Full Press Release Details
Provides Business Update and Preliminary Fourth Quarter 2020 Financial Results
majority-owned subsidiary Lucid Diagnostics intends to spin-off into a separate public company
Diagnostics to launch major new multi-channel commercialization initiative for its EsoGuard Esophageal DNA Test
call to be held today at 8:30 AM EST
YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) - PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"),
a highly differentiated, multi-product, commercial-stage medical device company, today provided a business update for the Company
and its subsidiaries, Lucid Diagnostics Inc. ("Lucid") and Solys Diagnostics Inc. ("Solys"), discussed
preliminary financial results for the three and 12 months ended December 31, 2020 and made two strategic announcements regarding
Lucid and its EsoGuard product.
a strong fourth quarter of 2020 and start of 2021, including raising over $30 million from institutional investors, we find ourselves
in the strongest financial position in our history and with the confidence and determination necessary to rapidly and effectively
advance and expand our mission," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "In
addition to providing an update on all areas of our business, we are making two important announcements regarding Lucid and EsoGuard
consistent with that sentiment."
conference call and webcast on today's Business Update and Preliminary Fourth Quarter Financial Results will take place
at 8:30 AM EST. To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should
dial (201) 493-6780. All listeners should provide the operator with the conference call name "PAVmed, Inc. Business Update
Conference Call" to join. Individuals interested in listening to the live conference call via webcast may do so by visiting
the investor relations section of the Company's website at www.pavmed.com.
Diagnostics Spin-Off
Company announced that its majority-owned subsidiary Lucid Diagnostics intends to spin off into a separate public company if favorable
market conditions continue to hold, either through an initial public offering ("IPO") or a business combination with
a healthcare special purpose acquisition corporation ("SPAC"). The Lucid board of directors determined that this long-contemplated
step is necessary for Lucid to fulfill its long-term potential, unlock its present value, and execute on a major new commercial
initiative. The Company believes that a Lucid spin-off that accomplishes the foregoing would also be in the best interests of
PAVmed and its shareholders. PAVmed will remain Lucid's largest shareholder following any spin-off transaction.
EsoGuard Commercialization Initiative
Company also announced that Lucid is launching a major new commercial initiative which seeks to accelerate EsoGuard commercialization
by simultaneously targeting multiple sales and marketing channels and building Lucid's own network of EsoCheck
operators to assure sufficient testing capacity and geographic coverage to accommodate demand.
plans to retain and train a network of full-time nurses or other clinical personnel to serve as EsoCheck operators deployed at
different types of venues, including leased space in physician practices, and potentially at free-standing EsoGuard testing centers
in locales where testing volume and economics can support them. Lucid also intends to seek joint-ventures with laboratory testing
companies as well as pharmacy mini-clinic networks to establish EsoGuard testing capacity at their facilities.
sufficient EsoGuard testing capacity and geographic coverage has been established in a specific locale, Lucid plans to initiate
multiple new sales and marketing channels, while continuing to aggressively drive adoption by gastroenterologists. These new channels
include direct-to-consumer marketing, as well as sales and marketing directly targeting primary care physicians.
pilot program in one major metropolitan area is planned for the second quarter.
the three months ended December 31, 2020, research and development expenses were $3.6 million and general and administrative expenses
were $3.9 million. GAAP net loss attributable to common stockholders was $8.8 million, or $(0.17) per common share. As illustrated
below and for the purpose of helping the reader understand the effect of derivative accounting and other non-cash income and expenses
on the Company's financial results, the Company reported a non-GAAP adjusted loss for the three months ended December 31,
2020 of $6.4 million or $(0.12) per common share.
had cash and cash equivalents of $17.3 million as of December 31, 2020, compared with $6.2 million as of December 31, 2019. Subsequently,
in early January 2021, the Company closed on its $13.4 million registered direct offering for the sale of 6.0 million shares of
common stock at $2.24 per share which was priced at-the-market under Nasdaq rules.
audited financial results for the year ended December 31, 2020 on Form 10-K will be filed with the SEC in the coming days and
will be available at www.pavmed.com or www.sec.gov.
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.
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.
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
reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release
for the three and 12 months ended December 31, 2020 and 2019 is as follows:
| For the three months ended December 31, | For the year ended December 31, | |||||||||||||||
| (ooo's except per-share amounts) | 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Net income (loss) per common share, basic and diluted | $ | (0.17 | ) | $ | (0.19 | ) | $ | (0.73 | ) | $ | (0.55 | ) | ||||
| Net loss attributable to common stockholders | (8,813 | ) | (6,313 | ) | (34,563 | ) | (16,727 | ) | ||||||||
| Preferred Stock dividends and deemed dividends | 73 | 69 | 287 | 270 | ||||||||||||
| Net income (loss) as reported | (8,740 | ) | (6,244 | ) | (34,276 | ) | (16,457 | ) | ||||||||
| Adjustments: | ||||||||||||||||
| Depreciation expense 1 | 7 | 4 | 23 | 14 | ||||||||||||
| Interest expense, net 3 | - | 33 | 52 | 33 | ||||||||||||
| EBITDA | (8,733 | ) | (6,207 | ) | (34,201 | ) | (16,410 | ) | ||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense 2 | 585 | 393 | 2,044 | 1,571 | ||||||||||||
| Debt extinguishment 3 | 1,897 | 1,165 | 6,497 | 666 | ||||||||||||
| Change in FV convertible debt 3 | (194 | ) | (482 | ) | 3,467 | 341 | ||||||||||
| Offering costs convertible debt 3 | - | 1,250 | 2,520 | - | ||||||||||||
| Non-GAAP adjusted (loss) | (6,445 | ) | (3,881 | ) | (19,673 | ) | (13,832 | ) | ||||||||
| Basic and Diluted shares outstanding | 52,487 | 33,223 | 45,564 | 29,212 | ||||||||||||
| Non-GAAP adjusted (loss) income per share | $ | (0.12 | ) | $ | (0.12 | ) | $ | (0.43 | ) | $ | (0.47 | ) |
| 1 | Included in general and administrative expenses in the financial statements |
| 2 | For the three months ended December 31, 2020 includes $450 of stock based compensation expense reported as general and administrative expenses and $136 reported as research and development expense. For the three months ended December 31, 2019 includes $310 of stock based compensation expense reported as general and administrative expenses and $84 reported as research and development expense. For the year ended December 31, 2020 includes $1,581 of stock based compensation expense reported as general and administrative expenses and $462 reported as research and development expense. For the year ended December 31, 2019 includes $1,162 of stock based compensation expense reported as general and administrative expenses and $408 reported as research and development expense. |
| 3 | Included in other income and expenses |
announced last week, the Company changed the time for today's conference call and webcast to 8:30 AM EST to accommodate
the schedule of Lucid's Strategic Advisor, medical diagnostics pioneer Stanley Lapidus. Mr. Lapidus will join PAVmed Chairman
and Chief Executive Officer Lishan Aklog, M.D., and President and Chief Financial Officer Dennis McGrath on the call.
McGrath will provide a financial update on the Company. Dr. Aklog will provide a business update and discuss Lucid's growth
strategy with Mr. Lapidus, who will provide his perspective on Lucid's EsoGuard commercial opportunity, based on his similar
experiences bringing early cancer detection technologies to market, including as the founder and former Chairman and CEO of Exact
access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780.
All listeners should provide the operator with the conference call name "PAVmed, Inc. Business Update Conference Call"
to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations
section of the Company's website at www.pavmed.com.
the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing (844) 512-2921 from
within the U.S. or (412) 317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number:
13715663. The webcast will be available for replay on the investor relations section of the Company's website at www.pavmed.com.
Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed
to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This
proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation
while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic
centers. PAVmed's diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical
areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard
Esophageal DNA Test, EsoCheck Esophageal Cell Collection Device, and EsoCure Esophageal Ablation
Device with Caldus Technology), Minimally Invasive Interventions (CarpX Minimally Invasive Device for Carpal
Tunnel Syndrome), Infusion Therapy (PortIO Implantable Intraosseus Vascular Access Device and NextFlo Highly Accurate
Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes,
on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please
visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please
press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements
that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed'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, our ability to complete our strategic initiatives,