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EX-10.2 - EX-10.2 - EMMAUS LIFE SCIENCES, INC.a16-11693_1ex10d2.htm
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EX-4.4 - EX-4.4 - EMMAUS LIFE SCIENCES, INC.a16-11693_1ex4d4.htm
EX-4.3 - EX-4.3 - EMMAUS LIFE SCIENCES, INC.a16-11693_1ex4d3.htm
EX-4.2 - EX-4.2 - EMMAUS LIFE SCIENCES, INC.a16-11693_1ex4d2.htm
EX-4.1 - EX-4.1 - EMMAUS LIFE SCIENCES, INC.a16-11693_1ex4d1.htm

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

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

 

For the Quarterly Period Ended March 31, 2016

 

OR

 

o         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.:  000-53072

 


 

EMMAUS LIFE SCIENCES, INC.

(Exact name of Registrant as specified in its charter)

 


 

Delaware

 

41-2254389

(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)

 


 

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 x   No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).  Yes x   No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company.  See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  o

 

Accelerated filer  o

 

 

 

Non-accelerated filer  o

 

Smaller reporting company  x

(Do not check if a smaller reporting company)

 

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o   No x

 

The registrant had 28,565,344 shares of common stock, par value $0.001 per share, outstanding as of May 31, 2016.

 

 

 



Table of Contents

 

EMMAUS LIFE SCIENCES, INC.

FORM 10-Q

For the Quarterly Period Ended March 31, 2016

INDEX

 

 

 

Page

Part I

Financial Information

 

 

 

 

 

Item 1.

Financial Statements

 

 

 

 

 

 

 

(a)

Consolidated Balance Sheets as of March 31, 2016 (Unaudited) and December 31, 2015

1

 

 

 

 

 

 

 

(b)

Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2016 and 2015 (Unaudited)

2

 

 

 

 

 

 

 

(c)

Consolidated Statement of Changes in Stockholders’ Deficit for the Three Months Ended March 31, 2016 (Unaudited)

3

 

 

 

 

 

 

 

(d)

Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2016 and 2015 (Unaudited)

4

 

 

 

 

 

 

 

(e)

Notes to Consolidated Financial Statements as of and for the Three Months Ended March 31, 2016 (Unaudited)

5

 

 

 

 

 

Item 2.

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

19

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

27

 

 

 

 

 

Item 4.

Controls and Procedures

27

 

 

 

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

29

 

 

 

Signatures

 

 



Table of Contents

 

Item 1. Financial Statements

 

EMMAUS LIFE SCIENCES, INC.

CONSOLIDATED BALANCE SHEETS

 

 

 

As of

 

 

 

March 31, 2016

 

December 31, 2015

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

Cash and cash equivalents

 

$

323,938

 

$

472,341

 

Accounts receivable

 

61,314

 

101,639

 

Inventories, net

 

302,030

 

219,163

 

Marketable securities, pledged to creditor

 

244,920

 

219,015

 

Prepaid expenses and other current assets

 

96,917

 

131,113

 

Total current assets

 

1,029,119

 

1,143,271

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT, Net

 

55,079

 

58,227

 

 

 

 

 

 

 

OTHER ASSETS

 

 

 

 

 

Deposits

 

260,727

 

275,500

 

Total other assets

 

260,727

 

275,500

 

Total Assets

 

$

1,344,925

 

$

1,467,998

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

Accounts payable and accrued expenses

 

$

3,943,670

 

$

3,780,494

 

Other current liability

 

67,589

 

88,331

 

Notes payable, net

 

4,780,349

 

4,656,749

 

Notes payable to related parties, net

 

2,961,838

 

2,766,304

 

Convertible notes payable, net

 

6,455,879

 

6,000,347

 

Convertible notes payable to related parties, net

 

254,000

 

298,000

 

Total current liabilities

 

18,463,325

 

17,590,225

 

 

 

 

 

 

 

LONG-TERM LIABILITIES

 

 

 

 

 

Deferred rent

 

59,555

 

59,886

 

Warrant derivative liabilities

 

8,726,000

 

7,863,000

 

Convertible notes payable, net

 

4,127,015

 

4,206,873

 

Convertible notes payable to related parties, net

 

320,000

 

320,000

 

Total long-term liabilities

 

13,232,570

 

12,449,759

 

Total Liabilities

 

31,695,895

 

30,039,984

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

STOCKHOLDERS’ DEFICIT

 

 

 

 

 

Preferred stock — par value $0.001 per share, 20,000,000 shares authorized, none issued and outstanding

 

 

 

Common stock — par value $0.001 per share, 100,000,000 shares authorized, 28,563,478 and 28,163,478 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively

 

28,563

 

28,163

 

Additional paid-in capital

 

59,143,596

 

56,508,984

 

Accumulated other comprehensive loss

 

(281,415

)

(318,324

)

Accumulated deficit

 

(89,241,714

)

(84,781,809

)

Total Stockholders’ Deficit

 

(30,350,970

)

(28,562,986

)

Total Liabilities & Stockholders’ Deficit

 

$

1,344,925

 

$

1,476,998

 

 

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

 

1



Table of Contents

 

EMMAUS LIFE SCIENCES, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

2015

 

 

 

 

 

(Note 1)

 

REVENUES, net

 

$

79,399

 

$

96,759

 

 

 

 

 

 

 

COST OF GOODS SOLD

 

28,066

 

49,990

 

GROSS PROFIT

 

51,333

 

46,769

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

Research and development

 

502,301

 

244,118

 

Selling

 

93,580

 

157,186

 

General and administrative

 

2,292,922

 

2,854,342

 

 

 

2,888,803

 

3,255,646

 

 

 

 

 

 

 

LOSS FROM OPERATIONS

 

(2,837,470

)

(3,208,877

)

 

 

 

 

 

 

OTHER INCOME (EXPENSE)

 

 

 

 

 

Change in fair value of liability classified warrants

 

 

186,000

 

Change in fair value of warrant derivative liabilities

 

(863,000

)

382,000

 

Interest and other income (loss)

 

(25,833

)

43,538

 

Interest expense

 

(731,202

)

(644,497

)

 

 

(1,620,035

)

(32,959

)

 

 

 

 

 

 

LOSS BEFORE INCOME TAXES

 

(4,457,505

)

(3,241,836

)

INCOME TAXES

 

2,400

 

2,200

 

NET LOSS

 

(4,459,905

)

(3,244,036

)

 

 

 

 

 

 

COMPONENTS OF OTHER COMPREHENSIVE INCOME (LOSS)

 

 

 

 

 

Unrealized holding gain (loss) on securities available-for-sale

 

25,905

 

(133,026

)

Unrealized foreign currency translation

 

11,004

 

915

 

 

 

36,909

 

(132,111

)

COMPREHENSIVE LOSS

 

$

(4,422,996

)

$

(3,376,147

)

NET LOSS PER COMMON SHARE

 

$

(0.16

)

$

(0.11

)

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING

 

28,465,798

 

30,581,171

 

 

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

 

2



Table of Contents

 

EMMAUS LIFE SCIENCES, INC.

CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT

FOR THE PERIOD FROM DECEMBER 31, 2015 TO MARCH 31, 2016

(UNAUDITED)

 

 

 

Common stock — par value $0.001
per share, 100,000,000
shares authorized

 

Additional

 

Accumulated
Other

 

 

 

 

 

 

 

Shares

 

Common
Stock

 

Paid-in
Capital

 

Comprehensive
Loss

 

Accumulated
Deficit

 

Total Stockholders’
Deficit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2015

 

28,163,478

 

$

28,163

 

$

56,508,984

 

$

(318,324

)

$

(84,781,809

)

$

(28,562,986

)

Stock issued for cash

 

400,000

 

400

 

1,799,599

 

 

 

1,799,999

 

Beneficial conversion feature relating to convertible and promissory notes payable

 

 

 

294,497

 

 

 

294,497

 

Share-based compensation

 

 

 

540,516

 

 

 

540,516

 

Unrealized loss on marketable securities, net of tax

 

 

 

 

25,905

 

 

25,905

 

Foreign currency translation effect

 

 

 

 

11,004

 

 

11,004

 

Net loss

 

 

 

 

 

(4,459,905

)

(4,459,905

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2016

 

28,563,478

 

$

28,563

 

$

59,143,596

 

$

(281,415

)

$

(89,241,714

)

$

(30,350,970

)

 

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

 

3



Table of Contents

 

EMMAUS LIFE SCIENCES, INC.

CONSOLIDATED STATEMENT OF CASH FLOWS

(UNAUDITED)

 

 

 

Three Months ended March 31,

 

 

 

2016

 

2015

 

 

 

 

 

(Note 1)

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

Net loss

 

$

(4,459,905

)

$

(3,244,036

)

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

 

 

 

 

 

Depreciation and amortization

 

3,668

 

59,094

 

Interest expense accrued from discount of convertible notes

 

238,130

 

339,006

 

Foreign exchange adjustments on convertible notes and notes payable

 

142,760

 

14,523

 

Share-based compensation

 

540,516

 

1,280,790

 

Change in fair value of liability classified warrants

 

 

(186,000

)

Change in fair value of warrant derivative liabilities

 

863,000

 

(382,000

)

Net changes in operating assets and liabilities

 

 

 

 

 

Accounts receivable

 

43,136

 

27,918

 

Inventories

 

(78,021

)

(16,823

)

Prepaid expenses and other current assets

 

57,246

 

21,283

 

Deposits

 

16,859

 

9,196

 

Accounts payable and accrued expenses

 

338,171

 

803,645

 

Other current liability

 

(65,000

)

 

Deferred rent

 

(424

)

44,957

 

Net cash flows used in operating activities

 

(2,359,864

)

(1,228,447

)

 

 

 

 

 

 

CASH FLOWS USED IN INVESTING ACTIVITIES

 

 

 

 

 

Purchases of property and equipment

 

 

(1,467

)

Net cash flows used in investing activities

 

 

(1,467

)

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

Proceeds from notes payable issued

 

400,000

 

698,783

 

Proceeds from convertible notes payable issued

 

279,950

 

200,000

 

Payments of notes payable

 

(228,000

)

 

Payments of convertible notes

 

(44,000

)

 

Proceeds from exercise of warrants

 

 

102,885

 

Proceeds from issuance of common stock

 

1,799,999

 

 

Net cash flows from financing activities

 

2,207,949

 

1,001,668

 

Effect of exchange rate changes on cash

 

3,512

 

287

 

 

 

 

 

 

 

Net decrease in cash and cash equivalents

 

(148,403

)

(227,959

)

Cash and cash equivalents, beginning of period

 

472,341

 

556,318

 

Cash and cash equivalents, end of period

 

$

323,938

 

$

328,359

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW ACTIVITIES

 

 

 

 

 

Interest paid

 

$

146,727

 

$

62,240

 

Income taxes paid

 

$

2,400

 

$

2,200

 

 

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

 

4



Table of Contents

 

EMMAUS LIFE SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2016

(UNAUDITED)

 

NOTE 1 — BASIS OF PRESENTATION

 

The accompanying unaudited consolidated interim financial statements of Emmaus Life Sciences, Inc. and subsidiaries (the “Company” or “Emmaus”) 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. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany transactions have been eliminated. The Company’s unaudited consolidated interim financial statements contain adjustments, including normal recurring accruals necessary to present fairly the Company’s consolidated financial position, results of operations, comprehensive income (loss) and cash flows. Due to the uncertainty of the Company’s ability to meet its current operating and capital expenses, there is substantial doubt about the Company’s ability to continue as a going concern, as the continuation and expansion of its business is dependent upon obtaining further financing, successful and sufficient market acceptance of its products, and finally, achieving a profitable level of operations. The consolidated interim financial statements do not include any adjustments that might result from the outcome of these uncertainties. The accompanying consolidated interim financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on May 20, 2016 (“Annual Report”). Interim results for the periods presented herein are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2016.

 

The preparation of the consolidated financial statements requires the use of management estimates. Actual results could differ materially from those estimates.

 

Correction of immaterial errors — During the first quarter of 2016, management became aware of prior period accounting errors related to stock option accounting that were made in the previously filed SEC Form 10-Q for the quarter ended March 31, 2015. Specifically, the prior period accounting errors involving shared based payments instruments related to not appropriately accounting for stock option modifications and not re-measuring the fair value of stock options issued to non-employees from the issuance date until the services required under the arrangement has been completed. The adjustment to the consolidated statements of comprehensive loss for three months ended March 31, 2015 for the stock option accounting errors was a decrease in expense of $360,454.

 

Pursuant to the guidance of Staff Accounting Bulletin (“SAB”) No. 99, Materiality, the Company evaluated these errors individually as well as in the aggregate and concluded that the errors were not material to any of its prior period financial statements. Although the errors were immaterial to prior periods, the prior period financial statements were revised, in accordance with SAB No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, due to the significance of the out-of-period correction.

 

A reconciliation of the effects of the adjustment to the previously reported consolidated balance sheet at March 31, 2015 follows:

 

 

 

As Previously
Reported

 

Adjustment

 

As Revised

 

 

 

As of March 31, 2015

 

Additional paid in capital

 

53,216,812

 

290,720

 

53,507,532

 

Accumulated deficit

 

(75,037,152

)

(290,720

)

(75,327,872

)

 

A reconciliation of the effect of the adjustment to the previously reported consolidated statement of comprehensive loss for the three months ended March 31, 2015 follows:

 

 

 

As Previously
Reported

 

Adjustment

 

As Revised

 

 

 

For Three Months Ended March 31, 2015

 

General and administrative

 

3,214,796

 

(360,454

)

2,854,342

 

Loss from operations

 

(3,569,331

)

360,454

 

(3,208,877

)

Loss before income taxes

 

(3,602,290

)

360,454

 

(3,241,836

)

 

5



Table of Contents

 

A reconciliation of the effect of the adjustments to the previously reported consolidated statement of cash flows for the three months ended March 31, 2015 follows:

 

 

 

As Previously
Reported

 

Adjustment

 

As Revised

 

 

 

For Three Months Ended March 31, 2015

 

Net loss

 

(3,604,490

)

360,454

 

(3,244,036

)

Share-based compensation

 

1,641,244

 

(360,454

)

1,280,790

 

 

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Refer to the Company’s Annual Report for a summary of significant accounting policies. There have been no material changes to our significant accounting policies during the three months ended March 31, 2016. Below are disclosures of certain interim balances, transactions, and significant assumptions used in computing fair value as of and for the three months ended March 31, 2016 and comparative amounts from the prior fiscal periods:

 

Inventories — All of the raw material purchased during the three months ended March 31, 2016 and for the year ended December 31, 2015 was from one vendor. The below table presents inventory by category:

 

Inventory by category

 

March 31, 2016

 

December 31, 2015

 

Work-in-process

 

$

161,194

 

$

45,355

 

Finished goods

 

140,836

 

173,808

 

 

 

$

302,030

 

$

219,163

 

 

Advertising cost — Advertising costs are expensed as incurred. Advertising costs for the three months ended March 31, 2016 and 2015 were $3,939 and $19,263, respectively.

 

Marketable securities — The Company’s marketable securities consist of 39,250 shares of CellSeed, Inc. (“CellSeed”) stock which are part of 147,100 shares acquired in January 2009 for 100,028,000 Japanese Yen (equivalent to $1,109,819), at 680 Yen per share. CellSeed’s IPO (Tokyo Stock Exchange symbol 7776) was completed on March 16, 2010. As of March 31, 2016 and December 31, 2015, the closing price per share for CellSeed was 701 Yen ($6.24) and 672 Yen ($5.58), respectively.

 

As of March 31, 2016, 39,250 shares of CellSeed stock are pledged to secure a $500,000 convertible note issued to Mitsubishi UFJ Capital III Limited Partnership that is due on demand and are classified as current assets, as marketable securities, pledged to creditor.

 

Prepaid expenses and other current assets — Prepaid expenses and other current assets consisted of the following at March 31, 2016 and December 31, 2015:

 

 

 

March 31, 2016

 

December 31, 2015

 

Prepaid insurance

 

$

67,948

 

$

97,708

 

Other prepaid expenses and current assets

 

28,969

 

33,405

 

 

 

$

96,917

 

$

131,113

 

 

Fair value measurements — The following table presents the activity for those items measured at fair value on a recurring basis using Level 3 inputs during the three months ended March 31, 2016 and the year ended December 31, 2015:

 

 

 

Period ended

 

Liability Classified Warrants—Stock Purchase Warrants

 

March 31, 2016

 

December 31, 2015

 

Balance, beginning of period

 

$

 

$

3,206,000

 

Reclassification to warrant derivative liabilities

 

 

(2,545,000

)

Change in fair value included in the statements of comprehensive loss

 

 

(661,000

)

Balance, end of period

 

$

 

$

 

 

6



Table of Contents

 

 

 

Period ended

 

Warrant Derivative Liabilities—Stock Purchase Warrants

 

March 31, 2016

 

December 31, 2015

 

Balance, beginning of period

 

$

7,863,000

 

$

6,520,000

 

Reclassification from liability classified warrants

 

 

2,545,000

 

Change in fair value included in the statements of comprehensive loss

 

863,000

 

(1,202,000

)

Balance, end of period

 

$

8,726,000

 

$

7,863,000

 

 

The value of the liability classified warrants, the value of warrant derivative liability and the change in fair value of the liability classified warrants and warrant derivative liability were determined using a Binomial Monte-Carlo Cliquet (aka “Ratchet”) Option Pricing Model. The model is similar to traditional Black-Scholes-type option pricing models, except that the exercise price resets at certain dates in the future. The values as of March 31, 2016, December 31, 2015, December 31, 2014, December 31, 2013 and the initial value as of September 11, 2013 were calculated based on the following assumptions:

 

 

 

March 31, 2016

 

December 31, 2015

 

Initial Value

 

Stock price

 

$

5.00

 

$

4.70

 

$

3.60

 

Risk-free interest rate

 

0.79

%

1.23

%

1.72

%

Expected volatility (peer group)

 

69.20

%

64.10

%

72.40

%

Expected life (in years)

 

2.45

 

2.70

 

5.00

 

Number outstanding

 

3,320,501

 

3,320,501

 

3,320,501

 

Balance, end of period:

 

 

 

 

 

 

 

Liability classified warrants

 

$

 

$

 

$

7,541,000

 

Warrant derivative liabilities

 

$

8,726,000

 

$

7,863,000

 

$

 

 

Debt and related party debt — The following table presents the effective interest rates on the original loan principal amount for loans originated in the respective periods that either had a beneficial conversion feature or an attached warrant:

 

Type of Loan

 

Term of
Loan

 

Stated
Annual
Interest
Rate

 

Original
Loan
Principal
Amount

 

Conversion
Rate

 

Beneficial
Conversion
Discount
Amount

 

Warrants
Issued
with
Notes

 

Exercise
Price

 

Warrant
FMV
Discount
Amount

 

Effective
Interest Rate
Including
Discounts

 

2015 convertible notes payable

 

Due on demand ~ 2 years

 

10

%

4,051,022

 

$3.50~ $4.50

 

1,388,201

 

110,417

 

$

4.90

 

220,071

 

14% ~ 109%

 

2016 convertible notes payable

 

Due on demand ~ 2 years

 

10

%

1,028,959

 

$3.60~ $4.50

 

294,497

 

 

 

 

14% ~ 49%

 

Total

 

 

 

 

 

$

5,079,981

 

 

 

$

1,682,698

 

110,417

 

 

 

$

220,071

 

 

 

 

Related party notes are disclosed as separate line items in the Company’s balance sheet presentation.

 

Net loss per share — As of March 31, 2016 and 2015, potentially dilutive securities exercisable or convertible into 11,837,427 and 12,838,502 shares of the Company’s common stock were outstanding, respectively. As the Company reported a net loss, none of the potentially dilutive securities were included in the calculation of diluted loss per share since their effect would be anti-dilutive for all periods presented.

 

Recent accounting pronouncements — In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities. The amendments applicable to the Company in this Update (1) supersede the guidance to classify equity securities, except equity method securities, with readily determinable fair values into trading or available-for-sale categories and require equity securities to be measured at fair value with changes in the fair value recognized through net income, (2) allow equity investments that do not have readily determinable fair values to be remeasured at fair value either upon the occurrence of an observable price change or upon identification of an impairment, (3) require assessment for impairment of equity investments without readily determinable fair values qualitatively at each reporting period, (4) eliminate the requirement to disclose the methods and significant assumptions used in calculating the fair value of financial instruments required to be disclosed for financial instruments measured at amortized cost on the balance sheet, (5) require public business entities to use the exit price notion when measuring the fair value of financial instruments for disclosure purposes, (6) require separate presentation of financial assets and financial liabilities by measurement category and form of financial asset (that is, securities or loans and receivables) on the balance sheet or the accompanying notes to the financial statements, (7) clarify that an entity should evaluate the need for a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with the entity’s other deferred tax assets. The amendments in this Update are effective for the Company for fiscal years beginning after December 15, 2017, including interim periods within those years. The amendments should be applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. The amendments related to equity securities without readily determinable fair values (including disclosure requirements) should be applied prospectively to equity investments that exist as of the date of adoption of the Update. The impact of the adoption of the amendments in this Update will depend on the amount of equity securities and financial instruments subject to the amendments in this Update held by the Company at the time of adoption.

 

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Table of Contents

 

In February 2016, the FASB issued ASU No. 2016-02, Leases. The amendments in this Update require a lessee to recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term for all leases with terms greater than twelve months. For leases less than twelve months, an entity is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. The amendments in this Update are effective for the Company for fiscal years beginning after December 15, 2018, including interim periods within those years, with early adoption permitted. The Company is currently in the process of evaluating the impact of adoption of the amendments in this Update on the Company’s consolidated financial position and results of operations; however, adoption of the amendments in this Update are expected to be material for most entities who have a material lease with a term of greater than twelve months.

 

In March 2016, the FASB issued ASU 2016-09, Compensation — Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The amendments in this Update simplify the accounting for share-based payment award transactions including: income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. This Update is effective for annual periods beginning after December 15, 2016, including interim periods within those annual periods. Early adoption is permitted. The Company is currently in the process of evaluating this new Update.

 

NOTE 3 — PROPERTY AND EQUIPMENT

 

Property and equipment consisted of the following at:

 

 

 

March 31, 2016

 

December 31, 2015

 

Equipment

 

$

165,196

 

$

164,931

 

Leasehold improvements

 

31,123

 

30,579

 

Furniture and fixtures

 

74,868

 

74,682

 

Sub total

 

271,187

 

270,192

 

Less: accumulated depreciation

 

(216,108

)

(211,965

)

Total

 

$

55,079

 

$

58,227

 

 

During the three months ended March 31, 2016 and 2015, depreciation expense was $3,668 and $5,523, respectively.

 

NOTE 4 — INTANGIBLE ASSETS

 

Intangible assets, related to license fees and patent filing costs associated with NutreStore® L-glutamine powder for oral solution as a treatment for short bowel syndrome (“SBS”) consisted of the following at:

 

 

 

March 31, 2016

 

December 31, 2015

 

License fees and patent filing costs

 

$

500,000

 

$

2,000,000

 

Less: accumulated amortization

 

(500,000

)

(1,321,429

)

Less: intangible asset impairment

 

 

(678,571

)

Total

 

$

 

$

 

 

During the three months ended March 31, 2016 and 2015, amortization expense was $0 and $53,571, respectively.

 

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Table of Contents

 

NOTE 5 — ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

Accounts payable and accrued expenses consisted of the following at:

 

 

 

March 31, 2016

 

December 31, 2015

 

Accounts payable

 

 

 

 

 

Clinical and regulatory expenses

 

$

145,003

 

$

322,193

 

Legal expenses

 

209,196

 

242,384

 

Other vendors

 

1,116,151

 

959,333

 

Total accounts payable

 

1,470,350

 

1,523,910

 

Accrued interest payable, related parties

 

126,214

 

176,940

 

Accrued interest payable

 

1,853,934

 

1,586,472

 

Accrued expenses

 

201,506

 

201,506

 

Deferred salary

 

291,666

 

291,666

 

Total accounts payable and accrued expenses

 

$

3,943,670

 

$

3,780,494

 

 

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Table of Contents

 

NOTE 6 — NOTES PAYABLE

 

Notes payable consisted of the following at March 31, 2016 and December 31, 2015:

 

Year
Issued

 

Interest Rate
Range

 

Term of Notes

 

Conversion
Price

 

Principal
Outstanding
March 31,
2016

 

Discount
Amount
March 31,
2016

 

Carrying
Amount
March 31, 2016

 

Shares
Underlying
Notes March
31, 2016

 

Principal
Outstanding
December 31,
2015

 

Discount Amount
December 31, 2015

 

Carrying
Amount
December 31,
2015

 

Shares
Underlying
Notes
December 31,
2015

 

Notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2013

 

10%

 

Due on demand

 

 

$

890,000

 

$

 

$

890,000

 

 

$

830,000

 

$

 

$

830,000

 

 

2014

 

11%

 

Due on demand ~ 2 years

 

 

613,614

 

 

613,614

 

 

1,446,950

 

 

1,446,950

 

 

2015

 

11%

 

Due on demand ~ 2 years

 

 

2,443,400

 

 

2,443,400

 

 

2,379,799

 

 

2,379,799

 

 

2016

 

11%

 

Due on demand

 

 

833,335

 

 

833,335

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

4,780,349

 

$

 

$

4,780,349

 

 

$

4,656,749

 

$

 

$

4,656,749

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current

 

 

 

$

4,780,349

 

$

 

$

4,780,349

 

 

$

4,656,749

 

$

 

$

4,656,749

 

 

 

 

 

 

Non-current

 

 

 

$

 

$

 

$

 

 

$

 

$

 

$

 

 

Notes payable - related party

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2012

 

8% ~ 10%

 

Due on demand

 

 

$

626,730

 

$

 

$

626,730

 

 

$

626,730

 

$

 

$

626,730

 

 

2013

 

8%

 

Due on demand

 

 

50,000

 

 

50,000

 

 

50,000

 

 

50,000

 

 

2014

 

11%

 

Due on demand ~ 2 years

 

 

 

 

 

 

240,308

 

 

240,308

 

 

2015

 

10% ~ 11%

 

Due on demand ~ 2 years

 

 

1,621,265

 

 

1,621,265

 

 

1,849,266

 

 

1,849,266

 

 

2016

 

11%

 

Due on demand ~ 2 years

 

 

663,843

 

 

 

663,843

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

2,961,838

 

$

 

$

2,961,838

 

 

$

2,766,304

 

$

 

$

2,766,304

 

 

 

 

 

 

Current

 

 

 

$

2,961,838

 

$

 

$

2,961,838

 

 

$

2,766,304

 

$

 

$

2,766,304

 

 

 

 

 

 

Non-current

 

 

 

$

 

$

 

$

 

 

$

 

$

 

$

 

 

Convertible notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2010

 

6%

 

5 years

 

$3.05

 

$

2,000

 

$

 

$

2,000

 

656

 

$

2,000

 

$

 

$

2,000

 

656

 

2011

 

10%

 

5 years

 

$3.05

 

500,000

 

 

500,000

 

165,173

 

500,000

 

 

500,000

 

163,809

 

2013

 

10%

 

2 years

 

$3.60

 

200,257

 

 

200,257

 

71,446

 

525,257

 

 

525,257

 

185,553

 

2014

 

10%

 

Due on demand ~ 2 years

 

$3.05~$7.00

 

4,403,470

 

236,542

 

4,166,928

 

1,151,351

 

4,378,563

 

353,700

 

4,024,863

 

1,120,470

 

2015

 

10%

 

Due on demand ~ 2 years

 

$3.50~$7.00

 

5,384,340

 

420,490

 

4,963,850

 

1,462,149

 

5,681,166

 

526,066

 

5,155,100

 

1,517,996

 

2016

 

10%

 

Due on demand ~ 2 years

 

$3.60~$4.50

 

1,028,959

 

279,100

 

749,859

 

272,872

 

 

 

 

 

 

 

 

 

 

 

 

 

$

11,519,026

 

$

936,132

 

$

10,582,894

 

3,123,647

 

$

11,086,986

 

$

879,766

 

$

10,207,220

 

2,988,484

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current

 

 

 

$

6,913,862

 

$

457,983

 

$

6,455,879

 

1,915,803

 

$

6,358,698

 

$

358,351

 

$

6,000,347

 

1,762,849

 

 

 

 

 

Non-current

 

 

 

$

4,605,164

 

$

478,149

 

$

4,127,015

 

1,207,844

 

$

4,728,288

 

$

521,415

 

$

4,206,873

 

1,225,635

 

Convertible notes payable - related party

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2012

 

10%

 

Due on demand

 

$3.30

 

$

254,000

 

$

 

$

254,000

 

88,733

 

$

298,000

 

$

 

$

298,000

 

108,505

 

2015

 

10%

 

2 years

 

$4.50

 

320,000

 

 

320,000

 

74,127

 

320,000

 

 

320,000

 

72,354

 

 

 

 

 

 

 

 

 

$

574,000

 

$

 

$

574,000

 

162,860

 

$

618,000

 

$

 

$

618,000

 

180,859

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current

 

 

 

$

254,000

 

$

 

$

254,000

 

88,733

 

$

298,000

 

$

 

$

298,000

 

108,505

 

 

 

 

 

Non-current

 

 

 

$

320,000

 

$

 

$

320,000

 

74,127

 

$

320,000

 

$

 

$

320,000

 

72,354

 

 

 

 

 

Grand Total

 

 

 

$

19,835,213

 

$

936,132

 

$

18,899,081

 

3,286,507

 

$

19,128,039

 

$

879,766

 

$

18,248,273

 

3,169,343

 

 

10



Table of Contents

 

The average stated interest rate of notes payable as of March 31, 2016 and December 31, 2015 was 10%. The average effective interest rate of notes payable for each of the three-month period ended March 31, 2016 and the year ended December 31, 2015 was 23% and 23%, respectively, after giving effect to discounts relating to beneficial conversion features and the fair value of warrants issued in connection with these notes. The notes payable and convertible notes payable do not have restrictive financial covenants or acceleration clauses associated with a material adverse change event. The holders of the convertible notes have the option to convert their notes into the Company’s common stock at the stated conversion price during the term of their convertible notes. Conversion prices on these convertible notes payable range from $3.05 to $3.60 per share. Certain notes with a $4.50 or a $7.00 stated conversion price in the second year of their two year term are subject to automatic conversion into shares of our common stock at a conversion price equal to 80% of the initial public offering price at the time of a qualified public offering. All due on demand notes are treated as current liabilities.

 

Contractual principal payments due on notes payable are as follows:

 

Year Ending

 

at March 31, 2016

 

2016

 

$

13,973,596

 

2017

 

5,239,167

 

2018

 

622,450

 

Total

 

$

19,835,213

 

 

The Company estimated the total fair value of any beneficial conversion feature and accompanying warrants in allocating the debt proceeds. The proceeds allocated to the beneficial conversion feature were determined by taking the estimated fair value of shares issuable under the convertible notes less the fair value of the number of shares that would be issued if the conversion rate equaled the fair value of the Company’s common stock as of the date of issuance (see Note 2). The fair value of the warrants issued in conjunction with notes was determined using the Black Scholes Merton option pricing model with the following inputs for the periods ended:

 

 

 

March 31, 2016

 

December 31, 2015

 

Stock price

 

$

 

$

4.50

 

Exercise price

 

$

 

$

4.90

 

Term

 

 

5 years

 

Risk-free interest rate

 

%

1.57

%

Expected dividend yield

 

 

 

Expected volatility

 

%

67.3

%

 

In situations where the debt included both a beneficial conversion feature and a warrant, the proceeds were allocated to the warrants and beneficial conversion feature based on their respective pro-rata fair values.

 

NOTE 7 — STOCKHOLDERS’ DEFICIT

 

Private placement — On September 11, 2013, the Company issued an aggregate of 3,020,501 units at a price of $2.50 per unit (the “Private Placement”). Each unit consisted of one share of common stock and one common stock warrant for the purchase of an additional share of common stock. The aggregate purchase price for the units was $7,551,253. In addition, 300,000 warrants for the purchase of a share of common stock were issued to a broker under the same terms as the Private Placement transaction (the “Broker Warrants”).

 

The warrants issued in the Private Placement and the Broker Warrants entitle the holders thereof to purchase, at any time on or prior to September 11, 2018, shares of common stock of the Company at an exercise price of $3.50 per share. The warrants contain non-standard anti-dilution protection and, consequently, are being accounted for as liabilities, were originally recorded at fair value, and are adjusted to fair market value each reporting period. Because the shares of common stock underlying the Private Placement warrants and Broker Warrants were not effectively registered for resale by September 11, 2014, the warrant holders have an option to exercise the warrants using a cashless exercise feature. The shares have not been registered for resale as of March 31, 2016. The availability to warrant holders of the cashless exercise feature as of September 11, 2014 caused the then-outstanding 2,225,036 Private Placement warrants and Broker Warrants with fair value of $7,068,000 to be reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period.

 

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Table of Contents

 

On June 10, 2014, certain warrant holders exercised 1,095,465 warrants issued in the Private Placement for the exercise price of $3.50 per share, resulting in the Company receiving aggregate exercise proceeds of $3.8 million and issuing 1,095,465 shares of common stock. Prior to exercise, these Private Placement warrants were accounted for at fair value as liability classified warrants. As of June 10, 2014, immediately prior to exercise, the carrying value of these Private Placement warrants was reduced to their fair value immediately prior to exercise of $1.8 million, representing their intrinsic value, with this adjusted carrying value of $1.8 million being transferred to additional paid-in capital. Also on June 10, 2014, based on an offer made to holders of Private Placement warrants in connection with such exercises, the Company issued an aggregate of 1,095,465 replacement warrants to holders exercising Private Placement warrants, which replacement warrants have terms that are generally the same as the exercised warrants, including an expiration date of September 11, 2018 and an exercise price of $3.50 per share. The replacement warrants are treated for accounting purposes as liability classified warrants, and their issuance gave rise to a $3.5 million warrant exercise inducement expense based on their fair value as of issuance as determined using a Binomial Monte-Carlo Cliquet (aka Ratchet) Option Pricing Model. Because the shares of common stock underlying the replacement warrants were not effectively registered for resale by June 10, 2015, the warrant holders have an option to exercise the warrants using a cashless exercise feature. The shares have not been registered for resale as of March 31, 2016. The availability to warrant holders of the cashless exercise feature as of June 10, 2015 caused the then-outstanding 1,095,465 replacement warrants with fair value of $2,545,000 to be reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period.

 

As of March 31, 2016, the fair value of these Private Placement warrants, replacement warrants, and Broker Warrants was $8,726,000 (see Note 2). For further details regarding registration rights associated with the Private Placement warrants, replacement warrants and Broker Warrants, see the Registration Rights section below in this footnote.

 

A summary of outstanding warrants as of March 31, 2016 and December 31, 2015 is presented below.

 

 

 

Three months ended
March 31, 2016

 

Year ended
December 31, 2015

 

Warrants outstanding, beginning of period

 

3,530,918

 

5,101,450

 

Granted

 

 

110,417

 

Exercised

 

 

(148,256

)

Cancelled, forfeited or expired

 

 

(1,532,693

)

Warrants outstanding, end of period

 

3,530,918

 

3,530,918

 

 

A summary of outstanding warrants by year issued and exercise price as of March 31, 2016 is presented below.

 

 

 

 

 

Outstanding

 

Exercisable

 

Exercise Price

 

Number of
Warrants Issued

 

Weighted Average
Remaining
Contractual Life
(Years)

 

Weighted
Average
Exercise Price

 

Total

 

Weighted
Average
Exercise Price

 

Balance 2013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$3.30

 

50,000

 

2.08

 

$

3.30

 

50,000

 

$

3.30

 

 

 

$3.50

 

2,225,036

 

2.45

 

$

3.50

 

2,225,036

 

$

3.50

 

 

 

2013 total

 

2,275,036

 

 

 

 

 

2,275,036

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

During 2014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$3.50

 

1,145,465

 

2.48

 

$

3.50

 

1,145,465

 

$

3.50

 

 

 

2014 total

 

1,145,465

 

 

 

 

 

1,145,465

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

During 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$4.90

 

110,417

 

3.93

 

$

4.90

 

110,417

 

$

4.90

 

 

 

Total

 

3,530,918

 

 

 

 

 

3,530,918

 

 

 

 

Stock options — During the three months ended March 31, 2016, the Company’s Board of Directors granted 300,000 options to its independent directors. These options will equally vest one-third on each of the first three anniversaries of the grant date, have an exercise price of $4.70 per share and are exercisable through 2026. During the year ended December 31, 2015, no options were granted by the Company’s Board of Directors. As of March 31, 2016, there were 5,020,001 options outstanding under the Emmaus Life Sciences, Inc. 2011 Stock Incentive Plan.

 

12



Table of Contents

 

A summary of outstanding options as of March 31, 2016 is presented below.

 

 

 

March 31, 2016

 

December 31, 2015

 

 

 

Number of
Options

 

Weighted-
Average
Exercise
Price

 

Number of
Options

 

Weighted-
Average
Exercise
Price

 

Options outstanding, beginning of period

 

4,753,335

 

$

3.60

 

5,669,000

 

$

3.68

 

Granted or deemed issued

 

300,000

 

$

4.70

 

 

$

 

Exercised

 

 

 

(2,000

)

$

3.60

 

Cancelled, forfeited and expired

 

(33,334

)

$

5.10

 

(913,665

)

$

4.05

 

Options outstanding, end of period

 

5,020,001

 

$

3.85

 

4,753,335

 

$

3.60

 

Options exercisable, end of period

 

4,628,112

 

$

3.59

 

4,379,335

 

$

3.60

 

Options available for future grant, end of period

 

3,979,999

 

 

 

4,246,665

 

 

 

 

No options were issued during the three months ended March 31, 2015.

 

During the three months ended March 31, 2016 and 2015, the Company recognized $0.5 million and $1.3 million, respectively, of share-based compensation cost arising from stock options. As of March 31, 2016, there was $0.9 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the 2011 Stock Incentive Plan. That cost is expected to be recognized over the weighted average remaining period of 2.4 years.

 

Registration rights — Pursuant to the Subscription Agreements relating to the Private Placement and certain warrants, as well as pursuant to the replacement of certain warrants by the Company on June 10, 2014, the Company agreed to use its commercially reasonable best efforts to have on file with the SEC, by September 11, 2014 and at the Company’s sole expense, a registration statement to permit the public resale of 4,115,966 shares of the Company’s common stock and 3,320,501 shares of common stock underlying warrants (collectively, the “Registrable Securities”). In the event such registration statement includes securities to be offered and sold by the Company in a fully underwritten primary public offering pursuant to an effective registration under the Securities Act, and the Company is advised in good faith by any managing underwriter of securities being offered pursuant to such registration statement that the number of Registrable Securities proposed to be sold in such offering is greater than the number of such securities which can be included in such offering without materially adversely affecting such offering, the Company will include in such registration the following securities in the following order of priority: (i) any securities the Company proposes to sell, and (ii) the Registrable Securities, with any reductions in the number of Registrable Securities actually included in such registration to be allocated on a pro rata basis among the holders thereof. The registration rights described above apply until all Registrable Securities have been sold pursuant to Rule 144 under the Securities Act or may be sold without registration in reliance on Rule 144 under the Securities Act without limitation as to volume and without the requirement of any notice filing.

 

If the shares of common stock underlying these warrants to purchase 3,320,501 shares are not registered for resale at the time of exercise, and the registration rights described above then apply with respect to the holder of such warrants, such holder may exercise such warrants on a cashless basis. In such a cashless exercise of all the shares covered by the warrant, the warrant holder would receive a number of shares equal to the quotient of (i) the difference between the fair market value of the common stock, as defined, and the $3.50 exercise price, as adjusted, multiplied by the number of shares exercisable under the warrant, divided by (ii) the fair market value of the common stock, as defined. As of March 31, 2016, based on a fair market value of a share of the Company’s common stock of $5.00 and 3,320,501 warrants issued and outstanding and eligible for cashless exercise, the maximum number of shares the Company would be required to issue, if the warrant holders elected to exercise the cashless exercise feature with respect to all then eligible warrants, is 996,150 shares. If the fair market value of a share of the Company’s common stock were to increase by $1.00 from $5.00 to $6.00, the maximum number of shares the Company would be required to issue, if the warrant holders elected to exercise the cashless exercise feature with respect to all then eligible warrants, would increase to 1,383,542 shares as of March 31, 2016.

 

The Company has not yet filed a registration statement with respect to the resale of the Registrable Securities because doing so is not feasible prior to the completion by the Company of its initial public offering. As previously reported, the Company has filed a draft registration statement with the SEC with respect to its proposed initial public offering. The Company believes that it has used commercially reasonable efforts to pursue an initial public offering and, accordingly, considers itself to be in compliance with its registration rights obligations notwithstanding that it has not filed a registration statement with respect to the resale of the Registrable Securities and the deadline for doing so has passed without extension.

 

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Table of Contents

 

NOTE 8 — COMMITMENTS AND CONTINGENCIES

 

Distribution contract — Cardinal Health Specialty Pharmacy Services has been contracted to distribute NutreStore to other wholesale distributors and some independent pharmacies since April 2008. For these services, the Company pays a monthly commercialization management fee of $5,000.

 

Operating leases — The Company leases its office space under operating leases with unrelated entities. The rent expense during the three months ended March 31, 2016 and 2015 amounted to $144,364 and $118,192, respectively.

 

Future minimum lease payments under the agreements are as follows as of March 31, 2016:

 

Year

 

Amount

 

2016 (nine months)

 

$

415,702

 

2017

 

525,023

 

2018

 

491,240

 

2019

 

123,875

 

 

 

$

1,555,840

 

 

14



Table of Contents

 

NOTE 9 — RELATED PARTY TRANSACTIONS

 

On March 18, 2016, the Company issued 22,222 shares of common stock to Yutaka & Soomi Niihara, the Company’s Chairman and Chief Executive Officer for $99,999 or $4.50 per share price.

 

The following table sets forth information relating to the Company’s loans from related persons outstanding as of March 31, 2016.

 

Class

 

Lender

 

Interest
Rate

 

Date of 
Loan

 

Term of Loan

 

Principal
Amount
Outstanding at
March 31, 2016

 

Highest
Principal
Outstanding

 

Amount of
Principal
Repaid

 

Amount

of
Interest
Paid

 

Conversion
Rate

 

Shares
Underlying
Notes
March 31,
2016

 

Current, Promissory note payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hope Hospice (1)

 

8

%

1/17/2012

 

Due on demand

 

$

200,000

 

$

200,000

 

$

 

$

8,000

 

$

 

 

 

 

Hope Hospice (1)

 

8

%

6/14/2012

 

Due on demand

 

200,000

 

200,000

 

 

4,000

 

 

 

 

 

Hope Hospice (1)

 

8

%

6/21/2012

 

Due on demand

 

100,000

 

100,000

 

 

2,000

 

 

 

 

 

Yutaka Niihara (2)(4)

 

10

%

12/5/2012

 

Due on demand

 

126,730

 

1,213,700

 

1,086,970

 

 

 

 

 

 

 

Hope Hospice (1)

 

8

%

2/11/2013

 

Due on demand

 

50,000

 

50,000

 

 

2,000

 

 

 

 

 

Hope Hospice (1)

 

10

%

1/7/2015

 

2 years (3)

 

100,000

 

100,000

 

 

 

 

 

 

 

James Lee (5)

 

10

%

1/26/2015

 

2 years (3)

 

50,000

 

50,000

 

 

 

 

 

 

 

Hope Hospice (1)

 

10

%

1/29/2015

 

2 years (3)

 

 

30,000

 

30,000

 

2,770

 

 

 

 

 

Lan T. Tran (2)

 

10

%

2/9/2015

 

2 years (3)

 

10,000

 

10,000

 

 

 

 

 

 

 

Charles Stark (2)

 

10

%

2/10/2015

 

2 years (3)

 

10,000

 

10,000

 

 

 

 

 

 

 

IRA Service Trust Co. FBO Peter B. Ludlum (2)

 

10

%

2/20/2015

 

2 years (3)

 

10,000

 

10,000

 

 

 

 

 

 

 

Cuc T. Tran (5)

 

11

%

3/5/2015

 

1 year

 

13,161

 

13,161

 

 

 

 

 

 

 

Yutaka Niihara (2)(4)

 

10

%

4/7/2015

 

2 years (3)

 

302,000

 

500,000

 

198,000

 

15,603

 

 

 

 

 

Yutaka Niihara (2)(4)

 

10

%

5/21/2015

 

Due on demand

 

826,105

 

826,105

 

 

47,822

 

 

 

 

 

Masaharu & Emiko Osato (4)

 

11

%

12/29/2015

 

Due on demand

 

300,000

 

300,000

 

 

 

 

 

 

 

Lan Tran (2)

 

11

%

2/10/2016

 

2 years (3)

 

130,510

 

130,510

 

 

 

 

 

 

 

Hideki & Eiko Uehara (5)

 

11

%

2/15/2016

 

Due on demand

 

133,333

 

133,333

 

 

 

 

 

 

 

Masaharu & Emiko Osato (4)

 

11

%

2/25/2016

 

Due on demand

 

400,000

 

400,000

 

 

 

 

 

 

 

 

 

 

 

 

 

Sub total

 

$

2,961,838

 

$

4,276,809

 

$

1,314,970

 

$

82,195

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current, Convertible notes payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yasushi Nagasaki (2)

 

10

%

6/29/2012

 

Due on demand

 

$

254,000

 

$

388,800

 

$

134,800

 

$

27,824

 

$

3.30

 

88,733

 

 

 

 

 

 

 

 

 

Sub total

 

$

254,000

 

$

388,800

 

$

134,800

 

$

27,824

 

 

88,733

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-Current, Convertible notes payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yutaka Niihara (2)(4)

 

10

%

9/29/2015

 

2 years

 

$

100,000

 

$

100,000

 

$

 

$

 

$

4.50

 

23,348

 

 

 

Charles & Kimxa Stark (2)

 

10

%

10/1/2015

 

2 years

 

20,000

 

20,000

 

 

 

4.50

 

4,667

 

 

 

Yutaka & Soomi Niihara (2)(4)

 

10

%

11/16/2015

 

2 years

 

200,000

 

200,000

 

 

 

4.50

 

46,112

 

 

 

 

 

 

 

 

 

Sub total

 

$

320,000

 

$

320,000

 

$

 

$

 

$

 

74,127

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

3,535,838

 

$

4,985,609

 

$

1,449,770

 

$

110,019

 

$

 

162,860

 

 


(1) Dr. Niihara, a director and officer of the Company, is also the CEO of Hope Hospice.

(2) Officer

(3) Due on Demand

(4) Director

(5) Family of Officer/Director

 

15



Table of Contents

 

The following table sets forth information relating to the Company’s loans from related persons outstanding as of December 31, 2015.

 

Class

 

Lender

 

Annual
Interest
Rate

 

Date
of
Loan

 

Term
of
Loan

 

Principal
Amount
Outstanding
at
December 31,
2015

 

Highest
Principal
Outstanding

 

Amount
of
Principal
Repaid

 

Amount
of
Interest
Paid

 

Conversion
Rate

 

Shares
Underlying
Notes at
December 31,
2015

 

Current, Notes payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hope Hospice(1)

 

8

%

1/17/2012

 

Due on demand

 

$

200,000

 

$

200,000

 

$

 

$

8,000

 

$

 

 

 

 

Hope Hospice(1)

 

8

%

6/14/2012

 

Due on demand

 

200,000

 

200,000

 

 

8,000

 

 

 

 

 

Hope Hospice(1)

 

8

%

6/21/2012

 

Due on demand

 

100,000

 

100,000

 

 

4,000

 

 

 

 

 

Yutaka Niihara(2)(4)

 

10

%

12/5/2012

 

Due on demand

 

126,730

 

1,213,700

 

1,086,970

 

56,722

 

 

 

 

 

Hope Hospice(1)

 

8

%

2/11/2013

 

Due on demand

 

50,000

 

50,000

 

 

2,000

 

 

 

 

 

Lan T. Tran(2)

 

11

%

2/10/2014

 

2 years(3)

 

106,976

 

106,976

 

 

 

 

 

 

 

Hideki & Eiko Uehara(5)

 

11

%

2/15/2014

 

2 years

 

133,333

 

133,333

 

 

 

 

 

 

 

Hope Hospice(1)

 

10

%

1/7/2015

 

2 years(3)

 

100,000

 

100,000

 

 

 

 

 

 

 

James Lee(5)

 

10

%

1/26/2015

 

2 years(3)

 

50,000

 

50,000

 

 

 

 

 

 

 

Hope Hospice(1)

 

10

%

1/29/2015

 

2 years(3)

 

30,000

 

30,000

 

 

 

 

 

 

 

Yutaka Niihara(2)(4)

 

10

%

1/29/2015

 

Due on demand

 

 

20,000

 

20,000

 

773

 

 

 

 

 

 

 

Lan T. Tran(2)

 

10

%

2/9/2015

 

2 years(3)

 

10,000

 

10,000

 

 

 

 

 

 

 

Charles Stark(2)

 

10

%

2/10/2015

 

2 years(3)

 

10,000

 

10,000

 

 

 

 

 

 

 

IRA Service Trust Co. FBO Peter B. Ludlum(2)

 

10

%

2/20/2015

 

2 years(3)

 

10,000

 

10,000

 

 

 

 

 

 

 

Cuc T. Tran(5)

 

11

%

3/5/2015

 

1 year

 

13,161

 

13,161

 

 

 

 

 

 

 

Yutaka Niihara(2)(4)

 

10

%

4/7/2015

 

2 years(3)

 

500,000

 

500,000

 

 

 

 

 

 

 

Yutaka Niihara(2)(4)

 

10

%

5/21/2015

 

Due on demand

 

826,105

 

826,105

 

 

 

 

 

 

 

Masaharu & Emiko Osato(4)

 

11

%

12/29/2015

 

Due on demand

 

300,000

 

300,000

 

 

 

 

 

 

 

 

 

 

 

 

 

Sub total

 

$

2,766,304

 

$

3,873,275

 

$

1,106,970

 

$

79,495

 

$

 

 

Current, Convertible notes payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yasushi Nagasaki(2)

 

10

%

6/29/2012

 

Due on demand

 

$

298,000

 

$

388,800

 

$

90,800

 

$

 

$

3.30

 

108,505

 

 

 

 

 

 

 

 

 

Sub total

 

$

298,000

 

$

388,800

 

$

90,800

 

$

 

$

 

108,505

 

Non-Current, convertible notes payable to related parties:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yutaka Niihara(2)(4)

 

10

%

9/29/2015

 

2 years

 

$

100,000

 

$

100,000

 

$

 

$

 

$

4.50

 

22,794

 

 

 

Charles & Kimxa Stark(2)

 

10

%

10/1/2015

 

2 years

 

20,000

 

20,000

 

 

 

 

 

4.50

 

4,556

 

 

 

Yutaka & Soomi Niihara(2)(4)

 

10

%

11/16/2015

 

2 years

 

200,000

 

200,000

 

 

 

 

 

4.50

 

45,004

 

 

 

 

 

 

 

 

 

Sub total

 

320,000

 

320,000

 

$

 

$

 

$

 

72,354

 

 

 

 

 

 

 

 

 

Total

 

$

3,384,304

 

$

4,582,075

 

$

1,197,770

 

$

 

$

 

180,859

 

 


(1) Dr. Niihara, a director and officer of the Company, is also the CEO of Hope Hospice.

(2) Officer

(3) Due on Demand

(4) Director

(5) Family of Officer/Director

 

16



Table of Contents

 

NOTE 10 — GEOGRAPHIC INFORMATION

 

For the three months ended March 31, 2016 and 2015, the Company earned revenue from countries outside of the United States as outlined in the table below:

 

Country

 

Revenues for
the three months ended
March 31, 2016

 

% of total revenue for the
three months ended
March 31, 2016

 

Revenues for the
three months ended
March 31, 2015

 

% of total revenue for the
three months ended
March 31, 2015

 

Japan

 

$

51,074

 

64

%

$

42,743

 

44

%

Taiwan

 

25,211

 

32

%

42,613

 

44

%

 

The Company did not have any significant currency translation or foreign transaction adjustments during the three months ended March 31, 2016 and 2015.

 

NOTE 11 — SUBSEQUENT EVENTS

 

Subsequent to March 31, 2016, the Company issued the following:

 

Notes issued after March 31, 2016

 

Loan Principal Outstanding

 

Annual Interest Rate

 

Term of Notes

 

Conversion Price

 

Convertible notes (1)

 

$

210,160

 

10.00

%

2 years

 

$

4.50

 

Promissory notes

 

550,000

 

11.00

%

Due on demand - 6 months

 

 

Promissory notes — related party

 

409,700

 

10.00

%

2 years (Due on demand)

 

 

 

 

$

1,169,860

 

 

 

 

 

 

 

 


(1)         Includes mandatory conversion at the time of an initial public offering at a conversion price equal to 80% of the initial public offering price.

 

In April and May of 2016, the Company entered into secured loan agreements, pursuant to which it borrowed an aggregate amount of $1,295,000 at a fixed interest rate of 10% per annum. These loans will mature on the earlier of the closing of a new debt financing (subject to certain exceptions, including refinancings of the Company’s outstanding convertible notes) or May 1, 2017. These loans are secured by all personal property of the Company and are personally guaranteed by Dr. Niihara and secured by certain of his real property. Furthermore, the loan agreements contain certain negative covenants including restrictions on the Company’s ability to (1) acquire material assets outside of the ordinary course of business, (2) sell, lease, license transfer or dispose of its personal property outside of the ordinary course of business, (3) pay or declare dividends, (4) make investments in or loans to other persons, (5) redeem or repurchase its stock, (6) make deposits or investments unless they are subject to a deposit control account, (7) incur additional indebtedness other than permitted debt, (8) make payments on subordinated obligations, (9) undergo a merger, change in control or sale of a substantial portion of its assets, or (10) use loan proceeds to make payments to its affiliates.

 

In connection with these loans, the Company also issued its lender warrants for the purchase of 62,500 shares of the Company’s common stock at an exercise price of $4.50 per share. In addition, if these loans remain outstanding for at least 30 days during the 90-day periods ending June 30, 2016, September 30, 2016 and December 31, 2016, the Company will be obligated to issue the lender additional warrants for the purchase of 37,500, 18,750 and 18,750 shares of its common stock, respectively, for an exercise price of the lowest of the fair market value of our common stock as of the start or end of such 90-day period or the lowest public sale price of our common stock during the quarter ended on the applicable measurement date. These warrants may be exercised through a cashless feature.

 

Secured Loans after March 31, 2016

 

Principal
Amounts

 

Annual
Interest
Rate

 

Term of Loans

 

Secured loans

 

$

1,295,000

 

10

%

Earlier of closing of new debt financing or May 1, 2017

 

Total

 

$

1,295,000

 

 

 

 

 

 

17



Table of Contents

 

On May 1, 2016, U.S. Patent No. 5,693,671, entitled “L-glutamine Therapy for SCD and Thalassemia” issued on December 2, 1997 to Niihara et al., (the “SCD Patent”) expired and subsequently, the license agreement pursuant to which the Company was permitted utilize the SCD Patent to develop a treatment approach for SCD and thalassemia using L-glutamine has terminated. Since the SCD Patent is expired, competitors with more resources than the Company may develop similar products which may subject its product to greater competition than the Company expects and reduces its ability to generate revenue from its product candidate, possibly materially. These circumstances may also impair the Company’s ability to obtain license partners or other international commercialization opportunities on terms acceptable to the Company, if at all.

 

Although the SCD patent is expired, the Company will continue to seek market exclusivity protection for the SCD treatment by way of its orphan designation which, if the product is approved, will grant the Company seven years market exclusivity. In addition, under the Title I of the Drug Price Competition and Patent Term Resolution Act or the Hatch/Waxman Act, the Company may be eligible for three-year period market exclusivity if approved by the FDA. The FDA may not agree that the Company’s product is entitled to data exclusivity under the Hatch/Waxman Act and, if granted, data exclusivity protection under the Hatch/Waxman Act will expire three years after its product is approved.

 

With the termination of the license agreement, the Company will no longer be bound by the terms of the agreement which include but are not limited to paying royalties. The royalties were equal to 4.5% of net sales of Licensed Products in the United States until lifetime royalty payments made to the licensor total $100,000, at which time the royalty rate will decrease to 2.5% of net sales of the Licensed Products.

 

18



Table of Contents

 

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

 

With respect to the following discussion, the terms, “we,” “us,” “our” or the “Company” refer to Emmaus Life Sciences, Inc., and its wholly-owned subsidiary Emmaus Medical, Inc., a Delaware corporation which we refer to as Emmaus Medical, and Emmaus Medical’s wholly-owned subsidiaries, Newfield Nutrition Corporation, a Delaware corporation which we refer to as Newfield Nutrition; Emmaus Medical Japan, Inc., a Japanese corporation which we refer to as EM Japan, and Emmaus Medical Europe Ltd., a U.K. corporation which we refer to as EM Europe.

 

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 for the years ended December 31, 2015 and 2014 and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on May 20, 2016 (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, without limitation, our ability to raise additional capital to fund our operations, obtaining U.S. Food and Drug Administration (“FDA”) and other regulatory authorization to market our drug and biological products, successful completion of our clinical trials, our ability to achieve regulatory authorization to market our pharmaceutical grade L-glutamine treatment for sickle cell disease (“SCD”), our ability to commercialize our pharmaceutical grade L-glutamine treatment for SCD; our reliance on third party manufacturers for our drug products, market acceptance of our products, our dependence on licenses for certain of our products, our reliance on the expected growth in demand for our products, exposure to product liability and defect claims, development of a public trading market for our securities, and various other matters, 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 of the forward-looking statements made in this Form 10-Q are qualified by these cautionary statements and accordingly there can be no assurances made with respect to the actual results or developments.

 

Company Overview

 

We are a biopharmaceutical company engaged in the discovery, development and commercialization of innovative treatments and therapies primarily for rare and orphan diseases. We are initially focusing our product development efforts on SCD, a genetic disorder and a significant unmet medical need. Our lead product candidate is an oral pharmaceutical grade L-glutamine treatment that demonstrated positive clinical results in our completed Phase 3 clinical trial for sickle cell anemia and sickle ß0-thalassemia, two of the most common forms of SCD.

 

We are in the process of preparing a new drug application (“NDA”) for submission to the FDA, with respect to this product candidate. If the FDA accepts our submission and approves this NDA, we will be authorized to market in the United States our pharmaceutical grade L-glutamine treatment for SCD patients who are at least five years old.

 

We plan to market our L-glutamine treatment in the United States, if approved, by either strategic partnership or by building our own targeted sales force of approximately 30 sales representatives. We intend to utilize strategic partnerships to market our treatment in the rest of the world. L-glutamine for the treatment of SCD has received Fast Track designation from the FDA as well as Orphan Drug designation from both the FDA and the European Commission (“EC”).

 

We have extensive experience in the field of SCD, including the development, outsourced manufacturing and conduct of clinical trials of our prescription grade L-glutamine product candidate for the treatment of SCD. Yutaka Niihara, M.D., MPH, is a leading hematologist in the field of SCD. Dr. Niihara is licensed to practice medicine in both the United States and Japan and has been actively engaged in SCD research and the care of patients with SCD for over 20 years, primarily at the University of California Los Angeles and the Los Angeles Biomedical Research Institute (“LA BioMed”) a nonprofit biomedical research institute at Harbor UCLA Medical Center.

 

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To a lesser extent, we are also engaged in the marketing and sale of NutreStore L-glutamine powder for oral solution, which has received FDA approval, as a treatment for short bowel syndrome (“SBS”) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication. Our indirect wholly owned subsidiary, Newfield Nutrition, sells L-glutamine as a nutritional supplement under the brand name AminoPure through retail stores in multiple states and via importers and distributors in Japan, Taiwan and South Korea. Since inception, we have generated minimal revenues from the sale and promotion of NutreStore and AminoPure.

 

In May 2006, we formed Newfield Nutrition, a wholly-owned subsidiary of Emmaus Medical, that distributes L-glutamine as a nutritional supplement under the brand name AminoPure.

 

In October 2010, we formed EM Japan, a wholly-owned subsidiary of Emmaus Medical, that markets and sells AminoPure in Japan and other countries in Asia. EM Japan also manages our distributors in Japan and may also import other medical products and drugs in the future.

 

In November 2011, we formed EM Europe, a wholly-owned subsidiary of Emmaus Medical, whose primary focus is expanding our business in Europe.

 

Our corporate structure is illustrated as follows:

 

 

Emmaus Medical, LLC was organized on December 20, 2000. In October 2003, Emmaus Medical, LLC undertook a reorganization and merged with Emmaus Medical, which was originally incorporated in September 2003.

 

Pursuant to an Agreement and Plan of Merger dated April 21, 2011, which we refer to as the Merger Agreement, by and among us, AFH Merger Sub, Inc., our wholly-owned subsidiary, which we refer to as AFH Merger Sub, AFH Advisory and Emmaus Medical, Emmaus Medical merged with and into AFH Merger Sub on May 3, 2011 with Emmaus Medical continuing as the surviving entity, which we refer to as the Merger. Upon the closing of the Merger, we changed our name from “AFH Acquisition IV, Inc.” to “Emmaus Holdings, Inc.” Subsequently, on September 14, 2011, we changed our name from “Emmaus Holdings, Inc.” to “Emmaus Life Sciences, Inc.”

 

Our future capital requirements are substantial and may increase beyond our current expectations depending on many factors, including, but not limited to: the duration and results of the clinical trials for our various products candidates going forward; unexpected delays or developments when seeking regulatory approvals; the time and cost in preparing, filing, prosecuting, maintaining and enforcing patent claims; current and future unexpected developments encountered in implementing our business development and commercialization strategies; the outcome of litigation in which we are currently engaged or may become engaged in the future; and further arrangements, if any, with collaborators. Until we can generate a sufficient amount of product revenue, future cash requirements are expected to be financed through registered or unregistered equity offerings, debt financings or corporate collaboration and licensing arrangements. As of March 31, 2016, our accumulated deficit was $89.2 million and we had cash and cash equivalents of $0.3 million. Since inception we have had minimal revenues and have been required to rely on funding from sales of equity securities and borrowings from officers and stockholders. Currently, we estimate we will need approximately $1.4 million to submit a NDA to the FDA for our pharmaceutical grade L-glutamine treatment for SCD. We expect the NDA will be submitted in mid-2016.

 

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We also own a minority interest of less than 1% in CellSeed, Inc., a Japanese company listed on the Tokyo Stock Exchange, which is engaged in research and development of regenerative medicine products and the manufacture and sale of temperature-responsive cell culture equipment. In collaboration with CellSeed, we are engaged in research and development of cell sheet engineering regenerative medicine products.

 

Financial Overview

 

Revenue

 

Since our inception in 2000, we have had limited revenue from the sale of NutreStore, an FDA approved prescription drug to treat SBS and AminoPure, a nutritional supplement. We have funded operations principally through the private placement of equity securities and debt financings. Our operations to date have been primarily limited to staffing, licensing and promoting products for SBS, outsourcing distribution and sales activities, developing and sponsoring clinical trials of our pharmaceutical grade L-glutamine treatment for SCD, manufacturing products and maintaining and improving our patent portfolio.

 

Currently, we generate revenue through the sale of NutreStore L-glutamine powder for oral solution as a treatment for SBS as well as AminoPure, a nutritional supplement. Pursuant to the exclusive sublicense agreement for US Patent No. 5,288,703, we are required to pay an annual royalty equal to 10% of adjusted gross sales of NutreStore to CATO Holding Company (“CATO”). Management expects that any revenues generated from the sale of NutreStore and AminoPure will fluctuate from quarter to quarter based on the timing of orders and the amount of product sold.

 

Cost of Goods Sold

 

Cost of goods sold includes the raw materials, packaging, shipping and distribution costs of NutreStore and AminoPure.

 

Research and Development Expenses

 

Research and development costs consist of expenditures for new products and technologies, which primarily involve fees paid to the contract research organization (“CRO”), that conducts the 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 supplies. The costs of later stage clinical studies, such as Phase 2 and 3 trials, are generally higher than those of earlier stages of development, such as preclinical studies and Phase 1 trials. This is primarily due to the increased size, expanded scope, patient related healthcare and regulatory compliance costs, and generally longer duration of later stage clinical studies.

 

The most significant clinical trial expenditures in prior years have been related to the CRO costs and the payments to study sites. The contract with the CRO is based on time and material expended, whereas the study site agreements are based on per patient costs as well as other pass-through costs, including, but not limited to, 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 forecast with any degree of certainty which product candidates may be subject to future 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. We currently estimate that we will need an additional $1.4 million to submit a NDA to the FDA for our pharmaceutical grade L-glutamine treatment for SCD. We expect the NDA will be submitted in the summer of 2016.

 

At this time, due to the inherently unpredictable nature of the process for developing drugs, biologics and cell-based therapies and the interpretation of the regulatory requirements, we are unable to estimate with any degree of certainty the amount of costs which will be incurred in obtaining FDA approval of our pharmaceutical grade L-glutamine treatment for SCD and the continued 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 Development of our Product Candidates,” “Risk Factors—Risks Related to our Reliance on Third Parties,” and “Risk Factors—Risks Related to Regulatory Approval of our Product Candidates and Other Legal Compliance Matters.”

 

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We estimate that the cost to us to develop in the United States corneal cell sheet products based on Cultured Autologous Oral Mucosal Epithelial Cell-Sheets (“CAOMECS”) technology will be approximately $3.0 million. This estimate includes the anticipated cost of obtaining FDA approval for the corneal cell sheets and assumes that we will need the FDA to approve a Biologic License Application (“BLA”) for the corneal cell sheets, rather than a NDA. We estimate that we will need another $2.4 million to commercialize any approved products based on corneal cell sheet technology.

 

In addition, we estimate that we will need $2.5 million for research related to other cell sheet applications and to build a current Good Manufacturing Practices (“cGMP”) laboratory to establish the infrastructure and production capabilities related to regenerative medicine products. At this time, we do not plan to incur any research and development costs for our NutreStore and AminoPure products.

 

General and Administrative Expenses

 

General and administrative expenses consist principally of salaries and related costs, including share-based compensation, for personnel in executive, finance, business development, information technology, marketing and legal functions. Other general and administrative expenses include facility costs, patent filing costs and professional fees and expenses for legal, consulting, auditing and tax services. Inflation has not had a material impact on our general and administrative expenses over the past two years.

 

Environmental Expenses

 

The cost of compliance with environmental laws has not been material over the past two years and any such costs are included in general and administrative costs.

 

Inventories

 

Inventories consist of finished goods and work-in-process and are valued on a first-in, first-out basis and at the lower of cost or market value. All of the raw material purchased during the three months ended March 31, 2016 and 2015 were from one vendor.

 

Results of Operations

 

Three months ended March 31, 2016 and 2015

 

Net Losses. Net losses increased by $1.2 million, or 37%, to $4.4 million from $3.2 million for the three months ended March 31, 2016 and 2015, respectively. The increase in losses is primarily a result of increased other expenses, partially offset by decreased operating expenses, in each case as discussed below. As of March 31, 2016, we had an accumulated deficit of approximately $89.2 million. Losses, partially offset by revenue from commercialized products, will continue as we advance our sickle cell treatment toward potential regulatory approval and commercialization. As a result, we anticipate that we will continue to incur net losses and be unprofitable for the foreseeable future. There can be no assurance that we will ever operate at a profit, even if all of our products are commercialized.

 

Revenues, Net. Net revenues decreased by $17,000, or 18%, to $79,000 from $96,000 for the three months ended March 31, 2016 and 2015. Combined revenues from our AminoPure® L-glutamine nutritional supplement product and our NutreStore® L-glutamine powder for oral solution for treatment of SBS decreased during these periods. The decrease is primarily due to decreased sales volume of our AminoPure® L-glutamine nutritional supplement product in both US and international markets.

 

Cost of Goods Sold. Cost of goods sold decreased by $22,000, or 44%, to $28,000 from $50,000 for the three months ended March 31, 2016 and 2015. Cost of goods sold includes costs for raw material, packaging, testing, shipping and costs related to scrapped inventory. All of the raw material purchased during the three months ended March 31, 2016 and 2015 was from one vendor. Cost of sales decreased due to decreased sales associated with our AminoPure® L-glutamine nutritional supplement product and our NutreStore® L-glutamine powder for oral solution for treatment of SBS during these periods. The decrease in the cost of goods sold in 2016 can be attributed to the increase in international sales, which has a higher gross profit margin.

 

Research and Development Expenses. Research and development expenses increased by $0.3 million, or 106%, to $0.5 million from $0.2 million for the three months ended March 31, 2016 and 2015. This increase was primarily due to an increase in our preparation of NDA submission activities. We expect our research and development costs to increase in the rest of 2016 to support our NDA post-submission activities, work on marketing approvals outside the US and potentially future clinical trial activity.

 

Selling Expenses. Selling expenses decreased by $63,000, or 40%, to $94,000 from $157,000 for the three months ended March 31, 2016 and 2015 due primarily to a decrease in advertising. Selling expenses includes the costs for distribution, promotion, travel, tradeshows and exhibits related to NutreStore® and AminoPure® as well as the marketing expense for our pharmaceutical grade L-glutamine treatment for SCD.

 

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General and Administrative Expenses. General and administrative expenses decreased $0.6 million, or 20%, to $2.3 million from $2.9 million for the three months ended March 31, 2016 and 2015. General and administrative expenses include share-based compensation expenses, professional fees, office rent, and payroll expenses. This decrease was primarily due to a decrease of $0.7 million for share-based compensation due to expiration of the service period for certain options in prior periods partially offset by an increase of $0.2 million for professional fees and office rent expenses.

 

Other Income and Expense. Total other expense increased by $1.6 million, or 4,815%, to $1.6 million expense for the three months ended March 31, 2016, compared to $33,000 expense for the three months ended March 31, 2015, primarily due to a negative change in fair value of warrant derivative liabilities of $1.2 million, a negative change in fair value of liability classified warrants of $0.2 million, an increase in interest costs of $0.1 million as a result of increased debt and an increase of $0.1 million in foreign exchange loss.

 

We anticipate that our operating expenses will increase for, among others, the following reasons:

 

·                  as a result of future debt repayments, increased payroll, expanded infrastructure and higher consulting, legal, accounting and investor relations costs, and director and officer insurance premiums associated with being a public company;

 

·                  to support research and development activities, which we expect to expand as development of our product candidate(s) continues and we approach submission of an NDA for pharmaceutical grade L-glutamine treatment for SCD; and

 

·                  to build a sales and marketing team before we receive regulatory approval of a product candidate in anticipation of commercial launch.

 

Liquidity and Capital Resources

 

Based on our losses to date, anticipated future revenue and operating expenses, debt repayment obligations and cash and cash equivalents balance of $0.3 million as of March 31, 2016, we do not have sufficient operating capital for our business without raising additional capital. We incurred losses of $4.5 million for the three months ended March 31, 2016 and $3.2 million for the three months ended March 31, 2015. We had an accumulated deficit at March 31, 2016 of $89.2 million. We anticipate that we will continue to incur net losses for the foreseeable future as we incur expenses for submission of the NDA, the commercialization of our pharmaceutical grade L-glutamine treatment of SCD, research costs for the corneal cell sheets using CAOMECS technology and the expansion of corporate infrastructure, including costs associated with being a public reporting company and potentially additional expenses that may be associated with an initial public offering. We have previously relied on unregistered equity offerings, debt financings and loans, including loans from related parties. As part of this effort, we have received various loans from officers, stockholders and other investors as discussed below. As of March 31, 2016, we had outstanding notes payable in an aggregate principal amount of $19.8 million, consisting of $7.7 million of non-convertible promissory notes and $12.1 million of convertible notes. Of the $19.8 million aggregate principal amount of notes outstanding as of March 31, 2016, approximately $14.5 million is either due on demand or will become due and payable within the next twelve months. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategies, including the commercialization of our pharmaceutical grade L-glutamine treatment for SCD and the development in the United States of CAOMECS-based cell sheet technology.

 

We have had recurring operating losses, have a significant amount of notes payable and other obligations due within the next year and projected operating losses including the expected costs relating to the commercialization of our pharmaceutical grade L-glutamine treatment for SCD that exceed both the existing cash balances and cash expected to be generated from operations for at least the next year. In order to meet our expected obligations, management intends to raise additional funds through equity and debt financings and partnership agreements. In addition, we may seek to raise additional funds through collaborations with other companies or financing from other sources. As previously reported, we have filed a draft registration statement with the SEC with respect to an initial public offering. Additional funding may not be available in amounts or on terms which are acceptable to us, if at all. Due to the uncertainty of our ability to meet our current operating and capital expenses, there is substantial doubt about our ability to continue as a going concern. Furthermore, our ability to raise capital may be negatively impacted by our current shareholder litigation, or by any adverse aspects of a settlement or judgment related to such litigation.

 

In addition, we currently estimate that we will need an additional $1.4 million to submit a NDA to the FDA for our pharmaceutical grade L-glutamine treatment for SCD. Our cash burn rate for the first three months ending March 31, 2016 was approximately $0.8 million per month.

 

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As discussed in our Annual Report under the heading “Risk Factors—Risks Related to Development of our Product Candidates,” if the FDA does not accept for filing our NDA for our pharmaceutical grade L-glutamine treatment or does not approve our NDA based on a single Phase 3 clinical trial, in each case unless we conduct a second Phase 3 clinical trial or confirmatory study, the potential approval of our product candidate will be delayed. Under these circumstances, we will incur additional costs to seek to convince the FDA that a confirmatory study is unnecessary for filing or approval, or to design and conduct a second Phase 3 clinical trial or confirmatory study, or both. If we conduct a second Phase 3 clinical trial or confirmatory study prior to the approval of our NDA, it is possible that the results of that trial will be less favorable than the results of our completed Phase 3 trial and further delay or complicate the approval process. The incurrence of additional costs may require us to raise additional capital, and any delay in obtaining approval of our product candidate will reduce the period during which we can market and sell our product with patent protection and may affect our ability to obtain other protections against competition.

 

Our cash flow from operations is not adequate and our future capital requirements will be substantial and may increase beyond our current expectations depending on many factors including, but not limited to: the number, duration and results of the clinical trials for our various product candidates going forward; unexpected delays or developments in seeking regulatory approvals; the time and cost in preparing, filing, prosecuting, maintaining and enforcing patent claims; other unexpected developments encountered in implementing our business and commercialization strategies; the outcome of and expenses incurred during existing and any future litigation; and further arrangements, if any, with collaborators. We will rely, in part, on sales of AminoPure for revenues, which we expect will increase due to the expected growth in its export volume as we have added additional distributors and expanded retail markets outside of the United States. Revenues from NutreStore currently are not significant and we are unsure whether sales of NutreStore will increase. Until we can generate a sufficient amount of product revenue, future cash needs are expected to be financed through registered or unregistered equity offerings, debt financings, loans, including loans from related parties, or other sources, such as strategic partnership agreements and corporate collaboration and licensing arrangements. Until we can generate a sufficient amount of product revenue, there can be no assurance of the availability of such capital on terms acceptable to us (or at all).

 

For the three months ended March 31, 2016 and during the year ended December 31, 2015, we borrowed $0.7 million and $7.3 million, respectively, pursuant to convertible notes and non-convertible promissory notes, of which $0.4 million and $2.2 million, respectively, have been issued to related parties. As of March 31, 2016 and December 31, 2015, the aggregate principal amounts outstanding under convertible notes and non-convertible promissory notes totaled $19.8 million and $19.1 million, respectively. The convertible notes and non-convertible promissory notes bear interest at rates ranging from 6.0% to 11% and are unsecured, except for a 2011 convertible note in the principal amount of $0.5 million. The net proceeds of the loans were used for working capital.

 

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The table below lists our outstanding notes payable as of March 31, 2016 and December 31, 2015 and the material terms of our outstanding borrowings:

 

Year Issued

 

Interest Rate
range

 

Term of Notes

 

Conversion
 Price

 

Principal
Outstanding
March 31,
2016

 

Discount
Amount
March 31,
2016

 

Carrying
Amount
March 31,
2016

 

Shares
Underlying
Notes March
31, 2016

 

Principal
Outstanding
December 31,
2015

 

Discount
Amount
December 31,
2015

 

Carrying
Amount
December 31,
2015

 

Shares
Underlying
Notes
December
31, 2015

 

Notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2013

 

10%

 

Due on demand

 

 

$

890,000

 

$

 

$

890,000

 

 

$

830,000

 

$

 

$

830,000

 

 

2014

 

11%

 

Due on demand ~ 2 years

 

 

613,614

 

 

613,614

 

 

1,446,950

 

 

1,446,950

 

 

2015

 

11%

 

Due on demand ~ 2 years

 

 

2,443,400

 

 

2,443,400

 

 

2,379,799

 

 

2,379,799

 

 

2016

 

11%

 

Due on demand

 

 

833,335

 

 

833,335

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

4,780,349

 

$

 

$

4,780,349

 

$

 

$

4,656,749

 

$

 

$

4,656,749

 

 

 

 

 

 

Current

 

 

 

$

4,780,349

 

$

 

$

4,780,349

 

 

$

4,656,749

 

$

 

$

4,656,749

 

 

 

 

 

 

Non-current

 

 

 

$

 

$

 

$

 

 

$

 

$

 

$

 

 

Notes payable - related party

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2012

 

8% ~ 10%

 

Due on demand

 

 

$

626,730

 

$

 

$

626,730

 

 

$

626,730

 

$

 

$

626,730

 

 

2013

 

8%

 

Due on demand

 

 

50,000

 

 

50,000

 

 

50,000

 

 

50,000

 

 

2014

 

11%

 

Due on demand ~ 2 years

 

 

 

 

 

 

240,308

 

 

240,308

 

 

2015

 

10% ~ 11%

 

Due on demand ~ 2 years

 

 

1,621,265

 

 

1,621,265

 

 

1,849,266

 

 

1,849,266

 

 

2016

 

11%

 

Due on demand ~ 2 years

 

 

663,843

 

 

 

663,843

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

2,961,838

 

$

 

$

2,961,838

 

 

$

2,766,304

 

$

 

$

2,766,304

 

 

 

 

 

 

Current

 

 

 

$

2,961,838

 

$

 

$

2,961,838

 

 

$

2,766,304

 

$

 

$

2,766,304

 

 

 

 

 

 

Non-current

 

 

 

$

 

$

 

$

 

 

$

 

$

 

$

 

 

Convertible notes payable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2010

 

6%

 

5 years

 

$ 3.05

 

$

2,000

 

$

 

$

2,000

 

656

 

$

2,000

 

$

 

$

2,000

 

656

 

2011

 

10%

 

5 years

 

$ 3.05

 

500,000

 

 

500,000

 

165,173

 

500,000

 

 

500,000

 

163,809

 

2013

 

10%

 

2 years

 

$ 3.60

 

200,257

 

 

200,257

 

71,446

 

525,257

 

 

525,257

 

185,553

 

2014

 

10%

 

Due on demand ~ 2 years

 

$ 3.05 ~$7.00

 

4,403,470

 

236,542

 

4,166,928

 

1,151,351

 

4,378,563

 

353,700

 

4,024,863

 

1,120,470

 

2015

 

10%

 

Due on demand ~ 2 years

 

$ 3.50 ~$7.00

 

5,384,340

 

420,490

 

4,963,850

 

1,462,149

 

5,681,166

 

526,066

 

5,155,100

 

1,517,996

 

2016 

 

10%

 

Due on demand ~ 2 years

 

$ 3.60~$4.50

 

1,028,959

 

279,100

 

749,859

 

272,872

 

 

 

 

 

 

 

 

 

 

 

 

 

$

11,519,026

 

$

936,132

 

$

10,582,894

 

3,123,647

 

$

11,086,986

 

$

879,766

 

$

10,207,220

 

2,988,484

 

 

 

 

 

Current

 

 

 

$

6,913,862

 

$

457,983

 

$

6,455,879

 

1,915,803

 

$

6,358,698

 

$

358,351

 

$

6,000,347

 

1,762,849

 

 

 

 

 

Non-current

 

 

 

$

4,605,164

 

$

478,149

 

$

4,127,015

 

1,207,844

 

$

4,728,288

 

$

521,415

 

$

4,206,873

 

1,225,635

 

Convertible notes payable - related party

2012

 

10%

 

Due on demand

 

$ 3.30

 

$

254,000

 

$

 

$

254,000

 

88,733

 

$

298,000

 

$

 

$

298,000

 

108,505

 

2015

 

10%

 

2 years

 

$ 4.50

 

320,000

 

 

320,000

 

74,127

 

320,000

 

 

320,000

 

72,354

 

 

 

 

 

 

 

 

 

$

574,000

 

$

 

$

574,000

 

162,860

 

$

618,000

 

$

 

$

618,000

 

180,859

 

 

 

 

 

Current

 

 

 

$

254,000

 

$

 

$

254,000

 

88,733

 

$

298,000

 

$

 

$

298,000

 

108,505

 

 

 

 

 

Non-current

 

 

 

$

320,000

 

$

 

$

320,000

 

74,127

 

$

320,000

 

$

 

$

320,000

 

72,354

 

 

 

 

 

Grand Total

 

 

 

$

19,835,213

 

$

936,132

 

$

18,899,081

 

3,286,507

 

$

19,128,039

 

$

879,766

 

$

18,248,273

 

3,169,343

 

 

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Subsequent to March 31, 2016, the Company issued the following:

 

Notes issued after March 31, 2016

 

Loan Principal Outstanding

 

Annual Interest Rate

 

Term of Notes

 

Conversion Price

 

Convertible notes (1)

 

$

210,160

 

10.00

%

2 years

 

$

4.50

 

Promissory notes

 

$

550,000

 

11.00

%

Due on demand - 6 months

 

 

Promissory notes — related party

 

159,700

 

11.00

%

2 years (Due on demand)

 

 

 

 

$

919,860

 

 

 

 

 

 

 

 


(1)         Includes mandatory conversion at the time of an initial public offering at a conversion price equal to 80% of the initial public offering price.

 

In April and May of 2016, we entered into secured loan agreements, pursuant to which we borrowed in the aggregate amount of $1,295,000 at a fixed interest rate of 10% per annum. These loans will mature on the earlier of the closing of a new debt financing (subject to certain exceptions, including refinancings of our outstanding convertible notes) or May 1, 2017. These loans are secured by all of our personal property and are personally guaranteed by Dr. Niihara and secured by certain of his real property. Furthermore, the loan agreements contain certain negative covenants that may hinder our ability to raise additional capital or might otherwise affect our liquidity, including restrictions on our ability to (1) acquire material assets outside of the ordinary course of business, (2) sell, lease, license transfer or dispose of our personal property outside of the ordinary course of business, (3) pay or declare dividends, (4) make investments in or loans to other persons, (5) redeem or repurchase our stock, (6) make deposits or investments unless they are subject to a deposit control account, (7) incur additional indebtedness other than permitted debt, (8) make payments on subordinated obligations, (9) undergo a merger, change in control or sale of a substantial portion of our assets, or (10) use loan proceeds to make payments to our affiliates. If we are unable to repay these loans when they become due, or if we otherwise suffer an event of default under the loan agreements, the lender may have the right to foreclose on their collateral, which could have a material and adverse effect on our business, financial condition, liquidity and operations.

 

In connection with these loans, we also issued the lender warrants for the purchase of 62,500 shares of our common stock at an exercise price of $4.50 per share. In addition, if these loans remain outstanding for at least 30 days during the 90-day periods ending June 30, 2016, September 30, 2016 and December 31, 2016, we will be obligated to issue the lender additional warrants for the purchase of 37,500, 18,750 and 18,750 shares of our common stock, respectively, for an exercise price of the lowest of the fair market value of our common stock as of the start or end of such 90-day period or the lowest public sale price of our common stock during the quarter ended on the applicable measurement date. As these loans have been outstanding for more than 30 days during the 90-day period ending June 30, 2016, we will be obligated to issue the lender an additional warrant for the purchase of 37,500 shares of our common stock on the terms set forth above. These warrants may be exercised through a cashless feature.

 

Secured Loans after September 30, 2015

 

Principal
Amounts

 

Annual
Interest
Rate

 

Term of Loans

 

Secured loans

 

$

1,295,000

 

10

%

Earlier of closing of new debt financing or May 1, 2017

 

Total

 

$

1,295,000

 

 

 

 

 

 

Cash flows for the three months ended March 31, 2016 and March 31, 2015

 

Net cash used in operating activities

 

Net cash flows used in operating activities increased by $1.1 million, or 92%, to $2.3 million from $1.2 million for the three months ended March 31, 2016 and 2015, respectively. This increase was primarily due to a $1.2 million increase in net loss and an increase of working capital of $0.6 million, partially offset by a $0.7 million decrease in the non-cash adjustments to net income. The decrease in non-cash adjustments to net income was primarily attributable to the following: $1.4 million for the change in the fair value of liability classified warrants and warrant derivative liabilities and $0.1 million for a foreign exchange adjustment on notes payable, partially offset by a $0.7 million decrease in share-based compensation, the impact of a decrease of $0.1 million in interest expense accrued from discount of convertible notes and a $0.1 million decrease in depreciation and amortization expense.

 

Net cash used in investing activities

 

Net cash flows used in investing activities decreased by $1,467, to $0.0 from $1,467 for the three months ended March 31, 2016 and 2015, respectively. The decrease was due to absence of purchase of property and equipment in the three months ended March 31, 2016.

 

Net cash from financing activities

 

Net cash flows from financing activities increased by $1.2 million, or 120%, to $2.2 million from $1.0 million for the three months ended March 31, 2016 and 2015, respectively, as a result of an $1.8 million increase in proceeds of issuance of common stocks, partially offset by a $0.2 million decrease in proceeds from issuance of convertible and non-convertible promissory notes, a $0.3 million increase in repayment of convertible and non-convertible promissory notes and a $0.1 million decrease in proceeds from exercise of warrants.

 

Off-Balance-Sheet Arrangements

 

Since our inception, we have not engaged in any off-balance sheet arrangements.

 

Critical Accounting Policies

 

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 GAAP, on the basis that the Company will continue as a going concern. Due to the uncertainty of the Company’s ability to meet its current operating and capital expenses, there is substantial doubt about the Company’s ability to continue as a going concern, as the continuation and expansion of its business is dependent upon obtaining further financing, successful and sufficient market acceptance of its products, and finally, achieving a profitable level of operations. The consolidated

 

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interim financial statements do not include any adjustments that might result from the outcome of these uncertainties. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of 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 our Annual Report for our critical accounting policies. There have been no material changes in any of our critical accounting policies during the three months ended March 31, 2016.

 

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 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 (“Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures 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 disclosure.

 

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 Interim Chief Financial Officer, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act). Based upon this evaluation and due to the material weakness in our internal control over financial reporting as of December 31, 2015 described below, our Chief Executive Officer and Interim Chief Financial Officer concluded that the Company’s disclosure controls and procedures are not effective. Our management is working at remediating the material weakness in our internal controls over financial reporting. However, we have not yet completed a full annual accounting cycle since December 31, 2015 to fully validate the remediation of the material weakness in our internal controls and the effectiveness of the Company’s disclosure controls and procedures.

 

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 March 31, 2016 which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Material Weakness and Plan of Remediation

 

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is 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 would permit 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 internal control over financial reporting as of December 31, 2015. This evaluation was conducted under the supervision of our management, including our Chief Executive Officer, Chief Business Officer, Sr. Vice President of Finance, and the Interim Chief Financial Officer. Based on that evaluation, we have concluded that our internal control over financial reporting was not effective as of December 31, 2015 principally due to the continuance of a material weakness in our internal control over financial reporting, initially identified in our evaluations of the effectiveness of our internal control over financial reporting as of December 31, 2014 and 2013, with respect to the application of generally accepted accounting principles (GAAP) in the United States of America on certain complex transactions as well as maintaining effective controls over the completeness and accuracy of financial reporting for complex or unusual transactions . Further, as of mid-August 2015 through December 2015 we did not have a sufficient number of independent directors to constitute audit committee.

 

Our management and Board of Directors are committed to the remediation of the material weakness, as well as the continued improvement of our overall system of internal control over financial reporting. We are in the process of implementing measures to remediate the underlying causes of the control deficiency that gave rise to the material weakness, which primarily include engaging additional and supplemental internal and external resources with the technical expertise in US GAAP as well as to implement new policies and procedures to provide more effective controls to track, process, analyze, and consolidate the financial data and reports.

 

We believe these measures will remediate the control deficiencies that gave rise to a material weakness. As we continue to evaluate and work to remediate these control deficiencies, we may determine that additional remedial measures are required.

 

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Part II. Other Information

 

Item 1. Legal Proceedings

 

Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on May 20, 2016 (the “Annual Report”), for a prior discussion of our legal proceedings.

 

Item 1A. Risk Factors

 

There have been no material changes from the risk factors disclosed in the “Risk Factors” section of the Annual Report.

 

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

 

On January 1, 2016, the Company issued a convertible note to a third party in the principal amount of $80,000, which bears interest at 10% per annum and matures on the two-year anniversary date of the note. If the Company completes a qualified public offering, the principal amount of the note will automatically convert into shares of the Company’s common stock at a conversion price equal to 80% of the initial public offering price in the qualified public offering. At or after the first anniversary of the loan date, the holder of the note may convert some or all of the unpaid principal amount thereof, including unpaid accrued interest, into shares of the Company’s common stock at a conversion price of $4.50 per share.

 

On January 6, 2016, the Company issued a convertible note to a third party in the principal amount of $99,950, which bears interest at 10% per annum and mature on the two-year anniversary date of the note. If the Company completes a qualified public offering, the principal amount of the note will automatically convert into shares of the Company’s common stock at a conversion price equal to 80% of the initial public offering price in the qualified public offering. At or after the first anniversary of the loan date, the holder of the note may convert some or all of the unpaid principal amount thereof, including unpaid accrued interest, into shares of the Company’s common stock at a conversion price of $4.50 per share.

 

On January 7, 2016, the Company issued 377,778 shares of common stock to Korea Bio Medical Science Institute, at a price of $4.50 per share for an aggregate price of $1,700,000.

 

On February 5, 2016, the Company issued a convertible note to a third party in the principal amount of $100,000, which bears interest at 10% per annum and mature on the two-year anniversary date of the note. If the Company completes a qualified public offering, the principal amount of the note will automatically convert into shares of the Company’s common stock at a conversion price equal to 80% of the initial public offering price in the qualified public offering. At or after the first anniversary of the loan date, the holder of the note may convert some or all of the unpaid principal amount thereof, including unpaid accrued interest, into shares of the Company’s common stock at a conversion price of $4.50 per share.

 

On February 21, 2016, the Company refinanced a convertible note payable to a third party in the original principal amount of $100,800 with a new convertible note in the principal amount of $110,880 which bears interest at 10% per annum. The note has a one year term. The principal amount plus any unpaid accrued interest due under the convertible note is convertible into shares of the Company’s common stock at $3.60 per share at any time during the term of this note upon election of the holder.

 

On March 2, 2016, the Company refinanced a convertible note payable a third party in the original principal amount of $196,026 with a new convertible note in the principal amount of $215,629 which bears interest at 10% per annum. The term of this note is due on demand up to one year from the date of issuance. The principal amount and any unpaid interest due under the note are convertible into shares of the Company’s common stock at $3.60 per share at any time during the term of this note upon election of the holder.

 

On March 15, 2016, the Company refinanced a convertible note payable to a third party in the original principal amount of $125,000 with a new convertible note in the principal amount of $162,500 which bears interest at 10% per annum. The term of this note is two year from the date of issuance. The principal amount and any unpaid interest due under the note are convertible into shares of the Company’s common stock at $3.60 per share at any time during the term of this note upon election of the holder.

 

On March 18, 2016, the Company issued 22,222 shares of common stock to Yutaka & Soomi Niihara, the Company’s Chairman and Chief Executive Officer, at a price of $4.50 per share for an aggregate price of $99,999.

 

On March 19, 2016, the Company refinanced a convertible note payable to a third party in the original principal amount of $200,000 with a new convertible note in the principal amount of $260,000 which bears interest at 10% per annum. The term of this note is two year from the date of issuance. The principal amount and any unpaid interest due under the note are convertible into shares of the Company’s common stock at $3.60 per share.

 

Except as explicitly noted above, all such securities were issued in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act or, in the case of refinancings, upon the exemption from registration provided by Section 3(a)(9) of the Securities Act. These securities qualified for exemption under Section 4(a)(2) of the Securities Act because the issuance of securities by the Company did not involve a “public offering.” The issuance was not a public offering based upon the following factors: (i) a limited number of securities were issued to a limited number of offerees; (ii) there was no public solicitation; (iii) each offeree was an “accredited investor” as such term is defined by Rule 501 under the Securities Act; and (iv) the investment intent of the offerees. No underwriters were used in connection with such sales of unregistered securities.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

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Item 5. Other Information

 

None.

 

Item 6. Exhibits

 

(a)           Exhibits

 

Exhibit
Number

 

Description of Document

 

 

 

4.1

 

Form of Convertible Promissory Note issued by the registrant to the persons indicated in Schedule A attached to the Form of Convertible Promissory Note.

 

 

 

4.2

 

Convertible Promissory Note dated February 21, 2016 issued by the registrant to Sun Moo & Hyon Sil Lee.

 

 

 

4.3

 

Convertible Promissory Note dated March 2, 2016 issued by the registrant to J.R. Dowey.

 

 

 

4.4

 

Form of Convertible Promissory Note issued by the registrant to the persons indicated in Schedule A attached to the Form of Convertible Promissory Note.

 

 

 

10.1

 

Promissory Note dated February 25, 2016 by the registrant to Masaharu & Emiko Osato.

 

 

 

10.2

 

Form of Promissory Note issued by the registrant to the persons indicated in Schedule A attached to the Form of Promissory Note.

 

 

 

10.3

 

Termination Agreement dated March 14, 2016 by and among the registrant, Yutaka Niihara and T. R. Winston & Company, LLC (incorporated by reference from Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 18, 2016).

 

 

 

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 to 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 the 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

 

XBRL Instance Document

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 


*

 

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.

 

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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: June 6, 2016

By:

/s/ Yutaka Niihara

 

Name:

Yutaka Niihara, M.D., MPH

 

Its:

Chief Executive Officer
(principal executive officer and duly authorized officer)

 

 

 

 

 

 

 

By:

/s/ Steve Lee

 

Name:

Steve Lee

 

Its:

Interim Chief Financial Officer

 

 

(principal financial and accounting officer)

 

30