Annual Statements Open main menu

electroCore, Inc. - Quarter Report: 2021 June (Form 10-Q)

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 June 30, 2021



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

 

The Nasdaq Global Select 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 July 30, 2021 the registrant had 69,392,030 shares of common stock outstanding. 


1




PART I. FINANCIAL INFORMATION

Page Number


Cautionary Note Regarding Forward-Looking Statements 3
Item 1. Financial Statements

Condensed Consolidated Balance Sheets as of June 30, 2021 (unaudited) and December 31, 2020 4

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2021 and 2020 (Unaudited) 5

Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2021 and 2020 (Unaudited) 6

Condensed Consolidated Statements of Equity for the Three and Six Months Ended June 30, 2021 and 2020 (Unaudited) 7

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020 (Unaudited) 9

Notes to Condensed Consolidated Financial Statements (Unaudited) 10
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 22
Item 3. Quantitative and Qualitative Disclosures About Market Risk 28
Item 4. Controls and Procedures 28

PART II. OTHER INFORMATION
Item 1. Legal Proceedings 29
Item 1A. Risk Factors 31
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 31
Item 3. Defaults Upon Senior Securities 31
Item 4. Mine Safety Disclosures 31
Item 5. Other Information 31
Item 6. Exhibits 32

Signatures 33


2



REFERENCES TO ELECTROCORE

In this Quarterly Report on Form 10-Q, 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 and affiliate.

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 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, (i) risks and uncertainties related to the impact of the COVID-19 pandemic on general political and economic conditions, including as a result of efforts by governmental authorities to mitigate the COVID-19 pandemic, such as travel bans, shelter in place orders and third-party business closures and resource allocations, manufacturing and supply chains and patient access to commercial products; our ability to execute our operational and budget plans in light of the COVID-19 pandemic, and (ii) those included in our Form 10-Qs, our Annual Report on Form 10-K for the year ended December 31, 2020, in our other filings with the U.S. Securities and Exchange Commission or in materials incorporated by reference therein, as well as information in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report. Furthermore, any such forward-looking statements in this Quarterly Report speak only as of the date of this 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 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., SUBSIDIARIES AND AFFILIATE

(Unaudited)

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

14,699,111

 

 

$

4,241,937

 

Marketable securities

 

 

9,027,807

 

 

 

18,386,160

 

Accounts receivable, net

 

 

369,189

 

 

 

270,546

 

Inventories, net

 

 

1,077,818

 

 

 

876,436

 

Prepaid expenses and other current assets

 

 

235,705

 

 

 

1,288,588

 

Total current assets

 

 

25,409,630

 

 

 

25,063,667

 

Inventories, noncurrent

 

 

4,450,569

 

 

 

4,865,181

 

Property and equipment, net

 

 

195,852

 

 

 

244,047

 

Operating lease right of use assets

 

 

555,238

 

 

 

517,257

 

Other assets, net

 

 

685,894

 

 

 

828,011

 

Total assets

 

$

31,297,183

 

 

$

31,518,163

 

Liabilities and Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,298,721

 

 

$

2,078,699

 

Accrued expenses

 

 

2,916,080

 

 

 

2,800,820

 

Notes payable, current

 

 

 

 

 

476,236

 

Current portion of operating lease liabilities

 

 

542,695

 

 

 

534,547

 

Total current liabilities

 

 

5,757,496

 

 

 

5,890,302

 

Noncurrent liabilities:

 

 

 

 

 

 

 

 

Operating lease liabilities, noncurrent

 

 

923,181

 

 

 

885,333

 

      Note payable, noncurrent





1,097,946

Total liabilities

 

 

6,680,677

 

 

 

7,873,581

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Preferred Stock, par value $0.001 per share; 10,000,000 shares authorized at June 30, 2021 and December 31, 2020; 0 shares issued and outstanding at June 30, 2021 and December 31, 2020

 

 

 

 

 

 

Common Stock, par value $0.001 per share; 500,000,000 shares authorized at June 30, 2021 and December 31, 2020; 48,690,424 shares issued and outstanding at June 30, 2021 and 45,559,765 shares issued and outstanding at December 31, 2020

 

 

48,690

 

 

 

45,560

 

Additional paid-in capital

 

 

139,302,400

 

 

 

130,205,027

 

Accumulated deficit

 

 

(115,267,732

)

 

 

(106,990,148

)

Accumulated other comprehensive loss

 

 

(102,462

)

 

 

(251,467

)

Total stockholders' equity

 

 

23,980,896

 

 

 

23,008,972

 

Noncontrolling interest

 

 

635,610

 

 

 

635,610

 

Total equity

 

 

24,616,506

 

 

 

23,644,582

 

Total liabilities and equity

 

$

31,297,183

 

 

$

31,518,163

 

 

 


 

 

 

 

 

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

4


ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)

 

 

Three months ended 

June 30,


 

Six months ended 

June 30,

 

 

2021

2020

 

2021

 

 

2020

 

Net sales

$ 1,269,464

$ 752,955

 

$

2,473,308

 

 

$

1,486,726

 

Cost of goods sold


374,271


272,986

 

 

738,258

 

 

 

571,101

 

Gross profit


895,193


479,969

 

 

1,735,050

 

 

 

915,625

 

Operating expenses








 

 

 

 

 

 

 

 

Research and development


824,906


1,030,530

 

 

1,323,871

 

 

 

2,553,644

 

Selling, general and administrative


5,272,921


5,273,329

 

 

10,997,509

 

 

 

11,834,055

 

Restructuring and other severance related charges





99,606

 

 

 

 

 

464,606

 

Total operating expenses


6,097,827


6,403,465

 

 

12,321,380

 

 

 

14,852,305

 

     Loss from operations


(5,202,634 )

(5,923,496 )

 

 

(10,586,330

)

 

 

(13,936,680

)

Other (income) expense








 

 

 

 

 

 

 

 

      Gain on extinguishment of debt
(1,422,214 )




(1,422,214

)


Interest and other income


(1,273)

(11,765 )

 

 

(1,137

)

 

 

(74,741

)

Other expense





687

 

 

 

 

 

9,828

 

     Total other (income) expense


(1,423,487 )

(11,078 )

 

 

(1,423,351

)

 

 

(64,913

)
Loss before income taxes
(3,779,147 )

(5,912,418 )

(9,162,979 )

(13,871,767 )
Benefit from income taxes (see Note 13)
885,395


1,170,890


885,395


1,170,890
Net loss $ (2,893,752 )
$ (4,741,528 )

 

$

(8,277,584

)

 

$

(12,700,877

)

Net loss per share of common stock - Basic and Diluted (see Note 12)

$ (0.06 )
$ (0.13 )

 

$

(0.17

)

 

$

(0.38

)

Weighted average common shares outstanding - Basic and Diluted (see Note 12)


48,520,241


36,658,797

 

 

48,089,117

 

 

 

33,216,512

 

 

See accompanying notes to unaudited condensed consolidated financial statements.


5



ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)

 

 

Three months ended  

June 30,



Six months ended  

June 30,

 

 

2021

2020

2021

 

 

2020

 

Net loss

$ (2,893,752 )
$ (4,741,528 )

$

(8,277,584

)

 

$

(12,700,877

)

   Other comprehensive income (loss):









 

 

 

 

 

 

 

        Foreign currency translation adjustment 


5,267

(109,337 )

 

146,648

 

 

(64,015

)

        Unrealized (loss) gain on securities, net of taxes as applicable


(406 )

(7,059 )

 

2,357

 

 

(1,233

)

             Other comprehensive income (loss)


4,861

(116,396 )

 

149,005

 

 

(65,248

)

Comprehensive loss

$ (2,888,891 )
$ (4,857,924 )

$

(8,128,579

)

 

$

(12,766,125

)

 

See accompanying notes to unaudited condensed consolidated financial statements.


6



ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)


 

Common

 

 

Additional

 

 

 

 

 

 

Accumulated other

 

 

Total electroCore, Inc.

 

 

 

 

 


 

 

 

 

Stock

 

 

paid-in

 

 

Accumulated

 

 

comprehensive

 

 

stockholders'

 

 

Noncontrolling

 


Total

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

income (loss)

 

 

equity

 

 

interest

 


equity

 

Balances as of January 1, 2021
45,559,765

$ 45,560

$ 130,205,027

$ (106,990,148 )
$ (251,467 )
$ 23,008,972

$ 635,610

$ 23,644,582

Net loss











(5,383,832 )




(5,383,832 )




(5,383,832 )

Other comprehensive income 














144,144


144,144





144,144

Issuance of stock (see Note 11)


2,750,000


2,750


6,917,600








6,920,350





6,920,350

Issuance of stock related to employee compensation plans, net of forfeitures 


17,599


18


(18 )














Settlement of accrued bonus 


165,413


165


399,832








399,997





399,997

Share based compensation








942,183








942,183





942,183
Balances as of March 31, 2021
48,492,777

$ 48,493

$ 138,464,624

$ (112,373,980 )
$ (107,323 )
$ 26,031,814

$ 635,610

$ 26,667,424

Net loss

 

 

 

 

 

 

 

 

 

 

(2,893,752

)

 

 


 

 

(2,893,752

)

 

 

 


 

(2,893,752

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

4,861

 

 

4,861

 

 

 


 

4,861

Issuance of stock related to employee compensation plans, net of forfeitures

 

197,647

 

 

 

197

 

 

 

(197)

 

 

 

 

 


 

 

 

 

 

 


 

 

Share based compensation

 

 

 

 

 

 

 

837,973

 

 

 

 

 

 


 

 

837,973

 

 

 

 


 

837,973

 

Balances as of June 30, 2021

 

48,690,424

 

 

  $

48,690

 

 

$

139,302,400

 

 

$

(115,267,732

)

 

$

(102,462

)

 

$

23,980,896

 

 

$

635,610

 


$

24,616,506

 


 


 

 

 


 

 

 


 

 

 



 

 


 

 

 



 

 


 


 



 

See accompanying notes to unaudited condensed consolidated financial statements

 

7



ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE


Condensed Consolidated Statements of Equity

(Unaudited)


 

Common

 

 

Additional

 

 

 

 

 

 

Accumulated other

 

 

Total electroCore, Inc.

 

 

 

 

 


 

 

 

 

Stock

 

 

paid-in

 

 

Accumulated

 

 

comprehensive

 

 

stockholders'

 

 

Noncontrolling

 


Total

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

income (loss)

 

 

equity

 

 

interest

 


equity

 

Balances as of January 1, 2020
29,835,183

$ 29,835

$ 107,752,066

$ (83,479,098 )
$ (41,295 )
$ 24,261,508

$ 635,610

$ 24,897,118

Net loss











(7,959,349 )




(7,959,349 )




(7,959,349 )

Other comprehensive income














51,148


51,148





51,148

Equity financing commitment fee* 


461,676


462


(462 )














Issuance of stock related to employee compensation plans, net of forfeitures 


124,568


125


(125 )














Share based compensation








744,865








744,865





744,865
Balances as of March 31, 2020
30,421,427

$ 30,422

$ 108,496,344

$ (91,438,447 )
$ 9,853
$ 17,098,172

$ 635,610

$ 17,733,782

Net loss

 

 

 

 

 

 

 

 

 

 

(4,741,528

)

 

 


 

 

(4,741,528

)

 

 

 


 

(4,741,528

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

(116,396

)

 

 

(116,396

)

 

 

 


 

(116,396

)

Issuance of stock (see Note 11)


8,028,372


8,028


7,823,507










7,831,535






7,831,535

Equity financing commitment fee*

 

181,273

 

 

 

181

 

 

 

(181

)

 

 

 

 

 


 

 

 

 

 

 


 

 

Financing fees









(167,299 )








(167,299 )




(167,299 )

Issuance of stock related to employee compensation plans, net of forfeitures

 

184,073

 

 

 

184

 

 

 

(184

)

 

 

 

 

 


 

 

 

 

 

 


 

 

Share based compensation

 

 

 

 

 

 

 

1,002,758

 

 

 

 

 

 


 

 

1,002,758

 

 

 

 


 

1,002,758

 

Balances as of June 30, 2020

 

38,815,145

 

 

  $

38,815

 

 

$

117,154,945

 

 

$

(96,179,975

)

 

$

(106,543

)

 

$

20,907,242

 

 

$

635,610

 


$

21,542,852

 


 


 

 

 


 

 

 


 

 

 



 

 


 

 

 



 

 


 


 



* Reflects commitment shares issued in accordance with the Company's equity facility purchase agreement with Lincoln Park. For additional information see Note 11. Lincoln Park Stock Purchase Agreement.



8



ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)

 

 

 

Six months ended

June 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(8,277,584

)

 

$

(12,700,877

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

1,780,156

 

 

 

1,747,623

 

Depreciation and amortization

 

 

191,342

 

 

 

193,687

 

Amortization of marketable securities discount

 

 

114,404

 

 

(1,396

)
           Gain on extinguishment of debt

(1,422,214 )


Legal expense settled with stock






156,434

Net noncash lease expense

 

 

40,641

 

 

178,302

           Inventory reserve charge

39,478





Other

 

 

 

 

 

10,058

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable, net

 

 

(98,643

)

 

 

376,654

Inventories

 

 

173,752

 

 

(58,286

)

Prepaid expenses and other current assets

 

 

1,081,918

 

 

897,481

 

Accounts payable

 

 

220,022

 

 

(1,787,364

)

Accrued expenses and other current liabilities

 

 

363,289

 

 

(1,294,684

)

                 Right of use operating leases

(78,622 )


                 Operating lease liabilities

45,996

(228,572 )

Net cash used in operating activities

 

 

(5,826,065

)

 

 

(12,510,940

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of marketable securities

 

 

(5,082,730

)

 

 

(3,998,604

)

Proceeds from maturities of marketable securities

 

 

14,300,000

 

 

 

10,500,000

 

Net cash provided by investing activities

 

 

9,217,270

 

 

6,501,396

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from shares issued

 

 

6,920,350

 

 

 

5,959,101

 

Proceeds from note issued






1,410,524

Net cash provided by financing activities 

 

 

6,920,350

 

 

 

7,369,625

Effect of changes in exchange rates on cash and cash equivalents

 

 

145,619

 

 

(60,744

)

Net increase in cash and cash equivalents

 

 

10,457,174

 

 

1,299,337

Cash and cash equivalents – beginning of period

 

 

4,241,937

 

 

 

13,563,791

 

Cash and cash equivalents – end of period

 

$

14,699,111

 

 

$

14,863,128

 

 

 

 

 

 

 

 

 

 

Supplemental cash flows disclosures:

 

 

 

 

 

 

 

 

      Proceeds from sale of state net operating losses
$

1,425,395



$ 1,170,890

Interest paid

  

 

 


5,797

 

      Income taxes paid




4,666
Supplemental schedule of noncash activity:







      2020 Accrued bonus awarded in equity

399,997



Accounts payable paid through issuance of common stock






1,548,702

 

See accompanying notes to unaudited condensed consolidated financial statements. 


9


ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)

Note 1. The Company

electroCore, Inc. (“electroCore” or the “Company”) is a medical device company, engaged in the commercialization and development of a platform non-invasive Vagus Nerve Stimulation (“nVNS”) therapy that can be self-administered by patients. electroCore was founded in 2005 and has primarily focused on primary headache conditions (migraine and cluster headache). 

electroCore, headquartered in New Jersey, has two wholly owned subsidiaries: electroCore Germany GmbH, and electroCore UK Ltd. The Company has ceased its operations in Germany, although sales to Germany are still supported by electroCore UK Ltd. 

Note 2Summary of Significant Accounting Policies


(a)

Basis of Presentation

The accompanying condensed consolidated financial statements were prepared in conformity with U.S. generally accepted accounting principles (“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, 2020 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2021. The results for the three and six months ended June 30, 2021 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 subsidiary. 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 these condensed 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 allowances for doubtful accounts, trade credits, rebates, co-payment assistance and sales returns, valuation of inventory, stock compensation, and contingencies.


(d)

Reclass of Statement of Cash Flows Activity 

In order to reflect certain activity for the six months ended June 30, 2020 consistent with the June 30, 2021 presentation, this activity as reflected in the accompanying Condensed Consolidated Statements of Cash Flows was reclassed for presentation purposes only. The repayments of note payable of $111,878, included under the caption Cash flows from financing activities for the six months ended June 30, 2020 was reclassed to Net cash used in operating activities under the caption Accrued expense and other current liabilities within the accompanying Condensed Consolidated Statements of Cash Flows. Additionally, the decrease in operating lease liabilities of $228,572 previously included under the caption Net noncash lease expense for the six months ended June 30, 2020 was reclassed to Operating lease liabilities within the accompanying Condensed Consolidated Statements of Cash Flows. 


(e)

Recent Accounting Standards Not Yet Adopted

In December 2019, the FASB issued an update to simplify the accounting for income taxes and improve consistent application by clarifying or amending existing guidance. This guidance is effective for the year ended December 31, 2021. The Company does not expect this guidance to have a material impact on its consolidated financial statements upon adoption.


10


Note 3Significant 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 for the acute treatment of episodic cluster headache (“eCH”), the prevention of cluster headache, and the preventive and acute treatment of migraine in adults and adolescents. The Company has never been profitable and has incurred net losses in each year since its inception. The Company incurred net losses of $8.3 million and $12.7 million for the six months ended June 30, 2021 and 2020, respectively.

The Company’s expected cash requirements for the next 12 months and beyond are largely based on the commercial success of its products. There are significant risks and uncertainties as to its ability to achieve these operating results, including as a result of the adverse impact on its headache business from the ongoing COVID-19 pandemic. These conditions raised substantial doubt about the Company’s ability to continue as a going concern.

The Company has historically funded its operations from the sale of its common stock. During the six months ended June 30, 2021, the Company received net proceeds of approximately $6.9 million from such sales and as of June 30, 2021, the Company’s cash, cash equivalents and marketable securities totaled $23.7 million. Further, on July 2, 2021 the Company closed a public offering resulting in approximately $18.8 million of additional net proceeds, See FN 16. Subsequent Events, Public Offering of Common.

The Company believes that the substantial doubt of its ability to continue as a going concern is alleviated based on proceeds received from these public offerings. The Company believes its cash and marketable securities 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.


Concentration of Revenue Risks 

The Company earns a significant amount of its revenue (i) in the United States from the Department of Veterans Affairs and Department of Defense pursuant to its qualifying contract under the Federal Supply Schedule and open market sales to individual Department of Veterans Affairs facilities and (ii) in the United Kingdom from the National Health Service. Each of these two channels accounted for 10% or more of the Company's net sales as summarized below:


 


Three months ended June 30,

Six months ended June 30,

 

 


2021


2020

2021

 

 

2020

 

Revenue channel:









 

 

 

 

 

 

 

    Department of Veterans Affairs and Department of Defense


61.3%


55.1%


59.0%

  

 


58.4%


    National Health Service


27.0%


30.0%

 

26.4%

  

 

 

31.0%


During the three months ended June 30, 2021 and 2020 six and four specific VA/DoD facilities represented approximately 64.4% and 46.0% of the Company’s revenue from this channel, and two facilities accounted for more than 10% individually, respectively. During the six months ended June 30, 2021 and 2020 four and two specific VA/DoD facilities represented approximately 51.0% and 38.8% of the Company’s revenue from this channel, and two facilities accounted for more than 10% individually, respectively. 

Foreign Currency Exchange

The Company has foreign currency exchange risk 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 functional currency values of its assets, liabilities, and cash flows denominated in foreign currencies

COVID-19 Risks and Uncertainties

The Company continues to monitor the impact of the COVID-19 pandemic on all aspects of its business and geographies, including how it will impact business partners. While the Company experienced disruptions during the three and six months ended June 30, 2021 and 2020 from the COVID-19 pandemic, it is unable to predict the full impact that the COVID-19 pandemic may have on its financial condition, results of operations and cash flows due to numerous uncertainties. These uncertainties include the scope, severity and duration of the pandemic, the actions taken to contain the pandemic or mitigate its impact and the direct and indirect economic effects of the pandemic and containment measures, among others. COVID-19 has significantly adversely impacted global economic activity and has contributed to significant volatility and negative pressure in financial markets. Depending upon the duration and severity of the pandemic, the continuing effect on the Company's results and outlook over the long term remains uncertain.


11


Note 4. Revenue Recognition

Geographical Net Sales

The following table presents net sales disaggregated by geographic area: 


 


Three months ended June 30,



Six months ended June 30,

 

 


2021


2020

2021

 

 

2020

 

Geographic Market









 

 

 

 

 

 

 

United States

$ 882,572

$ 506,451

$

1,706,548

 

 

$

964,010

 

United Kingdom


353,949


233,137

 

670,942

 

 

 

478,603

 

Other
32,943


13,367


95,818


44,113

Total Net Sales

$ 1,269,464

$ 752,955

$

2,473,308

 

 

$

1,486,726

 


Performance Obligations 

Revenue, net of discounts, vouchers, rebates, returns, and co-payment assistance is solely generated from the sales of the gammaCore products. Revenue is recognized when delivery of the product is completed. The Company deems control to have transferred upon the completion of delivery because that is the point in which (1) it has a present right to payment for the product, (2) it has transferred the physical possession of the product, (3) the customer has legal title to the product, (4) the customer has risks and rewards of ownership and (5) the customer has accepted the product. After the products have been delivered and control has transferred, the Company has no remaining unsatisfied performance obligations.

Revenue is measured based on the consideration that the Company expects to receive in exchange for gammaCore, which represents the transaction price. The transaction price includes the fixed per-unit price of the product and variable consideration in the form of trade credits, rebates, and co-payment assistance. The per-unit price is based on the Company’s established wholesale acquisition cost less a contractually agreed upon distributor discount with the customer.  

Trade credits are discounts that are contingent upon a timely remittance of payment and are estimated based on historical experience. For the three and six months ended June 30, 2021 and 2020, trade credits and discounts were immaterial. 

Reimbursement for co-payments made by patients under the co-payment assistance program is considered variable consideration. Effective March 1, 2020, the amount of monthly co-payment assistance was reduced to a maximum of $100 per prescription. For the three and six months ended June 30, 2021 and 2020, net sales reflect a reduction for the reduced cost of therapy under the co-payment assistance program. The calculation of the accrual is based on an estimate of claims and the cost per claim that the Company expects to incur associated with inventory that exists in the distribution channel at period end.

Managed care rebates represent our estimated obligations to pharmacy benefit managers. Rebate accruals are recognized in the same period the related revenue is recognized. Gross to net accruals based on estimated rebates were determined to be de minimis.

Contract Balances

The Company generally invoices the customer and recognizes revenue once its performance obligations are satisfied, at which point payment is unconditional. Accordingly, under ASC 606, the Company’s contracts with customers did not give rise to contract assets or liabilities during the three and six months ended June 30, 2021 and 2020.

Agreed upon payment terms with customers are within 120 days of shipment. Accordingly, contracts with customers do not include a significant financing component.



12


Note 5. Cash, Cash Equivalents and Marketable Securities

The following tables summarize the Company’s cash, cash equivalents and marketable securities as of June 30, 2021 and December 31, 2020.


As of June 30, 2021

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized (Loss)

 

 

Fair Value

 

Cash and cash equivalents

 

$

14,699,111

 

 

$

 

 

$

 

$

14,699,111

 

Marketable securities:

















     U.S. Treasury Bonds

 


9,028,260

 

 


 

 


(453

)

 


9,027,807

 

Total cash, cash equivalents, and marketable securities

 

$

23,727,371

 

 

$

 

 

$

(453

)

 

$

23,726,918

 

 

As of December 31, 2020

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized (Loss)

 

 

Fair Value

 

Cash and cash equivalents

 

$

4,241,937

 

 

$

 

 

$

 

$

4,241,937

 

Marketable securities:















     U.S. Treasury Bonds

 


18,388,970

 

 


 

 


(2,810

)

 


18,386,160

 

Total cash, cash equivalents, and marketable securities

 

$

22,630,907

 

 

$

 

 

$

(2,810

)

 

$

22,628,097

 


13



Note 6Fair 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: 


 

 

 

 

 

Fair Value Hierarchy

 

June 30, 2021

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

14,699,111

 

 

$

14,699,111

 

 

$

 

 

$

 

Marketable Securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury bonds

 

 

9,027,807

 

 

 

9,027,807

 

 

 

 

 

 

 

Total

 

$

23,726,918

 

 

$

23,726,918

 

 

$

 

 

$



 

 

 

 

 

 

Fair Value Hierarchy

 

December 31, 2020

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

4,241,937

 

 

$

4,241,937

 

 

$

 

 

$

 

Marketable Securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury bonds

 

 

18,386,160

 

 

 

18,386,160

 

 

 

 

 

 

 

Total

 

$

22,628,097

 

 

$

22,628,097

 

 

$

 

 

$

 


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 six months ended June 30, 2021 and year ended December 31, 2020. The carrying amount of the Company’s receivables and payables approximate their fair values due to their short maturities.

Note 7Inventories

As of June 30, 2021 and December 31, 2020, inventories consisted of the following:  


 

 

June 30, 2021

 

 

December 31, 2020

 

Raw materials

 

$

867,096

 

 

$

1,008,653

 

Work in process

 

 

 4,245,931

 

 

 

4,304,415

 

Finished goods

 

 

415,360

 

 

 

428,549

 

     Total inventories, net

 

 

5,528,387

 

 

 

5,741,617

 

Less: noncurrent inventories

 

 

4,450,569

 

 

4,865,181

     Current inventories, net

 

$

1,077,818

 

 

$

876,436

 

The reserve for obsolete inventory was $760,940 and $721,462 as of June 30, 2021 and December 31, 2020 respectively. The Company records charges for obsolete inventory in cost of goods sold. As of June 30, 2021 and December 31, 2020, noncurrent inventory was comprised of approximately $0.8 million and $0.7 million of raw materials, respectively, and $3.7 million and $4.2 million of work in process, respectively. 


14


Note 8. Leases

For the three and six months ended June 30, 2021, the Company recognized lease expense of $46,942 and $87,247, respectively, and $119,650 and $273,034 for the three and six months ended June 30, 2020, 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.

The tables below provide the details of the right of use assets and lease liabilities:

Supplemental Balance Sheet Information for Operating Leases


 


June 30, 2021

 

 

December 31, 2020

 

Operating leases:

 

 

 

 

 

 

 

 

Operating lease right of use assets


$

555,238

 

 

$

517,257

 

Operating lease liabilities:


 

 

 

 

 

 

 

Current portion of operating lease liabilities

 

 

542,695

 

 

 

534,547

 

Noncurrent operating lease liabilities


 

923,181

 

 

 

885,333

 

Total operating lease liabilities


$

1,465,876

 

 

$

1,419,880

 

Weighted average remaining lease term (in years)


 

5.3

 

 

 

5.7

 

Weighted average discount rate


 

13.8

%

 

 

13.8

%

 

 Future minimum lease payments under non-cancellable operating leases as of June 30, 2021:


Remainder of 2021

 

$

665,504

 

2022

 

 

355,923

 

2023

 

 

163,962

 

2024

 

 

167,524

 

2025 and thereafter

 

 

705,844

 

Total future minimum lease payments

 

 

2,058,757

 

Less: Amounts representing interest

 

 

(592,881

)

Total

 

$

1,465,876

 

Note 9Accrued Expenses and Other Current Liabilities

Accrued expenses as of June 30, 2021 and December 31, 2020 consisted of the following:


 

 

June 30, 2021

 

 

December 31, 2020

 

Accrued professional fees

 

$

200,850

 

 

$

270,543

 

Accrued bonuses

 

 

959,903

 

 

 

1,424,878

 

Other employee related expenses  

464,009


371,033
Accrued state taxes

540,000



Other

 

 

751,318

 

 

 

734,366

 

 


$

2,916,080

 

 

$

2,800,820

 

Note 10. Notes Payable

 

Loan Under the PPP

On May 4, 2020, the Company received proceeds of $1.4 million in connection with a promissory note (the “Note”) entered into with Citibank, N.A. (the “Lender”) evidencing an unsecured loan (the “Loan”) under the Paycheck Protection Program ("PPP"). The PPP is a program of the Small Business Administration ("SBA") established under the CARES Act. Under the PPP, the proceeds of the Loan may be used for payroll and certain covered interest payments, lease payments and utility payments (“Qualifying Expenses”). The Company used the entire Loan amount for Qualifying Expenses under the PPP.



15



On May 18, 2021, the Company received notification from the Lender of  SBA's approval of the Company's application for loan forgiveness. Accordingly, the Company is not required to repay the loan. The Company has recorded the loan forgiveness as a gain in the accompanying Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2021 under the caption Gain on extinguishment of debt.

Finance and Security Agreements

On July 1, 2020, the Company entered into a Commercial Insurance Premium Finance and Security Agreement (“the 2020 Agreement”). The 2020 Agreement provided for a single borrowing by the Company of $1.2 million, with a seven-month term and an annual interest rate of 2.18%. The proceeds from this transaction were used to partially fund the premiums due under certain of the Company’s insurance policies. All borrowings were fully repaid as of June 30, 2021. See Note 16. Subsequent Events for information about the Commercial Insurance Premium Finance and Security Agreement dated July 2, 2021.

Note 11. Stockholders’ Equity

Sales of Common Stock

On March 27, 2020, the Company and Lincoln Park Capital Fund, LLC ("Lincoln Park") entered into an equity facility purchase agreement ("Purchase Agreement") pursuant to which the Company had the right to sell to Lincoln Park shares of its common stock having an aggregate value of up to $25,000,000, subject to certain limitations and conditions set forth in the Purchase Agreement.

Upon entering into the Purchase Agreement, the Company issued an aggregate of 461,676 shares of common stock to Lincoln Park as a commitment fee. The fair value of these shares on the date of issuance was approximately $186,300. During 2020, the Company issued an additional 230,838 shares of common stock to Lincoln Park as a further commitment fee based on the first $5,000,000 of shares of common stock issued to Lincoln Park under the Purchase Agreement as Purchase Shares (as such term is defined in the Purchase Agreement). The Company did not receive any cash proceeds from the issuance of any of the foregoing commitment shares.

During 2020, the Company sold 10,179,676 shares of its common stock under the Purchase Agreement, resulting in aggregate proceeds of approximately $15.5 million to the Company. During the six months ended June 30, 2021, the Company sold an additional 2,750,000 shares of its common stock under the Purchase Agreement, resulting in aggregate proceeds of approximately $6.9 million to the Company. The Company expects to use the proceeds from this agreement for general corporate purposes and working capital. On March 11, 2021, the Company terminated the Purchase Agreement and, accordingly, the Company will not sell any further shares of its common stock to Lincoln Park under the Purchase Agreement. See Note 16. Subsequent Events for information about the Company's July 2, 2021 public offering of common stock.

Settlement of Accrued Bonus

During the six months ended June 30, 2021, the Company issued 165,413 shares of its common stock as payment for certain executive incentive bonuses accrued in 2020.

Note 12.  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. Restricted stock and unit awards, stock options, and 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:  



 

Six months ended June 30,


 

 

2021

 

 

2020


Outstanding stock options

 

 

 5,070,536

 

 

 

 4,606,407


Nonvested restricted stock and unit awards


1,264,852

 


1,433,866


Stock purchase warrants

 


216,944

 


715,199





6,552,332


6,755,472
 
16



The following table presents a summary of stock purchase warrants outstanding at June 30, 2021:

Number of Warrants

 Exercise Price

Expiration Date

22,253

$

5.68

3/30/2022

17,066

$

12.60

6/30/2022
151,364 $ 12.60 8/18/2022
14,286 $

12.60

8/31/2022
11,975 $ 15.30 12/22/2025
216,944


 
During the three months ended June 30, 2021, a total of 498,255 warrants expired. The exercise price of these warrants ranged between $8.86 and $12.60.

Note 13. Income Taxes 

The Company may be eligible, from time to time, to receive cash from the sale of its net operating losses and research and development tax credits under New Jersey's Department of the Treasury - Division of Taxation NOL Transfer Program. On June 7, 2021, the Company received a net cash amount of approximately $1.4 million from the sale of its New Jersey state net operating losses and tax credits and recorded a tax benefit of approximately $900 thousand in connection with this receipt. On May 6, 2020, the Company received a net cash amount of approximately $1.2 million from the sale of its New Jersey state net operating losses and research and development tax credits related to the year ended December 31, 2018. These sale proceeds are included in the Condensed Consolidated Statement of Operations for the three and six months ended June 30, 2021 and June 30, 2020, under the caption Benefit from income taxes.


Note 14.  Stock Based Compensation

The following table presents a summary of activity related to stock options during the six months ended June 30, 2021:


 

Number of Options

 

 

Weighted Average Exercise Price

 

 

Weighted Average Remaining Contractual Term (Years)

 

 

Aggregate Intrinsic Value

Outstanding, January 1, 2021 

 

3,815,585

 

 

$

5.56

 

 

 

8.9

 

 $

342,551

Granted

 

1,275,136

 

 

 

2.02

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 —

Cancelled

 

(20,185

)

 

 

3.29

 

 

 

 

 

 

Outstanding, June 30, 2021


5,070,536


 

$

4.47



 

8.5


 $

78,000

Exercisable, June 30, 2021

 

1,885,468

 

 

$

7.70

 

 

 

7.8

 

$

39,500

 

The intrinsic value is calculated as the difference between the fair market value at June 30, 2021 and the exercise price per share of the stock options. The options granted to employees generally vest over a four-year period.

 

The following table presents a summary of activity related to restricted stock awards (“RSAs”) granted during the six months ended June 30, 2021:  


 

 

Number of Shares

 

 

Weighted Average Grant Date Fair Value

 

 

Nonvested, January 1, 2021

  

 

25,645

 

 

$

10.07

 

 

Granted

 

 

167,413

 

 

 

2.41

 

 

Vested

 

 

(145,265

)

 

 

3.45

 

 

Cancelled

 

  

(5,687

)

 

 

9.24

 

 

Nonvested, June 30, 2021

 

 

42,106

 

 

$

6.11

 

 

 

In general, RSAs granted to employees vest over a four-year period.


17



The following table presents a summary of activity related to restricted and deferred stock units (“Stock Units”) granted during the six months ended June 30, 2021:


 

 

Number of Shares

 

 

Weighted Average Grant Date Fair Value

 

Nonvested, January 1, 2021

 

 

1,014,123

 

 

$

1.50

 

Granted

 

 

436,316

 

 

 

2.07

 

Vested

 

 

(227,693)

 

 

1.59

 

Cancelled

 

 

 

 

 

Nonvested, June 30, 2021

 

 

1,222,746

 

 

$

1.69

 

 

In general, Stock Units granted to employees vest over two to 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:


 



Three months ended June 30,

Six months ended June 30,


 


2021


2020


2021

 

 

2020


Selling, general and administrative


$ 703,261

$ 700,275

$

1,512,808

 

 

$

1,247,365

 

Research and development



114,502


283,222

 

227,488

 

 

 

469,821

 

Cost of goods sold



20,210


19,261

 

39,860

 

 

 

30,437

 

Total expense 
$ 837,973

$ 1,002,758

$

1,780,156

 

 

$ 1,747,623

 

 

Total unrecognized compensation cost related to unvested awards as of June 30, 2021 was $5.8 million and is expected to be recognized over the next 2.4 years.

Valuation Information for Stock-Based Compensation

The fair value of each stock option award during the three and six months ended June 30, 2021 and 2020 was estimated on the date of grant using the Black-Scholes model. For the six months ended June 30, 2021, expected volatility was based on historical common stock volatility of the Company’s peers. Expected volatility for the six months ended June 30, 2020, was based on historical volatility of the Company’s common stock. The risk-free interest rate was based on the average U.S. Treasury rate that most closely resembled the expected life of the related award. The expected term of the award was calculated using the simplified method. No dividend was assumed as the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.

The weighted average assumptions used in the Black-Scholes option pricing model in valuing stock options granted in the three and six months ended June 30, 2021 are summarized in the table below. 



Six months ended June 30,


2021


2020

Fair value at grant date

$

1.36

 

$ 0.98

Expected volatility

80.1


142.1
 

Risk-free interest rate

0.7


0.7 %

Expected holding period, in years

6.0

 


6.1

Dividend yield

 


%

 

18


Note 15. Commitments and Contingencies

Stockholders Litigation

On July 8, 2019 and August 1, 2019, purported stockholders of the Company served putative class action lawsuits in the Superior Court of New Jersey for Somerset County, captioned Paul Kuehl vs. electroCore, Inc., et al., Docket No. SOM-L 000876-19 and Shirley Stone vs. electroCore, Inc., et al., Docket No. SOM-L 001007-19, respectively. In addition to the Company, the defendants included present and past directors and officers, Evercore Group L.L.C., Cantor Fitzgerald & Co., JMP Securities LLC and BTIG, LLC, the underwriters for its IPO; and two of the Company’s stockholders. On August 15, 2019, the Superior Court entered an order consolidating the Kuehl and Stone actions, which proceeded under Docket No. SOM-L 000876-19. Each plaintiff was appointed a co-lead plaintiff. The plaintiffs filed a consolidated amended complaint, which sought certification of a class of stockholders who purchased common stock in the IPO or whose purchases are traceable to that offering. The consolidated amended complaint alleged that the defendants violated Sections 11, 12(a)(2) and 15 of the Securities Act with respect to the registration statement and related prospectus for the IPO. The complaint sought unspecified compensatory damages, interest, costs and attorneys’ fees. On October 31, 2019, the Company and the other defendants filed a motion to dismiss the complaint or in the alternative to stay the action in favor of the pending federal action (discussed below).

On February 21, 2020 the court granted the defendants’ motion to dismiss the consolidated amended complaint with prejudice. On March 2, 2020 the court entered an amended order dismissing the consolidated amended complaint with prejudice. On March 27, 2020, the plaintiffs filed a notice of appeal with the N.J. Superior Court – Appellate Division. The appeal was fully briefed as of July 17, 2020. The date for argument of the appeal has not yet been set.

On September 26, 2019 and October 31, 2019, purported stockholders of the Company served putative class action lawsuits in the United States District Court for the District of New Jersey captioned Allyn Turnofsky vs. electroCore, Inc., et al., Case 3:19-cv-18400, and Priewe vs. electroCore, Inc., et al., Case 1:19-cv-19653, respectively. In addition to the Company, the defendants include present and past directors and officers, and Evercore Group L.L.C., Cantor Fitzgerald & Co., JMP Securities LLC and BTIG, LLC, the underwriters for the IPO. The plaintiffs each seek to represent a class of stockholders who (i) purchased the Company’s common stock in the IPO or whose purchases are traceable to the IPO, or (ii) who purchased common stock between the IPO and September 25, 2019. The complaints each alleged that the defendants violated Sections 11 and 15 of the Securities Act and Sections 10(b) and 20(a) of the Exchange Act, with respect to (i) the registration statement and related prospectus for the IPO, and (ii) certain post-IPO disclosures filed with the SEC. The complaints sought unspecified compensatory damages, interest, costs and attorneys’ fees.  

In the Turnofsky case, on November 25, 2019 several plaintiffs and their counsel moved to be selected as lead plaintiff and lead plaintiff’s counsel. On April 24, 2020, the Court granted the motion of Carole Tibbs and the firm Bragar, Eagel & Squire, P.C. On July 17, 2020 the plaintiffs filed an amended complaint in Turnofsky. In addition to the prior claims, the amended complaint added an additional director defendant and two investors as defendants and adds a claim against the Company and the underwriters for violating Section 12(a)(2) of the Securities Act. On September 15, 2020, the Company and the other defendants filed a motion to dismiss the amended complaint for failure to state a claim. On November 6, 2020, the plaintiffs filed their opposition to the motion to dismiss. The Company and the other defendants filed reply papers in support of the motion on December 7, 2020. Argument of the motion to dismiss occurred on June 18, 2021, and the motion is sub judice. The parties are participating in a non-binding mediation with JAMS. A session with the JAMS mediator occurred on March 30, 2021.

The Priewe case was voluntarily dismissed on February 19, 2020.


19


On March 4, 2021, purported stockholder Richard Maltz brought a purported stockholder derivative action in the United States District Court for the District of New Jersey. The action is captioned Richard Maltz, derivatively on behalf of electroCore, Inc., vs. Francis R. Amato, et al., Case 3:21-cv-04135. The defendants include present and past directors and officers of the Company. The plaintiff purports to pursue derivative claims on behalf of the Company in connection with the IPO and actions occurring between the IPO and September 25, 2019. The complaint alleges that demand on the board of directors is excused. The complaint purports to allege claims against the defendants for violating Section 14(a) of the Exchange Act, breaching fiduciary duties, unjust enrichment and waste of corporate assets. The complaint also purports to allege claims for contribution in connection with the Turnofsky case described above, pursuant to Section 11(f) of the Securities Act and Sections 10(b) and 21D of the Exchange Act. The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to the Bylaws and Certificate of Incorporation. On March 8, 2021, purported stockholder Erin Yuson brought a purported stockholder derivative action in the United States District Court for the District of New Jersey. The action is captioned Erwin Yuson, derivatively on behalf of electroCore, Inc., vs. Francis R. Amato, et al., Case 3:21-cv-04481. The defendants include present and past directors and officers of the Company. The plaintiff purports to pursue derivative claims on behalf of the Company in connection with a 2019 proxy statement and actions occurring from the IPO through September 25, 2019. The complaint alleges that demand on the board of directors is excused. The complaint purports to allege claims against the defendants for violating Section 14(a) of the Exchange Act and breaching fiduciary duties. The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to the Bylaws and Certificate of Incorporation.  

The plaintiffs in the Maltz and Yuson derivative actions have agreed to consolidate and stay those actions. The actions shall be stayed until and through the resolution of any motion for summary judgement in the Turnofsky federal securities class action. The actions are stayed until and through the resolution of any motion for summary judgment in the Turnofsky federal securities class action. A stipulation to that effect was filed by the plaintiffs on April 14, 2021 and ordered by the court on April 30, 2021.

The Company intends to continue to vigorously defend itself in these matters. However, in light of, among other things, the preliminary stage of these litigation matters, the Company is unable to determine the reasonable probability of loss or a range of potential loss. Accordingly, the Company has not established an accrual for potential losses, if any, that could result from any unfavorable outcome, and there can be no assurance that these litigation matters will not result in substantial defense costs and/or judgments or settlements that could adversely affect the Company’s financial condition. 

The Company expenses associated legal fees in the period they are incurred.


20



Note 16. Subsequent Events

Public Offering of Common Stock
On July 2, 2021, the Company completed a public offering of 20,700,000 shares of its common stock at a purchase price of $1.00 per share. The net proceeds of the offering to the Company were approximately $18.8 million, after deducting the underwriting discounts and commissions and other estimated offering expenses. 
Finance and Security Agreement

On July 2, 2021, the Company entered into a Commercial Insurance Premium Finance and Security Agreement (“the 2021 Agreement”). The 2021 Agreement provides for a single borrowing by the Company of $1.2 million, with a ten-month term and an annual interest rate of 1.55%. 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. The Company began to pay monthly installments of approximately $124,800 in July 2021.



21




You should read this section in conjunction with our unaudited interim condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q 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, 2020 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or SEC. 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 those 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

Overview

We are a commercial-stage medical device company with a proprietary non-invasive vagus nerve stimulation, or nVNS, therapy. nVNS is a platform bioelectronic medical therapy that modulates neurotransmitters and immune function through its effects on both the peripheral and central nervous systems. We are initially focused on neurology, and our therapy, gammaCore, is cleared by the FDA for use by adults for the following four neurology indications: the acute treatment of pain associated with each of migraine and episodic cluster headache, or eCH, the preventive treatment of migraine headache and adjunctive use for the preventive treatment of cluster headaches, or CH. Recently, the FDA cleared the use of gammaCore for acute and preventive treatment of migraine in adolescents. We are also considering the potential for several additional indications for our nVNS technology, which is being studied through several investigator-initiated studies. These indications include post traumatic headache, stroke, traumatic brain injury, post-traumatic stress disorder, opioid use disorders and post-operative ileus.

Following our initial FDA clearance in early 2017, our commercial strategy was to establish gammaCore as a first-line treatment option for the acute treatment of episodic CH in adult patients, who have few alternative treatment options available to them. This strategy was supported by a product registry conducted from July 2017 through June 2018 to build advocacy among key opinion leaders in leading headache centers in the United States, and to generate patient demand in the form of prescriptions submitted to payers. We leveraged this advocacy during the registry period as we expanded into migraine and prepared for a full commercial launch of gammaCore and gammaCore Sapphire for the acute treatment of pain associated with eCH and migraine in adult patients, which was accomplished in the third quarter of 2018. With the clearance of adjunctive use for the prevention of CH in December 2018, we continued to build upon our existing base of advocacy and patient support. In March 2020, the FDA cleared gammaCore for the preventive treatment of migraine headache in adult patients. In February 2021, gammaCore was cleared by the FDA for the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age.

Since May 2019, we have focused our sales efforts in two channels, the U.S. Department of Veterans Affairs and U.S. Department of Defense, and the United Kingdom.

We continue to evaluate strategies to expand commercial adoption of gammaCore, including the potential use of telemedicine and cash pay, direct to physician and consumer approaches. We are unable to predict the impact these strategies will have on our financial condition, results of operations and cash flows due to numerous uncertainties.

Recently, we have announced agreements with new distributors to make gammaCore Sapphire available in several countries beyond the U.S. and United Kingdom.

Capital Activities

On July 2, 2021, we completed a public offering of 20,700,000 shares of our common stock at a purchase price of $1.00 per share. The net proceeds of the offering to us were approximately $18.8 million, after deducting the underwriting discounts and commissions and other estimated offering expenses. We intend to use the net proceeds of the offering for sales and marketing, working capital, and general corporate purposes. In addition, we believe that opportunities may exist from time to time to expand our current business through acquisitions or in-licenses of, or investments in, complementary companies, medicines, intellectual property, or technologies. While we have no current agreements or commitments for any specific acquisitions, in-licenses or investments at this time, we may use a portion of the net proceeds for these purposes.


22


Impact of COVID-19

We are closely monitoring the impact of the COVID-19 pandemic on all aspects of our business and geographies, including how it will impact business partners. In particular, the pandemic has resulted in a significant reduction in non-essential contact between patients and healthcare providers, shifting of focus by healthcare providers to the acute treatment of COVID-19 related illness regardless of specialty. We believe these restrictions have limited our sales force’s ability to generate additional interest in the Company’s products. We are unable to predict the impact that the COVID-19 pandemic may have on our financial condition, results of operations and cash flows due to numerous uncertainties. These uncertainties include the scope, severity and duration of the pandemic, the actions taken to contain the pandemic or mitigate its impact, the development, rollout and availability of effective treatments and vaccines, and the direct and indirect economic effects of the pandemic and containment measures, among others. The COVID-19 pandemic in many countries, including the United States, has significantly adversely impacted global economic activity. The global impact of the pandemic has been rapidly evolving and many countries have reacted by instituting quarantines, mandating business and school closures and restricting travel. Certain states and cities, including those where our principal place of business is located and sales force seeks to operate, have also reacted by instituting quarantines, restrictions on travel, “shelter in place” rules, and restrictions on types of business that may continue to operate. We cannot predict if additional states and cities will implement similar restrictions or when restrictions currently in place will expire. As a result, the COVID-19 pandemic is negatively impacting almost every industry directly or indirectly, including industries in which we operate. Further, the impacts of a potential worsening of global economic conditions and the continued disruptions to, and volatility in, the credit and financial markets, consumer spending as well as other unanticipated consequences remain unknown.

Because the COVID-19 pandemic affected, among other things, our access to prescribing physicians and their access to headache patients, we believe that our results for the six months ended June 30, 2021 and 2020 reflect a negative impact from, among other things, the global pandemic. Moreover, our expectations for at least the first half of 2021 have also been adversely affected by both the uncertainty and potential negative impact of the global pandemic. Depending upon the duration and severity of the pandemic, the continuing effect on our results and outlook over the long term remains uncertain.

In July 2020, the Company received an EUA for use of its gammaCore Sapphire CV nVNS therapy for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients. This EUA is expected to remain in effect for the duration of the COVID-19 pandemic justifying emergency use of these devices unless terminated or revoked by the FDA (after which products may no longer be used). The length of the effective period of this EUA is uncertain. We did not recognize material revenue from the sales of gammaCore Sapphire CV during the six months ended June 30, 2021 and we do not expect to recognize material revenue from the sales of gammaCore Sapphire CV in general.


23


Results of Operations

Comparison of the three months ended June 30, 2021 to the three months ended June 30, 2020

The following table sets forth amounts from our condensed consolidated statements of operations for the three months ended June 30, 2021 and 2020:

 

 

 

For the three months ended June 30,

 

 

 

 

 

 

 

2021

 

 

2020 

 

 

Change

 

 

 

(in thousands)

 

Consolidated statements of operations:

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

1,269.5

 

 

$

753.0

 

 

$

516.5

Cost of goods sold

 

 

374.3

 

 

 

273.0

 

 

 

101.3

Gross profit

 

 

895.2

 

 

 

480.0

 

 

 

415.2

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

824.9

 

 

 

1,030.5

 

 

 

(205.6

)

Selling, general and administrative

 

 

5,272.9

 

 

 

5,273.3

 

 

 

(0.4

)

Restructuring and other severance related charges

 

 

 

 

 

99.6

 

 

 

(99.6

)

Total operating expenses

 

 

6,097.8

 

 

6,403.4

 

 

 

(305.6

)

Loss from operations

 

 

(5,202.6

)

 

 

(5,923.4

)

 

 

720.8

 

Other (income) expense

 

 

 

 

 

 

 

 

 

 

 

 

     Gain on extinguishment of debt

(1,422.2

)




(1,422.2

)

Interest and other income

 

 

(1.3)

 

 

(11.7

)

 

 

10.4

Other expense

 

 

 

 

0.7

 

 

 

(0.7

)

     Total other (income) expense

 

 

(1,423.5

)

 

 

(11.0

)

 

 

(1,412.5

)
Loss before income taxes

(3,779.1 )

(5,912.4 )

2,133.3
Benefit from income taxes

885.4


1,170.9


(285.5)

Net loss

 

$

(2,893.7

)

 

$

(4,741.5

)

 

$

1,847.8

 


Net Sales

Net sales increased 69% for the three months ended June 30, 2021 compared to the prior year period. This increase of $516.5 thousand is due to increased sales across all major channels including Commercial, the Department of Veteran Affairs, and in the United Kingdom, as well as sales from our new distributors outside of the United States. For the remainder of our 2021 fiscal year, we expect revenue from the Department of Veterans Affairs and United Kingdom to continue to be a majority of our revenue.

Gross Profit

Gross profit increased $415.2 thousand for the three months ended June 30, 2021 compared to the prior year period due to the increase in net sales. Gross margin was 71% and 64% for the three months ended June 30, 2021 and 2020, respectively. The increase in gross margin was largely due to increased sales resulting in a more favorable absorption of labor and overhead costs and product mix.

Research and Development

Research and development expense decreased by $0.2 million or 20% for the three months ended June 30, 2021 compared to the prior year period. This reduction was primarily due to significant reductions in near-term investment in research and development, including the early termination of our Premium II clinical trial, offset by non-recurring expense associated with the destruction of clinical units associated with Premium II and the initial payment for an investigator initiated study for the treatment of post-traumatic headache.

Selling, General and Administrative

Selling, general and administrative expense was $5.3 million for the three months ended June 30, 2021, and consistent with the prior year period. We do not expect a material increase in our selling, general, and administrative expense for the remainder of our 2021 fiscal year, however, we may make targeted expenditures to support our commercial efforts. 


24


Restructuring and Other Severance Related Charges

There were no restructuring and other severance related costs for the three months ended June 30, 2021. Restructuring and other severance related costs for the three months ended June 30, 2020 of $99,606 consisted of severance related expenses in connection with personnel changes. 

Other (Income) Expense

Other (income) expense for the three months ended June 30, 2021 primarily represents the gain of $1.4 million recorded by the Company in association with the forgiveness of its Paycheck Protection Program ("PPP") loan. Interest and other income of $1,273 and $11,765 for the three months ended June 30, 2021 and 2020, respectively, primarily consists of interest earned on cash, cash equivalents and marketable securities. 

Benefit from Income Taxes

The Benefit from income taxes of $0.9 million and $1.2 million for the three months ended June 30, 2021 and 2020, respectively, represent the sale of our 2019 and 2018 state net operating losses and research and development tax credits under the State of New Jersey’s NOL Transfer Program. 


Comparison of the six months ended June 30, 2021 to the six months ended June 30, 2020

The following table sets forth amounts from our consolidated statements of operations for the six months ended June 30, 2021 and 2020:


 

 

For the six months ended June 30,

 

 

 

 

 

 

 

2021

 

 

2020

 

 

Change

 

 

 

(in thousands)

 

Consolidated statements of operations:

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,473.4

 

 

$

1,486.7

 

 

$

986.7

Cost of goods sold

 

 

738.3

 

 

 

571.1

 

 

 

167.2

Gross profit

 

 

1,735.1

 

 

 

915.6

 

 

 

819.5

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,323.9

 

 

 

2,553.6

 

 

 

(1,229.7 )

Selling, general and administrative

 

 

10,997.5

 

 

 

11,834.1

 

 

 

(836.6 )

Restructuring and other severance related charges

 

 

 

 

 

464.6

 

 

 

(464.6 )

Total operating expenses

 

 

12,321.4

 

 

 

14,852.3

 

 

 

(2,530.9 )

Loss from operations

 

 

(10,586.3

)

 

 

(13,936.7

)

 

 

3,350.4

 

Other (income) expense

 

 

 

 

 

 

 

 

 

 

 

 

     Gain on extinguishment of debt

(1,422.2 )




(1,422.2 )

Interest and other income

 

 

(1.1

)

 

 

(74.7

)

 

 

73.6

 

Other expense

 

 

 

 

9.8

 

 

 

(9.8 )

Total other (income) expense

 

 

(1,423.3

)

 

 

(64.9

)

 

 

(1,358.4 )

Loss before income taxes

 

 

(9,163.0

)

 

 

(13,871.8

)

 

 

4,708.8

 

Benefit from income taxes

 

 

885.4

 

 

 

1,170.9

 

 

 

(285.5)

Net loss

 

$

(8,277.6

)

 

$

(12,700.9

)

 

$

4,423.3

 

Net Sales

Net sales increased 66% for the six months ended June 30, 2021 compared to the prior year period. The increase of $986.7 thousand is due to increased sales across all major channels including Commercial, the Department of Veteran Affairs, and in the United Kingdom, as well as sales from our new distributors outside of the United States. For the remainder of our 2021 fiscal year, we expect revenue from the Department of Veterans Affairs and United Kingdom to continue to be a majority of our revenue.

Gross Profit

Gross profit increased $819.5 thousand for the six months ended June 30, 2021 compared to the prior year. Gross margin increased to 70% for the six months ended June 30, 2021 compared to 62% for the six months ended June 30, 2020. These favorable results were largely due to increased sales resulting in more favorable absorption of labor and overhead costs and product mix. 



25


Research and Development

Research and development expense decreased by $1.2 million or 48% for the six months ended June 30, 2021 compared to the prior year period. This reduction was primarily due to significant reductions in near-term investment in research and development, including the early termination of our Premium II clinical trial, offset by non-recurring expense associated with the destruction of clinical units associated with Premium II and the initial payment for an investigator initiated-study for the treatment of post-traumatic headache.

Selling, General and Administrative

Selling, general and administrative expense was $11.0 million and $11.8 million for the six months ended June 30, 2021 and 2020, respectively. This decrease was primarily due to cost reductions associated with the outbreak of the COVID-19 pandemic, offset by reinvestment in the commercial business as the pandemic began to subside. We do not expect a material increase in our selling, general, and administrative expense for the remainder of our 2021 fiscal year, however, we may make targeted expenditures to support our commercial efforts. 

Restructuring and Other Severance Related Charges

There were no restructuring and other severance related costs for the six months ended June 30, 2021. Restructuring and other severance related costs for the six months ended June 30, 2020 of $464,606 consisted of severance related expenses in connection with personnel changes.

Other (Income) Expense 

Other (income) expense for the three months ended June 30, 2021 primarily represents the gain of $1.4 million recorded by the Company in association with the forgiveness of its PPP loan. Interest and other income of $1,137 and $74,741 for the six months ended June 30, 2021 and 2020, respectively, primarily consists of interest earned on cash, cash equivalents and marketable securities. 

Benefit from Income Taxes

The Benefit from income taxes of $0.9 million and $1.2 million for the six months ended June 30, 2021 and 2020, respectively, represent the sale of our 2019 and 2018 state net operating losses and research and development tax credits under the State of New Jersey’s NOL Transfer Program. 

Cash Flows

The following table sets forth the significant sources and uses of cash for the periods noted below: 

 


 

For the six months ended June 30,

 

 

 

2021

 

 

2020 

 

 

 

(in millions)

 

Net cash (used in) provided by

 

 

 

 

 

 

 

 

Operating activities

 

$

(5.8

)

 

$

(12.5

)

Investing activities

 

$

9.2

 

$

6.5

 

Financing activities

 

$

6.9

 

 

$

7.4

 

 

Operating Activities

Net cash used in operating activities was $5.8 million and $12.5 million for the six months ended June 30, 2021 and 2020, respectivelyThis decrease is primarily due to (i) a decrease in our net loss from operations, and (ii) less cash being used for working capital components such as inventory and accounts payable.

Investing Activities

Net cash provided by investing activities was $9.2 million and $6.5 million for the six months ended June 30, 2021 and 2020, respectively. This increase reflects the increase in funds received from the maturity of marketable securities, partially offset by an increase in our purchases of marketable securities.

Financing Activities

Net cash provided by financing activities was $6.9 million for the six months ended June 30, 2021, representing proceeds from the sale of common stock. 


26


Liquidity Outlook

As of June 30, 2021, our cash, cash equivalents and marketable securities totaled $23.7 million.

We have experienced recurring losses since our inception. We incurred net losses of $8.3 million and $12.7 million for the six months ended June 30, 2021 and 2020, respectively.  We expect to continue to incur substantial negative cash flows from operations for at least the next several years as we work to increase market acceptance of our gammaCore therapy for the acute treatment of eCH, the prevention of cluster headache, and the preventive and acute treatment of migraine in adults and adolescents. 

Our expected cash requirements for the next 12 months and beyond are largely based on the commercial success of our products. There are significant risks and uncertainties as to our ability to achieve these operating results, including as a result of the adverse impact on its headache business from the ongoing COVID-19 pandemic. These conditions raised substantial doubt about our ability to continue as a going concern.

We have historically funded our operations from the sale of our common stock. During the six months ended June 30, 2021, we received net proceeds of approximately $6.9 million from such sales and as of June 30, 2021, our cash, cash equivalents and marketable securities totaled $23.7 million. Further, on July 2, 2021, we closed a public offering resulting in approximately $18.8 million of additional net proceeds.

We believe that the substantial doubt of our ability to continue as a going concern is alleviated based on proceeds received from these public offerings. We believe our cash and marketable securities will enable us to fund our 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.

27


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. 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 currencies in which our sales were denominated, our net income would have correspondingly increased or decreased by an immaterial amount for the six months ended June 30, 2021.

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 CROs, investigational sites, suppliers and other vendors in Europe and internationally. 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 June 30, 2021.

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 June 30, 2021 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 June 30, 2021 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 June 30, 2021 that has materially affected or is reasonably likely to materially affect our internal control over financial reporting. 


28


PART II OTHER INFORMATION
On July 8, 2019 and August 1, 2019, purported stockholders of our company served putative class action lawsuits in the Superior Court of New Jersey for Somerset County, captioned Paul Kuehl vs. electroCore, Inc., et al., Docket No. SOM-L 000876-19 and Shirley Stone vs. electroCore, Inc., et al., Docket No. SOM-L 001007-19, respectively. In addition to our company, the defendants included present and past directors and officers, Evercore Group L.L.C., Cantor Fitzgerald & Co., JMP Securities LLC and BTIG, LLC, the underwriters for our IPO; and two of our stockholders. On August 15, 2019, the Superior Court entered an order consolidating the Kuehl and Stone actions, which proceeded under Docket No. SOM-L 000876-19. Each plaintiff was appointed a co-lead plaintiff. The plaintiffs filed a consolidated amended complaint, which sought certification of a class of stockholders who purchased our common stock in our IPO or whose purchases are traceable to that offering. The consolidated amended complaint alleged that the defendants violated Sections 11, 12(a)(2) and 15 of the Securities Act with respect to the registration statement and related prospectus for the IPO. The complaint sought unspecified compensatory damages, interest, costs and attorneys’ fees. On October 31, 2019, the Company and the other defendants filed a motion to dismiss the complaint or in the alternative to stay the action in favor of the pending federal action (discussed below). On February 21, 2020 the court granted the defendants’ motion to dismiss the consolidated amended complaint with prejudice. On March 2, 2020 the court entered an amended order dismissing the consolidated amended complaint with prejudice. On March 27, 2020, the plaintiffs filed a notice of appeal with the N.J. Superior Court - Appellate Division. The appeal was fully briefed as of July 17, 2020. The date for argument of the appeal has not yet been set. 
On September 26, 2019 and October 31, 2019, purported stockholders of our company served putative class action lawsuits in the United States District Court for the District of New Jersey captioned Allyn Turnofsky vs. electroCore, Inc., et al., Case 3:19-cv-18400, and Priewe vs. electroCore, Inc., et al., Case 1:19-cv-19653, respectively. In addition to our company, the defendants include present and past directors and officers, and Evercore Group L.L.C., Cantor Fitzgerald & Co., JMP Securities LLC and BTIG, LLC, the underwriters for our IPO. The plaintiffs each seek to represent a class of stockholders who (i) purchased our common stock in our IPO or whose purchases are traceable to the IPO, or (ii) who purchased common stock between the IPO and September 25, 2019. The complaints each alleged that the defendants violated Sections 11 and 15 of the Securities Act and Sections 10(b) and 20(a) of the Exchange Act, with respect to (i) the registration statement and related prospectus for the IPO, and (ii) certain post-IPO disclosures filed with the SEC. The complaints sought unspecified compensatory damages, interest, costs and attorneys’ fees. 
In the Turnofsky case, on November 25, 2019, several plaintiffs and their counsel moved to be selected as lead plaintiff and lead plaintiff’s counsel. On April 24, 2020, the Court granted the motion of Carole Tibbs and the firm Bragar, Eagel & Squire, P.C. On July 17, 2020 the plaintiffs filed an amended complaint in Turnofsky. In addition to the prior claims, the amended complaint adds an additional director defendant and two investors as defendants, adds a claim against the Company and the underwriters for violating Section 12(a)(2) of the Securities Act. On September 15, 2020, the Company and the other defendants filed a motion to dismiss the amended complaint for failure to state a claim. On November 6, 2020, the plaintiffs filed their opposition to the motion to dismiss. The Company and the other defendants filed reply papers in support of the motion on December 7, 2020. Argument of the motion to dismiss occurred on June 18, 2021, and the motion is sub judice. The parties are participating in a non-binding mediation with JAMS. A session with the JAMS mediator occurred on March 30, 2021.
The Priewe case was voluntarily dismissed on February 19, 2020.
29


On March 4, 2021, purported stockholder Richard Martz brought a purported stockholder derivative action in the United States District Court for the District of New Jersey. The action is captioned Richard Maltz, derivatively on behalf of electroCore, Inc., vs. Francis R. Amato, et al., Case 3:21-cv-04135. The defendants include present and past directors and officers of the Company. The plaintiff purports to pursue derivative claims on behalf of the Company in connection with the IPO and actions occurring between the IPO and September 25, 2019. The complaint alleges that demand on the board of directors is excused. The complaint purports to allege claims against the defendants for violating Section 14(a) of the Exchange Act, breaching fiduciary duties, unjust enrichment and waste of corporate assets. The complaint also purports to allege claims for contribution in connection with the Turnofsky case described above, pursuant to Section 11(f) of the Securities Act and Sections 10(b) and 21D of the Exchange Act. The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to the Bylaws and Certificate of Incorporation.
On March 8, 2021, purported stockholder Erin Yuson brought a purported stockholder derivative action in the United States District Court for the District of New Jersey. The action is captioned Erwin Yuson, derivatively on behalf of electroCore, Inc., vs. Francis R. Amato, et al., Case 3:21-cv-04481. The defendants include present and past directors and officers of the Company. The plaintiff purports to pursue derivative claims on behalf of the Company in connection with a 2019 proxy statement and actions occurring from the IPO through September 25, 2019. The complaint alleges that demand on the board of directors is excused. The complaint purports to allege claims against the defendants for violating Section 14(a) of the Exchange Act and breaching fiduciary duties. The complaint seeks unspecified compensatory damages, interest, costs and attorneys’ fees; declaratory relief; and an order requiring changes to corporate governance and internal procedures and a vote on proposed amendments to the Bylaws and Certificate of Incorporation.
The plaintiffs in the Maltz and Yuson derivative actions have agreed to consolidate and stay those actions. The actions shall be stayed until and through the resolution of any motion for summary judgment in the Turnofsky federal securities class action. The actions are stayed until and through the resolution of any motion for summary judgment in the Turnofsky federal securities class action. A stipulation to that effect was filed by the plaintiffs on April 14, 2021 and ordered by the court on April 30, 2021.
We intend to continue to vigorously defend ourselves in these matters. However, in light of, among other things, the preliminary stage of these litigation matters, we are unable to determine the reasonable probability of loss or a range of potential loss. Accordingly, we have not established an accrual for potential losses, if any, that could result from any unfavorable outcome, and there can be no assurance that these litigation matters will not result in substantial defense costs and/or judgments or settlements that could adversely affect our financial condition.


30



Item 1A.

You should carefully consider the risk factors included in our Form 10-Qs; Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 11, 2021; and in our other filings with the U.S. Securities and Exchange Commission or in materials incorporated by reference therein. In addition, you should carefully consider the other information in this report on Form 10-Q, including the section of this 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 risk factors and the risks described elsewhere in this report on Form 10-Q occur, our business, operating results and financial condition could be seriously harmed. This report on Form 10-Q 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 our risk factors and risks elsewhere in this report, or otherwise.

  

None.
Item 4. MINE SAFETY DISCLOSURES

Not applicable.

Item 5OTHER INFORMATION

(a) Not applicable.

(b) Not applicable. 


31


 

Item 6. EXHIBITS

Furnish the exhibits required by Item 601 of Regulation S-K (§ 229.601 of this chapter).

 

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

 

Incline 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

 

Incline XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

Incline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

Incline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

Incline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

Incline XBRL Taxonomy Extension Presentation Linkbase Document




104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

*

Filed herewith. 

 

**

Furnished herewith.


32




Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Company Name

 

 

 

 

Date:  August 5, 2021

 

By:

/s/ DANIEL S. GOLDBERGER

 

 

 

Daniel S. Goldberger

 

 

 

Chief Executive Officer

(Principal Executive Officer)

 

 

 

 

Date:  August 5, 2021

 

By:

/s/ BRIAN M. POSNER

 

 

 

Brian M. Posner

 

 

 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

33