PAVmed Provides Business Update and Third Quarter 2024 Financial Results
Lucid reports record quarterly EsoGuard(® )revenue and completes clinical evidence package for imminent submission to formally seek Medicare coverage
Veris Health completes pilot program with The Ohio State's James Cancer Hospital and continues pursuit of financing to relaunch development of implantable monitor
Ongoing initiatives position PAVmed to preserve Nasdaq listing
Conference call and webcast to be held today, November 14(th) at 8:30 AM EST
NEW YORK, Nov. 14, 2024 /PRNewswire/ -- 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.
Conference Call and Webcast
The 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.
Following 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.
Business Update Highlights
"During 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."
Highlights 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.
Financial Results:
-- For the three months ended September 30, 2024, EsoGuard related revenues
were $1.0 million, net of the deconsolidation. Operating expenses were
approximately $12.6 million which include stock-based compensation
expenses of $1.9 million. GAAP net income attributable to common
stockholders was approximately $64.3 million, or $1.44 per common share
on a diluted basis.
-- 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.
PAVmed Non-GAAP Measures
-- 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.
-- A reconciliation to the most directly comparable GAAP measure of all
non-GAAP financial measures included in this press release for the three
and nine months ended September 30, 2024 and 2023 are as follows:
Condensed Consolidated Statement of Operations (Unaudited)
For the three months ended For the nine months ended
September 30,
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)
1
Included in general and administrative expenses in the financial statements.
2 Included in other income and expenses.
3 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:
Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses
(in thousands except per-share amounts) For the three months ended For the nine months ended
September 30,
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
About PAVmed and its Subsidiaries
PAVmed 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.
For more and for more information about PAVmed, please visit pavmed.com.
For more information about Lucid Diagnostics, please visit luciddx.com.
For more information about Veris Health, please visit verishealth.com.
Forward-Looking Statements
This 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.
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SOURCE PAVmed Inc.
