PAVmed Provides Business Update and Second Quarter 2024 Financial Results
Lucid reports record quarterly EsoGuard® test volume and held productive meeting with CMS Medicare Administrative Contractor (MAC)
Conference call and webcast to be held today,
Conference Call and Webcast
The webcast will take place on
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
"Our strategy for
Highlights from the second quarter and recent weeks:
-
Lucid reported that 2Q24 EsoGuard® Esophageal DNA Test revenue was
$1.0 million , which was flat compared to 1Q24 and represents a 514 percent increase from 2Q23. - Lucid's CLIA-certified clinical laboratory performed 3,147 commercial EsoGuard tests in 2Q24, which represents a single-quarter record and 31 percent increase sequentially from 1Q24 and a 44 percent annual increase from 2Q23.
- Released positive data from both the ENVET-BE clinical utility study and ESOGUARD BE-1 clinical validation study
- Held productive meeting with CMS Medicare Administrative Contractor (MAC)
Palmetto GBA's Molecular Diagnostics Program (MolDX) focused on EsoGuard's clinical data. - Lucid held first major #CheckYourFoodTube Precancer Testing Event with upfront contracted payment.
-
Veris launched pilot program with The
Ohio State's James Cancer Hospital and enrolled first patients onto the Veris Cancer Care Platform. - Veris actively pursuing financing to relaunch the development of its implantable monitor.
- PMX incubator making meaningful advancements in its efforts to raise capital for
PortIO Corp.
Financial Results:
- For the three months ended
June 30, 2024 , EsoGuard related revenues were$1.0 million . Operating expenses were approximately$14.6 million , which includes stock-based compensation expenses of$1.9 million . GAAP net loss attributable to common stockholders was approximately$10.9 million , or$(1.19) 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 non-GAAP adjusted loss was approximately
$7.7 million or$(0.84) per common share. -
PAVmed had cash and cash equivalents of$25.5 million as ofJune 30, 2024 , compared to$19.6 million as ofDecember 31, 2023 . - The unaudited financial results for the three months ended
June 30, 2024 were filed with theSEC on Form 10-Q onAugust 12, 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 six months ended
June 30, 2024 and 2023 are as follows:
Condensed Consolidated Statement of Operations (Unaudited) |
||||||||
|
|
For the three months ended
|
|
For the six months ended
|
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
(in thousands except per-share amounts) |
|
|
|
|
|
|
|
|
Revenue |
|
$ 979 |
|
$ 166 |
|
$ 1,989 |
|
$ 612 |
Operating expenses |
|
14,663 |
|
16,650 |
|
29,711 |
|
37,496 |
Other (Income) Expense |
|
1,230 |
|
1,408 |
|
5,704 |
|
3,222 |
Net Loss |
|
14,914 |
|
17,892 |
|
33,426 |
|
40,106 |
Net income (loss) per common share, basic and diluted |
|
$ (1.19) |
|
$ (2.10) |
|
$ (3.78) |
|
$ (4.86) |
Net loss attributable to common stockholders |
|
(10,908) |
|
(14,612) |
|
(33,696) |
|
(32,617) |
Preferred Stock dividends and deemed dividends |
|
81 |
|
75 |
|
7,657 |
|
149 |
Net income (loss) as reported |
|
(10,827) |
|
(14,537) |
|
(26,039) |
|
(32,468) |
Adjustments: |
|
|
|
|
|
|
|
|
Depreciation and amortization expense1 |
|
305 |
|
747 |
|
891 |
|
1,474 |
Interest expense, net2 |
|
(99) |
|
65 |
|
(156) |
|
128 |
NCI ownership share of Interest and Depreciation adjustments |
|
(40) |
|
(225) |
|
(180) |
|
(403) |
EBITDA |
|
(10,661) |
|
(13,950) |
|
(25,484) |
|
(31,269) |
|
|
|
|
|
|
|
|
|
Other non-cash or financing related expenses: |
|
|
|
|
|
|
|
|
Stock-based compensation expense3 |
|
1,904 |
|
2,507 |
|
3,786 |
|
6,926 |
ResearchDx acquisition/settlement paid in stock1 |
|
— |
|
— |
|
— |
|
713 |
Operating expenses issued in stock1 |
|
140 |
|
625 |
|
163 |
|
625 |
Change in FV convertible debt2 |
|
566 |
|
340 |
|
2,728 |
|
1,380 |
Offering costs convertible debt2 |
|
— |
|
— |
|
— |
|
1,186 |
Loss on debt extinguishment2 |
|
763 |
|
743 |
|
1,132 |
|
1,268 |
Debt modification expense |
|
— |
|
— |
|
2,000 |
|
— |
Other non-cash charges |
|
— |
|
— |
|
— |
|
— |
NCI ownership share of non-GAAP adjustments |
|
(363) |
|
(450) |
|
(602) |
|
(2,192) |
Non-GAAP adjusted (loss) |
|
$ (7,651) |
|
$ (10,185) |
|
$ (16,277) |
|
$ (21,363) |
Basic and Diluted shares outstanding |
|
9,153 |
|
6,957 |
|
8,924 |
|
6,716 |
Non-GAAP adjusted (loss) income per share |
|
|
|
|
|
|
|
|
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 six months ended
|
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ 1,666 |
|
$ 1,685 |
|
$ 3,411 |
|
$ 3,030 |
Stock-based compensation expense3 |
|
(44) |
|
(31) |
|
(80) |
|
(54) |
Net cost of revenue |
|
1,622 |
|
1,654 |
|
3,331 |
|
2,976 |
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets |
|
105 |
|
505 |
|
477 |
|
1,010 |
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
4,242 |
|
4,339 |
|
8,552 |
|
8,877 |
Stock-based compensation expense3 |
|
(387) |
|
(455) |
|
(790) |
|
(899) |
Net sales and marketing |
|
3,855 |
|
3,884 |
|
7,762 |
|
7,978 |
|
|
|
|
|
|
|
|
|
General and administrative |
|
7,009 |
|
6,652 |
|
13,688 |
|
17,060 |
Depreciation expense |
|
(200) |
|
(242) |
|
(414) |
|
(464) |
ResearchDx acquisition/settlement paid in stock |
|
— |
|
— |
|
— |
|
(713) |
Operating expenses issued in stock |
|
(140) |
|
(625) |
|
(163) |
|
(625) |
Stock-based compensation expense3 |
|
(1,214) |
|
(1,674) |
|
(2,292) |
|
(5,262) |
Net general and administrative |
|
5,455 |
|
4,111 |
|
10,819 |
|
9,996 |
|
|
|
|
|
|
|
|
|
Research and development |
|
1,641 |
|
3,469 |
|
3,583 |
|
7,519 |
Stock-based compensation expense3 |
|
(259) |
|
(347) |
|
(624) |
|
(711) |
Net research and development |
|
1,382 |
|
3,122 |
|
2,959 |
|
6,808 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
14,663 |
|
16,650 |
|
29,711 |
|
37,496 |
Depreciation and amortization expense |
|
(305) |
|
(747) |
|
(891) |
|
(1,474) |
ResearchDx acquisition/settlement paid in stock |
|
— |
|
— |
|
— |
|
(713) |
Operating expenses issued in stock |
|
(140) |
|
(625) |
|
(163) |
|
(625) |
Stock-based compensation expense3 |
|
(1,904) |
|
(2,507) |
|
(3,786) |
|
(6,926) |
Net operating expenses |
|
$ 12,314 |
|
$ 12,771 |
|
$ 24,871 |
|
$ 27,758 |
|
|
|
|
|
|
|
|
|
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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
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