PAVmed Provides Business Update and Third Quarter 2024 Financial Results
PAVmed reported key developments in Q3 2024, including record quarterly EsoGuard® revenue of $1.2M, representing a 20% sequential increase. Lucid performed 2,787 commercial EsoGuard tests in Q3, with October seeing a record 1,400+ tests. The company completed Lucid's deconsolidation and is finalizing debt restructuring to maintain Nasdaq listing compliance. PAVmed reported Q3 operating expenses of $12.6M and GAAP net income of $64.3M. Cash position stood at $0.8M as of September 30, 2024, compared to $19.6M at end of 2023.
PAVmed ha riportato sviluppi chiave nel terzo trimestre del 2024, inclusi ricavi record trimestrali di EsoGuard® pari a 1,2 milioni di dollari, con un aumento del 20% rispetto al trimestre precedente. Lucid ha effettuato 2.787 test commerciali di EsoGuard nel Q3, con ottobre che ha registrato oltre 1.400 test. L'azienda ha completato la deconsolidazione di Lucid ed è in fase di finalizzazione della ristrutturazione del debito per mantenere la compliance alla quotazione Nasdaq. PAVmed ha riportato spese operative nel Q3 pari a 12,6 milioni di dollari e un reddito netto GAAP di 64,3 milioni di dollari. La posizione di cassa era di 0,8 milioni di dollari al 30 settembre 2024, rispetto ai 19,6 milioni di dollari alla fine del 2023.
PAVmed informó sobre desarrollos clave en el tercer trimestre de 2024, incluyendo ingresos trimestrales récord de EsoGuard® de 1,2 millones de dólares, lo que representa un incremento del 20% en comparación con el trimestre anterior. Lucid realizó 2,787 pruebas comerciales de EsoGuard en el Q3, y octubre registró más de 1,400 pruebas. La compañía completó la desconsolidación de Lucid y está finalizando la reestructuración de deuda para mantener la conformidad con el listado en Nasdaq. PAVmed reportó gastos operativos de 12,6 millones de dólares en el Q3 y un ingreso neto GAAP de 64,3 millones de dólares. La posición de caja era de 0,8 millones de dólares al 30 de septiembre de 2024, en comparación con 19,6 millones de dólares a finales de 2023.
PAVmed는 2024년 3분기에 중요한 발전 사항을 보고했으며, 여기에는 EsoGuard® 매출 120만 달러라는 분기별 기록이 포함되어 있으며 이는 전 분기 대비 20% 증가한 수치입니다. Lucid는 3분기에 2,787개의 상업적 EsoGuard 테스트를 수행하였고, 10월에는 1,400건 이상의 테스트를 기록하였습니다. 이 회사는 Lucid의 분리를 완료하고 Nasdaq 상장 규정을 준수하기 위해 부채 재조정을 마무리하고 있습니다. PAVmed는 3분기 운영 비용이 1,260만 달러, GAAP 순이익이 6,430만 달러라고 보고했습니다. 2024년 9월 30일 기준 현금 잔고는 80만 달러였으며, 이는 2023년 말 1,960만 달러에 비해 감소한 수치입니다.
PAVmed a rapporté des développements clés au troisième trimestre 2024, y compris des revenus trimestriels records de 1,2 million de dollars pour EsoGuard®, représentant une augmentation séquentielle de 20 %. Lucid a effectué 2 787 tests commerciaux d'EsoGuard au T3, avec octobre atteignant un record de plus de 1 400 tests. L'entreprise a achevé la déconsolidation de Lucid et finalise la restructuration de sa dette pour maintenir la conformité avec le listing Nasdaq. PAVmed a annoncé des dépenses opérationnelles de 12,6 millions de dollars au T3 et un revenu net GAAP de 64,3 millions de dollars. La position de trésorerie s'élevait à 0,8 million de dollars au 30 septembre 2024, contre 19,6 millions de dollars à la fin de 2023.
PAVmed berichtete über wichtige Entwicklungen im dritten Quartal 2024, einschließlich eines Rekordquartalsumsatzes von 1,2 Millionen US-Dollar für EsoGuard®, was einem sequenziellen Anstieg von 20 % entspricht. Lucid führte im Q3 2.787 kommerzielle EsoGuard-Tests durch, wobei der Oktober einen Rekord von über 1.400 Tests verzeichnete. Das Unternehmen hat die De-Konsolidierung von Lucid abgeschlossen und finalisiert die Schuldenrestrukturierung, um die Anforderungen für die Nasdaq-Listung zu erfüllen. PAVmed berichtete im Q3 über Betriebsausgaben von 12,6 Millionen US-Dollar und einen GAAP-Nettoeinkommen von 64,3 Millionen US-Dollar. Die Liquiditätsposition betrug am 30. September 2024 0,8 Millionen US-Dollar, verglichen mit 19,6 Millionen US-Dollar zum Ende des Jahres 2023.
- Record quarterly EsoGuard® revenue of $1.2M, up 20% from Q2 2024
- Strong EsoGuard test volume with 2,787 commercial tests in Q3
- GAAP net income of $64.3M ($1.44 per diluted share)
- Completion of Lucid deconsolidation to help regain Nasdaq compliance
- Veris Health secured $1.8M NIH grant
- Cash position declined to $0.8M from $19.6M at year-end 2023
- Operating expenses remain high at $12.6M for Q3
- Ongoing Nasdaq listing compliance challenges requiring debt restructuring
Insights
The Q3 2024 results present a mixed financial picture for PAVmed and its subsidiary Lucid Diagnostics. EsoGuard revenue reached a record
The deconsolidation of Lucid and planned debt restructuring are critical steps toward maintaining Nasdaq compliance. While GAAP net income shows
The completion of Lucid's ESOGUARD BE-1 clinical validation study marks a significant milestone, positioning the company to formally pursue Medicare coverage. The expansion into new market segments including #CYFT Precancer Testing Events, employer markets and concierge medicine demonstrates a strategic approach to commercialization. The record-breaking October performance of over 1,400 tests indicates growing market adoption.
The Veris Health division shows promise with its
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 14th at 8:30 AM EST
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,
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 - 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 - 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
Financial Results:
- For the three months ended September 30, 2024, EsoGuard related revenues were
$1.0 million $12.6 million $1.9 million $64.3 million $1 - 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 $(0.54) - PAVmed had cash and cash equivalents of
$0.8 million $19.6 million - PAVmed's Equity Method Investment (Lucid Diagnostics) fair value at September 30, 2024 was
$25.5 million - 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 underU.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 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 expense1 | 238 | 733 | 1,129 | 2,207 | ||||
Interest expense, net2 | (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 expense3 | 1,931 | 2,245 | 5,716 | 9,171 | ||||
ResearchDx acquisition/settlement paid in stock1 | — | — | — | 713 | ||||
Operating expenses issued in stock1 | 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 debt2 | (240) | 4,392 | 2,488 | 5,772 | ||||
Offering costs convertible debt2 | — | — | — | 1,186 | ||||
Loss on debt extinguishment2 | 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 | ||||||||
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 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 expense3 | (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 expense3 | (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 expense3 | (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 expense3 | (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 expense3 | (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.
FAQ
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