NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
1. Organization and operations
The Company
Flex Pharma Inc., or the Company, is a biotechnology company that was previously focused on developing innovative and proprietary treatments for muscle cramps, spasms and spasticity associated with severe neurological conditions. In June 2018, the Company announced that it was ending its ongoing Phase 2 clinical trials of its lead drug product candidate, FLX-787, in patients with motor neuron disease, or MND, primarily with amyotrophic lateral sclerosis, or ALS, and in patients with Charcot-Marie-Tooth disease, or CMT, due to oral tolerability concerns observed in both studies. The wind-down of the activities associated with these studies was completed in the third quarter of 2018.
In 2016, the Company launched its consumer product, HOTSHOT®, to prevent and treat exercise-associated muscle cramps, or EAMCs. The Company continues to market and sell HOTSHOT to endurance athletes who drink it before, during and after exercise to prevent and treat EAMCs.
In June 2018, the Company initiated a process to explore a range of strategic alternatives for enhancing stockholder value, including the potential sale or merger of the Company. Following an extensive process of evaluating strategic alternatives for the Company, on January 3, 2019, the Company entered into an Agreement and Plan of Merger, or the Merger Agreement, with Salarius Pharmaceuticals, LLC, or Salarius, under which the privately held Salarius will merge with a wholly owned subsidiary of the Company. At a special meeting on July 12, 2019, the merger was approved by the Company's stockholders and the merger is expected to close on or about July 19, 2019. Upon completion of the merger, the business of Salarius will continue as the business of the combined company.
The Company operates as
two
reportable segments, Consumer Operations and Drug Development. See Note 12 for additional discussion and information on the reportable segments.
Liquidity
The Company incurred a loss of
$1,384,777
for the three months ended
June 30, 2019
, a loss of
$3,615,207
for the
six
months ended
June 30, 2019
and had an accumulated deficit of
$136,576,482
as of
June 30, 2019
. The Company had unrestricted cash and cash equivalents of
$6,514,215
at
June 30, 2019
. The Company's operating plan assumes limited research and development activities and that the Consumer Operations segment will continue to sell HOTSHOT.
In the event the merger with Salarius is not completed, the Company will reconsider its strategic alternatives, including to (i) pursue a dissolution and liquidation of the Company, (ii) pursue another strategic transaction or (iii) continue to market HOTSHOT and operate its consumer business. If the Company dissolves and liquidates, the Company's common stockholders may lose their entire investment. The amount of assets available for distribution to the Company's stockholders would depend heavily on the timing of such liquidation as well as the amount of cash that would be needed for commitments and contingent liabilities.
Based on the Company's current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to allow the Company to fund its current operating plan for at least 12 months from the date the financial statements are issued.
The Company cannot predict the outcome of the merger or whether and to what extent it will resume drug development activities and to what extent it will promote and sell HOTSHOT or other consumer products in the future. Accordingly, it is difficult to predict future cash needs. Management does expect the Company to continue to incur losses for the foreseeable future. The Company's ability to achieve profitability in the future is dependent upon achieving a level of revenues adequate to support the Company's cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. If the Company raises funds through the sale of equity or convertible debt securities, the issuance of those securities could result in substantial dilution of the stockholders' ownership in the Company. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company, or at all.
2. Summary of significant accounting policies and recent accounting pronouncements
The accompanying unaudited condensed consolidated financial statements reflect the application of certain significant accounting policies as described below and elsewhere in these notes to the condensed consolidated financial statements. As of
June 30, 2019
, the Company’s significant accounting policies, which are detailed in the Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018
(the “
2018
10-K”), have not changed, other than as noted below.
Accounts receivable and allowance for doubtful accounts
Accounts receivable are stated at their carrying values, net of any allowances for doubtful accounts. Accounts receivable consist primarily of amounts due from specialty retailers and sports teams, for which collection is probable based on the customer's intent and ability to pay. Receivables are evaluated for collection probability on a regular basis and an allowance for doubtful accounts is recorded, if necessary. No allowance for doubtful accounts was deemed necessary at
June 30, 2019
or
December 31, 2018
.
Restricted cash
As of
December 31, 2018
, the Company had restricted cash in the form of a letter of credit it maintained as a security deposit on the lease of its former corporate headquarters in Boston, Massachusetts that was set to expire on August 31, 2019. The Company terminated this lease on December 13, 2018. The letter of credit was released, and the cash became unrestricted on January 4, 2019.
Advertising expense
Advertising expense consists of media and production costs related to print and digital advertising. All advertising is expensed as incurred. Total advertising expenses are included in selling, general and administrative expenses in the condensed consolidated statement of operations, and were approximately
$8,000
and
$18,000
for the
three and six
months ended
June 30, 2019
and approximately
$264,000
and
$772,000
for the
three and six
months ended
June 30, 2018
.
Shipping and handling costs
Shipping and handling costs related to the movement of inventory to the Company's co-packer and from the co-packer to the Company's third-party warehousing and fulfillment partners are capitalized as inventory and expensed as cost of product revenue when revenue is recognized. Shipping and handling costs to move finished goods from the Company's third-party warehousing and fulfillment partners to customer locations are included in selling, general and administrative expenses in the condensed consolidated statement of operations, and were approximately
$20,000
and
$35,000
for the
three and six
months ended
June 30, 2019
,
and approximately
$29,000
and
$54,000
for the
three and six
months ended
June 30, 2018
.
Restructuring-related costs
The Company records employee termination costs in accordance with Accounting Standards Codification ("ASC") Topic 712,
Compensation - Nonretirement and Postemployment Benefits
("ASC 712"), if the termination benefits are paid as part of an ongoing benefit arrangement, which includes benefits provided as part of the Company's established severance policy or as part of an executive employment agreement. The Company accrues employee termination costs associated with an on-going benefit arrangement if the obligation is attributable to prior services rendered, the rights to the benefits have vested, the payment is probable, and the Company can reasonably estimate the liability. The Company accounts for employee termination benefits that represent a one-time benefit in accordance with ASC Topic 420,
Exit or Disposal Cost Obligations
("ASC 420"). Upon communication of the termination to the employee, the Company expenses these costs over the employee’s future service period, if any.
Restructuring-related costs are recorded within research and development expenses and selling, general and administrative expenses on the Company's consolidated statement of operations. Liabilities associated with the Company's restructuring activities are recorded as a component of accrued expenses and other current liabilities on its consolidated balance sheets. See Note 7 for additional information on the Company's current restructuring plan.
Unaudited interim financial information
Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the
2018
10-K.
The condensed consolidated financial statements as of
June 30, 2019
, for the
three and six
months ended
June 30, 2019
and
2018
, and the related information contained within the notes to the condensed consolidated financial statements, are unaudited. The unaudited condensed consolidated financial statements have been prepared on the same basis as annual audited consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s condensed consolidated financial position as of
June 30, 2019
, and the statements of operations, comprehensive loss, cash flows and stockholders' equity for the
three and six
month periods ended
June 30, 2019
and
2018
. The results for the
three and six
months ended
June 30, 2019
are not necessarily indicative of results to be expected for the year ending
December 31, 2019
, or any other future annual or interim periods.
Basis of presentation and use of estimates
The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the ASC and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company's management evaluates its estimates, which include, but are not limited to, estimates related to clinical study accruals, estimates related to inventory realizability, stock-based compensation expense and amounts of expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.
Principles of consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: TK Pharma, Inc., a Massachusetts Securities Corporation, Flex Innovation Group LLC, a Delaware limited liability company which contains the Company's consumer-related operations, and Falcon Acquisition Sub, LLC, a Delaware limited liability company established for purposes of the merger. All significant intercompany balances and transactions have been eliminated in consolidation.
Recent accounting pronouncements
In February 2016, the FASB issued ASU No. 2016-02,
Leases (Topic 842)
("ASU 2016-02"). The ASU requires lessees to recognize the assets and liabilities on their balance sheet for the rights and obligations created by most leases and continue to recognize expenses on their income statements over the lease term. It also requires disclosures designed to give financial statement users information on the amount, timing and uncertainty of cash flows arising from leases. The guidance is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those years. The Company adopted ASU No. 2016-02 in the first quarter of 2019, which did not materially impact the Company's condensed consolidated financial statements or disclosures.
In August 2018, the FASB issued ASU No. 2018-13,
Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement.
This ASU modifies the disclosure requirements on fair value measurements in Topic 820,
Fair Value Measurement
. The guidance is effective for annual reporting periods beginning after December 15, 2019, and interim periods within those years. Early adoption is permitted. The Company is currently evaluating the impact of ASU No. 2018-13 on its consolidated financial statements and disclosures.
The Company believes that the impact of other recently issued standards that are not yet effective will not have a material effect on its consolidated financial position or results of operations upon adoption.
3. Revenue from contracts with customers
Revenue recognition
Revenue includes sales of HOTSHOT bottled finished goods to e-commerce customers, specialty retailers and sports teams, including professional and amateur teams. Revenue also consists of payments made by customers for expedited shipping and handling.
The Company expenses fulfillment costs as incurred because the amortization period would be less than one year in accordance with the ASC 606, Revenue from Contracts with Customers ("ASC 606"), practical expedient.
In accordance with ASC 606, the Company applies the following steps to recognize revenue for the sale of bottled finished goods that reflects the consideration to which the Company expects to be entitled to receive in exchange for the promised goods:
|
|
1.
|
Identify the contract with a customer
|
A contract with a customer exists when the Company enters into an enforceable contract with a customer. The contract is based on either the acceptance of standard terms and conditions on the websites for e-commerce customers, or the execution of terms and conditions contracts with specialty retailers and sports teams. These contracts define each party's rights, payment terms and other contractual terms and conditions of the sale. The Company applies judgment in determining the customer’s ability and intention to pay, which is based on a variety of factors including the customer’s historical payment experience and, in some circumstances, published credit and financial information pertaining to the customer.
|
|
2.
|
Identify the performance obligations in the contract
|
Performance obligations promised in a contract are identified based on the goods that will be transferred to the customer that are both capable of being distinct and are distinct in the context of the contract, whereby the transfer of the goods is separately identifiable from other promises in the contract. The Company has concluded the sale of bottled finished goods and related shipping and handling are accounted for as a single performance obligation.
|
|
3.
|
Determine the transaction price
|
The transaction price is determined based on the consideration to which the Company will be entitled to receive in exchange for transferring goods to the customer. For sales through June 18, 2018, the Company offered refunds to e-commerce customers, upon request, within
30
days of delivery. For sales subsequent to June 18, 2018, the Company now offers refunds to e-commerce customers, upon request, within
14
days of delivery. The Company estimates the amount of potential refunds at each reporting period using a portfolio approach of historical data, adjusted for changes in expected customer experience, including seasonality and changes in economic factors, as necessary. For specialty retailers and sports teams, the Company does not offer a right of return or refund and revenue is recognized at the time products are delivered to customers.
Discounts provided to customers are accounted for as an element of the transaction price and as a reduction to revenue, and were approximately
$1,000
and
$2,000
for the
three and six
months ended
June 30, 2019
, respectively, and approximately
$9,000
and
$17,000
for the
three and six
months ended
June 30, 2018
, respectively.
Revenue is presented net of taxes collected from customers and remitted to governmental authorities.
|
|
4.
|
Determine the satisfaction of performance obligation
|
Revenue is recognized when control of the bottled finished goods is transferred to the customer. Control of the bottled finished goods is transferred at a point in time, upon delivery to the customer. The period of time between the satisfaction of the performance obligation and when payment is due from the customer is not significant.
Concentrations of credit risk
The Company had no customers that represented greater than 10% of total revenue during the
three and six
months ended
June 30, 2019
or the
three and six
months ended
June 30, 2018
. All of the Company's revenue was generated from sales within the United States.
4. Fair value measurements
The Company records cash equivalents at fair value. ASC Topic 820,
Fair Value Measurements and Disclosures,
established a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels:
Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability.
Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.
The following tables summarize the cash equivalents measured at fair value on a recurring basis as of
June 30, 2019
and
December 31, 2018
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Balance as of
June 30, 2019
|
Cash equivalents
|
$
|
2,360,092
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,360,092
|
|
|
$
|
2,360,092
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,360,092
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Balance as of
December 31, 2018
|
Cash equivalents
|
$
|
2,333,771
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,333,771
|
|
|
$
|
2,333,771
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,333,771
|
|
Cash equivalents have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or other market observable data. The third-party pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. The Company's cash equivalents consist of money market funds that are valued based on publicly available quoted market prices for identical securities as of
June 30, 2019
. After completing its validation procedures, the Company did not adjust or override any fair value carrying amounts as of
June 30, 2019
.
The carrying amounts reflected in the condensed consolidated balance sheets for cash, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate their fair values at
June 30, 2019
and
December 31, 2018
, due to their short-term nature.
The Company evaluates transfers between levels at the end of each reporting period. There were no transfers of assets or liabilities between Level 1 and Level 2 during the
six
months ended
June 30, 2019
or the year ended
December 31, 2018
. The Company had no financial assets or liabilities that were classified as Level 3 at any time during the
six
months ended
June 30, 2019
or the year ended
December 31, 2018
.
5. Cash equivalents
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Cash equivalents as of
June 30, 2019
and
December 31, 2018
consisted of money market funds.
The Company held
no
marketable securities at
June 30, 2019
and
December 31, 2018
.
The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of such amounts in the condensed consolidated statements of cash flows:
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
Cash and cash equivalents
|
$
|
6,514,215
|
|
|
$
|
9,829,624
|
|
Restricted cash
|
—
|
|
|
126,595
|
|
Cash, cash equivalents and restricted cash shown on the condensed consolidated statement of cash flows
|
$
|
6,514,215
|
|
|
$
|
9,956,219
|
|
6. Inventory
Inventory has been recorded at cost as of
June 30, 2019
and
December 31, 2018
. Costs capitalized at
June 30, 2019
and
December 31, 2018
relate to HOTSHOT finished goods, as well as raw materials available to be used for future production runs.
The following table presents inventory:
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
Raw materials
|
$
|
7,247
|
|
|
$
|
7,247
|
|
Finished goods
|
123,673
|
|
|
179,673
|
|
Total inventory
|
$
|
130,920
|
|
|
$
|
186,920
|
|
There were
no
inventory write-offs during the
three
and
six
months ended
June 30, 2019
.
Write-offs totaled approximately
$85,000
for the
three
and
six
months ended
June 30, 2018
, and were included in cost of product revenue in the accompanying condensed consolidated statement of operations. In the second quarter of 2018, the Company wrote off raw materials that were not expected to be used in future production runs, as well as finished goods inventory no longer expected to be used for product sampling.
7. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following:
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
Professional fees
|
$
|
171,474
|
|
|
$
|
269,544
|
|
Payroll and other employee-related costs
|
48,797
|
|
|
417,997
|
|
Consumer product-related costs
|
10,481
|
|
|
5,360
|
|
Restructuring-related costs
|
—
|
|
|
68,593
|
|
Other research and development-related costs
|
—
|
|
|
2,846
|
|
Total
|
$
|
230,752
|
|
|
$
|
764,340
|
|
Restructuring-related costs
In June 2018, the Company's Board of Directors, or the Board, approved a corporate restructuring plan to reduce the Company's cost structure. In connection with the corporate restructuring plan, the Company reduced its
workforce by approximately
60%
, with the reduction completed as of September 30, 2018. As of
June 30, 2019
, the Company had paid
$51,000
in retention bonuses and
$889,000
in severance benefits associated with these arrangements.
Also, in June 2018, the Board approved employee retention arrangements and certain increased severance payments related to the corporate restructuring plan, to incentivize certain employees to remain with the Company through a potential sale or merger. As of June 30, 2019, the Company had paid
$214,000
in retention bonuses,
$410,000
in annual bonuses and
$185,000
in severance benefits associated with these arrangements. As of June 30, 2019, cash retention benefits totaling approximately
$603,000
will be payable to the remaining employees and certain former employees who continue to provide service as consultants, upon the occurrence of a change in control event, including a sale or merger of the Company. Upon a change in control event and termination without cause, the remaining employees will be eligible for up to approximately
$928,000
, in the aggregate, of severance benefits.
During the six months ended
June 30, 2019
, the Company recognized a reduction in the accrual for restructuring-related activities of approximately
$11,000
, which is composed of approximately
$3,000
for one-time termination benefit costs and approximately
$8,000
for termination benefits under ongoing benefit arrangements for terminated employees as certain benefit payments are no longer expected to occur. Cumulatively, through
June 30, 2019
, the Company recognized expense for restructuring-related activities of approximately
$1,355,000
which is composed of approximately
$1,029,000
of termination benefits under ongoing benefit arrangements for terminated employees, approximately
$97,000
as one-time termination benefit costs for terminated employees, approximately
$214,000
in retention benefits for
seven
retained employees who had retention bonuses not triggered by a change in control event and approximately
$15,000
of other restructuring related costs including consulting and legal fees.
As of June 30, 2019, the Company’s stockholders had not yet approved the merger with Salarius, and accordingly, there were no assurances a change in control event would take place. As a result, the Company does not consider the payment of severance benefits for retained employees or the payment of retention benefits only payable upon a change in control to be probable for accounting purposes as of
June 30, 2019
. The Company's probability assessment regarding a change in control event changed on July 12, 2019 when the merger was approved by the Company's stockholders.
The Company expects to incur between approximately
$1,765,000
and
$3,343,000
in total costs for its restructuring-related activities, including approximately
$1,355,000
in termination and retention charges and approximately
$410,000
related to the annual bonus program, both of which were recorded between the second quarter of 2018 and the first quarter of 2019. The range noted above includes approximately
$928,000
of severance benefits for retained employees upon a change in control event and termination under certain circumstances and
$603,000
related to retention benefits only payable upon a change in control event. Upon the Company's stockholders approval of the merger with Salarius at the special meeting on July 12, 2019, the payment of these amounts became probable. The merger is expected to close on or about July 19, 2019, at which time, the remaining termination and retention charges will be paid out.
The following table outlines the Company's restructuring activities for the
six
months ended
June 30, 2019
:
|
|
|
|
|
Accrued restructuring balance as of December 31, 2018
|
$
|
68,593
|
|
Adjustments:
|
|
Employee termination benefits
|
(11,228
|
)
|
Payments
|
(57,365
|
)
|
Accrued restructuring balance as of June 30, 2019
|
$
|
—
|
|
During the three months ended
June 30, 2019
, there were
no
restructuring charges recorded.
For the six months ended
June 30, 2019
, the
$11,000
of the reduction in the accrual for restructuring-related activities is included in research and development expenses in the Company's condensed consolidated statement of operations. Cumulatively through
June 30, 2019
, approximately
$957,000
of the restructuring-related and annual
bonus charges are included in research and development expenses and approximately
$808,000
are included in selling, general and administrative expenses.
For the six months ended
June 30, 2019
, the reduction in the accrual for restructuring-related activities of approximately
$11,000
was incurred by the Company's Drug Development segment. Cumulatively through
June 30, 2019
, approximately
$94,000
of the restructuring-related and annual bonus charges were incurred by the Company's Consumer Operations segment, approximately
$957,000
were incurred by the Company's Drug Development segment and the remaining charges of approximately
$714,000
related to corporate costs. Including approximately
$1,765,000
of cumulative costs incurred through June 30, 2019, the Company may incur total restructuring-related charges of up to approximately
$114,000
and
$1,024,000
within its Consumer Operations and Drug Development segments, respectively. The Company may incur up to
$2,205,000
of corporate costs that do not relate to a reportable segment.
8. Common stock
As of
June 30, 2019
, the Company had authorized
100,000,000
shares of common stock,
$0.0001
par value per share. Each share of common stock is entitled to
one
vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors. The Company does not intend to declare dividends for the foreseeable future.
Restricted common stock to consultants
During 2016, the Company issued
18,194
shares of restricted common stock to non-employee consultants and advisors. Such shares are not accounted for as outstanding until they vest. There were
17,360
shares of restricted common stock issued to consultants outstanding as of
June 30, 2019
.
The following is a summary of restricted common stock activity:
|
|
|
|
|
|
|
|
|
Number of
Shares
|
|
Weighted-Average
Grant Date
Fair Value
|
Unvested at December 31, 2018
|
2,084
|
|
|
$
|
11.05
|
|
Issued
|
—
|
|
|
—
|
|
Vested
|
(1,250
|
)
|
|
11.05
|
|
Forfeited
|
—
|
|
|
—
|
|
Unvested at June 30, 2019
|
834
|
|
|
$
|
11.05
|
|
9. Stock-based compensation
In March 2014, the Company adopted the Flex Pharma, Inc. 2014 Equity Incentive Plan (the "2014 Plan"), under which it had the ability to grant incentive stock options ("ISOs"), non-qualified stock options, restricted stock awards, restricted stock units and stock appreciation rights. Terms of stock award agreements, including vesting requirements, were determined by the board of directors, subject to the provisions of the 2014 Plan. For options granted under the 2014 Plan, the exercise price equaled the fair market value of the common stock as determined by the board of directors on the date of grant. No further awards will be granted under the 2014 Plan.
In January 2015, the Company's Board adopted, and the Company's stockholders approved, the 2015 Equity Incentive Plan (the "2015 Plan"), which became effective immediately prior to the closing of the Company's initial public offering ("IPO"). The 2015 Plan provides for the grant of ISOs, nonstatutory stock options, restricted stock awards, restricted stock units, stock appreciation rights, performance-based stock awards and other stock-based awards. Additionally, the 2015 Plan provides for the grant of performance-based cash awards. ISOs may be granted only to the Company's employees. All other awards may be granted to the Company's employees, including officers,
and to non-employee directors and consultants. As of
June 30, 2019
, there were
2,487,140
shares remaining available for the grant of stock awards under the 2015 Plan.
The Company has awarded stock options to its employees, directors, advisors and consultants, pursuant to the plans described above. Stock options subsequent to the completion of the Company's IPO were granted with an exercise price equal to the closing market price of the Company's common stock on the date of grant. Stock options generally vest over
one
to
four years
and have a contractual term of
ten years
. Stock options are valued using the Black-Scholes option pricing model and compensation cost is recognized based on the resulting value over the service period.
The following table summarizes stock option activity for employees and non-employees for the
six
months ended
June 30, 2019
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
Weighted-Average
Exercise Price
|
|
Weighted-Average
Remaining
Contractual
Term (in years)
|
|
Aggregate
Intrinsic
Value
|
Outstanding at December 31, 2018
|
2,320,981
|
|
|
$
|
4.10
|
|
|
7.61
|
|
$
|
—
|
|
Granted
|
—
|
|
|
—
|
|
|
|
|
|
Exercised
|
—
|
|
|
—
|
|
|
|
|
|
Forfeited
|
—
|
|
|
—
|
|
|
|
|
|
Expired
|
(23,945
|
)
|
|
4.41
|
|
|
|
|
|
Outstanding at June 30, 2019
|
2,297,036
|
|
|
$
|
4.10
|
|
|
7.11
|
|
$
|
—
|
|
Exercisable at June 30, 2019
|
1,346,425
|
|
|
$
|
5.11
|
|
|
6.05
|
|
$
|
—
|
|
Vested or expected to vest at June 30, 2019
|
2,297,036
|
|
|
$
|
4.10
|
|
|
7.11
|
|
$
|
—
|
|
Total stock-based compensation expense recognized for employee and non-employee restricted common stock, and stock options granted to employees and non-employees is included in the Company's condensed consolidated statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2019
|
|
Three Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2019
|
|
Six Months Ended June 30, 2018
|
Research and development
|
$
|
19,323
|
|
|
$
|
244,869
|
|
|
$
|
38,765
|
|
|
$
|
631,406
|
|
Selling, general and administrative
|
193,224
|
|
|
266,124
|
|
|
394,757
|
|
|
788,527
|
|
Total
|
$
|
212,547
|
|
|
$
|
510,993
|
|
|
$
|
433,522
|
|
|
$
|
1,419,933
|
|
As of
June 30, 2019
, there was approximately
$1,726,000
of total unrecognized compensation cost related to unvested equity awards. Total unrecognized compensation cost will be adjusted for future changes in employee and non-employee forfeitures, if any. The Company expects to recognize that cost over a remaining weighted-average period of
2.35 years
.
On June 14, 2018, the Company granted
654,544
stock options, in the aggregate, to
seven
employees as part of the Company's retention arrangements with these employees. These awards vest monthly over
48
months as the employees provide continuous service, and expense is being recognized over this period. The awards are exercisable for
one
to
three
-years post termination depending on the employee to which the stock options were granted. The awards vest in full upon a change in control event and termination under certain circumstances. As of June 30, 2019, a change in control event was not considered probable for accounting purposes. The Company's
probability assessment regarding a change in control event did not change until the merger with Salarius was approved by the Company's stockholders at a special meeting on July 12, 2019.
Employee stock purchase plan
As of
June 30, 2019
, no shares of common stock have been purchased under the ESPP.
10. Income taxes
Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using statutory rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. Based upon the Company's history of operating losses and the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s otherwise recognizable net deferred tax assets. There was
no
significant income tax provision or benefit for the
six
months ended
June 30, 2019
or
2018
.
11. Net loss per share
Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury stock method and the if-converted method, for convertible securities, if inclusion of these is dilutive.
As the Company has reported a net loss for the periods presented, diluted net loss per common share is the same as basic net loss per common share.
The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding for the periods indicated, because including them would have had an anti-dilutive impact:
|
|
|
|
|
|
|
|
June 30, 2019
|
|
June 30, 2018
|
Options to purchase common stock
|
2,297,036
|
|
|
3,098,813
|
|
Unvested restricted common stock
|
834
|
|
|
3,334
|
|
Total
|
2,297,870
|
|
|
3,102,147
|
|
12. Segment Information
The Company operates as
two
reportable segments:
|
|
•
|
The Consumer Operations segment, which reflects the total revenue and costs and expenses related to HOTSHOT and the Company's consumer operations.
|
|
|
•
|
The Drug Development segment, which reflects the costs and expenses related to the Company's efforts to develop innovative and proprietary drug products; previously to treat muscle cramps, spasms and spasticity associated with severe neurological conditions.
|
The Company discloses information about its reportable segments based on the way that the Company's Chief Operating Decision Maker, who the Company has identified as the Chief Executive Officer, and management, organizes segments within the Company for making operating decisions and assessing financial performance. The Company evaluates the performance of its reportable segments based on revenue and operating income or loss. Although the Company reduced its research and development efforts in connection with its strategic assessment in
June 2018, the Company continues to manage and operate as two segments and it is unclear to what extent it may resume research and development activities in the future. The accounting policies of the segments are the same as those described herein as well as those described in Note 2. Corporate and unallocated amounts that do not relate to a reportable segment have been allocated to "Corporate." No asset information has been provided for the Company's reportable segments as management does not measure or allocate such assets on a reportable segment basis.
Information for the Company's reportable segments for the
three
months ended
June 30, 2019
and
2018
are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2019
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
Total revenue
|
$
|
164,705
|
|
—
|
|
—
|
|
$
|
164,705
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
13,361
|
|
$
|
13,361
|
|
Income (loss) from operations
|
$
|
11,821
|
|
(29,294
|
)
|
(1,380,665
|
)
|
$
|
(1,398,138
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2018
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
Total revenue
|
$
|
245,502
|
|
—
|
|
—
|
|
$
|
245,502
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
51,809
|
|
$
|
51,809
|
|
Loss from operations
|
$
|
(645,687
|
)
|
(6,170,488
|
)
|
(2,287,506
|
)
|
$
|
(9,103,681
|
)
|
Information for the Company's reportable segments for the
six
months ended
June 30, 2019
and
2018
are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2019
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
Total revenue
|
$
|
269,682
|
|
—
|
|
—
|
|
$
|
269,682
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
26,574
|
|
$
|
26,574
|
|
Loss from operations
|
$
|
(41,287
|
)
|
(29,678
|
)
|
(3,570,816
|
)
|
$
|
(3,641,781
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2018
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
Total revenue
|
$
|
424,084
|
|
—
|
|
—
|
|
$
|
424,084
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
111,402
|
|
$
|
111,402
|
|
Loss from operations
|
$
|
(1,902,993
|
)
|
(10,834,565
|
)
|
(4,648,943
|
)
|
$
|
(17,386,501
|
)
|
13. Subsequent Event
At a special meeting of the Company's stockholders held on July 12, 2019, the merger with Salarius was approved by the Company's stockholders. The merger is expected to close on or about July 19, 2019.