| Loss Per Share | Note
12 — Loss Per Share The
respective “Net loss per share - attributable to PAVmed Inc. - basic and diluted” and “Net loss per share - attributable
to PAVmed Inc. common stockholders - basic and diluted” - for the periods indicated - is as follows: Schedule of Comparison of Basic and Fully Diluted Net Loss Per Share
2021 2020 2021 2020
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 2021 2020
Numerator
Net loss - before noncontrolling interest $ (12,670 ) $ (5,844 ) $ (22,779 ) $ (20,755 )
Net loss attributable to noncontrolling interest 1,199 266 1,877 702
Net loss - as reported, attributable to PAVmed Inc. $ (11,471 ) $ (5,578 ) $ (20,902 ) $ (20,053 )
Series B Convertible Preferred Stock dividends: $ (74 ) $ (71 ) $ (149 ) $ (141 )
Net loss attributable to PAVmed Inc. common stockholders $ (11,545 ) $ (5,649 ) $ (21,051 ) $ (20,194 )
Denominator
Weighted average common shares outstanding, basic and diluted 82,235,397 44,780,538 78,117,637 44,140,126
Loss per share
Basic and diluted
Net loss - as reported, attributable to PAVmed Inc. $ (0.14 ) $ (0.12 ) $ (0.27 ) $ (0.45 )
Net loss attributable to PAVmed Inc. common stockholders $ (0.14 ) $ (0.13 ) $ (0.27 ) $ (0.46 ) The
Series B Convertible Preferred Stock dividends earned as of the each of the respective periods noted, are included in the calculation
of basic and diluted net loss attributable to PAVmed Inc. common stockholders for each respective period presented. Notwithstanding,
the Series B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable
by the Company’s board of directors. Basic
weighted-average number of shares of common stock outstanding for the three and six months ended June 30, 2021 and 2020
include the shares of the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average
number of shares common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number
of shares outstanding includes such incremental shares. However, as the Company was in a loss position for all periods presented, basic
and diluted weighted average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The
common stock equivalents excluded from the computation of diluted weighted average shares outstanding are as follows: Schedule of Antidilutive Securities Excluded from Computation of Diluted Earnings Per Share
June 30,
2021 2020
PAVmed Inc. 2014 Equity Plan stock options and 10,573,530 7,965,195
Unit purchase options - as to shares of common stock — 53,000
Unit purchase options - as to shares underlying Series Z Warrants — 53,000
Series Z Warrants 15,074,281 16,815,039
Series W Warrants 381,818 381,818
Series
B Convertible Preferred Stock (3) 1,185,685 1,179,872
Total 27,215,314 26,447,924 Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2020 (the “Form 10-K”) as filed with the Securities
and Exchange Commission (the “SEC”). Unless the context otherwise requires, references herein to “we”, “us”,
and “our”, and to the “Company” or “PAVmed” are to PAVmed Inc. and Subsidiaries, including each of
the PAVmed Inc. majority-owned subsidiaries of: Lucid Diagnostics Inc. (“Lucid Diagnostics” or “LUCID”),
Solys Diagnostics, Inc. (“Solys Diagnostics” or “SOLYS”), and Veris Health Inc. (“Veris Health” or
“VERIS”). Forward-Looking
Statements This
Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our (unaudited) condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties. All
statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future consolidated
results of operations and consolidated financial position, our estimates regarding expenses, future revenue, capital and operating expenditure
requirements and needs for additional financing, our business strategy and plans and the objectives of management for future operations,
are forward-looking statements. The words “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,”
“believes,” “estimates,” “predicts,” “potential” or “continue” or the negative
of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements
contain these identifying words. Forward-looking statements are not guarantees of future performance and our actual results may differ
significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are
not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.” Important
factors that may affect our actual results include:
● our
limited operating history;
● our
financial performance, including our ability to generate revenue;
● our
ability to obtain regulatory approval for commercialization of our products;
● the
ability of our products to achieve market acceptance;
● our
success in retaining or recruiting, or changes required in, our officers, key employees, or directors;
● our
potential ability to obtain additional financing when and if needed;
● our
ability to sustain status as a going concern;
● our
ability to protect our intellectual property;
● our ability to identify and complete strategic acquisitions
and integrate the acquired operations;
● our
ability to manage growth;
● the
liquidity and trading of our securities;
● our
regulatory or operational risks;
● cybersecurity
risks;
● risks
related to the COVID-19 pandemic;
● our
estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; and
● our
status as an “emerging growth company” under the JOBS Act. In
addition, our forward-looking statements do not incorporate the potential impact of any future financings, acquisitions, mergers, dispositions,
joint ventures, or investments we may make. We
may not actually achieve the plans, intentions, and /or expectations disclosed in our forward-looking statements, and you should not
rely on our forward-looking statements. You should read this Form 10-Q and the Form 10-K, and the documents we have filed as exhibits
to this Form 10-Q and the Form 10-K, completely and with the understanding our actual future results may be materially different from
what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future
events, or otherwise, except as required by applicable law. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Overview PAVmed
Inc. and Subsidiaries (“PAVmed” or “the Company”) is a highly differentiated, multi-product, commercial-stage
technology medical device company organized to advance a broad pipeline of innovative medical technologies from concept to commercialization,
employing a business model focused on capital efficiency and speed to market. Since inception on June 26, 2014, the Company’s activities
have focused on advancing its lead products towards regulatory approval and commercialization, protecting its intellectual property,
and building its corporate infrastructure and management team. The Company operates in one segment
as a medical technology company, with the following lines-of-business: “GI Health”, “Minimally Invasive Interventions”,
“Infusion Therapy”, “Digital Health”, and “Emerging Innovations”. The Company has ongoing
operations conducted through PAVmed Inc. and its majority-owned subsidiaries of Lucid Diagnostics, Inc. (“Lucid Diagnostics”
or “LUCID”), Solys Diagnostics, Inc. (“Solys Diagnostics” or “SOLYS”) and Veris Health Inc. (“Veris
Health” or “VERIS”). PAVmed
Inc. and /or its subsidiaries have proprietary rights to the trademarks used herein, including, among others, PAVmed™, Lucid Diagnostics™,
LUCID™, Veris Health™, VERIS™, Oncodisc™, Solys Diagnostics™, SOLYS™, Caldus™, CarpX ® ® ® ® Our
multiple products and services are in various phases of development, regulatory clearances, approvals, and commercialization.
● The
EsoCheck device received 510(k) marketing clearance from the U.S. Food and Drug Administration (“FDA”), in June 2019
and European CE Mark Certification in May 2021 as an esophageal cell collection device; and, EsoGuard has been established as a Laboratory
Developed Test (“LDT”), completed European CE Mark Certification in June 2021, and was launched commercially in December
2019 after Clinical Laboratory Improvement Amendment (“CLIA”) and College of American Pathologists accreditation of the
test at Lucid Diagnostics commercial diagnostic laboratory partner ResearchDx Inc., headquartered in Irvine, California. In August
2021, Lucid Diagnostics launched a strategic partnership with direct-to-consumer telemedicine company UpScriptHealth to support our
commercialization efforts. Also in August 2021, we tested our first patients referred by primary care physicians (“PCPs”)
in three Lucid Test Centers opened in the Phoenix metropolitan area.
● Our
CarpX device is a patented, single-use, disposable, minimally-invasive surgical device designed
as a precision cutting tool to treat carpal tunnel syndrome while reducing recovery times
that was cleared by the FDA under section 510(k) in April 2020, with the first commercial
procedure successfully performed in December 2020. In May 2021 European CE Mark Certification
was received for CarpX.
● In
May 2021, we formed Veris Health, which is our newest majority-owned subsidiary. Also
in May 2021, Veris Health acquired
Oncodisc Inc (“Oncodisc”), a digital health company with ground breaking
tools to improve personalized cancer care through remote patient monitoring. Oncodisc’s
core technologies include the first intelligent implantable vascular healthcare platform
that provides patients and physicians with new tools to improve outcomes and optimize the
delivery of cost-effective care through remote monitoring and data analytics. Its vascular
access port contains biologic sensors capable of generating continuous data on key physiologic
parameters known to predict adverse outcomes in cancer patients undergoing treatment. Wireless
communication to the patient’s smartphone and its cloud-based digital healthcare platform
efficiently and effectively delivers actionable real time data to patients and physicians.
The technologies are the subject of multiple patent applications and one allowed patent awaiting
final issuance. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Overview
- continued As
discussed herein below, our current lines-of-business are as follows:
● GI
Health EsoGuard EsoCheck EsoCure
● Minimally
Invasive Interventions CarpX
● Infusion
Therapy PortIO NextFlo
● Digital
Health
● Emerging
Innovations GI
Health EsoGuard,
EsoCheck, and EsoCure EsoGuard
and EsoCheck are based on patented technology licensed from Case Western Reserve University (“CWRU”) through our majority-owned
subsidiary, Lucid. EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly screening test for
the early detection of adenocarcinoma of the esophagus (“EAC”) and Barrett’s Esophagus (“BE”), including
dysplastic BE and related pre-cursors to EAC in patients with chronic gastroesophageal reflux (“GERD”). EsoGuard
is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It
quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient multicenter
case-control study published in Science Translational Medicine, et al. Sci
Transl Med. EsoCheck
is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells
in a less than five-minute office. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from
which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the
balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted
region during device withdrawal. We believe this proprietary Collect+Protect ™ EsoCure
is in development as an Esophageal Ablation Device, with the intent to allow a clinician to treat dysplastic BE before it can progress
to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment. We have successfully
completed a pre-clinical feasibility animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal
mucosal lining. We have also completed an acute and survival animal study of EsoCure ™ In December 2019, we secured
“gapfill” determination for the EsoGuard PLA code 0114U through the United States Department of Health and Human Services
(“HHS”) Centers for Medicare and Medicaid Services (“CMS”) Clinical Laboratory Fee Schedule (“CLFS”)
process, which has allowed us to engage directly with Medicare contractor Palmetto GBA, LLC and its MolDx Program on CMS payment and
coverage. In October 2020, CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021. We are
still awaiting Medicare local coverage determination from MolDx, which we understand is working to clear a significant backlog of reviews. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Overview
- continued GI Health - continued EsoGuard, EsoCheck, and EsoCure We
are also aggressively pursuing EsoGuard private payor payment and coverage in the United States. Our first advisor board meeting with medical directors
of major insurers provided positive feedback and good alignment with our strategic approach. Although the claim cycle can be
prolonged during the early commercialization of a new test, PacificDx is starting to receive out-of-network private insurance
payments on our behalf. Our
initial EsoGuard commercialization efforts focused on gastroenterology (GI) physicians who have generally embraced our message that EsoGuard
has the potential to expand the funnel of BE-EAC patients who will need long-term EGD surveillance and, potentially, treatment with endoscopic
esophageal ablation. We have utilized a hybrid sales model with full-time sales management and approximately fifty independent sales
representatives. We significantly expanded our full-time commercial team in 2021 and are actively recruiting full-time territory managers
nationwide. EsoGuard testing has accelerated as pandemic-related healthcare facility limitations have eased. We
are now expanding EsoGuard commercialization to target primary care physicians (PCPs). The vast majority of at-risk GERD patients are
cared for by PCPs and never see a gastroenterologist. To assure sufficient testing capacity and geographic coverage during this expansion,
we are building our own network of Lucid Test Centers, where Lucid-employed clinical personnel will perform the EsoCheck procedure for
EsoGuard testing. We have hired personnel and leased medical office space to launch three pilot Lucid Test Centers in the Phoenix metropolitan
area. The next phase of this pilot program will be to establish an EsoGuard Telemedicine Program, in partnership with an independent
third-party telemedicine provider, UpScriptHealth, that can accommodate EsoGuard self-referrals from direct-to-consumer marketing. Our
active clinical research and development program seeks to expand the clinical evidence of our products’ efficacy to support our
ongoing regulatory, reimbursement and commercial efforts. We are actively enrolling patients in two international multicenter clinical
trials to support FDA PMA approval of EsoGuard, used with EsoCheck, as an IVD indicated to detect NDBE. ESOGUARD-BE-1 is a screening
study which will enroll approximately 500 to 900 male GERD patients over 50 years of age with one other risk factor. ESOGUARD-BE-2 is
a case control study which will enroll approximately 500 male GERD patients with a previous diagnosis of NDBE, LGD, HGD, or EAC, along
with normal controls. In
February 2020, we received FDA “Breakthrough Device Designation” for EsoGuard as an IVD device. The FDA Breakthrough Device
Program was created to offer patients more timely access to breakthrough technologies which provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human disease or conditions by expediting their development, assessment and review through
enhanced communications and more efficient and flexible clinical study design, including more favorable pre/post market data collection
balance. Breakthrough Devices receive priority FDA review, and a bipartisan bill before Congress (H.R. 5333) seeks to require Medicare
to temporarily cover all Breakthrough Devices for three years while determining permanent coverage. We
have received ISO 13485:2016 certification for Lucid’s quality management system and received CE Mark certification for EsoCheck
in May 2021 which allows it to be marketed in CE Mark European countries, which include the European Economic Area (the EU, Norway, Iceland,
and Lichtenstein), Switzerland, and, until July 1, 2023, the United Kingdom. In June 2021, we completed the European Directive
98/79/EC for In-Vitro Diagnostic Medical Devices (“IVDD”) CE Mark certification for EsoGuard after Lucid and its European
Union (“EU”) authorized representative completed the Commission of the European Union (“EC”) declaration
of conformity procedure, including the associated technical documentation, ensuring and declaring EsoGuard meets the essential requirements
of the IVDD. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Overview
- continued Minimally
Invasive Interventions CarpX CarpX
is a minimally invasive surgical device for use in the treatment of carpal tunnel syndrome which received FDA 510(k) marketing clearance
in April 2020, with the first commercial procedure successfully performed in December 2020. We
believe CarpX is designed to allow the physician to relieve the compression on the median nerve without an open incision or the need
for endoscopic or other imaging equipment. To use CarpX, the operator first advances a guidewire through the carpal tunnel under the
ligament, and then advanced over the wire and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance. When the
CarpX balloon is inflated it creates tension in the ligament positioning the cutting electrodes underneath it and creates space within
the tunnel, providing anatomic separation between the target ligament and critical structures such as the median nerve. Radiofrequency
energy is briefly delivered to the electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve. We believe CarpX
will be significantly less invasive than existing treatments. We
are commercializing CarpX through a network of independent U.S. sales representatives and/or inventory-stocking medical distributors
together with our in-house sales management and marketing teams. Our focus on CarpX, and other high margin products and services, is
particularly suitable to this mode of distribution. A high gross margin allows us to properly incentivize our distributors, which in
turn allows us to attract the top distributors with the most robust networks in our targeted specialties. Independent distributors play
an even larger role in many parts of Europe, most of Asia and emerging markets worldwide. We
may eventually choose to build (or obtain through a strategic acquisition) our own sales and marketing team to commercialize CarpX, along
with some or all of our products, if it is in our long-term interests. We may also choose to enter into distribution agreements with
larger strategic partners whereby we take full responsibility for the manufacturing of CarpX but outsource some or all of its distribution
to a partner, particularly outside the United States, with its own robust distribution channels. We
have received ISO 13485:2016 certification for PAVmed’s quality management system and received CE Mark certification for CarpX
in May 2021 which allows it to be marketed in CE Mark European countries, which include the European Economic Area (the EU, Norway, Iceland,
and Lichtenstein), Switzerland, and, until July 1, 2023, the United Kingdom. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Overview
- continued Infusion
Therapy PortIO PortIO
is a novel, patented, implantable, intraosseous vascular access device which does not require accessing the central venous system and
does not have an indwelling intravascular component. It is designed to be highly resistant to occlusion and may not require regular flushing.
It features simplified, near-percutaneous insertion and removal, without the need for surgical dissection or radiographic confirmation.
It provides a near limitless number of potential access sites and can be used in patients with chronic total occlusion of their central
veins. The absence of an intravascular component will likely result in a very low infection rate. Based
on encouraging animal data, we are preparing to initiate a long-term (60-day implant duration) first-in-human clinical study in dialysis
patients or those with poor venous access in Colombia, South America and intend to fulfill the likely FDA request for human clinical
data with a clinical safety study in the U.S. following FDA clearance of our Investigational Device Exemption (“IDE”) submission
to begin clinical testing in dialysis patients to support a future de novo NextFlo NextFlo
is a patented, disposable, and highly accurate infusion platform technology including intravenous (“IV”) infusion sets and
disposable infusion pumps designed to eliminate the need for complex and expensive electronic infusion pumps for most of the estimated
one million infusions of fluids, medications and other substances delivered each day in hospitals and outpatient settings in the U.S.
NextFlo is designed to deliver highly accurate gravity-driven infusions independent of the height of the IV bag. It maintains constant
flow by incorporating a proprietary, passive, pressure-dependent variable flow-resistor consisting entirely of inexpensive, easy-to-manufacture
disposable mechanical parts. NextFlo testing has demonstrated constant flow rates across a wide range of IV bag heights, with accuracy
rates comparable to electronic infusion pumps. We
are seeking a long-term strategic partnership or acquiror. We have been running a formal M&A process for NextFlo targeting strategic
and financial partners. Discussions and technologic diligence engagement with large strategic partners to license NextFlo technology
for disposable infusion pumps continue while PAVmed advances technology towards self-commercialization. We have initiated design freeze
verification testing in preparation for final verification and validation testing of NextFlo IV Infusion Set, to support FDA 510(k) submission
and clearance targeted for the first half of 2022. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Overview
- continued Digital Health Veris Health Inc. In
May 2021, we formed Veris Health, which is our newest majority majority-owned subsidiary, focused on digital health technology.
Also in May 2021, Veris Health acquired Oncodisc Inc. (“Oncodisc”), a digital health company with groundbreaking
tools to improve personalized cancer care through remote patient monitoring. Oncodisc
was founded by experienced physician entrepreneurs, James Mitchell, M.D., who joins Veris Health as its full-time Chief Medical
Officer, and Andrew Thoreson, M.D., who will serve as a Veris Health consultant. Oncodisc’s core technologies include the
first intelligent implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist-designed
remote digital healthcare platform that provides patients and physicians with new tools to improve outcomes and optimize the delivery
of cost-effective care through remote monitoring and data analytics. Oncodisc
was founded in 2018 by Mitchell, a radiation-oncologist, and Thoreson, an interventional radiologist, who previously co-founded Redsmith,
Inc., an interventional catheter company whose technology was acquired by C.R. Bard Inc., now BD Inc. (NYSE: BDX), in 2017. Oncodisc
received a National Science Foundation (“NSF”) Small Business Innovation Research (“SBIR”) grant award to support
its early work and completed both the MedTech Innovator Accelerator and UCSF Rosenman Institute Accelerator programs. Its
groundbreaking vascular access port contains biologic sensors capable of generating continuous data on key physiologic parameters
known to predict adverse outcomes in cancer patients undergoing treatment. Wireless communication to the patient’s smartphone
and its cloud-based digital healthcare platform efficiently and effectively delivers actionable real time data to patients and
physicians. The technologies are the subject of multiple patent applications and one allowed patent awaiting final issuance. Veris Health
is targeting FDA 510(k) clearance of the intelligent implantable vascular access port and launch of the remote digital healthcare
platform for the last six months of 2022. The
planned Veris Health business model seeks to generate 100% recurring revenue through oncology practice and hospital-based subscriptions.
These entities would purchase seats on the platform and pay a monthly remote monitoring charge to drive revenues from remote patient
monitoring and device implantation under existing CPT codes, as well as established CMS Oncology Care Model (OCM) bonuses and CMS Quality
Reporting Program incentives. Veris Health also anticipates strong demand for its intelligent implantable vascular access port
and remote monitoring platform from oncology biotherapeutic companies to support clinical trials of their novel immunotherapy and chemotherapy
agents with continuous physiologic data and transformative analytics. Emerging
Innovations Emerging
Innovations include a diversified and expanding portfolio of innovative products designed to address unmet clinical needs across a broad
range of clinical conditions. We are evaluating a number of these product opportunities and intellectual property covering a wide spectrum
of clinical conditions, which have either been developed internally or have been presented to us by clinician innovators and academic
medical institutions for consideration of a partnership to develop and commercialize these products. This collection of products includes,
without limitation, initiatives in non-invasive laser-based glucose monitoring, mechanical circulatory support cannulas, single-use ventilators
and resorbable pediatric ear tubes. In June 2020, we announced the execution of a letter of intent to consummate a series of agreements
to develop and utilize Canon Virginia’s commercial grade and scalable aqueous silk fibroin molding process to manufacture PAVmed’s
DisappEAR molded pediatric ear tubes for commercialization. Furthermore, we are exploring other opportunities to grow our business and
enhance shareholder value through the acquisition of pre-commercial or commercial stage products and/or companies with potential strategic
corporate and commercial synergies. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Impact
of the COVID-19 Pandemic Previously,
in December 2019, an outbreak of a novel strain of a coronavirus occurred. The coronavirus spread on a global basis to other countries,
including the United States. On March 11, 2020, the United Nations World Health Organization (“WHO”) declared a pandemic
resulting from the spread of the coronavirus, with such pandemic commonly referred to by its resulting illness, “COVID-19”.
The COVID-19 pandemic is ongoing, and we continue to monitor the ongoing impact of the COVID-19 pandemic on the United States national
economy, the global economy, and our business. The
COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors
of our laboratory partner, and increase our expenses, including as a result of impacts associated with preventive and precautionary measures
being taken, restrictions on travel, quarantine polices, and social distancing. Such adverse impact may include, for example, the inability
of our employees and /or those of our contractors or laboratory partner to perform their work or curtail their services provided to us. We
expect the significance of the COVID-19 pandemic, including the extent of its effect on our consolidated financial condition and consolidated
operational results and cash flows, to be dictated by the success of United States and global efforts to mitigate the spread of and /or
to contain the coronavirus and the impact of such efforts. In
addition, the spread of the coronavirus has disrupted the United States’ healthcare and healthcare regulatory systems which could
divert healthcare resources away from, or materially delay FDA approval with respect to our products. Furthermore,
our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be
delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as travel restrictions
imposed by governments, and the inability to access clinical test sites for initiation and monitoring. The
COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the United States, resulting
in an economic downturn that could adversely affect demand for our products and services and /or our product candidates. Although
we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic
(or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,
consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material. Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results
of Operations Overview Commercial
operations expenses Commercial
operations expenses consist primarily of salaries and related costs for sales, sales operations, marketing, and payor reimbursement
personnel, along with advertising and promotion expenses. We
anticipate our commercial operations expenses will increase in the future, as we anticipate an increase in payroll and related expenses
related to the roll-out of our commercial sales and marketing operations as we execute on our business strategy. General
and administrative expenses General
and administrative expenses consist primarily of salaries and related costs for personnel, travel expenses, facility-related costs, professional
fees, accounting and legal services, consultants and expenses associated with obtaining and maintaining patents within our intellectual
property portfolio. We
anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in payroll and related expenses
related with the growth and expansion of our business operations objectives. We also anticipate continued expenses related to being a
public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance as a public company,
insurance premiums and investor relations costs. Research
and development expenses Research
and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred
for the research and development of our products, including:
● consulting
costs charged to us by various extern |
