Original from: PAVmed 

 

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.

 

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.

 

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

 

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.

 

Source: PAVmed Provides Business Update and Third Quarter 2024 Financial Results