UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2022
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
File Number: 001-37685
PAVMED
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
47-1214177
(State
or Other Jurisdiction of
(IRS
Employer
Incorporation
or Organization)
Identification
No.)
One
Grand Central Place
60
E. 42nd Street
Suite
4600
New
York , NY 10165
10165
(Address
of Principal Executive Offices
(Zip
Code)
(212)
949-4319
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each Class
Trading
Symbol(s)
Name
of each Exchange on which Registered
Common
Stock, $0.001 par value per share
PAVM
The
NASDAQ Stock Market LLC
Series
Z Warrants, each to purchase one share of Common Stock
PAVMZ
The
NASDAQ Stock Market LLC
Securities
registered under Section 12(g) of the Exchange Act: None
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”
, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated filer
☐
Accelerated
filed
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of May 12, 2022 there were 87,974,146 shares of the registrant’s Common Stock, par value $0.001 per share, issued
(with such number of shares inclusive of shares of common stock underlying granted but unvested restricted stock awards granted under
the PAVmed Inc. 2014 Long-Term Incentive Equity Plan as of such date).
TABLE
OF CONTENTS
Page
Part I - Financial Information
Item
1.
Financial Statements
Condensed Consolidated Balance Sheets (unaudited) as of March 31, 2022 and December 31, 2021
1
Condensed Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2022 and 2021
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three months ended March 31, 2022 and 2021
3
Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2022 and 2021
5
Notes to Unaudited Condensed Consolidated Financial Statements
6
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
25
Item
4.
Controls and Procedures
35
PART II - Other Information
Item
1.
Legal Proceedings
36
Item
5.
Other Information
36
Item
6.
Exhibits
36
Signature
37
Exhibit Index
38
i
PART
I. Financial Information
Item
1. Financial Statements
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
March
31, 2022
December
31, 2021
Assets:
Current
assets:
Cash
$ 64,737
$ 77,258
Accounts
receivable
89
200
Prepaid
expenses, deposits, and other current assets
6,176
5,179
Total
current assets
71,002
82,637
Fixed
assets, net
2,066
1,585
Operating
lease right-of-use assets
2,951
—
Intangible
assets, net
7,620
2,029
Other
assets
695
725
Total
assets
$ 84,334
$ 86,976
Liabilities,
Preferred Stock and Stockholders’ Equity
Current
liabilities:
Accounts
payable
$ 8,235
$ 3,299
Accrued
expenses and other current liabilities
3,498
4,259
Operating
lease liabilities, current portion
873
—
Contingent
purchase consideration payable
4,887
—
Total
current liabilities
17,493
7,558
Long-term
liabilities
Operating
lease liabilities, less current portion
2,108
—
Total
long-term liabilities
2,108
—
Total
liabilities
19,601
7,558
Commitments
and contingencies (Note 10)
-
-
Stockholders’
Equity:
Preferred
stock, $ 0.001 par value. Authorized, 20,000,000 shares; Series B Convertible Preferred Stock, par value $ 0.001 , issued and outstanding
1,136,210 at March 31, 2022 and 1,113,919 shares at December 31, 2021
2,486
2,419
Common
stock, $ 0.001 par value. Authorized, 150,000,000 shares; 86,911,646 and 86,367,845 shares outstanding as of March 31, 2022 and December
31, 2021, respectively
87
86
Additional
paid-in capital
199,719
198,071
Accumulated
deficit
( 155,849 )
( 138,910 )
Treasury
stock
( 512 )
—
Total
PAVmed Inc. Stockholders’ Equity
45,931
61,666
Noncontrolling
interests
18,802
17,752
Total
Stockholders’ Equity
64,733
79,418
Total
Liabilities and Stockholders’ Equity
$ 84,334
$ 86,976
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share amounts - unaudited)
Three
Months Ended March 31,
2022
2021
Revenue
$ 189
$ —
Cost
of revenue
369
—
Gross
profit (loss)
( 180 )
—
Operating
expenses:
Sales
and marketing
3,925
1,387
General
and administrative
9,423
3,375
Research
and development
5,932
3,315
Total
operating expenses
19,280
8,077
Loss
from operations
( 19,460 )
( 8,077 )
Other
income (expense):
Change
in fair value - contingent consideration payable
( 173 )
—
Change
in fair value - Senior Secured Convertible Notes and Senior Convertible Note
—
1,682
Debt
extinguishments loss - Senior Secured Convertible Notes
—
( 3,715 )
Other
income (expense), net
( 173 )
( 2,033 )
Loss
before provision for income tax
( 19,633 )
( 10,110 )
Provision
for income taxes
—
—
Net
loss before noncontrolling interests
( 19,633 )
( 10,110 )
Net
loss attributable to the noncontrolling interests
2,761
679
Net
loss attributable to PAVmed Inc.
( 16,872 )
( 9,431 )
Less:
Series B Convertible Preferred Stock dividends earned
( 68
)
( 75 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 16,940 )
$ ( 9,506 )
Per
share information:
Net
loss per share attributable to PAVmed Inc. - basic and diluted
$ ( 0.20 )
$ ( 0.13 )
Net
loss per share attributable to PAVmed Inc. common stockholders – basic and diluted
$ ( 0.20 )
$ ( 0.13 )
Weighted
average common shares outstanding, basic and diluted
86,336,427
73,954,126
See
accompanying notes to the unaudited condensed consolidated financial statements.
2
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the THREE MONTHS ENDED March 31, 2022
(in
thousands except number of shares and per share data - unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
PAVmed
Inc. Stockholders’ Equity (Deficit)
Series
B
Convertible
Additional
Non
Preferred
Stock
Common
Stock
Paid-In
Accumulated
Treasury
controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
Balance
- December 31, 2021
1,113,919
$ 2,419
86,367,845
$ 86
$ 198,071
$ ( 138,910 )
$ —
$ 17,752
$ 79,418
Dividends
declared - Series B Convertible Preferred Stock
22,291
67
—
—
—
( 67 )
—
—
—
Restricted
stock awards vestings
—
—
466,666
—
—
—
—
—
—
Exercise
- Series Z warrants
—
—
5
—
—
—
—
—
—
Exercise
- stock options
—
—
237,499
1
241
—
—
—
242
Exercise
- stock options of majority-owned subsidiary
—
—
—
—
—
—
—
187
187
Purchase
- Employee Stock Purchase Plan
—
—
194,240
—
217
—
—
—
217
Impact
of subsidiary equity transactions
—
—
—
—
( 87 )
—
—
87
—
Stock-based
compensation - PAVmed Inc.
—
—
—
—
1,277
—
—
—
1,277
Stock-based
compensation - majority-owned subsidiary
—
—
—
—
—
—
—
3,537
3,537
Treasury
stock
—
—
( 354,609 )
—
—
—
( 512 )
—
( 512 )
Net
loss
—
—
—
—
—
( 16,872 )
—
( 2,761 )
( 19,633 )
Balance
- March 31, 2022
1,136,210
$ 2,486
86,911,646
$ 87
$ 199,719
$ ( 155,849 )
$ ( 512 )
$ 18,802
$ 64,733
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the THREE MONTHS ENDED March 31, 2021
(in
thousands, except number of shares and per share data - unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
PAVmed
Inc. Stockholders’ Equity (Deficit)
Series
B
Convertible
Additional
Non
Preferred
Stock
Common
Stock
Paid-In
Accumulated
controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
Balance
- December 31, 2020
1,228,075
$ 2,537
63,819,935
$ 64
$ 87,570
$ ( 88,275 )
$ ( 2,369 )
$ ( 473 )
Issue
common stock – registered offerings, net
—
—
15,782,609
16
53,688
—
—
53,704
Issue
common stock upon partial conversions of Senior Secured Convertible Note
—
—
667,668
—
1,723
—
—
1,723
Issue
common stock – exercise Series Z warrants
—
—
860,217
1
1,375
—
—
1,376
Issue
common stock – conversion Series B Convertible Preferred Stock
( 10,835 )
( 22 )
10,835
—
22
—
—
—
Series
B Convertible Preferred Stock dividends declared
24,198
72
—
—
—
( 72 )
—
—
Issue
common stock - Employee Stock Purchase Plan
—
—
203,480
—
304
—
—
304
Exercise
- stock options
—
—
80,000
—
80
—
—
80
Stock-based
compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
631
—
—
631
Stock-based
compensation - majority-owned subsidiary
—
—
—
—
3
—
802
805
Net
Loss
—
—
—
—
—
( 9,431 )
( 679 )
( 10,110 )
Balance
- March 31, 2021
1,241,438
$ 2,587
81,424,744
$ 81
$ 145,396
$ ( 97,778 )
$ ( 2,246 )
$ 48,040
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands, except number of shares and per share data - unaudited)
2022
2021
Three
Months Ended March 31,
2022
2021
Cash
flows from operating activities
Net
loss - before noncontrolling interest (“NCI”)
$ ( 19,633 )
$ ( 10,110 )
Adjustments
to reconcile net loss - before NCI to net cash used in operating activities
Depreciation
expense
93
12
Amortization
expense
123
—
Stock-based
compensation
4,814
1,436
Fair
value adjustment to contingent consideration payable
173
—
Change
in fair value - Senior Secured Convertible Notes and Senior Convertible Note
—
( 1,682 )
Debt
extinguishment loss - Senior Secured Convertible Notes and Senior Convertible Note
—
3,715
Non-cash
lease expense
29
—
Changes
in operating assets and liabilities:
Accounts
receivable
111
—
Prepaid
expenses and other current assets
( 134 )
( 277 )
Accounts
payable
3,922
( 1,070 )
Accrued
expenses and other current liabilities
( 1,761 )
( 1,192 )
Net
cash flows used in operating activities
( 12,263 )
( 9,168 )
Cash
flows from investing activities
Purchase
of equipment
( 574 )
( 36 )
Acquisitions,
net of cash acquired
—
—
Net
cash flows used in investing activities
( 574 )
( 36 )
Cash
flows from financing activities
Proceeds
– issue of common stock – registered offerings
—
55,016
Payment
– offering costs – registered offerings
—
( 1,312 )
Payment
– repayment of Senior Convertible Note and Senior Secured Convertible Note
—
( 14,816 )
Payment
– Senior Convertible Note and Senior Secured Convertible Note – non-installment payments
—
( 154 )
Proceeds
– exercise of Series Z warrants
—
1,376
Proceeds
– exercise of stock options
241
80
Proceeds
– issue common stock – Employee Stock Purchase Plan
217
304
Proceeds
– exercise of stock options issued under equity plan of majority owned subsidiary
187
—
Purchase
Treasury Stock – payment of employee
payroll tax obligation in connection with stock-based compensation
( 329 )
—
Net
cash flows provided by financing activities
316
40,494
Net
increase (decrease) in cash
( 12,521 )
31,290
Cash,
beginning of period
77,258
17,256
Cash,
end of period
$ 64,737
$ 48,546
See
accompanying notes to the unaudited condensed consolidated financial statements.
5
PAVMED
INC.
and
SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(amounts
in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)
Note
1 — The Company
Description
of the Business
PAVmed
Inc and Subsidiaries, referred to herein as “PAVmed” or the “Company” is comprised of PAVmed Inc. and its wholly-owned
subsidiary and its majority-owned subsidiaries, inclusive of Lucid Diagnostics Inc. (“Lucid Diagnostics” or “LUCID”),
Veris Health Inc. (“Veris Health” or “VERIS”), and Solys Diagnostics Inc. (“Solys Diagnostics”
or “SOLYS”).
The
Company is organized to advance a broad pipeline of innovative medical technologies from concept to commercialization, employing a business
model focused on capital efficiency and speed to market. The Company’s activities have focused on advancing the lead products towards
regulatory approval and commercialization, protecting its intellectual property, and building its corporate infrastructure and management
team.
The
ability of the Company to generate revenue depends upon the Company’s ability to successfully advance the commercialization of
EsoGuard and CarpX while also completing the development and the necessary regulatory approvals of its other products and services.
Although
the Company’s current operational activities are principally focused on the commercialization of EsoGuard and CarpX its development
activities are focused on pursuing FDA approval and clearance of other lead products in our product portfolio pipeline, including EsoGuard
IVD, PortIO, NextFlo, EsoCure and digital health technologies acquired by the Company’s majority-owned subsidiary Veris Health
Inc.
The Company has financed
its operations principally through public and private issuances of its common stock, preferred stock, common stock purchase warrants,
and debt. The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that
devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research and development
activities and conducting clinical trials. The Company expects to continue to experience recurring losses from operations and will continue
to fund its operations with debt and equity financing transactions. Notwithstanding, however, with the cash on-hand as of the date hereof
and other debt and equity committed sources of financing, the Company expects to be able to fund its operations for one year from the
date of the issue of the Company’s unaudited condensed consolidated financial statements, as included herein in this Quarterly
Report on Form 10-Q for the period ended March 31, 2022.
6
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates
Significant
Accounting Policies
The
Company’s significant accounting policies are as disclosed in the Company’s annual report on Form 10-K for the year ended
December 31, 2021 as filed with the SEC on April 6, 2022, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities
and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned and majority-owned subsidiaries.
All significant intercompany transactions and balances have been eliminated in consolidation. The Company holds a majority-ownership
interest and has controlling financial interest in each of: Lucid Diagnostics Inc., Veris Health Inc., and Solys Diagnostics Inc., with
the corresponding noncontrolling interest included as a separate component of consolidated stockholders’ equity (deficit), including
the recognition in the unaudited condensed consolidated statement of operations of a net loss attributable to the noncontrolling interest
based on the respective minority-interest equity ownership of each majority-owned subsidiary. See Note 16, Noncontrolling Interest ,
for a discussion of each of the majority-owned subsidiaries noted above. The Company manages its operations as a single operating segment
for the purposes of assessing performance and making operating decisions.
All
amounts in the accompanying consolidated financial statements and these notes thereto are presented in thousands of dollars, if not otherwise
noted as being presented in millions of dollars, except for shares and per share amounts.
Contingent
Consideration
Contingent
Consideration relates to the potential payment for an acquisition that is contingent upon the achievement of the acquired business meeting
certain milestones. The Company records contingent consideration at fair value at the date of acquisition based on the consideration
expected to be transferred. For potential payments related to milestone achievements, the Company estimated the
fair value based on the probability of achievement of such milestones. The assumptions utilized in the calculation of the acquisition
date fair value include probability of success and the discount rates. Contingent consideration involves certain assumptions requiring
significant judgment and actual results may differ from assumed and estimated amounts. Contingent consideration is remeasured each reporting
period, and subsequent changes in fair value, including accretion for the passage of time, are recognized within other income (expense),
net in the Company’s unaudited condensed consolidated statements of operations.
Use
of Estimates
In
preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets, inclusive of acquired intangible assets and the determination of corresponding
carrying value reserve, if any, and liabilities and the disclosure of contingent losses, as of the date of the consolidated financial
statements, as well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these consolidated
financial statements include those related to the estimated fair value of stock-based equity awards, contingent consideration
and common stock purchase warrants. Other significant estimates include the provision or benefit for income taxes and the corresponding
valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as
a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company
evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed
to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected
by changes in these estimates.
Recent
Accounting Standards Updates Adopted
Effective
December 31, 2021, the Company adopted FASB ASC Topic 842, Leases, (“ASC 842”). ASC 842 established a right-of-use (“ROU”)
model requiring a lessee to recognize a ROU asset and a lease liability for all leases with terms greater-than 12 months. Leases are
classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement.
The Company’s adoption of ASC 842 did not have an effect on the Company’s consolidated financial statements. See Note 8,
Leases .
7
Note
3 — Patent License Agreement - Case Western Reserve University
The Company has a patent
license agreement with Case Western Reserve University (“CWRU”) which provides for each of patent fees reimbursement payments,
milestone payments and royalty payments - each as discussed below. For further details of this agreement, see Note 3 of the Company’s
Consolidated Financial Statements in the Company’s Form 10-K for the year ended December 31, 2021.
Lucid
Diagnostics Inc. is responsible for reimbursement of certain CWRU billed patent fees. See Note 5, Related Party Transactions ,
for patent fee reimbursement payments paid to CWRU in the periods ended March 31, 2022 and 2021.
The CWRU License Agreement contained
milestones for which a $ 75
research and development expense was recognized and paid with respect to the achievement of the regulatory milestone related
to FDA clearance of EsoCheck. The CWRU License Agreement was amended effective February 12, 2021 such that a regulatory milestone related
to FDA PMA submission of a licensed product (“PMA Milestone”) is included in the Amended CWRU License Agreement, and is the
sole remaining unachieved milestone, for which a $ 200
milestone payment would be payable to CWRU upon its achievement.
Under
the Amended CWRU License Agreement, the Company is required to pay a royalty fee to CWRU with respect to the “Licensed Products”
(as defined in the CWRU License Agreement) of a percentage of “Net Sales”, as defined in the Amended CWRU License Agreement,
as follows: 5.0 % of Net Sales up to $ 100.0
million per year; and 8.0 %
of Net Sales of $ 100.0
million or greater per year, with such amounts
subject-to a minimum annual royalty fee. The Company recorded a royalty expense of $ 10 for the three months ended March 31, 2022
Note
4 — Revenue from Contracts with Customers
Revenue
is recognized when the satisfaction of the performance obligation occurs, which is when the delivery of product and /or the provision
of service is rendered, and is measured as the amount of estimated consideration expected to be realized. In the period ended March 31,
2022, the Company recognized revenue under the EsoGuard Commercialization Agreement, dated August 1, 2021, as discussed below.
EsoGuard
Commercialization Agreement
The
Company, through its majority-owned subsidiary, Lucid Diagnostics Inc., entered into the EsoGuard Commercialization Agreement, dated
August 1, 2021, with its Commercial Laboratory Improvements Act (“CLIA”) certified commercial laboratory service provider,
ResearchDx Inc. (“RDx”), an unrelated third-party. The EsoGuard Commercialization Agreement is on a month-to-month basis,
and may be terminated by either party thereto, with or without cause, upon forty-five (45) days prior written notice.
On
February 25, 2022, the EsoGuard Commercialization Agreement was terminated in conjunction with the execution of an Asset Purchase Agreement
between LucidDx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc. and RDx, as such agreement is further discussed in Note
6 , Acquisitions .
Revenue
Recognized
In
the period ended March 31, 2022, the Company recognized total revenue of $ 189 , which represents the minimum fixed monthly fee of $ 100
to be paid by RDx for the delivery of services under the EsoGuard Commercialization Agreement for the period from the agreement inception
date of August 1, 2021 and prorated to February 25, 2022. The monthly fee was deemed to be collectible for such period as RDx has timely
paid the applicable respective monthly fee.
Cost
of Revenue
The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement for the period ended
March 31, 2022 totaled $ 369 , inclusive of employee related costs of employees engaged in the delivery of the administration to patients
of the EsoCheck cell sample collection procedure, EsoCheck devices and EsoGuard mailers (cell sample shipping costs) distributed to medical
practitioners’ locations and the Lucid Test Centers; Lucid Test Centers operating expenses, including rent expense and supplies;
and royalty fees incurred under the Amended CWRU License Agreement.
8
Note
5 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors of the intellectual property licensed under
the CWRU License Agreement (“Physician Inventors”) each hold equity ownership minority interests in Lucid Diagnostics Inc.
The expenses incurred with respect to the CWRU License Agreement and the three Physician Inventors, as classified in the accompanying
consolidated statement of operations for the periods indicated are summarized as follows:
Schedule of Incurred Expenses of Minority Shareholders
2022
2021
Three
Months Ended March 31,
2022
2021
Cost
of Revenue
CWRU
– Royalty Fee
$ 9
$ —
General
and Administrative Expense
Stock-based
compensation expense – Physician Inventors’ restricted stock awards
272
91
Research
and Development Expense
CWRU
License Agreement - reimbursement of patent legal fees
—
—
Fees
- Physician Inventors’ consulting agreements
8
13
Sponsored
research agreement
3
—
Stock-based
compensation expense – Physician Inventors’ stock options
46
6
Total
Related Party Expenses
$ 338
$ 110
Lucid
Diagnostics Inc. entered into consulting agreements with each of the three Physician Inventors, with each such consulting agreement providing
for compensation on a contractual rate per hour for consulting services provided, and an expiration date of May 12, 2024, upon the agreements’
renewal effective May 12, 2021. Additionally, as discussed below, each of the Physician Inventors have been granted stock options under
the PAVmed Inc. 2014 Long-Term Incentive Equity Plan, and stock options and restricted stock awards under the Lucid Diagnostics Inc.
2018 Long-Term Incentive Equity Plan.
Under
each of their respective (initial) consulting agreements with Lucid Diagnostics Inc., the three Physician Inventors were each granted
25,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of May 12, 2018, an exercise price of $ 1.59 per share
of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2018 and ending March 31, 2021, and a contractual
period of ten years from the date of grant. As of March 31, 2021, such stock options were fully vested and exercisable. Each of the Physician
Inventors were granted 50,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of June 21, 2021, an exercise price
of $ 6.41 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2021 and ending March 31,
2024, and a contractual period of ten years from the date of grant.
On
March 1, 2021, restricted stock awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan to each of the three Physician
Inventors, with such restricted stock awards having a single vesting date of March 1, 2023, with the fair value of such restricted stock
awards recognized as stock-based compensation expense ratably on a straight-line basis over the vesting period, which is commensurate
with the service period. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.
See
Note 13, Stock-Based Compensation , for information regarding each of the “PAVmed Inc. 2014 Long-Term Incentive Equity
Plan” and the separate “Lucid Diagnostics Inc 2018 Long-Term Incentive Equity Plan”; and Note 16, Noncontrolling
Interest , for a discussion of Lucid Diagnostics Inc. and the corresponding noncontrolling interests.
9
Note
5 — Related Party Transactions - continued
Other
Related Party Transactions
Lucid
Diagnostics Inc. previously entered into a consulting agreement with Stanley N. Lapidus, effective June 2020 with such consulting agreement
providing for compensation on a contractual rate per hour for consulting services provided. In July 2021, Mr. Lapidus was appointed as
Vice Chairman of the Board of Directors of Lucid Diagnostics Inc. Lucid Diagnostics Inc. recognized general and administrative expense
of $ 6
in the period ended March 31, 2021 in connection with the consulting agreement.
Veris
Health Inc. entered into a consulting agreement with Andrew Thoreson, M.D. effective June 2021 with such consulting agreement providing
for compensation on a contractual rate per hour for consulting services provided. Veris Health Inc. recognized general and administrative
expense of $ 25 in the period ended March 31, 2022 in connection with the consulting agreement.
10
Note
6 — Acquisitions
Asset Purchase Agreement - ResearchDx
Inc.
On February 25, 2022, LucidDx
Labs, Inc., entered into an asset purchase agreement (“APA”) with ResearchDx, Inc. (“RDx”), an unrelated third-party
- “RDx APA”. Under the RDx APA, LucidDx Labs Inc. acquired certain assets from RDx to be combined with LucidDx Labs Inc.
purchased and leased property and equipment to establish a Company-owned CLIA certified, CAP accredited commercial clinical laboratory
capable of performing the EsoGuard® Esophageal DNA assay, inclusive of DNA extraction, next generation sequencing (“NGS”)
and specimen storage. Prior to consummation of the RDx APA, RDx provided such laboratory services at its owned CLIA-certified, CAP-accredited
laboratory.
As of March 31, 2022, the
Company’s preliminary analysis is that the RDx APA transaction is a business combination, resulting in the recognition and measurement
of a preliminary purchase consideration in accordance with the valuation methodology described in Note 2, Summary of Significant Accounting
Policies and Recent Accounting Standards Updates .
Under
the terms of the RDx APA, LucidDx Labs Inc. will pay RDx an aggregate purchase price of up to $ 6.2
million for the acquired assets. The total
of $ 6.2
million is comprised of non-contingent purchase
consideration of $ 1.0
million (included in “Accrued expenses
and other liabilities” on the accompanying unaudited condensed consolidated balance sheets, as of March 31, 2022), and contingent
purchase consideration of a total of $ 5.2
million face value, with such contingent
purchase consideration having a preliminary $ 4,714
initial estimated fair value as of the
transaction date. The preliminary $ 5,714 purchase consideration (inclusive of both the non-contingent and contingent purchase consideration
discussed above) is unallocated as of March 31, 2022, and as such is included in intangible assets in the accompanying unaudited consolidated
balance sheet. The preliminary estimated fair value of the contingent purchase price consideration and the identification and estimated
fair value of acquired assets are subject-to further revision.
Concurrent with the RDx APA,
LucidDx Labs Inc. and RDx also entered into a management services agreement (“RDx MSA”), with a term of three years , and
a total of approximately $ 1.8 million payable in equal quarterly payments.
Pro
Forma Information
The
RDx acquisition impact for purposes of pro forma financial disclosures would have primarily impacted the Company’s EsoGuard Commercialization
Agreement with RDx. The impact is reflected in the table below:
Schedule
Of Business Acquisition Pro Forma Information
Three Months Ended March 31,
2022
2021
Revenue
As reported
$ 189
$ —
Pro forma
$ —
$ —
Net Loss
As reported
$ ( 16,940 )
$ ( 9,506 )
Pro forma
$ ( 17,129 )
$ ( 9,506 )
Basic and diluted net loss per share
As reported
$ ( 0.20 )
$ ( 0.13 )
Pro forma
$ ( 0.20 )
$ ( 0.13 )
11
Note
7 — Prepaid Expenses, Deposits, and Other Current Assets
Current
Assets
Prepaid
expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
March
31, 2022
December
31, 2021
Advanced
payments to service providers and suppliers
$ 651
$ 808
Prepaid
insurance
1,174
1,856
Deposits
2,973
1,989
Deferred
financing charges
1,014
—
EsoCheck
cell collection supplies
266
434
EsoGuard
mailer supplies
65
59
CarpX
devices
33
33
Total
prepaid expenses, deposits and other current assets
$ 6,176
$ 5,179
Note
8 — Leases
Supplemental
disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:
Schedule
of Supplemental Balance Sheet Information Related to Cash and Non-cash Activities with Leases
2022
2021
Three
Months Ended March 31,
2022
2021
Cash
paid for amounts included in the measurement of lease liabilities
Operating
cash flows from operating leases
$ 224
$ —
Non-cash
investing and financing activities
Right-of-use
assets obtained in exchange for new operating lease liabilities
$ 3,151
$ —
Weighted-average
remaining lease term - operating leases (in years)
3.32
—
Weighted-average
discount rate - operating leases
7.875 %
— %
As
of March 31, 2022, the Company’s right-of-use assets from operating leases are $ 2,951 , which are reporting in right-of-use assets
- operating leases in the unaudited condensed consolidated balance sheets. As of March 31, 2022, the Company has outstanding operating
lease obligations of $ 2,981 , of which $ 873 is reported in operating lease liabilities, current portion and $ 2,108 is reporting in operating
lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company did not have
operating leases as of December 31, 2021. The Company calculates its incremental borrowing rates for specific lease terms, used to discount
future lease payments, as a function of the financing terms the Company would likely receive on the open market.
The
Company executed lease agreements for: office space in Horsham, Pennsylvania, which commenced May 1, 2022; and a new light manufacturing
facility in Riverton, Utah, with expected commencement of October 2022.
12
Note
9 — Intangible Assets
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule
of Intangible Assets
Estimated
Useful Life
March
31, 2022
December
31, 2021
Defensive
asset
5
years
$ 2,105
$ 2,105
Other
1
year
70
70
Identified finite intangible assets
2,175
2,175
Unallocated purchase consideration 1
5,714
—
Total
Intangible asset
7,889
2,175
Less
Accumulated Amortization
( 269 )
( 146 )
Total
Intangible Assets, net
$ 7,620
$ 2,029
(1) See
Note 6, Acquisitions - Asset Purchase Agreement - Research Dx Inc. , for a discussion
of the “unallocated purchase consideration” recognized as an intangible asset
as of March 31, 2022, as presented in the table above.
Amortization
expense of the acquired intangible assets discussed above was $ 123
for the period ended March 31, 2022 (there was
no such amortization expense for the prior period ended March 31, 2021), and is included in general and administrative expenses in the
accompanying consolidated statements of operations. As of March 31, 2022, the estimated future amortization expense associated with the
Company’s identified finite-lived intangible assets (except for the unallocated purchase consideration included in total
intangible asset presented above) for each of the five succeeding fiscal years is as follows:
Schedule
of Estimated Amortization Expense for Intangible Assets
2022
(remainder of year)
$ 327
2023
421
2024
421
2025
421
2026
316
Thereafter
—
Total
$ 1,906
13
Note
10 — Commitment and Contingencies
Legal
Proceedings
On
November 2, 2020, a stockholder of the Company, on behalf of himself and other similarly situated stockholders, filed a complaint in
the Delaware Court of Chancery alleging broker non-votes were not properly counted in accordance with the Company’s bylaws at the
Company’s Annual Meeting of Stockholders on July 24, 2020, and, as a result, asserted certain matters deemed to have been approved
were not so approved (including matters relating to the increase in the size of the 2014 Equity Plan and the ESPP). The relief sought
under the complaint includes certain corrective actions by the Company, but did not seek any specific monetary damages. The Company did
not believe it was clear the prior approval of these matters was invalid or otherwise ineffective. However, to avoid any uncertainty
and the expense of further litigation, on January 5, 2021, the Company’s Board of Directors determined it would be advisable and
in the best interests of the Company and its stockholders to re-submit these proposals to the Company’s stockholders for ratification
and/or approval. In this regard, the Company held a special meeting of stockholders on March 4, 2021, at which such matters were ratified
and approved. The parties have reached agreement on a proposed Settlement Term Sheet Agreement, dated January 28, 2021, to settle the
complaint, the terms of which do not contemplate payment of monetary damages to the putative class in the proceeding. The settlement
of the complaint is pending approval by the Court. The settlement hearing before the Court is scheduled for November 3, 2022.
On
December 23, 2020, Benchmark Investments, Inc. filed a complaint against the Company in the U.S. District Court of the Southern District
of New York alleging the registered direct offerings of shares of common stock of the Company completed in December 2020 were in violation
of provisions set forth in an engagement letter between the Company and Kingswood Capital Markets, a “division” of Benchmark
Investments, Inc. On December 16, 2021, the court granted PAVmed’s motion to dismiss the case for lack of subject matter jurisdiction.
On February 7, 2022, Benchmark Investments LLC, which claimed to be affiliated with Benchmark Investments, Inc., filed a new complaint
in the Supreme Court of the State of New York, New York County, asserting claims similar to those in the federal action, and adding to
its allegations that financings conducted by the Company in January 2021 and February 2021 also violated the Company’s engagement
letter with Kingswood Capital Markets. The Company disagrees with the allegations set forth in the complaint and intends to vigorously
contest the complaint.
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to certain
other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from
time to time. Except as otherwise noted herein, the Company does not believe it is currently a party to any other pending legal proceedings.
Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable outcome could include monetary damages,
and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business,
financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain
potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse
impact on the Company’s business, financial position, results of operations, and /or cash flows.
14
Note
11 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the reporting dates noted is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
Fair
Value Measurement on a Recurring Basis at Reporting
Date
Using (1)
Level-1
Inputs
Level-2
Inputs
Level-3
Inputs
Total
March
31, 2022
Contingent
consideration payable
$ —
$ —
$ 4,887
$ 4,887
Totals
$ —
$ —
$ 4,887
$ 4,887
(1)
As noted above, as presented in the fair value hierarchy table,
Level-1 represents quoted prices in active markets for identical items, Level-2 represents significant other observable inputs, and Level-3
represents significant unobservable inputs. There were no transfers between the respective Levels during the period ended March 31, 2022.
Fair
value measurements of contingent consideration
The
Company recorded $ 4.9
million, which is the fair value, of contingent consideration
related to the RDx acquisition. The Company is required to make contingent consideration payments of up to $ 5.2
million related to the RDx APA agreement. The
contingent agreement is based on achieving milestones to obtain certain certifications and licensing rights. The Company estimated
the fair value on a probability based model that assessed achievement of such milestones. The model used present
value factors, that applied probability ranges of 94-99%, a discount rate of 7.875% and achievement times ranging from one month to six
months to achieve the respective milestones.
The
final settlement of contingent consideration liabilities for the acquisition could vary from current estimates based on
the actual results of the financial measures described above. This liability is considered to be a Level 3 financial liability that is
re-measured each reporting period. The change in fair value of contingent consideration for these acquisitions is included in other income
(expense), net.
The
following table presents a reconciliation of the liability measured at fair value on a recurring basis using significant unobservable
inputs (Level 3):
Schedule
of Reconciliation of Liability Measured at Fair Value on a Recurring Basis
March
31, 2022
Fair
value of contingent consideration at the date of acquisition
$ 4,714
Payments
—
Change
in fair value of contingent consideration
173
Contingent
consideration payable
$ 4,887
As
of December 31, 2021 there were no fair value measurements.
See
Note 12, Debt for convertible notes the Company has entered into subsequent to March 31, 2022.
15
Note
12 — Debt
Subsequent
to March 31, 2022, on April 4, 2022, the Company entered into a Senior Secured Convertible Note in the amount of $ 27.5
million, pursuant to a Securities Purchase
Agreement (“SPA”) with an accredited institutional investor. Under the SPA, the Company agreed to sell, and the investor
agreed to purchase, up to an additional $ 22.5 in additional initial principal amount of Senior Secured Convertible Notes (for an aggregate
of $ 50.0 million in initial principal amount of Secured Promissory Notes) upon the satisfaction of certain conditions (as more fully
described below). The notes are being offered and sold in a registered direct offering under the Company’s effective shelf registration
statement (the “Offering”). The purchase price of the Secured Promissory Notes is $1,000 for each $1,100 in principal amount
of the notes, representing an original issue discount of $100 per $1,100 in principal amount of the notes . We herein refer to the Senior
Secured Convertible Notes issued from time to time under the SPA as March 2022 Notes.
Pursuant
to the SPA we completed an initial closing for the sale of $ 27.5
million in principal amount of March 2022 Notes,
of which the investor funded and the Company received cash proceeds of $ 24.9
million on April 5, 2022, after deduction of
lender fees. Subject
to certain conditions being met or waived, from time to time after such time that stockholder approval for an increase in our authorized
shares from 150 million to 250 million is obtained, but before March 31, 2024, one or more additional closings for up to the remaining
principal amount of March 2022 Notes may occur, upon five trading days’ notice by us to the investor. The aggregate principal amount
of March 2022 Notes that may be offered in the additional closings may not be more than $22.5 million .
The investor’s obligation to purchase the notes at each additional closing is subject to certain conditions set forth in the March
2022 SPA (including minimum price and volume thresholds, maximum ratio of debt to market capitalization, and minimum market capitalization),
which may be waived by the Required Holders (as defined in the March 2022 SPA). Under the March 2022 SPA, the investor will be required
to purchase March 2022 Notes in the additional closings if such conditions are met or waived. In addition, from and after March 31, 2023,
the investor may by written notice to us elect to require us to issue up to $ 22.5
million in initial principal amount of March
2022 Notes, so long as in doing so it would not cause the ratio of (a) the outstanding principal amount of the March 2022 Notes (including
the additional March 2022 Notes), accrued and unpaid interest thereon and accrued and unpaid late charges to (b) our average market capitalization
over the prior ten trading days, to exceed 25%. If we fail to complete the sale of the additional March 2022 Notes contemplated
by any such written notice, or if the investor is unable to deliver any such notice prior to March 31, 2024 as a result of the limitation
described in the preceding sentence, then we will be obligated to pay a break-up fee to the investor at such time in an aggregate amount
equal to $ 1.35
million.
The
March 2022 Notes have a voluntary fixed conversion price of $ 5.00
per share, a stated interest rate of 7.875 %
per annum, and a maturity of 24 months (subject to extension in certain circumstances). The March 2022 Notes will be secured by all our
existing and future assets (including those of our significant subsidiaries, other than Lucid and its subsidiaries), but including only
9.99 %
of Lucid’s outstanding common stock held by us, pursuant to a security agreement by and between the Company and the investor.
We
will be subject to certain customary affirmative and negative covenants regarding the rank of the March 2022 Notes, 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 will be 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 March 2022 Notes, 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%, and (iii) that our market capitalization shall at no time be less than $75 million.
The March 2022 Notes include certain customary
events of default.
16
Note
13 — Stock-Based Compensation
PAVmed
Inc. 2014 Long-Term Incentive Equity Plan
The
PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed Inc. 2014 Equity Plan”) is designed to enable PAVmed Inc. to
offer employees, officers, directors, and consultants, as defined, an opportunity to acquire shares of common stock of PAVmed Inc. The
types of awards that may be granted under the PAVmed Inc. 2014 Equity Plan include stock options, stock appreciation rights, restricted
stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the PAVmed Inc.
board of directors.
A
total of 16,352,807 shares of common stock of PAVmed Inc. are reserved for issuance under the PAVmed Inc. 2014 Equity Plan, with 2,776,706
shares available for grant as of March 31, 2022. The share reservation is not diminished by a total of 600,854 PAVmed Inc. stock options
and restricted stock awards granted outside the PAVmed Inc. 2014 Equity Plan as of March 31, 2022.
PAVmed
Inc. 2014 Equity Plan - Stock Options
Stock
options issued and outstanding under the PAVmed Inc. 2014 Equity Plan and including PAVmed stock options granted outside the plan is
as follows:
Schedule of Summarizes Information About Stock Options
Number
of Stock Options
Weighted
Average Exercise Price
Remaining
Contractual Term (Years)
Intrinsic
Value (2)
Outstanding
stock options at December 31, 2021
8,720,198
$ 3.39
6.8
$ 3,516
Granted (1)
3,109,350
$ 1.67
Exercised
( 237,499 )
$ 1.02
Forfeited
( 273,757 )
$ 2.94
Outstanding
stock options at March 31, 2022
11,318,292
$ 2.98
7.1
$ 439
Vested
and exercisable stock options at March 31, 2022
6,519,615
$ 3.08
5.4
$ 428
(1) Stock
options granted under the PAVmed Inc. 2014 Equity Plan generally vest ratably over twelve
quarters, with the vesting commencing with the grant date quarter, and have a ten-year contractual
term from date-of-grant.
(2) The
intrinsic value is computed as the difference between the quoted price of the PAVmed Inc.
common stock on each of March 31, 2022 and December 31, 2021 and the exercise price of the
underlying PAVmed Inc. stock options, to the extent such quoted price is greater than the
exercise price.
PAVmed
Inc. 2014 Equity Plan - Restricted Stock Awards
A
summary of PAVmed Inc. 2014 Equity Plan restricted stock award activity is as follows:
Schedule of Restricted Stock Award Activity
Number
of Stock Options
Weighted
Average Grant Date Fair Value
Unvested
restricted stock awards as of December 31, 2021
1,566,666
$ 2.31
Granted
—
—
Vested
( 466,666 )
1.06
Forfeited
( 150,000 )
2.04
Unvested
restricted stock awards as of March 31, 2022
950,000
$ 2.97
17
Note
13 — Stock-Based Compensation - continued
Lucid
Diagnostics Inc. 2018 Long-Term Incentive Equity Plan
The
Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics Inc. 2018 Equity Plan”) is separate and apart
from the PAVmed Inc. 2014 Equity Plan discussed above. The Lucid Diagnostics Inc. 2018 Equity Plan is designed to enable Lucid Diagnostics
Inc. to offer employees, officers, directors, and consultants, as defined, an opportunity to acquire shares of common stock of Lucid
Diagnostics Inc. The types of awards that may be granted under the Lucid Diagnostics Inc. 2018 Equity Plan include stock options, stock
appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject
to approval by the Lucid Diagnostics Inc. board of directors.
A
total of 5,644,000 shares of common stock of Lucid Diagnostics Inc. are reserved for issuance under the Lucid Diagnostics Inc. 2018 Equity
Plan, with 733,541 shares available for grant as of March 31, 2022, with the share reservation not diminished by a total of 473,300 Lucid
Diagnostics Inc. stock options and restricted stock awards granted outside the Lucid Diagnostics Inc. 2018 Equity Plan.
Lucid
Diagnostics Inc. 2018 Equity Plan - Stock Options
Stock
options issued and outstanding under the Lucid Diagnostics Inc. 2018 Equity Plan and including Lucid Diagnostics options granted outside
the plan is as follows:
Schedule of Summarizes Information About Stock Options
Number
of Stock Options
Weighted
Average Exercise Price
Remaining
Contractual Term (Years)
Outstanding
stock options at December 31, 2021
1,419,242
$ 0.73
7.0
Granted (1)
1,760,000
$ 4.16
Exercised
( 253,889 )
$ 0.74
Forfeited
( 60,926 )
$ 4.61
Outstanding
stock options at March 31, 2022
2,864,427
$ 2.75
6.9
Vested
and exercisable stock options at March 31, 2022
1,277,026
$ 0.99
3.3
(1)
Stock
options granted under the Lucid Diagnostics Inc. 2018 Equity Plan generally vest ratably
over twelve quarters, with the vesting commencing with the grant date quarter, and have a
ten-year contractual term from date-of-grant.
Lucid
Diagnostics Inc. 2018 Equity Plan – Restricted Stock Awards
A
summary of Lucid Diagnostics Inc. 2018 Equity Plan restricted stock award activity is as follows:
Schedule of Restricted Stock Award Activity
Number
of Restricted Stock Awards
Weighted
Average Grant Date Fair Value
Unvested
restricted stock awards as of December 31, 2021
1,890,740
$ 12.94
Granted
320,000
4.53
Vested
—
—
Forfeited
—
—
Unvested restricted stock awards as of March 31, 2022
2,210,740
$ 11.07
On
January 7, 2022, 320,000
restricted stock awards were granted under the
Lucid Diagnostics Inc 2018 Equity Plan, with such restricted stock awards having a single vesting date on January 7, 2025, and an aggregate
grant date fair value of approximately $ 1.4
million, measured as the grant date closing price
of Lucid Diagnostics Inc. common stock, with such aggregate estimated fair value recognized as stock-based compensation expense ratably
on a straight-line basis over the vesting period, which is commensurate with the service period. The restricted stock awards are subject
to forfeiture if the requisite service period is not completed.
18
Note
13 — Stock-Based Compensation - continued
Consolidated
Stock-Based Compensation Expense
The
consolidated stock-based compensation expense recognized by each of PAVmed Inc. and Lucid Diagnostics Inc. for both the PAVmed Inc. 2014
Equity Plan and the Lucid Diagnostics Inc. 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above,
for the periods indicated, was as follows:
Schedule of Stock-Based Compensation Awards Granted
Three
Months Ended March 31,
2022
2021
Sales
and marketing expenses
$ 625
$ 202
General
and administrative expenses
4,002
1,124
Research
and development expenses
187
110
Total
stock-based compensation expense
$ 4,814
$ 1,436
Stock-Based
Compensation Expense Recognized by Lucid Diagnostics Inc.
As
noted, the consolidated stock-based compensation expense presented above is inclusive of stock-based compensation expense recognized
by Lucid Diagnostics Inc., inclusive of each of: stock options granted under the PAVmed Inc. 2014 Equity Plan to the three physician
inventors of the intellectual property underlying the CWRU License Agreement (“Physician Inventors”) (as discussed above
in Note 5, Related Party Transactions ); and stock options and restricted stock awards granted to employees of PAVmed Inc. and
non-employee consultants under the Lucid Diagnostics Inc. 2018 Equity Plan.
The
stock-based compensation expense recognized by Lucid Diagnostics Inc. for both the PAVmed Inc. 2014 Equity Plan and the Lucid Diagnostics
Inc. 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above, for the periods indicated, was as
follows:
Schedule
of Stock-Based Compensation Expense Classified in Research and Development Expenses
Three
Months Ended March 31,
2022
2021
Lucid
Diagnostics Inc 2018 Equity Plan – sales and marketing expenses
$ 265
$ —
Lucid
Diagnostics Inc 2018 Equity Plan – general and administrative expenses
3,201
789
Lucid
Diagnostics Inc 2018 Equity Plan – research and development expenses
71
13
PAVmed
Inc 2014 Equity Plan - sales and marketing expenses
175
—
PAVmed
Inc 2014 Equity Plan - general and administrative expenses
68
—
PAVmed
Inc 2014 Equity Plan - research and development expenses
55
3
Total
stock-based compensation expense – recognized by Lucid Diagnostics Inc
$ 3,835
$ 805
19
Note
13 — Stock-Based Compensation - continued
The
consolidated unrecognized stock-based compensation expense and weighted average remaining requisite service period with respect to stock
options and restricted stock awards issued under each of the PAVmed Inc. 2014 Equity Plan and the Lucid Diagnostics Inc. 2018 Equity
Plan, as discussed above, is as follows:
Schedule of Unrecognized Compensation Expense
Unrecognized
Expense
Weighted
Average Remaining Service Period (Years)
PAVmed
Inc. 2014 Equity Plan
Stock
Options
$ 9,667
2.4
Restricted
Stock Awards
$ 1,796
1.4
Lucid
Diagnostics Inc. 2018 Equity Plan
Stock
Options
$ 4,660
2.7
Restricted
Stock Awards
$ 14,080
1.3
Stock-based
compensation expense recognized with respect to stock options granted under the PAVmed Inc. 2014 Equity Plan was based on a weighted
average estimated fair value of such stock options of $ 1.22 per share and $ 2.79 per share during the periods ended March 31, 2022 and
2021, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions
Three
Months Ended March 31,
2022
2021
Expected
term of stock options (in years)
5.8
5.7
Expected
stock price volatility
87.7 %
75.0 %
Risk
free interest rate
1.8 %
1.0 %
Expected
dividend yield
— %
— %
Stock-based
compensation expense recognized with respect to stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan was based on
a weighted average estimated fair value of such stock options of $ 2.95 per share during the year ended March 31, 2022. There were no
stock-based awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan during the period ended March 31, 2021. The stock-based
compensation was calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions
Three
Months Ended March 31,
2022
Expected
term of stock options (in years)
5.6
Expected
stock price volatility
85.7 %
Risk
free interest rate
1.7 %
Expected
dividend yield
— %
20
Note
13 — Stock-Based Compensation - continued
PAVmed
Inc. Employee Stock Purchase Plan (“ESPP”)
A
total of 194,240
shares and 203,480
shares of common stock of the Company were purchased
for proceeds of approximately $ 217
and $ 304 ,
on March 31, 2022 and 2021, respectively under the PAVmed Inc Employee Stock Purchase Plan (“PAVmed Inc ESPP”). The
PAVmed Inc. ESPP has a total reservation of 3,010,690
shares of common stock of PAVmed Inc. of which
2,192,531
shares are available-for-issue as of March 31,
2022.
Lucid
Diagnostics, Inc Employee Stock Purchase Plan (“ESPP”)
The
Lucid Diagnostics Inc Employee Stock Purchase Plan (“Lucid Diagnostics Inc ESPP”), initial six-month stock purchase
period is April 1, 2022 to September 30, 2022. The Lucid Diagnostics Inc. ESPP share purchase dates are March 31 and September
30. The Lucid Diagnostics Inc. ESPP has a total reservation of 500,000
shares of common stock of Lucid Diagnostics
Inc. for which all shares are available-for-issue as of March 31, 2022.
Note
14 — Preferred Stock
As
of March 31, 2022 and 2021, there were 1,136,210 and 1,241,438 shares of Series B Convertible Preferred Stock (classified in permanent
equity) issued and outstanding, respectively.
The
Series B Convertible Preferred Stock dividends earned are included in the calculation of basic and diluted net loss attributable to PAVmed
Inc. common stockholders for each of the corresponding periods presented. Notwithstanding, the Series B Convertible Preferred Stock dividends
are recognized as a dividend payable only upon the dividend being declared payable by the Company’s board of directors.
Subsequent
to March 31, 2022, in April 2022, the Company’s board-of-directors declared a Series B Convertible Preferred Stock dividend earned
as of March 31, 2022 and payable as of April 1, 2022, of approximately $ 68 ,
which will be settled by the issue of an additional
22,740
shares of Series B Convertible Preferred
Stock (with such dividend not recognized as a dividend payable as of March 31, 2022, as the Company’s board of directors had not
declared such dividends payable as of such date).
21
Note
15 — Common Stock and Common Stock Purchase Warrants
Common
Stock
During
the period ended March 31, 2022, 237,499
shares of common stock of the Company were issued
upon exercise of stock options for cash of approximately $ 241 .
See Note 13, Stock-Based Compensation , for a discussion of the PAVmed Inc. 2014 Equity Plan. During the period
ended, the PAVmed Inc. Employee Stock Purchase Plan purchased 194,240
shares of common stock of the Company. See Note
13, Stock-Based Compensation , for a discussion of the PAVmed Inc. Employee Stock Purchase Plan.
Common
Stock Purchase Warrants
The
common stock purchase warrants (classified in permanent equity) outstanding as of the dates indicated are as follows:
Schedule of Outstanding Warrants to Purchase Common Stock
Common
Stock Purchase Warrants Issued and Outstanding
March
31, 2022
Weighted
Average Exercise Price / Share
December
31, 2021
Weighted
Average Exercise Price / Share
Expiration
Date
Series
Z Warrants
11,937,450
$ 1.60
11,937,455
$ 1.60
April
2024
Series
W Warrants
—
$ —
377,873
$ 5.00
January
2022
Total
11,937,450
$ 1.60
12,315,328
$ 1.68
During
the period ended March 31, 2022, a total of 5 Series Z Warrants were exercised for cash at $ 1.60 per share, resulting in the issue of
the same number of shares of common stock of the Company.
The
remaining 377,873
Series W Warrants expired unexercised as of January
29, 2022.
Note
16 — Noncontrolling Interest
The
noncontrolling interest (“NCI”) included as a component of consolidated total stockholders’ equity is summarized for
the periods indicated as follows:
Schedule of Noncontrolling Interest of Stockholders' Equity
March
31, 2022
December
31, 2021
NCI
– equity (deficit) – beginning of period
$ 17,752
$ ( 2,369 )
Investment
in Veris Health Inc.
—
6
Net
loss attributable to NCI
( 2,761 )
( 5,779 )
Impact
of subsidiary equity transactions
87
16,760
Lucid
Diagnostics Inc. 2018 Equity Plan stock option exercise
187
—
Stock-based
compensation expense - Lucid Diagnostics Inc. 2018 Equity Plan
3,537
9,134
NCI
– equity (deficit) – end of period
$ 18,802
$ 17,752
22
Note
16 — Noncontrolling Interest - continued
The
consolidated NCI presented above is with respect to the Company’s consolidated majority-owned subsidiaries, inclusive of:
Lucid Diagnostics Inc., Veris Health Inc. and Solys Diagnostics Inc., as a component of consolidated total
stockholders’ equity as of March 31, 2022 and December 31, 2021; and the recognition of a net loss attributable to the
NCI in the unaudited condensed consolidated statement of operations with respect to Lucid Diagnostics Inc. and Solys Diagnostics
Inc. for the three months ended March 31, 2022 and 2021; and with respect to Veris Health Inc. for the three
months ended March 31, 2022 (as the Veris Health Inc inception date was May 28, 2021).
Lucid
Diagnostics Inc.
As
of March 31, 2022, there were 35,171,796
shares of common stock of Lucid Diagnostics
Inc. issued and outstanding, of which, PAVmed Inc. holds 27,927,190
shares, representing a majority ownership
equity interest and a controlling financial interest in Lucid Diagnostics Inc., and accordingly, Lucid Diagnostics Inc. is a consolidated
majority-owned subsidiary of PAVmed Inc.
On
March 28, 2022, Lucid Diagnostics Inc. entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”).
Under the terms of the committed equity facility, Cantor has committed to purchase up to $ 50 million of Lucid Diagnostics Inc. common
stock from time to time at the request of Lucid Diagnostics Inc.
In
connection with the execution of the agreement for the committed equity facility, Lucid Diagnostics Inc. agreed to pay Cantor $ 1.0 million
as consideration for its irrevocable commitment to purchase the shares upon the terms and subject to the satisfaction of the conditions
set forth in such agreement. In addition, pursuant to the agreement, Lucid Diagnostics agreed to reimburse Cantor for certain of its
expenses. Lucid Diagnostics Inc. also entered into a registration rights agreement with Cantor. Lucid Diagnostics Inc. has the right
to terminate the agreement at any time after initial satisfaction of the conditions to Cantor’s obligation to purchase shares under
the facility, at no cost or penalty, upon three trading days’ prior written notice.
Veris
Health Inc.
As
of March 31, 2022, there were 8,000,000
shares of common stock of Veris Health Inc. issued
and outstanding, of which PAVmed Inc. holds an 80.44 %
majority-interest ownership and has a controlling financial interest, with the remaining 19.56 %
minority-interest ownership held by an unrelated third-party. Accordingly, Veris Health Inc. is a consolidated majority-owned subsidiary
of the Company, for which a provision of a noncontrolling interest (NCI) is included as a separate component of consolidated stockholders’
equity in the unaudited condensed consolidated balance sheet as of March 31, 2022 along with the recognition of a net loss attributable
to the NCI in the unaudited condensed consolidated statement of operations for the period of May 28, 2021 to December 31, 2021, upon
its formation and contemporaneous acquisition of Oncodisc Inc.
Solys
Diagnostics Inc.
As
of each of March 31, 2022 and December 31, 2021, there were 9,189,190 shares of common stock of Solys Diagnostics Inc. issued and outstanding,
of which PAVmed Inc. holds a 90.3235 % majority-interest ownership and has a controlling financial interest, with the remaining 9.6765 %
minority-interest ownership held by unrelated third parties.
23
Note
17 — Net Loss Per Share
The
respective “Net loss per share - attributable to PAVmed Inc. - basic and diluted” and “Net loss per share - attributable
to PAVmed Inc. common stockholders - basic and diluted” - for the periods indicated - is as follows:
Schedule of Comparison of Basic and Fully Diluted Net Loss Per Share
2022
2021
Three
Months Ended March 31,
2022
2021
Numerator
Net
loss - before noncontrolling interest
$ ( 19,633 )
$ ( 10,110 )
Net
loss attributable to noncontrolling interest
2,761
679
Net
loss - as reported, attributable to PAVmed Inc.
$ ( 16,872 )
$ ( 9,431 )
Series
B Convertible Preferred Stock dividends – earned
$ ( 68 )
$ ( 75 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 16,940 )
$ ( 9,506 )
Denominator
Weighted
average common shares outstanding, basic and diluted
86,336,427
73,954,126
Loss
per share
Basic
and diluted
Net
loss - as reported, attributable to PAVmed Inc.
$ ( 0.20 )
$ ( 0.13 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 0.20 )
$ ( 0.13 )
The
common stock equivalents have been excluded from the computation of diluted weighted average shares outstanding as their inclusion would
be anti-dilutive, are as follows:
The
Series B Convertible Preferred Stock dividends earned as of the each of the respective periods noted, are included in the calculation
of basic and diluted net loss attributable to PAVmed Inc. common stockholders for each respective period presented. Notwithstanding,
the Series B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable
by the Company’s board of directors.
Basic
weighted-average number of shares of common stock outstanding for the periods ended March 31, 2022 and 2021 include the shares of the
Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares common
stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding includes
such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted average
shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents excluded
from the computation of diluted weighted average shares outstanding are as follows:
Schedule of Antidilutive Securities Excluded from Computation of Diluted Earnings Per Share
2022
2021
March
31,
2022
2021
Stock options and restricted stock awards
12,368,292
8,539,362
Series
Z Warrants
11,937,450
15,954,722
Series
W Warrants
—
381,818
Series
B Convertible Preferred Stock
1,136,210
1,241,438
Total
25,441,952
26,117,340
The total stock options and restricted stock awards are inclusive of 500,854 stock options as of March 31, 2022 and
2021; and 100,000 restricted stock awards as of March 31, 2022, granted outside the PAVmed Inc. 2014 Equity Plan.
24
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, 2021 (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 Subsidiaries, including each of
the PAVmed Inc. and its majority-owned subsidiaries, including: Lucid Diagnostics Inc. (“Lucid Diagnostics” or “LUCID”),
Veris Health Inc. (“Veris Health” or “VERIS”), and Solys Diagnostics, Inc. (“Solys Diagnostics” or
“SOLYS”).
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 SARS-CoV-2 /COVID-19 pandemic;
●
the
impact of the material weakness identified by our management; 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 Form 10-K, 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.
25
Overview
The
Company is a highly differentiated, multi-product, commercial-stage medical technology company organized to advance a broad pipeline
of innovative medical technologies from concept to commercialization, employing a business model focused on capital efficiency and speed
to market. Since the Company’s inception of PAVmed Inc. on June 26, 2014, its activities have focused on advancing
its lead products towards regulatory approval and commercialization, protecting its intellectual property, and building its corporate
infrastructure and management team. The Company has ongoing operations conducted through PAVmed Inc. and its majority-owned subsidiaries.
The
Company operates in one segment as a medical technology company, with the following lines-of-business: “Medical Devices”,
“Diagnostics”, “Digital Health”, and “Emerging Innovations”.
Our products, services, and
opportunities, as discussed herein and in Item 1 of Part I of the Form 10-K under the heading Business Background and Overview, are as
follows:
●
Diagnostics - EsoGuard Esophageal DNA Laboratory Developed Test,
EsoCheck Esophageal Cell Collection Device, and EsoCure Esophageal Ablation Device with Caldus Technology;
●
Medical Devices - CarpX Minimally Invasive Surgical Device for Carpal
Tunnel Syndrome; Infusion Therapy - PortIO Implantable Intraosseous Vascular Access Device and NextFlo Highly Accurate Disposable
Intravenous Infusion Platform Technology;
●
Digital Health - Veris cancer healthcare platform and implantable
intelligent vascular port combining remote monitoring and data analytics;
●
Emerging Innovations -Include a diversified and expanding portfolio
of innovative products designed to address unmet clinical needs across a broad range of clinical conditions. We are evaluating a
number of these product opportunities and intellectual property covering a wide spectrum of clinical conditions, which have either
been developed internally or have been presented to us by clinician innovators and academic medical institutions for consideration
of a partnership to develop and commercialize these products.
Our
multiple products and services are in various phases of development, regulatory clearances, approvals, and commercialization.
●
The
EsoCheck device received 510(k) marketing clearance from the U.S. Food and Drug Administration (“FDA”), in June 2019 and
European CE Mark Certification in May 2021 as an esophageal cell collection device; and, EsoGuard has been established as a
Laboratory Developed Test (“LDT”), completed European CE Mark Certification in June 2021, and was launched commercially
in December 2019 after Clinical Laboratory Improvement Amendment (“CLIA”) and College of American Pathologists
(“CAP”) accreditation of the test at Lucid Diagnostics commercial diagnostic laboratory partner ResearchDx Inc.
(“RDx”), headquartered in Irvine, California. On February 25, 2022, Lucid Diagnostics’ wholly owned subsidiary,
LucidDx Labs Inc. (“LucidDx Labs”) acquired from RDx certain licenses and other related assets necessary for LucidDx
Labs to operate its own new CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA. In August 2021, Lucid
Diagnostics launched a strategic partnership with direct-to-consumer telemedicine company UpScriptHealth to support our
commercialization efforts. Also in August 2021, we tested our first patients referred by primary care physicians
(“PCPs”) in our initial Lucid Test Centers opened in the Phoenix metropolitan area. We have since expanded our Lucid
Test Centers into six additional cities expanding from its origin in the Southwest United States and stretching to the
Northwest.
26
Overview - continued
●
In
connection with our efforts to expand our presence in the diagnostic market, we are developing EsoCure as an Esophageal Ablation
Device, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer,
and to do so without the need for complex and expensive capital equipment. We have successfully completed a pre-clinical feasibility
animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. We have also
completed an acute and survival animal study of EsoCure™ Esophageal Ablation Device, demonstrating successful direct thermal
balloon catheter ablation of esophageal lining through the working channel of a standard endoscope. We plan to conduct additional
development work and animal testing of EsoCure to support a future FDA 510(k) submission.
●
CarpX is a minimally invasive surgical device for use
in the treatment of carpal tunnel syndrome which received FDA 510(k) marketing clearance in April 2020, with the first commercial
procedure successfully performed in December 2020. After an initial slowdown in commercialization related to COVID, more recently
we have recruited new sales leadership and have recently trained eight new surgeons to perform the CarpX procedure with four more
scheduled to undergo training in the coming months. Our limited-release commercialization efforts thru 2022 are focused on engaging
key opinion hand surgeons designed to solicit input for ergonomic improvements to the device, procedure development and surgical-time
optimization, and ease of use. Concurrently, we are presently working on improvements to the device that will be released in stages
over the next several quarters
●
We believe CarpX is designed to allow the physician
to relieve the compression on the median nerve without an open incision or the need for endoscopic or other imaging equipment. To
use CarpX, the operator first advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire
and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance. When the CarpX balloon is inflated it creates
tension in the ligament positioning the cutting electrodes underneath it and creates space within the tunnel, providing anatomic
separation between the target ligament and critical structures such as the median nerve. Radiofrequency energy is briefly delivered
to the electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve. We believe CarpX will be significantly
less invasive than existing treatments .
●
In
May 2021, we formed Veris Health, and concurrently, acquired Oncodisc Inc (“Oncodisc”), a digital health company
with ground breaking tools to improve personalized cancer care through remote patient monitoring. Oncodisc’s core technologies
include the first intelligent implantable vascular healthcare platform that provides patients and physicians with new tools to improve
outcomes and optimize the delivery of cost-effective care through remote monitoring and data analytics. Its vascular access port
contains biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes in
cancer patients undergoing treatment. Wireless communication to the patient’s smartphone and its cloud-based digital healthcare
platform efficiently and effectively delivers actionable real time data to patients and physicians. The technologies are the subject
of multiple patent applications and one allowed patent awaiting final issuance.
●
Our other products in development have not yet received
clearance or approval to be marketed or sold in the U.S. or elsewhere
27
Overview
- continued
Financing
Subsequent
to March 31, 2022, on April 4, 2022, the Company
entered into a Senior Secured Convertible Note in the amount of $27.5 million, pursuant to a Securities Purchase Agreement
(“SPA”) executed in March 2022 with an accredited institutional investor (“investor”). Under the SPA,
the Company agreed to sell, and the investor agreed to purchase, up to an additional $22.5 million initial principal amount of
Senior Secured Convertible Notes (for an aggregate of $50.0 million in initial principal) upon the satisfaction of certain
conditions. The purchase price of the Secured Promissory Notes is $1,000 for each $1,100 in principal amount of the notes, representing
an original issue discount of $100 per $1,100 in principal amount of the notes. A further discussion of the SPA dated, March 31,
2022, can be found herein below under Liquidity and Capital Resources - PAVmed Inc - Private Placement - Securities Purchase
Agreement .
In March 2022, Lucid Diagnostics,
Inc. entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of
the facility, Cantor has committed to purchase up to $50 million of Lucid Diagnostics Inc. common stock from time to time at the request
of Lucid Diagnostics Inc. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity
facility, insofar as it allows Lucid Diagnostics Inc. to raise primary capital on a periodic basis at prices based on the existing market
price.
Impact
of SARS-CoV-2 - COVID-19 Pandemic
Previously,
in December 2019, there was an outbreak of a novel strain of a coronavirus occurred, with such coronavirus designated by the United
Nations (UN) World Health Organization (“WHO”) as the “Severe Acute Respiratory Syndrome Coronavirus 2” - or
“SARS-CoV-2”. The SARS-CoV-2 spread on a global basis to other countries, including the United States. On March 11,
2020, the WHO declared a pandemic resulting from SARS-CoV-2, with such pandemic commonly referred to by its resulting illness of coronavirus
disease 2019, or “COVID-19”. The COVID-19 pandemic is ongoing, and we continue to monitor the ongoing impact of the COVID-19
pandemic on the United States national economy, the global economy, and our business.
The
COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors
of our laboratory partner, and increase our expenses, including as a result of impacts associated with preventive and precautionary measures
being taken, restrictions on travel, quarantine polices, and social distancing. Such adverse impact may include, for example, the inability
of our employees and /or those of our contractors or laboratory partner to perform their work or curtail their services provided to us.
We
expect the significance of the COVID-19 pandemic, including the extent of its effect on our consolidated financial condition and consolidated
operational results and cash flows, to be dictated by the success of United States and global efforts to mitigate the spread of and /or
to contain the SARS-CoV-2 and the impact of such efforts.
In
addition, the spread of the SARS-CoV-2 has disrupted the United States’ healthcare and healthcare regulatory systems which could
divert healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”) approval with
respect to our products.
Furthermore,
our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be
delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as travel restrictions
imposed by governments, and the inability to access clinical test sites for initiation and monitoring.
The
COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the United States, resulting
in an economic downturn that could adversely affect demand for our products and services and /or our product candidates.
Although
we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic
(or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,
consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.
28
Results
of Operations
Overview
Revenue
Revenue
was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company’s majority-owned
subsidiary, 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 an Asset Purchase
Agreement between LucidDx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc. and RDx.
Cost
of revenue
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; employee related costs of employees engaged in the administration to patients
of the EsoCheck cell sample collection procedure (principally at the LUCID Test Centers); the 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, as we anticipate an
increase in payroll and related expenses related to the roll-out of our commercial sales and marketing operations as we execute on our
business strategy.
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 we anticipate an increase in payroll and related expenses
related with the growth and expansion of our business operations objectives. 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.
29
Results of Operations - continued
Overview - continued
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 preclinical studies and engineering
studies;
●
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.
We
plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
well as new innovations. Our research and development activities are focused principally on obtaining FDA approvals and developing product
improvements or extending the utility of the lead products in our pipeline, including CarpX, EsoCheck and EsoGuard, along with advancing
our PortIO and NextFlo products, our Digital Health product, and two of our Emerging Innovation product candidates through
their respective development phase, including our DisappEAR reabsorable ear tubes product and a non-invasive glucose monitoring product.
Other
Income and Expense, net
Other
income and expense, net, consists principally of changes in fair value of our contingent consideration and our convertible notes
and losses on extinguishment of debt upon repayment of such convertible notes.
Presentation of Dollar Amounts
All dollar amounts in this Management’s
Discussion and Analysis of Financial Condition and Results of Operations are presented in thousands of dollars, if not otherwise indicated
as being presented as dollars in millions, except for the number of shares and per share amounts.
30
Three
months ended March 31, 2022 as
compared to three months ended March 31, 2021
Revenue
In
the three months ended March 31, 2022, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior year.
The $0.2 million relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue recognition of
$0.1 million per month beginning August 2021 - through the February 25, 2022 termination date of such agreement.
Cost
of revenue
In
the three months ended March 31, 2022, cost of revenue was approximately $0.4 million as compared to no cost of revenue in the corresponding
period in the prior year. The $0.4 million increase principally relates to costs associated with the EsoGuard Commercialization Agreement
noted above.
Sales
and marketing expenses
In
the three months ended March 31, 2022, sales and marketing costs were approximately $3.9 million, compared to $1.4 million for the corresponding
period in the prior year. The net increase of $2.5 million was principally related to:
●
approximately
$1.6 million increase in compensation related costs principally related to an increase in headcount and severance expense incurred
for 2 former employees;
●
approximately
$0.4 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
in stock options granted corresponding with the increase in the number of employees; and
●
approximately
$0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees.
General
and administrative expenses
In
the three months ended March 31, 2022, general and administrative costs were approximately $9.4 million, compared to $3.4 million for
the corresponding period in the prior year. The net increase of $6.0 million was principally related to:
●
approximately
$1.1 million increase in compensation related costs principally related to an increase in headcount;
●
approximately
$1.8 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
in stock options granted corresponding with the increase in the number of employees; and
●
approximately
$2.3 million in consulting services related to patents, regulatory compliance, legal processes for contract review, transition of
public relations and investor relations firms, and public company expenses; and
●
approximately
$0.8 million in general business expenses.
Research
and development expenses
In
the three months ended March 31, 2022, research and development costs were approximately $5.9 million as compared to $3.3 million for
the corresponding period in the prior year. The net increase $2.6 million was principally related to:
●
approximately
$2.1 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees
with respect to EsoCheck, EsoCure, CarpX, NextFlo, Port IO, our Digital Health product, and one of our Emerging Innovation product
candidates (the non-invasive glucose monitoring product); and
●
approximately
$0.5 million increase in compensation related costs and related to expanded clinical and engineering staff.
31
Three months ended March 31, 2022 as compared
to three months ended March 31, 2021 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In
the three months ended March 31, 2021, the non-cash income (expense) recognized for the change in the fair value of our convertible notes
was approximately $1.7 million. The change in the fair value adjustment of the convertible notes is principally related to each of the
convertible notes being repaid-in-full during the three months ended March 31, 2021, as discussed herein below under “Other Income
and Expense - Loss from Extinguishment of Debt”.
Loss
from Extinguishment of Debt
In
the three months ended March 31, 2021, a debt extinguishment loss in the aggregate of approximately $3.7 million was recognized in connection
with the convertible notes, as discussed below.
●
On
January 5, 2021, the repayment of the remaining face value principal of the November 2019 Senior Convertible Note, along with
the payment of interest thereon, of approximately $1.0 million, were settled with the issuance of 667,668 shares of
our common stock, with a fair value of approximately $1,7 million (with such fair value measured as the respective conversion
date quoted closing price of our common stock), resulting in the recognition of a loss from extinguishment of debt of approximately
$0.8 million in the six months ended June 30, 2021; and,
●
On
January 30, 2021, we paid in cash a $350 partial principal repayment of the Senior Convertible Note dated April 30, 2020 (“April
2020 Senior Convertible Note”); and on March 2, 2021, we made a cash payment of approximately $14,466, resulting in the repayment-in-full
on such date of both the April 2020 Senior Convertible Note and the Senior Secured Convertible Note dated August 6, 2021, resulting
in the recognition of a loss from extinguishment of debt of approximately $2,955 in the six months ended June 30, 2021.
See
our unaudited condensed consolidated financial statements Note 12 , Debt , for additional information with respect
to the convertible notes.
32
Liquidity
and Capital Resources
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 expect to continue to experience recurring losses 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 March 31, 2022,
we expect to be able to fund our future operations for one year from the date of the issue of our unaudited condensed consolidated financial
statements, as included in this Quarterly Report on Form 10-Q for the period ended March 31, 2022.
Common
Stock Transactions
During
the three months ended March 31, 2022:
●
We
issued 237,499 shares of our common stock
for cash proceeds of approximately $241 upon exercise of stock options granted under the PAVmed Inc 2014 Equity Plan,
as such equity plan is discussed in Note 13, Stock-Based Compensation , of our unaudited condensed consolidated
financial statements.
●
We
issued 194,240 shares of our common stock under the
PAVmed Inc. Employee Stock Purchase Plan (“ESPP”), as such ESPP is discussed in Note 13, Stock-Based Compensation ,
of our unaudited condensed consolidated financial statements.
Debt
Transactions
Subsequent
to March 31, 2022, on April 4, 2022, the Company entered into a Senior Secured Convertible Note in the amount of
$27.5 million, pursuant to the SPA with an accredited institutional investor. Under the SPA, the Company agreed to sell, and the
investor agreed to purchase, up to an additional $22.5 in additional initial principal amount of Senior Secured Convertible Notes
(for an aggregate of $50.0 million in initial principal amount of Secured Promissory Notes) upon the satisfaction of certain
conditions (as more fully described below). The notes are being offered and sold in a registered direct offering under the
Company’s effective shelf registration statement (the “Offering”). The purchase price of the Secured Promissory
Notes is $1,000 for each $1,100 in principal amount of the notes, representing an original issue discount of $100 per $1,100 in
principal amount of the notes. We herein refer to the Senior Secured Convertible Notes issued or issuable under the SPA as March
2022 Notes.
Pursuant
to the SPA we completed an initial closing for the sale of $27.5 million in principal amount of March 2022 Notes, of which the
investor funded and the Company received cash proceeds of $24.9 million on April 5, 2022, after deduction of lender fees. Subject
to certain conditions being met or waived, from time to time after such time stockholder approval for an increase in our authorized shares
from 150 million to 250 million is obtained, but before March 31, 2024, one or more additional closings for up to the remaining principal
amount of March 2022 Notes may occur, upon five trading days’ notice by us to the investor. The aggregate principal amount of March
2022 Notes that may be offered in the additional closings may not be more than $22.5 million. The investor’s obligation to purchase
the notes at each additional closing is subject to certain conditions set forth in the March 2022 SPA (including minimum price and volume
thresholds, maximum ratio of debt to market capitalization, and minimum market capitalization), which may be waived by the Required Holders
(as defined in the March 2022 SPA). Under the March 2022 SPA, the investor will be required to purchase March 2022 Notes in the additional
closings if such conditions are met or waived. In addition, from and after March 31, 2023, the investor may by written notice to us elect
to require us to issue up to $22.5 million in initial principal amount of March 2022 Notes, so long as in doing so it would not cause
the ratio of (a) the outstanding principal amount of the March 2022 Notes (including the additional March 2022 Notes), accrued and unpaid
interest thereon and accrued and unpaid late charges to (b) our average market capitalization over the prior ten trading days, to exceed
25%. If we fail to complete the sale of the additional March 2022 Notes contemplated by any such written notice, or if the investor
is unable to deliver any such notice prior to March 31, 2024 as a result of the limitation described in the preceding sentence, then
we will be obligated to pay a break-up fee to the investor at such time in an aggregate amount equal to $1.35 million.
33
Liquidity and Capital Resources - continued
We will not pay any selling
commission to any party in connection with the Offering, although we will pay a financial advisory fee equal to 1.8% of the gross proceeds
from the Offering to an independent financial advisor. We estimate that the net cash proceeds will be approximately $20.4 million from
the additional closings of the Offering, after deducting the estimated expenses of the Offering, assuming the sale of all of the March
2022 Notes.
The March 2022 Notes have a
voluntary fixed conversion price of $5.00 per share, a stated interest rate of 7.875% per annum, and a maturity of 24 months (subject
to extension in certain circumstances). The March 2022 Notes will be secured by all our existing and future assets (including those of
our significant subsidiaries, other than Lucid and its subsidiaries), but including only 9.99% of Lucid’s outstanding common stock
held by us, pursuant to a security agreement by and between the Company and the investor.
On
the date six months after the issuance of a March 2022 Note, on the 1st and 10th trading day of each calendar month thereafter, and on
the maturity date (each an “Installment Date”), the Company will make an amortization payment on the March 2022 Note in an
amount equal to the initial principal balance of the note divided by the total number of such amortization payments (such that the entire
initial principal balance will be repaid by the maturity date), plus any amounts that have been deferred or accelerated to the applicable
installment date, plus all accrued and unpaid interest and any late charges (the “Installment Amount”). Each Installment
Amount will be satisfied in shares of the Company’s common stock, subject to certain customary equity conditions (including
minimum price and volume thresholds) at 100% of the Installment Amount or otherwise (or at our election, in whole or in part) in cash
at 115% of the Installment Amount. The conversion price for any Installment Amount so converted will be based on the then current market
price, but not more than the fixed conversion price then in effect and not less than a floor price. The March 2022 Notes also may required
to be repaid in shares of our common stock, at a price per share of our common stock based on the then current market price,
but not more than the fixed conversion price then in effect and not less than a floor price, upon the occurrence of certain events of
default. We may be required to repay the March 2022 Notes, in cash, at a premium to the outstanding principal balance, upon the
occurrence of an event of default or upon a Change of Control (as defined in the March 2022 Notes).
We
will be subject to certain customary affirmative and negative covenants regarding the rank of the March 2022 Notes, 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 will be 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 March 2022 Notes, 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%, and (iii) that our market capitalization shall at no time be less than $75 million. The March 2022 Notes include certain customary
events of default.
Lucid
Diagnostics Inc - Committed Equity Facility
In March 2022, Lucid Diagnostics
Inc. entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of
the facility, Cantor has committed to purchase up to $50 million of Lucid Diagnostics Inc. common stock from time to time at the request
of Lucid Diagnostics Inc. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity
facility, insofar as it allows Lucid Diagnostics Inc. to raise primary equity capital on a periodic basis at prices based on the existing
market price.
Critical
Accounting Policies and Significant Judgments and Estimates
The
discussion and analysis of our (unaudited) financial condition and consolidated 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 affecting the reported amounts of assets, liabilities, and equity, along with the disclosure of
contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of
expenses during the corresponding periods. In accordance with U.S. GAAP, we base our estimates on historical experience and on various
other assumptions we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions
or conditions. Please see Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates , of our unaudited
condensed consolidated financial statements included herein in this Form 10-Q, for a summary of significant accounting policies.
34
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness
of our disclosure controls and procedures as of March 31, 2022. Based on such evaluation, our principal executive officer and principal
financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information
required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required
disclosure.
Changes
to Internal Controls Over Financial Reporting
There
has been no change in internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act) that occurred during our fiscal quarter ended March 31, 2022 that has materially affected, or is reasonably likely to materially
affect, our internal controls over financial reporting.
35
Part
II - Other Information
Item
1. Legal Proceedings
See
Note 10, Commitment and Contingencies - Legal Proceedings , of the unaudited condensed consolidated financial statements
included in this Quarterly Report, for a description of certain material legal proceedings involving the Company, which description is
incorporated herein by reference.
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to certain
other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from
time to time. Except as otherwise noted herein, the Company does not believe it is currently a party to any other pending legal proceedings.
Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable outcome could include monetary damages,
and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business,
financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain
potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse
impact on the Company’s business, financial position, results of operations, and /or cash flows.
Item
5. Other Information
None.
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “ Exhibit Index ” below.
36
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
PAVmed
Inc.
May
16, 2022
By:
/s/
Dennis M McGrath
Dennis
M McGrath
President
and Chief Financial Officer
(Principal
Financial and Accounting Officer)
37
EXHIBIT
INDEX
Exhibit
No.
Description
2.1
Asset Purchase Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc., Lucid Diagnostics Inc. and ResearchDx, Inc. (incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K filed by Lucid on March 3, 2022).
10.1
Common Stock Purchase Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Lucid Diagnostics on April 1, 2022).
10.2
Registration Rights Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc. (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed by Lucid on April 1, 2022).
10.3
Management Services Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc. and ResearchDx, Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Lucid on March 3, 2022).
10.4
Employment Agreement, dated as of February 22, 2022, by and between Lishan Aklog, M.D. and Lucid Diagnostics Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Lucid Diagnostics on January 20, 2022).
10.5
Employment Agreement, dated as of February 22, 2022, by and between Dennis McGrath and Lucid Diagnostics Inc. (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed by Lucid Diagnostics on January 20, 2022).
10.6
Employment Agreement, dated as of February 22, 2022, by and between Shaun O’Neil and PAVmed Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Company on February 24, 2022).
10.7
Employment Agreement, dated as of February 22, 2022, by and between Shaun O’Neil and Lucid Diagnostics Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Lucid Diagnostics on March 23, 2022).
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.†
31.2
Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. †
32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. †
32.2
Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. †
101.INS
Inline
XBRL Instance Document
101.SCH
Inline
XBRL Taxonomy Extension Schema
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
†
Filed herewith
38
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.