0001493152-23-041370.txt : 20231115 0001493152-23-041370.hdr.sgml : 20231115 20231114210010 ACCESSION NUMBER: 0001493152-23-041370 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231114 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231115 DATE AS OF CHANGE: 20231114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PAVmed Inc. CENTRAL INDEX KEY: 0001624326 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 471214177 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37685 FILM NUMBER: 231408855 BUSINESS ADDRESS: STREET 1: 360 MADISON AVENUE STREET 2: 25TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10017 BUSINESS PHONE: (212) 949-4319 MAIL ADDRESS: STREET 1: 360 MADISON AVENUE STREET 2: 25TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10017 FORMER COMPANY: FORMER CONFORMED NAME: PAXmed Inc. DATE OF NAME CHANGE: 20141105 8-K 1 form8-k.htm
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): November 14, 2023

 

PAVMED INC.
(Exact Name of Registrant as Specified in Charter)

 

Delaware   001-37685   47-1214177

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

360 Madison Avenue, 25th Floor   10017
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (917) 813-1828

 

N/A
(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, Par Value $0.001 Per Share   PAVM   The Nasdaq Stock Market LLC
Series Z Warrants to Purchase Common Stock   PAVMZ   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 14, 2023, PAVmed Inc. (the “Company”) issued a press release announcing financial results for its fiscal quarter ended September 30, 2023 and providing a business update. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated herein by reference.

 

Item 7.01. Regulation FD Disclosure.

 

The disclosure set forth under Item 2.02 is incorporated herein by reference.

 

The information furnished under Items 2.02 and 7.01, including the exhibit related thereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of the Company, except as shall be expressly set forth by specific reference in such document.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits:

 

Exhibit No.   Description
99.1   Press release.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 
 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: November 14, 2023 PAVMED INC.
     
  By: /s/ Dennis McGrath
    Dennis McGrath
    President and Chief Financial Officer

 

 

 

EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

PAVmed Provides Business Update and Third Quarter Financial Results

 

Lucid’s quarterly revenue increased 392 percent sequentially

 

Veris Health commercial expansion efforts underway, with next-generation Veris Cancer Care Platform launching in Q4

 

Conference call and webcast to be held tomorrow, November 15th at 8:30 AM EST

 

NEW YORK, November 14, 2023 - 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 and nine months ended September 30, 2023.

 

Conference Call and Webcast

 

The webcast will take place on Wednesday, November 15, 2023, 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 1-833-816-1419 and international listeners should dial 412-317-0512. 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

 

“Lucid’s sustained commercial success and Veris’s future commercial execution will be the primary drivers of PAVmed’s long-term success,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “As noted in yesterday’s Lucid business update, Q3 was the most important quarter in Lucid’s, and therefore PAVmed’s, history, as we have now begun to translate increasing commercial activity into revenue and revenue growth. Whether it be commercial execution, revenue cycle management, laboratory operations, or clinical research productivity, Lucid is firing on all cylinders. As we have done with Lucid, we are now laying the foundation for Veris’s future commercial success. This includes upgrading the Veris Cancer Care Platform to incorporate early adopter feedback; restructuring and expanding the commercial infrastructure; engaging with large academic cancer centers; and initiating dialogue with large pharma companies to have our platform serve as a digital companion to novel cancer therapeutics undergoing market surveillance.”

 

 
 

 

Highlights from the third quarter and recent weeks include:

 

Yesterday, Lucid Diagnostics reported that quarterly EsoGuard testing volumes increased 17 percent sequentially from 2Q23 and 137 percent annually from 3Q22.

 

Lucid’s upgraded revenue cycle management infrastructure showed sustained impact, driving $783K in quarterly revenue, representing a 392 percent increase sequentially from 2Q23 and a 930 percent annual increase from 3Q22.

 

Lucid substantially increased its clinical utility data portfolio to support in-network payor coverage engagement, with near-perfect clinical utility data (98-100 percent concordance) from three studies.

 

Lucid launched EsoGuard 2.0, the next generation of the EsoGuard Esophageal DNA test, which enhances performance and lowers per-sample costs.

 

Veris restructured its commercial organization, including two new hires, with expansion efforts now underway aiming to accelerate patient enrollment at small-to-medium sized oncology practices and to secure strategic accounts, such as large academic cancer centers.

 

Veris advanced development of the next-generation Veris Cancer Care Platform incorporating feedback from early adopters, including key enhancements for practice workflow and provider billing, with version 2.0 launching during 4Q23.

 

Veris is in active discussions with several pharma companies to incorporate the platform as a digital companion for novel cancer therapeutics. The biopharma module will facilitate market surveillance to allow these drugs to become first- or second-line treatment options.

 

Veris is working to upgrade the platform from an FDA-designated Medical Device Data System (“MDDS”), to a Software-as-a-Medical-Device (“SaMD”), with the goal of an FDA 510(k) submission next year. The upgraded platform will provide unlimited potential to grow into a clinical decision support tool that includes threshold alarms for faster provider response, analytical algorithms for effective triage, and digital biomarkers based on artificial intelligence and machine learning that will provide a risk assessment for cancer patients.

 

Veris remains on track for a 2024 regulatory submission of its implantable cardiac and physiologic monitor, designed to be implanted in conjunction with a vascular access port. The team has held multiple, successful FDA pre-submission meetings on various design features.

 

 
 

 

Financial Results:

 

For the three months ended September 30, 2023, revenues were $0.8 million. Operating expenses were approximately $16.3 million, which include stock-based compensation expenses of $2.2 million. GAAP net loss attributable to common stockholders was approximately $17.7 million, or $(0.16) per common share.

 

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 preliminary non-GAAP adjusted loss for the three months ended September 30, 2023, was approximately $9.7 million or $(0.09) per common share.

 

PAVmed had cash and cash equivalents of $26.4 million as of September 30, 2023, compared to $37.2 million as of June 30, 2023.

 

The unaudited financial results for the three months ended September 30, 2023 were filed with the SEC on Form 10-Q on November 13, 2023, and are available at www.pavmed.com or www.sec.gov.

 

PAVmed Non-GAAP Measures

 

To 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.

 

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 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 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, 2023, and 2022 are as follows:

 

   For the three months ended
September 30,
   For the nine months ended
September 30,
 
   2023   2022   2023   2022 
(in thousands except per-share amounts)                
Revenue  $791   $76   $1,403   $265 
Operating expenses   16,319    23,443    53,815    66,751 
Other (Income) Expense   6,222    6,565    9,443    12,180 
Net Loss   21,750    29,932    61,855    78,666 
Net income (loss) per common share, basic and diluted  $(0.16)  $(0.29)  $(0.48)  $(0.78)
Net loss attributable to common stockholders   (17,748)   (26,197)   (50,365)   (68,732)
Preferred Stock dividends and deemed dividends   77    71    226    209 
Net income (loss) as reported   (17,671)   (26,126)   (50,139)   (68,523)
Adjustments:                    
Depreciation and amortization expense1   733    700    2,207    1,731 
Interest expense, net2   35    471    162    986 
NCI ownership share of Interest and Depreciation adjustments   (159)   (136)   (470)   (312)
EBITDA   (17,062)   (25,091)   (48,240)   (66,118)
                     
Other non-cash or financing related expenses:                    
Stock-based compensation expense3   2,245    4,764    9,171    14,583 
ResearchDx acquisition paid in stock       188    713    427 
Change in FV convertible debt2   4,392    (261)   5,772    1,739 
Offering costs convertible debt2       1,232    1,186    4,332 
Loss on debt extinguishment   1,764    5,123    3,032    5,123 
Change in fair value - derivative liability   31        291     
Other non-cash charges       25        82 
NCI ownership share of non-GAAP adjustments   (1,040)   (864)   (2,733)   (2,721)
Non-GAAP adjusted (loss)  $(9,670)  $(14,884)  $(30,808)  $(42,553)
Basic and Diluted shares outstanding   111,941    89,759    104,516    87,724 
Non-GAAP adjusted (loss) income per share  $(0.09)  $(0.17)  $(0.29)  $(0.49)

 

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,
 
   2023   2022   2023   2022 
                 
Cost of revenue  $1,779   $1,626   $4,809   $1,996 
Stock-based compensation expense3   (32)   (9)   (86)   (9)
Net cost of revenue   1,747    1,617    4,723    1,987 
                     
Amortization of acquired intangible assets   505    505    1,516    1,278 
                     
Sales and marketing   4,016    4,736    12,893    13,559 
Stock-based compensation expense3   (403)   (643)   (1,302)   (1,859)
Net sales and marketing   3,613    4,093    11,591    11,700 
                     
General and administrative   6,858    10,374    23,916    31,254 
Depreciation expense   (228)   (195)   (691)   (453)
Stock-based compensation expense3   (1,499)   (3,854)   (6,761)   (12,016)
Net general and administrative   5,131    6,325    16,464    18,785 
                     
Research and development   3,161    6,202    10,681    18,664 
Stock-based compensation expense3   (311)   (258)   (1,022)   (699)
Net research and development   2,850    5,944    9,659    17,965 
                     
Total operating expenses   16,319    23,443    53,815    66,751 
Depreciation and amortization expense   (733)   (700)   (2,207)   (1,731)
Stock-based compensation expense3   (2,245)   (4,764)   (9,171)   (14,583)
Net operating expenses  $13,341   $17,979   $42,437   $50,437 

 

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 majority-owned 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 majority-owned 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.

 

Investor and Media Contact

 

Michael Parks

PAVmed and Lucid Diagnostics

484.356.7105

mep@pavmed.com

 

 

 

 

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