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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q



(Mark One)


QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


FOR THE QUARTERLY PERIOD ENDED March 31, 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 April 30, 2021 the registrant had 48,544,384 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 March 31, 2021 (unaudited) and December 31, 2020 4

Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2021 and 2020 (Unaudited) 5

Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2021 and 2020 (Unaudited) 6

Condensed Consolidated Statements of  Equity for the Three Months Ended March 31, 2021 and 2020 (Unaudited) 7

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2021 and 2020 (Unaudited) 8

Notes to Condensed Consolidated Financial Statements 9
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 20
Item 3. Quantitative and Qualitative Disclosures About Market Risk 25
Item 4. Controls and Procedures 25

PART II. OTHER INFORMATION
Item 1. Legal Proceedings 26
Item 1A. Risk Factors 28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 28
Item 3. Defaults Upon Senior Securities 28
Item 4. Mine Safety Disclosures 28
Item 5. Other Information 28
Item 6. Exhibits 29

Signatures 30


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 Annual Report on Form 10-K for the year ended December 31, 2020 and in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report and elsewhere herein. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update 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)

 

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,064,385

 

 

$

4,241,937

 

Marketable securities

 

 

16,388,339

 

 

 

18,386,160

 

Accounts receivable, net

 

 

259,319

 

 

 

270,546

 

Inventories, net

 

 

944,715

 

 

 

876,436

 

Prepaid expenses and other current assets

 

 

936,080

 

 

 

1,288,588

 

Total current assets

 

 

27,592,838

 

 

 

25,063,667

 

Inventories, noncurrent

 

 

4,678,013

 

 

 

4,865,181

 

Property and equipment, net

 

 

220,307

 

 

 

244,047

 

Operating lease right of use assets

 

 

502,108

 

 

 

517,257

 

Other assets, net

 

 

756,953

 

 

 

828,011

 

Total assets

 

$

33,750,219

 

 

$

31,518,163

 

Liabilities and Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,110,288

 

 

$

2,078,699

 

Accrued expenses

 

 

2,152,152

 

 

 

2,800,820

 

Note payable, current

 

 

545,551

 

 

 

476,236

 

Current portion of operating lease liabilities

 

 

537,002

 

 

 

534,547

 

Total current liabilities

 

 

5,344,993

 

 

 

5,890,302

 

Noncurrent liabilities:

 

 

 

 

 

 

 

 

Operating lease liabilities, noncurrent

 

 

874,003

 

 

 

885,333

 

      Note payable, noncurrent


863,799




1,097,946

Total liabilities

 

 

7,082,795

 

 

 

7,873,581

 

Commitments and contingencies (Note 14)

 

 

 

 

 

 


 

Stockholders' equity:

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

Common Stock, par value $0.001 per share; 500,000,000 shares authorized at March 31, 2021 and December 31, 2020; 48,492,777 shares issued and outstanding at March 31, 2021 and 45,559,765 shares issued and outstanding at December 31, 2020

 

 

48,493

 

 

 

45,560

 

Additional paid-in capital

 

 

138,464,624

 

 

 

130,205,027

 

Accumulated deficit

 

 

(112,373,980)

 

 

(106,990,148)


Accumulated other comprehensive loss

 

 

(107,323)

 

 

(251,467)


Total stockholders' equity

 

 

26,031,814

 

 

 

23,008,972

 

Noncontrolling interest

 

 

635,610

 

 

 

635,610

 

Total equity

 

 

26,667,424

 

 

 

23,644,582

 

Total liabilities and equity

 

$

33,750,219

 

 

$

31,518,163

 

 

 


 

 

 

 

 

 

 

See accompanying notes to unaudited condensed consolidated financial statements.


4


ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)

 

 

 

Three months ended 

March 31,

 

 

 

2021

 

 

2020

 

Net sales

 

$

1,203,844

 

 

$

733,771

 

Cost of goods sold

 

 

363,987

 

 

 

298,115

 

Gross profit

 

 

839,857

 

 

 

435,656

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

498,965

 

 

 

1,523,114

 

Selling, general and administrative

 

 

5,724,588

 

 

 

6,560,726

 

Restructuring and other severance related charges

 

 

 

 

 

365,000

 

Total operating expenses

 

 

6,223,553

 

 

 

8,448,840

 

Loss from operations

 

 

(5,383,696

)

 

 

(8,013,184

)

Other (income)/expense

 

 

 

 

 

 

 

 

Interest and other income

 

 

(3,386

)

 

 

(62,976

)

Other expense

 

 

3,522

 

 

 

9,141

 

Total other (income)/expense

 

 

136

 

 

(53,835

)
Net loss

 

$

(5,383,832

)

 

$

(7,959,349

)

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

 

$

(0.11

)

 

$

(0.27

)

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

 

 

47,653,202

 

 

 

29,774,226

 

 

See accompanying notes to unaudited condensed consolidated financial statements.


5



ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)

 

 

 

Three months ended

 March 31,

 

 

 

2021

 

 

2020

 

Net loss

 

$

(5,383,832

)

 

$

(7,959,349

)

   Other comprehensive income:

 

 

 

 

 

 

 

 

   Foreign currency translation adjustment

 

 

141,381

 

 

45,322

   Unrealized gain on securities, net of taxes as applicable

 

 

2,763

 

 

5,826

   Other comprehensive income

 

 

144,144

 

 

51,148

Comprehensive loss

 

$

(5,239,688

)

 

$

(7,908,201

)

 

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

 

 

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































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

 


 


 

 

 


 

 

 


 

 

 



 

 


 

 

 



 

 


 

 



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

 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

7


ELECTROCORE, INC., SUBSIDIARIES AND AFFILIATE

(Unaudited)

 

 

 

Three months ended

March 31,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(5,383,832

)

 

$

(7,959,349

)

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

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

942,183

 

 

 

744,865

 

Depreciation and amortization

 

 

95,680

 

 

 

97,419

 

Amortization of marketable securities discount

 

 

54,278

 

 

1,176

Net noncash lease expense

 

 

15,149

 

 

87,000

Other

 

 

 

 

 

10,937

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable, net

 

 

11,227

 

 

224,096

Inventories

 

 

118,889

 

 

(638

)

Prepaid expenses and other current assets

 

 

381,543

 

 

238,376

 

Accounts payable

 

 

31,589

 

 

(1,562,615

)

Accrued expenses and other current liabilities

 

 

(413,503

)

 

 

(262,933

)

                 Operating lease liabilities

(8,875 )

(108,581 )

Net cash used in operating activities

 

 

(4,155,672

)

 

 

(8,490,247

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of marketable securities

 

 

(5,082,730

)

 

 

Proceeds from maturities of marketable securities

 

 

7,000,000

 

 

 

10,500,000

 

Net cash provided by investing activities

 

 

1,917,270

 

 

10,500,000

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from shares issued

 

 

6,920,350

 

 

 

 

Net cash provided by financing activities

 

 

6,920,350

 

 

 

Effect of changes in exchange rates on cash and cash equivalents

 

 

140,500

 

 

46,952

Net increase in cash and cash equivalents

 

 

4,822,448

 

 

2,056,705

Cash and cash equivalents – beginning of period

 

 

4,241,937

 

 

 

13,563,791

 

Cash and cash equivalents – end of period

 

$

9,064,385

 

 

$

15,620,496

 

 

 

 

 

 

 

 

 

 

Supplemental cash flows disclosures:

 

 

 

 

 

 

 

 

Interest paid

 

$

3,522

 

 

$

4,623

 

Supplemental schedule of noncash activity:







     2020 Accrued bonus awarded in equity
$ 399,997

$


 

See accompanying notes to unaudited condensed consolidated financial statements. 


8


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 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. In addition, an affiliate, electroCore (Aust) Pty Limited (“electroCore Australia”), is subject to electroCore’s control on a basis other than voting interests and is a variable interest entity (“VIE”), for which electroCore is the primary beneficiary. As of May 2017, the VIE ceased operations.

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 months ended March 31, 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. electroCore Australia, a VIE for which electroCore is the primary beneficiary, is also consolidated with the non-controlled equity presented as a non-controlling interest. 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 three months ended March 31, 2020 consistent with the March 31, 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 three months ended March 31, 2020 was reclassed to Net cash used in operating activities on the line Accrued expense and other current liabilities within the accompanying Condensed Consolidated Statements of Cash Flows. Additionally, the decrease in operating lease liabilities of $108,581 included on the line Net noncash lease expense for the three months ended March 31, 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.


9


Note 3. Significant Risks and Uncertainties

Going Concern

The Company is subject to risks common to emerging medical device companies, including uncertainties related to commercialization of products and failing to secure additional funding. 

The Company has experienced significant net losses, and it expects to continue to incur 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. The Company has never been profitable and has incurred net losses in each year since its inception.

The Company incurred net losses of $5.4 million and $8.0 million for the three months ended March 31, 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 COVID-19 pandemic. Due to these risks and uncertainties, the Company may need to reduce its activities significantly more than in its current operating plan and cash flow projections assume in order to fund its operations beyond one year of the date the accompanying financial statements are issued. There can be no assurance that the Company will have sufficient cash flow and liquidity to fund its planned activities, which could force it to significantly reduce or curtail its activities and ultimately, potentially cease operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

There is no assurance that the Company will generate sufficient funding through its operating results or financing activity, raising substantial doubt about the Company’s ability to continue as a going concern within one year of the date the accompanying financial statements are issued. The accompanying financial statements do not include any adjustment that might result from the outcome of this uncertainty. 

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. In total, net sales from these two channels represented 81.3% and 93.9% of the Company’s net sales for three months ended March 31, 2021, and 2020 respectively.

Each of these two channels accounted for 10% or more of the Company's net sales as summarized below:

 

Three months ended March 31,

 

 

2021

 

 

2020

 

Revenue channel:

 

 

 

 

 

 

 

    Department of Veterans Affairs and Department of Defense


55.5

 %

 


61.9

    National Health Service

 

25.8

 %

 

 

32.0

%

During the three months ended March 31, 2021, five specific VA/DoD facilities represented approximately 55.2% of the Company’s revenue from this channel, and two of those facilities each accounted for more than 10% individually. 

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 months ended March 31, 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.


10


Note 4. Revenue Recognition

Geographical Net Sales

The following table presents net sales disaggregated by geographic area: 


 

Three months ended

March 31,

 

 

2021

 

 

2020

 

Geographic Market

 

 

 

 

 

 

 

United States

$

823,976

 

 

$

457,559

 

United Kingdom

 

316,993

 

 

 

245,466

 

Other
62,875


30,746

Total Net Sales

$

1,203,844

 

 

$

733,771

 


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 months ended March 31, 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 months ended March 31, 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 months ended March 31, 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.


11


Note 5. Cash, Cash Equivalents and Marketable Securities

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


As of March 31, 2021

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized (Loss)

 

 

Fair Value

 

Cash and cash equivalents

 

$

9,064,385

 

 

$

 

 

$

 

$

9,064,385

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury Bonds

 

$

16,388,386

 

 

$

 

 

$

(47

)

 

$

16,388,339

 

Total marketable securities

 

$

16,388,386

 

 

$

 

 

$

(47

)

 

$

16,388,339

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total cash, cash equivalents, and marketable securities

 

$

25,452,771

 

 

$

 

 

$

(47

)

 

$

25,452,724

 

 

As of December 31, 2020

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized (Loss)

 

 

Fair Value

 

Cash and cash equivalents

 

$

4,241,937

 

 

$

 

 

$

 

$

4,241,937

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury Bonds

 

$

18,388,970

 

 

$

 

 

$

(2,810

)

 

$

18,386,160

 

Total marketable securities

 

$

18,388,970

 

 

$

 

 

$

(2,810

)

 

$

18,386,160

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total cash, cash equivalents, and marketable securities

 

$

22,630,907

 

 

$

 

 

$

(2,810

)

 

$

22,628,097

 


12



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

 

March 31, 2021

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,064,385

 

 

$

9,064,385

 

 

$

 

 

$

 

Marketable Securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury bonds

 

 

16,388,339

 

 

 

16,388,339

 

 

 

 

 

 

 

Total

 

$

25,452,724

 

 

$

25,452,724

 

 

$

 

 

$



 

 

 

 

 

 

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 three months ended March 31, 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 March 31, 2021 and December 31, 2020, inventories consisted of the following:  


 

 

March 31, 2021

 

 

December 31, 2020

 

Raw materials

 

$

981,452

 

 

$

1,008,653

 

Work in process

 

 

 4,367,610

 

 

 

4,304,415

 

Finished goods

 

 

273,666

 

 

 

428,549

 

Total inventory

 

 

5,622,728

 

 

 

5,741,617

 

Less: noncurrent

 

 

4,678,013

 

 

4,865,181

Total - current

 

$

944,715

 

 

$

876,436

 

 

The reserve for obsolete inventory was $721,426 as of March 31, 2021 and December 31, 2020. The Company records charges for obsolete inventory in cost of goods sold. As of March 31, 2021 and December 31, 2020, noncurrent inventory was comprised of approximately $0.8 million and $0.7 million of raw materials, respectively, and $3.9 million and $4.2 million of work in process, respectively.


13


Note 8. Leases

For the three months ended March 31, 2021 and 2020 the Company recognized lease expense of $40,304 and $119,650, 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


 


March 31, 2021 

 

 

December 31, 2020

 

Operating leases:

 

 

 

 

 

 

 

 

Operating lease right of use assets


$

502,108

 

 

$

517,257

 

Operating lease liabilities:


 

 

 

 

 

 

 

Current portion of operating lease liabilities

 

 

537,002

 

 

 

534,547

 

Noncurrent operating lease liabilities


 

874,003

 

 

 

885,333

 

Total operating lease liabilities


$

1,411,005

 

 

$

1,419,880

 

Weighted average remaining lease term (in years)


 

5.7

 

 

 

5.7

 

Weighted average discount rate


 

13.75

%

 

 

13.75

%

 


 Future minimum lease payments under non-cancellable operating leases as of March 31, 2021:


Remainder of 2021

 

$

750,778

 

2022

 

 

337,254

 

2023

 

 

142,892

 

2024

 

 

146,044

 

2025 and there after

 

 

676,260

 

Total future minimum lease payments

 

 

2,053,228

 

Less: Amounts representing interest

 

 

(642,223

)

Total

 

$

1,411,005

 

Note 9Accrued Expenses and Other Current Liabilities

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



 

 

March 31, 2021

 

 

December 31, 2020

 

Accrued professional fees

 

$

233,544

 

 

$

270,543

 

Accrued bonuses

 

 

709,445

 

 

 

1,424,878

 

Other employee related expenses

424,953


371,033

Other

 

 

784,210

 

 

 

734,366

 

 

 

$

2,152,152

 

 

$

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 PPP. The PPP is a program of the 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.

14


The interest rate on the Loan is 1.0% per annum. The Note matures on February 2, 2023. On September 2, 2021 (the “First Payment Date”), the Company is required to pay all accrued interest under the Loan that is not forgiven in accordance with the terms of the PPP. Additionally, on the First Payment Date and on the second day of each month thereafter until February 2, 2023, the Company must make equal monthly payments of the amount of principal under the Loan that is not forgiven in accordance with the terms of the PPP and related accrued interest thereon. The Note contains events of default and other conditions customary for a Note of this type.

Under the terms of the CARES Act, PPP loan recipients can be granted forgiveness for all or a portion of the loan granted under the PPP, with such forgiveness to be determined, subject to limitations, based on the use of the loan proceeds for payment of Qualifying Expenses and the recipient maintaining its payroll levels over certain required thresholds under the PPP. The terms of any forgiveness also may be subject to further requirements in any regulations and guidelines the SBA may adopt. No assurance can be provided that the Company will obtain forgiveness of the Note in whole or in part. Official guidance and interpretations of the requirements of the program have been limited and have been changing over time. Despite the Company’s good-faith belief that it properly satisfied all eligibility requirements for the PPP loan, there has been increasing scrutiny of public companies that received loans, and there can be no assurance that the Company will not become subject to regulatory or other scrutiny, including a request or requirement for repayment of some or all of the loan. 

On March 24, 2021, the Company applied for loan forgiveness with the Lender under the guidelines of the SBA. If approved, the Company would not be required to repay all, or a part, of the loan.

The Company has accounted for the Loan in accordance with FASB ASC Topic 470, Debt. Accordingly, the Loan is reflected as a liability on its Condensed Consolidated Balance Sheet as of March 31, 2021. As of March 31, 2021, $0.5 million was included under the caption Current liabilities and $0.9 million was included under the caption Noncurrent liabilities. The Company will record a gain if the Loan is forgiven.

Finance and Security Agreement

On July 1, 2020, the Company entered into a Commercial Insurance Premium Finance and Security Agreement (“the Agreement”). The Agreement provides 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 some of the Company’s insurance policies. The amounts payable are secured by the Company’s rights under such policies. The Company is required to pay monthly installments of approximately $164,800 beginning in July 2020. All borrowings were fully repaid as of March 31, 2021.

Note 11. Stockholders’ Equity

Lincoln Park Purchase Agreement

On March 27, 2020, the Company and 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 three months ended March 31, 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.

Settlement of Accrued Bonus

During the three months ended March 31, 2021, the Company issued 165,413 shares of its common stock in payment of certain executive accrued 2020 incentive bonuses.

15



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, and stock options 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:  




 

Three months ended March 31,

 

 

2021

 

 

2020 

Outstanding stock options

 

 

 4,905,585

 

 

 

 3,808,563

Nonvested restricted stock and unit awards

 


1,216,455

 


1,094,825

Stock purchase warrants

 


715,199

 


715,199




6,837,239


5,618,587
 

Note 13.  Stock Based Compensation

The following table presents a summary of activity related to stock options during the three months ended March 31, 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

 

1,090,000

 

 

 

2.05

 

 

 

 

 

 

218,950

Exercised

 

 

 

 

 

 

 

 

 

 

 —

Cancelled

 

 

 

 

 

 

 

 

 

Outstanding, March 31, 2021


4,905,585


 

$

4.78



 

8.7


 $

1,396,195

Exercisable, March 31, 2021

 

1,597,409

 

 

$

8.38

 

 

 

8.0

 

$

223,339

 

The intrinsic value is calculated as the difference between the fair market value at March 31, 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 three months ended March 31, 2021:  


 

 

Number of Shares

 

 

Weighted Average Grant Date Fair Value

 

 

Nonvested, January 1, 2021

  

 

25,645

 

 

$

10.07

 

 

Granted

 

 

165,413

 

 

 

2.42

 

 

Vested

 

 

(120,051

)

 

 

3.33

 

 

Cancelled

 

  

 

 

 

 

Nonvested, March 31, 2021

 

 

71,007

 

 

$

4.74

 

 

 

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


16



The following table presents a summary of activity related to restricted and deferred stock units (“Stock Units”) granted during the three months ended March 31, 2021:


 

 

Number of Shares

 

 

Weighted Average Grant Date Fair Value

 

Nonvested, January 1, 2021

 

 

1,014,123

 

 

$

1.50

 

Granted

 

 

147,000

 

 

 

2.83

 

Vested

 

 

(15,675

)

 

 

1.83

 

Cancelled

 

 

 

 

 

Nonvested, March 31, 2021

 

 

1,145,448

 

 

$

1.67

 

 

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

March 31,


 

2021

 

 

2020


Selling, general and administrative

$

809,547

 

 

$

547,090

 

Research and development

 

112,986

 

 

 

186,599

 

Cost of goods sold

 

19,650

 

 

 

11,176

 

Total expense  $

942,183

 

 

$ 744,865

 

 

Total unrecognized compensation cost related to unvested awards as of March 31, 2021 was $6.0 million and is expected to be recognized over the next 2.6 years.

Valuation Information for Stock-Based Compensation

The fair value of each stock option award during the three months ended March 31, 2021 and 2020 was estimated on the date of grant using the Black-Scholes model. For the three months ended March 31, 2021, expected volatility was based on historical common stock volatility of the Company’s peers. Expected volatility for the three months ended March 31, 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 months ended March 31, 2021 and 2020 are summarized in the table below. 


 

Three months ended

March 31, 2021

 


Three months ended

March 31, 2020


Fair value at grant date

$

1.39

 

$ 1.27

Expected volatility

79.9


113.4  

Risk-free interest rate

0.6


1.4 %

Expected holding period, in years

6.1

 


6.1

Dividend yield

 


%

 

17


Note 14. 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 on the motion to dismiss has not yet been scheduled. The parties have agreed to 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.


18


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 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 plantiffs 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.


19



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 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 a number of investigator-initiated studies. These indications include COVID-19 respiratory symptoms, stroke, mild 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. With an earlier-than-anticipated FDA clearance for our acute treatment of migraine indication, 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 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 several new distributors to make gammaCore Sapphire available beyond the U.S. and United Kingdom, including in multiple European countries, Australia, Canada, and Qatar.


20


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 three months ended March 31, 2021 and 2020 reflect a negative impact from, among other things, the global pandemic. Moreover, our expectations for at least the beginning 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 three months ended March 31, 2021 and we do not expect to recognize material revenue from the sales of gammaCore Sapphire CV.


21


Results of Operations

Comparison of the three months ended March 31, 2021 to the three months ended March 31, 2020

The following table sets forth amounts from our condensed consolidated statements of operations for the three months ended March 31, 2021 and 2020:

 

 

 

For the three months ended March 31,

 

 

 

 

 

 

 

2021

 

 

2020 

 

 

Change

 

 

 

(in thousands)

 

Consolidated statements of operations:

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

1,203.8

 

 

$

733.7

 

 

$

470.1

Cost of goods sold

 

 

364.0

 

 

 

298.1

 

 

 

65.9

Gross profit

 

 

839.8

 

 

 

435.6

 

 

 

404.2

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

499.0

 

 

 

1,523.1

 

 

 

(1,024.1

)

Selling, general and administrative

 

 

5,724.5

 

 

 

6,560.7

 

 

 

(836.2

)

Restructuring and other severance related charges

 

 

 

 

 

365.0

 

 

 

(365.0

)

Total operating expenses

 

 

6,223.5

 

 

8,448.8

 

 

 

(2,225.3

)

Loss from operations

 

 

(5,383.7

)

 

 

(8,013.2

)

 

 

2,629.5

 

Other (income)/expense

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income

 

 

(3.4

)

 

 

(63.0

)

 

 

59.6

Other expense

 

 

3.5

 

 

 

9.1

 

 

 

(5.6

)

Total other (income)/expense

 

 

0.1

 

 

(53.9)


 

 

54.0

Net loss

 

$

(5,383.8

)

 

$

(7,959.3

)

 

$

2,575.5

 


Net Sales

Net sales increased 64% for the three months ended March 31, 2021 compared to the prior year period. The increase of $470.1 thousand is due to increased sales across all major channels including Commercial, the Department of Veteran Affairs, and in the United Kingdom. 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 $404.2 thousand for the three months ended March 31, 2021 compared to the prior year period due to the increase in net sales. Gross margin was 70% and 59% for the three months ended March 31, 2021 and 2020, respectively. The increase in gross margin was largely due to the more favorable absorption of labor and overhead costs, and product mix.

Research and Development

Research and development expense decreased by $1.0 million or 67% for the three months ended March 31, 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.


22


Selling, General and Administrative

Selling, general and administrative expense was $5.7 million and $6.6 million for the three months ended March 31, 2021 and 2020, respectively. The decrease in expense was due to the cost reduction plan put in place during 2019 and 2020, including the restructuring of the commercial channel. 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 three months ended March 31, 2021. Restructuring and other severance related costs for the three months ended March 31, 2020 of $365,000 consists of severance related expenses in connection with personnel changes in the position of Chief Medical Officer. 

Interest and Other Income

Interest and other income of $3,386 and $62,976 for the three months ended March 31, 2021 and 2020, respectively, primarily consisted of interest earned on cash, cash equivalents and marketable securities. Interest income was slightly offset by interest expense incurred in the current period related to our loan under the PPP, and financing related to certain of our insurance premiums during both the 2021 and 2020 periods. 

Cash Flows

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

 


 

For the three months ended March 31,

 

 

 

 2021

 

 

 2020 

 

 

 

(in millions)

 

Net cash (used in) provided by

 

 

 

 

 

 

 

 

Operating activities

 

$

(4.2

)

 

$

(8.5

)

Investing activities