Full Press Release Details
Provides Business Update and Third Quarter 2024 Financial Results
reports record quarterly EsoGuard revenue and completes clinical evidence package for imminent submission to formally
seek Medicare coverage
Health completes pilot program with The Ohio State's James Cancer Hospital and continues pursuit of financing to relaunch development
of implantable monitor
initiatives position PAVmed to preserve Nasdaq listing
call and webcast to be held today, November 14th at 8:30 AM EST
YORK, November 14, 2024 - PAVmed Inc. (NASDAQ: PAVM, PAVMZ) ("PAVmed" or the "Company"), 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 Company for the three months ended September 30, 2024.
webcast will take place on Thursday, November 14, 2024, at 8:30 AM and is accessible in the investor relations section of the Company's
website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184
and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed
Business Update" to join.
the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's
website at pavmed.com.
the third quarter and in recent weeks, we have taken important transformational steps to solidify and stabilize PAVmed as a sustainable
and diversified commercial life sciences company with multiple independently-financed subsidiaries, consistent with the updated business
strategy we laid out earlier this year," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "We
have completed the deconsolidation and are in the final stages of a debt restructuring necessary for us to regain compliance with the
Nasdaq listing requirements. Lucid continues to make significant strides, both commercially and clinically, and is now ready to submit
its complete clinical evidence package to formally seek Medicare coverage of EsoGuard. Our other subsidiaries, Veris Health and the PMX
incubator, also continue to execute their strategic plans. In light of these developments, I am optimistic about what the future holds
for PAVmed and its subsidiaries."
from the third quarter and recent weeks:
| Lucid reported that 3Q24 EsoGuard Esophageal DNA Test revenue was $1.2M, which represents a single-quarter record and 20 percent increase sequentially from 2Q24. | |
| Lucid performed 2,787 commercial EsoGuard tests in 3Q24. Additionally, in October the lab performed a single-month record of more than 1,400 tests, contributing to the largest three-month total in the Company's history. | |
| Lucid's ESOGUARD BE-1 clinical validation study accepted for peer-reviewed publication completing the clinical evidence package for submission to formally seek Medicare coverage of EsoGuard. | |
| Lucid is now leveraging this clinical evidence to expand its direct contracting initiative with multiple programs focused on driving near-term revenue growth, including a shift to fully-contracted #CYFT Precancer Testing Events, broadening employer markets activity, and a new foray into the concierge medicine sector. | |
| Veris completed pilot program with The Ohio State's James Cancer Hospital and is now in active discussions on long-term commercial and strategic partnerships. | |
| Veris awarded a $1.8 million National Institutes of Health (NIH) grant to further optimize Veris Cancer Care Platform in partnership with an academic cancer center. | |
| Veris continuing to pursue financing to relaunch the development of its implantable monitor. | |
| As part of PAVmed's efforts to regain compliance with the Nasdaq listing standards by increasing its stockholders' equity above the minimum required, the Company completed the deconsolidation of Lucid from its balance sheet on September 10, and reached an agreement in principle with its convertible debt holder (the structure of which was presented to the Nasdaq hearing panel) regarding the terms on which $25 million of PAVmed's convertible debt would be exchanged into preferred equity of an equivalent value. Nasdaq has granted PAVmed until January 31, 2025 to regain compliance through this exchange transaction, which remains subject to the Company's accounting advisors completing their analysis of the transaction structure and stockholder approval. |
| As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's non-GAAP adjusted loss was approximately $5.4 million or $(0.54) per common share. | |
| PAVmed had cash and cash equivalents of $0.8 million as of September 30, 2024, compared to $19.6 million as of December 31, 2023. | |
| PAVmed's Equity method investment (Lucid Diagnostics) fair value at September 30, 2024 was $25.5 Million. In accordance with GAAP, the comparable periods before deconsolidation of Lucid are not reflected on PAVmed's balance sheets prior to September 10, 2024. | |
| The unaudited financial results for the three months ended September 30, 2024 were filed with the SEC on Form 10-Q on November 13, 2024, and are available at www.pavmed.com or www.sec.gov. |
| To supplement our 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. | |
| Non-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 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 measures. | |
| 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. |
Consolidated Statement of Operations (Unaudited)
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (in thousands except per-share amounts) | ||||||||||||||||
| Revenue | $ | 996 | $ | 791 | $ | 2,985 | $ | 1,403 | ||||||||
| Operating expenses | 12,574 | 16,319 | 42,285 | 53,815 | ||||||||||||
| Other (Income) Expense | (72,289 | ) | 6,222 | (66,585 | ) | 9,443 | ||||||||||
| Net (Income) Loss | (60,711 | ) | 21,750 | (27,285 | ) | 61,855 | ||||||||||
| Net income (loss) attributable to common stockholders | 64,316 | (17,748 | ) | 30,620 | (50,365 | ) | ||||||||||
| Preferred Stock dividends and deemed dividends | 83 | 77 | 7,740 | 226 | ||||||||||||
| Net income (loss) as reported | 64,399 | (17,671 | ) | 38,360 | (50,139 | ) | ||||||||||
| Adjustments: | ||||||||||||||||
| Depreciation and amortization expense 1 | 238 | 733 | 1,129 | 2,207 | ||||||||||||
| Interest expense, net 2 | (58 | ) | 35 | (214 | ) | 162 | ||||||||||
| NCI ownership share of Interest and Depreciation adjustments | (43 | ) | (213 | ) | (229 | ) | (627 | ) | ||||||||
| EBITDA | 64,536 | (17,116 | ) | 39,046 | (48,397 | ) | ||||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense 3 | 1,931 | 2,245 | 5,716 | 9,171 | ||||||||||||
| ResearchDx acquisition/settlement paid in stock 1 | - | - | - | 713 | ||||||||||||
| Operating expenses issued in stock 1 | 285 | 625 | 448 | 625 | ||||||||||||
| Gain on deconsolidation of subsidiary | (72,287 | ) | - | (72,287 | ) | - | ||||||||||
| Change in FV equity method investments | (407 | ) | - | (407 | ) | - | ||||||||||
| Change in FV convertible debt 2 | (240 | ) | 4,392 | 2,488 | 5,772 | |||||||||||
| Offering costs convertible debt 2 | - | - | - | 1,186 | ||||||||||||
| Loss on debt extinguishment 2 | 1,403 | 1,764 | 2,535 | 3,032 | ||||||||||||
| Debt modification expense | - | - | 2,000 | - | ||||||||||||
| Other non-cash charges | - | - | - | - | ||||||||||||
| NCI ownership share of non-GAAP adjustments | (660 | ) | (1,453 | ) | (1,262 | ) | (3,645 | ) | ||||||||
| Non-GAAP adjusted (loss) | $ | (5,439 | ) | $ | (9,543 | ) | $ | (21,723 | ) | $ | (31,543 | ) | ||||
| Non-GAAP shares outstanding, basic and diluted | 10,005 | 7,463 | 9,287 | 6,968 | ||||||||||||
| Non-GAAP adjusted (loss) income per share, basic and diluted | $ | (0.54 | ) | $ | (1.28 | ) | $ | (2.34 | ) | $ | (4.53 | ) |
Included in general and administrative expenses in the financial statements.
Included in other income and expenses.
Stock-based compensation ("SBC") expense included in operating expenses is detailed as follows in the table below by
category within operating expenses for the non-GAAP Net operating expenses:
of GAAP Operating Expenses to Non-GAAP Net Operating Expenses
| (in thousands except per-share amounts) | For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Cost of revenue | $ | 1,381 | $ | 1,779 | $ | 4,792 | $ | 4,809 | ||||||||
| Stock-based compensation expense 3 | (32 | ) | (32 | ) | (112 | ) | (86 | ) | ||||||||
| Net cost of revenue | 1,349 | 1,747 | 4,680 | 4,723 | ||||||||||||
| Amortization of acquired intangible assets | 82 | 505 | 559 | 1,516 | ||||||||||||
| Sales and marketing | 2,920 | 4,016 | 11,472 | 12,893 | ||||||||||||
| Stock-based compensation expense 3 | (292 | ) | (403 | ) | (1,082 | ) | (1,302 | ) | ||||||||
| Net sales and marketing | 2,628 | 3,613 | 10,390 | 11,591 | ||||||||||||
| General and administrative | 6,649 | 6,858 | 20,337 | 23,916 | ||||||||||||
| Depreciation expense | (156 | ) | (228 | ) | (570 | ) | (691 | ) | ||||||||
| ResearchDx acquisition/settlement paid in stock | - | - | - | (713 | ) | |||||||||||
| Operating expenses issued in stock | (285 | ) | (625 | ) | (448 | ) | (625 | ) | ||||||||
| Stock-based compensation expense 3 | (1,426 | ) | (1,499 | ) | (3,717 | ) | (6,761 | ) | ||||||||
| Net general and administrative | 4,782 | 4,506 | 15,602 | 15,126 | ||||||||||||
| Research and development | 1,542 | 3,161 | 5,125 | 10,681 | ||||||||||||
| Stock-based compensation expense 3 | (181 | ) | (311 | ) | (805 | ) | (1,022 | ) | ||||||||
| Net research and development | 1,361 | 2,850 | 4,320 | 9,659 | ||||||||||||
| Total operating expenses | 12,574 | 16,319 | 42,285 | 53,815 | ||||||||||||
| Depreciation and amortization expense | (238 | ) | (733 | ) | (1,129 | ) | (2,207 | ) | ||||||||
| ResearchDx acquisition/settlement paid in stock | - | - | - | (713 | ) | |||||||||||
| Operating expenses issued in stock | (285 | ) | (625 | ) | (448 | ) | (625 | ) | ||||||||
| Stock-based compensation expense 3 | (1,931 | ) | (2,245 | ) | (5,716 | ) | (9,171 | ) | ||||||||
| Net operating expenses | $ | 10,120 | $ | 12,716 | $ | 34,992 | $ | 41,099 |
PAVmed and its Subsidiaries
Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors.
Its subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a commercial-stage cancer prevention medical diagnostics company that 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 mitigate the risks of esophageal cancer deaths. Its other
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. Veris is concurrently
developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the
Veris Cancer Care Platform.
more and for more information about PAVmed, please visit pavmed.com.
more information about Lucid Diagnostics, please visit luciddx.com.
more information about Veris Health, please visit verishealth.com.
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. 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 statements.
and Lucid Diagnostics