Full Press Release Details
Provides Business Update and
Third Quarter 2022 Financial Results
test volume shows steady sequential growth
Veris Cancer Care Platform poised for commercial launch
call and webcast to be held today at 4:30 PM EDT
YORK, November 15, 2022 (BUSINESS WIRE) -PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"),
a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors,
today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") and
Veris Health Inc. ("Veris"), and presented financial results for the three and nine months ended September 30, 2022.
conference call and webcast for today's business update and third quarter 2022 financial results will take place at 4:30 PM EDT.
To access the conference call, listeners should dial 877-407-3982 toll-free in the U.S., and international listeners should dial 201-493-6780,
and ask to join the "PAVmed Inc. Business Update Conference Call". The webcast presentation and conference call will
be available live and for replay at the investor relations section of the Company's website at https://ir.pavmed.com/. Following
the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing 844-512-2921 toll-free
in the U.S. or 412-317-6671 from outside the U.S., followed by the PIN number: 13732745.
this past quarter and recent weeks, the PAVmed team continued its relentless focus on executing our long-term strategy and vision to
build a high growth diversified medical technology company in devices, diagnostics and digital health," said Lishan Aklog, M.D.,
PAVmed's Chairman and Chief Executive Officer. "The Lucid team is delivering steady test volume growth and has begun to receive
commercial payments for its services. The Veris team has wrapped up software development work and built the necessary infrastructure
for Veris' first commercial launch by the end of this year. And, finally, the technology team is steadily advancing our portfolio
of pre-commercial products toward important development and regulatory milestones. The teams are delivering these results on schedule
and under budget, as we seek to create value while keeping a close eye on cash preservation to protect the long-term position of the
from the third quarter and recent weeks include:
supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management
provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net
loss before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based
compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible
securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized
terms under U.S. GAAP.
financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance
analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors,
shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing
the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be,
a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial
financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further
information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and
investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook.
Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand
the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities,
the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management
believes non-GAAP financial measures enhance the comparability of results against prior periods.
reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the
three months and nine months ended September 30, 2022, and 2021 is as follows:
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 76 | $ | 200 | $ | 265 | $ | 200 | ||||||||
| Operating expenses | 23,389 | 13,868 | 66,688 | 34,914 | ||||||||||||
| Other (Income) Expense | 6,619 | - | 12,243 | 1,733 | ||||||||||||
| Net Loss | 29,932 | 13,668 | 78,666 | 36,447 | ||||||||||||
| Net income (loss) per common share, basic and diluted | $ | (0.29 | ) | $ | (0.15 | ) | $ | (0.78 | ) | $ | (0.42 | ) | ||||
| Net loss attributable to common stockholders | (26,197 | ) | (12,294 | ) | (68,732 | ) | (33,345 | ) | ||||||||
| Preferred Stock dividends and deemed dividends | 71 | 67 | 209 | 216 | ||||||||||||
| Net income (loss) as reported | (26,126 | ) | (12,227 | ) | (68,523 | ) | (33,129 | ) | ||||||||
| Adjustments: | ||||||||||||||||
| Depreciation and amortization expense 1 | 700 | 32 | 1,731 | 60 | ||||||||||||
| Interest expense, net | 525 | - | 1,049 | 53 | ||||||||||||
| EBITDA | (24,901 | ) | (12,195 | ) | (65,743 | ) | (33,016 | ) | ||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense 2 | 4,764 | 3,990 | 14,583 | 10,629 | ||||||||||||
| Debt extinguishment 2 | 5,123 | - | 5,123 | 3,715 | ||||||||||||
| Acquisition related 2 | 188 | - | 427 | 133 | ||||||||||||
| Change in FV convertible debt | (261 | ) | - | 1,739 | (1,682 | ) | ||||||||||
| Offering costs convertible debt | 1,232 | - | 4,332 | - | ||||||||||||
| Other non-cash charges | 25 | - | 82 | (300 | ) | |||||||||||
| Non-GAAP adjusted (loss) | (13,830 | ) | (8,205 | ) | (39,457 | ) | (20,521 | ) | ||||||||
| Basic and Diluted shares outstanding | 89,759 | 83,307 | 87,724 | 79,874 | ||||||||||||
| Non-GAAP adjusted (loss) income per share | $ | (0.15 | ) | $ | (0.10 | ) | $ | (0.45 | ) | $ | (0.26 | ) |
| Non-GAAP Operating Expenses | For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Cost of revenue | 1,626 | 144 | 1,996 | 144 | ||||||||||||
| 2 Stock-based compensation expense (SBC) | (9 | ) | - | (9 | ) | - | ||||||||||
| Net cost of revenue | 1,617 | 144 | 1,987 | 144 | ||||||||||||
| Amortization of acquired intangible assets | 505 | 17 | 1,278 | 23 | ||||||||||||
| Sales and marketing expense | 4,736 | 2,293 | 13,559 | 5,555 | ||||||||||||
| 2 Stock -based compensation expense | (643 | ) | (327 | ) | (1,859 | ) | (814 | ) | ||||||||
| Net sales and marketing expense | 4,093 | 1,966 | 11,700 | 4,741 | ||||||||||||
| General and administrative expense total | 10,320 | 6,109 | 30,982 | 16,314 | ||||||||||||
| 1 Depreciation and amortization expense | (195 | ) | (15 | ) | (453 | ) | (37 | ) | ||||||||
| 2 Stock-based compensation expense | (3,854 | ) | (3,353 | ) | (12,016 | ) | (9,088 | ) | ||||||||
| Net general and administrative expense | 6,271 | 2,741 | 18,513 | 7,189 | ||||||||||||
| Research and development expense total | 6,202 | 5,305 | 18,873 | 12,878 | ||||||||||||
| 2 Stock-based compensation expense | (258 | ) | (310 | ) | (699 | ) | (727 | ) | ||||||||
| Net research and development expense | 5,944 | 4,995 | 18,174 | 12,151 | ||||||||||||
| Total operating expenses | 23,389 | 13,868 | 66,688 | 34,914 | ||||||||||||
| 1 Depreciation and amortization | (700 | ) | (32 | ) | (1,731 | ) | (60 | ) | ||||||||
| 2 Stock-based compensation expense | (4,764 | ) | (3,990 | ) | (14,583 | ) | (10,629 | ) | ||||||||
| Net Non-GAAP operating expenses | 17,925 | 9,846 | 50,374 | 24,225 |
Diagnostics (Nasdaq: LUCD) Financial Results
| Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. | |
| A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three months and nine months ended September 30, 2022, and 2021 is as follows: |
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 76 | $ | 200 | $ | 265 | $ | 200 | ||||||||
| Operating expenses | 14,425 | 6,710 | 41,508 | 16,378 | ||||||||||||
| Other (Income) expense | - | 447 | - | 594 | ||||||||||||
| Net loss | (14,349 | ) | (6,957 | ) | (41,243 | ) | (16,772 | ) | ||||||||
| Net income (loss) per common share, basic and diluted | $ | (0.39 | ) | $ | (0.49 | ) | $ | (1.15 | ) | $ | (1.19 | ) | ||||
| Adjustments: | ||||||||||||||||
| Depreciation and amortization expense 1 | 593 | - | 1,321 | 3 | ||||||||||||
| Interest expense, net | - | 447 | - | 147 | ||||||||||||
| EBITDA | (13,756 | ) | (6,510 | ) | (39,922 | ) | (16,622 | ) | ||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense 2 | 3,572 | 2,772 | 11,251 | 6,156 | ||||||||||||
| Non-GAAP adjusted (loss) | $ | (10,184 | ) | $ | (3,738 | ) | $ | (28,671 | ) | $ | (10,466 | ) | ||||
| Basic and Diluted shares outstanding | 36,406 | 14,115 | 35,768 | 14,115 | ||||||||||||
| Non-GAAP adjusted (loss) income per share | $ | (0.28 | ) | $ | (0.26 | ) | $ | (0.80 | ) | $ | (0.74 | ) |
| Non-GAAP Operating Expenses | For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Cost of revenue | 1,626 | 144 | 1,996 | 144 | ||||||||||||
| 2 Stock-based compensation expense (SBC) | (9 | ) | - | (9 | ) | - | ||||||||||
| Net cost of revenue | $ | 1,617 | $ | 144 | $ | 1,987 | $ | 144 | ||||||||
| 1 Amortization of acquired intangible assets | 505 | - | 1,144 | - | ||||||||||||
| Sales and marketing expense total | 3,930 | 918 | 11,121 | 2,627 | ||||||||||||
| 2 Stock-based compensation expense | (414 | ) | - | (1,230 | ) | - | ||||||||||
| Net sales and marketing expense | $ | 3,516 | $ | 918 | $ | 9,891 | $ | 2,627 | ||||||||
| General and administrative expense total | 5,660 | 3,458 | 18,223 | 7,793 | ||||||||||||
| 1 Depreciation and amortization expense | (88 | ) | - | (177 | ) | (3 | ) | |||||||||
| 2 Stock-based compensation expense | (3,069 | ) | (2,695 | ) | (9,728 | ) | (5,988 | ) | ||||||||
| Net general and administrative expense | $ | 2,503 | $ | 763 | $ | 8,318 | $ | 1,802 | ||||||||
| Research and development expense total | 2,704 | 2,190 | 9,024 | 5,814 | ||||||||||||
| 2 Stock-based compensation expense | (80 | ) | (77 | ) | (284 | ) | (168 | ) | ||||||||
| Net research and development expense | $ | 2,624 | $ | 2,113 | $ | 8,740 | $ | 5,646 | ||||||||
| Total operating expenses | 14,425 | 6,710 | 41,508 | 16,378 | ||||||||||||
| 1 Depreciation and amortization | (593 | ) | - | (1,321 | ) | (3 | ) | |||||||||
| 2 Stock-based compensation expense | (3,572 | ) | (2,772 | ) | (11,251 | ) | (6,156 | ) | ||||||||
| Net Non-GAAP operating expenses | $ | 10,260 | $ | 3,938 | $ | 28,936 | $ | 10,219 |
Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors.
Its major subsidiary, Lucid Diagnostics Inc. (Nasdaq: LUCD), is a commercial-stage cancer prevention medical diagnostics company which
markets the EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device-the first
and only commercial tools for widespread early detection of esophageal precancer to prevent esophageal cancer deaths. Lucid operates
its own CLIA-certified, CAP-approved molecular diagnostic laboratory, LucidDx Labs and a network of Lucid Test Centers. Another major
subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring
using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. The product pipeline
also includes the CarpX Minimally Invasive Device for Carpal Tunnel Syndrome, EsoCure Esophageal Ablation Device
with Caldus Technology, which complements EsoGuard and EsoCheck, NextFlo Intravenous Infusion Set, PortIO Implantable
Intraosseous Vascular Access Device, and other earlier stage technologies. For more information on PAVmed, please visit PAVmed.com
and follow PAVmed on Twitter, LinkedIn, and YouTube. For more information on Lucid, please visit LucidDx.com
and follow Lucid on Twitter, and LinkedIn. For detailed information on EsoGuard, please visit EsoGuard.com and
follow EsoGuard on Twitter, Facebook and Instagram.
press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are any statements
that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of PAVmed's
and Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking
statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed's
and Lucid's common stock; PAVmed's Series Z warrants; general economic and market conditions; the uncertainties inherent
in research and development, including the cost and time required to advance PAVmed's and Lucid's products to regulatory
submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed's and Lucid's clinical
and preclinical studies; whether and when PAVmed's and Lucid's products are cleared by regulatory authorities; market acceptance
of PAVmed's and Lucid's products once cleared and commercialized; PAVmed's and Lucid's ability to raise additional
funding as needed; and other competitive developments. In addition, new risks and uncertainties may arise from time to time and are difficult
to predict. For a further list and description of these and other important risks and uncertainties that may affect PAVmed's and
Lucid's future operations, see Part I, Item 1A, "Risk Factors," in PAVmed's and Lucid's most recent Annual
Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors"
in any Quarterly Report on Form 10-Q filed by PAVmed or Lucid after its most recent Annual Report and Lucid's Registration Statement
No. 333-259721 filed with the Securities and Exchange Commission. PAVmed and Lucid disclaim any intention or obligation to publicly update
or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which
those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking