What changed in this filing

/stocks — the workspaceLOADING

Item 5. Market for Registrant’s Common Equity

2021-03-16 compared with 2020-03-05 · 169 added, 187 removed, 161 unchanged (69% of the section changed)

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on the Nasdaq Global Market on December 31, 2020, the last trading date in 2020, was $8.13 per share.

of February 28, 2020, we had 16 holders of record of our common stock.

The actual number of stockholders is greater

than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name

by brokers and other nominees.

This number of holders of record also does not include stockholders whose shares may be held in

trust by other entities.

The closing price per share of our common stock on February 28, 2020 was $5.40

of March 8, 2021, we had 14 holders of record of our common stock.

The actual number of stockholders is greater than this number

of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and

other nominees.

This number of holders of record also does not include stockholders whose shares may be held in trust by other

The closing price per share of our common stock on March 8, 2021 was $7.48.

have never declared or paid a cash dividend on our common stock.

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Sales of Unregistered Securities

November 2018, we entered into an underwriting agreement, relating to the public offering of 4,140,000 shares of common stock

at a price to the public of $6.00 per share, less underwriting discounts and commissions.

In November 2018, in connection with

the underwriting agreement, we issued warrants exercisable for 414,000 shares of common stock at an exercise price of $7.50 per

share to National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc.

issuance of these warrants was made in reliance on the exemption from registration contained in Section 4(a)(2) of the Securities

Act of 1933, as amended (the “Securities Act”) and/or Regulation D promulgated thereunder as private transactions

not involving a public offering of securities.

November 2019, in connection with the Credit Agreement, we issued a warrant exercisable for shares of common stock equal to six

percent (6%) of the principal amount of draws upon exercise of each tranche under the Credit Agreement divided by the average

trading price of common stock for the ten trading days immediately preceding such exercise.

issuance of this warrant was made in reliance on the exemption from registration contained in Section 4(a)(2) of the Securities

Act and/or Regulation as private transactions not involving a public offering of securities.

Selected Financial Data

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Risk Factors.”

were formed in April 2017 as a specialty pharmaceutical company focused on developing and commercializing innovative pharmaceutical

products utilizing the FDA’s 505(b)(2) regulatory pathway.

Our business model is to develop proprietary innovative products

that fulfill an unmet patient need.

Since our formation, we have focused our efforts on the development of our initial product

candidates, engaging in preliminary discussions with the FDA concerning the regulatory pathway for certain additional product

candidates, registration filings of our initial product candidates and the licensing of late-stage product candidates.

December 2019 we launched our Biorphen product and we have established a diversified pipeline of other product candidates

in various stages of development, four of which have been submitted to the FDA and are under review.

We intend to focus on product

candidates that are liquid in formulation, including injectables, oral liquids and ophthalmics, and qualify under the FDA’s

505(b)(2) regulatory pathway.

corporate strategy is to pursue what we perceive to be low-risk product candidates where existing published literature, historical

clinical trials, or physician usage has established safety and/or efficacy of the molecule, thereby reducing the incremental clinical

burden required for us to bring the product to patients.

We intend to pursue product candidates that require a single small Phase

3 trial, a bioequivalence trial, or literature-based filings.

Prior to initiating significant development activities on

a product candidate, we typically meet with the FDA to establish a defined clinical and regulatory path to approval.

believe our product candidates can address situations where patient needs are not being met by current FDA-approved pharmaceutical

This may include products that are being supplied on an unapproved basis, products that are currently being compounded,

and products that are approved and widely used internationally but not approved in the United States.

are a unique pharmaceutical company focused on developing, acquiring, and commercializing innovative pharmaceutical products that

fulfill an unmet patient need.

Since the formation of our company in 2017, we have used our expertise in business development,

regulatory, and product development to assemble a diversified portfolio of nine products.

All nine products have now been submitted

to the FDA and three of them have been approved and commercially launched.

We plan to continue growing our business through the

acquisition of additional late-stage, high-value product candidates.

of Operations

date we have realized only limited revenues from a licensing arrangement on our EM-100 product and the launch of our Biorphen

We anticipate successfully completing development of additional product candidates in 2020 and beyond and growing our

date we have realized limited revenues from a licensing arrangement on our EM-100 product that was sold to Bausch Health and the

launch of our Biorphen®

and Alkindi Sprinkle®

products in December 2019 and December 2020, respectively.

We anticipate

successfully growing our sales for these products and commercializing additional product candidates in 2021 and beyond.

Ended December 31, 2020 Compared to Year Ended December 31, 2019

the years ended December 31, 2019 and 2018, we generated $1.0 and $0 in revenue, respectively.

The revenue realized in 2019 was

from a licensing arrangement for our EM-100 product which is pending additional FDA review and the launch of our Biorphen product

in December 2019.

revenues for 2020 reflected limited benefit from Alkindi Sprinkle which launched in December.

In addition, revenue was

negatively impacted by a price discount for Biorphen related to the shelf stock at our wholesale customers.

Our gross profit was

also adversely impacted by a reserve charge to cost of sales for certain slow-moving Biorphen inventory that we do not believe

we will be able to sell before its expiry date.

Revenue and gross profit in 2019 reflected the initial launch for Biorphen and

a $0.5 million milestone payment for our sale of EM-100 to Bausch Health.

For the years ended December 31, 2020 and 2019, we incurred

$14.1 million and $11.6 million of research and development (“R&D”) expenses, respectively, and $12.8 million

and $7.6 million of general and administrative (“G&A”) expenses, respectively.

The comparative period detail of

our R&D expense is listed in the table below.

The $5.2 million increase in G&A expenses was primarily due to personnel

additions and increased sales/marketing spending to support our recent product launches.

In addition, we incurred significant

legal expenses associated with our patent challenge against Exela Pharma Sciences for the Cysteine product that we have in development.

We incurred a net loss of $28.0 million and $18.3 million for the years ended December 31, 2020 and 2019, respectively.

and Administrative Expenses

expenses consist primarily of employee compensation expenses, selling and adverting/promotional expenses, legal and professional

fees, business insurance and travel expenses.

We anticipate that our G&A expenses will increase to support our business growth

particularly with respect to sales and marketing for additional personnel and promotional expenses.

and Development Expenses

forth below is our R&D spending for our current product candidates.

We currently have six employees that support our

overall product development and we also have facility and operating costs for a laboratory to support product development.

do not track internal costs by product for our employees and laboratory expenses and they are listed as indirect expenses in

the table below (amounts are in thousands).

Product Candidate

December 31, 2020

December 31, 2019

Alkindi Sprinkle

Selenious acid

Other products

Indirect expenses

Ended December 31, 2019 Compared to Year Ended December 31, 2018

the years ended December 31, 2019 and 2018, we generated $1.0 million and $0 in revenue, respectively.

The revenue realized in

2019 was from a licensing arrangement for our EM-100 product which is pending additional FDA review and the launch of our Biorphen

product in December 2019.

For the years 2019 and 2018, we incurred $11.6 million and $5.6 million of research and development

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The comparative period detail of our R&D expense is listed in the table below.

The $2.9 million

increase in G&A expenses was primarily due to additional expenses related to becoming a public company, sales and marketing

for the launch of our Biorphen product, and the impact of personnel additions in the second half

of 2018 and first half of 2019.

This was partially offset by lower stock-based consulting expenses.

In addition, the change in

the fair value of our warrant liability reflected in other expense decreased by $2.6 million as this mark–to–market

accounting treatment was terminated in conjunction with our November 2018 IPO.

The $2.9 million increase

in G&A expenses was primarily due to additional expenses related to becoming a public company, sales and marketing for the

launch of our Biorphen product, and the impact of personnel additions in the second half of 2018 and first half of 2019.

was partially offset by lower stock-based consulting expenses.

In addition, the change in the fair value of our warrant liability

reflected in other expense decreased by $2.6 million as this mark–to–market accounting treatment was terminated in

conjunction with our November 2018 initial public offering (the “IPO”).

We incurred a net loss of $18.3 million and

$12.7 million for the years ended December 31, 2019 and 2018, respectively.

and Administrative Expenses

expenses consist primarily of employee compensation expenses, stock-based consulting service fees, sales and marketing expenses,

business insurance, legal and professional fees and travel expenses.

and Development Expenses

forth below is our R&D spending for our current product candidates.

We currently have ten employees that support our overall

product development and we also have facility and operating costs for a laboratory that supports our product development.

laboratory personnel and related capital equipment additions were added in late 2018.

forth below is our R&D spending for our product candidates.

As of December 31, 2019, we have ten employees that support

our overall product development and we also have facility and operating costs for a laboratory that supports our product development.

The laboratory personnel and related capital equipment additions were added in late 2018.

We do not track internal costs by product

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December 31, 2018

Other products

Indirect expenses

Ended December 31, 2018 Compared to Period Ended December 31, 2017

the periods ended December 31, 2018 and 2017, we incurred $5.6 million and $3.9 million of research and development (“R&D”)

expenses, respectively, and $4.7 million and $3.2 million of general and administrative (“G&A”) expenses, respectively.

The comparative period detail of our R&D expense is listed in the table below.

The $1.5 million increase in G&A expenses

was primarily due to the partial year start-up in late April 2017 as compared to a full year of operations in 2018 combined with

personnel additions in the second half of 2018.

Our compensation-related costs increased by $1.1 million plus costs for our board

of directors increased by $0.4 million.

In addition, the fair value of our warrant liability reflected in other expense increased

by $2.5 million as a result of the increase in our stock price up to the date of our IPO.

We incurred a net loss of $12.7 million

and $7.2 million for the periods ended December 31, 2018 and 2017, respectively.

and Administrative Expenses

expenses consist primarily of employee compensation expenses, stock-based consulting service fees, legal and professional fees

and travel expenses.

We anticipate that our G&A expenses will significantly increase to support our business growth and the

additional costs associated with being a public company.

and Development Expenses

forth below is our R&D spending for our current product candidates.

We currently have nine employees that support our overall

product development and we also have facility and operating costs for a laboratory that will support product development.

not track internal costs by product for our employees and laboratory expenses and they are listed as indirect expenses in the

table below (amounts are in thousands).

Product Candidate

Year ended December 31, 2018

April 27,2017 (Inception) to December 31, 2017

Selenious acid

Preservative Fee (fka EM-100)

Other products

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and Capital Resources

of December 31, 2019, we had total assets of $17.1 million and working capital of $13.0 million.

We had previously capitalized

our operations primarily from the June 2017 private placement of approximately $20.1 million of Series A preferred stock, par

value $0.001 (the “Series A Preferred”).

Our Series A Preferred accumulated dividends at the rate of 6% per annum

and those shares of stock plus all accrued but unpaid dividends automatically converted into shares of our common stock concurrent

with our IPO in November 2018 at the conversion price of 50% of the IPO price.

The IPO provided us with net proceeds of $22.0

million and we also entered into a Credit Agreement with SWK Holdings in November 2019 which provides for up to $10 million in

additional borrowing, $5.0 million of which was received at closing.

We believe that our existing funding and the revenue from

our Biorphen product and potential milestones and royalty payments from EM-100 will be sufficient for at least the next

twelve months of our operations.

However, our projected estimates for our product development spending, administrative

expenses and our working capital requirements could be inaccurate, or we may experience growth more quickly or on a larger scale

than we expect, any of which could result in the depletion of capital resources more rapidly than anticipated and could require

us to seek additional financing earlier than we expect to support our operations.

following table sets forth a summary of our cash flows for the periods ended December 31, 2019, 2018 and 2017 (amounts are in

of December 31, 2020, we had total assets of $26.3 million, cash and cash equivalents of $21.3 million and working capital of

$20.9 million.

We had previously capitalized our operations from the June 2017 private placement of approximately $20.1 million

of Series A preferred stock which converted into shares of our common stock concurrent with our IPO in November 2018 and also

the IPO which provided us with net proceeds of $22.0 million.

In addition, we entered into a Credit Agreement with SWK Holdings

in November 2019 whereby we drew a $5.0 million loan amount at closing and an additional $2.0 million in August 2020.

and April 2020, we received net proceeds of approximately $7.8 million from the sale of shares of its common stock, and in October

2020, the Company received net proceeds of approximately $21.0 million from a public offering for its shares at an offering price

of $7.00 per share.

We believe that our existing funding, revenues from our approved products and $9.5 million received in February

2021 from the sale of three pediatric neurology product candidates will be sufficient for at least the next twelve months of our

However, our projected estimates for our product development spending, administrative expenses and our working capital

requirements could be inaccurate, or we may experience growth more quickly or on a larger scale than we expect, any of which could

result in the depletion of capital resources more rapidly than anticipated and could require us to seek additional financing earlier

than we expect to support our operations.

following table sets forth a summary of our cash flows for the years ended December 31, 2020, 2019 and 2018 (amounts are in thousands):

December 31, 2020

December 31, 2019

April 27, 2017

(Inception) to

December 31, 2018

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Cash flows provided by financing activities

Net increase in cash and cash equivalents

Net change in cash and cash equivalents

increase in cash used in operating activities is primarily a result of higher operating losses due to our business expansion including

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The financing activity

primarily consists of the Series A Preferred private placement funding in June 2017, the November 2018 IPO and the November 2019

Credit Agreement with SWK Holdings.

primarily consists of the November 2018 IPO, the November 2019 Credit Agreement borrowing from SWK Holdings and the October 2020

follow-on common stock offering.

Accounting Policies

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requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses in our

condensed financial statements.

We base our estimates on historical experience, known trends and events and various other factors

that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying

values of assets and liabilities that are not readily apparent from other sources.

We evaluate our estimates and assumptions on

an ongoing basis.

financial statements.

We base our estimates on historical experience, known trends and events and various other factors that we

believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values

of assets and liabilities that are not readily apparent from other sources.

We evaluate our estimates and assumptions on an ongoing

Our actual results may differ from these estimates under different assumptions or conditions.

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that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial

account for contracts with its customers in accordance with Accounting Standards Codification (“ASC”) 606 —

account for contracts with our customers in accordance with Accounting Standards Codification (“ASC”) 606 —

Revenue from Contracts with Customers.

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accounted for as a contract modification for accounting purposes.

recognizes as revenue the amount of the transaction price that

is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time

or over time, and if over time this is based on the use of an output or input method.

Any amounts received prior to revenue recognition

will be recorded as deferred revenue.

Amounts expected to be recognized as revenue within the twelve months following the balance

sheet date will be classified as current portion of deferred revenue in our balance sheets.

Amounts not expected to be recognized

as revenue within the twelve months following the balance sheet date are classified as long-term deferred revenue, net of current

recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as)

each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output

or input method.

Any amounts received prior to revenue recognition will be recorded as deferred revenue.

Amounts expected to be

recognized as revenue within the twelve months following the balance sheet date will be classified as current portion of deferred

revenue in our balance sheets.

Amounts not expected to be recognized as revenue within the twelve months following the balance

sheet date are classified as long-term deferred revenue, net of current portion.

Payments –

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to wholesalers to generate pull-through sales.

In addition, we sell our Alkindi Sprinkle product to one pharmacy distributor customer

which provides order fulfillment and inventory storage/distribution services.

prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers

sell Biorphen at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government

In addition, the we pay fees to wholesalers for their distribution services, inventory reporting and chargeback processing.

In addition, we pay fees to wholesalers for their distribution services, inventory reporting and chargeback processing.

We pay GPOs fees for administrative services and for access to GPO members and concluded the benefits received in exchange for

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return period, there may be a significant period of time between when the product is shipped and when we issue credits on returned

For our Alkindi Sprinkle product, we bill at the initial product list prices which are subject to offsets for patient

co-pay assistance and potential state Medicaid reimbursements which are recorded as a reduction of net revenues at the date of

sale/shipment.

estimate the transaction price when we receive each purchase order, taking into account the expected reductions of the selling

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and chargebacks of Biorphen and the impact of the other discounts and fees we pay.

When estimating these adjustments to the transaction

price, we reduce it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue

when the ultimate adjustment amounts are known.

Our sales of Alkindi Sprinkle to our distributor

are not subject to returns.

When estimating these adjustments to the transaction price, we reduce it sufficiently to be able to

assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known.

recognize revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location.

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Although wholesalers have product return rights, we do not believe they have a significant incentive to return the product to

recognition of revenue from product sales of Biorphen, the estimated amounts of credit for product returns, chargebacks, distribution

fees, prompt payment discounts, and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable.

We store our Alkindi Sprinkle inventory at our pharmacy distributor customer location and sales are recorded when stock is

pulled and shipped to fulfill specific patient orders.

recognition of revenue from product sales, the estimated amounts of credit for product returns, chargebacks, distribution fees,

prompt payment discounts, state Medicaid and GPO fees are included in sales reserves, accrued liabilities and net of accounts

We monitor actual product returns, chargebacks, discounts and fees subsequent to the sale.

If these amounts end up differing from

our estimates, we will make adjustments to these allowances, which are applied to increase or reduce product sales revenue and

earnings in the period of adjustment.

If these amounts end up

differing from our estimates, we will make adjustments to these allowances, which are applied to increase or reduce product sales

revenue and earnings in the period of adjustment.

addition, we anticipate we will receive revenues from product licensing agreements where we have contracted for milestone payments

and royalties from products we have developed or for which we have acquired the rights to a product developed by a third party.

account for stock-based compensation under the provisions of the Financial Accounting Standards Board (the “FASB”)

Accounting Standards Codification (“ASC”) –

account for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) –

Compensation –

Stock Compensation.

The guidance under

ASC 718 requires companies to estimate the fair value of the stock-based compensation awards on the date of grant for employees

and directors and record expense over the related service periods, which are generally the vesting period of the equity awards.

Awards for consultants are accounted for under ASC 505-50 - Equity Based Payments to Non-Employees.

Compensation expense is recognized

over the period during which services are rendered by such consultants and non-employees until completed.

At the end of each financial

reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair

value of our common stock and updated assumption inputs in the Black-Scholes option-pricing model (“BSM”).

estimate the fair value of stock-based option awards to our employees and directors using the BSM.

The BSM requires the input

of subjective assumptions, including the expected stock price volatility, the calculation of expected term, forfeitures and the

fair value of the underlying common stock on the date of grant, among other inputs.

The risk-free interest rate was determined

from the implied yields for zero-coupon U.S.

government issues with a remaining term approximating the expected life of the options

Dividends on common stock are assumed to be zero for the BSM valuation of the stock options.

The expected term of

stock options granted is based on vesting periods and the contractual life of the options.

Expected volatilities are based on

comparable companies’

historical volatility, which management believes represents the most accurate basis for estimating

expected future volatility under the current conditions.

We account for forfeitures as they occur.

to our initial public offering in November 2018 (the “IPO”),

the fair value of the shares of common stock underlying our stock-based awards was determined by our board of directors, with

input from management.

Because there had been no public market for our common stock prior to the IPO, our board of directors had

determined the fair value of the common stock on the grant-date of the stock-based award by considering a number of objective

and subjective factors, including enterprise valuations of our common stock performed by an unrelated third-party specialist,

valuations of comparable companies, sales of our convertible preferred stock to unrelated third parties, operating and financial

performance, the lack of liquidity of our capital stock, and general and industry-specific economic outlook.

The guidance under ASC 718 requires companies to estimate the fair value of the stock-based

compensation awards on the date of grant and record expense over the related service periods, which are generally the vesting

period of the equity awards.

Compensation expense is recognized over the period during which services are rendered by consultants

and non-employees until completed.

At the end of each financial reporting period prior to completion of the service, the fair

value of these awards is remeasured using the then-current fair value of our common stock and updated assumption inputs in the

Black-Scholes option-pricing model (“BSM”).

estimate the fair value of stock-based option awards to our using the BSM.

The BSM requires the input of subjective assumptions,

including the expected stock price volatility, the calculation of expected term, forfeitures and the fair value of the underlying

common stock on the date of grant, among other inputs.

The risk-free interest rate was determined from the implied yields for

zero-coupon U.S.

government issues with a remaining term approximating the expected life of the options or warrants.

on common stock are assumed to be zero for the BSM valuation of the stock options.

The expected term of stock options granted

is based on vesting periods and the contractual life of the options.

Expected volatilities are based on comparable companies’

historical volatility along with a limited weighting included for our own volatility subsequent to our IPO, which we believe represents

the most accurate basis for estimating expected future volatility under the current conditions.

We account for forfeitures as

to our initial public offering in November 2018, the fair value of the shares of common stock underlying our stock-based awards

was determined by our board of directors, with input from management.

Because there had been no public market for our common stock

prior to the IPO, our board of directors had determined the fair value of the common stock on the grant-date of the stock-based

award by considering a number of objective and subjective factors, including enterprise valuations of our common stock performed

by an unrelated third-party specialist, valuations of comparable companies, sales of our convertible preferred stock to unrelated

third parties, operating and financial performance, the lack of liquidity of our capital stock, and general and industry-specific

economic outlook.

Following our IPO, we use the closing stock price on the date of grant for the fair value of the common stock.

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on the relevant dates on which adoption of such standards is required for other public companies.

are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS

Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without

limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant

to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company

Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional

information about the audit and the financial statements, known as the auditor discussion and analysis.

We will remain an emerging

growth company until the earlier to occur of (1) the last day of the fiscal year (a) December 31, 2023, which is the end of the

fiscal year following the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenues of

at least $1.07 billion or (c) in which we are deemed to be a “large accelerated filer”

under the rules of the SEC,

which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th,

and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation,

(i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section

404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting

Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information

about the audit and the financial statements, known as the auditor discussion and analysis.

We will remain an emerging growth

company until the earlier to occur of (1) the last day of the fiscal year (a) December 31, 2023, which is the end of the fiscal

year following the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenues of at least

$1.07 billion or (c) in which we are deemed to be a “large accelerated filer”

under the rules of the SEC, which means

the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th, and (2) the

date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

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-K

Item 5. Market for Registrant’s Common Equity