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y

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

For the Quarterly Period Ended September 30, 2022

OR

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

For the transition period from            to

Commission File No.:  001-35527

 

EMMAUS LIFE SCIENCES, INC.

(Exact name of Registrant as specified in its charter)

 

 

Delaware

 

87-0419387

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

21250 Hawthorne Boulevard, Suite 800, Torrance, California

 

90503

(Address of principal executive offices)

 

(Zip code)

 

(310) 214-0065

(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

None

 

 

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 definition 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 

The registrant had 49,558,501 shares of common stock, par value $0.001 per share, outstanding as of November 10, 2022.

 

 


 

 

EMMAUS LIFE SCIENCES, INC.

For the Quarterly Period Ended September 30, 2022

INDEX

 

 

 

Page

 

 

 

 

Part I. Financial Information

 

 

 

 

Item 1.

Financial Statements (Unaudited)

1

 

 

 

 

(a)Condensed Consolidated Balance Sheets as of September 30, 2022  and December 31, 2021

1

 

 

 

 

(b)Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2022 and 2021

2

 

 

 

 

(c)Condensed Consolidated Statements of Changes in Stockholders’ Deficit for the three and nine months ended September 30, 2022 and 2021

3

 

 

 

 

(d)Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021 

5

 

 

 

 

(e)Notes to Condensed Consolidated Financial Statements 

6

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

21

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

26

 

 

 

Item 4.

Controls and Procedures

26

 

 

 

Part II Other Information

 

 

 

 

Item 1.

Legal Proceedings

28

 

 

 

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

29

 

 

 

Item 6.

Exhibits

30

 

 

 

Signatures

31

 

 


 

 

Item 1. Financial Statements

 

EMMAUS LIFE SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

As of

 

 

 

September 30, 2022

 

 

December 31, 2021

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

1,179

 

 

$

2,279

 

Accounts receivable, net

 

 

1,491

 

 

 

1,040

 

Inventories, net

 

 

2,739

 

 

 

4,392

 

Prepaid expenses and other current assets

 

 

973

 

 

 

1,380

 

Total current assets

 

 

6,382

 

 

 

9,091

 

Property and equipment, net

 

 

79

 

 

 

147

 

Equity method investment

 

 

16,594

 

 

 

17,616

 

Right of use assets

 

 

2,944

 

 

 

3,485

 

Investment in convertible bond

 

 

15,943

 

 

 

26,100

 

Other assets

 

 

259

 

 

 

295

 

Total assets

 

$

42,201

 

 

$

56,734

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

11,134

 

 

$

9,189

 

Operating lease liabilities, current portion

 

 

653

 

 

 

740

 

Conversion feature derivative, notes payable

 

 

4,272

 

 

 

7,507

 

Other current liabilities

 

 

2,270

 

 

 

4,404

 

Revolving line of credit from related party

 

 

400

 

 

 

400

 

Warrant derivative liabilities

 

 

33

 

 

 

1,503

 

Notes payable, current portion, net of discount

 

 

5,635

 

 

 

2,399

 

Notes payable to related parties

 

 

2,780

 

 

 

800

 

Convertible notes payable, net of discount

 

 

14,346

 

 

 

10,158

 

Total current liabilities

 

 

41,523

 

 

 

37,100

 

Operating lease liabilities, less current portion

 

 

2,764

 

 

 

3,261

 

Other long-term liabilities

 

 

32,122

 

 

 

33,173

 

Notes payable, less current portion

 

 

 

 

 

1,500

 

Notes payable to related parties, net

 

 

3,381

 

 

 

 

Convertible notes payable

 

 

 

 

 

3,150

 

Total liabilities

 

 

79,790

 

 

 

78,184

 

STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Preferred stock, par value $0.001 per share, 15,000,000 shares authorized, none issued or outstanding

 

 

 

 

 

 

Common stock, par value $0.001 per share, 250,000,000 shares authorized, 49,558,501 and 49,311,864 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

 

50

 

 

 

49

 

Additional paid-in capital

 

 

220,803

 

 

 

220,022

 

Accumulated other comprehensive loss

 

 

(5,905

)

 

 

(255

)

Accumulated deficit

 

 

(252,537

)

 

 

(241,266

)

Total stockholders’ deficit

 

 

(37,589

)

 

 

(21,450

)

Total liabilities & stockholders’ deficit

 

$

42,201

 

 

$

56,734

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

1


 

EMMAUS LIFE SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

REVENUES, NET

 

$

4,939

 

 

$

5,766

 

 

$

12,460

 

 

$

17,590

 

COST OF GOODS SOLD

 

 

540

 

 

 

445

 

 

 

1,943

 

 

 

1,311

 

GROSS PROFIT

 

 

4,399

 

 

 

5,321

 

 

 

10,517

 

 

 

16,279

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

432

 

 

 

470

 

 

 

1,196

 

 

 

3,032

 

Selling

 

 

1,664

 

 

 

1,518

 

 

 

5,076

 

 

 

4,254

 

General and administrative

 

 

2,963

 

 

 

3,364

 

 

 

9,413

 

 

 

10,156

 

  Total operating expenses

 

 

5,059

 

 

 

5,352

 

 

 

15,685

 

 

 

17,442

 

LOSS FROM OPERATIONS

 

 

(660

)

 

 

(31

)

 

 

(5,168

)

 

 

(1,163

)

OTHER INCOME (EXPENSE)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on debt extinguishment

 

 

(421

)

 

 

 

 

 

(421

)

 

 

(1,172

)

Change in fair value of warrant derivative liabilities

 

 

51

 

 

 

(131

)

 

 

1,341

 

 

 

(322

)

Change in fair value of conversion feature derivative, notes payable

 

 

3,850

 

 

 

(1,357

)

 

 

3,235

 

 

 

(1,132

)

Realized loss on investment in convertible bond

 

 

 

 

 

 

 

 

(133

)

 

 

 

Net loss on equity method investment

 

 

(431

)

 

 

(663

)

 

 

(1,490

)

 

 

(1,999

)

Foreign exchange loss

 

 

(1,470

)

 

 

(246

)

 

 

(5,131

)

 

 

(1,421

)

Interest and other income

 

 

175

 

 

 

192

 

 

 

530

 

 

 

573

 

Interest expense

 

 

(1,520

)

 

 

(683

)

 

 

(3,544

)

 

 

(2,390

)

  Total other income (expense)

 

 

234

 

 

 

(2,888

)

 

 

(5,613

)

 

 

(7,863

)

LOSS BEFORE INCOME TAXES

 

 

(426

)

 

 

(2,919

)

 

 

(10,781

)

 

 

(9,026

)

Income tax provision (benefit)

 

 

(35

)

 

 

232

 

 

 

44

 

 

 

58

 

NET LOSS

 

 

(391

)

 

 

(3,151

)

 

 

(10,825

)

 

 

(9,084

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

COMPONENTS OF OTHER COMPREHENSIVE LOSS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on debt securities available for sale (net of tax)

 

 

(3,047

)

 

 

(2,754

)

 

 

(7,112

)

 

 

(2,150

)

Reclassification adjustment for loss included in net income

 

 

 

 

 

 

 

 

7

 

 

 

 

Foreign currency translation adjustments

 

 

481

 

 

 

86

 

 

 

1,455

 

 

 

243

 

Other comprehensive loss

 

 

(2,566

)

 

 

(2,668

)

 

 

(5,650

)

 

 

(1,907

)

COMPREHENSIVE LOSS

 

$

(2,957

)

 

$

(5,819

)

 

$

(16,475

)

 

$

(10,991

)

NET LOSS PER COMMON SHARE - BASIC AND DILUTED

 

$

(0.01

)

 

$

(0.06

)

 

$

(0.22

)

 

$

(0.18

)

WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING

 

 

49,558,501

 

 

 

49,311,864

 

 

 

49,397,690

 

 

 

49,233,371

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.


2


 

 

EMMAUS LIFE SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

(In thousands, except share and per share amounts)

(Unaudited)

 

 

Common stock

 

 

Additional paid-in

 

 

Accumulated other comprehensive

 

 

Accumulated

 

 

Total stockholders'

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

deficit

 

Balance at January 1,2022

 

49,311,864

 

 

$

49

 

 

$

220,022

 

 

$

(255

)

 

$

(241,266

)

 

$

(21,450

)

Share-based compensation

 

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

5

 

Unrealized gain on debt securities available for sale (net of tax)

 

 

 

 

 

 

 

 

 

 

350

 

 

 

 

 

 

350

 

Reclassification adjustment for loss included in net income

 

 

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

7

 

Foreign currency translation effect

 

 

 

 

 

 

 

 

 

 

331

 

 

 

 

 

 

331

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,542

)

 

 

(1,542

)

Balance, March 31, 2022

 

49,311,864

 

 

 

49

 

 

 

220,027

 

 

 

433

 

 

 

(242,808

)

 

 

(22,299

)

Reclassification of warrants from liability to equity

 

 

 

 

 

 

 

213

 

 

 

 

 

 

 

 

 

213

 

Fair value of warrants including down-round protection adjustments

 

 

 

 

 

 

 

446

 

 

 

 

 

 

(446

)

 

 

 

Common stock issued for services

 

246,637

 

 

 

1

 

 

 

109

 

 

 

 

 

 

 

 

 

 

 

110

 

Share-based compensation

 

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

5

 

Unrealized loss on debt securities available for sale (net of tax)

 

 

 

 

 

 

 

 

 

 

(4,415

)

 

 

 

 

 

(4,415

)

Foreign currency translation effect

 

 

 

 

 

 

 

 

 

 

643

 

 

 

 

 

 

643

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,892

)

 

 

(8,892

)

Balance, June 30, 2022

 

49,558,501

 

 

$

50

 

 

$

220,800

 

 

$

(3,339

)

 

$

(252,146

)

 

$

(34,635

)

Share-based compensation

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

Unrealized loss on debt securities available for sale (net of tax)

 

 

 

 

 

 

 

 

 

 

(3,047

)

 

 

 

 

 

(3,047

)

Foreign currency translation effect

 

 

 

 

 

 

 

 

 

 

481

 

 

 

 

 

 

481

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(391

)

 

 

(391

)

Balance, September 30, 2022

$

49,558,501

 

 

$

50

 

 

$

220,803

 

 

$

(5,905

)

 

$

(252,537

)

 

$

(37,589

)

 


3


 

 

EMMAUS LIFE SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Common stock

 

 

Additional paid-in

 

 

Accumulated other comprehensive

 

 

Accumulated

 

 

Total stockholders'

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

deficit

 

Balance at January 1,2021

 

48,987,189

 

 

$

49

 

 

$

218,728

 

 

$

1,144

 

 

$

(225,079

)

 

$

(5,158

)

Fair value of warrants including down-round protection adjustments

 

 

 

 

 

 

 

241

 

 

 

 

 

 

(241

)

 

 

 

Common stock issued for services

 

324,675

 

 

 

 

 

 

500

 

 

 

 

 

 

 

 

 

500

 

Share-based compensation

 

 

 

 

 

 

 

181

 

 

 

 

 

 

 

 

 

181

 

Unrealized gain on debt securities available for sale (net of tax)

 

 

 

 

 

 

 

 

 

 

58

 

 

 

 

 

 

58

 

Foreign currency translation effect

 

 

 

 

 

 

 

 

 

 

165

 

 

 

 

 

 

165

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,422

)

 

 

(8,422

)

Balance, March 31, 2021

 

49,311,864

 

 

 

49

 

 

 

219,650

 

 

 

1,367

 

 

 

(233,742

)

 

 

(12,676

)

Share-based compensation

 

 

 

 

 

 

 

274

 

 

 

 

 

 

 

 

 

274

 

Unrealized gain on debt securities available for sale (net of tax)

 

 

 

 

 

 

 

 

 

 

546

 

 

 

 

 

 

546

 

Foreign currency translation effect

 

 

 

 

 

 

 

 

 

 

(8

)

 

 

 

 

 

(8

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

2,489

 

 

 

2,489

 

Balance, June 30, 2021

 

49,311,864

 

 

 

49

 

 

 

219,924

 

 

 

1,905

 

 

 

(231,253

)

 

 

(9,375

)

Share-based compensation

 

 

 

 

 

 

 

93

 

 

 

 

 

 

 

 

 

93

 

Unrealized loss on debt securities available for sale (net of tax)

 

 

 

 

 

 

 

 

 

 

(2,754

)

 

 

 

 

 

(2,754

)

Foreign currency translation effect

 

 

 

 

 

 

 

 

 

 

86

 

 

 

 

 

 

86

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,151

)

 

 

(3,151

)

Balance at September 30, 2021

 

49,311,864

 

 

$

49

 

 

$

220,017

 

 

$

(763

)

 

$

(234,404

)

 

$

(15,101

)

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 


4


 

 

 

 

EMMAUS LIFE SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

 

 

Net loss

 

$

(10,825

)

 

$

(9,084

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

40

 

 

 

44

 

Inventory reserve

 

 

1,240

 

 

 

423

 

Amortization of discount of notes payable and convertible notes payable

 

 

1,303

 

 

 

1,410

 

Foreign exchange adjustments

 

 

5,072

 

 

 

1,415

 

Net gain on investment in marketable securities

 

 

133

 

 

 

Loss on equity method investment

 

 

1,490

 

 

 

1,999

 

Loss on debt extinguishment

 

 

421

 

 

 

1,172

 

Gain on disposal of property and equipment

 

 

 

 

 

(1

)

Loss on leased assets

 

 

22

 

 

 

 

Share-based compensation

 

 

13

 

 

 

548

 

Shares issued for services

 

 

55

 

 

 

500

 

Change in fair value of warrant derivative liabilities

 

 

(1,341

)

 

 

322

 

Change in fair value of conversion feature derivative, notes payable

 

 

(3,235

)

 

 

1,132

 

Net changes in operating assets and liabilities

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(485

)

 

 

(2,469

)

Inventories

 

 

390

 

 

 

404

 

Prepaid expenses and other current assets

 

 

148

 

 

 

202

 

Other non-current assets

 

 

446

 

 

 

417

 

Income tax receivable and payable

 

 

28

 

 

 

15

 

Accounts payable and accrued expenses

 

 

1,479

 

 

 

(173

)

Other current liabilities

 

 

(3,199

)

 

 

242

 

Other long-term liabilities

 

 

55

 

 

 

(637

)

Net cash flows used in operating activities

 

 

(6,750

)

 

 

(2,119

)

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 

 

Sale of convertible bond

 

 

2,919

 

 

 

 

Purchases of property and equipment

 

 

(18

)

 

 

(11

)

Loan to equity method investee

 

 

(4,226

)

 

 

(5,241

)

Net cash flows used in investing activities

 

 

(1,325

)

 

 

(5,252

)

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

Proceeds from notes payable issued, net of issuance cost

 

 

4,283

 

 

 

 

Proceeds from notes payable issued, net of issuance cost, related party

 

 

5,469

 

 

 

1,000

 

Proceeds from convertible notes payable issued, net of issuance cost and discount

 

 

 

 

 

14,490

 

Payments of notes payable

 

 

(2,689

)

 

 

(1,079

)

Payments of convertible notes

 

 

 

 

 

(7,200

)

Net cash flows provided by financing activities

 

 

7,063

 

 

 

7,211

 

Effect of exchange rate changes on cash

 

 

(88

)

 

 

(6

)

Net decrease in cash, cash equivalents and restricted cash

 

 

(1,100

)

 

 

(166

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

2,279

 

 

 

2,487

 

Cash, cash equivalents and restricted cash, end of period

 

$

1,179

 

 

$

2,321

 

 

 

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW ACTIVITIES

 

 

 

 

 

 

 

 

Interest paid

 

$

817

 

 

$

840

 

Income taxes paid

 

$

16

 

 

$

43

 

NON-CASH INVESING AND FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

Debt discount due to embedded derivative

 

$

68

 

 

$

5,555

 

Debt discount due to deferred financing cost

 

$

213

 

 

$

 

Debt discount due to warrants

 

 

70

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


 

EMMAUS LIFE SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

NOTE 1 — BASIS OF PRESENTATION

The accompanying unaudited condensed consolidated interim financial statements of Emmaus Life Sciences, Inc., (“Emmaus”) and its direct and indirect consolidated subsidiaries (collectively, “we,” “our,” “us” or the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) on the basis that the Company will continue as a going concern. All significant intercompany transactions have been eliminated. The Company’s unaudited condensed consolidated interim financial statements contain adjustments, including normal recurring accruals necessary to fairly state the Company’s consolidated financial position, results of operations and cash flows. Due to the uncertainty of the Company’s ability to meet its current liabilities and operating expenses, there is substantial doubt about the Company’s ability to continue as a going concern, as the continuation and any expansion of its business is dependent upon obtaining financing, market acceptance of Endari®, and achieving a profitable level of revenues. The consolidated interim financial statements do not include any adjustments that might result from the outcome of these uncertainties. The condensed consolidated interim financial statements should be read in conjunction with the Annual Report on Form 10-K for the year ended December 31, 2021 (the “Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on March 31, 2022 and Quarterly Reports on Form 10-Q filed with the SEC on May 13, 2022 and August 15, 2022. The accompanying condensed consolidated balance sheet at December 31, 2021 has been derived from the audited consolidated balance sheet at December 31, 2021 contained in the Annual Report. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the full year or any future interim period.

Nature of Operations

The Company is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, primarily for rare and orphan diseases. The Company’s lead product, Endari® (prescription grade L-glutamine oral powder), is approved by the U.S. Food and Drug Administration, or FDA, to reduce the acute complications of sickle cell disease (“SCD”) in adult and pediatric patients five years of age and older.

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” in the Annual Report. There have been no material changes in these policies or their application.

 

Going concern The accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern. The Company incurred a net loss of $10.8 million for the nine months ended September 30, 2022 and had a working capital deficit of $35.1 million as of September 30, 2022. Management expects that the Company’s current liabilities, operating losses and expected capital needs, including the expected costs relating to the commercialization of Endari® in the Middle East North Africa region and elsewhere, will exceed its existing cash balances and cash expected to be generated from operations for the foreseeable future. In order to meet the Company’s current liabilities and future obligations, the Company will need to restructure or refinance its existing indebtedness and raise additional funds through related-party loans, equity or debt financings or licensing or other strategic agreements. The Company is in discussions with the holders of its outstanding convertible promissory notes and certain other creditors to restructure or refinance the convertible promissory notes and other current liabilities but has no understanding or agreement to do so and has no understanding or arrangement for any additional financing. There can be no assurance that the Company will be able to restructure or refinance its existing indebtedness or other current liabilities or complete any additional equity or debt financings on favorable terms, or at all, or enter into licensing or other strategic arrangements. Due to the uncertainty of the Company’s ability to meet its current liabilities and operating expenses, there is substantial doubt about the Company’s ability to continue as a going concern for 12 months from the date of this filing. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

Management has considered all recent accounting pronouncements and determined that they will not have a material effect on the Company’s condensed consolidated financial statements.

 

Factoring accounts receivables — Emmaus Medical, Inc., or Emmaus Medical, an indirect wholly owned subsidiary of Emmaus, is party to a purchase and sales agreement with Prestige Capital Finance, LLC or Prestige Capital, pursuant to which Emmaus Medical may offer and sell to Prestige Capital from time to time eligible accounts receivable in exchange for Prestige Capital’s down payment, or advance, to Emmaus Medical of 75% of the face amount of the accounts receivable, subject to a $7.5

6


 

million cap on advances at any time. The balance of the face amount of the accounts receivable will be reserved by Prestige Capital and paid to Emmaus Medical, less fees of Prestige Capital ranging from 2.25% to 7.25% of the face amount, as and when Prestige Capital collects the entire face amount of the accounts receivable. Emmaus Medical’s obligations to Prestige Capital under the purchase and sale agreement are secured by a security interest in the accounts receivable and all or substantially all other assets of Emmaus Medical. In connection with the purchase and sale agreement, Emmaus has guaranteed Emmaus Medical’s obligations under the purchase and sale agreement. Accounts receivable included $86,000 and $472,000 of factoring accounts receivable and there were $17,000 and $9,000 liabilities related to factoring reflected in other current liabilities at September 30, 2022 and September 30, 2021, respectively. For three and nine months ended September 30, 2022, the Company incurred approximately $121,000, and $275,000, respectively, of factoring fees. For three and nine months ended September 30, 2021, the Company incurred approximately $106,000 and $181,000, respectively of factoring fees.

Net loss per share — In accordance with Accounting Standard Codification (“ASC”) 260, “Earnings per Share,” the basic loss per common share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding. Diluted net loss per share is computed in a manner similar to basic net loss per common share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. As of September 30, 2022 and September 30, 2021, the Company had outstanding potentially dilutive securities exercisable for or convertible into 52,635,590 shares and 23,276,594 shares, respectively, of the Company’s common stock. No potentially dilutive securities were included in the calculation of diluted net loss per share since the potential dilutive securities were anti-dilutive for periods ended September 30, 2022 and September 30, 2021.

NOTE 3 — REVENUES

Revenues disaggregated by category were as follows (in thousands):

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Endari®

 

$

4,763

 

 

$

5,590

 

 

$

12,072

 

 

$

17,186

 

Other

 

 

177

 

 

 

176

 

 

$

389

 

 

 

404

 

Revenues, net

 

$

4,939

 

 

$

5,766

 

 

$

12,460

 

 

$

17,590

 

 

The following table summarizes the revenue allowance and accrual activities for the nine months ended September 30, 2022 and September 30, 2021 (in thousands):

 

 

 

Trade Discounts, Allowances and Chargebacks

 

 

Government Rebates and Other Incentives

 

 

Returns

 

 

Total

 

Balance as of December 31, 2021

 

$

1,481

 

 

$

3,133

 

 

$

539

 

 

$

5,153

 

Provision related to sales in the current year

 

 

1,859

 

 

 

1,828

 

 

 

210

 

 

 

3,897

 

Adjustments related to prior period sales

 

 

(56

)

 

 

18

 

 

 

569

 

 

 

531

 

Credits and payments made

 

 

(2,379

)

 

 

(1,656

)

 

 

(977

)

 

 

(5,012

)

Balance as of September 30, 2022

 

$

905

 

 

$

3,323

 

 

$

341

 

 

$

4,569

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2020

 

$

134

 

 

$

2,119

 

 

$

473

 

 

$

2,726

 

Provision related to sales in the current year

 

 

2,374

 

 

 

2,627

 

 

 

188

 

 

 

5,189

 

Adjustments related to prior period sales

 

 

13

 

 

 

8

 

 

 

(111

)

 

 

(90

)

Credits and payments made

 

 

(1,217

)

 

 

(2,201

)

 

 

(20

)

 

 

(3,438

)

Balance as of September 30, 2021

 

$

1,304

 

 

$

2,553

 

 

$

530

 

 

$

4,387

 

 

 


7


 

 

The following table summarizes revenues attributable to each of our customers that accounted for 10% or more of our net revenues in any of the periods shown:

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Customer A

 

 

9

%

 

 

31

%

 

 

23

%

 

 

47

%

Customer B

 

 

35

%

 

 

49

%

 

 

27

%

 

 

35

%

Customer C

 

 

13

%

 

 

12

%

 

 

12

%

 

 

10

%

Customer D

 

 

15

%

 

 

0

%

 

 

11

%

 

 

0

%

Customer E

 

 

14

%

 

 

0

%

 

 

7

%

 

 

0

%

 

The Company is party to a distributor agreement with Telcon Pharmaceutical RF, Inc., or Telcon pursuant to which the Company granted Telcon exclusive rights to the Company’s prescription grade L-glutamine (“PGLG”) oral powder for the treatment of diverticulosis in South Korea, Japan and China in exchange for Telcon’s payment of a $10 million upfront fee and agreement to purchase from the Company specified minimum quantities of the PGLG. In a related license agreement with Telcon, the Company agreed to use commercially reasonable best efforts to obtain product registration in these territories within three years of obtaining FDA marketing authorization for PGLG in this indication. Telcon has the right to terminate the distributor agreement in certain circumstances specified in the distributor agreement for failure to obtain such product registrations, in which event the Company would be obliged to return to Telcon the $10 million upfront fee. The fee is included in other long-term liabilities as unearned revenue as of September 30, 2022 and December 31, 2021. Refer to Note 6 and 11 and for additional transaction details.

NOTE 4 — SELECTED FINANCIAL STATEMENT — ASSETS

Inventories consisted of the following (in thousands):

 

 

September 30, 2022

 

 

December 31, 2021

 

Raw materials and components

$

1,493

 

 

$

1,439

 

Work-in-process

 

278

 

 

 

115

 

Finished goods

 

5,598

 

 

 

6,228

 

Inventory reserve

 

(4,630

)

 

 

(3,390

)

Total inventories, net

$

2,739

 

 

$

4,392

 

 

Prepaid expenses and other current assets consisted of the following (in thousands):

 

 

September 30, 2022

 

 

December 31, 2021

 

Prepaid insurance

$

134

 

 

$

660

 

Prepaid expenses

 

328

 

 

 

326

 

Other current assets

 

511

 

 

 

394

 

Total prepaid expenses and other current assets

$

973

 

 

$

1,380

 

 

Property and equipment consisted of the following (in thousands):

 

 

September 30, 2022

 

 

December 31, 2021

 

Equipment

$

360

 

 

$

342

 

Leasehold improvements

 

39

 

 

 

39

 

Furniture and fixtures

 

99

 

 

 

103

 

Construction-in-progress

 

 

 

 

57

 

Total property and equipment

 

498

 

 

 

541

 

Less: accumulated depreciation

 

(420

)

 

 

(394

)

Total property and equipment, net

$

79

 

 

$

147

 

 

During the three months ended September 30, 2022 and 2021, depreciation expense was approximately $9,000 and $11,000, respectively. During the nine months ended September 30, 2022 and 2021, depreciation expense was approximately $30,000 and $34,000, respectively.

8


 

NOTE 5 — INVESTMENTS

Investment in convertible bond - On September 28, 2020, the Company entered into a convertible bond purchase agreement pursuant to which it purchased at face value a convertible bond of Telcon in the principal amount of approximately $26.1 million which matures on October 16, 2030 and bears interest at the rate of 2.1% per year, payable quarterly. Beginning October 16, 2021, the Company became entitled on a quarterly basis to call for early redemption of all or any portion of the principal amount of the convertible bond. The convertible bond is convertible at the holder’s option at any time and from time to time into common shares of Telcon at an initial conversion price of KRW9,232, or approximately $8.00 per share. The initial conversion price is subject to downward adjustment monthly based on the volume-weighted average market price of Telcon shares as reported on Korean Securities Dealers Automated Quotations Market and in the event of the issuance of Telcon shares or share equivalents at a price below the market price of Telcon shares or upon a merger or similar reorganization of Telcon or a stock split, reverse stock split, stock dividend or similar event. The conversion price as of September 30, 2022 is set forth in the “Investment in convertible bond” table below. The convertible bond and any proceeds therefrom, including proceeds from any exercise of the early redemption right described above or the call option described below, are pledged as collateral to secure the Company’s obligations under the API Supply Agreement and revised API Agreement with Telcon described in Note 6 and Note 11.

Concurrent with the purchase of the convertible bond, the Company entered into an agreement dated September 28, 2020 pursuant to which Telcon or its designee is entitled to repurchase, at par, up to 50% in principal amount of the convertible bond at any time and from time to time commencing October 16, 2021 and prior to maturity.

The Company has elected the fair value option method of accounting for the investment in convertible bond. The investment in convertible bond is classified as an available for sale security and remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other comprehensive income (loss). The fair value and any changes in fair value in the convertible bond is determined using a binominal lattice model. The model produces an estimated fair value based on changes in the price of the underlying common stock over successive periods of time.

In February 2022, the Company and Telcon agreed to settle a “target shortfall” under the revised API agreement with Telcon for the years ended 2020 and 2021 by exchanging KRW3.5 billion, or approximately US$2.9 million, principal amount and accrued and unpaid interest of the Telcon convertible bond and KRW400 million, or approximately US$310,000, in cash proceeds of the convertible bond. As a result, the Company realized a net loss on investment convertible bond of $126,000, which previously was classified as unrealized loss on debt securities available-for-sale in the other comprehensive income, and other income of $41,000. See Notes 6 and 11 for additional information on the “target shortfall.”

The following table sets forth the fair value and changes in fair value of the investment in the Telcon convertible bond as of September 30, 2022 and December 31, 2021 (in thousands):

 

Investment in convertible bond

 

September 30, 2022

 

 

December 31, 2021

 

Balance, beginning of period

 

$

26,100

 

 

$

27,866

 

Sales of convertible bond

 

 

(2,919

)

 

 

 

Net loss on investment on convertible bond

 

 

(126

)

 

 

 

Change in fair value included in the statement of other comprehensive income

 

 

(7,112

)

 

 

(1,766

)

Balance, end of period

 

$

15,943

 

 

$

26,100

 

The fair value as of September 30, 2022 and December 31, 2021 was based upon following assumptions:

 

 

 

September 30, 2022

 

 

December 31, 2021

 

Principal outstanding (South Korean won)

 

KRW 26.5 billion

 

 

KRW 30 billion

 

Stock price

 

KRW1,075

 

 

KRW2,925

 

Expected life (in years)

 

 

8.04

 

 

 

8.79

 

Selected yield

 

 

16.75

%

 

 

10.50

%

Expected volatility (Telcon common stock)

 

 

78.80

%

 

 

81.31

%

Risk-free interest rate (South Korea government bond)

 

 

4.14

%

 

 

2.19

%

Expected dividend yield

 

 

 

 

 

 

Conversion price

 

KRW1,150 (US$0.80)

 

 

KRW2,847 (US$2.39)

 

Equity method investment – During 2018, the Company and Japan Industrial Partners, Inc., or JIP, formed EJ Holdings, Inc., or EJ Holdings, to acquire, own and operate a shuttered amino acids manufacturing facility in Ube, Japan. In connection with the formation, the Company invested approximately $32,000 in exchange for 40% of EJ Holdings voting shares. JIP owns 60% of EJ

9


 

Holdings voting shares. In October 2018, the Company entered into a loan agreement with EJ Holdings under which the Company made an unsecured loan to EJ Holdings in the amount of $13.2 million. The loan proceeds were used by EJ Holdings to purchase the Ube facility in December 2019 and pay related taxes. The loan matures on September 30, 2028 and bears interest at the annual rate of 1%, payable annually. The parties also contemplated that the Ube facility would eventually supply the Company with the facility’s output of amino acids and that the operation of the facility would be principally for the Company’s benefit and, as such, that major decisions affecting EJ Holdings and the Ube facility would be made by EJ Holdings’ board of directors, a majority of which are representatives of JIP, in consultation with the Company. During the nine months ended September 30, 2022, the Company made an additional $4.2 million of loans to EJ Holdings. As of September 30, 2022, and December 31, 2021, the loans receivable from EJ Holdings were approximately $21.7 million and $22.6 million, respectively, as reflected in equity method investment on the consolidated balance sheets.

EJ Holdings is engaged in retrofitting the Ube facility in order to seek regulatory approvals for the manufacture of PGLG in accordance with cGMP. EJ Holdings has had no substantial revenues since its inception, has depended on loans from the Company to acquire the Ube facility and fund its operations and will continue to be dependent on loans from the Company or other financing unless and until the Ube facility is activated and EJ Holdings can secure customers for its products. There is no assurance the Company will be able to continue to provide loan financing to support EJ Holdings’ activities at the Ube facility or that EJ Holdings will be able to obtain other financing. If EJ Holdings is unable to obtain financing, it may need to seek to sell all or part of the Ube facility. In such event, the Company could lose all or part of its investment.

The Company has determined that EJ Holdings is a variable interest entity, or VIE, based upon its dependence upon loan financing provided by the Company to acquire the Ube facility and fund EJ Holdings’ activities, which are principally for the Company’s benefit. JIP, however, owns 60% of EJ Holdings and is entitled to designate a majority of the directors of EJ Holdings and its Chief Executive Officer and outside auditors, and, as such, controls the management, business, and operations of EJ Holdings. Accordingly, the Company accounts for its variable interest in EJ Holdings under the equity method.

The Company’s share of the loss reported by EJ Holdings are classified as net loss on equity method investment. The investment is evaluated for impairment and if facts and circumstances indicate that the carrying value may not be recoverable, an impairment charge would be recorded.

The following table sets forth certain financial information of EJ Holdings for the three and nine months ended September 30, 2022 and 2021 (in thousands):  

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

(Unaudited)

 

 

(Unaudited)

 

 

(Unaudited)

 

 

(Unaudited)

 

REVENUES, NET

$

46

 

 

$

57

 

 

$

148

 

 

$

174

 

NET LOSS

$

(1,077

)

 

$

(1,657

)

 

$

(3,725

)

 

$

(4,998

)

 

 


10


 

 

NOTE 6 — SELECTED FINANCIAL STATEMENT - LIABILITIES

Accounts payable and accrued expenses consisted of the following at September 30, 2022 and December 31, 2021 (in thousands):

 

 

September 30, 2022

 

 

December 31, 2021

 

Accounts payable:

 

 

 

 

 

 

 

 

Clinical and regulatory expenses

 

$

444

 

 

$

534

 

Professional fees

 

 

579

 

 

 

477

 

Selling expenses

 

 

1,138

 

 

 

932

 

Manufacturing costs

 

 

532

 

 

 

378

 

Non-employee board member compensation

 

 

401

 

 

 

136

 

Other vendors

 

 

313

 

 

 

262

 

Total accounts payable

 

 

3,407

 

 

 

2,719

 

Accrued interest payable, related parties

 

 

325

 

 

 

91

 

Accrued interest payable

 

 

1,673

 

 

 

579

 

Accrued expenses:

 

 

 

 

 

 

 

 

Payroll expenses

 

 

1,196

 

 

 

1,097

 

Government rebates and other rebates

 

 

4,157

 

 

 

4,371

 

Other accrued expenses

 

 

376

 

 

 

332

 

Total accrued expenses

 

 

5,729

 

 

 

5,800

 

Total accounts payable and accrued expenses

 

$

11,134

 

 

 

9,189

 

 

Other current liabilities consisted of the following at September 30, 2022 and December 31, 2021 (in thousands):

 

September 30, 2022

 

 

December 31, 2021

 

Trade discount

$

1,200

 

 

$

3,000

 

Other current liabilities

 

1,070

 

 

 

1,404

 

Total other current liabilities

$

2,270

 

 

$

4,404

 

 

Other long-term liabilities consisted of the following at September 30, 2022 and December 31, 2021 (in thousands):

 

 

September 30, 2022

 

 

December 31, 2021

 

Trade discount

$

22,095

 

 

$

23,148

 

Unearned revenue

 

10,000

 

 

 

10,000

 

Other long-term liabilities

 

27

 

 

 

25

 

Total other long-term liabilities

$

32,122

 

 

$

33,173

 

 

 On June 12, 2017, the Company entered into an API Supply Agreement with Telcon pursuant to which Telcon advanced to the Company approximately $31.8 million as an advance trade discount in consideration of the Company’s agreement to purchase from Telcon the Company’s estimated annual target requirements for bulk containers of PGLG. On July 12, 2017, the Company entered into a raw material supply agreement with Telcon which revised certain items of the API Supply Agreement (the “revised API Agreement”). The Company purchased $523,000 of PGLG from Telcon in the nine months ended September 30, 2022 and purchased $250,000 of PGLG in the nine months ended September 30, 2021 of which $537,000 and $382,000 were reflected in accounts payable as of September 30, 2022 and December 31, 2021, respectively. The revised API Agreement provided for an annual API purchase target of $5 million and a target “profit” (i.e., gross margin) to Telcon of $2.5 million. To the extent these targets are not met, which management refers to as a “target shortfall,” Telcon may be entitled to payment of the target shortfall or to settle the target shortfall by exchange of principal and interest on the Telcon convertible bond and proceeds thereof that are pledged as a collateral to secure the Company’s obligations under the API Supply Agreement and the revised API Agreement. See Note 5 for information regarding the settlement in the nine months ended September 30, 2022 of the target shortfall for 2021 and 2020.

 


11


 

 

NOTE 7 — NOTES PAYABLE

Notes payable consisted of the following at September 30, 2022 and December 31, 2021 (in thousands except for number of underlying shares) excluding the revolving line of credit agreement with related party discussed below:

 

Year

Issued

 

Interest Rate

Range

 

 

Term of Notes

 

Conversion

Price

 

 

Principal

Outstanding September 30, 2022

 

 

Unamortized Discount September 30, 2022

 

 

Carrying

Amount September 30, 2022

 

 

Underlying Shares September 30, 2022

 

 

Notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2013

 

10%

 

 

Due on demand

 

 

 

 

$

692

 

 

$

 

 

$

692

 

 

 

 

 

2021

 

11%

 

 

Due on demand - 2 years

 

 

 

 

 

2,719

 

 

 

 

 

 

2,719

 

 

 

 

 

2022

 

11%-36%

 

 

Due on demand - 7 month

 

 

 

 

 

2,243

 

 

 

19

 

 

 

2,224

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

5,654

 

 

$

19

 

 

$

5,635

 

 

 

 

 

 

 

 

 

 

 

Current

 

 

 

 

 

$

5,654

 

 

$

19

 

 

$

5,635

 

 

 

 

 

Notes payable - related parties

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2020

 

12%

 

 

Due on demand

 

 

 

 

 

100

 

 

 

 

 

 

100

 

 

 

 

 

2021

 

12%

 

 

Due on demand

 

 

 

 

 

700

 

 

 

 

 

 

700

 

 

 

 

 

2022

 

6%-12%

 

 

Due on demand - 5 years

 

 

 

 

 

5,501

 

 

 

135

 

 

 

5,361

 

(c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

6,301

 

 

$

135

 

 

$

6,161

 

 

 

 

 

 

 

 

 

 

 

Current

 

 

 

 

 

$

2,780

 

 

$

 

 

$

2,780

 

 

 

 

 

 

 

 

 

 

 

Non-current

 

 

 

 

 

$

3,521

 

 

$

135

 

 

$

3,381

 

 

 

 

 

Convertible notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2020(a)

 

12%

 

 

3 years

 

$

10.00

 

 

 

3,150

 

 

 

 

 

 

3,150

 

 

 

320,067

 

 

2021(b)

 

2%

 

 

3 years

 

$

0.37

 

 

 

14,315

 

 

 

3,119

 

 

 

11,196

 

 

 

41,112,131

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

17,465

 

 

$

3,119

 

 

$

14,346

 

 

 

41,432,198

 

 

 

 

 

 

 

 

Current

 

 

 

 

 

$

17,465

 

 

$

3,119

 

 

$

14,346

 

 

 

41,432,198

 

 

 

 

 

 

 

 

Total

 

 

 

 

 

$

29,421

 

 

$

3,273

 

 

$

26,143

 

 

 

41,432,198

 

 

 

Year

Issued

 

Interest Rate

Range

 

 

Term of Notes

 

Conversion

Price

 

 

Principal

Outstanding

December 31,

2021

 

 

Unamortized

Discount

December 31,

2021

 

 

Carrying

Amount

December 31,

2021

 

 

Underlying Shares

December 31, 2021

 

 

Notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2013

 

10%

 

 

Due on demand

 

 

 

 

$

869

 

 

$

 

 

$

869

 

 

 

 

 

2021

 

11%

 

 

Due on demand - 2 years

 

 

 

 

 

3,030

 

 

 

 

 

 

3,030

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

3,899

 

 

$

 

 

$

3,899

 

 

 

 

 

 

 

 

 

 

 

Current

 

 

 

 

 

$

2,399

 

 

$

 

 

$

2,399

 

 

 

 

 

 

 

 

 

 

 

Non-current

 

 

 

 

 

$

1,500

 

 

$

 

 

$

1,500

 

 

 

 

 

Notes payable - related parties

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2020

 

12%

 

 

Due on demand

 

 

 

 

$

100

 

 

$

 

 

$

100

 

 

 

 

 

2021

 

12%

 

 

Due on demand

 

 

 

 

 

700

 

 

 

 

 

 

700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

800

 

 

$

 

 

$

800

 

 

 

 

 

 

 

 

 

 

 

Current

 

 

 

 

 

$

800

 

 

$

 

 

$

800

 

 

 

 

 

Convertible notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2020(a)

 

12%

 

 

3 years

 

$

10.00

 

 

 

3,150

 

 

 

 

 

 

3,150

 

 

 

316,756

 

 

2021(b)

 

2%

 

 

3 years

 

$

1.48

 

 

 

14,490

 

 

 

4,332

 

 

 

10,158

 

 

 

9,856,343

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

17,640

 

 

$

4,332

 

 

$

13,308

 

 

 

10,173,099

 

 

 

 

 

 

 

 

Current

 

 

 

 

 

$

14,490

 

 

$

4,332

 

 

$

10,158

 

 

 

9,856,343

 

 

 

 

 

 

 

 

Non-current

 

 

 

 

 

$

3,150

 

 

$

 

 

$

3,150

 

 

 

316,756

 

 

 

 

 

 

 

 

Total

 

 

 

 

 

$

22,339

 

 

$

4,332

 

 

$

18,007

 

 

$

10,173,099

 

 

 

 

(a)

This note is convertible into shares of EMI Holding, Inc., a wholly owned subsidiary of Emmaus Life Sciences, Inc.

 

(b)

The notes are convertible into shares of common stock of Emmaus Life Sciences, Inc. Beginning February 28, 2022, the note holders became entitled to call for redemption of the convertible notes payable at any time. Accordingly, the notes are classified as current liabilities.

 

(c)

Includes $41,000 of the fair value of embedded derivative.

12


 

 

The weighted-average stated annual interest rate of notes payable was 7% and 6% as of September 30, 2022 and December 31, 2021, respectively. The weighted-average effective annual interest rate of notes payable as of September 30, 2022 and December 31, 2021 was 19% and 15%, respectively, after giving effect to discounts relating to conversion features, warrants and deferred financing costs relating to the notes.

As of September 30, 2022, future contractual principal payments due on notes payable were as follows (in thousands):

 

Year Ending

 

 

 

 

2022 (three months)

$

25,900

 

(a)

2025

 

1,200

 

 

2027

 

2,321

 

 

Total

$

29,421

 

 

 

(a)

Includes $14.3 million principal amount of convertible notes subject to redemption at any time at the election of the holders.

 

The Company is party to a revolving line of credit agreement with Yutaka Niihara, M.D., M.P.H., the Company’s Chairman and Chief Executive Officer. Under the agreement, at the Company’s request from time to time Dr. Niihara may, but is not obligated to, loan or re-loan to the Company up to $1,000,000. Outstanding amounts under the agreement are due and payable upon demand and bear interest, payable monthly, at a variable annual rate equal to the Prime Rate in effect from time to time plus 3%. In addition to the payment of interest, the Company is obligated to pay Dr. Niihara a “tax gross-up” intended to make him whole for federal and state income and employment taxes payable by him with respect to interest and tax gross-up paid to him in the previous year. As of September 30, 2022 and December 31, 2021, the outstanding principal balance under the agreement of $400,000 was reflected in revolving line of credit from related party on the condensed consolidated balance sheets. With the tax-gross up, the effective interest rate on the outstanding balance as of September 30, 2022, was 10.4%. The revolving line of credit agreement will expire on November 22, 2022. Refer to Note 12 for more information on related party transactions.

On February 9, 2021, the Company entered into a securities purchase agreement pursuant to which the Company agreed to sell and issue to the purchasers thereunder in a private placement pursuant to Rule 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D thereunder a total of up to $17 million in principal amount of convertible promissory notes of the Company for a purchase price equal to the principal amount thereof. The Company sold and issued approximately $14.5 million of the convertible promissory notes.

Commencing one year from the original issue date, the convertible promissory notes became convertible at the option of the holder into shares of the Company’s common stock at an initial conversion price of $1.48 per share, which equaled the “Average VWAP” (as defined) of the Company’s common stock on the effective date. The initial conversion price is subject to adjustment as of the end of each three-month period commencing May 31, 2021, to equal the Average VWAP as of the end of such three-month period if such Average VWAP is less than the then-conversion price. There is no floor on the conversion price. The conversion price will be subject to further adjustment in the event of a stock split, reverse stock split or certain other events specified in the convertible promissory notes. As of September 30, 2022, the conversion price was $0.37 per share.

The convertible promissory notes bear interest at the stated rate of 2% per year (10% in the event of a default), payable semi-annually on the last business day of August and January of each year and will mature on the 3rd anniversary of the original issue date, unless earlier converted or prepaid. The convertible promissory notes are redeemable in whole or in part at the election of the holders. The Company is entitled to prepay up to 50% of the principal amount of the convertible promissory notes at any time on or before February 28, 2023 for a prepayment amount equal to the principal amount being prepaid, accrued and unpaid interest thereon and a prepayment premium equal to 50% of such principal amount. The convertible promissory notes are general, unsecured obligations of the Company.

The conversion feature of the convertible promissory notes is separately accounted for at fair value as a derivative liability under guidance in ASC 815 that is remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value of the conversion feature liability recorded in the condensed consolidated statements of operations. The following table sets forth the fair value of the conversion feature liability as of September 30, 2022 and December 31, 2021 (in thousands):

 

Convertible promissory notes

 

September 30, 2022

 

 

December 31, 2021

 

Balance, beginning of period

 

$

7,507

 

 

$

 

Fair value at issuance date

 

 

 

 

 

5,594

 

Change in fair value included in the statement of operations

 

 

(3,235

)

 

 

1,913

 

Balance, end of period

 

$

4,272

 

 

$

7,507

 

 

13


 

 

The fair value and any change in fair value of conversion feature liability are determined using a binominal lattice model. The model produces an estimated fair value based on changes in the price of the underlying common stock.

The fair value as of September 30, 2022 and December 31, 2021was based upon following assumptions:

Convertible promissory notes

 

September 30, 2022

 

 

December 31, 2021

 

Stock price

 

$

0.17

 

 

$

1.67

 

Conversion price

 

$

0.37

 

 

$

1.48

 

Selected yield

 

 

30.93

%

 

 

21.99

%

Expected volatility

 

 

50

%

 

 

50

%

Time until maturity (in years)

 

 

1.41

 

 

 

2.16

 

Dividend yield

 

 

 

 

Risk-free rate

 

 

4.12

%

 

 

0.77

%

 

In June 2022, the Company entered into a Business Loan and Security Agreement and Addenda with a third-party lender pursuant to which the lender loaned the Company $1,800,000, which we refer to as the “loan amount,” of which we received net proceeds of approximately $1,666,000 after deduction of the lender’s origination fee but without deduction for other transaction expenses. The loan amount, together with interest of $738,000, was payable over the 40-week loan term in weekly installments of $31,725 for the first eight weeks and $71,381 for the remaining 32 weeks. The loan amount and interest were prepayable by the Company at any time within 90 days from the disbursement date for a repayment amount of $2,250,000, less all prior payments on the loan, unless an event of default has occurred under the Business Loan and Security Agreement. Repayment of the loan was secured by a security interest in all or substantially all our assets and all assets of our U.S. subsidiaries and was personally guaranteed by Yutaka Niihara, M.D., M.P.H., our Chairman and Chief Executive Officer and principal stockholder, and his wife and Hope Hospice International, Inc., which is wholly owned by Dr. Niihara and his wife. The personal guarantee was secured by a deed of trust on certain real property of Dr. Niihara and his wife. In August 2022, the Company repaid in full $1.6 million principal of the outstanding balance of the loan and recognized debt extinguishment loss of $421,000.

 

In July 2022, Dr. Niihara and his wife loaned the Company $370,000, representing the net proceeds of personal loans to them from unaffiliated parties in the principal amount of $402,000. The loan is due and payable in a lump sum on maturity on July 31, 2027 and bears interest at the rate of 12% per annum, payable monthly in arrears. In connection with the loan, the Company granted Dr. Niihara a warrant as described in Note 8. The issuance cost of $32,000 and the fair value of warrant of $84,000 were treated as debt discount and will be amortized over the five-year term of the warrant using effective interest method. .

 

In August 2022, Dr. Niihara and his wife loaned the Company $1,576,574, representing the net proceeds of personal loans to them from unaffiliated third parties in the principal amount of $1,668,751, as well as $250,000 from personal funds. The loans are evidenced by promissory notes, which are due and payable in a lump sum on maturity on August 16, 2027 and bear interest at the rate of 10% per annum, payable monthly in arrears. The foregoing loans were in addition to a $50,000 loan to us from Hope International Hospice, Inc., an affiliate of Dr. and Mrs. Niihara, on August 15, 2022, which is evidenced by a demand promissory note of the Company bearing interest at the rate of 10% per annum. The proceeds of the loans were used to prepay $1,924,819 indebtedness of the Company under the Business Loan and Security Agreement referred to above.

 

In September 2022, Seah Lim, M.D., Ph.D. loaned the Company $1.2 million, the proceeds of which were used to augment the Company’s working capital. The principal amount of the loan and interest thereon at the rate of 6% per annum, together with 240,000 shares of the Company’s common stock, is due and payable in lump sum on maturity in September 2025. In October 2022, Dr. Lim was appointed as a director of the Company. In accordance with ACS 835, the Company accounted the right to receive shares as the bifurcated embedded derivative and the embedded derivative is measured at fair value at the inception and subsequently measured at fair value with changes in fair value recognized in income statements. The fair values of the embedded derivatives at the inception were $68,000 at inception and $41,000 as of September 30, 2022.

 

In July 2022, Emmaus Medical, Inc., or Emmaus Medical, an indirect wholly owned subsidiary of the Company, entered into a Standard Merchant Cash Advance Agreement with a third party pursuant to which it sold $816,000 of accounts receivable (the “Receivables Purchased Amount”) in exchange for net proceeds of $516,000. Under the agreement, the third party is entitled to collect a specified percentage of all accounts receivable of Emmaus Medical, not to exceed $34,000 weekly, until the third party receives total proceeds equal to the Receivables Purchased Amount. In September 2022, Emmaus Medical and the third party entered into a similar agreement pursuant to which Emmaus Medical sold $694,960 of accounts receivable (the “Receivables Purchased Amount”) for net proceeds of $500,000. Under the agreement, the third party is entitled to collect a specified percentage of all accounts receivable of Emmaus Medical, not to exceed $25,969 weekly, until the third party receives total proceeds equal to the Receivables Purchased Amount. Emmaus Medical’s obligations under the two agreements are guaranteed by the Emmaus Life Sciences, Inc. Company and its U.S. subsidiaries, and the obligations of Emmaus Medical and the guarantors are secured by a security interest in all or substantially all the assets of Emmaus Life Sciences and its U.S. subsidiaries.

14


 

NOTE 8 — STOCKHOLDERS’ DEFICIT

Extension of Convertible Promissory Note - On June 15, 2020, the holder of a convertible promissory note in the principal amount of $3,150,000 agreed to an extension of the maturity date of the convertible promissory note to June 15, 2023 in exchange for an increase in the interest rate on the note from 11% to 12%. In conjunction with the extension, the Company issued to the note holder a five-year warrant to purchase up to 1,250,000 shares (500,000 shares if the related convertible promissory note was repaid by June 15, 2022) of the Company common stock at an exercise price of $2.05 a share. Under ASC 815-40, the warrant is recognized at fair value as a liability. The warrant liability is remeasured at fair value on a recurring basis using Level 3 input and any change in the fair value of liability is recorded in earnings. Since the loan was not repaid before June 15, 2022, the number of warrant shares became fixed per the warrant terms and the warrant was reclassified as equity.

The following table presents the fair value and the change in fair value of the warrants as of June 15, 2022 and December 31, 2020 (in thousands):

Warrant liability—Convertible Promissory Note

 

June 15, 2022

 

 

December 31, 2021

 

Balance, beginning of period

 

$

1,463

 

 

$

988

 

Change in fair value included in the statement of operations

 

 

(1,250

)

 

 

475

 

Reclassification to equity

 

 

(213

)

 

 

 

Balance, end of period

 

$

 

 

$

1,463

 

 

The fair value of the warrant derivative liability was determined using the Black-Scholes Merton model based upon following assumptions:

 

 

 

June 15, 2022

 

 

December 31, 2021

 

Exercise price

 

$

2.05

 

 

$

2.05

 

Stock price

 

$

0.36

 

 

$

1.67

 

Risk‑free interest rate

 

 

3.35

%

 

 

1.04

%

Expected volatility (peer group)

 

 

126.00

%

 

 

117.00

%

Expected life (in years)

 

 

3.00

 

 

 

3.46

 

Expected dividend yield

 

 

 

 

Number outstanding

 

 

1,250,000

 

 

 

1,250,000

 

 

A summary of outstanding warrants as of September 30, 2022 and December 31, 2021 is presented below:

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

Number of

Warrants

 

 

Weighted‑

Average

Exercise

Price

 

 

Number of

Warrants

 

 

Weighted‑

Average

Exercise

Price

 

Warrants outstanding, beginning of period

 

 

8,236,017

 

 

$

5.78

 

 

 

8,439,480

 

 

$

6.09

 

Granted

 

 

500,000

 

 

$

2.50

 

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cancelled, forfeited or expired

 

 

(2,125,497

)

 

$

14.38

 

 

 

(203,463

)

 

$

4.36

 

Warrants outstanding, end of period

 

 

6,610,520

 

 

$

2.88

 

 

 

8,236,017

 

 

$

5.78

 

Warrants exercisable end of period

 

 

6,610,520

 

 

$

2.88

 

 

 

7,486,017

 

 

$

6.12

 

 

Warrants —In September 2022, in connection with the loans from Dr. Niihara and Mrs. Niihara, the Company granted Dr. Niihara a five-year warrant to purchase up to 500,000 shares of common stock of the Company at an exercise price of $2.50 per share. Under ASC 480-10 and ASC 815, the warrant is classified as a liability. The fair value of the warrant liability was determined using Black-Scholes Merton model and the fair value of the warrant was $33,000 as of September 30, 2022. The change in fair value was recorded in the condensed consolidated statements of operations. For three month ended September 30, 2022, the change in fair value of warrant liability was $51,000.

 

As of September 30, 2022, the weighted-average remaining contractual life of outstanding warrants was 2.3 years.

15


 

Stock options—The Company’s former Amended and Restated 2011 Stock Incentive Plan expired on May 3, 2021, and no further awards may be made under the 2011 Plan. The expiration of the 2011 Plan did not affect outstanding stock awards thereunder.

The Company also previously maintained an Amended and Restated 2012 Omnibus Incentive Compensation Plan, which was terminated in September 2021 in connection with the adoption of the 2021 Stock Incentive Plan described below.

On September 29, 2021, the Board of Directors of the Company adopted the Emmaus Life Sciences, Inc. 2021 Stock Incentive Plan upon the recommendation of the Compensation Committee of the Board. The 2021 Stock Incentive Plan was approved by stockholders on November 23, 2021. No more than 4,000,000 shares of common stock may be issued pursuant to awards under the 2021 Stock Incentive Plan. The number of shares available for Awards and the terms of outstanding awards are subject to adjustment for stock splits, stock dividends, reverse stock splits, recapitalizations and other similar events. As of September 30, 2022 and December 31, 2021, no awards were outstanding under the 2021 Stock Incentive Plan.   

A summary of outstanding stock options as of September 30, 2022 and December 31, 2021 is presented below.

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

Number of

Options

 

 

Weighted‑

Average

Exercise

Price

 

 

Number of

Options

 

 

Weighted‑

Average

Exercise

Price

 

Options outstanding, beginning of period

 

 

5,968,338

 

 

$

4.78

 

 

 

7,110,025

 

 

$

4.63

 

Granted or deemed granted

 

 

 

 

$

 

 

 

 

 

$

 

Exercised

 

 

 

 

$

 

 

 

 

 

$

 

Cancelled, forfeited and expired

 

 

(1,055,399

)

 

$

3.45

 

 

 

(1,141,687

)

 

$

3.82

 

Options outstanding, end of period

 

 

4,912,939

 

 

$

5.07

 

 

 

5,968,338

 

 

$

4.78

 

Options exercisable, end of period

 

 

4,894,938

 

 

$

5.09

 

 

 

5,937,837

 

 

$

4.80

 

Options available for future grant

 

 

4,000,000

 

 

 

 

 

 

 

4,000,000

 

 

 

 

 

 

During the three months ended September 30, 2022 and September 30, 2021, the Company recognized $3,000 and $93,000, respectively of share-based compensation expense. During the nine months ended September 30, 2022 and September 30, 2021 the Company recognized $13,000 and $548,000, respectively, of share-based compensation expense. As of September 30, 2022, there was approximately $8,000 of unrecognized share-based compensation expense related to unvested stock options which is expected to be recognized over the weighted-average remaining vesting period of 0.7 year.

Collaborative Research and Development Agreement with Kainos Medicine, IncOn February 26, 2021, the Company entered into a collaborative research and development agreement with Kainos Medicine, Inc. (“Kainos”) to lead the preclinical development of Kainos’ patented IRAK4 inhibitor (“KM10544”) as an anti-cancer drug and further advance Kainos’s research and development activities. The companies also entered into a letter of intent regarding possible future joint development of small molecule therapeutics and other pharmaceutical assets.

Pursuant to the collaborative research and development agreement, the Company paid and issued to Kainos $500,000 in cash and 324,675 shares of common stock of the Company equivalent to $500,000 in additional consideration, which amounts were recorded as research and development expenses in the statement of operations and comprehensive income (loss) for each of the periods ended September 30, 2021. The Company, in turn, was granted rights of first negotiation and first refusal for an exclusive license regarding the development and commercialization of products based on the intellectual property resulting from the agreement.

 

On October 7, 2021, the Company entered into a license agreement with Kainos under which Kainos granted the Company an exclusive license in the territory encompassing the U.S., the U.K. and the EU to patent rights, know-how and other intellectual property relating to Kainos’s novel IRAK4 inhibitor, referred to as KM10544, for the treatment of cancers, including leukemia, lymphoma and solid tumor cancers. In consideration of the license, the Company paid Kainos a six-figure upfront fee in cash and agreed to make additional cash payments upon the achievement of specified milestones totaling in the mid-eight figures and pay a single-digit percentage royalty based on net sales of the licensed products and a similar percentage of any sublicensing consideration.

 

During the nine months ended September 30, 2021, the Company incurred $1.0 million of research and development expenses related to the Kainos collaboration and license agreement. The Company incurred no such expenses in the nine months ended September 30, 2022.

Amended and Restated Warrants The Company evaluated its outstanding amended and restated warrants to purchase up to 4,038,200 shares of common stock under ASC 815-40 and concluded that the warrants should be accounted for as equity.

16


 

In June 2022, the exercise price of outstanding amended and restated warrants was reduced to $0.446 per share pursuant to the anti-dilution adjustment provisions of the warrants triggered by the Company’s issuance of restricted shares of common stock for professional relations and consulting services discussed below. The warrants were valued using the Black-Scholes Merton model and the $446,000 change in fair value was recorded as additional paid-in capital and accumulated deficit.

Stock issued for services – In June 2022, the Company issued 246,637 shares of restricted share of common stock, with an estimated fair value of $110,000 for professional relations and consulting services to be rendered over the six-month period beginning July 1, 2022. The value of the shares issued in connection with this agreement was recorded in prepaid expenses and other current assets in the condensed consolidated balance sheet as of September 30, 2022 and is being amortized over the six-month period beginning July 1, 2022.

NOTE 9 — INCOME TAX

The quarterly provision for or benefit from income taxes is computed based upon the estimated annual effective tax rate and the year-to-date pre-tax income (loss) and other comprehensive income.

 

For the three and nine months ended September 30, 2022, the Company recorded an income tax benefit of $35,000 and provision of $44,000, respectively. For three and nine month ended September 30, 2021, the Company recorded an income tax provision of $232,000 and $58,000, respectively. The Company did not record a provision for federal income tax due to its net operating loss carryforwards. The Company established a full valuation allowance against its federal and state deferred tax asset and there was no unrecognized tax benefit as of September 30, 2022 or September 30, 2021.  

NOTE 10 — LEASES

Operating leases — The Company leases its office space under operating leases with unrelated entities.

The Company leases 21,293 square feet of office space for our headquarters in Torrance, California, at a base rental of $80,886 per month, which lease will expire on September 30, 2026. In addition, the Company leases 1,163 square feet of office space in Dubai, United Arb Emirates, which lease will expire on June 19, 2023. During nine month ended September 30, 2020, the Company terminated leases of office space in New York, New York and Tokyo, Japan. Upon termination of New York lease, the Company recognized $31,000 of loss on leased assets.

The rent expense during the three months ended September 30, 2022 and 2021 was approximately $272000 and $300,000, respectively, and during the nine months ended September 30, 2022 and September 30, 2021 was approximately $868,000 and $889,000, respectively.

Future minimum lease payments under the lease agreements were as follows as of September 30, 2022 (in thousands):

 

 

 

Amount

 

2022 (three months)

 

$

263

 

2023

 

 

1,049

 

2024

 

 

1,063

 

2025

 

 

1,092

 

2026

 

 

836

 

Total lease payments

 

 

4,303

 

Less: Interest

 

 

887

 

Present value of lease liabilities

 

$

3,416

 

As of September 30, 2022, the Company had an operating lease right-of-use asset of $2.9 million and lease liability of $3.4 million reflected on the condensed consolidated balance sheet. The weighted average remaining term of the Company’s leases as of September 30, 2022 was 4.0 years and the weighted-average discount rate was 12.9%.

17


 

NOTE 11 — COMMITMENTS AND CONTINGENCIES

API Supply Agreement — On June 12, 2017, the Company entered into an API Supply Agreement (the “API Supply Agreement”) with Telcon pursuant to which Telcon paid the Company approximately $31.8 million in consideration of the right to supply 25% of the Company’s requirements for bulk containers of PGLG for a fifteen-year term. The amount was recorded as deferred trade discount. On July 12, 2017, the Company entered into a raw material supply agreement with Telcon which revised certain terms of the API Supply Agreement (the “revised API Agreement”). The revised API Agreement is effective for a term of five years and will renew automatically for ten successive one-year renewal periods, except as either party may determine. In the revised API agreement, the Company has agreed to purchase a cumulative total of $47.0 million, over the term of the agreement. The revised API Agreement provided for an annual API purchase target of $5 million and a target “profit” (i.e., gross margin) to Telcon of $2.5 million. To the extent these targets are not met, which management refers to as a “target shortfall,” Telcon may be entitled to payment of the target shortfall or to settle the target shortfall by exchange of principal and interest on the Telcon convertible bond and proceeds thereof that are pledged as a collateral to secure the Company’s obligations under the API Supply Agreement and the revised API Agreement. In September 2018, the Company entered into an agreement with Ajinomoto Health and Nutrition North America, Inc. (“Ajinomoto”), the producer of the PGLG, and Telcon to facilitate Telcon’s purchase of PGLG from Ajinomoto for resale to the Company under the revised API Agreement. The PGLG raw material purchased from Telcon is recorded in inventory at net realized value and the excess purchase price is recorded against deferred trade discount. Refer to Notes 5 and 6 for more information.

18


 

NOTE 12 — RELATED PARTY TRANSACTIONS

The following table sets forth information relating to loans from related parties outstanding at any time during the nine months ended September 30, 2022 (in thousands):

 

Class

Lender

 

Interest

Rate

 

 

Date of

Loan

 

Term of Loan

 

Principal Amount Outstanding at September 30, 2022

 

 

Highest

Principal

Outstanding

 

 

Amount of

Principal

Repaid

 

 

Amount of

Interest

Paid

 

 

Promissory note payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Willis Lee(2)

 

12%

 

 

10/29/2020

 

Due on Demand

 

 

100

 

 

 

100

 

 

 

 

 

 

 

 

 

Soomi Niihara(1)

 

12%

 

 

12/7/2021

 

Due on Demand

 

 

700

 

 

 

700

 

 

 

 

 

 

 

 

 

Soomi Niihara(1)

 

12%

 

 

1/18/2022

 

Due on Demand

 

 

300

 

 

 

300

 

 

 

 

 

 

 

 

 

Yasushi Nagasaki(2)

 

10%

 

 

2/9/2022

 

Due on Demand

 

 

50

 

 

 

50

 

 

 

 

 

 

 

 

 

Hope International Hospice, Inc.(1)

 

10%

 

 

2/9/2022

 

Due on Demand

 

 

350

 

 

 

350

 

 

 

 

 

 

 

 

 

Hope International Hospice, Inc.(1)

 

10%

 

 

2/15/2022

 

Due on Demand

 

 

210

 

 

 

210

 

 

 

 

 

 

 

 

 

Soomi Niihara(1)

 

10%

 

 

2/15/2022

 

Due on Demand

 

 

100

 

 

 

100

 

 

 

 

 

 

 

 

 

George Sekulich(2)

 

10%

 

 

2/16/2022

 

Due on Demand

 

 

26

 

 

 

26

 

 

 

 

 

 

 

 

 

Soomi Niihara(1)

 

10%

 

 

3/7/2022

 

Due on Demand

 

 

200

 

 

 

200

 

 

 

 

 

 

 

 

 

Hope International Hospice, Inc.(1)

 

12%

 

 

3/15/2022

 

Due on Demand

 

 

150

 

 

 

150

 

 

 

 

 

 

 

 

 

Hope International Hospice, Inc.(1)

 

12%

 

 

3/30/2022

 

Due on Demand

 

 

150

 

 

 

150

 

 

 

 

 

 

 

 

 

Wei Pei Derek Zen(2)

 

10%

 

 

3/31/2022

 

Due on Demand

 

 

200

 

 

 

200

 

 

 

 

 

 

 

 

 

Willis Lee(2)

 

10%

 

 

4/14/2022

 

Due on Demand

 

 

45

 

 

 

45

 

 

 

 

 

 

 

 

 

Hope International Hospice, Inc.(1)

 

10%

 

 

5/25/2022

 

Due on Demand

 

 

40

 

 

 

40

 

 

 

 

 

 

 

 

 

Yutaka and Soomi Niihara(1)

 

12%

 

 

7/27/2022

 

5 years

 

 

402

 

 

 

402

 

 

 

 

 

 

8

 

 

 

Hope International Hospice, Inc.(1)

 

10%

 

 

8/15/2022

 

Due on Demand

 

 

50

 

 

 

50

 

 

 

 

 

 

 

 

 

Yutaka and Soomi Niihara(1)

 

10%

 

 

8/16/2022

 

5 years

 

 

250

 

 

 

250

 

 

 

 

 

 

2

 

 

 

Yutaka and Soomi Niihara(1)

 

10%

 

 

8/16/2022

 

5 years

 

 

1,669

 

 

 

1,669

 

 

 

 

 

 

14

 

 

 

Hope International Hospice, Inc.(1)

 

10%

 

 

8/17/2022

 

Due on Demand

 

 

50

 

 

 

50

 

 

 

 

 

 

 

 

 

Yutaka and Soomi Niihara(1)

 

10%

 

 

8/17/2022

 

Due on Demand

 

 

60

 

 

 

60

 

 

 

 

 

 

 

 

 

Seah Lim(2)

 

6%

 

 

9/16/2022

 

3 years

 

 

1,200

 

 

 

1,200

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Subtotal

 

$

6,302

 

 

$

6,302

 

 

$

 

 

$

24

 

 

Revolving line of credit agreement

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yutaka Niihara(2)

 

5.25% (3)

 

 

12/27/2019

 

Due on Demand

 

 

400

 

 

 

400

 

 

 

 

 

 

16

 

 

 

 

 

 

 

 

 

 

 

Subtotal

 

 

400

 

 

 

400

 

 

 

 

 

 

16

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

6,702

 

 

$

6,702

 

 

$

 

 

$

40

 

 

 

19


 

 

The following table sets forth information relating to loans from related parties outstanding at any time during the year ended December 31, 2021:

 

Class

Lender

 

Interest

Rate

 

 

Date of

Loan

 

Term of Loan

 

Principal Amount Outstanding at December 31, 2021

 

 

Highest

Principal

Outstanding

 

 

Amount of

Principal

Repaid

 

 

Amount of

Interest

Paid

 

 

Promissory note payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Willis Lee(2)

 

12%

 

 

10/29/2020

 

Due on Demand

 

$

100

 

 

$

100

 

 

$

 

 

$

 

 

 

Soomi Niihara(1)

 

12%

 

 

1/20/2021

 

Due on Demand

 

 

 

 

 

700

 

 

 

700

 

 

 

13

 

 

 

Soomi Niihara(1)

 

12%

 

 

9/15/2021

 

Due on Demand

 

 

 

 

 

300

 

 

 

300

 

 

 

3

 

 

 

Soomi Niihara(1)

 

12%

 

 

12/7/2021

 

Due on Demand

 

 

700

 

 

 

700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Subtotal

 

$

800

 

 

$

1,800

 

 

$

1,000

 

 

$

16

 

 

Revolving line of credit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yutaka Niihara(1)

 

5.25%(3)

 

 

12/27/2019

 

Due on Demand

 

 

400

 

 

 

800

 

 

 

400

 

 

 

35

 

 

 

 

 

 

 

 

 

 

 

Subtotal

 

 

400

 

 

 

800

 

 

 

400

 

 

 

35

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

1,200

 

 

$

2,600

 

 

$

1,400

 

 

$

51

 

 

 

(1)

Dr. Niihara, a Director and the Chairman, and Chief Executive Officer of the Company, is also a director and the Chief Executive Officer of Hope International Hospice, Inc.

(2)

Officer or director.

(3)The rate varies with changes in the prime rate and does not give effect to the “tax gross-up” described in Note 7.

 

See Note 7 for a discussion of the Company’s revolving line of credit agreement with Dr. Niihara and Note 13 for information regarding recent related party loans.

Notes 6 and 11 for a discussion of the Company’s agreements with Telcon, which holds 4,147,491 shares of the Emmaus common stock, or approximately 8.4% of the common stock outstanding as of September 30, 2022. As of September 30, 2022, the Company held a Telcon convertible bond in the principal amount of approximately $18.4 million as discussed in Note 5.

NOTE 13 — SUBSEQUENT EVENTS

 

Subsequent to September 30, 2022, the Company redeemed $175,000 principal amount of its outstanding convertible promissory notes.

 

 

 

20


 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

In the following discussion, the terms, “we,” “us,” “our,” “Emmaus” or the “Company” refer to Emmaus Life Sciences, Inc. and its direct and indirect subsidiaries.

Forward-Looking Statements

This Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (“SEC”) on March 31, 2022 (the “Annual Report”).

This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. All statements other than historical facts contained in this report, including statements regarding our future financial position, capital expenditures, cash flows, business strategy and plans and objectives of management for future operations are forward-looking statements. The words “anticipate,” “believe,” “expect,” “plan,” “intend,” “seek,” “estimate,” “project,” “could,” “may” and similar expressions are intended to identify forward-looking statements. These statements include, among others, information regarding future operations, future capital expenditures, and future net cash flow. Such statements reflect our management’s current views with respect to future events and financial performance and involve risks and uncertainties, including those set forth in the “Risk Factors” section of the Annual Report, many of which are beyond our control.

Should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated or otherwise indicated. Consequently, all forward-looking statements made in this Form 10-Q are qualified by these cautionary statements. We undertake no duty to amend or update these statements beyond what is required by SEC reporting requirements.

Company Overview

We are a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, primarily for rare and orphan diseases. Our lead product, Endari® (prescription-grade L-glutamine oral powder) is approved by the U.S. Food and Drug Administration, or FDA, to reduce the acute complications of sickle cell disease (“SCD”), in adult and pediatric patients five years of age and older. In April 2022, Endari® was approved by the Ministry of Health and Prevention in the United Arab Emirates, or U.A.E, in adults and pediatric patients five years of age and older. The approval of Endari® in the U.A.E. was the first granted outside the U.S. Applications for marketing authorization are pending in the Kingdom of Saudi Arabia, Bahrain, and other Gulf Cooperation Council, or GCC, countries, as well. While the applications are pending, the FDA approval of Endari® can be referenced to allow access to Endari® on a named-patient basis.

Endari® is marketed and sold in the U.S. by our internal commercial sales team. Endari® is reimbursable by the Centers for Medicare and Medicaid Services, and every state provides coverage for Endari® for outpatient prescriptions to all eligible Medicaid enrollees within their state Medicaid programs. Endari® is also reimbursable by many commercial payors. We have agreements in place with the nation’s leading distributors as well as physician group purchasing organizations and pharmacy benefits managers, making Endari® available at selected retail and specialty pharmacies nationwide. In April 2022 we launched a telehealth solution to afford SCD patients’ direct access to Endari® remotely through a web portal managed by our strategic partners, including Asembia LLC, US Bioservices Corporation and UpScript IP Holdings, LLC.

As of September 30, 2022, our accumulated deficit was $252.6 million and we had cash and cash equivalents of $1.2 million. We expect net revenues to increase as we expand our commercialization of Endari® in the U.S. and begin to realize revenues in the U.A.E. and perhaps other GCC countries. Until we can generate sufficient net revenues from Endari® sales, our future cash requirements are expected to be financed through public or private sales of equity or debt securities and loans, including loans from related parties, or possible corporate collaboration and licensing arrangements. We are unable to predict if or when we will become profitable.

Financial Overview

Revenues, net

We realize net revenues primarily from sales of Endari® to our distributors and specialty pharmacy providers. Distributors resell our products to other pharmacy and specialty pharmacy providers, health care providers, hospitals, and clinics. In addition to agreements with these distributors, we have contractual arrangements with specialty pharmacy providers, in-office dispensing providers, physician group purchasing organizations, pharmacy benefits managers and government entities that provide for government-mandated or privately negotiated rebates, chargebacks and discounts with respect to the purchase of our products. These

21


 

various discounts, rebates, and chargebacks are referred to as “variable consideration.Revenue from product sales is recorded net of variable consideration.

Management estimates variable consideration using the expected-value amount method, which is the sum of probability-weighted amounts in a range of possible transaction prices. Actual variable consideration may differ from our estimates. If actual results vary from the estimates, we adjust the variable consideration in the period such variances become known, which adjustments are reflected in net revenues in that period. The following are our significant categories of variable consideration:

Under the Accounting Standards Codification (“ASC”) 606, we recognize revenue when our customers obtain control of our product, which typically occurs on delivery. Revenue is recognized in an amount that reflects the consideration that we expect to receive in exchange for the product, or transaction price. To determine revenue recognition for contracts with customers within the scope of ASC 606, we perform the following: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to our performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the relevant performance obligations.

Sales Discounts: We provide our customers prompt payment discounts and from time to time offer additional discounts to encourage bulk orders to generate needed working capital. Sales attributable to bulk discounts offered by us increased in 2021 and adversely affected sales in the first quarter of 2022.

Product Returns: We offer our distributors a right to return product principally based upon (i) overstocks, (ii) inactive product or non-moving product due to market conditions, and (iii) expired product. Product return allowances are estimated and recorded at the time of sale.

Government Rebates: We are subject to discount obligations under state Medicaid programs and the Medicare Part D prescription drug coverage gap program. We estimate Medicaid and Medicare Part D prescription drug coverage gap rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenues are recognized, resulting in a reduction of product revenues and the establishment of a current liability that is included as accounts payable and accrued expenses on our balance sheet. Our liability for these rebates consists primarily of estimates of claims expected to be received in future periods related to recognized revenues.

Chargebacks and Discounts: Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to certain specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities at prices lower than the list prices charged to distributors.  The distributors charge us for the difference between what they pay for the products and our contracted selling price to these specialty pharmacy providers, in-office dispensing providers, group purchasing organizations, and government entities. In addition, we have contractual agreements with pharmacy benefit managers who charge us for rebates and administrative fee in connection with the utilization of product. These reserves are established in the same period that the related revenues are recognized, resulting in a reduction of revenues. Chargeback amounts are generally determined at the time of resale of product by our distributors.

Cost of Goods Sold

Cost of goods sold consists primarily of expenses for raw materials, packaging, shipping, and distribution of Endari®.

Research and Development Expenses

Research and development expenses consist of expenditures for new products and technologies consisting primarily of fees paid to contract research organizations (“CRO”) that conduct clinical trials of our product candidates, payroll-related expenses, study site payments, consultant fees and activities related to regulatory filings, manufacturing development costs and other related costs. The costs of later-stage clinical studies such as Phase 2 and 3 trials are generally higher than those of earlier studies. This is primarily due to the larger size, expanded scope, patient related healthcare and regulatory compliance costs, and generally longer duration of later-stage clinical studies.

Our contracts with CROs are generally based on time and materials expended, whereas study site agreements are generally based on costs per patient as well as other pass-through costs, including start-up costs and institutional review board fees. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones.

Future research and development expenses will depend on any new product candidates or technologies that we may introduce into our research and development pipeline. In addition, we cannot predict which product candidates may be subject to future

22


 

collaborations, when such arrangements will be secured, if at all, and to what degree, if any, such arrangements would affect our development plans and capital requirements.

Due to the inherently unpredictable nature of the drug approval process and the interpretation of the regulatory requirements, we are unable to estimate the amount of costs of obtaining regulatory approvals of Endari® outside of the U.S. or the development of our other preclinical and clinical programs. Clinical development timelines, the probability of success and development costs can differ materially from expectations and can vary widely. These and other risks and uncertainties relating to product development are described in the Annual Report under the headings “Risk Factors—Risks Related to Our Business” and “Risk Factors—Risks Related to Regulatory Oversight of our Business and Compliance with Law.”

General and Administrative Expense

General and administrative expense consists principally of salaries and related employee costs, including share-based compensation for our directors, officers, and employees. Other general and administrative expense includes facility costs, and professional fees and expenses for audit, legal, consulting, and tax services.

Selling Expenses

Selling expenses consist principally of salaries and related costs for personnel involved in the promotion, sale, and marketing of Endari®. Other selling cost include advertising, third party consulting costs, the cost of in-house sales personnel and travel-related costs. We expect selling expenses to increase as we acquire additional personnel to support the commercialization of Endari® in the U.S. and abroad.

COVID-19

In retrospect, we believe our business and net revenues were adversely affected in 2020 and 2021 by lockdowns, travel-related restrictions and other governmental responses to the pandemic related to the COVID 19 pandemic which inhibited the ability of our sales force to visit doctors’ offices and clinics and may have adversely affected the willingness of SCD patients to seek the care of a physician or to comply with physician-prescribed care. We do not expect the ongoing epidemic to have a material adverse effect on our business or results of operation but intend to consider future changes to our business to adapt to the new post-pandemic environment, including an increased focus on our telehealth solution.

Inflation

Inflation has not had a material impact on our expenses or results of operations over the past two years, but may result in increased manufacturing, research and development, general and administrative and selling expenses in the foreseeable future.

Environmental Expenses

The cost of compliance with environmental laws has not been material over the past two years and is not expected to have a material effect for the foreseeable future. Any such costs are included in general and administrative costs.

Inventories

Inventories consist of raw materials, finished goods and work-in-process and are valued on a first-in, first-out basis and at the lower of cost or net realizable value. Substantially all raw materials purchased during each of the nine months ended September 30, 2022 and 2021 were supplied by one vendor.

Results of Operations:

Three months ended September 30, 2022 and 2021

 

Net Revenues. Net revenues decreased by $0.8 million, or 14%, to $4.9 million for the three months ended September 30, 2022, compared to $5.8 million for the three months ended September 30, 2021. The decrease was primarily attributable to lower bulk order purchases in 2022 compared to the same period in 2021.

 

Cost of Goods Sold. Cost of goods sold increased by $0.1 million, or 21%, to $0.5 million for the three months ended September 30, 2022, compared to $0.4 million for the three months ended September 30, 2021. This increase was primarily due to the establishment of an additional reserve relating to Endari® inventory with a shelf-life of less than two years.

23


 

Research and Development Expenses. Research and development expenses remained consistent at $0.4 million for the three months ended September 30, 2022, compared to $0.5 million for the three months ended September 30, 2021.

Selling Expenses. Selling expenses increased by $0.1 million, or 10%, to $1.7 million for the three months ended September 30, 2022, compared to $1.5 million for the three months ended September 30, 2021. The increase was primarily due to increases in consulting fees.

General and Administrative Expenses. General and administrative expenses decreased by $0.4 million, or 12%, to $3.0 million for the three months ended September 30, 2022, compared to $3.4 million for the three months ended September 30, 2021. The decrease was primarily due to a decrease in professional fees

Other Income (Expense). Total other income increased by $3.1 million, or 106%, to $0.2 million for the three months ended September 30, 2022, compared to $2.9 million of other expense for the three months ended September 30, 2021. The increase was primarily due to an increase of $5.2 million in change in fair value of embedded conversion option of convertible promissory notes, partially offset by an increase of $1.2 million in foreign exchange loss.

 

Net Loss. Net loss for the three months ended September 30, 2022, decreased by $2.8 million, or 88%, to a net loss of $0.4 million for the three months ended September 30, 2022, compared to net loss of $3.2 million for the three months ended September 30, 2021. The decrease of net loss was primarily a result of an increase of $3.1 million in other income, partially offset by a decrease of $0.6 million in income from operations as discussed above.

Nine months ended September 30, 2022 and 2021

Net Revenues. Net revenues decreased by $5.1 million, or 29%, to $12.5 million for the nine months ended September 30, 2022 compared to $17.6 million for the nine months ended September 30, 2021. The decrease was primarily attributable to lower bulk orders in 2022 compared to the same period in 2021.

Cost of Goods Sold. Cost of goods sold increased by $0.6 million, or 48% to $1.9 million for nine months ended September 30, 2022 compared to $1.3 million for the nine months ended September 30, 2021. The increase was primarily due to $1.2 million of additional reserves relating to Endari® inventory with a shelf-life of less than two years.

Research and Development Expenses. Research and development expenses decreased by $1.8 million, or 61%, to $1.2 million for the nine months ended September 30, 2022, compared to $3.0 million for the nine months ended September 30, 2021. The decrease was primarily due to $0.5 million in cash and $0.5 million in shares of the common stock issued in the nine months ended September 30, 2021 under the agreement with Kainos Medicine, Inc. (“Kainos”) to lead the clinical development of Kainos’ patented IRAK4 inhibitor and a decrease of $0.5 million in expenses relating to a pharmacokinetic characteristic and safety study for Endari® in the U.S. and a clinical study in Europe. We expect our research and development costs to decrease in the remainder of 2022 as we have halted the sub-study under our Pilot/Phase 1 study of L-glutamine in diverticulosis and no new studies are currently planned for the year.

Selling Expenses. Selling expenses increased by $0.8 million, or 19%, to $5.1 million for the nine months ended September 30, 2022, compared to $4.3 million for the nine months ended September 30, 2021. The increase was primarily due to increases in the consulting fees and in travel expenses of in-house sales team.

General and Administrative Expenses. General and administrative expenses decreased by $0.7 million, or 7%, to $9.4 million for the nine months ended September 30, 2022 compared to $10.2 million for the nine months ended September 30, 2021. The decrease was primarily due to decreases of $1.0 million in professional fees and $0.2 million in travel expenses, partially offset by $0.5 million in increased payroll expenses.

Other Income (Expense). Total other expense decreased by $2.2 million, or 29%, to $5.6 million for the nine months ended September 30, 2022, compared to $7.9 million for the nine months ended September 30, 2021. The decrease was primarily due to increases of $4.4 million in change in fair value conversion feature derivatives and $1.7 million in change in fair value of warrant derivative liabilities partially offset by $3.7 million in loss in foreign exchange.

Net Income (Loss). Net loss for the nine months ended September 30, 2022 increased by $1.7 million, or 19%, to $10.8 million for the nine months ended September 30, 2022, compared to $9.1 million for the nine months ended September 30, 2021. The increase was primarily a result of a $4.0 million increase in loss from operations, partially offset by a decrease of $2.2 million in other expense as discussed above.

24


 

Liquidity and Capital Resources

Based on our losses to date, current liabilities, anticipated future net revenues and operating expenses, debt repayment obligations, planned funding to EJ Holdings and cash and cash equivalents balance of $1.2 million as of September 30, 2022, we do not have sufficient capital for our business without raising additional capital. We realized a net loss of $10.9 million for the nine months ended September 30, 2022 and anticipate that we will continue to incur net losses for the foreseeable future and until we can generate increased net revenues from Endari® sales. While we anticipate increased net revenues as we expand our commercialization of Endari® in the U.S. through telehealth and other initiatives, as well as in the U.A.E. and perhaps other GCC countries, there is no assurance that we will be able to significantly increase our Endari® sales or attain sustainable profitability or that we will have sufficient capital resources to fund our operations until we are able to generate sufficient cash flow from operations. If we are unable to raise needed capital, we may need to suspend all or substantially all business activities except those essential to support our Endari sales while we seek to restructure or refinance our existing indebtedness and other current liabilities and obtain needed financing.

Our subsidiary, Emmaus Medical, Inc., or Emmaus Medical, is party a purchase and sale agreement with Prestige Capital Finance, LLC, or Prestige Capital, pursuant to which Emmaus Medical may offer and sell to Prestige Capital from time to time eligible accounts receivable in exchange for Prestige Capital’s down payment, or advance, to Emmaus Medical of 75% of the face amount of the accounts receivable, subject to a $7,500,000 cap on advances at any time. The balance of the face amount of the accounts receivable will be reserved by Prestige Capital and paid to Emmaus Medical, less discount fees of Prestige Capital ranging from 2.25% to 7.25% of the face amount, as and when Prestige Capital collects the entire face amount of the accounts receivable.

 

Liquidity represents our ability to pay our liabilities when they become due, fund our business operations, fund the operations and retrofitting of EJ Holdings’ amino acid production plant in Ube, Japan, and meet our contractual obligations, including our obligations to purchase API under our supply arrangements with Telcon, and execute our business plan. Our primary sources of liquidity are our cash balances at the beginning of each period, net revenues, proceeds from our accounts receivable factoring arrangement with Prestige Capital and proceeds from related-party loans and other financing activities. Our short-term and long-term cash requirements consist primarily of working capital requirements, general corporate needs, our contractual obligations to purchase API from Telcon, debt service under our convertible notes payable and notes payable and planned ongoing loan funding to sustain EJ Holdings’ operations. We have no contractual commitment to provide funding to EJ Holdings, but plan to continue to do so in the foreseeable future to the extent we have cash available for this purpose.

 

As of September 30, 2022, we had outstanding $17.5 million principal amount of convertible promissory notes and $12.0 million principal amount of other notes payable. Our minimum lease payment obligations were $3.6 million, of which $0.6 million was payable within 12 months.

 

Of our outstanding convertible promissory notes, $14.3 million principal amount of the notes bear interest at the rate of 2% per year (10% in the event of a default), payable semi-annually on the last business day of August and January of each year and will mature on the 3rd anniversary of the original issue date, unless earlier converted or prepaid. We are in discussions with the holders of these convertible promissory notes to possibly restructure our obligations under the notes, but there can be no assurance whether, to what extent, or on what terms our obligations under the notes may be restructured.

 

Our API Supply Agreement and revised API Agreement with Telcon provide for an annual API purchase target of $5 million and a target “profit” (i.e., gross margin) to Telcon of $2.5 million. To the extent these targets are not met, which management refers to as a “target shortfall,” Telcon may be entitled to payment of the target shortfall in cash or to settle the target shortfall in exchange for principal and interest on the Telcon convertible bond and proceeds thereof that are pledged as collateral to secure our obligations. In February 2022 we agreed with Telcon to settle the target shortfall for 2020 and 2021 in exchange for a reduction in principal and accrued interest on our Telcon convertible bond and cash proceeds thereof as described in Note 5 of the Notes to condensed consolidated financial statements.

 

Due to uncertainties regarding our ability to meet our current liabilities and future operating expenses, there is substantial doubt about our ability to continue as a going concern for 12 months from the date of this filing as referred to in the “Risk Factors” section of this Quarterly Report and Note 2 of the Notes to condensed consolidated financial statements included herein.

Cash flows for the nine months ended September 30, 2022 and September 30, 2021

Net cash used in operating activities

Net cash used in operating activities increased by $4.6 million, or 219%, to $6.8 million for the nine months ended September 30, 2022 from $2.1 million for the nine months ended September 30, 2021. This increase was primarily due to an increase of $4.0 million in loss from operations.

25


 

Net cash used in investing activities

Net cash used in investing activities decreased by $3.9 million, or 75%, to $1.3 million for the nine months ended September 30, 2022 from $5.3 million for the nine months ended September 30, 2021. This decrease was primarily due to proceeds of $2.9 million from the deemed sale of a portion of the Telcon convertible bond resulting from the offset of target shortfalls under our revised API Agreement with Telcon against principal and interest of our Telcon convertible bond against our trade discount.

Net cash from financing activities

Net cash from financing activities decreased by $0.1 million, or 2%, to $7.1 million for the nine months ended September 30, 2022 from $7.2 million for the nine months ended September 30, 2021. This decrease was the result of $14.5 million in proceeds from the convertible promissory notes payable issued in 2021, partially offset by a $5.9 million used to prepay our outstanding Amended and Restated10% Senior Secured Convertible Debenture in the same period and $8.8 million of proceeds from notes payable issued in 2022.

Off-Balance-Sheet Arrangements

We have no off-balance sheet arrangements.

Critical Accounting Estimates

Management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of certain assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the present circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates.

Refer to “Critical Accounting Policies” in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the Annual Report for our critical accounting policies. There have been no material changes in any of our critical accounting policies during the nine months ended September 30, 2022.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Not required for a smaller reporting company.

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Disclosure controls and procedures (“DCP”) are controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. DCP include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is accumulated and communicated to our management, including our principal executive and financial officers, as appropriate to allow timely decisions regarding required disclosures.

 

As of the end of the period covered by this Form 10-Q, we conducted an evaluation, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our DCP. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that the Company’s DCP were not effective.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2022 which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

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Material Weakness and Plan of Remediation

 

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting that pose a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. Material weaknesses might cause information required to be disclosed by the Company in the reports that it files or submits to not be recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms.

 

We conducted an evaluation pursuant to Rule 13a‑15 of the Exchange Act of the effectiveness of the design and operation of our DCP as of June 30, 2022. This evaluation was conducted under the supervision (and with the participation) of our management, including our Chief Executive Officer and Chief Financial Officer. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our DCP were not effective as of September 30, 2022, because of the continuation of a material weakness (the “Material Weakness”) in our internal control over financial reporting due to inadequate financial closing process, segregation of duties including access control of information technology especially financial information, inadequate documentation of policies and procedures over risk assessments, internal control and significant account process and insufficient entity risk assessment process.

 

We engaged in ongoing efforts to remediate the control deficiencies that constituted the Material Weakness by implementing changes to our internal control over financial reporting without limitation:

 

 

engaging a third-party accounting consulting firm to assist us in the review of our application of GAAP on complex debt financing transactions and revenue recognition under ASC 606;

 

using a GAAP Disclosure and SEC Reporting Checklist;

 

increasing the continuing professional training and academic education on accounting subjects for accounting staff;

 

enhancing the level of the precision of review controls related to our financial close and reporting; and

 

subscribing to relevant online services other supplemental internal and external resources relating to SEC reporting.

 

Our management and board of directors are committed to the remediation of the material weaknesses, as well as the continued improvement of our overall system of internal control over financial reporting. In addition to the measures described above, we are in the process of implementing an integrated cloud-based enterprise resource planning system to manage our financial information to replace our outdated financial accounting systems and software. We also have established a Disclosure Committee to ensure more effective internal communications regarding significant transactions and other financial reporting matters.

 

We believe these measures will remediate the control deficiencies that gave rise to the Material Weakness. As we continue to evaluate and work to remediate these control deficiencies, we may determine that additional remediation measures may be required.

We are committed to maintaining a strong internal control environment and believe that these remediation actions will represent improvements in our internal control over financial reporting when they are fully implemented. The Material Weakness will not be considered fully remediated until controls have been designed and implemented for a sufficient period of time for our management to conclude that the control environment is operating effectively.

There is no assurance that our remediation efforts will be successful or that our internal control over financial reporting or DCP will be effective.

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Part II. Other Information

Not applicable.

Item 1A. Risk Factors

 

The following should be read in conjunction with the “Risk Factors” section of the Annual Report.

 

The Company’s consolidated financial statements included in this Quarterly Report have been prepared on the basis that the Company will continue as a going concern. The Company incurred a net loss of $10.8 million for the nine months ended September 30, 2022 and had a working capital deficit of $35.1 million at September 30, 2022. Management expects that the Company’s current liabilities and operating expenses, including the expected costs relating to the commercialization of Endari® in the Middle East North Africa region and elsewhere, will exceed our existing cash balances and cash expected to be generated from operations for the foreseeable future. To meet the Company’s current liabilities and operating expenses, the Company will need to restructure or refinance its existing indebtedness and raise additional funds through related-party loans, equity and debt financings or licensing or other strategic agreements. The Company has no understanding or arrangement to restructure or refinance its indebtedness or for any additional financing, and there can be no assurance that the Company will be able to restructure or refinance its existing indebtedness or complete any additional equity or debt financings on favorable terms, or at all, or enter into licensing or other strategic arrangements. If the Company is unable to do so, it may need to curtail business activities unrelated to the marketing and sale of Endari® or seek to restructure the Company in bankruptcy. Due to the uncertainty of the Company’s ability to meet its current liabilities and operating expenses, there is substantial doubt about the Company’s ability to continue as a going concern for 12 months from the date of this filing. The consolidated financial statements included in this Quarterly Report do not include any adjustments that might result from the outcome of these uncertainties.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

In August 2022, in consideration of financial accommodations by Dr. and Mrs. Niihara and their affiliated company, Hope International Hospice, Inc., the Company granted to Dr. Niihara a five-year warrant to purchase up to 500,000 shares of our common stock at an exercise price of $2.50 a share. If Dr. Niihara’s service to the Company terminates for any reason other than a termination for “cause” (as defined) or by reason of his death or disability, the warrant will expire to the extent it is not exercised within 90 days following his termination.  In the event of his termination as a director for “cause,” the warrant will immediately terminate. The warrant will remain exercisable for its full term in the event of termination of Dr. Niihara’s service by reason of his death or disability.

The warrant was granted without registration under the Securities Act of 1933, as amended, pursuant to the exemptions from registration under Section 4(a)(2) of such Act and Regulation D for transactions not involving a public offering based upon the facts that it was granted to the Chairman and Chief Executive Officer of the Company in a private transaction.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

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Item 5. Other Information

Related Party Loans

Over the period January 1, 2022 through September 30, 2022, certain of the Company’s directors and executive officers loaned the Company an aggregate of $5.8 million to augment the Company’s working capital as reflected in the following table (in thousands):

 

 

Principal

Amounts

 

 

Annual

Interest

Rate

 

 

Term

Soomi Niihara(1)

 

$

300

 

 

12%

 

 

Due on Demand

Yasushi Nagasaki(2)

 

$

50

 

 

10%

 

 

Due on Demand

Hope International Hospice, Inc.(1)

 

$

350

 

 

10%

 

 

Due on Demand

Hope International Hospice, Inc.(1)

 

$

210

 

 

10%

 

 

Due on Demand

Soomi Niihara(1)

 

$

100

 

 

10%

 

 

Due on Demand

George Sekulich(2)

 

$

26

 

 

10%

 

 

Due on Demand

Soomi Niihara(1)

 

$

200

 

 

10%

 

 

Due on Demand

Osato Medical Clinic.(3)

 

$

250

 

 

12%

 

 

Due on Demand

Alfred Lui(2)

 

$

50

 

 

12%

 

 

Due on Demand

Hope International Hospice, Inc.(1)

 

$

150

 

 

12%

 

 

Due on Demand

Hope International Hospice, Inc.(1)

 

$

150

 

 

12%

 

 

Due on Demand

Wei Pei Derek Zen(2)

 

$

200

 

 

10%

 

 

Due on Demand

Willis Lee(2)

 

$

45

 

 

10%

 

 

Due on Demand

Hope International Hospice, Inc.(1)

 

$

40

 

 

10%

 

 

Due on Demand

Yutaka and Soomi Niihara(1)

 

$

402

 

 

12%

 

 

5 years

Hope International Hospice, Inc.(1)

 

$

50

 

 

10%

 

 

Due on Demand

Yutaka and Soomi Niihara(1)

 

$

250

 

 

10%

 

 

5 years

Yutaka and Soomi Niihara(1)

 

$

1,669

 

 

10%

 

 

5 years

Hope International Hospice, Inc.(1)

 

$

50

 

 

10%

 

 

Due on Demand

Yutaka and Soomi Niihara(1)

 

$

60

 

 

10%

 

 

Due on Demand

Seah Lim(2)

 

$

1,200

 

 

6%

 

 

3 years

 

(1)

Soomi Niihara is Dr. Niihara’s wife. Dr. Niihara, a Director and the Chairman, and Chief Executive Officer of the Company, is also a director and the Chief Executive Officer of Hope International Hospice, Inc., which is wholly owned by him and his wife.

(2)

Officer or current or former director.

(3)

Dr. Osato, a former director of Emmaus, and his wife are the sole owners of Osato Medical Clinic.

Diverticulosis

As reported in the Annual Report, based upon data from the initial Pilot/Phase 1 study of the safety and efficacy of prescription grade L-glutamine oral powder (“PGLG”) in diverticulosis, in July 2021 we initiated a sub-study under an amendment to the original IND protocol. The purpose of the sub-study was to standardize data collection and recording using video capture to support the accurate assessment of any changes in the sigmoid colon, the most frequent site for diverticulosis, as well as diverticulitis, a more severe manifestation of diverticulosis. The sub-study objective was to provide additional safety and efficacy data to support further clinical development. For the sub-study, five patients were administered oral L-glutamine 15g BID over six months beginning early this year. Unfortunately, as the study was ending a patient in the sub-study experienced serious health complications unrelated to the sub-study which necessitated his withdrawal from the study before treatment could be completed, while other patients showed marginal improvement. As a result, we do not have definitive data to conclude the study.

At present, we have plan for further study of PGLG in diverticulosis but are considering a future study in diverticulitis patients in order to possibly increase measurable clinical endpoints from the treatment with PGLG.

 

29


 

 

Item 6. Exhibits

(a)Exhibits

 

 

Incorporated by Reference

 

Exhibit

Number

Exhibit Description

Form

File No.

Exhibit

Filing Date

Filed/
Furnished

4.1

Warrant to Purchase Shares of Common Stock dated as of August 9, 2022

 

 

 

 

*

10.1

Promissory Note dated July 27, 2022

 

 

 

 

*

10.2

Promissory Note dated August 15, 2022

 

 

 

 

*

10.3

Promissory Note dated August 16, 2022

 

 

 

 

*

10.4

Promissory Note dated August 16, 2022

 

 

 

 

*

10.5

Promissory Note dated August 17, 2022

 

 

 

 

*

10.6

Promissory Note dated August 17, 2022

 

 

 

 

*

10.7

Promissory Note dated September 16, 2022

 

 

 

 

*

31.1

Certification of Chief Executive Officer pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

*

31.2

Certification of Chief Financial Officer pursuant of Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

*

32.1

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

**

101.INS

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document

 

 

 

 

 

101.SCH

Inline XBRL Taxonomy Extension Schema Document

 

 

 

 

 

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

 

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

 

 

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

 

 

*

Filed herewith.

**

This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

30


 

EMMAUS LIFE SCIENCES, INC.

SIGNATURES

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

 

 

Emmaus Life Sciences, Inc.

 

 

 

 

Dated: November 14, 2022

By:

 

/s/ Yutaka Niihara

 

Name:

 

Yutaka Niihara, M.D., M.P.H.

 

Its:

 

Chief Executive Officer

 

 

 

 

 

 

 

 

 

By:

 

/s/ Yasushi Nagasaki

 

Name:

 

Yasushi Nagasaki

 

Its:

 

Chief Financial Officer

 

 

 

 

 

31

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