Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
(Unaudited)
June
30,
December
31,
2022
2021
Assets
Current
assets:
Cash
and cash equivalents
$ 4,981,193
$ 2,950,552
Marketable
investment securities
32,414,473
41,667,405
Accrued
interest income
80,411
247,253
Prepaid
and other current assets
603,546
1,514,465
Total
current assets
38,079,623
46,379,675
Marketable
investment securities
-
2,021,800
Contract
asset
4,050,000
4,050,000
Property and equipment,
net of accumulated depreciation of $ 1,148,374 and $ 1,144,077
40,013
7,211
Other
assets
23,753
23,753
Total
assets
$ 42,193,389
$ 52,482,439
Liabilities
and Stockholders’ Equity
Current
liabilities:
Accounts
payable
$ 814,004
$ 1,289,342
Accrued
expenses
899,301
1,016,458
Debt
- current portion
-
2,310,825
Litigation
settlement liability - current portion
-
1,000,000
Total
current liabilities
1,713,305
5,616,625
Warrant
liability
590,339
795,796
Litigation
settlement liability - non-current portion
-
500,000
Total
liabilities
2,303,644
6,912,421
Commitments
and contingencies (notes 6, 8, 9 and 11)
-
-
Stockholders’
equity:
Preferred
stock, par value $ 0.0001 per share, 10,000,000 shares authorized; zero issued and outstanding
-
-
Common
stock, par value $ 0.0001 per share, 200,000,000 shares authorized; 88,504,834 and 88,296,360 issued and 88,499,124 and 88,290,650
outstanding
8,850
8,829
Additional
paid-in capital
218,792,479
218,286,324
Treasury
stock at cost, 5,710 shares
( 40,712 )
( 40,712 )
Accumulated
other comprehensive loss
( 84,907 )
( 18,016 )
Accumulated
deficit
( 178,785,965 )
( 172,666,407 )
Total
stockholders’ equity
39,889,745
45,570,018
Total
liabilities and stockholders’ equity
$ 42,193,389
$ 52,482,439
See
accompanying notes to unaudited condensed consolidated financial statements
3
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
2022
2021
2022
2021
Three
Months Ended June 30,
Six
Months Ended June 30,
2022
2021
2022
2021
Revenues:
$ 500,000
$ -
$ 500,000
$ -
Operating
expenses:
Research
and development
2,898,012
1,464,687
4,785,965
3,045,228
General
and administrative
1,129,519
1,525,592
2,373,205
3,059,544
Total
operating expenses
4,027,531
2,990,279
7,159,170
6,104,772
Operating
loss
( 3,527,531 )
( 2,990,279 )
( 6,659,170 )
( 6,104,772 )
Other
income (expense):
Interest
and investment income
69,877
17,344
111,453
27,993
Interest
expense
( 7,568 )
( 57,428 )
( 27,098 )
( 126,401 )
Unrealized
gain on warrant liability
583,445
221,322
205,457
26,257
Gain
(loss) litigation settlement liability
250,000
( 4,000,000 )
250,000
( 4,000,000 )
Total
other income (expense), net
895,754
( 3,818,762 )
539,812
( 4,072,151 )
Loss
before income tax expense
( 2,631,777 )
( 6,809,041 )
( 6,119,358 )
( 10,176,923 )
Income
tax expense
-
-
( 200 )
( 200 )
Net
loss
$ ( 2,631,777 )
$ ( 6,809,041 )
$ ( 6,119,558 )
$ ( 10,177,123 )
Basic
loss per share attributable to common stock
$ ( 0.03 )
$ ( 0.08 )
$ ( 0.07 )
$ ( 0.12 )
Weighted
average common shares outstanding, basic
88,499,067
88,290,650
88,404,999
85,556,110
Diluted
loss per share attributable to common stock
$ ( 0.04 )
$ ( 0.08 )
$ ( 0.07 )
$ ( 0.12 )
Weighted
average common shares outstanding, diluted
88,998,515
88,998,292
88,987,800
86,294,935
Comprehensive
loss:
Net
loss
$ ( 2,631,777 )
$ ( 6,809,041 )
$ ( 6,119,558 )
$ ( 10,177,123 )
Net
unrealized gain (loss) on available-for-sale securities
( 17,491 )
22,273
( 66,891 )
( 186 )
Comprehensive
loss
$ ( 2,649,268 )
$ ( 6,786,768 )
$ ( 6,186,449 )
$ ( 10,177,309 )
See
accompanying notes to unaudited condensed consolidated financial statements
4
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
For
the Three and Six Months Ended June 30, 2022 and 2021
(Unaudited)
Number
of Shares
Amount
Number
of Shares
Amount
Paid-In
Capital
Comprehensive
Loss
Accumulated
Deficit
Stockholders’
Equity
Common
Stock
Treasury
Stock
Additional
Accumulated
Other
Total
Number
of Shares
Amount
Number
of Shares
Amount
Paid-In
Capital
Comprehensive
Loss
Accumulated
Deficit
Stockholders’
Equity
Balances
at March 31, 2021
88,290,650
$ 8,830
5,710
$ ( 40,712 )
$ 217,845,280
$ ( 22,459 )
$ ( 175,400,090 )
$ 42,390,849
Net
loss
-
-
-
-
-
-
( 6,809,041 )
( 6,809,041 )
Unrealized
net gain on marketable investment securities
-
-
-
-
-
22,273
-
22,273
Stock-based
compensation
-
-
-
-
146,747
-
-
146,747
Costs
associated with ATM offering
-
-
-
-
( 5,275 )
-
-
( 5,275 )
Balances
at June 30, 2021
88,290,650
$ 8,830
5,710
$ ( 40,712 )
$ 217,986,752
$ ( 186 )
$ ( 182,209,131 )
$ 35,745,553
Common
Stock
Treasury
Stock
Additional
Accumulated
Other
Total
Number
of Shares
Amount
Number
of Shares
Amount
Paid-In
Capital
Comprehensive
Loss
Accumulated
Deficit
Stockholders’
Equity
Balances
at December 31, 2020
70,036,257
$ 7,005
5,710
$ ( 40,712 )
$ 187,407,634
$ -
$ ( 172,032,008 )
$ 15,341,919
Net
loss
-
-
-
-
-
-
( 10,177,123 )
( 10,177,123 )
Unrealized
net loss on marketable investment securities
-
-
-
-
-
( 186 )
-
( 186 )
Stock-based
compensation
-
-
-
-
294,313
-
-
294,313
Option
exercises
4,584
-
-
-
6,693
-
-
6,693
Common
stock sold through equity offering
16,428,571
1,643
-
-
26,838,814
-
-
26,840,457
Common
stock issued for warrant exercises
10,000
1
-
-
4,999
-
-
5,000
Settlement
of warrant liability on warrant exercises
-
-
-
-
18,365
-
-
18,365
Common
stock sold through ATM offering
1,811,238
181
-
-
3,415,934
-
-
3,416,115
Balances
at June 30, 2021
88,290,650
$ 8,830
5,710
$ ( 40,712 )
$ 217,986,752
$ ( 186 )
$ ( 182,209,131 )
$ 35,745,553
Common
Stock
Treasury
Stock
Additional
Accumulated
Other
Total
Number
of Shares
Amount
Number
of Shares
Amount
Paid-In
Capital
Comprehensive
Gain (Loss)
Accumulated
Deficit
Stockholders’
Equity
Balances
at March 31, 2022
88,498,924
$ 8,850
5,710
$ ( 40,712 )
$ 218,663,319
$ ( 67,416 )
$ ( 176,154,188 )
$ 42,409,853
Net
loss
-
-
-
-
-
-
( 2,631,777 )
( 2,631,777 )
Unrealized
net loss on marketable investment securities
-
-
-
-
-
( 17,491 )
( 17,491 )
Stock-based
compensation
-
-
-
-
139,569
-
-
139,569
Option
Exercises
200
-
-
-
91
-
-
91
Costs
associated with ATM offering
-
-
-
-
( 10,500 )
-
-
( 10,500 )
Balances
at June 30, 2022
88,499,124
$ 8,850
5,710
$ ( 40,712 )
$ 218,792,479
$ ( 84,907 )
$ ( 178,785,965 )
$ 39,889,745
Common
Stock
Treasury
Stock
Additional
Accumulated
Other
Total
Number
of Shares
Amount
Number
of Shares
Amount
Paid-In
Capital
Comprehensive
Gain (Loss)
Accumulated
Deficit
Stockholders’
Equity
Balances
at December 31, 2021
88,290,650
$ 8,829
5,710
$ ( 40,712 )
$ 218,286,324
$ ( 18,016 )
$ ( 172,666,407 )
$ 45,570,018
Net
loss
-
-
-
-
-
-
( 6,119,558 )
( 6,119,558 )
Unrealized
net loss on marketable investment securities
-
-
-
-
-
( 66,891 )
-
( 66,891 )
Unrealized
net gain (loss) on marketable investment securities
-
-
-
-
-
( 66,891 )
-
( 66,891 )
Stock-based
compensation
-
-
-
-
310,597
-
-
310,597
Option
exercises
208,474
21
-
-
206,058
-
-
206,079
Costs
associated with ATM offering
-
-
-
-
( 10,500 )
-
-
( 10,500 )
Balances
at June 30, 2022
88,499,124
$ 8,850
5,710
$ ( 40,712 )
$ 218,792,479
$ ( 84,907 )
$ ( 178,785,965 )
$ 39,889,745
See
accompanying notes to unaudited condensed consolidated financial statements
5
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
2022
2021
Six
Months Ended June 30,
2022
2021
Cash
flows from operating activities:
Net
loss
$ ( 6,119,558 )
$ ( 10,177,123 )
Adjustments
to reconcile net loss to cash used in operating activities:
Depreciation
expense
4,297
-
Stock-based
compensation expense
310,597
294,313
Non-cash
interest expense
5,842
33,886
Non-cash
gain on change in fair value of warrant liability
( 205,457 )
( 26,257 )
Amortization
of premium on marketable investment securities
87,282
203,958
Changes
in operating assets and liabilities:
Accrued
interest income
166,842
( 232,177 )
Prepaid
and other current assets
910,919
378,078
Accounts
payable
( 475,338 )
( 690,744 )
Accrued
expenses
( 117,157 )
( 208,990 )
Litigation
settlement liability
( 1,250,000 )
4,000,000
Gain on extinguishment
of litigation settlement liability
( 250,000 )
-
Cash
used in operating activities
( 6,931,731 )
( 6,425,056 )
Cash
flows from investing activities:
Purchase
of fixed assets
( 37,099 )
-
Purchases
of marketable investment securities
( 22,681,441 )
( 35,876,211 )
Maturities
of marketable investment securities
33,802,000
450,000
Cash
provided by (used in) investing activities
11,083,460
( 35,426,211 )
Cash
flows from financing activities:
Debt
repayments
( 1,666,667 )
( 1,666,667 )
End
of loan payment
( 650,000 )
-
Net
proceeds from common stock offering
-
26,840,457
Proceeds
from (costs associated with) ATM
( 10,500 )
3,416,115
Proceeds
from stock option exercises
206,079
6,693
Net
proceeds from exercise of warrants
-
5,000
Cash
provided by (used in) financing activities
( 2,121,088 )
28,601,598
Net
increase (decrease) in cash, cash equivalents, and restricted cash
2,030,641
( 13,249,669 )
Cash,
cash equivalents, and restricted cash at beginning of period
2,950,552
24,217,382
Cash,
cash equivalents, and restricted cash at end of period
$ 4,981,193
$ 10,967,713
Supplemental
disclosure of cash flow information:
Interest
paid
$ 21,256
$ 92,515
Income
taxes paid
200
200
Supplemental
disclosure of non-cash investing and financing activity:
Settlement
of warrant liability on warrant exercises
$ -
$ 18,365
Net
unrealized loss on available-for-sale securities
( 66,891 )
( 186 )
Accrued
final payment charge on debt
5,842
33,886
See
accompanying notes to unaudited condensed consolidated financial statements
6
LIPOCINE
INC.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
(1)
Basis of Presentation
The
accompanying unaudited condensed consolidated financial statements included herein have been prepared by Lipocine Inc. (“Lipocine”
or the “Company”) in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”).
The unaudited condensed consolidated financial statements are comprised of the financial statements of Lipocine and its subsidiaries,
collectively referred to as the Company. In management’s opinion, the interim financial data presented includes all adjustments
(consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated.
Certain information required by U.S. generally accepted accounting principles (“U.S. GAAP”) has been condensed or omitted
in accordance with rules and regulations of the SEC. Operating results for the three and six months ended June 30, 2022 are not necessarily
indicative of the results that may be expected for any future period or for the year ending December 31, 2022.
These
unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial
statements and the notes thereto for the year ended December 31, 2021.
The
preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating
to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated
financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with U.S. GAAP. Actual
results could differ from these estimates.
The
Company believes that its existing capital resources, together with interest thereon, will be sufficient to meet its projected operating
requirements through at least June 30, 2023 which includes an on-going clinical study for LPCN 1148 and compliance with regulatory requirements.
The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital resources
sooner than it currently expects if additional activities are performed by the Company including clinical studies for LPCN 1148, LPCN
1144, LPCN 1111, LPCN1107, LPCN 1154 and LPCN 2101. While the Company believes it has sufficient liquidity and capital resources to fund
our projected operating requirements through at least June 30, 2023, the Company will need to raise additional capital at some point
through the equity or debt markets or via out-licensing activities, before or after June 30, 2023, to support its operations. If the
Company is unsuccessful in raising additional capital, its ability to continue as a going concern may become a risk. Further, the Company’s
operating plan may change, and the Company may need additional funds to meet operational needs and capital requirements for product development,
regulatory compliance and clinical trial activities sooner than planned. In addition, the Company’s capital resources may be consumed
more rapidly if it pursues additional clinical studies for LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107, LPCN 1154 and LPCN 2101. Conversely,
the Company’s capital resources could last longer if it reduces expenses, reduces the number of activities currently contemplated
under our operating plan, terminates, modifies the design or suspends on-going clinical studies or terminates or settles
any on-going litigation activities.
(2)
Revenue
The
Company generates most of its revenue from license and royalty arrangements. At inception of each contract, the Company identifies the
goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines
the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and
determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction
price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when
the uncertainty associated with the variable consideration is subsequently resolved. The Company reassess its reserves for variable consideration
at each reporting date and makes adjustments, if necessary, which may affect revenue and earnings in periods in which any such changes
become known.
See
Note 8 for a description of the license agreement with Antares Pharma, Inc. (“Antares”). See Note 12 for a description of
the agreement with Spriaso.
License
Fees . For distinct license performance obligations, upfront license fees are recognized when the Company satisfies the underlying
performance obligation. This generally occurs upon transfer of the right to use the Company’s licensed technology to the customer.
In addition, license arrangements may include contingent milestone payments, which are due following achievement by our licensee of specified
sales or regulatory milestones and the licensee and/or Company will fulfill its performance obligation prior to achievement of these
milestones. Because of the uncertainty of the milestone achievement, and/or the dependence on sales of our licensee, variable consideration
for contingent milestones is fully constrained and is not recognized as revenue until the milestone is achieved by our licensee, to the
extent collectability is reasonably certain.
7
Royalties .
Royalties revenue consists of sales-based and minimum royalties earned under licenses agreements for our products. Performance obligations
under these licenses, which consist of the right to use the Company’s proprietary technology, are satisfied at a point in time
corresponding with delivery of the underlying technology rights to the licensee, which is generally upon transfer of the licensed technology/product
to the customer. Sales-based royalties revenue represents variable consideration under the license agreements and is recognized in the
period a customer sells products incorporating the Company’s licensed technologies/products. The Company estimates sales-based
royalties revenue earned but unpaid at each reporting period using information provided by the licensee. The Company’s license
arrangements may also provide for minimum royalties, which the Company recognizes upon the satisfaction of the underlying performance
obligation, which generally occurs with delivery of the underlying technology rights to the licensee. Sales-based and minimum royalties
are generally due within 45 days after the end of each quarter in which they are earned.
Contract
Assets. Contract assets consist of minimum royalty revenue earned in relation to the license agreement but not yet payable based
on the terms of the contract. The contract asset as of June 30, 2022 is related to the Antares License Agreement. Based on the terms
of the license agreement, the Company estimates that it will receive a payment of approximately $ 235,000 for royalties on estimated second
quarter 2022 net sales of TLANDO under this agreement. Receipt of this payment will reduce the contract asset in the third quarter of
2022.
Revenue
Concentration. A major customer is considered to be one that comprises more than 10 %
of the Company’s total revenues. The Company recognized license revenue of $ 500,000 for
the three and six months ended June 30, 2022, and zero for the three and six months ended June 30, 2021. The revenue recognized was 100 %
from one major customer, Antares.
(3)
Earnings (Loss) per Share
Basic
earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number
of common shares outstanding during the period. Diluted earnings (loss) per share is based on the weighted average number of common shares
outstanding plus, where applicable, the additional potential common shares that would have been outstanding related to dilutive options,
warrants and, unvested restricted stock units to the extent such shares are dilutive.
The
following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the three and six months
ended June 30, 2022 and 2021:
Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock
2022
2021
2022
2021
Three
Months Ended June 30,
Six
Months Ended June 30,
2022
2021
2022
2021
Basic
loss per share attributable to common stock:
Numerator
Net
loss
$ ( 2,631,777 )
$ ( 6,809,041 )
$ ( 6,119,558 )
$ ( 10,177,123 )
Denominator
Weighted
avg. common shares outstanding
88,499,067
88,290,650
88,404,999
85,556,110
Basic
loss per share attributable to common stock
$ ( 0.03 )
$ ( 0.08 )
$ ( 0.07 )
$ ( 0.12 )
Diluted
loss per share attributable to common stock:
Numerator
Net
loss
$ ( 2,631,777 )
$ ( 6,809,041 )
$ ( 6,119,558 )
$ ( 10,177,123 )
Effect of dilutive securities on net loss:
Common stock warrants
583,445
221,322
205,457
26,257
Total net loss for purpose of calculating diluted net loss per common share
$ ( 3,215,222 )
$ ( 7,030,363 )
$ ( 6,325,015 )
$ ( 10,203,380 )
Denominator
Weighted
avg. common shares outstanding
88,499,067
88,290,650
88,404,999
85,556,110
Weighted average effect of dilutive securities:
Common
stock warrants
499,448
697,642
582,801
738,825
Total shares for purpose of calculating diluted net loss per common share
88,998,515
88,988,292
88,987,800
86,294,935
Diluted
loss per share attributable to common stock
$ ( 0.04 )
$ ( 0.08 )
$ ( 0.07 )
$ ( 0.12 )
8
The
computation of diluted loss per share for the three and six months ended June 30, 2022 and 2021 does not include the following stock
options and warrants to purchase shares of common stock in the computation of diluted loss per share because these instruments were antidilutive:
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
June
30,
2022
2021
Stock
options
4,026,882
3,915,790
Warrants
840,336
840,336
(4)
Marketable Investment Securities
The
Company has classified its marketable investment securities as available-for-sale securities, all of which are debt securities. These
securities are carried at fair value with unrealized holding gains and losses, net of the related tax effect, included in accumulated
other comprehensive income (loss) in stockholders’ equity until realized. Gains and losses on investment security transactions
are reported on the specific-identification method. Dividend income is recognized on the ex-dividend date and interest income is recognized
on an accrual basis. The amortized cost, gross unrealized holding gains, gross unrealized holding losses, and fair value for available-for-sale
securities by major security type and class of security at June 30, 2022 and December 31, 2021 were as follows:
Schedule of Available-for-Sale Securities
June
30, 2022
Amortized
Cost
Gross
unrealized holding gains
Gross
unrealized holding losses
Aggregate
fair value
Government
treasury bills
$ 9,514,989
$ -
$ ( 50,974 )
$ 9,464,015
Corporate
bonds, notes and commercial paper
22,984,391
-
( 33,933 )
22,950,458
$ 32,499,380
$ -
$ ( 84,907 )
$ 32,414,473
December
31, 2021
Amortized
Cost
Gross
unrealized holding gains
Gross
unrealized holding losses
Aggregate
fair value
Government
treasury bills
$ 5,526,122
-
( 10,202 )
$ 5,515,920
Commercial
paper
38,181,099
-
( 7,814 )
38,173,285
$ 43,707,221
$ -
$ ( 18,016 )
$ 43,689,205
Maturities
of debt securities classified as available-for-sale securities at June 30, 2022 are as follows:
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities
June
30, 2022
Amortized
Cost
Aggregate
fair
value
Due
within one year
$ 32,499,380
$ 32,414,473
$ 32,499,380
$ 32,414,473
9
There
were no sales of marketable investment securities during the three and six months ended June 30, 2022 and 2021, and therefore no realized
gains or losses. Additionally, during the three months ended June 30, 2022 and 2021, $ 8.6 million and $ 0 marketable investment securities
matured, and $ 33.8 million and $ 450,000 of marketable investment securities matured during the six months ended June 30, 2022 and 2021,
respectively. The Company determined there were no other-than-temporary impairments for the three and six months ended June 30, 2022
and 2021.
(5)
Fair Value
The
Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent
possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability
in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following
fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels:
●
Level
1 Inputs: Quoted prices for identical instruments in active markets.
●
Level
2 Inputs: Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets
that are not active, and model-derived valuation in which all significant inputs and significant value drivers are observable in
active markets.
●
Level
3 Inputs: Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
All
of the Company’s financial instruments are valued using quoted prices in active markets or based on other observable inputs. For
accrued interest income, prepaid and other current assets, accounts payable, and accrued expenses, the carrying amounts approximate fair
value because of the short maturity of these instruments. The following table presents the placement in the fair value hierarchy of assets
and liabilities that are measured at fair value on a recurring basis at June 30, 2022 and December 31, 2021:
Schedule of Fair Value, Assets Measured on Recurring Basis
Fair
value measurements at reporting date using
June
30, 2022
Level
1 inputs
Level
2 inputs
Level
3 inputs
Assets:
Cash
equivalents - money market funds
$ 4,753,610
$ 4,753,610
$ -
$ -
Government
treasury bills
9,464,015
9,464,015
-
-
Commercial
paper
17,157,364
-
17,157,364
-
Corporate
bonds and notes
5,793,094
-
5,793,094
-
$ 37,168,083
$ 14,217,625
$ 22,950,458
$ -
Liabilities:
Warrant
liability
$ 590,339
-
-
590,339
$ 37,758,422
$ 14,217,625
$ 22,950,458
$ 590,339
Fair
value measurements at reporting date using
December
31, 2021
Level
1 inputs
Level
2 inputs
Level
3 inputs
Assets:
Cash
equivalents - money market funds
$ 2,089,751
$ 2,089,751
$ -
$ -
Government
treasury bills
5,515,920
5,515,920
-
-
Commercial
paper
15,385,634
-
15,385,634
-
Corporate
bonds and notes
22,787,651
-
22,787,651
-
$ 45,778,956
$ 7,605,671
$ 38,173,285
$ -
Liabilities:
Warrant
liability
$ 795,796
-
-
795,796
$ 46,574,752
$ 7,605,671
$ 38,173,285
$ 795,796
10
The
following methods and assumptions were used to determine the fair value of each class of assets and liabilities recorded at fair
value in the balance sheets:
Cash
equivalents: Cash equivalents primarily consist of highly-rated money market funds and treasury bills with original maturities to the
Company of three months or less and are purchased daily at par value with specified yield rates. Cash equivalents related to money market
funds and treasury bills are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices
or broker or dealer quotations for similar assets.
Government
treasury bills: The Company uses a third-party pricing service to value these investments. United States treasury bills are classified
within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets for identical assets
and reportable trades.
Corporate
bonds, notes, and commercial paper: The Company uses a third-party pricing service to value these investments. Corporate bonds, notes
and commercial paper are classified within Level 2 of the fair value hierarchy because they are valued using broker/dealer quotes, bids
and offers, benchmark yields and credit spreads and other observable inputs.
Warrant
liability: The warrant liability (which relates to warrants to purchase shares of common stock)
is marked-to-market each reporting period with the change in fair value recorded to other income (expense) in the accompanying statements
of operations until the warrants are exercised, expire or other facts and circumstances lead the warrant liability to be reclassified
to stockholders’ equity. The fair value of the warrant liability is estimated using a Black-Scholes option-pricing model. The significant
assumptions used in preparing the option pricing model for valuing the warrant liability as of June 30, 2022, include (i) volatility
of 100.0 %, (ii) risk free interest rate of 2.99 %, (iii) strike price of $ 0.50 , (iv) fair value of common stock of $ 0.80 , and (v) expected
life of 2.38 years. The significant assumptions used in preparing the option pricing model for valuing the warrant liability as of December
31, 2021, include (i) volatility of 100.0 %, (ii) risk free interest rate of 0.97 %, (iii) strike price of $ 0.50 , (iv) fair value of common
stock of $ 0.99 , and (v) expected life of 2.88 years.
The
Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change
in circumstances that caused the transfer. There were no transfers into or out of Level 1, Level 2, or Level 3 for the three and six
months ended June 30, 2022.
(6)
Loan and Security Agreements and Other Liabilities
Silicon
Valley Bank Loan
On
January 5, 2018, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Silicon
Valley Bank (“SVB”) pursuant to which SVB agreed to lend the Company $ 10.0 million. The principal borrowed under the
Loan and Security Agreement bore interest at a rate equal to the Prime Rate, as reported in the money rates section of The Wall
Street Journal or any successor publication representing the rate of interest per annum then in effect, plus one percent per annum,
which interest was payable monthly. Additionally on April 1, 2020, the Company entered into a Deferral Agreement with SVB. Under the
Deferral Agreement, principal repayments were deferred by six months and the Company was only required to make monthly interest
payments. The loan matured and was paid in full on June 1, 2022 . The Company made a final payment at maturity equal to
$ 650,000 (the “Final Payment Charge”) at the time the loan matured. The expense of the final payment charge had been
recognized over the term of the facility using the effective interest method.
(7)
Income Taxes
The
tax provision for interim periods is determined using an estimate of the Company’s effective tax rate for the full year adjusted
for discrete items, if any, that are taken into account in the relevant period. Each quarter the Company updates its estimate of the
annual effective tax rate, and if the estimated tax rate changes, the Company makes a cumulative adjustment.
At
June 30, 2022 and December 31, 2021, the Company had a full valuation allowance against its deferred tax assets, net of expected reversals
of existing deferred tax liabilities, as it believes it is more likely than not that these benefits will not be realized.
(8)
Contractual Agreements
(a)
Abbott Products, Inc.
On
March 29, 2012, the Company terminated its collaborative agreement with Solvay Pharmaceuticals, Inc. (later acquired by Abbott
Products, Inc.) for TLANDO. As part of the termination, the Company reacquired the rights to the intellectual property from Abbott.
All obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1 % royalty on
net sales. Such royalties are limited to $ 1.0 million in the first two calendar years following product launch, after which period
there is not a cap on royalties and no maximum aggregate amount. If generic versions of any such product are introduced, then
royalties are reduced by 50 %. The Company incurred royalty expense of $ 17,000 during the three and six months ended June 30, 2022
and did not incur any royalties expense during the three and six months ended June 30, 2021.
11
(b)
Antares Pharma, Inc.
On
October 14, 2021, the Company entered into a license agreement (“License Agreement”) with Antares Pharma, Inc. (“Antares”)
pursuant to which the Company granted to Antares an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize,
upon final approval of TLANDO® from the U.S. Food and Drug Administration (“FDA”), the Company’s TLANDO product
with respect to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone,
as indicated in NDA No. 208088, treatment of Klinefelter syndrome, and pediatric indications relating to testosterone replacement therapy
in males for conditions associated with a deficiency or absence of endogenous testosterone (the “Field”), in each case within
the United States. The Antares License Agreement also provided Antares with an option, exercisable on or before March 31, 2022, to license
TLANDO XR (LPCN 1111), the Company’s potential once-daily oral product candidate for testosterone replacement therapy. On April
1, 2022, the Company entered into the First Amendment to the License Agreement (the “Amendment”), pursuant to which the License
Agreement was amended to extend the deadline by which Antares shall exercise its option to license TLANDO XR to June 30, 2022. As consideration
for the Company agreeing to enter into the Amendment, in April 2022 Antares paid the Company a non-refundable cash fee of $ 500,000 . On
June 24, 2022, Antares informed the Company that they would not be exercising their option to license TLANDO XR. Lipocine retains all
development and commercialization rights to TLANDO XR. Upon execution of the Antares License Agreement, Antares paid to the Company an
initial payment of $ 11.0 million. Antares will also make additional payments of $ 5.0 million to the Company on each of January 1, 2025,
and January 1, 2026, provided that certain conditions are satisfied. The Company is also eligible to receive milestone payments of up
to $ 160.0 million in the aggregate, depending on the achievement of certain sales milestones in a single calendar year with respect to
TLANDO, as licensed by Antares under the Antares License Agreement. In addition, upon commercialization, the Company will receive tiered
royalty payments at rates ranging from percentages in the mid-teens to up to 20 % of net sales of TLANDO in the United States, subject
to certain minimum royalty obligations. The Company retains development and commercialization rights in the rest of the world, and with
respect to applications outside of the Field inside or outside the United States. Antares also purchased certain existing inventory of
licensed products from the Company. Finally, pursuant to the terms of the Antares License Agreement, Antares is generally responsible
for expenses relating to the development (including the conduct of any clinical trials) and commercialization of TLANDO in the Field
in the United States, while the Company is generally responsible for expenses relating to development activities outside of the Field
and/or the United States. The Company recognized license revenue under the Antares Licensing Agreement of $ 500,000 during the three and six months ended June 30, 2022, and zero during the three months and six months ended June 30, 2021.
On
May 24, 2022, Halozyme Therapeutics completed an acquisition of Antares Pharma Inc. through the merger of a wholly owned subsidiary
of Halozyme with and into Antares, with Antares continuing as the surviving corporation and becoming a wholly owned subsidiary of
Halozyme.
(c)
Contract Research and Development
The
Company has entered into agreements with various contract organizations that conduct pre-clinical, clinical, analytical and manufacturing
development work on behalf of the Company as well as a number of independent contractors and primarily clinical researchers who serve
as advisors to the Company. The Company incurred expenses of $ 2.1 million and $ 786,000 , respectively, for the three months ended June
30, 2022 and 2021 and $ 3.2 million and $ 1.7 million, respectively, for the six months ended June 30, 2022 and 2021 under these agreements
and has recorded these expenses in research and development expenses.
(9)
Leases
The
Company has a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah. The term of the lease
has been extended through February 28, 2023.
12
Future
minimum lease payments under non-cancelable operating leases as of June 30, 2022 are:
Schedule of Future Minimum Rental Payments for Operating Leases
Operating
leases
Year
ending December 31:
2022
$ 171,819
2023
57,273
Total
minimum lease payments
$ 229,092
The
Company’s rent expense was $ 86,000 and $ 83,000 for the three months ended June 30, 2022 and 2021, respectively. The Company’s
rent expense was $ 170,000 and $ 165,000 for the six months ended June 30, 2022 and 2021, respectively.
(10)
Stockholders’ Equity
On
June 8, 2022, at the 2022 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the
Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s
common stock, par value $ 0.0001 , from 100,000,000 shares to 200,000,000 shares. The Company filed the amendment to the Restated
Certificate with the Secretary of State of the State of Delaware on June 28, 2022. The amendment to the Restated Certificate became
effective upon filing with the Secretary of State of the State of Delaware.
(a)
Issuance of Common Stock
On
January 28, 2021, the Company completed a public offering of securities registered under an effective registration statement filed pursuant
to the Securities Act of 1933, as amended (“January 2021 Offering”). The gross proceeds from the January 2021 Offering were
approximately $ 28.7 million, before deducting underwriter fees and other offering expenses of $ 1.9 million. In the January 2021 Offering,
the Company sold 16,428,571 shares of its common stock.
On
February 27, 2020, the Company completed a registered direct offering of securities registered under an effective registration statement
filed pursuant to the Securities Act of 1933, as amended (“February 2020 Offering”). The gross proceeds from the February
2020 Offering were approximately $ 6.0 million, before deducting placement agent fees and other offering expenses of $ 347,000 . In the
February 2020 Offering, the Company sold 10,084,034 Class A Units at an offering price of $ 0.595 per unit, with each Class A Unit consisting
of one share of its common stock and one-half of a common warrant to purchase one share of common stock at an exercise price of $ 0.53
per share of common stock. Additionally, the common stock warrants were immediately exercisable and expire on February 27, 2025. By their
terms, however, the common stock warrants cannot be exercised at any time that the common stock warrant holder would beneficially own,
after such exercise, more than 4.99% (or, at the election of the holder, 9.99%) of the shares of common stock then outstanding after
giving effect to such exercise.
On
November 18, 2019, the Company completed a public offering of securities registered under an effective registration statement filed pursuant
to the Securities Act of 1933, as amended (“November 2019 Offering”). The gross proceeds from the November 2019 Offering
were approximately $ 6.0 million, before deducting placement agent fees and other offering expenses of $ 404,000 . In the November 2019
Offering, the Company sold (i) 10,450,000 Class A Units, with each Class A Unit consisting of one share of its common stock and a common
warrant to purchase one share of its common stock, and (ii) 1,550,000 Class B Units, with each Class B Unit consisting of one pre-funded
warrant to purchase one share of its common stock and a common warrant to purchase one share of its common stock, at a price of $ 0.50
per Class A Unit and $ 0.4999 per Class B Unit. The pre-funded warrants, which were exercised for common stock in December 2019, were
issued in lieu of common stock in order to ensure the purchaser did not exceed certain beneficial ownership limitations. The pre-funded
warrants were immediately exercisable at an exercise price of $ .0001 per share, subject to adjustment. Additionally, the common stock
warrants were immediately exercisable at an exercise price of $ 0.50 per share, subject to adjustment, and expire on November 17, 2024.
By their terms, however, neither the pre-funded warrants nor the common stock warrants can be exercised at any time that the pre-funded
warrant holder or the common stock warrant holder would beneficially own, after such exercise, more than 4.99% (or, at the election of
the holder, 9.99%) of the shares of common stock then outstanding after giving effect to such exercise. On the date of the November 2019
Offering, the Company allocated approximately $ 768,000 and $ 4.8 million to common stock/additional paid-in capital and warrant liability,
respectively.
On
March 6, 2017, the Company entered into the Sales Agreement with Cantor Fitzgerald & Co. (“Cantor”) pursuant to which
the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to the amount
the Company registered on an effective registration statement pursuant to which the offering is being made. The Company currently has
registered up to $ 50.0 million for sale under the Sales Agreement, pursuant to the Registration Statement on Form S-3 (File No. 333-250072)
through Cantor as the Company’s sales agent. Cantor may sell the Company’s common stock by any method permitted by law deemed
to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or
through the Nasdaq Capital Market or any other existing trade market for our common stock, in negotiated transactions at market prices
prevailing at the time of sale or at prices related to prevailing market prices, or any other method permitted by law. Cantor uses its
commercially reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell these
shares. The Company pays Cantor 3.0 % of the aggregate gross proceeds from each sale of shares under the Sales Agreement. In addition,
the Company has also provided Cantor with customary indemnification rights.
13
The
shares of the Company’s common stock sold under the Sales Agreement are sold and issued pursuant to the Registration Statement
on Form S-3 (File No. 333-250072) (the “Form S-3”), which was previously declared effective by the Securities and Exchange
Commission, and the related prospectus and one or more prospectus supplements.
The
Company is not obligated to make any sales of its common stock under the Sales Agreement. The offering of common stock pursuant to the
Sales Agreement will terminate upon the termination of the Sales Agreement as permitted therein. The Company and Cantor may each terminate
the Sales Agreement at any time upon ten days’ prior notice.
As
of June 30, 2022, the Company had sold an aggregate of 15,023,073 shares at a weighted-average sales price of $ 2.19 per share under the
Sales Agreement for aggregate gross proceeds of $ 32.9 million and net proceeds of $ 31.7 million, after deducting sales agent commission
and discounts and our other offering costs. During the three months ended June 30, 2022 and 2021, the Company did not sell any shares
of its common stock pursuant to the Sales Agreement. During the six months ended June 30, 2022 and 2021, the Company sold zero and 1,811,238
shares of our common stock pursuant to the Sales Agreement. The shares sold during the six months ended June 30, 2021, were sold at a
weighted-average sales price of $ 1.95 per share, resulting in net proceeds of approximately $ 3.4 million under the Sales Agreement which
is net of $ 112,000 in expenses. As of June 30, 2022, the Company had $ 41.2 million available for sale under the Sales Agreement.
(b)
Rights Agreement
On
November 13, 2015, the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent, entered into a Rights Agreement.
Also on November 12, 2015, the board of directors of the Company authorized and the Company declared a dividend of one preferred stock
purchase right (each a “Right” and collectively, the “Rights”) for each outstanding share of common stock of
the Company. The dividend was payable to stockholders of record as of the close of business on November 30, 2015 and entitles the registered
holder to purchase from the Company one one-thousandth of a fully paid non-assessable share of Series A Junior Participating Preferred
Stock of the Company at a price of $ 63.96 per one-thousandth share (the “Purchase Price”). The Rights will generally become
exercisable upon the earlier to occur of (i) 10 business days following a public announcement that a person or group of affiliated or
associated persons has become an Acquiring Person (as defined below) or (ii) 10 business days (or such later date as may be determined
by action of the board of directors prior to such time as any person or group of affiliated or associated persons becomes an Acquiring
Person) following the commencement of, or announcement of an intention to make, a tender offer or exchange offer the consummation of
which would result in the beneficial ownership by a person or group of 15% or more of the outstanding common stock of the Company. Except
in certain situations, a person or group of affiliated or associated persons becomes an “Acquiring Person” upon acquiring
beneficial ownership of 15% or more of the outstanding shares of common stock of the Company.
In
general, in the event a person becomes an Acquiring Person, then each Right not owned by such Acquiring Person will entitle its holder
to purchase from the Company, at the Right’s then current exercise price, in lieu of shares of Series A Junior Participating Preferred
Stock, common stock of the Company with a market value of twice the Purchase Price. In addition, if after any person has become an Acquiring
Person, (a) the Company is acquired in a merger or other business combination, or (b) 50% or more of the Company’s assets, or assets
accounting for 50% or more of its earning power, are sold, leased, exchanged or otherwise transferred (in one or more transactions),
proper provision shall be made so that each holder of a Right (other than the Acquiring Person, its affiliates and associates and certain
transferees thereof, whose Rights became void) shall thereafter have the right to purchase from the acquiring corporation, for the Purchase
Price, that number of shares of common stock of the acquiring corporation which at the time of such transaction would have a market value
of twice the Purchase Price.
The
Company will be entitled to redeem the Rights at $ 0.001 per Right at any time prior to the time an Acquiring Person becomes such. The
terms of the Rights are set forth in the Rights Agreement, which is summarized in the Company’s Current Report on Form 8-K dated
November 13, 2015. The rights plan was originally set to expire on November 12, 2018; however, on November 5, 2018 our board of directors
approved an Amended and Restated Rights Agreement pursuant to which the expiration date was extended to November 5, 2021, and again on
November 2, 2021, the Company adopted a Second Amended and Restated Rights Agreement pursuant to which the expiration date was extended
to November 1, 2024, unless the rights are earlier redeemed or exchanged by the Company.
14
(c)
Share-Based Payments
The
Company recognizes stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under
the Company’s Incentive Plan to employees, nonemployees and nonemployee members of the Company’s board of directors based
on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over
the award’s requisite service period. In addition, the Company has granted performance-based stock option awards and restricted
stock units, which vest based upon the Company satisfying certain performance conditions. Potential compensation cost, measured on the
grant date, related to these performance options will be recognized only if, and when, the Company estimates that these options or units
will vest, which is based on whether the Company considers the performance conditions to be probable of attainment. The Company’s
estimates of the number of performance-based options or units that will vest will be revised, if necessary, in subsequent periods.
The
Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated
based on assumptions with respect to (i) expected volatility of the Company’s common stock price, (ii) the periods of time over
which employees and members of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected
dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which
is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. Stock-based compensation cost that has been expensed in the statements of
operations amounted to approximately $ 140,000 and $ 147,000 , respectively, for the three months ended June 30, 2022 and 2021, and approximately $ 311,000 and $ 294,000 , respectively, for the six months ended June 30, 2022 and 2021, and is allocated as follows:
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs
Three
Months Ended
June 30,
Six
Months Ended
June 30,
2022
2021
2022
2021
Research
and development
$ 63,021
$ 69,483
$ 142,673
$ 136,369
General
and administrative
76,548
77,264
167,924
157,944
$ 139,569
$ 146,747
$ 310,597
$ 294,313
The
Company issued 171,500 stock options and 504,000 stock options, respectively, during the three and six months ended June 30, 2022 and
issued 66,000 and 376,000 stock options during the three and six months ended June 30, 2021.
Key
assumptions used in the determination of the fair value of stock options granted are as follows:
Expected
Term : The expected term represents the period that the stock-based awards are expected to be outstanding. Due to limited historical
experience of similar awards, the expected term was estimated using the simplified method in accordance with the provisions of Staff
Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, for awards with stated or implied service periods. The simplified
method defines the expected term as the average of the contractual term and the vesting period of the stock option. For awards with performance
conditions, and that have the contractual term to satisfy the performance condition, the contractual term was used.
Risk-Free
Interest Rate : The risk-free interest rate used was based on the implied yield currently available on U.S. Treasury issues with an
equivalent remaining term.
Expected
Dividend : The expected dividend assumption is based on management’s current expectation about the Company’s anticipated
dividend policy. The Company does not anticipate declaring dividends in the foreseeable future.
Expected
Volatility : The volatility factor is based solely on the Company’s trading history.
15
For
options granted during the six months ended June 30, 2022 and 2021, the Company calculated the fair value of each option grant on the
respective dates of grant using the following weighted average assumptions:
Schedule of Key Assumption of Fair Value of Stock Options Granted
2022
2021
Expected
term
5.77
years
5.70
years
Risk-free
interest rate
1.93 %
0.52 %
Expected
dividend yield
—
—
Expected
volatility
101.67 %
95.52 %
FASB
ASC 718, Stock Compensation, requires the Company to recognize compensation expense for the portion of options that are expected
to vest. Therefore, the Company applied estimated forfeiture rates that were derived from historical employee termination behavior. If
the actual number of forfeitures differs from those estimated by management, additional adjustments to compensation expense may be required
in future periods.
As
of June 30, 2022, there was $ 1.1 million of total unrecognized compensation cost related to unvested share-based compensation
arrangements granted under the Company’s stock option plan. That cost is expected to be recognized over a weighted average
period of 2.0 years and will be adjusted for subsequent changes in estimated forfeitures.
(d)
Stock Option Plan
In
April 2014, the board of directors adopted the 2014 Stock and Incentive Plan (“2014 Plan”) subject to shareholder approval
which was received in June 2014. The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation
rights, restricted stock units, restricted stock and dividend equivalents. An aggregate of 1,000,000 shares were authorized for issuance
under the 2014 Plan. Additionally, 271,906 remaining authorized shares under the 2011 Equity Incentive Plan (“2011 Plan”)
were issuable under the 2014 Plan at the time of the 2014 Plan adoption. Upon receiving shareholder approval in June 2016, the 2014 Plan
was amended and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted
under the 2014 Plan from 1,271,906 to 2,471,906 . Additionally, upon receiving shareholder approval in June 2018, the 2014 Plan was further
amended and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted under
the 2014 Plan from 2,471,906 to 3,221,906 . Finally, upon receiving shareholder approval in June 2020, the 2014 Plan was further amended
and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014
Plan from 3,221,906 to 5,721,906 . The board of directors, on an option-by-option basis, determines the number of shares, exercise price,
term, and vesting period for options granted. Options granted generally have a ten -year contractual life. The Company issues shares of
common stock upon the exercise of options with the source of those shares of common stock being either newly issued shares or shares
held in treasury. An aggregate of 5,721,906 shares of common stock are authorized for issuance under the 2014 Plan, with 1,265,308 shares
remaining available for grant as of June 30, 2022.
A
summary of stock option activity is as follows:
Schedule of Stock Option Activity
Outstanding
stock options
Number
of shares
Weighted
average exercise price
Balance
at December 31, 2021
4,551,205
$ 2.82
Options
granted
504,000
1.06
Options
exercised
( 208,474 )
0.99
Options
forfeited
( 488,747 )
1.16
Options
cancelled
( 331,102 )
5.69
Balance
at June 30, 2022
4,026,882
2.65
Options exercisable
at June 30, 2022
2,629,346
3.47
16
The
following table summarizes information about stock options outstanding and exercisable at June 30, 2022:
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable
Options
outstanding
Options
exercisable
Number
outstanding
Weighted
average remaining contractual life (Years)
Weighted
average exercise price
Aggregate
intrinsic value
Number
exerciseable
Weighted
average remaining contractual life (Years)
Weighted
average exercise price
Aggregate
intrinsic value
4,026,882
6.26
$ 2.65
$ 152,241
2,629,346
4.72
$ 3.47
$ 123,331
The
intrinsic value for stock options is defined as the difference between the current market value and the exercise price. There were 200
and 208,474 , respectively, stock options exercised during the three and six months ended June 30, 2022, and there were zero and 4,584
stock options exercised during the three and six months ended June 30, 2021.
(e)
Common Stock Warrants
The
Company accounts for its common stock warrants under ASC 480, Distinguishing Liabilities from Equity , which requires any financial
instrument, other than an outstanding share, that, at inception, embodies an obligation to repurchase the issuer’s equity shares,
or is indexed to such an obligation, and requires or may require the issuer to settle the obligation by transferring assets, to be classified
as a liability. In accordance with ASC 480, the Company’s outstanding warrants from the November 2019 Offering are classified as
a liability. The liability is adjusted to fair value at each reporting period, with the changes in fair value recognized as gain (loss)
on change in fair value of warranty liability in the Company’s consolidated statements of operations. The warrants issued in the
November 2019 Offering allow the warrant holder, if certain change in control events occur, the option to receive an amount of cash equal
to the value of the warrants as determined in accordance with the Black-Scholes option pricing model with certain defined assumptions
upon a fundamental transaction.
As
of June 30, 2022, the Company had 1,094,030 common stock warrants outstanding from the November 2019 Offering to purchase an equal number
of shares of common stock. The fair value of these warrants on June 30, 2022 and on December 31, 2021 was determined using the Black-Scholes
option pricing model with the following Level 3 inputs (as defined in the November 2019 Offering):
Schedule of Fair Value of Warrants
June
30, 2022
December
31, 2021
Expected
life in years
2.38
2.88
Risk-free
interest rate
2.99 %
0.97 %
Dividend
yield
—
—
Volatility
100.00 %
100.00 %
Stock price
$ 0.80
$ 0.99
17
During
the three and six months ended June 30, 2022, the Company recorded a non-cash gain of $ 583,445 and $ 205,457 , respectively, from the change
in fair value of the November 2019 Offering warrants. During the three and six months ended June 30, 2021, the Company recorded a non-cash
gain of $ 221,000 and $ 26,000 from the change in fair value of the November 2019 Offering warrants. The following table is a reconciliation
of the warrant liability measured at fair value using level 3 inputs:
Schedule of Reconciliation of Warrant Liability
Warrant
Liability
Balance
at December 31, 2021
$ 795,796
Settlement
of liability on warrant exercise
-
Change
in fair value of common stock warrants
( 205,457 )
Balance
at June 30, 2022
$ 590,339
Additionally,
in the February 2020 Offering, the Company issued 5,042,017 common stock warrants, however, because these warrants do not provide the
warrant holder the option to put the warrant back to the Company, the warrants are classified as equity. As of June 30, 2022, there were
840,336 warrants outstanding that were issued in conjunction with the February 2020 Offering.
The
following table summarizes the number of common stock warrants outstanding and the weighted average exercise price:
Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price
Warrants
Weighted
Average Exercise Price
Outstanding
at December 31, 2021
1,934,366
$ 0.51
Issued
-
-
Exercised
-
-
Expired
-
-
Cancelled
-
-
Forfeited
-
-
Balance
at June 30, 2022
1,934,366
$ 0.51
During
the three and six months ended June 30, 2022, no common stock warrants were exercised. During the three and six months ended June
30, 2021, zero and 10,000 common stock warrants to purchase one share of our common stock were exercised, resulting in proceeds of
approximately $ 5,000 .
The
following table summarizes information about common stock warrants outstanding at June 30, 2022:
Warrants
outstanding
Number
exercisable
Weighted
average remaining contractual life (Years)
Weighted
average exercise price
Aggregate
intrinsic value
1,934,366
2.50
$ 0.51
$ 555,100
18
(11)
Commitments and Contingencies
Litigation
The
Company is involved in various lawsuits, claims and other legal matters from time to time that arise in the ordinary course of conducting
business. The Company records a liability when a particular contingency is probable and estimable.
On
April 2, 2019, the Company filed a lawsuit against Clarus in the United States District Court for the District of Delaware alleging that
Clarus’s JATENZO® product infringes six of Lipocine’s issued U.S. patents: 9,034,858; 9,205,057; 9,480,690; 9,757,390;
6,569,463; and 6,923,988. However; on February 11, 2020, the Company voluntarily dismissed allegations of patent infringement for expired
U.S. Patent Nos. 6,569,463 and 6,923,988 in an effort to streamline the issues and associated costs for dispute. Clarus has answered
the complaint and asserted counterclaims of non-infringement, inequitable conduct and invalidity. The Company answered Clarus’s
counterclaims on April 29, 2019. The Court held a scheduling conference on August 15, 2019, a claim construction hearing on February
11, 2020 and a Summary Judgment Hearing on January 15, 2021. In May 2021, the Court granted Clarus’ motion for Summary Judgment,
finding the asserted claims of Lipocine’s U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy
the written description requirement of 35 U.S.C. § 112. Clarus still had remaining counterclaims before the Court. On July 13, 2021,
Clarus and the Company entered into a global settlement agreement (“Global Agreement’) which resolved all outstanding claims
of this litigation as well as the on-going United States Patent and Trademark Office (“USPTO”) Interference No. 106,128 between
the parties. Under the terms of the Global Agreement, the Company agreed to pay Clarus $ 4.0 million payable as follows: $ 2.5 million
immediately, $ 1.0 million on July 13, 2022 and $ 500,000 on July 13, 2023. No future royalties are owing from either party. On April 29,
2022, the Company agreed to an amendment to Section 3.1 of the Global Agreement, pursuant to which the Company agreed to pay Clarus $ 1,250,000
in May 2022, with no additional payments required thereafter. On July 15, 2021, the Court dismissed with prejudice the Company’s
claims and Clarus’ counterclaims.
On
November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit,
Solomon Abady v. Lipocine Inc. et al ., 2:19-cv-00906-PMW, filed in the United District Court for the District of Utah. The complaint
alleges that the defendants made false and/or misleading statements and/or failed to disclose that our filing of the NDA for TLANDO to
the FDA contained deficiencies and as a result the defendants’ statements about our business and operations were false and misleading
and/or lacked a reasonable basis in violation of federal securities laws. The lawsuit seeks certification as a class action (for a purported
class of purchasers of the Company’s securities from March 27, 2019 through November 8, 2019), compensatory damages in an unspecified
amount, and unspecified equitable or injunctive relief. The Company has insurance that covers claims of this nature. The retention amount
payable by the Company under our policy is $ 1.25 million. The Company filed a motion to dismiss the class action lawsuit on July 24,
2020. In response, the plaintiffs filed their response to the motion to dismiss the class action lawsuit on September 22, 2020 and the
Company filed its reply to its motion to dismiss on October 22, 2020. A hearing on the motion to dismiss occurred on January 12, 2022.
The Company intends to vigorously defend itself against these allegations and has not recorded a liability related to this shareholder
class action lawsuit as the outcome is not probable nor can an estimate be made of loss, if any.
On
March 13, 2020, the Company filed U.S. patent application serial number 16/818,779 (“the Lipocine ‘779
Application”) with the USPTO. On October 16 and November 3, 2020, Lipocine filed suggestions for interference with the USPTO
requesting that a patent interference be declared between the Lipocine ‘779 Application and US patent application serial
number 16/656,178 to Clarus Therapeutics, Inc. (“the Clarus ‘178 Application”). Pursuant to the Company’s
request, the Patent Trial and Appeal Board (“PTAB”) at the USPTO declared the interference on January 4, 2021 to
ultimately determine, as between the Company and Clarus, who is entitled to the claimed subject matter. The interference number is
106,128, and the Company was initially declared Senior Party. A conference call with the PTAB was held on January 25, 2021 to
discuss proposed motions. On February 1, 2021, the PTAB issued an order authorizing certain motions and setting the schedule for the
preliminary motions phase. On July 13, 2021, Clarus and the Company entered into the Global Agreement to resolve interference No.
106,128 among other items. On July 26, 2021, the PTAB granted the Company’s request for adverse judgment in interference No.
106,128 in accordance with the Global Agreement.
Beyond
Solomon Abady v. Lipocine Inc. et al., 2:19-cv-00906-PM matter, management does not currently believe that any other matter, individually
or in the aggregate, will have a material adverse effect on our financial condition, liquidity or results of operations.
Guarantees
and Indemnifications
In
the ordinary course of business, the Company enters into agreements, such as lease agreements, licensing agreements, clinical trial agreements,
and certain services agreements, containing standard guarantee and / or indemnification provisions. Additionally, the Company has indemnified
its directors and officers to the maximum extent permitted under the laws of the State of Delaware.
19
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Related Party Transactions
Spriaso,
LLC Service Agreement
The
Company has a license and a services agreement with Spriaso, LLC (“Spriaso”), a related-party that is majority-owned by certain
current and former directors of Lipocine Inc. and their affiliates. Under the license agreement, the Company assigned and transferred
to Spriaso all of the Company’s rights, title and interest in its intellectual property to develop products for the cough and cold
field. In addition, Spriaso received all rights and obligations under the Company’s product development agreement with a third-party.
In exchange, the Company will receive a royalty of 20
percent of the net proceeds received by Spriaso,
up to a maximum of $ 10.0
million. Spriaso also granted back to the Company
an exclusive license to such intellectual property to develop products outside of the cough and cold field. The
Company also agreed to continue providing up to 10 percent of the services of certain employees to Spriaso for a period of time. The
agreement to provide services expired in 2021; however,
it may be extended upon written agreement of Spriaso and the Company. The Company did not receive any reimbursements from Spriaso for
the three and six months ended June 30, 2022 and 2021, respectively. Additionally, during the three and six months ended June 30, 2022
and 2021, the Company did not receive any royalty revenue from Spriaso. Spriaso filed its first NDA and as an affiliated entity of the
Company, and used up the one-time waiver for user fees for a small business submitting its first new drug application to the FDA. Spriaso
is considered a variable interest entity under the FASB ASC Topic 810-10, Consolidations , however the Company is not the primary
beneficiary and has therefore not consolidated Spriaso.
(13)
Recent Accounting Pronouncements
Accounting
Pronouncements Issued Not Yet Adopted
In
2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments
(“ASU 2016-13”). This standard replaces the incurred loss impairment methodology in current GAAP with a methodology that
reflects expected credit losses on instruments within its scope, including trade receivables, and requires entities to measure all expected
credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable
forecasts. The original effective date for ASU 2016-13 was for annual and interim periods beginning after December 15, 2019.
However,
in October 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses, Derivatives and Hedging, and Leases: Effective
Dates , which deferred the effective date of ASU 2016-13 for certain entities, including those that are eligible to be smaller reporting
companies . A company’s determination about whether it is eligible for the deferral is a one-time assessment as of November
15, 2019 based on its most recent determination of its small reporting company eligibility as of the last business day of the most recently
completed second quarter. Based on this determination, the Company qualifies as a smaller reporting entity and is therefore eligible
for the deferral of adoption of ASU 2016-13, resulting in a new effective date of January 1, 2023. The Company has historically not had
credit losses on financial instruments and is currently evaluating the impact the adoption of ASU 2016-13 will have on its consolidated
financial statements.
20
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.