non-compliance during such time period and thereafter through
May 31, 2023. Subject to the waiver, as of March 31, 2023, the Company was in compliance with the Financial Tests, and is presently in
compliance with the Financial Tests.
See
Note 11 , Debt , to the Financial Statements for additional information about the SPA, the April 2022 Senior Convertible Note, and the September 2022 Senior Convertible Note.
Lucid
Diagnostics - Series A Preferred Stock Offering
On
March 7, 2023, Lucid entered into subscription agreements for the sale of 13,625 shares of the Lucid Series A Preferred Stock. Each share
of the Lucid Series A Preferred Stock has a stated value of $1,000 and a conversion price of $1.394. The Lucid Series A Preferred Stock
is convertible into shares of our common stock at any time at the option of the holder from and after the six-month anniversary of its
issuance, and automatically converts into shares of our common stock on the second anniversary of its issuance. The terms of the Lucid
Series A Preferred Stock also include a preference on liquidation and a right to receive dividends equal to 20% of the number of shares
of Lucid common stock into which such Lucid Series A Preferred Stock is convertible, payable on each of the one-year and two-year anniversary
of the issuance date. The Lucid Series A Preferred Stock is a non-voting security, other than with respect to limited matters related
to changes in terms of the Lucid Series A Preferred Stock. The aggregate gross proceeds from the sale of shares in such offering were
$13.625 million.
Lucid
Diagnostics - Securities Purchase Agreement - March 13, 2023 - Senior Secured Convertible Note - March 21, 2023
Effective
as of March 13, 2023, Lucid Diagnostics entered into a Securities Purchase Agreement the Lucid SPA with the Investor, an accredited institutional
investor, pursuant to which Lucid Diagnostics agreed to sell, and the Investor agreed to purchase the Lucid March 2023 Senior Convertible
Note with a face value principal of $11.1 million. Lucid Diagnostics issued the Lucid March 2023 Senior Convertible Note on March 21,
2023 pursuant to the Lucid SPA. The Lucid March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million
lender fee and offering costs.
The
Lucid March 2023 Senior Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per
share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,
recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance.
The principal and interest on the Lucid March 2023 Senior Convertible Note is convertible into or otherwise payable in shares of Lucid
Diagnostics’ common stock (subject to the satisfaction of certain customary equity conditions and except for interest payable prior
to September 21, 2023).
Under
the Lucid March 2023 Senior Convertible Note, Lucid Diagnostics is subject to certain customary affirmative and negative covenants regarding
the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash
in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with
affiliates, among other customary matters. Under the Lucid March 2023 Senior Convertible Note, Lucid Diagnostics is also subject to financial
covenants requiring that (i) the amount of its available cash equal or exceed $5.0 million at all times, (ii) the ratio of (a) the outstanding
principal amount of the notes issued under the Lucid SPA, accrued and unpaid interest thereon and accrued and unpaid late charges, as of the last day of any fiscal quarter commencing with September 30, 2023, to
(b) Lucid Diagnostics’ average market capitalization over the prior ten trading days, not exceed 30%, and (iii) that Lucid Diagnostics’
market capitalization shall at no time be less than $30 million (the “Lucid Financial Tests”). As of March 31, 2023, Lucid Diagnostics was in compliance with the Lucid
Financial Tests. In addition, Lucid Diagnostics presently is in compliance with the Lucid Financial Tests.
31
Liquidity
and Capital Resources - continued
PAVmed
Inc. ATM Facility
In
December 2021, we entered into an “at-the-market offering” for up to $50 million of our common stock that may be offered
and sold under a Controlled Equity Offering Agreement between us and Cantor. In the three months ended March 31, 2023, the
Company sold 1,081,997 shares through its at-the-market equity facility for net proceeds of approximately $0.6 million, after payment of 3%
commissions. Subsequent to March 31, 2023, through May 11, 2023, we sold 878,634 shares through its at-the-market
equity facility for net proceeds of approximately $0.4 million, after payment of 3% commissions.
Lucid
Diagnostics Inc. - Committed Equity Facility and ATM Facility
In March 2022, Lucid Diagnostics
entered into a committed equity facility with a Cantor affiliate. Under the terms of the committed equity facility, the Cantor affiliate
has committed to purchase up to $50 million of Lucid Diagnostics’ common stock from time to time at Lucid Diagnostics’ request.
While there are distinct differences, the committed equity facility is structured similarly to a traditional at-the-market equity facility,
insofar as it allows Lucid Diagnostics to raise primary equity capital on a periodic basis at prices based on the existing market price.
Cumulatively a total of 680,263 shares of Lucid Diagnostics’ common stock were issued for net proceeds of approximately $1.8 million,
after payment of 4% commissions, as of March 31, 2023.
In November 2022, Lucid Diagnostics
also entered into an “at-the-market offering” for up to $6.5 million of its common stock that may be offered and sold under
a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor. In the three months ended March 31, 2023, Lucid Diagnostics
sold 230,068 shares through its at-the-market equity facility for net proceeds of approximately $0.3 million, after payment of 3% commissions.
Critical
Accounting Policies and Significant Judgments and Estimates
The
discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial
statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S.
GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions
that affect the amounts reporting in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing
basis, we evaluate our estimates and judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on
various other factors that are believed to be appropriate under the circumstances. Actual results may differ from these estimates under
different assumptions or conditions. Our critical accounting policies are as disclosed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022 as filed with the SEC on March 14, 2023. There have been no material changes to our critical accounting policies and estimates in the three months ended March 31, 2023.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.