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, 2025
☐
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 001-38538
electroCore, Inc.
(Exact name of Registrant as specified in its charter)
Delaware
20-3454976
(State
or other jurisdiction of incorporation or organization)
(I.R.S.
Employer Identification No.)
200 Forge Way , Suite 205 , Rockaway , NJ 07866
(Address of principal executive offices, including
zip code)
(973) 290-0097
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
ECOR
Nasdaq Capital 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 every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒
No ☐
Indicate by check mark whether the registrant is a
large accelerated filer, an accelerated filer, a non-accelerated filer, 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 May 2, 2025, the registrant
had 7,420,618 shares
of common stock outstanding.
PART I. FINANCIAL INFORMATION
Page Number
Cautionary Note Regarding Forward-Looking Statements
3
Item 1.
Financial Statements
Condensed Consolidated Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 2024
4
Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2025 and 2024 (Unaudited)
5
Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2025 and 2024 (Unaudited)
6
Condensed Consolidated Statements of Equity for the Three Months Ended March 31, 2025 and 2024 (Unaudited)
7
Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024(Unaudited)
8
Notes to Condensed Consolidated Financial Statements (Unaudited)
9
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
17
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
22
Item 4.
Controls and Procedures
22
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
23
Item 1A.
Risk Factors
23
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
23
Item 3.
Defaults Upon Senior Securities
23
Item 4.
Mine Safety Disclosures
23
Item 5.
Other Information
23
Item 6.
Exhibits
24
Signatures
25
2
REFERENCES TO ELECTROCORE
In this Quarterly Report on Form 10-Q (this “Quarterly
Report”), unless otherwise stated or the context otherwise requires, references to the “Company,” “electroCore,”
“we,” “us” and “our” refer to electroCore, Inc. a Delaware corporation and its subsidiaries.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly Report,
contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed
in the forward-looking statements. The statements contained in this Quarterly Report that are not purely historical are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the
Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are often identified by the use of words
such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,”
“should,” “strategy,” “target,” “will,” “would” and similar expressions or
variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management
based on information currently available to them. Such forward-looking statements are subject to risks, uncertainties and other important
factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied
by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to risks and
uncertainties included in our Form 10-Qs, our annual report on Form 10-K for the year ended December 31, 2024 (the “Annual Report”),
in our other filings with the U.S. Securities and Exchange Commission (the “SEC”) or in materials incorporated by reference
therein, including the information in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” in such filings. Furthermore, any such forward-looking statements in this Quarterly
Report speak only as of the date of this Quarterly Report. Except as required by law, we undertake no obligation to update or revise any
forward-looking statements to reflect events or circumstances after the date of such statements.
The electroCore
logo, gammaCore, Truvaga, TAC-STIM, names, logos, and other trademarks of electroCore, Inc. appearing in this Quarterly Report are the
property of electroCore, Inc. All other trademarks, service marks and trade names in this Quarterly Report are the property of their respective
owners. We have omitted the ® and ™ designations, as applicable, for the trademarks used in this Quarterly Report.
3
ELECTROCORE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share data)
March 31,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$ 3,777
$ 3,450
Restricted cash
250
250
Marketable securities
3,982
8,519
Accounts receivable, net
1,459
1,367
Inventories
1,733
1,676
Prepaid expenses and other current assets
771
1,038
Total current assets
11,972
16,300
Property and equipment, net
183
158
Operating lease right of use assets, net
3,700
3,739
Other assets, net
186
274
Total assets
$ 16,041
$ 20,471
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 1,764
$ 1,827
Accrued expenses and other current liabilities
5,728
6,964
Current portion of operating lease liabilities
364
361
Total current liabilities
7,856
9,152
Noncurrent liabilities:
Operating lease liabilities, noncurrent
3,820
3,775
Total liabilities
11,676
12,927
Contingencies (see Note 14)
Stockholders’ equity:
-
-
Common Stock, par value $ 0.001 per share; 500,000,000 shares authorized at March 31, 2025 and December 31, 2024; 7,420,452 shares issued and outstanding at March 31, 2025 and 6,650,854 shares issued and outstanding at December 31, 2024
7
7
Additional paid-in capital
185,233
184,513
Accumulated deficit
( 180,945 )
( 177,090 )
Accumulated other comprehensive income
70
114
Total stockholders’ equity
4,365
7,544
Total liabilities and stockholders’ equity
$ 16,041
$ 20,471
See accompanying notes to unaudited condensed consolidated
financial statements.
4
ELECTROCORE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data)
2025
2024
Three months ended March 31,
2025
2024
Net sales
$ 6,719
$ 5,443
Cost of goods sold
1,013
888
Gross profit
5,706
4,555
Operating expenses
Research and development
642
399
Selling, general and administrative
8,886
8,005
Total operating expenses
9,528
8,404
Loss from operations
( 3,822 )
( 3,849 )
Other (income) expense
Interest and other income
( 83 )
( 225 )
Other expense
164
4
Total other expense (income)
81
( 221 )
Loss before income taxes
( 3,903 )
( 3,628 )
Benefit from income taxes
48
122
Net loss
$ ( 3,855 )
$ ( 3,506 )
Net loss per share of common stock - Basic and Diluted
$ ( 0.47 )
$ ( 0.53 )
Weighted average common shares outstanding - Basic and Diluted (see Note 11)
8,289
6,617
See accompanying notes to unaudited condensed consolidated
financial statements.
5
ELECTROCORE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive
Loss
(unaudited)
(in thousands)
2025
2024
Three months ended March 31,
2025
2024
Net loss
$
( 3,855 )
$
( 3,506 )
Other comprehensive (loss) income:
Foreign currency translation adjustment
( 44 )
76
Other comprehensive (loss) income
( 44 )
76
Comprehensive loss
$
( 3,899 )
$
( 3,430
)
See accompanying notes to unaudited condensed consolidated
financial statements.
6
ELECTROCORE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Equity
For the Three Months Ended March 31, 2025 and 2024
(unaudited)
(in thousands)
Shares
Amount
capital
deficit
income (loss)
equity
Stockholders’ Equity
Common
Additional
Accumulated other
Total
Stock
paid-in
Accumulated
comprehensive
stockholders’
Shares
Amount
capital
deficit
income (loss)
equity
Balances as of January 1, 2025
6,651
$ 7
$ 184,513
$ ( 177,090 )
$ 114
$ 7,544
Net loss
—
—
—
( 3,855 )
—
( 3,855 )
Other comprehensive income
—
—
—
—
( 44 )
( 44 )
Issuance of stock related to employee compensation plan, net of forfeitures
Issuance of stock
related to employee compensation plan, net of forfeitures, shares
Sale of common stock
14
—
217
—
—
217
Financing fees
—
—
( 38 )
—
—
( 38 )
Proceeds from the exercise of warrants
755
—
1
—
—
1
Share based compensation
—
—
540
—
—
540
Balances as of March 31, 2025
7,420
7
185,233
( 180,945 )
70
4,365
Balances as of January 1, 2024
6,003
$ 6
$ 172,704
$ ( 165,204 )
$ ( 64 )
$ 7,442
Balance
6,003
$ 6
$ 172,704
$ ( 165,204 )
$ ( 64 )
$ 7,442
Net loss
—
—
—
( 3,506 )
—
( 3,506 )
Other comprehensive income
—
—
—
—
76
76
Issuance of stock related to employee compensation plan, net of forfeitures
3
—
—
—
—
—
Share based compensation
—
—
484
—
—
484
Balances as of March 31, 2024
6,006
6
173,188
( 168,710 )
12
4,496
Balance
6,006
6
173,188
( 168,710 )
12
4,496
See accompanying notes to unaudited condensed consolidated
financial statements.
7
ELECTROCORE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
2025
2024
Three months ended March 31,
2025
2024
Cash flows from operating activities:
Net loss
$
( 3,855
)
$
( 3,506
)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
540
484
Depreciation and amortization
155
206
Amortization of right of use assets
39
17
Amortization of operating lease liability
209
( 21 )
Inventory reserve charge
( 88
)
—
Changes in operating assets and liabilities:
Accounts receivable
( 73
)
242
Inventories
44
113
Prepaid expenses and other assets
210
207
Accounts payable
( 61
)
159
Accrued expenses and other current liabilities
( 1,316
)
( 459
)
Operating lease liabilities
( 159
)
—
Net cash used in operating activities
( 4,355
)
( 2,558
)
Cash flows from investing activities:
Sale of marketable securities
4,537
—
Purchase of equipment
( 37
)
—
Net cash used in investing activities
4,500
—
Cash flows from financing activities:
Sale of common stock
217
—
Financing fees
( 38
)
—
Proceeds from exercise of warrants
1
—
Net cash provided by financing activities
180
—
Effect of changes in exchange rates on cash and cash equivalents
2
76
Net decrease in cash and cash equivalents and restricted cash
327
( 2,482
)
Cash, cash equivalents, and restricted cash – beginning of period
3,700
10,581
Cash, cash equivalents, and restricted cash – end of period
$
4,027
$
8,099
Supplemental cash flows disclosures:
Proceeds from sale of state net operating losses
$
48
$
122
Interest paid
$
5
$
5
Supplemental schedule of noncash activity:
Right-of-use asset and liability
$
—
$
1,055
See accompanying notes to unaudited condensed consolidated
financial statements.
8
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated
Financial Statements (unaudited)
Note 1. The Company
electroCore, Inc. and its subsidiaries (“electroCore”
or the “Company”) is a commercial stage bioelectronic technology company whose mission is to improve health and quality of
life through innovative non-invasive bioelectronic technologies.
electroCore, headquartered in Rockaway, NJ,
has three
wholly owned subsidiaries: electroCore UK Ltd, electroCore Germany GmbH and NeuroMetrix, Inc. (“NURO”). The Company has paused operations in Germany, with sales
into the country and the rest of Europe being managed by electroCore UK Ltd.
Note 2. Summary of Significant Accounting Policies
(a)
Basis of Presentation
The accompanying condensed consolidated financial
statements were prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”)
and with instructions to Form 10-Q and Article 10 of Regulation S-X under the Securities Exchange Act of 1934, as amended. In
the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a
fair presentation of the Company’s condensed consolidated financial position and results of operations for the interim periods presented.
Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with U.S.
GAAP have been condensed or omitted. These interim condensed consolidated financial statements should be read in conjunction with the
audited consolidated financial statements and accompanying notes for the year ended December 31, 2024 ,
included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission
on March 12, 2025. The results for the three months ended March 31, 2025, are not necessarily indicative of the results to be expected
for a full year, any other interim periods or any future year or period.
(b)
Principles of Consolidation
The accompanying condensed consolidated financial
statements include the accounts of electroCore and its wholly owned subsidiaries. All intercompany balances and transactions have been
eliminated in consolidation.
(c)
Use of Estimates
The preparation of financial statements in conformity
with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions
include revenue, licensed products and loss contingencies.
(d)
Cash, Cash Equivalents and Restricted Cash
The following table provides a reconciliation of cash,
cash equivalents and restricted cash to the balance reflected on the Condensed Consolidated Statement of Cash Flows at March 31, 2025
and December 31, 2024:
Schedule of Cash, Cash Equivalents and
Restricted Cash
(in thousands)
March 31,
2025
December 31,
2024
Cash and cash equivalents
$ 3,777
$ 3,450
Restricted cash
250
250
Total cash, cash equivalents and restricted cash
$ 4,027
$ 3,700
As of March 31, 2025, cash equivalents represented
funds held in an interest-bearing demand deposit account, U.S. treasury bills, and a money market account.
The Company’s restricted cash consists of cash that the Company is
contractually obligated to maintain in accordance with the terms of its corporate credit card arrangement with Citibank, N.A.
( e)
Marketable Securities
Marketable securities are carried at fair value, with
unrealized gains and losses reported as accumulated other comprehensive income, except for losses from impairments which are determined
to be other than temporary. Realized gains and losses and declines in value judged to be other-than-temporary are included in the determination
of net loss and are included in interest and other income net. Fair values are based on quoted market prices at the reporting date. Interest
and dividends on available-for-sale securities are included in Interest and other income. As of March 31, 2025, marketable securities
amounted to $ 4.0 million and consist of U.S. treasury bills. The Company held $ 8.5 million of marketable securities at December 31, 2024.
9
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated Financial
Statements (unaudited)
(f)
Recent Accounting Standards Pronouncements
In December 2023, the FASB
issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes (Topic 740) , Improvements to Income Tax Disclosures which
will require companies to make additional income tax disclosures. The pronouncement is effective for annual filings for the year ended
December 31, 2025. The Company is still assessing the impact of the adoption of this standard but does not expect it to have a material
impact on its results of operations, financial position or cash flows.
On November 2024, the FASB
issued Accounting Standards Update (ASU) No. 2024-03, Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation
Disclosures, Disaggregation of Income Statement Expenses , which requires public companies to disclose, in interim and annual reporting
periods, additional information about certain expenses in the financial statements. The amendments in this pronouncement will be effective
for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption
is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently assessing the potential impacts
of adoption on its consolidated financial statements and related disclosures.
Note 3. Liquidity, Significant Risks and Uncertainties
Liquidity
The Company has experienced significant net losses,
and it expects to continue to incur net losses for the near future as it works to increase market acceptance of its gammaCore therapy
and general wellness and human performance products. The Company has never been profitable and has incurred net losses and negative cash
used in operations each year since its inception. The Company incurred net losses of $ 3.9 million and $ 3.5 million and used cash in its
operations of $ 4.4 million and $ 2.6 million for the three months ended March 31, 2025 and 2024, respectively.
The Company has historically funded its operations
from the sale of its securities. During the three months ended March 31, 2025, the Company received net proceeds of approximately $ 0.2
million from such sales and as of March 31, 2025, the Company’s cash, cash equivalents, restricted cash and marketable securities
totaled $ 8.0 million (“Cash Position”).
On November 29, 2024, we entered into an At The Market
Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), whereby the Company
may offer and sell shares of its common stock from time to time having an aggregate offering price of up to $ 20 million by any method
deemed to be an “at-the-market” offering as defined in Rule 415 of the Securities Act, or any other method specified in the
Sales Agreement.
In 2025, we intend to continue to make targeted investments
in sales and marketing to continue driving commercial activities. We have historically funded our operations from the sale of our common
stock and may continue to do so through utilization of the at-the-market facility or other equity or debt transactions if needed. As of
May 2, 2025, the Company had approximately $ 19.8 million shares of common stock remaining available for issuance under the Sales Agreement.
The Company’s expected cash requirements
for the next 12 months from the date these financial statements are issued and beyond are largely based on the commercial success of
its products. Based on its current assessment, the Company believes its Cash Position, and expected cash flow from operations, will
enable it to fund its operating expenses and capital expenditure requirements, as currently planned, for at least the next 12 months
from the date the accompanying financial statements are issued. There remain significant risks and uncertainties regarding the
Company’s business, financial condition and results of operations. The Company’s future capital requirements are
difficult to forecast and will depend on many factors that are out of its control. If the Company is unable to achieve its planned
operating results or maintain sufficient financial resources, including through potential positive cash flow from operations or
supplemental access to third-party debt, equity or hybrid capital, its business, financial condition and results of operations may
be materially and adversely affected.
Concentration of Revenue Risks
The Company earns a significant amount of its revenue
in the United States from the United States Department of Veterans Affairs and United State Department of Defense, or VA, pursuant to
its qualifying contract under the Federal Supply Schedule, or FSS, and open market sales to individual VA facilities. For the three months
ended March 31, 2025 and 2024, sales to the VA accounted for 70.3 % and 71.2 % of net sales, respectively.
For the three months ended March 31, 2025 and 2024,
Lovell Government Services, or Lovell, accounted for more than 10 % of our VA net sales . During
the three months ended March 31, 2025, sales associated with no single facility accounted for more than 10 % of the total VA net sales.
One facility accounted for more than 10 % of the total VA net sales during the three months ended March 31, 2024. During the three months
ended March 31, 2025 and 2024, one facility accounted for more than 10 % of net sales from the United Kingdom National Health Service (“NHS”).
10
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated Financial
Statements (unaudited)
Foreign Currency Exchange
The Company has foreign currency exchange risks related
to revenue and operating expenses in currencies other than the local currencies in which it operates. The Company is exposed to currency
risk from the potential changes in the functional currency values of its assets, liabilities, and cash flows denominated in foreign currencies.
Note 4. Revenue
The following tables present product net sales disaggregated by Channel
and Geographic Market (in thousands):
Schedule of Net Sales Disaggregated By Channel
Channel:
2025
2024
Three months ended March 31,
Channel:
2025
2024
Rx gammaCore – VA
$ 4,721
$ 3,875
Rx gammaCore - U.S. Commercial
289
433
Outside the United States
513
449
Truvaga
1,106
385
Total before TAC-STIM
6,629
5,142
TAC-STIM
90
301
Total Net Sales
$ 6,719
$ 5,443
Schedule of Net Slaes Disaggregated By Geographic Market
Product revenue
2025
2024
Geographic Market:
Three months ended March 31,
Product revenue
2025
2024
United States
$ 6,206
$ 4,994
United Kingdom
451
385
Other
47
45
License revenue
Japan
15
19
Total Net Sales
$ 6,719
$ 5,443
The Company generally invoices the customer and recognizes revenue once
its performance obligations are satisfied, at which point payment is unconditional. Agreed upon payment terms with customers are within
30 days of shipment. Accordingly, contracts with customers do not include a significant financing component.
Note 5. Cash, Cash Equivalents, Restricted Cash and Marketable Securities
The following tables summarize the Company’s
cash, cash equivalents, restricted cash and marketable securities as of March 31, 2025 and December 31, 2024.
Schedule of Cash, Cash Equivalents, Restricted
Cash and Marketable Securities
As of March 31, 2025
Amortized Cost
Unrealized Gain
Unrealized (Loss)
Fair Value
Cash, cash equivalents and restricted cash
$ 4,027
$ —
$ —
$ 4,027
Marketable Securities:
U.S. Treasury Bills
3,982
—
—
3,982
Total marketable securities
3,982
—
—
3,982
Total cash, cash equivalents, restricted cash and marketable securities
$ 8,009
$ —
$ —
$ 8,009
As of December 31, 2024
Amortized Cost
Unrealized
Gain
Unrealized
(Loss)
Fair Value
Cash, cash equivalents and restricted cash
$ 3,700
$ —
$ —
$ 3,700
Marketable Securities:
U.S. Treasury Bills
8,519
—
—
8,519
Total marketable securities
8,519
—
—
8,519
Total cash, cash equivalents, restricted cash and marketable securities
$ 12,219
$ —
$ —
$ 12,219
11
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated Financial
Statements (unaudited)
Note 6. Fair Value Measurements
Financial assets and liabilities carried at fair value are classified and
disclosed in one of the following three levels of the fair value hierarchy:
●
Level 1—Quoted prices in active markets for identical assets or liabilities.
●
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
●
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
A summary of the assets and liabilities carried at fair value in accordance
with the hierarchy defined above is as follows:
Summary of Assets and Liabilities Carried at Fair Value
March 31, 2025
Total
Level 1
Level 2
Level 3
Fair Value Hierarchy
March 31, 2025
Total
Level 1
Level 2
Level 3
Assets
Cash, cash equivalents and restricted cash
$ 4,027
$ 4,027
$ —
$ —
Marketable Securities:
U.S. treasury bills
3,982
3,982
—
—
Total cash, cash equivalents, restricted cash and marketable securities
$ 8,009
$ 8,009
$ —
$ —
December 31, 2024
Total
Level 1
Level 2
Level 3
Fair Value Hierarchy
December 31, 2024
Total
Level 1
Level 2
Level 3
Assets
Cash, cash equivalents and restricted cash
$ 3,700
$ 3,700
$ —
$ —
Marketable Securities:
U.S. treasury bills
8,519
8,519
—
—
Total cash, cash equivalents and restricted cash
$ 12,219
$ 12,219
$ —
$ —
As of March 31, 2025, the Company’s Marketable securities in the
amount of $ 4.0 million were carried at fair value in accordance with Level 1 as described above. As of March 31, 2025 and December 31,
2024, the Company had no financial assets or liabilities that required valuation in accordance with the levels described above. The Company
recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within
the hierarchy during the three months ended March 31, 2025, and year ended December 31, 2024. The carrying amount of the Company’s
receivables and payables approximate their fair value due to their maturity.
Note 7. Inventories
As of March 31, 2025 and December 31, 2024, inventories consisted of the
following:
Schedule of Inventories
(in thousands)
March 31, 2025
December 31, 2024
Raw materials
$ 1,199
$ 923
Work in process
101
193
Finished goods
433
560
Total inventories
$ 1,733
$ 1,676
The reserve for obsolete inventory was $ 0.5 million
and $ 0.6 million as of March 31, 2025 and December 31, 2024, respectively. The Company records charges for obsolete inventory in cost
of goods sold. Inventory classified under the category “Work in process” consists of prefabricated assembled product.
Note 8. Leases
For the three months ended March 31, 2025 and 2024,
the Company recognized lease expenses of approximately $ 178,000 and $ 38,000 , respectively. This expense does not include non-lease components
associated with the lease agreements as the Company elected not to include such charges as part of the lease expense.
On February 6, 2024, the Company entered into The
First Amendment to Lease Agreement (the “Rockaway Amendment”) to extend its Rockaway, New Jersey lease for an additional 10
years. The Rockaway Amendment was effective May 1, 2024 , and expires on July 31, 2034 , with a tenant option to renew for an additional
five years . The increase in the term of the lease for the existing leased property was accounted for as a lease modification, therefore,
the associated operating lease right of use assets and operating lease liabilities for the existing space were remeasured as of February
6, 2024. The Rockaway Amendment also includes the expansion of leased property from 13,643 square feet to 22,557 square feet. The Company
has accounted for the expansion space as an increase in lease right of use assets effective with the Rockaway Amendment commencement date
of June 1, 2024 .
12
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated Financial
Statements (unaudited)
Supplemental Balance Sheet Information for Operating
Leases:
Schedule of Operating Leases
(in thousands)
March 31,
2025
December 31,
2024
Operating leases:
Operating lease right of use assets
$ 3,700
$ 3,739
Operating lease liabilities:
Current portion of operating lease liabilities
364
361
Noncurrent operating lease liabilities
3,820
3,775
Total operating lease liabilities
$ 4,184
$ 4,136
Weighted average remaining lease term (in years)
14.2
14.5
Weighted average discount rate
13.5 %
13.5 %
Future lease payments as of March 31, 2025:
Schedule of Future Lease Payments
(in thousands)
Remainder of 2025
$ 279
2026
530
2027
625
2028
649
2029
663
2030 and thereafter
7,736
Total future lease payments
10,482
Less: Amounts representing interest
( 6,298 )
Total
$ 4,184
Note 9. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities as of March 31, 2025 and
December 31, 2024 consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
(in thousands)
March 31, 2025
December 31, 2024
Accrued professional fees
$ 700
$ 598
Accrued bonuses and incentive compensation
1,373
2,886
Accrued litigation legal fees
1,155
1,163
Accrued insurance expense
51
205
Accrued research and development expenses
655
655
Accrued vacation and other employee related expenses
1,003
781
Accrued tax expenses
407
382
Deferred revenue
62
78
Other
322
216
Accrued
expenses and other current liabilities
$ 5,728
$ 6,964
Finance and Security Agreement
On July 2, 2024, the Company
entered into a Commercial Insurance Premium Finance and Security Agreement (the “2024 Agreement”). The 2024 Agreement provides
for a single borrowing of approximately $ 493,000 with a ten-month term and an annual interest rate of 8.75 %. The proceeds from this transaction
were used to partially fund the premiums due under certain of the Company’s insurance policies. The amounts payable are secured
by the Company’s rights under such policies. Beginning July 2024, the Company began paying monthly installments of approximately
$ 51,000 .
During the three months ended
March 31, 2025 and 2024, the Company recognized $ 5,000 and $ 4,200 in aggregate interest expense related to the Company’s finance
and security agreements, respectively.
Note 10. Shareholders’ Equity
At-the-Market Facility
On November 29, 2024, we entered into the Sales Agreement
with Wainwright. Under the Sales Agreement, the Company may offer and sell shares of its common stock, par value $ 0.001 per share, from
time to time having an aggregate offering price of up to $ 20 million during the term of the Sales Agreement through Wainwright, acting
as sales agent. The Company intends to use the net proceeds from any offering pursuant to the Sales Agreement to continue to fund sales
and marketing, working capital and for other general corporate purposes. During the three months ended March 31, 2025 the company sold
14,265 shares of common stock for gross proceeds of approximately $ 217,000 . This amount has been offset by financing fees of approximately
$ 37,000 .
13
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated Financial
Statements (unaudited)
Stock Purchase Warrants
The following table presents a summary of stock purchase
warrants outstanding as of March 31, 2025.
Schedule of Stock Purchase Warrants Outstanding
Number of Warrants (in thousands)
Weighted Average Exercise Price
Weighted Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value (in thousands)
Outstanding, January 1, 2025
1,497
$ 5.31
4.2
$ 16,489
Stock purchase warrants granted
—
—
—
—
Exercised
—
—
—
—
Expired
—
—
—
—
Outstanding, March 31, 2025
1,497
$ 5.31
4.0
$ 2,250
Exercisable, March 31, 2025
1,497
$ 5.31
4.0
$ 2,250
A total of 883,433 pre-funded warrants were excluded from this table. During
the three months ended March 31, 2025 investors exercised 725,000 pre-funded warrants.
Note 11. Net Loss Per Share
Basic net loss per share is computed by dividing net
loss by the weighted-average number of shares of common stock outstanding during the period. Diluted loss per share is computed by dividing
net loss by the weighted-average number of shares of common stock outstanding adjusted to give effect to potentially dilutive securities.
Due to their nominal exercise price of $ 0.001 per share, 883,433 pre-funded warrants are considered common stock equivalents and are included
in weighted average shares outstanding in the accompanying condensed consolidated statement of operations as of the applicable purchase
date. Stock unit awards, stock options, and warrants (other than the pre-funded warrants) have not been included in the diluted loss per
share calculation as their inclusion would have had an anti-dilutive effect.
The potential common stock equivalents that have been
excluded from the computation of diluted loss per share consist of the following:
Schedule of Common Stock Equivalent from the
Computation of Diluted Loss Per Share
(in thousands)
2025
2024
Three months ended March 31,
(in thousands)
2025
2024
Stock options
548
501
Stock units
512
525
Stock purchase warrants
1,497
924
Total
2,557
1,950
Note 12. Income Taxes
The Company may be eligible, from time to time, to
receive cash from the sale of its net operating losses under New Jersey’s Department of the Treasury - Division of Taxation NOL
Transfer Program. For the three months ended March 31, 2025 and 2024, the Company received net cash payments of $ 48,000 and $ 122,000 ,
respectively from the sale of its New Jersey state net operating losses.
Note 13. Stock Based Compensation
There were no stock options granted, exercised or cancelled during the
three months ended March 31, 2025. The following table presents a summary of outstanding stock options as of March 31, 2025.
Schedule
of Outstanding Stock Options
Number of Options (in thousands)
Weighted Average Exercise Price
Weighted Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value (in thousands)
Outstanding, March 31, 2025
548
$ 31.39
6.7
$ 510
Exercisable, March 31, 2025
420
$ 39.33
6.3
$ 303
The intrinsic value is calculated as the difference
between the fair market value at March 31, 2025 and the exercise price per share of the stock option. The options granted to employees
generally vest over a three year period.
14
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated Financial
Statements (unaudited)
The following table presents a summary of activity
related to restricted and deferred stock units (“Stock Units”) granted during the three months ended March 31, 2025:
Schedule
of Restricted and Deferred Stock Units
Number of
Shares
(in thousands)
Weighted
Average
Grant
Date
Fair
Value
Outstanding, January 1, 2025
459
$ 6.86
Granted
84
15.80
Vested and delivered
( 30 )
6.62
Cancelled
( 1 )
42.45
Outstanding, March 31, 2025
512
$ 8.31
In general, Stock Units granted to employees vest over two 2
to 4 four-year
periods.
Immediately following the Company’s annual meeting
of stockholders, the Company generally grants each non-employee director an equity award that vests over a 12 -month period. Upon a non-employee
director’s initial appointment or election to the board of directors, the Company grants such non-employee director an equity award
subject to vesting as determined by the board of directors.
The Company recognized stock compensation expense
for its equity awards as follows:
Schedule of Stock Compensation Expenses
(in thousands)
2025
2024
Three months ended March 31,
(in thousands)
2025
2024
Selling, general and administrative
$ 500
$ 439
Research and development
24
35
Cost of goods sold
16
10
Total expense
$ 540
$ 484
Total unrecognized compensation cost related to unvested
awards as of March 31, 2025 was $ 2.8 million and is expected to be recognized over the next two years .
Note 14. Commitments and Contingencies
The Company may be a party to various legal
proceedings and claims arising out of the ordinary course of its business. Although the final results of all such matters and claims cannot
be predicted with certainty, the Company currently believes that there are no current proceedings or claims pending against it
the ultimate resolution of which would have a material adverse effect on its financial condition or results of operations. However, should
the Company fail to prevail in any legal matter or should several legal matters be resolved against the Company in the same reporting
period, such matters could have a material adverse effect on the Company’s operating results and cash flows for that particular
period. In all cases, at each reporting period, the Company evaluates whether or not a potential loss amount or a potential range
of loss is probable and reasonably estimable under ASC 450 , “Contingencies.” Legal costs are expensed as incurred.
Note 15. Related Party Transactions
In 2023, an executive of the Company co-founded the
Vagus Nerve Society, a society dedicated to the ongoing education and training of scientists and clinicians and the power of the vagus
nerve and its application in a broad spectrum of health-related conditions. During the first quarter of 2025, the Company incurred aggregate
expenses of $ 60,000
for unrestricted and directed educational grants to the Vagus Nerve Society.
Note 16. Segment Reporting
Operating segments are defined as components of an
enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker (CODM), or decision-making
group, in deciding how to allocate resources and in assessing performance. electroCore is a commercial stage bioelectronic technology
company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. The Company
views its operations and manages its business as one operating segment: Bioelectronic Innovations. The accounting policies of the Bioelectronic
Innovations segment are the same as those described in Note 2. Summary of Significant Accounting Policies.
Our CODM is our Chief Executive Officer. The CODM
uses loss from operations, as reported on our Consolidated Statements of Operations, in evaluating the performance of the Bioelectronic
Innovations segment and in determining how to allocate resources to the Company as a whole, The CODM does not review assets in evaluating
the results of the Bioelectronic Innovations segment, and therefore, such information is not presented below.
15
ELECTROCORE, INC. AND
SUBSIDIARIES
Notes to Condensed Consolidated Financial
Statements (unaudited)
The following table provides the non-GAAP operating
financial results of the Bioelectronic Innovations segment:
Schedule
of Operating Financial Segment
2025
2024
Three months ended March 31,
2025
2024
Net sales *
$ 6,719
$ 5,443
Cost of goods sold
1,013
888
Gross profit
5,706
4,555
Operating expenses
Research and development
642
399
General and administrative
4,333
3,884
Sales and marketing
4,553
4,121
Total operating expenses
9,528
8,404
Loss from operations
( 3,822 )
( 3,849 )
Other (income) expense
Interest and other income
( 83 )
( 225 )
Other expense
164
4
Total other (income) expense
81
( 221 )
Loss before income taxes
( 3,903 )
( 3,628 )
Benefit from income taxes
48
122
Net loss
$ ( 3,855 )
$ ( 3,506 )
* See Note 4 Revenue for geographical and disaggregation information.
Note 17. Subsequent Events
On May 1, 2025 (the “Closing
Date”), the Company completed its previously announced acquisition of NURO (following consummation of the Merger (as defined
below), the “Surviving Corporation”), pursuant to the terms of the Agreement and Plan of Merger, dated as of December
17, 2024 (the “Merger Agreement”), by and among the Company, NURO, and Nexus Merger Sub Inc., a Delaware corporation and
a wholly owned subsidiary of the Company (“Merger Sub”).
Pursuant to the Merger Agreement, on the Closing Date,
Merger Sub merged with and into NURO, with NURO surviving as a wholly-owned subsidiary of the Company (the “Merger”).
At the effective time (the “Effective
Time”) of the Merger, each share of common stock, par value $ 0.0001 per share, of NURO (the “NURO Common Stock”)
outstanding immediately prior to the Effective Time (including each share of NURO Common Stock underlying a NURO RSA or NURO RSU (as
such terms are defined below)), was canceled and converted into the right to receive from the Surviving Corporation (i) an amount in
cash equal to $ 4.49 per share of NURO Common Stock (the “Per Share Cash Consideration”) and (ii) one contingent value
right (a “CVR”), representing the right to receive certain contingent payments, subject to the terms and conditions set
forth in the CVR Agreement dated May 1, 2025, by and between the Company and Equiniti Trust Company, LLC (the “CVR
Agreement”) (the consideration contemplated by (i) and (ii), together, the “Merger Consideration”). Any shares of
NURO Common Stock held by NURO as treasury stock or owned by the Company, Merger Sub, or any other subsidiary of the Company or NURO
immediately prior to the Effective Time, were canceled, and no payment was made with respect thereto.
The foregoing description of the CVR Agreement does
not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the CVR Agreement.
All issued and outstanding shares of NURO’s
preferred stock, par value $ 0.001 per share (the “NURO Preferred Stock”) outstanding immediately prior to the Effective Time
will continue to be outstanding after the Effective Time, except that thereafter, such shares of NURO Preferred Stock will, in accordance
with their own terms, no longer be convertible into NURO Common Stock, but will instead be convertible into the right to receive from
the Surviving Corporation the Merger Consideration payable in respect of the shares of NURO Common Stock into which such shares of NURO
Preferred Stock would have been convertible immediately prior to the Effective Time.
At the Effective Time, outstanding awards of restricted
stock with respect to shares of NURO Common Stock (each, a “NURO RSA”), that were outstanding and unvested immediately prior
to the Effective Time, were converted into the right to receive consideration as follows (notwithstanding any vesting conditions, restrictions
or risk of forfeiture): (i) each NURO RSA for which the holder thereof made a timely and valid election (an “83(b) Election”)
under Section 83(b) of the Internal Revenue Code of 1986, as amended, was canceled and converted into the right to receive the Merger
Consideration with respect to each share of NURO Common Stock subject to such NURO RSA in accordance with the Merger Agreement and the
CVR Agreement; and (ii) each NURO RSA for which the holder thereof did not make a timely and valid 83(b) Election was canceled and converted
into the right to receive (a) an amount in cash (without interest and subject to deduction for any required withholding as contemplated
by the Merger Agreement) equal to: (A) the total number of shares of such NURO RSAs multiplied by (B) the Per Share Cash Consideration,
without any interest thereon, and (b) one CVR with respect to each share of NURO Common Stock subject to such NURO RSAs immediately prior
to the Effective Time.
At the Effective Time, each stock option granted by
NURO to purchase NURO Common Stock (each, a “NURO Option”) that was outstanding and unvested immediately prior to the Effective
Time (whether time- or performance-based) fully vested and became exercisable, and (i) each NURO Option that was then outstanding and
unexercised immediately prior to the Effective Time, and which had a per share exercise price that was less than the Per Share Cash Consideration,
was canceled and converted into the right to receive the sum of an amount in cash (without interest and subject to deduction for any required
withholding as contemplated in the Merger Agreement) equal to: (a) the excess, if any, of the Per Share Cash Consideration over the exercise
price per share of such NURO Option; multiplied by the number of shares of NURO Common Stock underlying such NURO Option and (b) one CVR,
and (ii) each NURO Option that was then outstanding and unexercised immediately prior to the Effective Time, and which had a per share
exercise price that was equal to or greater than the Per Share Cash Consideration, was canceled with no consideration payable in respect
thereof.
At the Effective Time, each NURO restricted stock
unit (“NURO RSU”) that was outstanding immediately prior to the Effective Time, was automatically canceled and converted into
the right to receive (i) an amount in cash equal to the product of (A) the number of shares of NURO Common Stock then underlying such
NURO RSU multiplied by (B) the Per Share Cash Consideration, without any interest thereon and (ii) one CVR with respect to each share
of NURO Common Stock subject to such NURO RSU.
At the Effective Time, subject to NURO’s
Amended and Restated Management Retention and Incentive Plan (the “MRIP”) and subject to NURO’s receipt of an
executed general release of claims, each eligible participant in the MRIP (a “Participant”) received the right to
receive from the Surviving Corporation: (a) an amount in cash equal to (i) such Participant’s percentage interest set forth in
the MRIP, multiplied by (ii) the aggregate cash consideration payable pursuant to the Merger Agreement; and (b) upon the making of
any Distributions (as defined in the CVR Agreement) pursuant to the CVR Agreement, such amounts in cash equal to (i) such
Participant’s percentage interest set forth in the MRIP, multiplied by (ii) the Pre-MRIP Adjusted Proceeds in respect of the
applicable Distribution Period (as each such term is defined in the CVR Agreement).
The foregoing description of the Merger does not purport to be complete and is subject to, and qualified in its entirety by reference
to, the full text of the Merger Agreement.
16
Item 2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
MANAGEMENT’S DISCUSSION
AND ANALYSIS OF FINANCIAL
CONDITION
AND RESULTS OF OPERATIONS
You should read this section in conjunction with
our unaudited interim condensed consolidated financial statements and related notes included in this Quarterly Report and our audited
consolidated financial statements and related notes thereto and management’s discussion and analysis of financial condition and
results of operations for the year ended December 31, 2024 included in our Annual Report. As discussed in the section titled “Cautionary
Note Regarding Forward-Looking Statements,” the following discussion and analysis contains forward-looking statements that involve
risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ
materially from tho se expressed or implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those identified below, and those under the caption “Risk
Factors” in the aforementioned Annual Report and this Quarterly Report.
We are a commercial stage bioelectronic technology
company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies.
Non-invasive vagus nerve stimulation or nVNS, a form
of bioelectronic technology, modulates neurotransmitters through its effects on both the peripheral and central nervous systems. Our nVNS
treatment is delivered through a proprietary high-frequency burst waveform that safely and comfortably passes through the skin and stimulates
therapeutically relevant fibers in the vagus nerve. Various scientific publications suggest that nVNS works through a variety of mechanistic
pathways including the modulation of neurotransmitters.
Historically, vagus nerve stimulation or VNS, required
an invasive surgical procedure to implant a costly medical device. This has generally limited VNS from being used by anyone other than
the most severe patients. Our non-invasive bioelectronic nVNS technologies es are self-administered and intended for regular or intermittent
use over many years.
Our capabilities include product development, regulatory
affairs and compliance, sales and marketing, product testing, electromechanical assembly, fulfillment, and customer support. We derive
revenues from the sale of products in the United States and select overseas markets. We have two principal product categories:
●
Handheld, personal use bioelectronic therapies for the management and treatment of certain medical conditions such as primary headache; and
●
Handheld, personal use consumer products utilizing bioelectronic technologies to promote general wellness and human performance.
We believe our bioelectronic technologies may be used
in the future to effectively treat additional medical conditions.
Our goal is to be a leader in non-invasive neuromodulation
to deliver better health. To achieve this, we offer multiple propositions:
●
Prescription gammaCore bioelectronic therapy for the treatment of certain prescription FDA cleared medical conditions such as primary headache;
●
Truvaga for the support of general health and wellbeing; and
●
TAC-STIM for human performance.
Our flagship gammaCore Sapphire is a prescription
medical device using our bioelectronic therapy that is FDA cleared for a variety of primary headache conditions. gammaCore is available
by prescription only and Sapphire is a portable, reusable, rechargeable and reloadable personal use option for patients to use at home
or on the go. Prescriptions are written by a health care provider and dispensed from a specialty pharmacy, through the patient’s
healthcare system, or shipped directly to certain patients in the United States from our facility in Rockaway, NJ. After the initial prescription
is filled, access to additional therapy can be refilled for certain of our gammaCore products through the input of a prescription-only
authorization.
We offer two versions of our bioelectronic technology
to support general health and wellbeing. Truvaga 350 is a personal use consumer electronics general wellness product and Truvaga Plus,
which was launched in April 2024, is our next generation, app-enabled general wellness product. Neither product requires a prescription,
and are available direct-to-consumer from electroCore at www.truvaga.com or through online retailers such as Amazon.com.
TAC-STIM handset is a form of nVNS for human performance
and has been developed in collaboration with the United States Department of Defense Biotech Optimized for Operational Solutions and Tactics,
or BOOST program. TAC-STIM handsets are available as a Commercial Off the Shelf (COtS) solution to professional organizations and are
the subject of ongoing research and evaluation within the United States Air Force Special Operations Command, the United States Army Special
Operations Command and at the United States Air Force Research Laboratory.
Truvaga and TAC-STIM are intended for general wellness
in compliance with the FDA guidance document entitled “General Wellness: Policy for Low-Risk Devices; Guidance for Industry and
FDA Staff, issued on September 27, 2019.” Truvaga and TAC-STIM handsets are not intended to diagnose, treat, cure, or prevent any
disease or medical condition.
Our two largest customers by revenue are the United
States Department of Veterans Affairs and United States Department of Defense, or VA, and the United Kingdom National Health Service,
or NHS, utilizing our FDA cleared and CE marked product, gammaCore.
17
Sales to the VA comprised 70.3% of our revenue during the three months
ended March 31, 2025. The majority of our 2024 sales were made pursuant to our qualifying contract under the Federal Supply Schedule,
or FSS, which was secured by us in December 2018 (the “Original FSS Contract”), as well as open market sales to individual
facilities within the government channel. The initial term of our Original FSS contract has been extended through June 14, 2025. In March
2025, we entered into a new FSS contract which will become effective on June 15, 2025, and run through June 14, 2030.
In August 2023, we signed a non-exclusive distribution
agreement with Lovell providing Lovell the right to list and distribute certain gammaCore products into the federal market. Lovell is
a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to federal healthcare
providers. Listing products with Lovell is intended to streamline the sales process to a variety of government procurement channels through
Lovell’s compliance with contracting regulations and its provision of logistical solutions connected directly into government contracting
portals, all of which are intended to help government agencies meet their SDVOSB procurement goals. Customers for these vehicles are federal
healthcare systems such as the Veterans Health Administration (VHA, which includes the VA), the Military Health System (MHS), and Indian
Health Services (IHS), which we believe serve up to approximately 21 million patients combined.
Between November 2023 and January 2024, certain gammaCore
products were added to the FSS, the VA Distribution and Pricing Agreement (DAPA), GSA Advantage, and Defense Logistics Agency’s
ECAT system procurement portals through the Lovell contract vehicles, enabling the purchase of gammaCore products within the government
channel and throughout the federal markets, including, but not limited to, the VA. The gammaCore products offered through Lovell provide
government customers with similar product configuration options to those currently sold through our existing FSS contract, new FSS contract
and open market sales made directly to individual VA facilities. We expect an increasing portion of our 2025 sales will be made pursuant
to the distribution agreement with Lovell and its contract vehicles as well as through our new FSS contract, and our sales function in
this channel is comprised of employees and an increasing number of independent contractors.
Sales under the UK Med Tech Funding Mandate, or MTFM,
for cluster headache in the UK comprised 5.3% of our revenue during the three months ended March 31, 2025. We plan on continuing use of
this program. In 2023, NHS granted a two-year extension in which our prescription gammaCore therapy will continue to be listed in the
NHS catalog. This extension is through March 17, 2026 with an option for us to extend an additional two years. In 2025, we expect NICE
to review the guidance document and any changes in recommendation or pricing may adversely impact our ability to work with NHS England
on the MTFM program and could have an adverse impact on our financial results. We continue to utilize distribution partners to commercialize
our nVNS technology in selected territories outside the United States and United Kingdom.
We believe there may be significant opportunities
beyond these two areas. Specifically, we believe there may be a large commercial opportunity for our gammaCore bioelectronic therapy with
additional insurance covered lives, cash pay, physician dispense, and direct-to-consumer approaches, along with wellness and human performance
propositions through our Truvaga and TAC-STIM handsets. Therefore, we will continue our investments to expand our efforts in these channels
and markets in 2025.
On December 17, 2024, we entered into a definitive
agreement to acquire NeuroMetrix, Inc. (“NURO”). NURO is a commercial stage healthcare company that develops and commercializes
neurotechnology devices to address unmet needs in the chronic pain market through its Quell® platform: a wearable, app and cloud-enabled
neuromodulation platform that is indicated for the treatment of fibromyalgia symptoms (Quell Fibromyalgia) and lower-extremity chronic
pain (Quell 2.0). The transaction closed on May 1, 2025. The transaction does not include
NURO’s DPNCheck® technology and business, which was divested by NURO prior to closing of the transaction.
We face a variety of challenges and risks that we
will need to address and manage as we pursue our strategies, including our ability to develop and retain an effective sales force, achieve
market acceptance of our gammaCore medical device among clinicians, patients, and third-party payers, expand the use of our gammaCore
medical device to additional therapeutic indications, and to develop our nascent wellness and human performance business including the
launch of Truvaga Plus, our next generation app-enabled device under the Truvaga brand.
As we continue to pursue opportunities in both
U.S. and select international markets, we remain subject to evolving global economic conditions, including uncertainties related to
international trade policies, tariffs, and supply chain dynamics. Uncertainties and changes in trade regulations, tariff structures,
or logistical constraints could influence the cost, availability, or timing of materials and components used in our manufacturing
and assembly processes. We intend to monitor these developments and are actively implementing contingency plans, including
alternative sourcing strategies and supplier diversification, to support supply chain continuity, maintain operational efficiency,
and help mitigate potential future impacts.
Because of the numerous risks and uncertainties associated
with our commercialization efforts, as well as research and product development activities, there may be uncertainty regarding our ability
to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability, then we may be unable to
continue our operations at planned levels and be forced to reduce or terminate our operations.
Our expected cash requirements for the next 12 months
and beyond are based on the commercial success of our products and our ability to control operating expenses. There are significant risks
and uncertainties as to our ability to achieve these operating results. Due to these risks and uncertainties, we may need to reduce our
activities significantly more than our current operating plan and cash flow projections assume in order to fund operations for the next
12 months. There can be no assurance that we will have sufficient cash flow and liquidity to fund our planned activities, which could
force us to significantly reduce or curtail our activities and, ultimately potentially cease operations. See also “Liquidity Outlook.”
18
Critical Accounting Estimates
The preparation of our financial statements is in
accordance with accounting principles generally accepted in the United States of America, or GAAP, which require us to make estimates
and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and other related disclosures. While we believe
our estimates, assumptions and judgments are reasonable, they are based on information presently available. Actual results may differ
significantly from these estimates due to changes in judgments, assumptions and conditions as a result of unforeseen events or otherwise,
which could have a material impact on our financial position and results of operations.
We consider an accounting estimate to be critical if: (i) the accounting
estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii)
changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could
have used in the current period, would have a material impact on our financial condition or results of operations. The critical accounting
estimates, that we believe have the greatest potential impact on the condensed consolidated financial statements are disclosed in the
section titled Critical Accounting Policies and Estimates in Part II of our Annual Report.
Results of Operations
Comparison of the three months ended March 31, 2025 to the three
months ended March 31, 2024
The following table sets forth amounts from our condensed consolidated
statements of operations for the three months ended March 31, 2025 and 2024:
For the three months ended March 31,
2025
2024
Change
(in thousands)
Consolidated statements of operations:
Net sales
$ 6,719
$ 5,443
$ 1,276
Cost of goods sold
1,013
888
125
Gross profit
5,706
4,555
1,151
Gross margin
85 %
84 %
Operating expenses
Research and development
642
399
243
Selling, general and administrative
8,886
8,005
841
Total operating expenses
9,528
8,404
1,084
Loss from operations
(3,822 )
(3,849 )
67
Other (income) expense
Interest and other income
(83 )
(225 )
142
Other expense
164
4
160
Total other expense (income)
81
(221 )
342
Loss before income taxes
(3,903 )
(3,628 )
(275 )
Benefit from income taxes
48
122
(74 )
Net loss
$ (3,855 )
$ (3,506 )
$ (349 )
Net Sales
Net sales for the three months ended March 31, 2025
increased 23% as compared to the three months ended March 31, 2024. The increase of $1.3 million is due to an increase in net sales of
Rx gammaCore sold into the VA and outside the United States and revenue from the sales of our nonprescription general wellness Truvaga
products. We expect that the majority of our remaining 2025 fiscal year revenue will continue to come from the prescription gammaCore
sold into the VA and the Truvaga direct-to-consumer product offering. See the above Overview for discussion regarding our FSS contract
with the VA.
19
The following table sets forth our product net sales:
(in thousands)
Three months ended March 31,
Product
2025
2024
Rx gammaCore - VA
$ 4,721
$ 3,875
Rx gammaCore - U.S. Commercial
289
433
Outside the United States
513
449
Truvaga
1,106
385
Total before TAC-STIM
6,629
5,142
TAC-STIM
90
301
Total Revenue
$ 6,719
$ 5,443
Gross Profit
Gross profit increased by $1.2 million for the three
months ended March 31, 2025 compared to the three months ended March 31, 2024. Gross margin was 85% and 84% for the three months ended
March 31, 2025 and 2024, respectively. The increase in gross profit is attributable to the increased net sales and product mix. Gross
profit and gross margin for the remainder of 2025 will be largely dependent on revenue levels, product mix, and any changes in the estimated
useful lives of licensed devices.
Research and Development
Research and development expense in the first quarter
of 2025 was $0.6 million, as compared to $0.4 million in the first quarter of 2024. This increase was primarily due to an increase in
headcount and effects of discontinuing certain clinical trial activities in the first quarter of 2024 that did not repeat in the first
quarter of 2025. For the remainder of 2025, we expect our research and development expense to be higher than the comparable periods in
2024.
Selling, General and Administrative
Selling, general and administrative expense of $8.9
million for the three months ended March 31, 2025 increased by $0.9 million, or 11%, as compared to $8.0 million for the previous year
period. This increase was primarily due to our greater investment in selling and marketing costs consistent with our increase in sales
and an increase in separation costs associated with select headcount reductions. For the remainder of 2025, we plan on continuing to make
targeted investments in sales and marketing to support our commercial efforts, particularly around sales and marketing efforts across
all major U.S. channels.
Other Expense (Income)
Total other expense was $81,000 for the three months
ended March 31, 2025, which consisted primarily of non-recurring expenses, as compared to and total other income of $221,000 for the three
months ended March 31, 2024, which consisted primarily of interest income.
Benefit from Income Taxes
We may be eligible, from
time to time, to receive cash from the sale of our net operating losses under New Jersey’s Department of the Treasury - Division
of Taxation NOL Transfer Program. During the three months ended March 31, 2025, the Company received a net cash payment of $48,000 from
the sale of its New Jersey state net operating losses as compared to a net cash payment of $122,000 from the sale of New Jersey net operating
loss for the three months ended March 31, 2024.
Cash Flows
The following table sets forth the significant sources and uses of cash
for the periods noted below:
For the three months ended March 31,
2025
2024
(in thousands)
Net cash (used in) provided by
Operating activities
$ (4,355 )
$ (2,558 )
Investing activities
$ 4,500
$ —
Financing activities
$ 180
$ —
20
Operating Activities
Net cash used in operating activities was $4.4 million
and $2.6 million for the three months ended March 31, 2025 and 2024, respectively. This increase is primarily due to the decrease in our
net loss adjusted for non-cash expense items and certain working capital changes consisting primarily of decreases in accrued expenses
and operating lease liabilities and increases in inventories and prepaid expenses and other assets.
Investing Activities
During the three months ended March 31, 2025, net
cash provided by investing activities was $4.5 million from the sale of marketable securities.
Financing Activities
During the three months ended March 31, 2025, net
cash provided by financing activities was $0.2 million which was attributable to utilization of our at-the-market facility pursuant to
the Sales Agreement.
Liquidity Outlook
We have experienced significant net losses, and we
expect to continue to incur net losses for the near future as we work to increase market acceptance of our gammaCore therapy and general
wellness and human performance products. We have never been profitable and we have incurred net losses and negative cash used in operations
in each year since our inception. We incurred net losses of $3.9 million and $3.5 million and used cash in our operations of $4.4 million
and $2.6 million for the three months ended March 31, 2025 and 2024, respectively.
We have historically funded our operations from the
sale of our securities. During the three months ended March 31, 2025, we received net proceeds of approximately $0.2 million from such
sales and as of March 31, 2025, our cash, cash equivalents, restricted cash and marketable securities totaled $8.0 million.
On November 29, 2024, we entered into an At The Market
Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), whereby the Company
may offer and sell shares of its common stock from time to time having an aggregate offering price of up to $20 million by any method
deemed to be an “at-the-market” offering as defined in Rule 415 of the Securities Act, or any other method specified in the
Sales Agreement. During the three months ended March 31, 2025, the Company sold 14,265 shares of its common stock at a weighted average
price of $15.20 per share, net of issuance costs for $0.2 million in net proceeds, pursuant to the Sales Agreement.
In 2025, we intend to continue to make targeted investments
in sales and marketing to continue driving commercial activities. We have historically funded our operations from the sale of our common
stock and may continue to do so through utilization of the at-the-market facility or other equity or debt transactions if needed. As of
May 2, 2025, the Company had approximately $19.8 million shares of common stock remaining available for issuance under the Sales Agreement.
The Company’s expected cash requirements for
the next 12 months from the date these financial statements are issued and beyond are largely based on the commercial success of its products.
Based on its current assessment, the Company believes its cash, cash equivalents, restricted cash marketable securities, and expected
cash flow from operations for such period will enable it to fund its operating expenses and capital expenditure requirements, as currently
planned, for at least the next 12 months from the date the accompanying financial statements are issued. There remain significant risks
and uncertainties regarding the Company’s business, financial condition and results of operations. The Company’s future capital
requirements are difficult to forecast and will depend on many factors that are out of its control. If the Company is unable to achieve
its planned operating results or maintain sufficient financial resources, including through potential positive cash flow from operations
or supplemental access to third-party debt, equity or hybrid capital, its business, financial condition and results of operations may
be materially and adversely affected.
21
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We develop our products in the United States and sell
those products into several countries. As a result, our financial results could be affected by factors such as changes in foreign currency
exchange rates or weak economic conditions in foreign markets. Most of our sales in Europe are denominated in British Pound Sterling and
our license agreement with Teijin Limited is denominated in Japanese Yen. As our sales in currencies other than the U.S. dollar increase,
our exposure to foreign currency fluctuations may increase. In addition, changes in exchange rates also may affect the end-user prices
of our products compared to those of our foreign competitors, who may be selling their products based on local currency pricing. These
factors may make our products less competitive in some countries.
If the U.S. dollar uniformly increased or decreased
in strength by 10% relative to the foreign currencies in which our sales were denominated, our net income would have correspondingly increased
or decreased by an immaterial amount for the three months ended March 31, 2025.
Our exposure to market interest rate risk is confined
to our cash and cash equivalents and marketable securities. The goals of our investment policy are preservation of capital, fulfillment
of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming
significant risk. To achieve our goals, we may maintain a portfolio of cash equivalents and investments in a variety of securities of
high credit quality. The securities in our investment portfolio, if any, are not leveraged, are classified as available for sale and are,
due to their very short-term nature, subject to minimal interest rate risk. We currently do not hedge interest rate exposure. Because
of the short-term maturities of our cash equivalents, we do not believe that an increase in market rates would have any material negative
impact on interest income recognized in our statement of operations. We have no investments denominated in foreign currencies and therefore
our investments are not subject to foreign currency exchange risk. We contract with investigational sites, suppliers and other vendors
in Europe and internationally. In addition, our license agreement requires payments to us to be denominated in Japanese Yen. We are subject
to fluctuations in foreign currency rates in connection with these agreements. We do not hedge our foreign currency exchange rate risk.
All of the potential changes noted above are based on sensitivity analyses
performed on our financial position as of March 31, 2025.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that
are designed to ensure that information required to be disclosed in our reports under the Exchange Act, is recorded, processed, summarized
and reported within the time periods specified in the rules and forms, and that such information is accumulated and communicated to us,
including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decision making regarding required
disclosure. In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed
to do, and we apply our judgment in evaluating whether the benefits of the controls and procedures that we adopt outweigh their costs.
As required by Rule 13a-15(b) of the Exchange Act,
an evaluation as of March 31, 2025 was conducted under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e)
under the Exchange Act). Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures, as of March 31, 2025 were effective for the purposes stated above.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial
reporting as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, that occurred during the three months ended
March 31, 2025 that has materially affected or is reasonably likely to materially affect our internal control over financial reporting.
22
PART II— OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
The information set forth in Note 14. Contingencies of the condensed
consolidated financial statements included in this Quarterly Report is incorporated here by reference to this Part II Item 1.
Item 1A.
RISK FACTORS
You should carefully consider the
risk factors included in Item 1A. of our Annual Report and the other information in this Quarterly Report, including the section of this
Quarterly Report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and
our financial statements and related notes. If any of the events described in our Annual Report and the
risks described elsewhere in this Quarterly Report occur, our business, operating results and financial condition could be seriously harmed.
This Quarterly Report also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially
from those anticipated in the forward-looking statements as a result of factors that are described in our Annual Report and elsewhere
in this Quarterly Report.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS
None.
Item 3. DEFAULTS UPON SENIOR SECURITIES
None.
Item 4. MINE SAFETY DISCLOSURES
Not applicable.
Item 5. OTHER INFORMATION
(a) Not applicable.
(b) Not applicable.
(c) Trading Plans.
During the quarter ended March 31, 2025, no director
or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements (in each case,
as defined in Item 408(a) of Regulation S-K promulgated by the SEC).
23
Item 6. EXHIBITS
Exhibit
Number
Description
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification of 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.INS
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL 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 (formatted as Inline XBRL and contained in Exhibit 101)
*
Filed herewith.
**
The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report are not deemed filed with the SEC and are not to be incorporated by reference into any filing of electroCore, Inc. under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date of this Annual Report, irrespective of any general incorporation language contained in such filing.
24
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned thereunto duly authorized.
Company Name
Date: May 7, 2025
By:
/s/
DANIEL S. GOLDBERGER
Daniel S. Goldberger
Chief Executive Officer
(Principal Executive Officer)
Date: May 7, 2025
By:
/s/
JOSHUA S. LEV
Joshua S. Lev
Chief Financial Officer
(Principal Financial and Accounting Officer)
25
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.