You should read the following discussion and analysis of our financial condition
and results of operations together with our condensed financial statements and
related notes appearing elsewhere in this quarterly report on Form 10-Q. This
discussion and analysis contains forward-looking statements that involve risks,
uncertainties and assumptions. The actual results may differ materially from
those anticipated in these forward-looking statements as a result of certain
factors, including, but not limited to, those set forth under 'Risk Factors' in
our annual report on Form 10-K for the fiscal year ended December 31, 2019,
filed with SEC on July 9, 2020.
Company Overview
United Health Products, Inc. ("UHP" or the "Company") develops, manufactures,
and markets a patented hemostatic gauze for the healthcare and wound care
sectors. The product, HemoStyp®, is derived from all natural, regenerated
oxidized cellulose and designed to absorb exudate/drainage from superficial
wounds and help control bleeding. We currently have limited sales of products
aimed at the consumer market via Walmart.com. We are in the process of seeking
regulatory approval to sell products into the U.S. Class III surgical market.
Impact of Covid-19 on our Business
In late 2019 the novel coronavirus, Covid-19, was identified. By February 2020,
the virus had spread to many countries around the world, including the United
States. By late February, authorities in the United States began advising
American businesses to prepare for the effects of the outbreak.
The extent of the long-term adverse effect of the Covid-19 pandemic on the
economy, our industry and our results of operations and financial condition is
unknown and largely dependent on future developments, most of which, including
the severity and duration of this pandemic, are beyond our control.
Our HemoStyp Gauze Products
HemoStyp Hemostatic Gauze is a collagen-like natural substance created from
chemically treated cellulose. It is an effective hemostatic agent registered
with the FDA to help control bleeding from open wounds and body cavities. The
HemoStyp hemostatic material contains no chemical additives, thrombin or
collagen, and is hypoallergenic. When the product comes in contact with blood it
expands slightly and converts to an adhesive gel that subsequently dissolves
into glucose and saline. Because of its purity and the fact that it simply
degrades to non-toxic end products, HemoStyp does not cause significant delay in
healing as do certain other hemostatic materials. Additional testing has shown
HemoStyp to be 100% absorbable in 24 hours or less. Tests have also been
conducted to demonstrate the effectiveness of HemoStyp in thoracic and abdominal
procedures.
HemoStyp Hemostatic Gauze is a flexible cloth-like material that is applied by
folding the gauze as needed to fit the size of the wound or incision, and then
placing the gauze onto the bleeding tissue. In surgical situations, the product
converts to a transparent gel with a neutral pH level that allows the surgeon to
monitor the coagulation process and also avoids damage to the surrounding
tissue. In first responder or other non-surgical situations, putting a bandage
on top of the gauze is optional and, in many cases, unnecessary. Since EMS
(Emergency Medical Services) work is pre-hospital, rinsing the gauze out with
saline or water is not necessary, as a wound will be debrided and possibly
reopened prior to suturing at the hospital.
Potential Target Markets
Our technology can be marketed as HemoStyp Gauze in various configurations and
sizes both nationally and internationally. Our potential customer base for our
HemoStyp includes, without limitation, the following (noting that we have
several formats of Trauma Gauze):
• Hospitals and Surgery Centers for all Internal Surgical usage, post FDA
Class III approval
• Hospitals, Clinics and Physicians - For external trauma
• EMS, Fire Departments and Other First Responders
• Public Safety, Police Departments and Military
• Correctional Facilities
• Schools, Universities and Day Care Facilities
• Nursing Homes and Assisted Living Environments
• Home Care Providers
• Dental offices for oral surgery
• Sports Medicine Providers
• Veterinarians
• Municipalities and Government Agencies
• Occupational and Industrial Healthcare Professionals
• Consumers
• Island dressings to support intravenous procedures such as kidney dialysis
14
Primary Strategy
In 2018, management made the decision that rather than focusing on immediate
sales activities of our products in targeted markets during this period of time
before receiving anticipated FDA approval for Class III surgical markets, the
Company would refocus efforts to become a stronger, medical technology company
with a patented technology for Class III surgical markets that would enhance the
Company's value and overall market strength. The FDA approval process requires
substantial amount of the Company's resources and energy so the focus was
removed from sales and marketing and full attention was focused on the FDA
process and seeking an acquisition/commercial partner candidate. Thus we made a
determination not to engage new distribution partners while pursuing this
strategy as that could create conflicts and limit or preclude opportunities with
a potential acquiror/commercial candidate and tie the Company's hands from a
revenue or branding perspective. The Class III surgical markets, both domestic
and international, represent the most attractive market for our products due to
the limited competition from other Class III approved ORC (Oxidized Regenerated
Cellulose) products and the resulting premium pricing for hemostatic agents that
can meet the demanding requirements of the human surgical environment. In
addition, our preliminary tests and our completed Human Trial study, leads us to
believe that the HemoStyp technology can compete against established market
participants and allow us to gain market share. Given this assessment, we have
devoted considerable resources since 2018 to completing the FDA process and
gaining access to this market in the U.S. As of the filing date of this Form
10-Q, the FDA review process, which was temporarily held up by the Covid-19
virus pandemic, is ongoing.
In anticipation of receiving Class III approval, we are evaluating the best
paths to rapidly grow our revenue and profits in all potential market segments,
which could include seeking (i) a potential sale or merger, which may include a
pre-sale commercialization component, (ii) one or more commercial partnerships
and licensing agreements with established market participants, without there
being a sale or merger, or (iii) to raise the necessary capital to establish and
grow our own marketing and distribution capabilities via organic growth.
The Company has been contacted by several medical technology companies that are
active in the surgical equipment and hemostatic products sectors, and who have
expressed an interest in the Company's products and business strategy. In
response to these inbound contacts, and to maximize shareholder value, the
Company's board of directors has determined to conduct a review of strategic
alternatives, which include, without limitation, identifying an acquisition
candidate, joint ventures or other commercial partnerships, or a standalone
growth plan. To assist in this review and strategy, the Company is working with
a financial advisory firm. There can be no assurances that any specific
transaction will occur as a result of the retention of this firm. No assurances
can be given that the Company will identify an acquisition or commercialization
candidate(s) or complete a transaction with one or more candidates on terms
satisfactory to us, if at all.
Manufacturing and Packaging of our Products
The Company's cellulose products are manufactured in the United States to our
specifications at various facilities. We have established various contract
manufacturing facilities. All of these facilities have been carefully vetted and
have supplied multiple Quality Control program certificates and are registered
FDA facilities. These facilities have been submitted as part of our PMA
submission, which includes the FDA inspection records of these facilities.
Patents and Trademarks
The Company's hemostatic gauze products are patented in the U.S. Patent and
Trademark Office ("USPTO"), which patent protection currently runs through 2029.
However, if our intellectual property positions are challenged, invalidated,
circumvented, or expire, or if we fail to prevail in future intellectual
property litigation, our business could be adversely affected. We have created
multiple variations of our gauze product and will protect each of these new
generation platforms and product with additional intellectual property. Our
success depends in part on our ability to defend our intellectual property
rights. The patent positions of pharmaceutical and biotechnology companies can
be highly uncertain and often involve complex legal, scientific, and factual
questions. Third parties may seek to challenge, invalidate, or circumvent our
intellectual property rights. In addition, our patent positions might not
protect us against competitors with similar products or technologies because
competing products or technologies may not infringe our patents. Also, there are
third parties who have patents or pending patent applications that they may
claim necessitate payment of a royalty or prevent us from commercializing our
patent in certain territories. Patent disputes are frequent, costly and can
preclude, delay, or increase the cost of commercialization of products.
15
The Company has registered trademarks for the following:
· Boo Boo Strips:
· The Ultimate Bandage
· Hemostrips
· Nik Fix
Results of Operations for the three months ending June 30, 2020 and 2019
The following table sets forth a summary of certain key financial information
for the three months ended June 30, 2020 and 2019:
For the Three Months Ended June 30,
2020 2019
Revenue $ 136 $ 4,927
Gross profit $ 56 $ 502
Operating (expenses) $ (647,956 ) $ (608,755 )
Operating (loss) $ (647,876 ) $ (604,330 )
Other income (expense) $ (45,176 ) $ (202,753 )
Net (loss) $ (693,052 ) $ (807,083 )
Basic and diluted $ (0.00 ) $ (0.00 )
Three Months ended June 30, 2020 versus Three Months ended June 30, 2019
During the three months ended June 30, 2020 and 2019, the Company had $136 and
$4,927 of revenues, respectively. Revenues were minimal in the second quarter of
2020 and 2019 and decreased compared to the prior year. The Company has
continued to devote its attention and efforts towards making our technology and
product more commercially viable, by seeking to obtain FDA class III approval
for internal surgical purposes. The Company is continuing this strategy based on
our belief that the greatest value to our shareholders will come from this FDA
Class III approval for general surgical use, and pursuing opportunities that we
anticipate will be available to the Company if this FDA approval is obtained,
including, among other things, fostering interest from potential merger and
acquisition candidates. In this strategy and approach, the Company made a
determination not to engage new distribution partners as that could create
conflicts with a potential acquiror/commercialization candidate and tie the
Company's hands from a revenue or branding perspective. The Company expects that
if an acquisition candidate is identified it may also include a pre-acquisition
commercialization component and in that case current vendor and future
relationships and all pending purchase orders will likely be facilitated by that
company. No assurances can be given that the Company will identify an
acquisition or commercialization candidate or complete a transaction with such a
candidate on terms satisfactory to us, if at all.
16
Total operating expenses for the three months ended June 30, 2020 and 2019 were
$647,956 and $608,755, respectively. The increase in operating expenses is due
primarily to an increase in consulting/professional fees of approximately
$288,000 offset by a decrease in travel of approximately $33,000 and a decrease
in advertising and marketing of approximately $4,500 offset by a decrease in
research and development of $195,975. The increase in consulting/professional
fees is due to additional expenses associated with restating prior years'
financial statements, ongoing litigation and issuing 125,000 shares of common
stock for services valued $100,625. The decrease in travel is due to Covid-19
and the limitations and restrictions on travel.
Our net loss for the three months ended June 30, 2020 was $693,052 as compared
to net loss of $807,083 for the comparable period of the prior year. The
decrease in the net loss is due to the Company having a decrease in operating
expenses of $39,201 as explained above along with interest expense decreasing
from $202,753 during the three months ended June 30, 2019 to $45,176 for the
three months ended June 30, 2020. The decrease in interest expense is due to the
Company only having $46,505 of amortization of debt discount during the three
months ended June 30, 2020 compared to $202,753 in the comparable period of
2019.
Results of Operations for the six months ending June 30, 2020 and 2019
The following table sets forth a summary of certain key financial information
for the six months ended June 30, 2020 and 2019:
For the Six Months Ended June 30,
2020 2019
Revenue $ 427 $ 4,927
Gross profit $ 161 $ 502
Operating (expenses) $ (1,271,948 ) $ (3,272,153 )
Operating (loss) $ (1,271,682 ) $ (3,267,729 )
Other income (expense) $ (47,191 ) $ (202,752 )
Net (loss) $ (1,318,873 ) $ (3,470,481 )
Basic and diluted $ (0.01 ) $ (0.02 )
17
Six Months ended June 30, 2020 versus Six Months ended June 30, 2019
During the six months ended June 30, 2020 and 2019, the Company had $427 and
$4,927 of revenues, respectively. Revenues were minimal during the six months
June 30, 2020 and 2019 and decreased compared to the prior year. The Company has
continued to devote its attention and efforts towards making our technology and
product more commercially viable, by seeking to obtain FDA class III approval
for internal surgical purposes. The Company is continuing this strategy based on
our belief that the greatest value to our shareholders will come from this FDA
Class III approval for general surgical use, and pursuing opportunities that we
anticipate will be available to the Company if this FDA approval is obtained,
including, among other things, fostering interest from potential merger and
acquisition candidates. In this strategy and approach, the Company made a
determination not to engage new distribution partners as that could create
conflicts with a potential acquiror/commercialization candidate and tie the
Company's hands from a revenue or branding perspective. The Company expects that
if an acquisition candidate is identified it may also include a pre-acquisition
commercialization component and in that case current vendor and future
relationships and all pending purchase orders will likely be facilitated by that
company. No assurances can be given that the Company will identify an
acquisition or commercialization candidate or complete a transaction with such a
candidate on terms satisfactory to us, if at all.
Total operating expenses for the six months ended June 30, 2020 and 2019 were
$1,271,948 and $3,272,153, respectively. The decrease in operating expenses is
due primarily to a decrease in consulting/professional fees. The Company issued
175,000 shares of common stock for services valued at $148,125 during the six
months ended June 30, 2020 compared to 400,000 shares of common stock for
services valued at $380,000 and recorded stock based modification expense of
$2,021,000 due to the change in vesting conditions of 2,150,000 shares of common
stock previously held in escrow during the six months ended June 30, 2019. The
decrease in stock-based compensation expenses related to consulting/professional
fees was offset by an increase in legal and accounting expenses related to the
restatement of prior year financial statements and ongoing litigation.
Our net loss for the six months ended June 30, 2020 was $1,318,873 as compared
to net loss of $3,470,081 for the comparable period of the prior year. The
decrease in the net loss is due to the Company having a decrease in operating
expenses of $1,996,046 as explained above along with interest expense decreasing
from $202,753 during the three months ended June 30, 2019 to $47,191 for the six
months ended June 30, 2020. The decrease in interest expense is due to the
Company only having $47,191 of amortization of debt discount during the six
months ended June 30, 2020 compared to $202,753 in the comparable period of
2019.
Financial Condition, Liquidity and Capital Resources
As of June 30, 2020, the Company had a negative working capital of $903,786. The
Company has not yet attained a level of operations, and for the foreseeable
future will not be pursuing commercial operations, which will allow the it to
meet its current overhead while it focuses on its strategy of seeking FDA class
III approval for internal surgical purposes, and opportunities which may arise
from that including, among other things, fostering interest from potential
merger and acquisition candidates or commercial partners. If we are not
successful in our strategy, we cannot assure that we will be able to adjust to
and fund a marketing and sale strategy, and if we do, we are unable to assure we
will attain profitable operations within the next few business operating cycles
or at all. The report of our independent registered public accounting firm on
our 2019 financial statements includes an explanatory paragraph expressing
substantial doubt about our ability to continue as a going concern. While the
Company has funded its initial operations with private placements, and secured
loans from related parties, there can be no assurance that adequate financing
will continue to be available to the Company and, if available, on terms that
are favorable to the Company. Our ability to continue as a going concern is also
dependent on many events outside of our direct control, including, among other
things, our ability to achieve our business goals and objectives, as well as
improvement in the economic climate.
Cash Flows
The Company's cash on hand at June 30, 2020 and December 31, 2019 was $15,193
and $16,624, respectively.
18
The following table summarizes selected items from our statements of cash flows
for the six months ended June 30, 2020 and 2019:
For the Six Months Ended June 30,
2020 2019
Net cash used in operating activities $ (904,342 ) $ (833,128 )
Net cash used in investing activities (87,000 ) -
Net cash provided by financing activities 989,911 1,302,750
Net increase (decrease) in cash and cash
equivalents $ (1,431 ) $ 469,622
Net Cash Provided by (Used in) Operating Activities
Net cash used in operating activities for the six months ended June 30, 2020 was
$904,342. The Company had net loss of $1,318,873 offset by stock based
compensation of $148,125, amortization of debt discount of $46,505 a decrease in
inventory of $160, an increase in accounts payable and accrued expenses of
$197,096 and an increase in accrued liabilities - related party of $32,645. The
Company also had an increase in prepaid and other current assets of $10,000.
Net cash used in operating activities for the six ended June 30, 2019 was
$833,128. The Company had a net loss $3,470,481 offset by stock based
compensation of $2,401,000, amortization of debt discount of $202,753, a
decrease in prepaid and other current assets of $50,000 and an increase in
accrued liabilities - related party of $35,000. The Company also had an increase
in accounts receivable of $4,927, an increase in inventory of $25,498 and a
decrease in accounts payable and accrued expenses of $20,974.
Net Cash Provided by (Used in) Investing Activities
Net cash used in investing activities for the six months ended June 30, 2020
was $87,000. The was due to the Company purchasing equipment during the period
in preparation of opening up its own facility.
The Company did not have any investing activities during the six months ended
June 30, 2019.
Net Cash Provided by (Used in) Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2020
was $989,911. This was due to the Company receiving $200,000 from in proceeds
related to a convertible loan, $180,230 from related parties, $1,105,696 in
proceeds from the sale of stock offset by making payments of $496,015 on related
party loans.
Net cash provided by financing activities for the six months ended June 30, 2019
was $1,302,750. This was due to the Company receiving $1,110,750 in proceeds
from the sale of stock and receiving $192,000 from related party loans.
Off-Balance Sheet Arrangements
As of June 30, 2020, we have no off-balance sheet arrangements.
Critical Accounting Policies
The preparation of financial statements and related disclosures in conformity
with generally accepted accounting principles in the United States requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities, disclosure of contingent assets and liabilities at the
date of the financial statements, and revenues and expenses during the periods
reported. Actual results could materially differ from those estimates. We have
identified the following items as critical accounting policies.
19
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from
Contracts with Customers. Under ASC 606, the Company recognizes revenue from the
sale of its HemoStyp product by applying the following steps: (1) identify the
contract with a customer; (2) identify the performance obligations in the
contract; (3) determine the transaction price; (4) allocate the transaction
price to each performance obligation in the contract; and (5) recognize revenue
when each performance obligation is satisfied.
The Company receives orders for its HemoStyp products directly from its
customers. Revenues are recognized based on the agreed upon sales or transaction
price with the customer when control of the promised goods are transferred to
the customer. The transfer of goods to the customer and satisfaction of the
Company's performance obligation will occur either at the time when products are
shipped or when the products arrive and are received by the customer. No
discounts were offered by the Company. The Company does not provide an estimate
for returns as there is no anticipation for any returns in the normal course of
business.
Stock Based Compensation
The Company accounts for share-based compensation under the provisions of ASC
718, Compensation-Stock Compensation. Under the fair value recognition
provisions, stock-based compensation expense is measured at the fair value of
the consideration received, or the fair value of the equity instruments issued,
or liabilities incurred, whichever is more reliably measured. Share-based
compensation for all stock-based awards to employees and directors is recognized
as an expense over the requisite service period, which is generally the vesting
period.
The Company accounts for stock compensation arrangements with non-employees in
accordance with Accounting Standard Update (ASU) 2018-07, Compensation-Stock
Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment
Accounting, which requires that such equity instruments are recorded at the
value on the grant date.
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