Full Press Release Details
Provides Business Update and Preliminary Fourth Quarter and Full Year 2021 Financial Results
call to be held today at 4:30 PM EDT
YORK, March 29, 2022 (GLOBE NEWSWIRE) - PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the "Company" or "PAVmed"),
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 preliminary financial results for the year ended December 2021.
conference call and webcast for today's business update and fourth quarter and year ended December 31, 2021, financial results
will take place at 4:30 PM EDT. To access the conference call, listeners should dial 877-407-3982 toll-free in the U.S. or 201-493-6780,
and ask to join the "PAVmed, Inc. Business Update Conference Call". The conference call will be available live via webcast
and for replay at the investor relations section of the Company's website at www.pavmed.com. Following the conclusion
of the conference call, a replay will be available for one week and can be accessed by dialing 844-512-2921 toll-free in the U.S. or
412-317-6671, followed by the PIN number: 13727143.
am happy to report that PAVmed and its subsidiaries are making solid progress on all fronts and are laying a solid foundation for us
to continue driving our long-term growth strategy and mission to create a leading, diversified medical technology company," said
Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "This includes EsoGuard commercialization, advancing
our Veris Health portfolio, CarpX's limited commercial release, preparing to commercially launch NextFlo, PortIO first-in-human
cases, and advancing the rest of our portfolio towards commercialization. Over the past several quarters we have transformed our business
model, expanded our infrastructure and substantially grown our team to accommodate our transition from a technology-focused to a commercial-focused
| 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 $1938 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 $1,150 per test representing approximately 60% out-of-network coverage. | |
| Veris is successfully advancing its software, device, and data programs 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 strategy, 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 for U.S. approval. |
| In March 2022, both the PAVmed and Lucid board of directors approved entering into an intercompany license between PAVmed 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 pay PAVmed a 5% royalty on all EsoCure sales up to $100 million per calendar year, and 8% above that threshold. | |
| In March 2022, both the PAVmed and Lucid board of directors approved entering into a purchase and sale of the CapNostics, LLC assets, including the EsophaCap non-endoscopic sponge-based esophageal cell collection device, from PAVmed to Lucid as well as transferring the consulting agreement with the principal owner of CapNostics, LLC prior to the purchase by PAVmed on October 5, 2021. |
| For the fourth quarter of 2021, EsoGuard related revenues were $0.3 million while for the year ended December 31, 2021, revenues were $0.5 million. Fourth-quarter and full-year 2021 operating expenses were approximately $19.5 million and $54.3 million, respectively, which include stock-based compensation expenses of $4.4 million and $15.0 million, respectively. GAAP net loss attributable to shareholders for the fourth quarter and full-year 2021 were approximately $17.3 million and $50.6 million, or $(0.20) and $(0.65) 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 fourth quarter and year ended December 31, 2021, were approximately $12.7 million and $33.2 million or $(0.15) and $(0.43) per common share. | |
| PAVmed had cash and cash equivalents of $77.3 million as of December 31, 2021, compared with $17.3 million as of December 31, 2020. | |
| On March 28, 2022, PAVmed's majority-owned subsidiary, Lucid Diagnostics, Inc. entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with CF Principal Investments LLC ("Cantor"), an affiliate of Cantor Fitzgerald, relating to a committed equity facility (the "Facility"). Pursuant to the Purchase Agreement, Lucid has the right to sell to Cantor up to $50.0 million 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 Lucid to raise primary equity capital on a periodic basis at a price related to the current market price. | |
| 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, Lucid 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. |
unaudited financial results for the year ended December 31, 2021, will be filed with the SEC on Form 10-K 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
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.
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 December 31, 2021, and 2020 is as follows:
| For the three months ended December 31, | For the year ended December 31, | |||||||||||||||
| 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 expense 1 | 166 | 6 | 226 | 23 | ||||||||||||
| Interest expense, net 2 | - | - | - | 53 | ||||||||||||
| EBITDA | (17,052 | ) | (8,734 | ) | (50,121 | ) | (34,200 | ) | ||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense 3 | 4,380 | 586 | 15,009 | 2,044 | ||||||||||||
| Debt extinguishment/debt forgiveness 2 | - | 1,897 | 3,415 | 6,497 | ||||||||||||
| Acquisition related 1 | - | - | 133 | - | ||||||||||||
| Change in FV convertible debt 2 | - | (194 | ) | (1,682 | ) | 5,327 | ||||||||||
| Offering costs convertible debt 2 | - | - | - | 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 | ) |
in general and administrative expenses in the financial statements
in other income and expenses
compensation ("SBC") expenses:
| (ooo's except per-share amounts) | For the three months ended December 31, | For the year ended December 31, | ||||||||||||||
| 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 |
Diagnostics (Nasdaq: LUCD) Preliminary Financial Results
| For the fourth quarter of 2021, EsoGuard related revenues were $0.3 million, while for the year ended December 31, 2021, revenues were $0.5 million. Fourth-quarter and full-year 2021 operating expenses were approximately $11.1 million and $27.3 million, respectively, which include stock-based compensation expenses of $3.2 million and $9.6 million, respectively. GAAP net loss attributable to common stockholders for the fourth quarter and full-year 2021 were approximately $11.3 million and $28.1 million, or $(0.32) and $(1.51) 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 fourth quarter and year ended December 31, 2021, were approximately $7.7 million and $17.8 million or $(0.22) and $(0.96) per common share. | |
| Lucid had cash and cash equivalents of $53.7 million as of December 31, 2021, compared to $0.1 million as of December 31, 2020. | |
| On March 28, 2022, the Company entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with CF Principal Investments LLC ("Cantor"), an affiliate of Cantor 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 $50.0 million 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. | |
| 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 the SEC on Form 10-K in the coming days and will be available at www.luciddx.com or www.sec.gov . |
| 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 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. |
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 December 31, 2021, and 2020 is as follows:
| For the three months ended December 31, | For the year ended December 31, | |||||||||||||||
| 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 expense 1 | - | - | 3 | - | ||||||||||||
| Interest expense, net 3 | 65 | - | 659 | - | ||||||||||||
| EBITDA | (11,241 | ) | (2,731 | ) | (27,416 | ) | (8,280 | ) | ||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense 3 | 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 | ) |
in general and administrative expenses in the financial statements
in other income and expenses
| For the three months ended December 31, | For the year ended December 31, | |||||||||||||||
| 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 |
Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics and digital health sectors.
Its major subsidiary, Lucid Diagnostics Inc. (Nasdaq: LUCD), 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 prevent esophageal cancer deaths. Another major subsidiary, Veris Health Inc., is a digital health company developing the first intelligent
implantable vascular access port with biologic sensors and wireless communication to improve personalized cancer care through remote
patient monitoring. PAVmed's CarpX Minimally Invasive Device for Carpal Tunnel Syndrome is currently in limited
commercial release. The product pipeline also includes the EsoCure Esophageal Ablation Device with Caldus Technology, which
complements EsoGuard and EsoCheck, the NextFlo Intravenous Infusion Set, the PortIO Implantable Intraosseous Vascular Access
Device, novel pediatric ear tubes, mechanical circulatory support technology and glucose monitoring. For more information, please visit
information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect
Diagnostics Inc. (Nasdaq: LUCD) is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq:
PAVM). Lucid is focused on the millions of patients with gastroesophageal disease (GERD), also known as chronic heartburn, who are at
risk of developing esophageal precancer and cancer. Lucid's EsoGuard Esophageal DNA Test, performed on samples collected in
a brief, noninvasive office procedure with its EsoCheck Esophageal Cell Collection Device, is the first and only commercially available
diagnostic test capable of serving as a widespread screening tool to prevent cancer and cancer deaths through early detection of esophageal
precancer in at-risk GERD patients. EsoGuard is commercialized in the U.S. as a Laboratory Developed Test (LDT). EsoCheck is commercialized
in the U.S. as a 510(k)-cleared esophageal cell collection device. EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device
designation and is the subject of two large, actively enrolling, international multicenter clinical trials to support FDA PMA approval.
Lucid is building nationwide direct sales and marketing team targeting primary care physicians, gastroenterologists, and consumers, as
well as a network of Lucid Test Centers where at-risk GERD patients can undergo the EsoCheck procedure for EsoGuard testing. For more
information, please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard,
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, PAVmed and Lucid have been monitoring the COVID-19 pandemic and the
pandemic's impact on PAVmed's and Lucid's businesses. PAVmed and Lucid expect the significance of the COVID-19 pandemic,
including the extent of its effect on its financial and operational results, to be dictated by, among other things, the success f efforts
to contain the pandemic and the impact of such efforts on PAVmed's and Lucid's businesses. These factors are difficult or
impossible to predict accurately and many of them are beyond PAVmed's and Lucid's control. 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 IA, "Risk Factors," in PAVmed'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 after its most recent Annual Report and Lucid's
Registration Statement No. 333-259721 filed with the Securities and Exchange Commission. 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.