PAVmed Provides Business Update and Preliminary Fourth Quarter and Full Year 2021 Financial Results
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) reported a business update and preliminary financial results for the year ended December 31, 2021. Key highlights include a significant increase in EsoGuard tests processed, reaching 303 in Q4 2021, a 50% sequential and nearly 200% annual growth. However, revenues for EsoGuard were only $0.3 million for Q4 and $0.5 million for the year. Operating expenses totaled approximately $54.3 million for 2021, resulting in a GAAP net loss of $50.6 million. The company had $77.3 million in cash at year-end and plans to raise up to $50 million through a new equity facility with Cantor Fitzgerald.
- EsoGuard tests processed increased by 50% sequentially and nearly 200% annually.
- Cash and cash equivalents reached $77.3 million at the end of 2021.
- Plans to raise up to $50 million through a committed equity facility.
- 2021 EsoGuard revenues were only $0.5 million.
- GAAP net loss for 2021 was approximately $50.6 million, $(0.65) per share.
Conference call to be held today at
Conference Call and Webcast
A conference call and webcast for today’s business update and fourth quarter and year ended
Business Update Highlights
“I am happy to report that
-
Lucid processed 303 commercial EsoGuard tests in the fourth quarter of 2021, which represents an approximately
50% increase sequentially from the third quarter and a nearly200% increase annually from the fourth quarter of 2020. The Lucid Test Center program completed its first stage and now covers seven metropolitan areas in the Southwest andPacific Northwest . Lucid is now launching the next stage of the program, with accelerated expansion into nine larger states. Lucid significantly expanded its sales infrastructure and operations. The team now consists of twenty-two sales professionals including ten sales representatives. It expects team to double in size and the number of sales reps to triple by the end of the calendar year. -
LucidDx Labs , a wholly owned subsidiary of Lucid, acquired the assets to operate its own new CLIA-certified, CAP-accredited clinical laboratory where it is now performing all EsoGuard testing.LucidDx Labs has upgraded its revenue cycle management provider and will start submitting Medicare claims using the effective$193 8 Medicare payment rate. It continues to wait for Medicare Administrative Contractor Palmetto GBA’s MolDx program to issue a draft local coverage determination (LCD). The laboratory has been submitting claims to private payors and has been receiving approximately per test representing approximately$1,150 60% out-of-network coverage. -
Veris is successfully advancing its software, device, and data programs with the with the help of world-class technology and medical advisory boards and working very closely with Microsoft, as a member of its Global Partner program, and its software development partner,
Loka Inc. The software platform is on schedule to launch commercially in 2H2022. Veris is hiring a Chief Commercial Officer and building its own data & analytics team to advance its data monetization strategy. - Veris successfully completed feasibility animal testing of multiple prototypes of an implantable device as well as an FDA pre-submission meeting. Based on FDA feedback it has developed a three-phase pipeline, an initial platform launch in 2H2022 with wearables and connected medical devices, a subsequent FDA 510(k) path clearance of separate implantable monitoring device to be implanted alongside a traditional port, and an FDA de novo and EU CE Mark path for a fully integrated intelligent vascular access port.
-
NextFlo product development is progressing well with FDA submission and commercial launch targeted for the second half of this year.
PAVmed has hired a VP, Sales for NextFlo who is working closely with Deloitte to lay the foundation for commercial launch targeting inpatient, outpatient, and home infusions. - CarpX continues with its limited commercial release utilizing early adopter key opinion leaders to advance procedural and product improvements. Eight new surgeons have been trained and five more are scheduled for training. Seven CarpX cases were performed in the fourth quarter of 2021. Clinical cases were then held to implement the product improvements and will restart this coming quarter. Development of next generation CarpX device incorporating integrated ultrasound imaging is progressing well.
-
PortIO launched its first-in-human clinical study in
Colombia ,South America with three successful implants. Although the Company remains engaged with FDA regarding its requirements for an IDE study, it has expanded its strategy to pursue a European study to support EU CE Mark clearance and provide additional human data forU.S. approval. -
In
March 2022 , both thePAVmed and Lucid boards of directors approved entering into an intercompany license betweenPAVmed and Lucid such that Lucid will be granted the rights to commercialize EsoCure for the endoscopic treatment of late esophageal precancer (dysplastic Barrett’s Esophagus), including a royalty arrangement whereby Lucid will payPAVmed a5% royalty on all EsoCure sales up to per calendar year, and$100 million 8% above that threshold. -
In
March 2022 , both thePAVmed and Lucid boards of directors approved entering into a purchase and sale of theCapNostics, LLC assets, including the EsophaCap® non-endoscopic sponge-based esophageal cell collection device, fromPAVmed to Lucid as well as transferring the consulting agreement with the principal owner ofCapNostics, LLC prior to the purchase byPAVmed onOctober 5, 2021 .
Preliminary Financial Results
-
For the fourth quarter of 2021, EsoGuard related revenues were
while for the year ended$0.3 million December 31, 2021 , revenues were . Fourth-quarter and full-year 2021 operating expenses were approximately$0.5 million and$19.5 million , respectively, which include stock-based compensation expenses of$54.3 million and$4.4 million , respectively. GAAP net loss attributable to shareholders for the fourth quarter and full-year 2021 were approximately$15.0 million and$17.3 million , or$50.6 million and$(0.20) per common share.$(0.65) -
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 fourth quarter and year ended
December 31, 2021 , were approximately and$12.7 million or$33.2 million and$(0.15) per common share.$(0.43) -
PAVmed had cash and cash equivalents of as of$77.3 million December 31, 2021 , compared with as of$17.3 million December 31, 2020 . -
On
March 28, 2022 , the Company entered into a Common Stock Purchase Agreement (the “Purchase Agreement”) withCF Principal Investments LLC (“Cantor”), an affiliate ofCantor Fitzgerald , relating to a committed equity facility (the “Facility”). Pursuant to the Purchase Agreement, the Company has the right to sell to Cantor up to of its common shares (the “Shares”), subject to certain conditions and limitations set forth in the Purchase Agreement. While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at a price related to the current market price.$50.0 million -
Sales of the Shares to Cantor under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time at its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Shares and determinations by the Company regarding the use of proceeds of such Shares. Upon the satisfaction of the conditions to Cantor’s obligation to purchase Shares, the Company will have the right, from time to time during the 36-month period after the commencement of the Facility, to direct Cantor to purchase up to a maximum number of Shares on any trading day. The purchase price of the Shares will be
96% of the volume-weighted average price of the Shares on such trading day. The unaudited financial results for the year endedDecember 31, 2021 , will be filed with theSEC on Form 10-K in the coming days and will be available at www.pavmed.com or www.sec.gov.
PAVmed Non-GAAP Measures
To supplement our unaudited financial results presented in accordance with
Non-GAAP financial measures are presented with the intent of providing greater transparency to 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 fourth quarter and year ended
For the three months ended |
For the year ended |
|||||||||||||||||
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
||||
Revenue | $ |
300 |
|
$ |
- |
|
$ |
500 |
|
$ |
- |
|
||||||
Gross profit |
|
(229 |
) |
|
- |
|
|
(85 |
) |
|
- |
|
||||||
Operating expenses |
|
19,538 |
|
|
7,556 |
|
|
54,308 |
|
|
23,351 |
|
||||||
Loss from operations |
|
(19,767 |
) |
|
(7,556 |
) |
|
(54,393 |
) |
|
(23,351 |
) |
||||||
Net income (loss) per common share, basic and diluted | $ |
(0.20 |
) |
$ |
(0.14 |
) |
$ |
(0.65 |
) |
$ |
(0.73 |
) |
||||||
Net loss attributable to common stockholders |
|
(17,285 |
) |
|
(8,812 |
) |
|
(50,630 |
) |
|
(34,563 |
) |
||||||
Preferred Stock dividends and deemed dividends |
|
67 |
|
72 |
|
|
283 |
|
|
287 |
|
|||||||
Net income (loss) as reported |
|
(17,218 |
) |
|
(8,740 |
) |
|
(50,347 |
) |
|
(34,276 |
) |
||||||
Adjustments: | ||||||||||||||||||
Depreciation and amortization expense1 |
|
166 |
|
|
6 |
|
|
226 |
|
|
23 |
|
||||||
Interest expense, net2 |
|
- |
|
|
- |
|
|
- |
|
|
53 |
|
||||||
EBITDA |
|
(17,052 |
) |
|
(8,734 |
) |
|
(50,121 |
) |
|
(34,200 |
) |
||||||
Other non-cash or financing related expenses: | ||||||||||||||||||
Stock-based compensation expense3 |
|
4,380 |
|
|
586 |
|
|
15,009 |
|
|
2,044 |
|
||||||
Debt extinguishment/debt forgiveness2 |
|
- |
|
|
1,897 |
|
|
3,415 |
|
|
6,497 |
|
||||||
Acquisition related1 |
|
- |
|
|
- |
|
|
133 |
|
|
- |
|
||||||
Change in FV convertible debt2 |
|
- |
|
|
(194 |
) |
|
(1,682 |
) |
|
5,327 |
|
||||||
Offering costs convertible debt2 |
|
- |
|
|
- |
|
|
- |
|
|
660 |
|
||||||
Non-GAAP adjusted (loss) |
|
(12,672 |
) |
|
(6,445 |
) |
|
(33,246 |
) |
|
(19,672 |
) |
||||||
Basic and Diluted shares outstanding |
|
86,368 |
|
|
63,820 |
|
|
77,516 |
|
|
47,432 |
|
||||||
Non-GAAP adjusted (loss) income per share | ($ |
0.15 |
) |
($ |
0.10 |
) |
($ |
0.43 |
) |
($ |
0.41 |
) |
||||||
1 |
Included in general and administrative expenses in the financial statements | |||||||||||||||||
2 |
Included in other income and expenses | |||||||||||||||||
3 |
Stock-based compensation ("SBC") expenses: | |||||||||||||||||
(ooo's except per-share amounts) |
For the three months ended
|
For the year ended
|
||||||||||||||||
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
||||
Commercial operations expense total |
|
3,103 |
|
|
1,257 |
|
|
8,895 |
|
|
2,789 |
|
||||||
Stock-based compensation expense |
|
(337 |
) |
|
(95 |
) |
|
(1,177 |
) |
|
(278 |
) |
||||||
Net commercial operations expense excluding SBC |
|
2,766 |
|
|
1,162 |
|
|
7,718 |
|
|
2,511 |
|
||||||
General and administrative expense total |
|
9,466 |
|
|
2,657 |
|
|
25,566 |
|
|
9,599 |
|
||||||
Stock-based compensation expense |
|
(3,737 |
) |
|
(356 |
) |
|
(12,799 |
) |
|
(1,304 |
) |
||||||
Net general and administrative expense excluding SBC |
|
5,729 |
|
|
2,301 |
|
|
12,767 |
|
|
8,295 |
|
||||||
Research and development expense total |
|
6,969 |
|
|
3,642 |
|
|
19,847 |
|
|
10,963 |
|
||||||
Stock-based compensation expense |
|
(306 |
) |
|
(135 |
) |
|
(1,033 |
) |
|
(462 |
) |
||||||
Net research and development expense excluding SBC |
|
6,663 |
|
|
3,507 |
|
|
18,814 |
|
|
10,501 |
|
||||||
Total operating expenses |
|
19,538 |
|
|
7,556 |
|
|
54,308 |
|
|
23,351 |
|
||||||
Stock-based compensation expense |
|
(4,380 |
) |
|
(586 |
) |
|
(15,009 |
) |
|
(2,044 |
) |
||||||
Net operating expenses excluding SBC |
|
15,158 |
|
|
6,970 |
|
|
39,299 |
|
|
21,307 |
|
||||||
-
For the fourth quarter of 2021, EsoGuard related revenues were
, while for the year ended$0.3 million December 31, 2021 , revenues were . Fourth-quarter and full-year 2021 operating expenses were approximately$0.5 million and$11.1 million , respectively, which include stock-based compensation expenses of$27.3 million and$3.2 million , respectively. GAAP net loss attributable to common stockholders for the fourth quarter and full-year 2021 were approximately$9.6 million and$11.3 million , or$28.1 million and$(0.32) per common share.$(1.51) -
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 fourth quarter and year ended
December 31, 2021 , were approximately and$7.7 million or$17.8 million and$(0.22) per common share.$(0.96) -
Lucid had cash and cash equivalents of
as of$53.7 million December 31, 2021 , compared to as of$0.1 million December 31, 2020 . -
On
March 28, 2022 , the Company entered into a Common Stock Purchase Agreement (the “Purchase Agreement”) withCF Principal Investments LLC (“Cantor”), an affiliate ofCantor Fitzgerald , relating to a committed equity facility (the “Facility”). Pursuant to the Purchase Agreement, the Company has the right to sell to Cantor up to of its common shares (the “Shares”), subject to certain conditions and limitations set forth in the Purchase Agreement. While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at a price related to the current market price.$50.0 million -
Sales of the Shares to Cantor under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time at its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Shares and determinations by the Company regarding the use of proceeds of such Shares. Upon the satisfaction of the conditions to Cantor’s obligation to purchase Shares, the Company will have the right, from time to time during the 36-month period after the commencement of the Facility, to direct Cantor to purchase up to a maximum number of Shares on any trading day. The purchase price of the Shares will be
96% of the volume-weighted average price of the Shares on such trading day. -
The unaudited financial results for the year ended
December 31, 2021 , will be filed with theSEC on Form 10-K in the coming days and will be available at www.luciddx.com or www.sec.gov.
Lucid 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 and other non-cash income and expenses, if any. 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 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 fourth quarter and year ended
For the three months ended |
For the year ended |
||||||||||||||||
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|||
Revenue | $ |
300 |
|
$ |
- |
|
$ |
500 |
|
$ |
- |
|
|||||
Gross profit |
|
(141 |
) |
|
- |
|
|
(85 |
) |
|
- |
|
|||||
Operating expenses |
|
11,100 |
|
|
2,731 |
|
|
27,334 |
|
|
8,280 |
|
|||||
Interest expense |
|
65 |
|
|
- |
|
|
659 |
|
|
- |
|
|||||
Net loss |
|
(11,306 |
) |
|
(2,731 |
) |
|
(28,078 |
) |
|
(8,280 |
) |
|||||
Net income (loss) per common share, basic and diluted | $ |
(0.32 |
) |
$ |
(0.19 |
) |
$ |
(1.51 |
) |
$ |
(0.59 |
) |
|||||
Adjustments: | |||||||||||||||||
Depreciation and amortization expense1 |
|
- |
|
|
- |
|
|
3 |
|
|
- |
|
|||||
Interest expense, net3 |
|
65 |
|
|
- |
|
|
659 |
|
|
- |
|
|||||
EBITDA |
|
(11,241 |
) |
|
(2,731 |
) |
|
(27,416 |
) |
|
(8,280 |
) |
|||||
Other non-cash or financing related expenses: | |||||||||||||||||
Stock-based compensation expense3 |
|
3,542 |
|
|
16 |
|
|
9,599 |
|
|
65 |
|
|||||
Non-GAAP adjusted (loss) |
|
(7,699 |
) |
|
(2,715 |
) |
|
(17,817 |
) |
|
(8,215 |
) |
|||||
Basic and Diluted shares outstanding |
|
34,918 |
|
|
14,115 |
|
|
18,604 |
|
|
14,114 |
|
|||||
Non-GAAP adjusted (loss) income per share | ($ |
0.22 |
) |
($ |
0.19 |
) |
($ |
0.96 |
) |
($ |
0.58 |
) |
|||||
1 |
Included in general and administrative expenses in the financial statements | ||||||||||||||||
2 |
Included in other income and expenses | ||||||||||||||||
For the three months ended |
For the year ended |
||||||||||||||||
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|||
3 |
Stock-based compensation ("SBC") expenses: | ||||||||||||||||
Commercial operations expense total |
|
2,571 |
|
|
633 |
|
|
5,260 |
|
|
1,305 |
|
|||||
Stock-based compensation expense |
|
- |
|
|
- |
|
|
(210 |
) |
|
- |
|
|||||
Net commercial operations expense excluding SBC |
|
2,571 |
|
|
633 |
|
|
5,050 |
|
|
1,305 |
|
|||||
General and administrative expense total |
|
5,047 |
|
|
272 |
|
|
12,778 |
|
|
1,532 |
|
|||||
Stock-based compensation expense |
|
(3,123 |
) |
|
- |
|
|
(9,111 |
) |
|
- |
|
|||||
Net general and administrative expense excluding SBC |
|
1,924 |
|
|
272 |
|
|
3,667 |
|
|
1,532 |
|
|||||
Research and development expense total |
|
3,482 |
|
|
1,826 |
|
|
9,296 |
|
|
5,443 |
|
|||||
Stock-based compensation expense |
|
(110 |
) |
|
(16 |
) |
|
(278 |
) |
|
(65 |
) |
|||||
Net research and development expense excluding SBC |
|
3,372 |
|
|
1,810 |
|
|
9,018 |
|
|
5,378 |
|
|||||
Total operating expenses |
|
11,100 |
|
|
2,731 |
|
|
27,334 |
|
|
8,280 |
|
|||||
Stock-based compensation expense |
|
(3,233 |
) |
|
(16 |
) |
|
(9,599 |
) |
|
(65 |
) |
|||||
Net operating expenses excluding SBC |
|
7,867 |
|
|
2,715 |
|
|
17,735 |
|
|
8,215 |
|
|||||
About
About
Forward-Looking Statements
This press release includes forward-looking statements that involve risk 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 W and 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,
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Investors
AKM@PAVmed.com
Media
LaVoieHealthScience
(609) 516-5761
PAVmed@lavoiehealthscience.com
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