UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2022
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _________________ to _______________________
Commission
file number: 001-38738
ETON
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
37-1858472
(State
of incorporation)
(I.R.S.
Employer Identification Number)
21925
W. Field Parkway , Suite 235
Deer
Park , Illinois
60010-7278
(Address
of principal executive offices) (Zip code)
Registrant’s
telephone number, including area code: (847) 787-7361
Securities
registered pursuant to Section 12(b) of the Act
Trading
Symbol
Name
of each exchange on which registered
Common
stock, $0.001 par value per share
ETON
Nasdaq
Global Market
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter time that the registrant was required to submit and post such files). Yes ☒ No
☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
As
of April 30, 2022, Eton Pharmaceuticals, Inc. had outstanding 25,224,452 shares of common stock, $0.001 par value.
Eton
Pharmaceuticals, Inc.
TABLE
OF CONTENTS
Part
No
Item
No
Description
Page
No.
I
FINANCIAL INFORMATION
1
1
Financial Statements
1
Condensed Balance Sheets as of March 31, 2022 (unaudited) and December 31, 2021
1
Unaudited
Condensed Statements of Operations for the three months ended March 31, 2022 and 2021
2
Unaudited Condensed Statements of Stockholders’ Equity for the three months ended March 31, 2022 and 2021
3
Unaudited Condensed Statements of Cash Flows for the three months ended March 31, 2022 and 2021
4
Notes to Condensed Financial Statements
5
2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
23
3
Quantitative and Qualitative Disclosures About Market Risk
28
4
Controls and Procedures
29
II
OTHER INFORMATION
30
1
Legal Proceedings
30
1A
Risk Factors
30
2
Unregistered Sales of Equity Securities and Use of Proceeds
30
3
Defaults Upon Senior Securities
30
4
Mine Safety Disclosures
30
5
Other Information
30
6
Exhibits
30
Index to Exhibits
30
Signatures
31
i
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
Eton
Pharmaceuticals, Inc.
Condensed
Balance Sheets
(in
thousands, except share and per share amounts)
March 31, 2022
December 31, 2021
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 15,229
$ 14,406
Accounts receivable, net
796
5,471
Inventories
510
550
Prepaid expenses and other current assets
2,216
3,177
Total current assets
18,751
23,604
Property and equipment, net
109
115
Intangible assets, net
4,240
3,621
Operating lease right-of-use assets, net
84
104
Other long-term assets, net
12
21
Total assets
$ 23,196
$ 27,465
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$ 2,131
$ 1,774
Current portion of long-term debt
—
1,418
Accrued liabilities
1,351
1,366
Total current liabilities
3,482
4,558
Long-term debt, net of discount and including accrued fees
6,331
5,262
Operating lease liabilities, net of current portion
—
15
Total liabilities
9,813
9,835
Commitments and contingencies (Note 11)
-
-
Stockholders’ equity
Common stock, $ 0.001 par value; 50,000,000 shares authorized; 24,626,004 shares issued and outstanding at March 31, 2022 and December 31, 2021
25
25
Additional paid-in capital
112,801
111,718
Accumulated deficit
( 99,443 )
( 94,113 )
Total stockholders’ equity
13,383
17,630
Total liabilities and stockholders’ equity
$ 23,196
$ 27,465
The
accompanying notes are an integral part of these condensed financial statements.
1
Eton
Pharmaceuticals, Inc.
Condensed
Statements of Operations
(In
thousands, except per share amounts)
(Unaudited)
For the three months ended
March 31,
March 31,
2022
2021
Revenues:
Licensing revenue
$ —
$ 11,500
Product sales and royalties
2,176
397
Total net revenues
2,176
11,897
Cost of sales
Licensing revenue
—
1,500
Product sales and royalties
718
90
Total cost of sales
718
1,590
Gross profit
1,458
10,307
Operating expenses:
Research and development
1,618
886
General and administrative
4,927
4,058
Total operating expenses
6,545
4,944
(Loss) income from operations
( 5,087 )
5,363
Other expense:
Interest and other expense, net
( 243 )
( 247 )
(Loss) income before income tax expense
( 5,330 )
5,116
Income tax expense
—
—
Net (loss) income
$ ( 5,330 )
$ 5,116
Net (loss) income per share, basic
$ ( 0.21 )
$ 0.21
Net (loss) income per share, diluted
$ ( 0.21 )
$ 0.19
Weighted average number of common shares outstanding, basic
25,301
24,453
Weighted average number of common shares outstanding, diluted
25,301
26,547
The
accompanying notes are an integral part of these condensed financial statements.
2
Eton
Pharmaceuticals, Inc.
Condensed
Statements of Stockholders’ Equity
For
the three months ended March 31, 2022 and 2021
(in
thousands, except share amounts)
(Unaudited)
Common Stock
Additional Paid-in
Accumulated
Total Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balances at December 31, 2021
24,626,004
$ 25
$ 111,718
$ ( 94,113 )
$ 17,630
Stock-based compensation
—
—
1,083
—
1,083
Net loss
—
—
—
( 5,330 )
( 5,330 )
Balances at March 31, 2022
24,626,004
$ 25
$ 112,801
$ ( 99,443 )
$ 13,383
Common Stock
Additional Paid-in
Accumulated
Total Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balances at December 31, 2020
24,312,808
$ 24
$ 107,797
$ ( 92,158 )
$ 15,663
Stock-based compensation
—
—
673
—
673
Stock option exercises
75,000
—
103
—
103
Warrant exercises
94,808
—
—
—
—
Net income
—
—
—
5,116
5,116
Net income (loss)
—
—
—
5,116
5,116
Balances at March 31, 2021
24,482,616
$ 24
$ 108,573
$ ( 87,042 )
$ 21,555
The
accompanying notes are an integral part of these condensed financial statements.
3
Eton
Pharmaceuticals, Inc.
Condensed
Statements of Cash Flows
(In
thousands)
(Unaudited)
Three months
ended
March 31, 2022
Three months
ended
March 31, 2021
Cash flows from operating activities
Net (loss) income
$ ( 5,330 )
$ 5,116
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
Stock-based compensation
1,083
673
Depreciation and amortization
181
155
Debt discount amortization
36
36
Changes in operating assets and liabilities:
Accounts receivable
4,675
( 252 )
Inventories
40
( 106 )
Prepaid expenses and other assets
961
( 846 )
Accounts payable
( 393 )
( 583 )
Accrued liabilities
( 30 )
( 478 )
Net cash provided by operating activities
1,223
3,715
Cash used in investing activities
Purchases of property and equipment
( 15 )
—
Net cash used in investing activities
( 15 )
—
Cash flows from financing activities
Repayment of long-term debt
( 385 )
—
Proceeds from employee stock option exercises
—
103
Net cash (used in) provided by financing activities
( 385 )
103
Change in cash and cash equivalents
823
3,818
Cash and cash equivalents at beginning of period
14,406
21,295
Cash and cash equivalents at end of period
$ 15,229
$ 25,113
Supplemental disclosures of cash flow information
Cash paid for interest
$ 215
$ 214
Cash paid for income taxes
$ —
$ —
Supplemental disclosures of non-cash investing activities:
Payable for product
license fee
$ 750
$ —
The
accompanying notes are an integral part of these condensed financial statements.
4
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
1 — Company Overview
Eton
Pharmaceuticals, Inc. (“Eton” or the “Company”) was incorporated as a Delaware “C” corporation on
April 27, 2017 and was initially set up as a wholly-owned subsidiary of Harrow Health, Inc. (“Harrow”, fka Imprimis Pharmaceuticals,
Inc.). In June 2017, the Company raised $ 20,055 in start-up capital through a private sale of preferred stock and a separate management
team was then established for Eton with its corporate offices located in Deer Park, Illinois. In November 2018, the Company completed
its initial public offering (the “IPO”) and received net proceeds of $ 21,960 , after deducting underwriting discounts and
commissions and offering-related expenses. In November 2019, the Company entered into a credit agreement and received net proceeds of
$ 4,750 and in August 2020 the Company received net proceeds of $ 1,965 under the credit agreement (see Note 5). In March and April 2020,
Eton received net proceeds of $ 7,756 from the sale of shares of its common stock in a private placement and in October 2020, the Company
received net proceeds of $ 21,026 from a public offering for its common stock at an offering price of $ 7.00 per share.
Eton
is an innovative pharmaceutical company focused on developing, acquiring, and commercializing innovative products to treat
rare diseases. The Company seeks to improve the formula, delivery system, or safety of existing molecules in order to address
unmet patient needs. Eton pursues what it perceives 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 the Company to bring the product to patients.
The
Company’s Biorphen® product was approved by the FDA in October 2019 and sales commenced for this product at the end of 2019.
Eton’s EM-100 product was sold to Bausch Health and the product was approved by the FDA in September 2020. Bausch Health launched
this product under the name of Alaway® Preservative Free in January 2021 and Eton receives royalties from the sale of the product.
The Company acquired the licensing rights to Alkindi Sprinkle® and this product was approved by the FDA in October 2020 and
launched in December 2020. The Company entered into a co-promotion agreement with Tolmar Pharmaceuticals in November 2021 whereby Tolmar
will promote Alkindi Sprinkle through its salesforce in exchange for a royalty on net sales. In February 2021, the Company sold three
pediatric neurology products it had under development to Azurity Pharmaceuticals (“Azurity”) and anticipates additional revenues
from Azurity based on various product-related milestones including the commercial launch for two of these products which are currently
under review with the FDA. Azurity launched one of the three products, Eprontia, in December 2021. In addition,
the Company launched Carglumic Acid tablets in December 2021 as the first and only FDA-approved generic version of Carbaglu®. In
March 2022, the Company’s U.S. marketing partner, XGen Pharmaceuticals (“XGen”) launched Rezipres® (a ready-to-use
form of injectable ephedrine) and the Company receives a profit share on the sale of the Rezipres product.
Note
2 — Liquidity Considerations
To
date, the Company has generated revenues from six products and expects further growth in 2022 and beyond in accordance with additional
market penetration from these products plus revenues from licensing and additional products where it anticipates FDA approval.
The
Company currently believes its existing cash and cash equivalents of $ 15,229 as of March 31, 2022 will be sufficient to fund its operating
expenses and capital expenditure requirements for at least the next twelve months from the date of filing of this quarterly report. This
estimate is based on the Company’s current assumptions, including assumptions relating to estimated sales and its ability to manage
its spending. The Company could use its available capital resources sooner than currently expected. Accordingly, the Company could seek
to obtain additional capital through equity financings, the issuance of debt or other arrangements. However, there can be no assurance
that the Company will be able to raise additional capital if needed or under acceptable terms, if at all. The sale of additional equity
may dilute existing stockholders and newly issued shares could contain senior rights and preferences compared to currently outstanding
common shares. The Company’s existing long-term debt obligation contains covenants and limits the Company’s ability to pay
dividends or make other distributions to stockholders. If the Company experiences delays in product sales growth and completing its product
development and obtaining regulatory approval for its other product candidates and is unable to obtain such additional financing, operations
would need to be scaled back or discontinued.
5
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
3 — Summary of Significant Accounting Policies
Basis
of Presentation
The
Company has prepared the accompanying condensed financial statements in accordance with accounting principles generally accepted
in the United States of America (“GAAP”).
Unaudited
Interim Financial Information
The
accompanying interim condensed financial statements are unaudited and have been prepared on the same basis as the audited financial statements
and, in the opinion of management, reflect all adjustments necessary for the fair presentation of the Company’s financial position
as of March 31, 2022 and the results of its operations and its cash flows for the periods ended March 31, 2022 and 2021. The financial
data and other information disclosed in these notes related to the three-month periods ended March 31, 2022 and 2021 are also unaudited.
The results for the three-month period ended March 31, 2022 are not necessarily indicative of results to be expected for the year ending
December 31, 2022, any other interim periods or any future year or period.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial
statements include, but are not limited to, provisions for uncollectible receivables and sales returns, valuation of inventories, useful
lives of assets and the impairment of property and equipment, the accrual of research and development expenses and the valuation of common
stock, stock options and warrants. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes
in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions.
Segment
Information
The
Company operates the business on the basis of a single reportable segment, which is the business of developing and commercializing prescription
drug products. The Company’s chief operating decision-maker is the Chief Executive Officer (“CEO”), who evaluates the
Company as a single operating segment.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and
cash equivalents are held in U.S. financial institutions or invested in short-term U.S. treasury bills or high-grade money market funds.
As of March 31, 2022, all of the Company’s cash is in a non-interest bearing account due to the current low-interest rate environment.
From time to time, amounts deposited with its bank exceed federally insured limits. The Company believes the associated credit risk to
be minimal.
Accounts
Receivable
Accounts
receivable are recorded at the invoiced amount and are non-interest bearing. Accounts receivable are recorded net of allowances for doubtful
accounts, cash discounts for prompt payment, distribution fees, chargebacks and returns and allowances. The total for these reserves
amounted to $ 132 and $ 96 as of March 31, 2022 and December 31, 2021, respectively.
Inventories
The
Company values its inventories at the lower of cost or net realizable value using the first-in, first-out method of valuation. The Company
reviews its inventories for potential excess or obsolete issues on an ongoing basis and will record a write-down if an impairment is
identified. Inventories at March 31, 2022 and December 31, 2021 consist solely of purchased finished goods. At March 31, 2022 and December
31, 2021 inventories are shown net of a reserve for its Biorphen product of $ 1,284 and $ 1,414 , respectively due to the risk of expiry
before this entire stock of inventories is sold.
6
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
3 — Summary of Significant Accounting Policies (continued)
Property
and Equipment
Property
and equipment are stated at cost. Depreciation of property and equipment is computed utilizing the straight-line method based on the
following estimated useful lives: computer hardware and software is depreciated over three years ; equipment, furniture and fixtures is
depreciated over five years ; leasehold improvements are amortized over their estimated useful lives or the remaining lease term , whichever
is shorter. Construction in progress is capitalized but not depreciated until it is placed into service.
Maintenance
and repairs are charged to expense as incurred, while renewals and improvements are capitalized.
Intangible
Assets
The
Company capitalizes payments it makes for licensed products when the payment is based on the FDA approval for the product and the cost
is recoverable based on expected future cash flows from the product. The cost is amortized on a straight-line basis over the estimated
useful life of the product commencing on the approval date in accordance with Accounting Standards Codification (“ASC”) 350
— Intangibles - Goodwill and Other. A $ 750
payment related to the approval of the Company’s
Biorphen product in 2019 has been capitalized and that cost is being amortized over five
years . In November 2021, the Company purchased
the rights for its Carglumic Acid product for $ 3,250
and that cost is being amortized over ten
years . During the first quarter of 2022, the
Company capitalized a $ 750
fee for its Rezipres product and that cost
is being amortized over five
years . The intangible assets, net on the Company’s
balance sheet reflected $ 510
of accumulated amortization as of March 31, 2022.
The Company recorded $ 131
of amortization expense for the three months ended March 31,
2022. The table below shows the estimated remaining amortization for these products for each of the five years from 2022
to 2026 and thereafter.
Schedule
of Intangible Assets Amortization Expense
Year
Amortization
Expense
Remainder of 2022
469
2023
625
2024
600
2025
475
2026
475
Thereafter
1,596
Total estimated amortization expense
4,240
Impairment
of Long-Lived Assets
Long-lived
assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not
be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future
cash flows, an impairment charge is recognized in the Company’s statements of operations for the amount by which the carrying amount
of the asset exceeds the fair value of the asset. No impairment has been recognized since the Company’s inception in 2017.
Debt
Issuance Costs and Debt Discount and Detachable Debt-Related Warrants
Costs
incurred to issue debt are deferred and recorded as a reduction to the debt balance in the accompanying balance sheets. The Company amortizes
debt issuance costs over the expected term of the related debt using the effective interest method. Debt discounts related to
the relative fair value of warrants issued in conjunction with the debt and are also recorded as a reduction to the debt balance and
accreted over the expected term of the debt to interest expense using the effective interest method.
7
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
3 — Summary of Significant Accounting Policies (continued)
Revenue
Recognition for Contracts with Customers
The
Company accounts for contracts with its customers in accordance with ASC 606 — Revenue from Contracts with Customers. ASC 606 applies
to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes
revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity
expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines
are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify
the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance
obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
At
contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised
within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.
The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation
when (or as) the performance obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable
at a customer’s discretion are generally considered options. The Company assesses whether these options provide a material right
to the customer and, if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract
modification for accounting purposes.
The
Company 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 the
Company’s 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.
Milestone
Payments – If a commercial contract arrangement includes development and regulatory milestone payments, the Company will evaluate
whether the milestone conditions have been achieved and if it is probable that a significant revenue reversal would not occur before
recognizing the associated revenue. Milestone payments that are not within the Company’s control or the licensee’s control,
such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received.
Royalties
– For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the
result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate,
the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which
some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any
royalty revenue resulting from any of its licensing arrangements.
Significant
Financing Component – In determining the transaction price, the Company will adjust consideration for the effects of the time
value of money if the expected period between payment by the licensees and the transfer of the promised goods or services to the licensees
will be more than one year.
The
Company sells Biorphen in the U.S. to wholesale pharmaceutical distributors, who then sell the product to hospitals and other end-user
customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual
shipments of Biorphen represent performance obligations under each purchase order. The Company uses a third-party logistics (“3PL”)
vendor to process and fulfill orders and has concluded it is the principal in the sales to wholesalers because it controls access to
the 3PL vendor services rendered and directs the 3PL vendor activities. The Company has no significant obligations to wholesalers to
generate pull-through sales. In addition, the Company sells its Alkindi Sprinkle and Carglumic Acid product to one pharmacy distributor
customer which provides order fulfilment and inventory storage/distribution services.
8
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
3 — Summary of Significant Accounting Policies (continued)
Selling
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 programs. In addition, the Company pays fees to wholesalers for their distribution services, inventory reporting and
chargeback processing. The Company pays GPOs fees for administrative services and for access to GPO members and concluded the
benefits received in exchange for these fees are not distinct from its sales of Biorphen, and accordingly it applies these amounts
to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf
life of Biorphen and the Company’s lengthy return period, there may be a significant period of time between when the product
is shipped and when it issues credits on returned product. For its Alkindi Sprinkle and Carglumic Acid products, the Company bills
at the initial product list price 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.
The
Company estimates the transaction price when it receives each purchase order taking into account the expected reductions of the selling
price initially billed to the wholesaler/distributor arising from all of the above factors. The Company has developed estimates for future
returns and chargebacks of Biorphen and the impact of the other discounts and fees it pays while Alkindi Sprinkle and Carglumic Acid
sales to its distributor are not subject to returns. When estimating these adjustments to the transaction price, the Company reduces
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.
The
Company recognizes revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location. At
that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable
obligation to pay the Company. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate.
Although wholesalers have product return rights, the Company does not believe they have a significant incentive to return the product.
The Company stores its Alkindi Sprinkle and Carglumic Acid inventory at its pharmacy distributor customer location and sales are recorded
when stock is pulled and shipped to fulfill specific patient orders.
Upon
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 receivable. The
Company monitors actual product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts end up differing from
its estimates, it will make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings
in the period of adjustment.
In
addition, the Company anticipates it will receive revenues from product licensing agreements where it has contracted for milestone payments
and royalties from products it has developed or for which it has acquired the rights to a product developed by a third party.
Revenues
for the three months ended March 31, 2022 consisted of $ 2,153
of product sales and $ 23 in royalty revenue.
Revenues for the three months ended March 31, 2021 reflected $ 11,500
of licensing milestone fees, $ 254
in product sales and $ 143
in royalty revenue.
Cost
of Sales
Cost
of sales consists of the profit-sharing and royalty fees with the Company’s product licensing and development partners, the purchase
costs for finished products from third-party manufacturers and freight and handling/storage costs from the Company’s 3PL logistics
service providers. The cost of sales for profit-sharing and royalty fees and costs for purchased finished products and the associated
inbound freight expense is recorded when the associated product sale revenue is recognized in accordance with the terms of shipment to
customers while outbound freight and handling/storage fees charged by the 3PL service provider are expensed as they are incurred. Cost
of sales also reflects any write-downs or reserve adjustments for the Company’s inventories.
9
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
3 — Summary of Significant Accounting Policies (continued)
Research
and Development Expenses
Research
and development (“R&D”) expenses include both internal R&D activities and external contracted services. Internal
R&D activity expenses include salaries, benefits and stock-based compensation and other costs to support the Company’s R&D
operations. External contracted services include product development efforts such as certain product licensor milestone payments, clinical
trial activities, manufacturing and control-related activities and regulatory costs. R&D expenses are charged to operations as incurred.
The Company reviews and accrues R&D expenses based on services performed and relies upon estimates of those costs applicable to the
stage of completion of each project. Significant judgments and estimates are made in determining the accrued balances at the end of any
reporting period. Actual results could differ from the Company’s estimates.
Upfront
payments and milestone payments made for the licensing of technology for products that are not yet approved by the FDA are expensed as
R&D in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for
use in R&D activities are recorded as prepaid expenses and are expensed as the related goods are delivered or the services are performed.
Income
(Loss) Per Share
Basic
net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders for the period by the
weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the
net income (loss) attributable to common stockholders for the period by the weighted average number of common and common equivalent shares,
such as unvested restricted stock, stock options and warrants that are outstanding during the period. Common stock equivalents are excluded
from the computation when their inclusion would be anti-dilutive. For the three-month period ended March 31, 2022 common stock equivalents
of 5,110,852
are excluded from the calculation of diluted
net loss per share because the effect is anti-dilutive. For the three-month period ended March 31, 2021, common stock equivalents (using
the treasury stock and “if converted” method) from stock options, unvested RSAs and warrants were 2,093,952
and excluded 729,692
shares that were anti-dilutive. Included in the
basic and diluted net income (loss) per share calculation are RSUs awarded to directors that have vested, but the issuance and delivery
of the common shares are deferred until the director retires from service as a director. Basic weighted average shares for the three
months ended March 31, 2022 include 600,000 vested warrants to purchase common shares. As the shares underlying these warrants can be
purchased for little to no consideration ($ 0.01 per share exercise price), they are included in the computation of basic earnings per
share.
Stock-Based
Compensation
The
Company accounts for stock-based compensation under the provisions of ASC — 718 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 and record expense
over the related service periods, which are generally the vesting period of the equity awards. The Company estimates the fair value of
stock-based option awards using the Black-Scholes-Merton option-pricing model (“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. 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 along with
a limited weighting included for the Company’s own volatility, which management believes represents the most accurate basis for
estimating expected future volatility under the current conditions. The Company accounts for forfeitures as they occur. The Company uses
the closing common stock price on the date of grant for the fair value of the common stock.
10
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
3 — Summary of Significant Accounting Policies (continued)
Fair
Value Measurements
We
measure certain of our assets and liabilities at fair value. Fair value represents the price that would be received to sell an asset
or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value accounting
requires characterization of the inputs used to measure fair value into a three-level fair value hierarchy as follows:
Level
1 — Inputs based on quoted prices in active markets for identical assets or liabilities. An active market is a market in
which transactions occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
Level
2 — Observable inputs that reflect the assumptions market participants would use in pricing the asset or liability developed
based on market data obtained from sources independent from the entity.
Level
3 — Unobservable inputs that reflect the entity’s own assumptions about the assumptions market participants would
use in pricing the asset or liability developed based on the best information available.
Fair
value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment
of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets
and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below take into
account the market for the Company’s financials, assets and liabilities, the associated credit risk and other factors as required.
The Company considers active markets as those in which transactions for the assets or liabilities occur in sufficient frequency and volume
to provide pricing information on an ongoing basis.
The
Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities,
and long-term debt obligation. The carrying amounts of these financial instruments, except for the long-term debt obligation, approximate
their fair values due to the short-term maturities of these instruments. Based on borrowing rates currently available to the Company,
the carrying value of the long-term debt obligation approximates its fair value.
Impact
of New Accounting Pronouncements
There
were no new accounting pronouncements issued by the FASB during the period that would apply to the Company would have a material impact
on its financial position or results of operations.
11
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
4 – Property and Equipment
Property
and equipment consist of the following:
Schedule of Property and Equipment
March 31,
2022
December 31,
2021
Computer hardware and software
$ 167
$ 157
Furniture and fixtures
111
106
Equipment
132
132
Leasehold improvements
71
71
Property and equipment, gross
481
466
Less: accumulated depreciation
( 372 )
( 351 )
Property and equipment, net
$ 109
$ 115
Depreciation
expense for the three-month periods ended March 31, 2022 and 2021 was $ 21 and $ 84 , respectively. The decrease in depreciation expense
was associated with the closure of the Company’s laboratory facility and sale of its equipment in 2021.
Note
5 — Long Term Debt
SWK
Loan
On
November 13, 2019, the Company entered into a credit agreement (the “SWK Credit Agreement”) with SWK Holdings Corporation
(“SWK”) which provided for up to $ 10,000 in financing. The Company received proceeds of $ 5,000 at closing and was able to
borrow an additional $ 5,000 upon the FDA approval of a second product developed by the Company, excluding EM-100. In March 2020, in conjunction
with the Company’s Alkindi Sprinkle product licensing agreement (see Note 11) and the Company’s March 2020 sale of additional
shares of its common stock, the Company and SWK amended the SWK Credit Agreement. The amendment provided the Company with the option
to immediately draw $ 2,000 and the ability to borrow an additional $ 3,000 based upon the FDA approval of EM-100 and Alkindi Sprinkle
which subsequently occurred in September 2020. Accordingly, the Company borrowed an additional $ 2,000 on August 11, 2020. The term of
the SWK Credit Agreement is for five years and borrowings bear interest at a rate of LIBOR 3-month plus 10.0 %, subject to a stated LIBOR
floor rate of 2.0 %. A 2.0 % unused credit limit fee is assessed during the first twelve months after the date of the SWK Credit Agreement
and loan fees include a 5.0 % exit fee based on the principal amounts drawn which is payable at the end of the term of the SWK Credit
Agreement. The Company was required to maintain a minimum cash balance of $ 3,000 , only pay interest on the debt until February 2022 and
then pay 5.5% of the loan principal balance commencing on February 15, 2022 and then every three months thereafter until November 13,
2024 at which time the remaining principal balance is due. Borrowings under the SWK Credit Agreement are secured by the Company’s
assets. The SWK Credit Agreement contains customary default provisions and covenants which include limits on additional indebtedness.
In March 2020, SWK provided a waiver for the Company to obtain loans with the Small Business Association. In February 2021, the Company
notified SWK that it will not require additional borrowing capacity under the SWK Credit Agreement and terminated the additional borrowing
capacity with SWK .
In
connection with the initial $ 5,000
borrowed in November 2019, the Company issued
warrants to SWK to purchase 51,239
shares of the Company’s common stock with
an exercise price of $ 5.86
per share. The relative fair value of these 51,239
warrants was $ 226
and was estimated using BSM with the following
assumptions: fair value of the Company’s common stock at issuance of $ 5.75
per share; seven -year
contractual term; 95 %
volatility; 0 %
dividend rate; and a risk-free interest rate of 1.8 %.
In
connection with the additional $ 2,000
borrowed in August 2020, the Company issued warrants
for 18,141
shares of its common stock at an exercise price
of $ 6.62
per share. The relative fair value of the 18,141
warrants was $ 94
and was estimated using BSM with the following
assumptions: fair value of the Company’s common stock at issuance of $ 6.85
per share; seven -year
contractual term; 95 %
volatility; 0 %
dividend rate; and a risk-free interest rate of 0.4 %.
12
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
5 — Long Term Debt (continued)
These
warrants (the “SWK Warrants”) are exercisable immediately and have a term of seven years from the date of issuance. The SWK
Warrants are subject to a cashless exercise feature, with the exercise price and number of shares issuable upon exercise subject to change
in connection with stock splits, dividends, reclassifications and other conditions.
Interest
expense of $ 247 was recorded during the three months ended March 31, 2022, which included $ 36 of debt discount amortization. Interest
expense of $ 264 was recorded during the three months ended March 31, 2021, which included $ 36 of debt discount amortization. As of March
31, 2022, $ 129 of accrued interest is included in accrued liabilities.
On
April 5, 2022, the Company and SWK entered into an amendment to the SWK Credit Agreement which allowed for a deferral of loan principal
payments until May 2023 and reduced the interest rate to LIBOR 3-month plus 8.0 %, subject to a stated LIBOR floor rate of 2.0 %. In accordance
with the change, the Company has classified all the loan principal as long-term in its balance sheet at March 31, 2022.
The
table below reflects the future payments for the SWK loan principal and interest as of March 31, 2022.
Schedule of Future Payments of Long Term Debt
Amount
2022
$ 499
2023
1,676
2024
6,452
Total payments
8,627
Less: amount representing interest
( 2,012 )
Loan payable, gross
6,615
Less: unamortized discount
( 284 )
Long-term debt, net of unamortized discount
$ 6,331
13
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
6 — Common Stock
The
Company has 50,000,000 authorized shares of $ 0.001 par value common stock under its Amended and Restated Certificate of Incorporation.
The
Company did not have any stock issuance activity for the three-month period ended March 31, 2022. During the three months ended March
31, 2021, the Company issued 75,000 shares of its common stock resulting from stock option exercises under its 2018 Equity Incentive
Plan (see Note 8). During the three months ended March 31, 2021, a holder of the Company’s common stock warrants exercised 135,650
warrants on a cashless basis and the Company issued 94,808 shares of its common stock in connection with the warrant exercise. The intrinsic
value of that warrant exercise was $ 806 .
Note
7 — Common Stock Warrants
The
Company’s outstanding warrants to purchase shares of its common stock at March 31, 2022 are summarized in the table below.
Summary of Warrants Outstanding
Description of Warrants
No. of Shares
Exercise Price
Business Advisory Warrants
600,000
$ 0.01
Placement Agent Warrants – 2017 Preferred Stock Offering
471,446
$ 3.00
Placement Agent Warrants - IPO
414,000
$ 7.50
SWK Warrants – Debt – Tranche #1
51,239
$ 5.86
SWK Warrants – Debt – Tranche #2
18,141
$ 6.62
Total
1,554,826
$ 3.18 (Avg)
The
holders of these warrants or their permitted transferees, are entitled to rights with respect to the registration under the Securities
Act of 1933, as amended (the “Securities Act”) for their shares that are converted to common stock, including demand registration
rights and piggyback registration rights. These rights are provided under the terms of a registration rights agreement between the Company
and the investors.
14
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
8 — Share-Based Payment Awards
The
Company’s board of directors and stockholders approved the Eton Pharmaceuticals, Inc. 2017 Equity Incentive Plan in May 2017 (the
“2017 Plan”), which authorized the issuance of up to 5,000,000
shares of the Company’s common stock. In
conjunction with the Company’s IPO in November 2018, the Company’s stockholders and board of directors approved the 2018
Equity Incentive Plan (the “2018 Plan”), as amended, which succeeded the 2017 Plan. The Company has granted restricted
stock awards (“RSAs”), stock options and restricted stock units (“RSUs”) for its common stock under the 2017
Plan and 2018 Plan as detailed in the tables below. There were 443,888
shares available for future issuance under the
2018 Plan as of March 31, 2022.
Shares
that are expired, terminated, surrendered or canceled without having been fully exercised will be available for future awards under the
2018 Plan. In addition, the 2018 Plan provides that commencing January 1, 2019 and through January 1, 2028, the share reserve will be
increased annually by 4 % of the total number of shares of common stock outstanding as of the preceding December 31, subject to a reduction
at the discretion of the Company’s board of directors. The exercise price for stock options granted is not less than the fair value
of common stock as determined by the board of directors as of the date of grant. The Company uses the closing stock price on the date
of grant as the exercise price.
To
date, all stock options issued have been non-qualified stock options, and the exercise prices were set at the fair value for the shares
at the dates of grant. Options typically have a ten -year life, except for options to purchase 50,000 shares of the Company’s common
stock granted to product consultants in July 2017 that expire within five years if the Company is not able to file certain product submissions
to the FDA prior to the five-year expiration date. Furthermore, these option awards to the Company’s product consultants do not
vest unless certain product submissions are made to the FDA, and accordingly, the Company has not recorded any expense for these contingently
vesting option awards to its product consultants.
For
the three months ended March 31, 2022 and 2021, the Company’s total stock-based compensation expense was $ 1,083 and $ 673 , respectively.
Of these amounts, $ 995 and $ 581 was recorded in general and administrative expenses, respectively, and $ 88 and $ 92 was recorded in research
and development expenses, respectively.
A
summary of stock option activity is as follows:
Summary of Stock Option Activity
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term (Yrs)
Aggregate
Intrinsic
Value
Options outstanding as of December 31, 2021
3,513,719
$ 5.22
7.9
$ 2,711
Issued
1,123,770
$ 3.79
Exercised
—
$
Forfeited/Cancelled
( 45,312 )
$ 5.90
Options outstanding as of March 31, 2022
4,592,177
$ 4.86
8.2
$ 3,474
Options exercisable at March 31, 2022
2,301,894
$ 4.48
7.2
$ 2,444
Options vested and expected to vest at March 31, 2022
4,542,177
$ 4.90
8.2
$ 3,325
The
aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair
value of the Company’s common stock at March 31, 2022 for those stock options that had strike prices lower than the fair
value of the Company’s common stock.
15
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
8 — Share-Based Payment Awards (continued)
As
of March 31, 2022, there was a total of $ 7,566
of unrecognized compensation costs related
to non-vested stock option awards. The weighted average grant date fair value of stock option awards for the three-month period ended
March 31, 2022 was $ 2.36 per share. There were no
stock option exercises during the three-month
period ended March 31, 2022. In the three-month period ended March 31, 2021, stock option exercises totaled 75,000
shares at an exercise price of $ 1.38
per share with an intrinsic value of $ 416 .
In
December 2018, the Company’s board of directors adopted an initial offering of the Company’s common stock under the Company’s
2018 Employee Stock Purchase Plan (the “ESPP”). The
Company’s ESPP provides for an initial reserve of 150,000
shares
and this reserve is automatically increased on January 1 of each year by the lesser of 1% of the outstanding common shares at December
31 of the preceding year or 150,000 shares, subject to reduction at the discretion of the Company’s board of directors .
As of March 31, 2022, there were 630,180
shares available for issuance under the ESPP.
The
initial offering of the ESPP began on December 17, 2018 and ended on December 10, 2019. The annual offerings consist of two stock purchase
periods, with the first purchase period ending in June and the second purchase period ending in December. The terms of the ESPP permit
employees of the Company to use payroll deductions to purchase stock at a price per share that is at least the lesser of (1) 85% of the
fair market value of a share of common stock on the first date of an offering or (2) 85% of the fair market value of a share of common
stock on the date of purchase. After the initial offering period ended, subsequent twelve-month offering periods automatically commence
over the term of the ESPP on the day that immediately follows the conclusion of the preceding offering, each consisting of two purchase
periods approximately six months in duration .
In
accordance with the June and December stock purchase periods for the ESPP, there were no
share issuances in the first three months of
2022 or 2021. The weighted average grant date fair value of share awards in 2022 and 2021 was $ 1.37
and $ 2.29 ,
respectively. Employees contributed $ 108
and $ 80
via payroll deductions during the three months
ended March 31, 2022 and 2021, respectively. The Company recorded an expense of $ 45
and $ 19
related to the ESPP in the three-month periods
ended March 31, 2022 and 2021, respectively. As of March 31, 2022 and December 31, 2021, the accompanying condensed balance sheets include
$ 130
and $ 22 ,
respectively, in accrued liabilities for remaining employee ESPP contributions.
16
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
9 — Related Party Transactions
Harrow
Harrow
was issued 3,500,000 shares of the Company’s common stock at the formation of the Company at the $ 0.001 par value per share price
as the paid-in-capital contribution from Harrow. In April 2021, Harrow sold 1,518,000 shares of the Eton common stock it owned in an
underwritten public offering. As of March 31, 2022, Harrow owned 1,982,000 shares of Eton’s common shares which represents 8.0 %
of the Company’s common shares outstanding. The Company and Harrow signed licensing agreements for two products developed by Harrow
whereby Harrow assigned the product rights to the Company. In July 2018, the Company determined that one of the products was not viable
for its portfolio of product opportunities and cancelled the licensing agreement whereby Harrow retains the product rights.
On
May 6, 2019, the Company entered into an Asset Purchase Agreement (the “CT-100 Asset Purchase Agreement”) with Harrow. Pursuant
to the CT-100 Asset Purchase Agreement, the Company sold all of its right, title and interest in CT-100 to Harrow, including any such
product that incorporates or utilizes its intellectual property rights (a “Product” or, collectively, “Products”).
Pursuant to the CT-100 Asset Purchase Agreement, Harrow will make certain payments to the Company upon the achievement of certain development
and commercial milestones. In addition, Harrow is required to pay the Company a royalty in the low-single digit percentage range worldwide
on a country-by-country basis on net sales for a period of the longer of 15 years from the date of the first commercial sale of a product
in a particular country or the time that a valid intellectual property claim on such Product remains in force in the applicable country.
The CT-100 Asset Purchase Agreement also contains customary representations, warranties, covenants and indemnities by the parties. To
date, there have not been any sales of the CT-100 product and therefore no earned royalties to the Company for this product.
Additionally,
the Chief Executive Officer of Harrow was a member of the Company’s board of directors until March 17, 2021 when he retired from
service with the board. The Company issued 25,000 shares to the Harrow CEO in April 2021 after his retirement from the Company’s
board associated with RSU’s that were previously fully vested.
In
late March 2021, the Company closed its laboratory operation in Lake Zurich, Illinois and in May 2021 it reached an agreement for Imprimis
Pharmaceuticals, a subsidiary of Harrow, to purchase its lab equipment for $ 700 which was $ 181 above the Company’s net book value
of the equipment.
17
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
9 — Related Party Transactions (continued)
Chief
Executive Officer
The
CEO has a partial interest in a company that the Company has partnered with for its EM-100/Alaway PF eye allergy product as described below.
The
Company acquired the exclusive rights to sell the EM-100 product in the United States pursuant to a sales and marketing agreement (the
“Eyemax Agreement”) dated August 11, 2017 between the Company and Eyemax LLC (“Eyemax”), an entity affiliated
with the Company’s CEO. The Company also held a right of first refusal to obtain the exclusive license rights for geographic areas
outside of the United States. Pursuant to the Eyemax Agreement, the Company was responsible for all costs of testing and FDA approval
of the product, other than the FDA filing fee which was paid by Eyemax. The Company was also to be responsible for commercializing the
product in the United States at its expense. The Company paid Eyemax $ 250 upon execution of the Eyemax Agreement, which was recorded
as a component of R&D expense. Under the terms of the original agreement, the Company would pay Eyemax $ 250 upon FDA approval and
$ 500 upon the first commercial sale of the product and pay Eyemax a royalty of 10 % on the net sales of all products. The Eyemax Agreement
was for an initial term of 10 years from the date of the Eyemax Agreement, subject to successive two-year renewals unless the Company
elected to terminate the Eyemax Agreement .
On
February 18, 2019, the Company entered into an Amended and Restated Agreement with Eyemax amending the Sales Agreement (the “Amended
Agreement”). Pursuant to the Amended Agreement, Eyemax sold the Company all of its right, title and interest in EM-100, including
any such product that incorporates or utilizes Eyemax’s intellectual property rights. Under the Amended Agreement, the Company
assumed certain liabilities of Eyemax under its Exclusive Development & Supply Agreement with Excelvision SAS dated as of July 11,
2013, as amended (the “Excelvision Agreement”), with respect to certain territories and arising during certain time periods.
Pursuant to the Amended Agreement, the Company paid Eyemax two milestone payments: (i) one milestone payment for $ 250
upon regulatory approval in the territory by
the FDA of the first single agent product and (ii) one milestone payment for $ 500
following the first commercial sale of the first
single agent product in the territory. Following payment of the milestones, the Company is entitled to retain all of the non-royalty
transaction revenues and royalties up to $ 2,000
(the “Recovery Amount”). After the
Company has retained the full Recovery Amount, it is entitled to retain half of all royalty and non-royalty transaction revenue. The
Company has realized $ 1,757
of the non-royalty and royalty revenue as
of March 31, 2022. The Amended Agreement also contains customary representations, warranties, covenants and indemnities by the parties.
The EM-100 asset and its associated product rights were sold to Bausch Health on February 18, 2019 and future potential royalties of
twelve percent on Bausch Health sales of the product, named Alaway® Preservative Free by Bausch, which was approved by the FDA in
September 2020, will be split between Eyemax and the Company. The royalty from Bausch Health is subject to reduction if a competitive
product with the same active pharmaceutical ingredient is launched in the U.S. or if the product’s U.S market share falls below
a specified target percentage.
There
were no amounts due to Eyemax under the terms of the Amended Agreement as of March 31, 2022 or December 31, 2021.
18
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
10 — Leases
The
Company recognizes a right-of-use (“ROU”) asset and a lease liability on the balance sheet for substantially all leases,
including operating leases, and separates lease components from non-lease components related to its office space lease.
The
Company’s operating lease cost as presented in the “Research and Development” and “General and Administrative”
captions in the condensed statements of operations was $ 0 and $ 21 , respectively, for the three months ended March 31, 2022 and $ 9 and
$ 21 , respectively, for the three months ended March 31, 2021. Cash paid for amounts included in the measurement of operating lease liabilities
was $ 20 for the three months ended March 31, 2022. The ROU asset amortization for the three-month periods ended March 31, 2022 and 2021
was $ 20 and $ 29 , respectively, and is reflected within depreciation and amortization on the Company’s condensed statements of cash
flows. As of March 31, 2022, the weighted-average remaining lease term was 1.0 years, and the weighted-average incremental borrowing
rate was 5.4 %.
The
table below presents the lease-related assets and liabilities recorded on the balance sheet as of March 31, 2021 (in thousands).
Schedule of Lease-related Assets and Liabilities
Assets
Classification
Operating lease right-of-use assets
Operating lease right-of-use assets, net
$ 84
Total leased assets
$ 84
Liabilities
Operating lease liabilities, current
Accrued liabilities
$ 79
Total operating lease liabilities
$ 79
The
Company’s future lease commitments for its administrative offices in Deer Park, Illinois as of March 31, 2022 is as indicated below:
Schedule of Future Lease Commitments
Total
2022
2023
2024
Thereafter
Undiscounted lease payments
$ 81
66
15
—
—
Less: Imputed interest
( 2 )
Total lease liabilities
$ 79
19
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
11 — Commitments and Contingencies
Legal
The
Company is subject to legal proceedings and claims that may arise in the ordinary course of business. The Company is not aware of any
pending or threatened litigation matters at this time that may have a material impact on the operations of the Company.
License
and product development agreements
The
Company has entered into various agreements in addition to those discussed above which are described below.
The
Company acquired the exclusive rights to sell the Cysteine injection product in the United States pursuant to a sales and marketing agreement
dated November 17, 2017 with an unaffiliated third party (the “Sales Agreement”). Pursuant to the Sales Agreement, the licensor
is responsible for obtaining FDA approval, at its expense, and the Company is responsible for commercializing the product in the United
States at its expense. The Company was to pay the third party 50 % of the net profit from the sale of the product, however, in February
2020, it executed an amendment to the Sales and Marketing Agreement. Under the revised terms, the Company will be responsible for paragraph
IV related litigation and will be entitled to 62.5 % of product profit. The initial term is for the first 10 years following the first
commercial sale of the product.
On
February 8, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-202 License Agreement”) with
Sintetica SA (“Sintetica”) for marketing rights in the United States to Biorphen® which is used for the treatment of
clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. The product was submitted to the
FDA for review and subsequently received FDA approval on October 21, 2019. Pursuant to the terms of the ET-202 License Agreement, the
Company is responsible for marketing activities and Sintetica is responsible for development, manufacturing, and the regulatory activities
related to approval. The Company paid Sintetica a licensing payment of $ 2,000 upon execution of the ET-202 License Agreement and $ 750
upon the commencement of commercial product shipments. Sintetica supplies Biorphen to the Company at its direct costs and the Company
retains 5 % of net sales as a marketing fee. Sintetica is entitled to receive the first $ 500 of product profits. All additional profit
will be split 50 % to the Company and 50 % to Sintetica. The ET-202 License Agreement has a ten-year term from the first commercial sale
of Biorphen which occurred in November 2019.
On
February 8, 2019, the Company also entered into an Exclusive Licensing and Supply Agreement (the “ET-203 License Agreement”)
with Sintetica for marketing rights in the United States to ephedrine HCl (brand name Rezipres®), an injectable product candidate
for use in the hospital setting. Pursuant to the terms of the ET-203 License Agreement, the Company will be responsible for marketing
activities and Sintetica will be responsible for development, manufacturing, and regulatory activities related to obtaining regulatory
approval. The Company paid Sintetica a licensing payment of $ 1,000 upon execution of the ET-203 License Agreement which was refunded
to Eton in early 2020 due to the FDA not accepting the ET-203 file submission by Sintetica. The Rezipres product was successfully resubmitted
in late 2020 and the Company paid a $ 600 milestone fee in July 2021 and paid $ 750 in April 2022 after the first commercial sale of the
product in March 2022. Sintetica supplies Rezipres to the Company at its direct costs. The Company retains 5 % of net sales as a marketing
fee. Sintetica is entitled to receive the first $ 500 of product profits. All additional profit will be split 50 % to the Company and 50 %
to Sintetica. The ET-203 License Agreement has a ten-year term from first commercial sale of product which occurred in March 2022.
The
three oral solution pediatric neurology product candidates discussed below, Topiramate, Zonisamide and Lamotrigine were developed by
the Company and its various product candidate development partners and the Company subsequently sold all its rights and interests in
these three products to Azurity in 2021. The Company has recognized $ 17,000 in milestone revenues to date from these three products and
may receive up to $ 25,000 in additional milestone revenues related to FDA product approvals and the future sales levels for the products.
During
the years ended December 31, 2021, 2020 and 2019, the Company worked with Tulex Pharmaceuticals, Inc. (“Tulex”) as a third-party
contract manufacturer to develop an oral solution for Topiramate (fka ET-101) which targets a neurological condition. The Company subsequently
filed the product with the FDA in October 2020 and paid a $ 1,438 filing fee. In November 2021, the product received approval from the
FDA and was launched by Azurity in December 2021. The Company recognized a $ 5,000 milestone revenue at launch which was reflected in
accounts receivable on the Company’s balance sheet at December 31, 2021 and subsequently collected in January 2022.
20
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
11 — Commitments and Contingencies (continued)
On
January 23, 2019, the Company entered into a Licensing and Supply Agreement (the “Agreement”) with Liqmeds Worldwide Limited
(“LMW”) for Zonisamide oral liquid, a development stage product candidate (“ET-104”). Pursuant to the terms
of the Agreement, the Company is responsible for regulatory and marketing activities and LMW is responsible for
development and manufacturing of ET-104. The Company paid the licensor $ 350
upon execution of the Agreement and an additional
$ 350
after receiving successful bioequivalence study
results, and $ 325
upon the FDA’s acceptance of the NDA for
review and will pay $ 325
upon FDA approval of the NDA, $ 650
upon issuance of patent covering ET-104 listed
in the FDA’s Orange Book and $ 500
in the event that product sales in excess of
$ 10,000
were achieved within a calendar year. In addition,
the Company was required to pay the licensor 35 %
of the net profit from product sales. The Agreement was for an initial term of 10
years from the date of the first commercial sale
of the product. The Company was to retain sole ownership of the NDA after expiration of the Agreement.
On
June 12, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-105 License Agreement”) with
Aucta Pharmaceuticals, Inc. (“Aucta”) for marketing rights in the United States to Lamotrigine, an oral suspension product
candidate for use as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of
Lennox-Gastaut syndrome in patients two years of age and older. Pursuant to the terms of the ET-105 License Agreement, the Company was
to be responsible for marketing activities and Aucta will be responsible for development, manufacturing, and regulatory activities related
to obtaining regulatory approval. The Company paid Aucta a licensing payment of $ 2,000 in August 2019 upon receiving an acceptance for
review letter from the FDA and will pay $ 2,450 upon FDA approval and commercial sales of the product candidate and another $ 1,000 upon
issuance of an Orange-book listed patent. If Aucta successfully completes a Lamotrigine product line extension product, Eton will pay
$ 1,500 upon FDA acceptance of the product filing, $ 1,500 upon FDA approval and commercial sales of the extension product candidate and
$ 450 if the intellectual property for the extension product is transferred to Azurity. Aucta will be entitled to receive milestone payments
from the Company of up to $ 3,000 based on commercial success of the product, including:
●
$ 1,000 when net sales exceed
$10 million in a calendar year
●
$ 2,000 when net sales exceed
$20 million in a calendar year
Azurity
has assumed royalty or profit share obligations owed to development partners as well as additional milestone payments based on
sales volume targets.
On
March 27, 2020, the Company entered into an Exclusive Licensing and Supply Agreement (the “Alkindi License Agreement”) with
Diurnal for marketing Alkindi Sprinkle in the United States. Alkindi Sprinkle’s New Drug Application (NDA) was approved by the
FDA on September 29, 2020 as a replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia
(CAH) in patients from birth to less than 17 years of age.
For
the initial licensing milestone fee, the Company paid Diurnal $ 3,500 in cash and issued 379,474 shares of its common stock to Diurnal
which were valued at $ 1,264 based on the Company’s closing stock price of $ 3.33 on March 26, 2020. The total amount of $ 4,764 was
recorded as a component of research and development expense in the Company’s statement of operations for the year ended December
31, 2020. The Company will also pay Diurnal $ 2,500 if the product obtains orphan drug exclusivity status from the FDA.
On
June 15, 2021, the Company acquired U.S. and Canadian rights to Crossject’s ZENEO® hydrocortisone needleless autoinjector,
which is under development as a rescue treatment for adrenal crisis. The Company expects to submit the New Drug Application (NDA) to
the FDA in 2023 and plans to request orphan drug designation. The Company paid Crossject $ 500
upon signing, $ 500
in March 2022 upon a completion of a successful
technical batch which is reflected as a component of research & development expense in the Company’s condensed statements
of operations for the period ended March 31, 2022, and could pay up to $ 4,000
in additional development milestones and up to
$ 6,000
in commercial milestones, as well as a 10 %
royalty on net sales.
On
October 28, 2021, the Company acquired the U.S. marketing rights to Carglumic Acid Tablets. The product’s Abbreviated New Drug
Application (“ANDA”), which is owned by Novitium Pharma, was approved by the FDA on October 12, 2021. The product is an AB-rated,
substitutable generic version of Carbaglu®. The Company paid $ 3,250
upon signing and retains 50 %
of the product profits with the balance being distributed to the licensor and manufacturer. The Company launched this product in December
2021.
21
Eton
Pharmaceuticals, Inc.
Notes
to Condensed Financial Statements
( in
thousands, except share and per share amounts)
(Unaudited)
Note
11 — Commitments and Contingencies (continued)
Indemnification
As
permitted under Delaware law and in accordance with the Company’s Amended and Restated Bylaws, the Company is required to indemnify
its officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company
is also party to indemnification agreements with its directors and officers. The Company believes the fair value of the indemnification
rights and agreements is minimal. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements
as of March 31, 2022 or December 31, 2021.
Note
12 — Subsequent Events
On
April 5, 2022, the Company amended its SWK Credit Agreement with SWK Holding Corporation (see Note 5).
22
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You
should read the following discussion and analysis of our financial condition and results of operations in conjunction with (i) our unaudited
interim condensed financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and (ii)
our audited financial statements and notes thereto and management’s discussion and analysis of financial condition and results
of operations Included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange
Commission (the “SEC”) on March 16, 2022 (the “2021 10-K”).
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section
21E of the Securities Exchange Act of 1934 (the “Exchange Act”), including, without limitation, statements regarding our
expectations, beliefs, intentions or future strategies that are signified by the words “expect,” “anticipate,”
“intend,” “believe,” “may,” “plan”, “seek” or similar language. All forward-looking
statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update
any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties. Actual
results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully
consider other matters set forth in our SEC filings including the Risk Factors set forth in Part I, Item 1A of our 2021 10-K.
Overview
We
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 eleven products. Six of our products have been approved by the FDA and commercially
launched. We plan to continue growing our business through the acquisition of additional late-stage, high-value product candidates.
Results
of Operations
For
the three months ended March 31, 2022, we had $2,176 in revenue from product sales and royalties which generated a gross profit
of $1,458. We had total revenue of $11,897 for the three-month period ended March 31, 2021 which reflected Azurity and Bausch
milestone revenues for $11,000 plus product sales and royalty revenues which generated a total gross profit of $10,307 for the period.
Research
and Development Expenses
For
the three months ended March 31, 2022 we incurred $1,618 of research and development expenses (“R&D”) as compared to
the $886 for the same period in 2021. The increase was primarily due to a $500 technical batch milestone fee to Crossject for Zeneo hydrocortisone
autoinjector development and continued development efforts for our other new product candidates.
General
and Administrative Expenses
General
and administrative (“G&A”) expenses consist primarily of employee compensation expenses, legal and professional fees,
product marketing expenses, distribution expenses, business insurance, travel expenses and general office expenses.
For
the three-month periods ended March 31, 2022 and 2021, we incurred $4,927 and $4,058, respectively, of G&A expenses. The $869 increase
in G&A expense was mainly due to increased compensation expenses to support our product sales growth and increased legal expenses
on our Paragraph IV patent challenge related to L-Cysteine, partially offset by reduced product marketing expenses related to Alkindi
Sprinkle commercialization.
23
Liquidity
and Capital Resources
As
of March 31, 2022, we had total assets of $23.2 million, cash and cash equivalents of $15.2 million and working capital of $15.3
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. In March and April 2020, we received net proceeds
of approximately $7.8 million from the sale of shares of our common stock, and in October 2020, we received net proceeds of approximately
$21.0 million from a public offering of our common stock at an offering price of $7.00 per share. We believe that our existing funding,
revenues from our approved products and additional milestone payments expected to be paid in 2022 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.
Cash
Flows
The
following table sets forth a summary of our cash flows for the three-month periods ended March 31, 2022 and 2021:
Three months ended
March 31, 2022
Three months ended
March 31, 2021
Net cash provided by operating activities
$ 1,223
$ 3,715
Cash used in investing activities
(15 )
—
Cash flows (used in) provided by financing activities
(385 )
103
Change in cash and cash equivalents
$ 823
$ 3,818
The
decrease in cash provided by operating activities was mainly a result of the net income in the 2021 period partially offset by changes
in working capital as compared to the net loss in the 2022 period and favorable working capital changes – in particular, the collection
of the $5,000 milestone from Azurity related to the December 2021 product launch for EPRONTIA®. The 2022 financing activity
was an initial payment on our loan principal (see Note 5) whereas the 2021 financing activity was the result of stock option exercises.
24
Critical
Accounting Policies
Our
condensed financial statements are prepared in accordance with accounting principles generally accepted in the United States of America
(“GAAP”). The preparation of our condensed financial statements and related disclosures 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. Our actual results may differ from these estimates
under different assumptions or conditions.
While
our significant accounting policies are described in more detail in Note 3 to our financial statements included herein, we believe that
the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue
Recognition
We
account for contracts with our customers in accordance with Accounting Standards Codification (“ASC”) 606 — Revenue
from Contracts with Customers. ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other
standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount
that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition
for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify
the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv)
allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies
a performance obligation.
At
contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within
each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. We
then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as)
the performance obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable at a customer’s
discretion are generally considered options. We assess whether these options provide a material right to the customer and, if so, they
are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes.
We
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.
Milestone
Payments – If a commercial contract arrangement includes development and regulatory milestone payments, we will evaluate whether
the milestone conditions have been achieved and if it is probable that a significant revenue reversal would not occur before recognizing
the associated revenue. Milestone payments that are not within our control or the licensee’s control, such as regulatory approvals,
are generally not considered probable of being achieved until those approvals are received.
Royalties
– For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the
result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate,
we will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or
all of the royalty has been allocated has been satisfied or partially satisfied.
Significant
Financing Component – In determining the transaction price, we will adjust consideration for the effects of the time value
of money if the expected period between payment by the licensees and the transfer of the promised goods or services to the licensees
will be more than one year.
25
We
sell Biorphen in the U.S. to wholesale pharmaceutical distributors, who then sell the product to hospitals and other end-user customers.
Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual shipments
of Biorphen represent performance obligations under each purchase order. We use a third-party logistics (“3PL”) vendor to
process and fulfill orders and have concluded it is the principal in the sales to wholesalers because it controls access to the 3PL vendor
services rendered and directs the 3PL vendor activities. We have no significant obligations 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.
Selling
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 programs.
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 these fees are not distinct
from our sales of Biorphen, and accordingly we apply these amounts to reduce revenues. Wholesalers also have rights to return unsold
product nearing or past the expiration date. Because of the shelf life of Biorphen and our lengthy return period, there may be a significant
period of time between when the product is shipped and when we issue credits on returned product. 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.
We
estimate the transaction price when we receive each purchase order, taking into account the expected reductions of the selling price
initially billed to the wholesaler arising from all of the above factors. We have developed estimates for future returns and chargebacks
of Biorphen and the impact of the other discounts and fees we pay. 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.
We
recognize revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location. At that time,
the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation
to pay us. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers
have product return rights, we do not believe they have a significant incentive to return the product to us. 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.
Upon
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 receivable. 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.
Stock-Based
Compensation
We
account for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) – 718 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 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”).
We
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. 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 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 they occur.
26
Prior
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.
Research
and Development Expenses
R&D
expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries,
benefits and stock-based compensation and other costs to support our R&D operations. External contracted services include product
development efforts including certain product licensor milestone payments, clinical trial activities, manufacturing and control-related
activities and regulatory costs. R&D expenses are charged to operations as incurred. We review and accrue R&D expenses based
on services performed and rely upon estimates of those costs applicable to the stage of completion of each project. Significant judgments
and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from our estimates.
Upfront
payments and milestone payments made for the licensing of technology for products that are not yet approved by the FDA are expensed as
R&D in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for
use in R&D activities are recorded as prepaid expenses and are expensed as the related goods are delivered or the services are performed.
Off
Balance Sheet Transactions
We
do not have any off-balance sheet transactions.
27
JOBS
Act Transition Period
In
April 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), was enacted. Section 107 of the JOBS Act provides
that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of
the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of
certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail
ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates
on which adoption of such standards is required for other public companies.
We
are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. 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.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
The
primary objective of our investment activities is to preserve capital. We do not utilize hedging contracts or similar instruments. We
are exposed to certain market risks relating primarily to interest rate risk on our cash and cash equivalents invested during the period
and risks relating to the financial viability of the institutions which hold our capital and through which we have invested our funds.
We manage such risks by investing in short-term, liquid, highly-rated instruments. As of March 31, 2022, all of our cash is in a non-interest
bearing account due to the current low-interest rate environment. We do not currently have exposure to foreign currency risk.
28
Item
4. Controls and Procedures
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange
Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information
is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, to allow timely
decisions regarding required disclosure.
The
design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
With
respect to the three-month period ended March 31, 2022, under the supervision and with the participation of our management, we conducted
an evaluation of the effectiveness of the design and operations of our disclosure controls and procedures. Based upon this evaluation,
the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and
procedures are effective.
Management
does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system,
no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control systems
are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls
must be considered relative to their costs. Because of the inherent limitations in a cost-effective control system, no evaluation of
internal control over financial reporting can provide absolute assurance that misstatements due to error or fraud will not occur or that
all control issues and instances of fraud, if any, have been or will be detected.
Changes
in Internal Control over Financial Reporting
There
has not been any change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act) that occurred during the period ended March 31, 2022 that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
29
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
We
operate in a dynamic and rapidly changing environment that involves numerous risks and uncertainties. Certain factors may have a material
adverse effect on our business, financial condition, and results of operations, and you should carefully consider them. Other events
that we do not currently anticipate or that we currently deem immaterial may also affect our results of operations and financial condition.
You
should carefully consider the factors discussed in Part I, Item 1A. “Risk Factors” in our 2021 10-K, which could materially
affect our business, financial condition, cash flows or future results. The risk factors described in our 2021 10-K, which was filed
with the SEC on March 16, 2022, are not the only risks facing our company. Additional risks and uncertainties not currently known to
us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, or future results.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
Not
applicable
Item
3. Defaults Upon Senior Securities
Not
applicable.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
Not
applicable.
Item
6. Exhibits
The
exhibits listed on the Exhibit Index are either filed or furnished with this report or incorporated herein by reference.
EXHIBIT
INDEX
Exhibit
No.
Description
10.1
Credit Agreement by and among the Company, the Lenders party thereto, and SWK Funding LLC , as administrative agent dated as of November 13, 2019 and conformed through Third Amendment dated as of April 5, 2022.
31.1
Certification of President and Chief Executive Officer (Principal Executive Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of Chief Financial Officer (Principal Financial Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certifications of President and Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101
The following financial
information from the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2022, formatted in Extensible Business
Reporting Language (XBRL): (i) the Condensed Balance Sheets, (ii) the Condensed Statements of Operations, (iii) the Condensed Statements
of Stockholders’ Equity, (iv) the Condensed Statements of Cash Flows and (v) Notes to Condensed Financial Statements.
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension
Schema Document
101.CAL
Inline XBRL Taxonomy Extension
Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension
Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension
Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension
Presentation Linkbase Document
104
Cover Page Interactive Data
File (embedded within the Inline XBRL document)
*
These certifications are
being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of
the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
30
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
ETON PHARMACEUTICALS, INC.
May 12, 2022
By:
/s/ Sean
E. Brynjelsen
Sean E. Brynjelsen
President and Chief Executive Officer
(Principal Executive Officer)
By:
/s/ James
R. Gruber
James R. Gruber
Chief Financial Officer
(Principal Financial Officer)
31
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.