What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2020-08-10 compared with 2020-05-11 · 106 added, 40 removed, 61 unchanged (71% of the section changed)

2 unchanged sentences

You should consider all of the factors described in this section as well as the risk factors and the other information

in our Annual Report on Form 10-K including our audited financial statements and the related notes and “Management’s

Discussion and Analysis of Financial Condition and Results of Operations”

when evaluating our business.

If any of the following

risks actually occurs, our business, financial condition, results of operations and future growth prospects would likely be materially

and adversely affected.

In these circumstances, the market price of our common stock would likely decline and you may lose all

or part of your investments.

Additional risks and uncertainties not presently known to us or that we currently deem

immaterial also may impair our business operations.

in our Quarterly Report on Form 10-Q for the three months ended March 31, 2020 and our Annual Report on Form 10-K including

our audited financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition

and Results of Operations” when evaluating our business.

If any of the following risks actually occurs, our business, financial

condition, results of operations and future growth prospects would likely be materially and adversely affected.

In these circumstances,

the market price of our common stock would likely decline and you may lose all or part of your investments.

risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

COVID-19 pandemic has had an adverse effect on our business and results of operations and is expected to continue to have further

7 unchanged sentences

home when possible and employees in our facilities increasing physical distancing.

March 18, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released guidance for U.S.

healthcare providers

8 unchanged sentences

not limited to:

revenues from our customers, including our major customers, whose products are impacted

by CMS guidance to limit elective medical procedures;

ability or willingness of third parties to market, distribute and sell our products,

due to reduced demand from, or lack of access to, healthcare facilities and providers;

ability, or inability, to complete clinical trials and other activities required to achieve

regulatory clearance of our products under development due to lack of access to healthcare

facilities, healthcare providers and patients;

or lost access to third party service providers that we use in our research and development

or marketing efforts;

cash flow from our operations due to reductions in revenues or collections from our customers

and increases in operating costs related to actions we have taken in response to the

business productivity due to inefficiencies in employees working from home or increasing

physical distancing and other pandemic response protocols in our production facilities;

susceptibility to the risk of information technology security breaches and other disruptions

due to increased volumes of remote access to our information systems from our employees

working at home;

revenues from our customers, including our major customers, whose products are impacted by CMS guidance to limit elective

medical procedures;

ability or willingness of third parties to market, distribute and sell our products, due to reduced demand from, or lack of

access to, healthcare facilities and providers;

ability, or inability, to complete clinical trials and other activities required to achieve regulatory clearance of our products

under development due to lack of access to healthcare facilities, healthcare providers and patients;

or lost access to third party service providers that we use in our research and development or marketing efforts;

cash flow from our operations due to reductions in revenues or collections from our customers and increases in operating costs

related to actions we have taken in response to the pandemic;

business productivity due to inefficiencies in employees working from home or increasing physical distancing and other pandemic

response protocols in our production facilities;

susceptibility to the risk of information technology security breaches and other disruptions due to increased volumes of remote

access to our information systems from our employees working at home;

to source sufficient components used in our products due to disruptions in supply chains;

ability to identify, evaluate and acquire, or effectively integrate, complementary businesses,

products, materials or technologies due to travel restrictions, physical distancing protocols,

and lack of access to third party service providers related to our development activities;

of manufacturing capacity, which could lead to failures to meet product delivery commitments,

or increased operating costs if one of our facilities were to experience a COVID-19 outbreak;

● Difficulties

in assessing and securing intellectual property rights due to lack of access to, or delayed

responsiveness of, third party service providers or governmental agencies;

ability to retain personnel over concerns about workplace exposure to COVID-19, or to

hire and effectively train new personnel, due to physical distancing protocols;

ability to identify, evaluate and acquire, or effectively integrate, complementary businesses, products, materials or technologies

due to travel restrictions, physical distancing protocols, and lack of access to third party service providers related to

our development activities;

of manufacturing capacity, which could lead to failures to meet product delivery commitments, or increased operating costs

if one of our facilities were to experience a COVID-19 outbreak;

in assessing and securing intellectual property rights due to lack of access to, or delayed responsiveness of, third party

service providers or governmental agencies;

ability to retain personnel over concerns about workplace exposure to COVID-19, or to hire and effectively train new personnel,

due to physical distancing protocols;

of goodwill or other assets due to reductions in the fair value of our reporting units.

11 unchanged sentences

events could materially harm our business and operating results.

business is significantly impacted by state and federal statutes and regulations.

proprietary formulations are comprised of active pharmaceutical ingredients that are components of drugs that have received marketing

approval from the FDA, although our proprietary compounded formulations have not themselves received FDA approval.

is not required in order to market and sell our compounded formulations.

In the future we may choose to pursue FDA approval to

market and sell certain potential drug candidates.

The marketing and sale of compounded formulations is subject to and must comply

with extensive state and federal statutes and regulations governing compounding pharmacies.

These statutes and regulations include,

among other things, restrictions on compounding for office use or in advance of receiving a patient-specific prescription or,

for outsourcing facilities, requirements regarding preparation, such as regular FDA inspections and cGMP requirements, prohibitions

on compounding drugs that are essentially copies of FDA-approved drugs, limitations on the volume of compounded formulations that

may be sold across state lines, and prohibitions on wholesaling or reselling.

These and other restrictions on the activities of

compounding pharmacies and outsourcing facilities may significantly limit the market available for compounded formulations, compared

to the market available for FDA-approved drugs.

pharmacy business is impacted by federal and state laws and regulations governing the following:

the purchase, distribution, management,

compounding, dispensing, reimbursement, marketing and labeling of prescription drugs and related services including;

and/or state regulation affecting the pharmacy and pharmaceutical industries, including state pharmacy licensure and registration

or permit standards;

rules and regulations issued pursuant to HIPAA and other state and federal laws related to the use, disclosure

and transmission of health information;

and state and federal controlled substance laws.

Our failure to comply with any of these

laws and regulations could severely limit or curtail our pharmacy operations, which would materially harm our business and prospects.

Further, our business could be adversely affected by changes in these or any newly enacted laws and regulations, and federal and

state agency interpretations of the statutes and regulations.

Statutory or regulatory changes could require us to make changes

to our business model and operations and/or could require us to incur significantly increased costs to comply with such regulations.

July 30, 2020, FDA issued a notice for comments related to certain bulk drug substances to be removed from the 503B Bulk’s

List (or Category 1 List).

Included in this notice for comment were certain bulk drug substances which we currently use in some

of our compounded products.

In the event one or more of these bulk substances are ultimately removed from the Category

1 List, we intend to utilize commercially available versions of these substances or similar active pharmaceutical ingredients

as replacements of the bulk powders contained in our sterile products.

In addition, nothing in the FDA’s notice affects

the dispensing of bulk powder-containing products from our 503A pharmacy.

Nonetheless, if all or some of the bulk drug substances

we use are removed from the 503B Bulk’s List, this may result in a disruption in our operations, revenues and cash flows.

loan under the Paycheck Protection Program may not be forgiven or may subject us to challenges and investigations

regarding qualification for the loan.

April 2020, we received the PPP Loan, which was established under the CARES Act in the principal amount of $1,967,000.

to Section 1106 of the CARES Act we may apply for and be granted forgiveness for all or a portion of the PPP Loan.

Such forgiveness

will be determined, subject to limitations, based on the use of the loan proceeds for qualifying expenses, which include payroll

costs, rent, and utility costs over the allowable measurement period following receipt of the loan proceeds.

The SBA continues to develop and issue

new and updated guidance regarding the PPP Loan application and forgiveness process, including guidance regarding required borrower

certifications and requirements for forgiveness of loans made under the program.

Given the evolving nature of the guidance and

depending upon our ability to use the loan proceeds for qualifying expenses, we cannot give any assurance that our PPP Loan will

be forgiven in whole or in part.

Additionally,

the PPP Loan application required us to certify that the current economic uncertainty made the PPP Loan request necessary to support

our ongoing operations.

While we made this certification in good faith after analyzing, among other things, our financial situation

and access to alternative forms of capital, and believe that we satisfied all eligibility criteria for the PPP Loan and that our

receipt of the PPP Loan is consistent with the broad objectives of the Paycheck Protection Program of the CARES

Act, the certification described above does not contain any objective criteria and is subject to interpretation.

the SBA has stated that it is unlikely that a public company with substantial market value and access to capital markets will

be able to make the required certification in good faith.

The lack of clarity regarding loan eligibility under the program has

resulted in significant media coverage and controversy with respect to public companies applying for and receiving loans.

despite our good faith belief that we satisfied all eligibility requirements for the PPP Loan, we are found to have been ineligible

to receive the PPP Loan or in violation of any of the laws or regulations that apply to us in connection with the PPP Loan, including

the False Claims Act, we may be subject to penalties, including significant civil, criminal and administrative penalties and would

be required to repay the PPP Loan.

In the event that we seek forgiveness of all or a portion of the PPP Loan, we will also be

required to make certain certifications which will be subject to audit and review by governmental entities and could subject us

to significant penalties and liabilities if found to be inaccurate, including being required to repay the PPP Loan.

In addition, our receipt of the PPP Loan may result in adverse publicity and damage to our reputation, and a review or audit by

the SBA or other government entity or claims under the False Claims Act could consume significant financial and management

Any of these events could materially harm our business, results of operations and financial condition.

disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

23 unchanged sentences

affect our ability to attain our operating goals on schedule and on budget.

Unregistered Sales of Equity Securities and Use of Proceeds

Defaults Upon Senior Securities

Mine Safety Disclosures

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors