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EX-32.1 - EX-32.1 - Zyla Life Scienceszcor-20200331ex321c788ac.htm
EX-31.1 - EX-31.1 - Zyla Life Scienceszcor-20200331ex311b3587f.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2020

 

Or

 

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

 

For the transition period from              to

 

Commission File Number 001-36295

 

Zyla Life Sciences

 

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

 

Delaware
(State or Other Jurisdiction of
Incorporation or Organization)

 

46-3575334
(I.R.S. Employer
Identification No.)

 

 

 

600 Lee Road
Suite 100
Wayne, PA
(Address of Principal Executive Offices)

 

19087
(Zip Code)

 

Registrant’s telephone number, including area code: (610) 833-4200

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒  No ☐

 

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

 

Large accelerated filer ☐

 

Accelerated filer ☐

 

 

 

Non-accelerated filer ☒ 

 

Smaller reporting company ☒

 

 

 

Emerging growth company ☐

 

 

 

 If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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

 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act

of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐No

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

 

 

 

Title of each class:

    

Trading Symbol

    

Name of each exchange on which registered:

Par value $0.001

 

ZCOR

 

OTCQX

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practical date.

 

Common Stock, $0.001 par value                                 Shares outstanding as of May 10, 2020: 9,611,957

 

 

 

 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. 

Financial Statements

 

 

Consolidated Balance Sheets as of March 31, 2020 (unaudited) and December 31, 2019

1

 

Consolidated Statements of Operations unaudited for the three months ended March 31, 2020 (Successor), the Period February 1, 2019 through March 31, 2019 (Successor) and the Period January 1, 2019 through January 31, 2019 (Predecessor)

2

 

Consolidated Statements of Comprehensive Loss unaudited for the three months ended March 31, 2020 (Successor), the Period February 1, 2019 through March 31, 2019 (Successor) and the Period January 1, 2019 through January 31, 2019 (Predecessor)

3

 

Consolidated Statements of Changes in Stockholders’ Equity (unaudited) for the three months ended March 31, 2020 (Successor), the Period February 1, 2019 through March 31. 2019 (Successor) and the Period January 1, 2019 through January 31, 2019 (Predecessor)

4

 

Consolidated Statements of Cash Flows unaudited for the three months ended March 31, 2020 (Successor), the Period February 1, 2019 through March 31, 2019 (Successor) and the Period January 1, 2019 to January 31, 2019 (Predecessor)

5

 

Notes to Unaudited Consolidated Financial Statements

6

Item 2. 

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

39

Item 3. 

Quantitative and Qualitative Disclosures About Market Risk

48

Item 4. 

Controls and Procedures

48

 

PART II - OTHER INFORMATION

 

Item 1. 

Legal Proceedings

49

Item 1A. 

Risk Factors

49

Item 2. 

Unregistered Sales of Equity Securities and Use of Proceeds

50

Item 3 

Defaults Upon Senior Securities

50

Item 4. 

Mine Safety Disclosures

50

Item 5. 

Other Information

51

Item 6. 

Exhibits

52

 

 

 

SIGNATURES 

56

 

Unless otherwise indicated or the context otherwise requires, references to the “Company”, “we”, “us” and “our” refer to Zyla Life Sciences and its subsidiaries. The Zyla logo is our trademark and Zyla is our registered trademark. All other trade names, trademarks and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. We have assumed that the reader understands that all such terms are source-indicating. Accordingly, such terms, when first mentioned in this Quarterly Report on Form 10-Q, appear with the trade name, trademark or service mark notice and then throughout the remainder of this Quarterly Report on Form 10-Q without the trade name, trademark or service mark notices for convenience only and should not be construed as being used in a descriptive or generic sense. Unless otherwise indicated, all statistical information provided about our business in this report is as of March 31, 2020.

 

 

i

PART I

 

ITEM 1.  FINANCIAL STATEMENTS

 

Zyla Life Sciences and Subsidiaries

 

Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

March 31, 2020

  

   

December 31, 2019

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

14,541

 

 

$

11,965

 

Accounts receivable, net

 

 

31,062

 

 

 

25,697

 

Inventory

 

 

10,281

 

 

 

9,049

 

Prepaid expenses and other current assets

 

 

3,445

 

 

 

4,102

 

Other receivables

 

 

878

 

 

 

815

 

Total current assets

 

 

60,207

 

 

 

51,628

 

Intangible assets, net

 

 

106,985

 

 

 

110,482

 

Restricted cash

 

 

400

 

 

 

400

 

Property and equipment, net

 

 

3,118

 

 

 

3,316

 

Right of use assets

 

 

2,479

 

 

 

2,672

 

Goodwill

 

 

53,917

 

 

 

58,747

 

Deposits and other assets

 

 

2,373

 

 

 

3,142

 

Total assets

 

$

229,479

 

 

$

230,387

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

23,101

 

 

$

12,752

 

Accrued expenses

 

 

55,310

 

 

 

50,357

 

Debt - current, net

 

 

7,797

 

 

 

8,177

 

Acquisition-related contingent consideration

 

 

5,825

 

 

 

3,500

 

Other current liabilities

 

 

1,008

 

 

 

985

 

Total current liabilities

 

 

93,041

 

 

 

75,771

 

Debt - non-current portion, net

 

 

91,346

 

 

 

91,710

 

Acquisition-related contingent consideration

 

 

14,475

 

 

 

14,400

 

Credit agreement

 

 

4,138

 

 

 

4,050

 

Other liabilities

 

 

1,783

 

 

 

2,065

 

Total liabilities

 

 

204,783

 

 

 

187,996

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock--$0.001 par value; 100,000,000 shares authorized; 9,591,957 shares issued and outstanding at March 31, 2020: and 9,437,883 shares issued and outstanding at December 31, 2019

 

 

10

 

 

 

 9

 

Additional paid-in capital

 

 

89,503

 

 

 

89,027

 

Accumulated other comprehensive income (loss)

 

 

62

 

 

 

(5)

 

Accumulated deficit

 

 

(64,879)

 

 

 

(46,640)

 

Total stockholders' equity

 

 

24,696

 

 

 

42,391

 

Total liabilities and stockholders’ equity

 

$

229,479

 

 

$

230,387

 

 

See accompanying notes to unaudited consolidated financial statements.

 

1

Zyla Life Sciences and Subsidiaries

 

Consolidated Statements of Operations (Unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

Period from

 

 

Period from

 

 

 

Three momths

 

February 1, 2019

 

 

January 1, 2019

 

 

 

ended

 

through

 

 

through

 

 

 

March 31, 2020

 

March 31, 2019

 

 

January 31, 2019

    

Revenue

    

 

 

    

 

 

 

 

 

 

 

Net product sales

 

$

19,066

 

$

15,810

 

 

$

1,775

 

Total revenue

 

 

19,066

 

 

15,810

 

 

 

1,775

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and Expenses

 

 

 

 

 

 

 

 

 

 

 

Cost of sales (excluding amortization of product rights)

 

 

3,444

 

 

12,461

 

 

 

554

 

Amortization of product rights

 

 

3,497

 

 

2,332

 

 

 

171

 

General and administrative

 

 

7,474

 

 

3,365

 

 

 

5,413

 

Sales and marketing

 

 

9,972

 

 

5,131

 

 

 

2,773

 

Research and development

 

 

 —

 

 

 5

 

 

 

186

 

Restructuring and other charges

 

 

284

 

 

 —

 

 

 

799

 

Change in fair value of contingent consideration payable

 

 

4,000

 

 

200

 

 

 

 —

 

Impairment of goodwill

 

 

4,830

 

 

 —

 

 

 

 —

 

Total costs and expenses

 

 

33,501

 

 

23,494

 

 

 

9,896

 

Loss from operations

 

 

(14,435)

 

 

(7,684)

 

 

 

(8,121)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

 

 

 

 

 

Interest expense (income), net

 

 

3,808

 

 

2,193

 

 

 

(52)

 

Other gain, net

 

 

 —

 

 

 —

 

 

 

(140)

 

Loss on foreign currency exchange

 

 

(4)

 

 

 —

 

 

 

 —

 

Total other expense (income)

 

 

3,804

 

 

2,193

 

 

 

(192)

 

Reorganization items

 

 

 —

 

 

606

 

 

 

(115,169)

 

Net (loss) income

 

$

(18,239)

 

$

(10,483)

 

 

$

107,240

 

Per share information:

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share of common stock, basic and diluted

 

$

(1.26)

 

$

(0.73)

 

 

$

1.90

 

Weighted-average shares outstanding, basic and diluted

 

 

14,443,541

 

 

14,333,332

 

 

 

56,547,101

 

 

See accompanying notes to unaudited consolidated financial statements.

 

 

2

Zyla Life Sciences and Subsidiaries

 

Consolidated Statements of Comprehensive Loss (Unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

Period from

 

 

Period from

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

ended

 

through

 

 

through

 

 

 

March 31, 2020

 

March 31, 2019

  

  

January 31, 2019

    

Net (loss) income

    

$

(18,239)

 

$

(10,483)

 

 

$

107,240

 

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available for sale securities

 

 

 —

 

 

(1)

 

 

 

 —

 

Foreign currency translation adjustments

 

 

67

 

 

(8)

 

 

 

 —

 

Comprehensive (loss) income

 

$

(18,172)

 

$

(10,492)

 

 

$

107,240

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

 

3

Zyla Life Sciences and Subsidiaries

 

Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited)

(in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

$0.001

 

Additional

 

 

 

 

Other

 

 

 

 

 

 

Number of

 

Par

 

Paid-in

 

Accumulated

 

Comprehensive

 

 

 

 

 

    

Shares

    

Value

    

Capital

    

Deficit

    

Income (loss)

    

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2018 (Predecessor)

 

56,547,101

 

$

55

 

$

276,569

 

$

(388,853)

 

$

869

 

$

(111,360)

 

Stock-based compensation expense

 

 —

 

 

 —

 

 

4,125

 

 

 —

 

 

 —

 

 

4,125

 

Net income

 

 —

 

 

 —

 

 

 —

 

 

107,240

 

 

 —

 

 

107,240

 

Cancellation of Predecessor common stock and stock-based compensation

 

(56,547,101)

 

 

(55)

 

 

(280,694)

 

 

 —

 

 

 —

 

 

(280,749)

 

Elimination of Predecessor accumulated deficit and accumulated other comprehensive income

 

 —

 

 

 —

 

 

 —

 

 

281,613

 

 

(869)

 

 

280,744

 

Common stock issued for settlement of predecessor debt

 

4,774,093

 

 

 5

 

 

31,000

 

 

 —

 

 

 —

 

 

31,005

 

Common stock issued for asset purchase

 

4,586,875

 

 

 4

 

 

29,784

 

 

 —

 

 

 —

 

 

29,788

 

Warrants issued for settlement of predecessor debt

 

 —

 

 

 —

 

 

14,303

 

 

 —

 

 

 —

 

 

14,303

 

Warrants issued for asset purchase

 

 —

 

 

 —

 

 

11,841

 

 

 —

 

 

 —

 

 

11,841

 

Balance as of January 31, 2019 (Predecessor)

 

9,360,968

 

$

 9

 

$

86,928

 

$

 —

 

$

 —

 

$

86,937

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of February 1, 2019 (Successor)

 

9,360,968

 

 

 9

 

 

86,928

 

 

 —

 

 

 —

 

 

86,937

 

Stock-based compensation expense

 

 —

 

 

 —

 

 

60

 

 

 —

 

 

 —

 

 

60

 

Unrealized loss on available for sale securities

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(1)

 

 

(1)

 

Foreign currency translation adjustment

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(8)

 

 

(8)

 

Net loss

 

 —

 

 

 —

 

 

 —

 

 

(10,483)

 

 

 —

 

 

(10,483)

 

Balance as of March 31, 2019 (Successor)

 

9,360,968

 

$

 9

 

$

86,988

 

$

(10,483)

 

$

(9)

 

$

76,505

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2019 (Successor)

 

9,437,883

 

$

 9

 

$

89,027

 

$

(46,640)

 

$

(5)

 

$

42,391

 

Stock-based compensation

 

 —

 

 

 —

 

 

476

 

 

 —

 

 

 —

 

 

476

 

Issuance of common stock

 

154,074

 

 

 1

 

 

 —

 

 

 —

 

 

 —

 

 

 1

 

Foreign currency translation adjustment

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

67

 

 

67

 

Net loss

 

 —

 

 

 —

 

 

 —

 

 

(18,239)

 

 

 —

 

 

(18,239)

 

Balance as of March 31, 2020 (Successor)

 

9,591,957

 

$

10

 

$

89,503

 

$

(64,879)

 

$

62

 

$

24,696

 

 

4

Zyla Life Sciences and Subsidiaries

 

Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

 

 

Period from

 

 

Period from

 

 

 

 

Three months

 

 

February 1, 2019

 

 

January 1, 2019

 

 

 

 

ended

 

 

through

 

 

through

 

 

 

 

March 31, 2020

    

    

March 31, 2019

    

 

January 31, 2019

    

 

Operating activities:

    

 

    

 

 

 

 

 

    

 

    

 

 

Net (loss) income

 

$

(18,239)

 

 

$

(10,483)

 

 

$

107,240

 

 

Adjustment to reconcile net (loss) income to net cash (used in) provided by operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

3,698

 

 

 

2,470

 

 

 

204

 

 

Non-cash reorganization items

 

 

 —

 

 

 

 —

 

 

 

(121,144)

 

 

Stock-based compensation expense

 

 

566

 

 

 

60

 

 

 

4,125

 

 

Non-cash interest and amortization of debt discount

 

 

470

 

 

 

954

 

 

 

(9)

 

 

Accretion of discount on marketable securities

 

 

 —

 

 

 

(3)

 

 

 

(5)

 

 

Change in right of use assets

 

 

193

 

 

 

109

 

 

 

 —

 

 

Change in fair value of contingent consideration

 

 

4,000

 

 

 

200

 

 

 

 —

 

 

Impairment of goodwill

 

 

4,830

 

 

 

 —

 

 

 

 —

 

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(5,365)

 

 

 

(35,802)

 

 

 

3,865

 

 

Inventory

 

 

(1,232)

 

 

 

10,562

 

 

 

340

 

 

Prepaid expenses

 

 

657

 

 

 

686

 

 

 

219

 

 

Other receivables

 

 

(64)

 

 

 

131

 

 

 

711

 

 

Deposits and other assets

 

 

768

 

 

 

(476)

 

 

 

 1

 

 

Accounts payable

 

 

10,348

 

 

 

3,231

 

 

 

103

 

 

Accrued expenses

 

 

4,957

 

 

 

12,142

 

 

 

5,172

 

 

Other current liabilities

 

 

45

 

 

 

13

 

 

 

 —

 

 

Other liabilities

 

 

(306)

 

 

 

(194)

 

 

 

 —

 

 

Net cash provided by (used in) operating activities

 

 

5,326

 

 

 

(16,400)

 

 

 

822

 

 

Investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Payments for purchase of property and equipment

 

 

(3)

 

 

 

(6)

 

 

 

 —

 

 

Sales of investments

 

 

 —

 

 

 

2,497

 

 

 

 —

 

 

Maturity of investments

 

 

 —

 

 

 

2,500

 

 

 

 —

 

 

Net cash (used in) provided by investing activities

 

 

(3)

 

 

 

4,991

 

 

 

 —

 

 

Financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Payments of contingent consideration

 

 

(1,600)

 

 

 

 —

 

 

 

 —

 

 

Payments on borrowings

 

 

(1,125)

 

 

 

 —

 

 

 

(19,104)

 

 

Payments of tax withholdings on restricted stock

 

 

(90)

 

 

 

 —

 

 

 

 —

 

 

Proceeds from credit agreement

 

 

 —

 

 

 

4,775

 

 

 

 —

 

 

Net cash (used in) provided by financing activities

 

 

(2,815)

 

 

 

4,775

 

 

 

(19,104)

 

 

Effect of foreign currency translation on cash and cash equivalents

 

 

69

 

 

 

(26)

 

 

 

 6

 

 

Net increase (decrease) cash, cash equivalents and restricted cash

 

 

2,577

 

 

 

(6,660)

 

 

 

(18,276)

 

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

12,365

 

 

 

17,447

 

 

 

35,723

 

 

Cash, cash equivalents and restricted cash at end of period

 

$

14,942

 

 

$

10,787

 

 

$

17,447

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash interest payments

 

$

120

 

 

$

 —

 

 

$

 —

 

 

 

See accompanying notes to unaudited consolidated financial statements.

5

Zyla Life Sciences and Subsidiaries

 

Notes to Unaudited Consolidated Financial Statements

 

1. Organization and Description of the Business

 

Interim Financial Statements

 

The consolidated financial statements of Zyla Life Sciences and its subsidiaries (“Zyla” or the “Company”) as of March 31, 2020 (Successor), the three months ended March 31, 2020 (Successor) and for the periods from February 1, 2019 through March 31, 2019 (Successor), and January 1, 2019 through January 31, 2019 (Predecessor) are unaudited and reflect all adjustments (consisting only of normal recurring adjustments), which are, in the opinion of management, necessary for a fair presentation of the financial position and operating results for the interim periods. The Company’s Consolidated Balance Sheet as of December 31, 2019 (Successor) has been derived from the audited financial statements as of that date contained in our Annual Report on Form 10-K for the year ended December 31, 2019 (the “2019 Annual Report on Form 10-K”). The Company’s consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto, together with management’s discussion and analysis of financial condition and results of operations, contained in the Company’s 2019 Annual Report on Form 10-K, though, as described below, such prior financial statements will not be comparable to the interim financial statements due to the adoption of fresh start accounting on January 31, 2019. For additional information, see Note 3- Fresh Start Accounting. The Company’s Consolidated Statements of Operations for the period from January 1, 2020 through March 31, 2020 (Successor) are not necessarily indicative of future financial results.

 

 

Organization and Business Overview

 

Zyla Life Sciences (the “Company”) is a commercial-stage life science company committed to bringing products to patients and healthcare providers and is focused on marketing its portfolio of medicines for pain and inflammation. Zyla’s portfolio includes six products: SPRIX® (ketorolac tromethamine) Nasal Spray, ZORVOLEX® (diclofenac), VIVLODEX® (meloxicam), INDOCIN® (indomethacin) suppositories, INDOCIN® oral suspension and OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII. 

SPRIX Nasal Spray is a nonsteroidal anti-inflammatory drug indicated in adult patients for the short‑term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. VIVLODEX and ZORVOLEX are SOLUMATRIX® Technology non-steroidal anti-inflammatory products. The Company acquired two forms of INDOCIN, an oral solution and a suppository, from Iroko Pharmaceuticals, Inc. and its subsidiaries (collectively, “Iroko”) in January 2019. Both products are approved for many indications including: moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis. OXAYDO is an immediate release (“IR”) oxycodone product designed to discourage abuse via snorting, indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. To augment its current product portfolio, the Company is seeking to acquire additional product candidates or approved products to develop and/or market.

Merger Agreement

 

On March 16, 2020, the Company entered into an the Agreement and Plan of Merger (the “Merger Agreement”) by and among the Company, Assertio Therapeutics, Inc. (“Assertio”), Alligator Zebra Holdings, Inc. (“Parent”), Zebra Merger Sub, Inc., a wholly-owned subsidiary of Parent (“Merger Sub”) and Alligator Merger Sub, Inc. The Merger Agreement provides that, upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will be merged with and into us, with us continuing as the surviving corporation and a wholly-owned subsidiary of Parent. Pursuant to the terms of the Merger Agreement, at the time the merger is effective, each issued and outstanding share of common stock, par value $0.001 per share, of the Company (the “Common Stock”) (other than Excluded Shares (as defined below) and Dissenting Shares (as defined below)) will be converted into the right to receive 2.5 shares (the “Exchange Ratio”) of common stock, par value $0.0001 per share, of Parent (“Parent Common Stock”).

6

Each share of Common Stock that is held by the Company as treasury stock or that is owned, directly or indirectly, by Parent, the Company, Merger Sub, or any subsidiary of the Company (collectively, “Excluded Shares”), immediately prior to the effective time of the Merger (the “Effective Time”) will cease to be outstanding and will be cancelled and retired and will cease to exist, and no consideration will be delivered in exchange therefor. “Dissenting Shares” are shares of the Common Stock (other than Excluded Shares) outstanding immediately prior to the Effective Time and held by a holder who is entitled to demand and has properly demanded appraisal for such shares of the Common Stock in accordance with Section 262 of the Delaware General Corporation Law. Consummation of the Merger is subject to certain conditions to closing, including, among others: (1) requisite approvals of Zyla’s and Assertio’s stockholders; (2) the absence of certain legal impediments to the consummation of the Merger; (3) the approval for listing on the Nasdaq Stock Market of the shares of Parent Common Stock to be issued as Merger consideration, (4) effectiveness of the registration statement on Form S-4 registering the shares of Parent Common Stock and other equity instruments to be issued in the Merger, (5) subject to certain exceptions, the accuracy of the representations, warranties and compliance with the covenants of each party to the Merger Agreement, and (6) Assertio, Parent and their respective Subsidiaries having minimum cash and cash equivalents equal to $25 million in the aggregate (as calculated pursuant to the Merger Agreement).  The Company is working toward completing the Merger as quickly as possible and currently expects to consummate the merger in the second calendar quarter of 2020.

In March 2020, the World Health Organization (“WHO”) declared a global pandemic attributable to the outbreak and continued spread of COVID-19. In connection with the mitigation and containment procedures recommended by the WHO and imposed by federal, state, and local governmental authorities, the Company implemented measures designed to keep its employees safe and address business continuity issues at its distribution centers and other locations. The Company continues to evaluate and plan for the potential effects of a prolonged disruption and the related impacts on its revenue, results of operations, and cash flows. These items include, but are not limited to, the financial condition of its customers and the realization of accounts receivable, decreased availability and demand for its products and services, and delays related to current and future projects. While the Company’s operational and financial performance may be significantly impacted by COVID-19, it is not possible for the Company to predict the duration or magnitude of the outbreak and its effects on its business and whether such effects could have a material adverse impact on its financial position, results of operations, or cash flows. See Part II. Other Information-Item 1A. Risk Factors of this Quarterly Report on Form 10-Q for additional information.

 

Emergence from Voluntary Reorganization Under Chapter 11 Proceedings

 

Chapter 11 Cases

 

On October 30, 2018, the Company entered into a definitive asset purchase agreement (the “Purchase Agreement”) to acquire the SOLUMATRIX products and INDOCIN products and one development product from Iroko. To facilitate the transactions contemplated by the Purchase Agreement (the “Iroko Products Acquisition”) and to reorganize its financial structure, the Company and its wholly-owned subsidiaries filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) and a related Joint Plan of Reorganization (“the Plan”) on October 30, 2018.

The Company requested that the Chapter 11 cases (the “Chapter 11 Cases”) be jointly administered for procedural purposes only under the caption “In re Egalet Corporation, et al., Case No. 18-12439”. Upon filing, the Company continued to operate its business as a “debtor-in-possession” under the jurisdiction of the Bankruptcy Court and in accordance with the applicable provisions of the Bankruptcy Code and orders of the Bankruptcy Court.  The Company continued ordinary course operations substantially uninterrupted during the Chapter 11 Cases and sought approval from the Bankruptcy Court for relief under certain “first day” motions authorizing the Company to continue to conduct its business in the ordinary course. On January 14, 2019, the Bankruptcy Court entered the Confirmation Order confirming the Plan under Chapter 11 of the Bankruptcy Code. On January 31, 2019 (the “Effective Date”), and substantially concurrent with the consummation of the acquisition of the Iroko products named below pursuant to the Purchase Agreement (the “Iroko Products Acquisition”), the Plan became effective. The Company divested assets related to TIVORBEX in November 2019.

 

7

Liquidity and Substantial Doubt in Going Concern

 

Substantial Doubt Regarding Going Concern

 

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred recurring operating losses since inception. As of March 31, 2020, the Company had an accumulated deficit of $64.9 million and a working capital deficit of $32.8 million. Even though the Company emerged from bankruptcy, it continues to have significant indebtedness and its ability to continue as a going concern is contingent upon the successful integration of the Iroko Products Acquisition, increasing its revenue, managing its expenses and complying with the terms of its debt agreements. Refer to Note 8—Debt for additional details of these debt agreements.

These factors, in combination with others described above, resulted in the conclusion that there is substantial doubt about the ability of the Company to continue as a going concern for the one-year period after the date that these financial statements are issued. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

2. Summary of Significant Accounting Policies and Basis of Accounting

 

Basis of Accounting

 

The unaudited consolidated financial statements are prepared in conformity with U.S. generally accepted accounting principles (“GAAP”) for interim financial information. Certain information and footnotes normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for quarterly reports on Form 10-Q. The Company’s consolidation policy requires the consolidation of entities where a controlling financial interest is held. All intercompany balances and transactions have been eliminated in consolidation.

 

Effective January 1, 2020, financial assets measured at amortized cost are assessed for future expected credit losses in accordance with the provisions of Financial Accounting Standards Board (“FASB”) guidance within Accounting Standards Codification (“ASC”) 326, Financial Instruments – Credit Losses, to determine if application of an expected credit losses reserve is necessary. On a monthly basis, receivables that resulted from revenue transactions within the scope of ASC 606 are reviewed on a customer-level basis to analyze expectations of future collections based upon past history of collections, payment, aging of receivables and viability of the customer to continue payment, as well as estimates of future economic conditions. The Company has minimal instances of bad debts or uncollected receivables.

 

Upon emergence from bankruptcy, the Company adopted fresh start accounting in accordance with the provisions of ASC 852, Reorganizations, which resulted in the Company becoming a new entity for financial reporting purposes on February 1, 2019.

 

References to “Successor” or “Successor Company” relate to the financial position and results of operations of the reorganized Company subsequent to January 31, 2019. References to “Predecessor” or “Predecessor Company” relate to the financial position and results of operations of the Company prior to, and including, January 31, 2019.

 

The Company’s significant accounting policies are described in Note 2 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K. Since the date of those financial statements, new accounting policies are noted below.

 

 

 

8

Recent Accounting Pronouncements

 

In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” This guidance applies to all entities and impacts how entities account for credit losses for financial assets measured at amortized cost and available for sale debt securities. ASU 2016-13 requires financial assets measured at amortized cost to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amounts. An entity must use judgment in determining the relevant information and estimation methods that are appropriate in its circumstances. For trade receivables, loans and held-to-maturity debt securities, entities will be required to estimate expected credit losses over the lifetime of the asset. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than an other-than-temporary impairment that reduces the cost basis of the investment. Further, an entity will recognize any improvements in estimated credit losses on its available-for-sale debt securities immediately in earnings.

 

Upon adoption, the Company assessed each financial asset measured at amortized cost for the impact of the guidance as of January 1, 2020 and noted an insignificant impact due to the minimal credit risk associated with its financial assets subject to ASC 326. As such, it was concluded that a reserve for credit losses was de minimis on the adoption date. Financial assets will continue to be assessed on a quarterly basis in future periods.

 

In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820)” which modifies the disclosure requirements of fair value measurements in Topic 820, Fair Value Measurement. For public companies the ASU removes disclosure requirements for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels and the valuation process for Level 3 fair value measurements. The ASU modifies the disclosure requirements for investments in certain entities that calculate net asset value and clarifies that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. The ASU adds the disclosure requirement for changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2019 including interim periods within that fiscal year. The Company adopted ASU 2018-13 as of January 1, 2020 as referenced in Note 11.  The adoption of this ASU did not have a material impact on the Company’s condensed consolidated financial statements.

 

In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes.” This guidance is effective for fiscal years beginning after December 15, 2020 and interim periods therein. Early adoption is permitted for any annual periods for which financial statements have not been issued and interim periods therein. The Company is currently analyzing the impact of ASU 2019-12 and does not anticipate the adoption of this ASU to have a material impact on the Company’s consolidated financial statements.

 

 

 

3. Fresh Start Accounting

 

Upon emergence from bankruptcy, the Company adopted fresh start accounting as (i) the reorganization value of the assets of the Successor Company immediately before the date of confirmation of the Plan was less than the total of all post-petition liabilities and allowed claims and (ii) the holders of the Predecessor Company’s voting shares immediately before confirmation of the Plan received less than 50 percent of the voting shares of the emerging entity.

 

GAAP requires the adoption of fresh start accounting on the later of (i) the Plan confirmation date, or (ii) when all material conditions precedent to the Plan’s becoming effective are resolved, which occurred on January 31, 2019. Accordingly, the Company selected January 31, 2019 as the fresh start reporting date. Upon the application of fresh start accounting, the Company allocated the reorganization value to its individual assets based on their estimated fair values.

9

Reorganization value represents the fair value of the Successor Company’s assets before considering liabilities. The excess reorganization value over the fair value of identified tangible and intangible assets is reported as goodwill.

 

The Bankruptcy Court confirmed the Plan based upon an estimated enterprise value of the Company between $162 million and $200 million, which was estimated using various valuation methods, including (i) comparable public company analysis, a method to estimate the value of a company relative to other publicly traded companies with similar operations and financial characteristics; (ii) discounted cash flow analysis, a calculation of the present value of the future cash flows to be generated by the asset or business based on its projection, and (iii) precedent transaction analysis, a method to estimate the value of a company by examining comparable public merger and acquisition transactions. Based upon a reevaluation of relevant factors used in determining the range of enterprise value and updated expected cash flow projections, the Company concluded the enterprise value, or fair value, was $196.6 million.

 

The basis of the discounted cash flow analysis used in developing the enterprise value was based on Company prepared projections that included a variety of estimates and assumptions. While the Company considers such estimates and assumptions reasonable, they are inherently subject to significant business, economic and competitive uncertainties, many of which are beyond the Company’s control and, therefore, may not be realized. Changes in these estimates and assumptions may have had a significant effect on the determination of the Company’s enterprise value. The assumptions used in the calculations for the discounted cash flow analysis, which had the most significant effect on our estimated enterprise value, included the following: forecasted revenue, costs and free cash flows through 2023, discount rate of 15.1 %. A terminal value of $217.3 million was established, which was determined using a perpetual long-term growth rate of 3%.

 

The four-column consolidated statement of financial position as of January 31, 2019, included herein, applies effects of the Plan and fresh start accounting to the carrying values and classifications of assets or liabilities. Upon adoption of fresh start accounting, the recorded amounts of assets and liabilities were adjusted to reflect their estimated fair values. Accordingly, the reported historical financial statements of the Predecessor Company prior to the adoption of fresh start accounting for periods ended on or prior to January 31, 2019 are not comparable to those of the Successor Company.

 

In applying fresh start accounting, the Company followed these principles:

 

·

The reorganization value, which represents the concluded enterprise value plus excess cash and cash equivalents and non-interesting bearing liabilities of the entity, was allocated to the entity’s reporting units in conformity with ASC 805, Business Combinations. The reorganization value exceeded the sum of the fair value assigned to assets and liabilities. This excess was recorded as Successor Company goodwill as of January 31, 2019.

·

Each asset and liability existing as of the fresh start accounting date, other than deferred taxes, has been stated at the fair value, and determined at appropriate risk adjusted interest rates.

·

Deferred taxes were reported in conformity with applicable income tax accounting standards, principally ASC 740, Income Taxes.

 

10

The following four-column consolidated statement of financial position table identifies the adjustments recorded to the Predecessor Company’s January 31, 2019 Consolidated Balance Sheets as a result of implementing the Plan and applying fresh start accounting:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Plan Effects

 

Fresh Start

 

 

 

 

(in thousands)

 

Predecessor

     

Adjustments

 

Adjustments

 

Successor

   

Assets

    

 

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

36,785

 

$

(19,738)

(a)

$

 —

 

$

17,047

 

Marketable securities, available for sale

 

 

4,994

 

 

 —

 

 

 —

 

 

4,994

 

Accounts receivable

 

 

4,141

 

 

 —

 

 

 —

 

 

4,141

 

Inventory

 

 

2,299

 

 

28,364

(b)

 

3,175

(h)

 

33,838

 

Prepaid expenses and other current assets

 

 

2,497

 

 

1,446

(b)

 

 —

 

 

3,943

 

Other receivables

 

 

133

 

 

 —

 

 

 —

 

 

133

 

Total current assets

 

 

50,849

 

 

10,072

 

 

3,175

 

 

64,096

 

Intangible assets, net

 

 

4,109

 

 

90,106

(b)

 

29,091

(i)

 

123,306

 

Restricted cash

 

 

400

 

 

 —

 

 

 —

 

 

400

 

Property and equipment, net 

 

 

1,027

 

 

3,047

(b)

 

 —

 

 

4,074

 

Right of use asset, net

 

 

1,854

 

 

 —

 

 

 —

 

 

1,854

 

Goodwill

 

 

 —

 

 

 —

 

 

58,747

(j)

 

58,747

 

Deposits and other assets

 

 

1,676

 

 

 —

 

 

 —

 

 

1,676

 

Total assets

 

$

59,915

 

$

103,225

 

$

91,013

 

$

254,153

 

Liabilities and stockholders’ (deficit) equity

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

 

9,839

 

 

(1,500)

(a)

 

 —

 

 

8,339

 

Accrued expenses

 

 

26,617

 

 

20,183

(c)

 

 —

 

 

46,800

 

Deferred revenue

 

 

52

 

 

 —

 

 

(52)

(k)

 

 —

 

Debt - current

 

 

 —

 

 

1,492

(d)

 

 —

 

 

1,492

 

Acquisition-related contingent consideration

 

 

 —

 

 

1,200

(d)

 

 —

 

 

1,200

 

Other current liabilities

 

 

1,030

 

 

 —

 

 

 —

 

 

1,030

 

Total current liabilities

 

 

37,538

 

 

21,375

 

 

(52)

 

 

58,861

 

Debt - non-current portion, net

 

 

 —

 

 

93,371

(d)

 

 —

 

 

93,371

 

Acquisition-related contingent consideration

 

 

 —

 

 

13,600

(d)

 

 —

 

 

13,600

 

Deferred income tax liabilities

 

 

24

 

 

 —

 

 

 —

 

 

24

 

Other liabilities

 

 

1,463

 

 

 —

 

 

(103)

(k)

 

1,360

 

Total liabilities not subject to compromise

 

 

39,025

 

 

128,346

 

 

(155)

 

 

167,216

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities subject to compromise

 

 

138,884

 

 

(138,884)

(e)

 

 —

 

 

 —

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ (deficit) equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock

 

 

55

 

 

(46)

(f)

 

 —

 

 

 9

 

Additional paid in capital

 

 

276,880

 

 

(189,952)

(f)

 

 —

 

 

86,928

 

Other comprehensive income (loss)

 

 

866

 

 

 —

 

 

(866)

(l)

 

 —

 

Accumulated deficit

 

 

(395,795)

 

 

303,761

(g)

 

92,034

(l)

 

 —

 

Total stockholders’ (deficit) equity

 

 

(117,994)

 

 

113,763

 

 

91,168

 

 

86,937

 

Total liabilities and shareholders’ (deficit) equity

 

$

59,915

 

$

103,225

 

$

91,013

 

$

254,153

 

 

11

Effects of Plan Adjustments

 

a)

Reflects cash distribution of $18.2 million and reimbursement to Iroko for transaction expenses incurred on the acquisition of $1.5 million.

b)

Reflects purchase accounting for Iroko Products Acquisition which was treated as a business combination for accounting purposes. Assets acquired and liabilities assumed are recorded at fair value on the acquisition date.

 

 

 

 

 

 

 

 

 

 

Iroko Purchase Price Allocation

    

(in thousands)

 

Iroko Note

 

$

45,000

 

Iroko Equity Value in Reorganization

 

 

41,630

 

Fair Value of Contingent Consideration

    

 

14,800

 

Iroko Promissory Note

 

 

4,500

 

Total Iroko Purchase Price

 

$

105,930

 

 

 

 

 

 

Identifiable Assets / (Liabilities)

 

 

 

 

Inventory

 

$

28,364

 

Prepaid expenses

 

 

1,446

 

Fixed Assets

 

 

3,047

 

Intangible — Indocin

 

 

90,106

 

Product Liability

 

 

(17,033)

 

Total Iroko Purchase Price

 

$

105,930

 

Goodwill attributable to Iroko acquisition

 

$

 —

 

 

c)

Adjustments to accrued expense reflect i) $2.15 million success fees to be paid after the Effective Date upon the completion of the Iroko Products Acquisition and Chapter 11 proceedings, ii) $1.0 million transaction fees to be paid after the Effective Date for expenses Iroko incurred in connection with the acquisition, and iii) $17.03 million product related liabilities such as rebate, coupon payment, etc. assumed from Iroko.

d)

Reflects obligations entered into upon emergence to finance transactions effectuated by the Plan: i) $90.3 million in 13% Notes, net of discount for interest-free period, and a royalty rights agreement giving the right to receive payment equal to 1.5% of net sales on all reorganized entity products, ii) $4.5 million pursuant to the Interim Promissory Note, and iii) $14.8 million in contingent consideration. Specifically, the contingent consideration represents the fair value of future royalty payments due to Iroko in the event Indocin net sales exceed $20.0 million in any fiscal year between the Effective Date and January 31, 2029 (“Indocin Royalty”). The current portion of the 13% Notes, Interim Promissory Note, and Indocin Royalty is $1.1 million, $0.4 million, and $1.2 million, respectively.

e)

The adjustment to liabilities subject to compromise relates to the extinguishment of the former 13% Notes and associated royalty rights, the 5.50% and 6.50% Notes, and rejected contracts. The former 13% Notes were settled with $50.0 million in aggregate principal amount of the 13% Notes newly issued common stock of the Successor Company representing approximately 19.38% of the common stock then outstanding, and $20.0 million in cash equal to the sum of adequate protection payments of $1.8 million and cash distribution of $18.2 million. The 5.50% and 6.50% Notes were settled with newly issued common stock of the Successor Company representing approximately 31.62% of the common stock then outstanding. Contracts rejected in the Chapter 11 cases did not receive any consideration.

f)

Pursuant to the Plan, the Company’s predecessor common stock was cancelled, and new common stock and warrants were issued.  The adjustment eliminated the Predecessor Company’s common stock, additional paid-in capital and recorded the Successor Company’s new $0.001 par value common stock, warrants and additional paid-in capital.  The Company issued 9,360,968 shares of new common stock and additional paid-in capital of $60.8 million and $26.1 million of warrants.  The warrants were valued using the Black Scholes model. Significant assumptions used in determining the fair value of such warrants at issuance include an assumed share price volatility of 60%, a risk-free rate of return of 2.43% with a 5 year term, and marketability discount between 7% and 20% for the lock-up periods.

g)

This adjustment reflects the net effect of the transaction related to the consummation of the Plan on Predecessor’s accumulated deficit. The table below provides a summary of the adjustments:

12

 

 

 

 

 

 

Liabilities subject to compromise

    

(in thousands)

 

13% Senior Secured Debt

 

$

85,438

 

5.50% Convertible Notes

 

 

24,650

 

6.50% Convertible Notes

    

 

23,888

 

Accrued interest

 

 

2,464

 

Accrued royalty rights ("Existing Senior Secured Royalty Rights")

 

 

2,119

 

Accrued expenses

 

 

325

 

Liabilities subject to compromise

 

$

138,884

 

 

 

 

 

 

Consideration given pursuant to the Plan:

 

 

 

 

Issuance of warrants

 

$

(14,303)

 

Issuance of new common stock

 

 

(31,004)

 

Issuance of new Senior Secured Notes

 

 

(45,363)

 

Cash payment

 

 

(18,238)

 

Total consideration given pursuant to the Plan

 

$

(108,908)

 

 

 

 

 

 

Gain on extinguishment of prepetition liabilities

 

 

29,976

 

 

 

 

 

 

Other adjustments to accumulated deficit:

 

 

 

 

Success fees

 

 

(2,150)

 

Reimbursement to Iroko of acquisition expense

 

 

(1,000)

 

Cancellation of Predecessor stock-based compensation expense

 

 

(3,814)

 

Tax related expenses on gain on extinguishment of prepetition liabilities

 

 

 —

 

Total other adjustments

 

 

(6,964)

 

 

 

 

 

 

Extinguishment of Predecessor Common Stock and Additional-paid-in-capital

 

 

280,749

 

Total adjustments to accumulated deficit:

 

$

303,761

 

 

Fresh Start Adjustments

 

h)

A $3.2 million adjustment was recorded to adjust the Company’s legacy inventory, excluding inventory assumed from Iroko, to fair value.  The Company obtained an independent third-party valuation specialist’s assistance in the determination of the fair values of inventory. The inventory valuation included an analysis of net realizable value of the work in progress inventory and finished goods. Finished goods are valued using the comparative sales method as a function of the estimated selling price less the sum of any cost to complete, costs of disposal, holding costs, and a reasonable profit allowance. Carrying value of raw materials and packaging is assumed to represent a reasonable proxy for fair value.

i)

Reflects fresh start adjustments recorded to adjust intangible assets related to the Company’s legacy products, SPRIX and OXAYDO, to fair value. The Company obtained independent-third party valuation specialist’s assistance in determination of the fair values of intangibles. SPRIX and OXAYDO intellectual property values are valued using the multi period excess earnings method under the income approach. The multi-period excess earnings method measures economic benefit indirectly by calculating the income attributable to an asset after appropriate returns are paid to complementary assets used in conjunction with the subject asset to produce contributory asset charges. Key components of the excess earnings methods include revenue, adjusted operating margin, charges for use of other assets, and discount rate.

j)

Adjustment to record the reorganization value of assets in excess of amounts allocated to identifiable tangible and intangible assets, also referred to as Successor Company goodwill. Estimated business enterprise value is

13

developed for the combined company upon emergence from bankruptcy and therefore allocated to both identified tangible and intangible assets from the Predecessor Company and assumed from acquisition of Iroko.

 

 

 

 

 

 

 

 

(in thousands)

 

Estimated business enterprise value

    

$

196,600

 

Add: Fair value of liabilities excluded from enterprise value

 

 

57,552

 

Less: Fair value of tangible assets

 

 

(72,099)

 

Less: Fair value of identified intangible assets

    

 

(123,306)

 

Reorganization value of assets in excess of amounts allocated to identified tangible and intangible assets (Successor company goodwill)

 

$

58,747

 

 

 

 

 

 

Total Successor Goodwill

 

$

58,747

 

 

k)

Adjustments to eliminate deferred revenue and related product advance.

l)

The Predecessor Company’s accumulated deficit and accumulated other comprehensive income was eliminated in conjunction with the adoption of fresh start accounting pursuant to ASC 852, Reorganization. The Predecessor Company recognized a $91.2 million gain related to the fresh start accounting adjustments related for revaluation of assets and liabilities as follows: 

 

 

 

 

 

 

 

 

(in thousands)

 

Establish Successor goodwill attributable to emergence from Chapter 11

    

$

58,747

 

Intangible fair value adjustments

 

 

29,091

 

Inventory fair value adjustments

 

 

3,175

 

Deferred revenue and product advance adjustments

    

 

155

 

Gain on fresh start adjustment for revaluation of assets and liabilities

 

 

91,168

 

 

 

 

 

 

Eliminate Predecessor Company Other comprehensive income

 

 

866

 

Total adjustment to stockholders' deficit

 

$

92,034

 

 

 

4. Revenue From Contracts with Customers

 

Revenue Recognition

Under ASC 606, revenue is recognized when, or as, performance obligations under the terms of a contract are satisfied, which occurs when control of the promised products or services is transferred to customers.  To recognize revenue pursuant to the provisions of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect substantially all the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the goods or services promised within each contract are distinct to determine those that are performance obligations.

Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.  To the extent that the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price to which the Company expects to be entitled after giving effect to returns, rebates, sales allowances and other variable elements with contracts between the Company and its customers.  Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.  Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance under the contract and all information (historical,

14

current and forecasted) that is reasonably available.  Sales taxes and other taxes collected on behalf of third parties are excluded from revenue.

When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component.  Applying the significant financing practical expedient, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less.  None of the Company’s contracts contained a significant financing component during the period ended March 31, 2020.

The Company’s existing contracts with customers contain only a single performance obligation and, as such, the entire transaction price is allocated to the single performance obligation.  Should future contracts contain multiple performance obligations, those would require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation.  The Company determines standalone selling prices based on observable prices or a cost-plus margin approach when one is not available.

The Company’s performance obligations are to provide pharmaceutical products to several wholesalers or a single specialty pharmaceutical distributor.  All of the Company's performance obligations, and associated revenue, are generally transferred to customers at a point in time. Revenue is recognized at the time the related performance obligation is satisfied by transferring control of a promised good to a customer, which is typically upon delivery.  Payments for invoices are generally due within 30 to 65 days of invoice date.

Disaggregation of Revenue

The following table reflects revenue by revenue source for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

Period from

 

 

Period from

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

ended

 

through

 

 

through

(in thousands)

    

March 31, 2020

   

March 31, 2019

    

    

January 31, 2019

Product lines

 

 

 

 

 

 

 

 

 

 

INDOCIN products

 

$

11,869

 

$

7,499

 

 

$

 —

SPRIX Nasal Spray

 

 

5,687

 

 

3,830

 

 

 

1,354

SOLUMATRIX products

 

 

858

 

 

3,808

 

 

 

 —

OXAYDO

 

 

652

 

 

673

 

 

 

421

Total

 

$

19,066

 

$

15,810

 

 

$

1,775

 

Reserves for Variable Consideration

Revenues from product sales are recorded at the transaction price, which includes estimates of variable consideration for which reserves are established and which result from returns, rebates and sales allowances that are offered within or impacted by contracts between the Company and its customers. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns.  Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract as of the date of determination.  The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.  Actual amounts of consideration ultimately received may differ from the Company’s estimates.  If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.

Product Returns   

Consistent with industry practice, the Company generally offers customers a limited right of return for its products. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized.  The Company estimates

15

product return liabilities using the expected value method based on its historical sales information and other factors that it believes could significantly impact its expected returns, including product discontinuations, product recalls and expirations, of which it becomes aware. These factors include its estimate of actual and historical return rates for non-conforming product and open return requests.

Specialty Pharmacy Fees 

The Company pays certain specialty pharmaceutical distributor fees based on a contractually determined rate. The Company records the fees on shipment to the distributor and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized.

Wholesaler and Title Fees

The Company pays certain pharmaceutical wholesalers and its third-party logistics provider fees based on a contractually determined rate. The Company accrues these fees on shipments to the respective wholesalers and recognizes the fees as a reduction of revenue in the same period the related revenue is recognized.

Prompt Pay Discount

The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company estimates cash discounts using the mostly likely amount method by reducing accounts receivable by the prompt pay discount amount. The discount is recognized as a reduction of revenue in the same period as the related revenue.

Patient Discount Programs

The Company offers co-pay discount programs for each of its products to patients, in which patients receive a co-pay discount on their prescriptions. The Company utilizes data provided by independent third parties to determine the total amount that was redeemed and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.

 

Rebates and Chargebacks

Managed care rebates are payments to governmental agencies and third parties, primarily pharmacy benefit managers and other health insurance providers. The reserve for these rebates is based on a combination of actual utilization provided by the third party and an estimate of customer buying patterns and applicable contractual rebate rates to be earned over each period. The Company recognizes the discount as a reduction of revenue in the same period the related revenue is recognized.

16

The following table reflects activity in each of the net product sales allowance and reserve categories for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Fees and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

distribution

 

Co-pay

 

 

 

 

 

 

 

 

 

(in thousands)

    

costs

    

assistance

    

Rebates

    

Returns

    

Total

Balances at December 31, 2019

 

$

5,418

 

$

17,829

 

$

5,909

 

$

10,542

 

$

39,698

Allowances for current period sales

 

 

5,421

 

 

45,289

 

 

6,289

 

 

1,117

 

 

58,116

Credits or payments made for prior period sales

 

 

(4,550)

 

 

(17,829)

 

 

(4,551)

 

 

(1,632)

 

 

(28,562)

Credits or payments made for current period sales

 

 

(358)

 

 

(24,565)

 

 

(1,135)

 

 

 —

 

 

(26,058)

Balances at March 31, 2020

 

$

5,931

 

$

20,724

 

$

6,512

 

$

10,027

 

$

43,194

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total gross product sales

 

 

 

 

 

 

 

 

 

 

 

 

 

$

78,391

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total provision for product sales allowances and accruals as a percentage of total gross sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

74%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Fees and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

distribution

 

Co-pay

 

 

 

 

 

 

 

 

 

(in thousands)

    

costs

    

assistance

    

Rebates

    

Returns

    

Total

Balances at January 31, 2019

 

$

605

 

$

19,330

 

$

5,498

 

$

7,964

 

$

33,397

Allowances for current period sales

 

 

11,161

 

 

29,602

 

 

3,900

 

 

1,262

 

 

45,925

Credits or payments made for prior period sales

 

 

 —

 

 

(935)

 

 

(692)

 

 

(76)

 

 

(1,703)

Credits or payments made for current period sales

 

 

(921)

 

 

(23,474)

 

 

(1,016)

 

 

 —

 

 

(25,411)

Balances at March 31, 2019

 

$

10,845

 

$

24,523

 

$

7,690

 

$

9,150

 

$

52,208

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total gross product sales

 

 

 

 

 

 

 

 

 

 

 

 

 

$

61,735

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total provision for product sales allowances and accruals as a percentage of total gross sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

74%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Predecessor

 

 

Fees and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

distribution

 

Co-pay

 

 

 

 

 

 

 

 

 

(in thousands)

    

costs

    

assistance

    

Rebates

    

Returns

    

Total

Balances at December 31, 2018

 

$

462

 

$

13,326

 

$

2,664

 

$

2,020

 

$

18,472

Allowances for current period sales

 

 

568

 

 

6,593

 

 

594

 

 

28

 

 

7,783

Assumed liabilities Iroko Products Acquisition

 

 

 —

 

 

5,791

 

 

2,799

 

 

5,944

 

 

14,534

Credits or payments made for prior period sales

 

 

(361)

 

 

(6,380)

 

 

(559)

 

 

(28)

 

 

(7,328)

Credits or payments made for current period sales

 

 

(64)

 

 

 —

 

 

 —

 

 

 —

 

 

(64)

Balances at January 31, 2019

 

$

605

 

$

19,330

 

$

5,498

 

$

7,964

 

$

33,397

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total gross product sales

 

 

 

 

 

 

 

 

 

 

 

 

 

$

9,559

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total provision for product sales allowances and accruals as a percentage of total gross sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

81%

 

 

Transaction Price Allocated to Future Performance Obligations

ASC 606 requires that the Company disclose the aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied as of March 31, 2020. The guidance provides certain practical

17

expedients that limit this requirement including performance obligations that are part of a contract that has an original expected duration of one year or less. All of the Company’s contracts are eligible for the practical expedient provided by ASC 606, therefore the Company elected not to disclose any remaining performance obligations.

Contract Balances from Contracts with Customers

When the Company receives consideration from a customer, or such consideration is unconditionally due from a customer prior to the transfer of goods or services to the customer under the terms of a contract, the Company records a contract liability. Contract liabilities are recognized as revenue after control of the products is transferred to the customer and all revenue recognition criteria have been met. The Company classifies contract liabilities as deferred revenue. The Company had no deferred revenue as of March 31, 2020 or December 31, 2019.

 

Contract assets primarily relate to rights to consideration for goods or services transferred to the customer when the right is conditional on something other than the passage of time.  Contract assets are transferred to accounts receivable when the rights become unconditional.  The Company had no contract assets as of March 31, 2020 or December 31, 2019.

Costs to Obtain and Fulfill a Contract

The Company accounts for shipping and handling activities related to contracts with customers as costs to fulfill the promise to transfer the associated products. When shipping and handling costs are incurred after a customer obtains control of the products, the Company has elected to account for these as costs to fulfill the promise and not as a separate performance obligation. Shipping and handling costs associated with the distribution of finished products to customers are expensed as incurred and are recorded in costs of goods sold in the accompanying consolidated statements of operations. The Company expenses incremental costs of obtaining a contract with a customer (for example, commissions) when incurred as the period of benefit is less than one year.

 

5. Inventory

 

Inventories are stated at the lower of cost or net realizable value, net of reserve for excess and obsolete inventory, if applicable, and cost is determined using the average-cost method. The following table reflects the components of inventory as of March 31, 2020 and December 31, 2019:

 

 

 

 

 

 

 

 

 

    

March 31

 

December 31,

(in thousands)

    

2020

    

2019

Raw materials

 

$

1,548

 

$

1,257

Work in process

 

 

2,665

 

 

4,864

Finished goods

 

 

6,068

 

 

2,928

Total

 

$

10,281

 

$

9,049

 

There was no reserve for excess and obsolete inventory as of March 31, 2020 or December 31, 2019.

 

 

 

6. Intangible Assets and Goodwill

 

The following table reflects the balance of the intangible assets of the Company as of March 31, 2020:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross

 

 

 

 

Net

 

Remaining Useful

 

    

Intangible

    

Accumulated

    

Intangible

    

Life

(in thousands)

 

Assets

 

Amortization

 

Assets

 

(in years)

INDOCIN product rights

 

$

90,106

 

$

(11,680)

 

$

78,426

 

7.84

SPRIX Nasal Spray product rights

 

 

31,900

 

 

(4,135)

 

 

27,765

 

7.84

OXAYDO product rights

 

 

1,300

 

 

(506)

 

 

794

 

1.84

Goodwill

 

 

53,917

 

 

 —

 

 

53,917

 

N/A

Total

 

$

177,223

 

$

(16,321)

 

$

160,902

 

 

 

18

The following table reflects the balance of the intangible assets of the Company as of December 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross

 

 

 

 

Net

 

Remaining Useful

 

    

Intangible

    

Accumulated

    

Intangible

    

Life

(in thousands)

 

Assets

 

Amortization

 

Assets

   

(in years)

INDOCIN product rights

 

$

90,106

 

$

(9,178)

 

$

80,928

 

8.09

SPRIX Nasal Spray product rights

 

 

31,900

 

 

(3,249)

 

 

28,651

 

8.09

OXAYDO product rights

 

 

1,300

 

 

(397)

 

 

903

 

2.09

Goodwill

 

 

58,747

 

 

 —

 

 

58,747

 

N/A

Total

 

$

182,053

 

$

(12,824)

 

$

169,229

 

 

 

As a result of fresh start accounting, the OXAYDO and SPRIX Nasal Spray product rights and their remaining useful lives were revalued.  The value of the OXAYDO product rights were reduced to $1.3 million and the remaining useful life decreased to 3 years as of January 31, 2019. The SPRIX Nasal Spray product rights were increased to $31.9 million and the remaining useful life increased to 9 years as of January 31, 2019.

 

As a result of the Iroko Products Acquisition, the Company acquired the product rights to the INDOCIN products.  The fair value of the INDOCIN product rights was determined to be $90.1 million and the remaining useful life to be 9 years as of January 31, 2019.

 

Goodwill is calculated as the excess of the reorganization equity value over the fair value of tangible and identifiable intangible assets pursuant to ASC 852 Reorganizations. Goodwill is not amortized but is tested for impairment at the reporting unit level at least annually or when a triggering event occurs that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net assets are below their carrying amounts. A reporting unit is the same as, or one level below, an operating segment. The Company’s operations are currently comprised of a single, entity wide reporting unit.

 

On January 31, 2019, the Company recognized $58.7 million of goodwill as a result of fresh start accounting adjustments.  See Note 3—Fresh Start Accounting for additional details.

 

On March 16, 2020, the Company entered into a Merger Agreement with Assertio. The execution of the merger agreement, which included an estimated merger consideration value, triggered the testing of goodwill for impairment and as a result, an impairment charge of $4.8 million was recognized during the three months ended March 31, 2020.

 

7. Accrued Expenses

 

The following table reflects the components of accrued expenses for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

March 31, 

 

 

December 31, 

 

    

2020

    

    

2019

Sales allowances

 

$

41,902

 

 

$

38,615

Interest

 

 

5,739

 

 

 

2,520

Payroll and related

 

 

2,410

 

 

 

3,086

Professional services

 

 

1,415

 

 

 

656

Restructuring

 

 

1,267

 

 

 

1,659

Sales and marketing

 

 

910

 

 

 

683

Manufacturing services

 

 

313

 

 

 

426

Royalties

 

 

232

 

 

 

493

Other

 

 

1,122

 

 

 

2,219

 

 

$

55,310

 

 

$

50,357

 

 

 

19

8. Debt

 

Successor Company Debt

 

The following table reflects the Successor Company’s debt as of March 31, 2020 and December 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

(in thousands)

 

 

 

 

 

 

 

Series A-1 Notes

 

$

50,000

 

 

$

50,000

Series A-2 Notes

 

 

45,000

 

 

 

45,000

Royalty rights obligation

 

 

5,366

 

 

 

5,236

Credit agreement

 

 

5,000

 

 

 

5,000

Interim promissory note

 

 

3,375

 

 

 

4,500

 

 

 

108,741

 

 

 

109,736

Unamortized debt discounts

 

 

(4,741)

 

 

 

(5,007)

Unamortized deferred financing fees

 

 

(719)

 

 

 

(792)

Carrying value

 

 

103,281

 

 

 

103,937

Less: current portion of long-term debt

 

 

(7,797)

 

 

 

(8,177)

Net, long-term debt

 

$

95,484

 

 

$

95,760

 

13% Senior Secured Notes Indenture Due 2024

 

On the Effective Date, the Company issued $95.0 million aggregate principal amount of its 13% senior secured notes (the “13% Notes”) and entered into an indenture (the “Indenture”) governing the 13% Notes with the guarantors party thereto (the “Guarantors”) and Wilmington Savings Fund Society, previously held by U.S. Bank National Association, as trustee (the “Trustee”) and collateral agent (the “Collateral Agent”). The 13% Notes were issued in two series: (x) $50.0 million of “Series A-1 Notes”, issued pursuant to the Plan to former holders of First Lien Secured Notes Claims (the “former 13% Notes”) and which was subject to an interest holiday from the Effective Date through November 1, 2019 and (y) $45.0 million of “Series A-2 Notes,” issued to Iroko and certain of its affiliates and which are subject to the rights of set-off and recoupment and related provisions set forth in the Purchase Agreement. On the Effective Date, the Company recorded a discount associated with the interest holiday on the Series A-1 Notes of $4.6 million.  The obligations of the Company under the Indenture and the 13% Notes are unconditionally guaranteed on a secured basis by the Guarantors.

 

Interest on the 13% Notes accrues at a rate of 13% per annum and is payable semi-annually in arrears on May 1 and November 1 of each year (each, a “Payment Date”) commencing on May 1, 2019 (subject to the interest holiday referred to above with respect to the Series A-1 Notes). On each Payment Date, the Company will also pay an installment of principal on the 13% Notes in an amount equal to 15% of the aggregate net sales of OXAYDO (oxycodone HCI, USP) tablets for oral use only —CII, SPRIX (ketorolac tromethamine) Nasal Spray, ARYMO ER, Egalet-002, the SOLUMATRIX® products and the INDOCIN products for the two consecutive fiscal quarter period most recently ended, less the amount of interest paid on the 13% Notes on such Payment Date.

 

The 13% Notes are senior secured obligations of the Company and will be equal in right of payment to all existing and future pari passu indebtedness of the Company, will be senior in right of payment to all existing and future subordinated indebtedness of the Company, will have the benefit of a security interest in the 13% Notes collateral and will be junior in lien priority in respect of any collateral that secures any first priority lien obligations incurred from time to time in accordance with the Indenture. The stated maturity date of the 13% Notes is January 31, 2024. Upon the occurrence of a Change of Control, subject to certain conditions, or certain Asset Sales events (each, as defined in the Indenture), holders of the 13% Notes may require the Company to repurchase for cash all or part of their 13% Notes at a repurchase price equal to 101% of the principal amount of the 13% Notes to be repurchased, plus accrued and unpaid interest to the date of repurchase.

 

20

The Company may redeem the 13% Notes at its option, in whole or in part from time to time, prior to January 31, 2020, at a redemption price equal to 100% of the principal amount of the 13% Notes being redeemed, plus accrued and unpaid interest, if any, through the redemption date, plus a make-whole premium computed using a discount rate equal to the treasury rate in respect of such redemption date plus 1%. The Company may redeem the 13% Notes at its option, in whole or in part from time to time, on or after January 31, 2020, at a redemption price equal to: (i) from and including January 31, 2020 to and including January 30, 2021, 103% of the principal amount of the 13% Notes to be redeemed and (ii) from and including January 31, 2021 and thereafter, 100% of the principal amount of the 13% Notes to be redeemed, in each case, plus accrued and unpaid interest to the redemption date. In addition, prior to January 31, 2020, the Company may redeem, at its option, up to 35% of the aggregate principal amount of the 13% Notes with the proceeds of one or more public or private equity offerings at a redemption price equal to 113.50% of the aggregate principal amount of the 13% Notes to be redeemed, plus accrued and unpaid interest to the date of redemption in accordance with the Indenture; provided that at least 65% of the aggregate principal amount of 13% Notes issued under the Indenture remains outstanding immediately after each such redemption and provided further that each such redemption occurs within 90 days of the date of closing of each such equity offering. No sinking fund is provided for the 13% Notes, which means that the Company is not required to periodically redeem or retire the 13% Notes.

 

Pursuant to the Indenture, the Company and its restricted subsidiaries must also comply with certain affirmative covenants, such as furnishing financial statements to the holders of the 13% Notes, and negative covenants, including limitations on the following: the incurrence of debt; the issuance of preferred and/or disqualified stock; the payment of dividends, the repurchase of shares and under certain conditions making certain other restricted payments; the prepayment, redemption or repurchase of subordinated debt; the merger, amalgamation or consolidation involving the Company; engaging in certain transactions with affiliates; and the making of investments other than those permitted by the Indenture.  In addition, commencing December 31, 2019, the Company must maintain a minimum level of consolidated liquidity, based on unrestricted cash on hand and availability under any revolving credit facility, equal to the greater of (1) the quotient of the outstanding principal amount of the Notes divided by 9.5 and (2) $7.5 million.

 

The Indenture governing the 13% Notes contains customary events of default with respect to the 13% Notes (including the Company’s failure to make any payment of principal or interest on the 13% Notes when due and payable or the Company’s failure to comply with the minimum consolidated liquidity covenant described above), and upon certain events of default occurring and continuing, the Trustee by notice to the Company, or the holders of at least 25% in principal amount of the outstanding 13% Notes by notice to the Company and the Trustee, may (subject to the provisions of the Indenture) declare 100% of the principal of and accrued and unpaid interest, if any, on all the 13% Notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, as well as the then-applicable optional redemption premium under the Indenture, will be due and payable immediately. In the case of certain events of bankruptcy, insolvency or reorganization involving the Company or a Restricted Subsidiary (as defined in the Indenture), the Notes will automatically become due and payable. With respect to any event of default due to the Company’s non-compliance with the minimum liquidity covenant, the Company may, within ten business days, cure such default through the issuance of equity securities, subordinated debt securities or certain other capital contributions.

 

Preemptive Rights Agreements

 

On the Effective Date, the Company entered into preemptive rights agreements (the “Preemptive Rights Agreements”) with certain of the holders of the former 13% Notes. The Preemptive Rights Agreements provide for customary preemptive rights in favor of the parties thereto with respect to certain future issuances of debt or equity securities by the Company, subject to certain exceptions, for so long as such party continues to hold at least 2.5% of the outstanding shares of the Company’s common stock.

 

Collateral Agreement

 

On the Effective Date and in connection with its entry into the Indenture, the Company entered into a collateral agreement, dated as of the Effective Date, with the Collateral Agent and the subsidiary parties from time to time party thereto (the “Collateral Agreement”). Pursuant to the terms of the Collateral Agreement, the Notes and the related guarantees are secured by a first priority lien on substantially all of the Company’s and the Guarantors’ assets, in each

21

case, subject to certain prior liens and other exclusions, and a pledge of 65% of the voting equity interests and 100% of the non-voting equity interests of the Company’s foreign subsidiaries (other than Egalet Limited and any Specified IP Subsidiary (as defined in the Indenture), of which 100% of the voting equity interests have been pledged) to the extent and only for so long as the Company determines in good faith that permitting a pledge of 100% of such voting Equity Interests would result in material adverse tax consequences for the Company or any of its subsidiaries, it being understood that, if a percentage less than 100% but greater than 65% of such voting equity interests may be pledged without any such material adverse tax consequences, then such percentage shall be pledged.

 

Royalty Rights Obligation

 

In connection with 13% Notes, the Company entered into royalty rights agreements (the “Royalty Rights”) with each of the holders of the 13% Notes pursuant to which the Company will pay the holders of the 13% Notes an aggregate 1.5% royalty on Net Sales (as defined in the Indenture) from the Effective Date through December 31, 2022.

 

The Royalty Rights were determined to be a freestanding element with respect to the 13% Notes and the Company is accounting for the Royalty Rights obligation relating to future royalties as a debt instrument.  The Company has Royalty Rights obligations of $5.4 million as of March 31, 2020, which are classified as current and non-current debt in the Company’s Consolidated Balance Sheets.

 

The accounting for the 13% Notes requires the Company to make certain estimates and assumptions about the future net sales. The estimates of the magnitude and timing of net sales are subject to significant variability due to the extended time period associated with the financing transaction, and are thus subject to significant uncertainty. Therefore, these estimates and assumptions are likely to change, which may result in future adjustments to the portion of the debt that is classified as a current liability, the amortization of debt issuance costs and discount as well as the accretion of the interest expense. Any such adjustments could be material.  On the Effective Date, the fair value of the Royalty Rights obligation associated with net product sales was estimated to be approximately $5.7 million using a probability-weighted present value analysis.  On the Effective Date, the Royalty Rights obligation was recorded with an offsetting discount recognized on the 13% Notes.

 

Credit Agreement

 

On March 20, 2019, (the “Closing Date”), the Company entered into a credit agreement (the “Credit Agreement”) with Cantor Fitzgerald Securities as administrative agent and collateral agent (in such capacities, the “Agent”) and certain funds managed by Highbridge Capital Management, LLC, as lenders (collectively, the “Lenders”), which Credit Agreement consists of a $20.0 million revolving line of credit. The Company drew $5.0 million on the Closing Date and must maintain at least 25% of the commitment amount outstanding at all times. The Company will use the proceeds of the loans under the Credit Agreement for working capital purposes and to pay costs and expenses incurred by the Credit Agreement and related transactions. This arrangement will be recognized as a related party transaction as the Lenders are holders of a portion of the Company’s 13% Notes that were issued on January 31, 2019.

 

Advances under the Credit Agreement bear interest at the Company’s option at either the LIBOR Rate (as defined in the Credit Agreement) plus 5.00% or the Base Rate (as defined in the Credit Agreement) plus 4.00%. The Credit Agreement matures on March 20, 2022.

 

The obligations of the Company under the Credit Agreement are unconditionally guaranteed on a senior secured basis by the Company’s wholly-owned subsidiaries, Zyla Life Sciences US Inc. and Egalet Ltd. (collectively, the “Guarantors”). As security for the Company’s obligations under the Credit Agreement, the Company and the Guarantors have granted to the Agent, for the benefit of the Lenders and other secured parties, a first priority lien on substantially all of their tangible and intangible personal property (other than certain specified excluded assets), including proceeds and accounts related to this property and the capital stock of the Guarantors, pursuant to the terms of that certain Collateral Agreement, dated as of the Closing Date (the “Collateral Agreement”), among the Company and the Guarantors in favor of the Agent for the benefit of the Lenders and other secured parties. The Credit Agreement will (i) be equal in right of payment to all existing and future pari passu indebtedness of the Company, (ii) be senior in right of payment to the obligations of the Company pursuant to that certain Indenture, dated as of January 31, 2019 (the

22

“Indenture”), among the Company, the Guarantors and U.S. Bank National Association, as trustee and collateral agent, and (iii) be senior in right of payment to all existing and future subordinated indebtedness of the Company.

 

The Company may terminate the commitments under the Credit Agreement at its option, in whole or in part from time to time, subject to a termination fee equal to (x) 1.0% from the Closing Date through March 20, 2020 and (y) 0.50% from March 20, 2020 through March 20, 2021.

 

Pursuant to the Credit Agreement, the Company and its subsidiaries must also comply with certain customary affirmative covenants, such as furnishing financial statements to the Lenders, and negative covenants, including limitations on the following: incurring debt; issuing preferred and/or disqualified stock; paying dividends, repurchasing shares and, under certain conditions, making certain other restricted payments; prepaying, redeeming or purchasing subordinated debt; conducting a merger or consolidation involving the Company; engaging in certain transactions with affiliates; disposing of assets under certain circumstances; and making certain investments, in each case, other than those permitted by the Credit Agreement. In addition, commencing with the fiscal quarter ending on December 31, 2019, the Company must maintain a minimum level of consolidated liquidity, based on unrestricted cash on hand and availability under any revolving credit facility, equal to the greater of (1) the quotient of the outstanding principal amount of the senior secured notes issued pursuant to the Indenture divided by 9.5 and (2) $7,500,000. As of March 31, 2020 the Company’s minimum level of consolidated liquidity is $10.0 million.

 

The Credit Agreement contains customary events of default (including the Company’s failure to make any payment of principal or interest when due and payable, the failure to comply with the minimum consolidated liquidity covenant or other covenants described above, or upon a Change of Control (as defined in the Credit Agreement)), and, upon such events of default occurring and continuing, the Lenders may accelerate the loans.  In the event of certain events of bankruptcy, insolvency or reorganization involving the Company or its subsidiaries, the obligations under the Credit Agreement will automatically become due and payable. With respect to any event of default due to the Company’s non-compliance with the minimum liquidity covenant (described above), the Company may, within ten business days, cure such default through the issuance of equity securities, subordinated debt securities or certain other capital contributions.

 

On the Closing Date and in connection with its entry into of the Credit Agreement, the Company and the Guarantors entered into the Collateral Agreement, which granted a first priority lien on substantially all of the Company’s and the Guarantors’ assets, in each case subject to certain existing liens and other exclusions.

 

Interim Promissory Note

 

On the Effective Date, pursuant to the Purchase Agreement, the Company issued a $4.5 million promissory note to an affiliate of Iroko in respect of certain inventory purchases by Iroko as a part of the Iroko Products Acquisition (the “Interim Promissory Note”). The Interim Promissory Note bears interest at a rate of 8% per annum (payable by way of increasing the principal amount of the Interim Promissory Note on each interest payment date) and matures on July 31, 2020.

 

The following table reflects unamortized discounts and deferred financing fees on Successor Company debt as of March 31, 2020 and December 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31, 2020

 

December 31, 2019

 

 

 

 

 

Deferred

 

 

 

 

Deferred

(in thousands)

  

Discounts

  

Financing Fees

 

Discounts

  

Financing Fees

Series A-1 Notes, interest holiday

 

$

1,469

 

$

 —

 

$

2,297

 

$

 —

13% Notes, Royalty Rights Obligation

 

 

3,129

 

 

 —

 

 

2,553

 

 

 —

Credit agreement

 

 

143

 

 

719

 

 

157

 

 

792

 

 

$

4,741

 

$

719

 

$

5,007

 

$

792

 

23

The following table reflects the Company’s estimated future principal payments as of March 31, 2020, and excludes payments to be made under the Royalty Rights Obligation, which are included in the carrying value of the Company’s current and non-current debt on the Company’s Consolidated Balance Sheet as of March 31, 2020:

 

 

 

 

 

(in thousands)

   

 

 

Remainder of 2020

 

$

5,678

2021

 

 

6,006

2022

 

 

12,237

2023

 

 

10,111

2024

 

 

69,343

 

Predecessor Company Debt

 

Former 13% Senior Secured Notes

 

In August 2016 and January 2017, the Company issued a total of $80.0 million aggregate principal amount of the 13% Notes (the “former 13% Notes”). The former 13% Notes were sold only to qualified institutional buyers within the meaning of Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).

 

The former 13% Notes were senior secured obligations of the Company and equal in right of payment to all existing and future pari passu indebtedness of the Company (including the 5.50% Notes), were senior in right of payment to all existing and future subordinated indebtedness of the Company, had the benefit of a security interest in the Notes collateral and are junior in lien priority in respect of any collateral that secures any first priority lien obligations incurred, which includes intellectual property, from time to time in accordance with the indenture governing the former 13% Notes.

 

On the Effective Date, in addition to the cash settlement of $20.0 million, the outstanding 13% Notes were converted into the number of shares of common stock of the Company (or Warrants) representing, in the aggregate, 19.4% of the shares outstanding as of the Effective Date and the issuance of the Series A-1 Notes of $50.0 million.  As of December 31, 2018, a total of $80.0 million in principal amount of the former 13% Notes remained outstanding. Refer to Note 3 – Fresh Start Accounting for further details.

 

Former 5.50% Convertible Senior Notes

 

In April and May 2015, the Company issued through a private placement $61.0 million in aggregate principal amount of the 5.50% Convertible Senior Notes (the “5.50% Notes”). 

 

The 5.50% Notes were general, unsecured and unsubordinated obligations of the Company and ranked senior in right of payment to all of the Company’s indebtedness that was expressly subordinated in right of payment to the 5.50% Notes.  The 5.50% Notes were effectively subordinated to any secured indebtedness of the Company to the extent of the value of the assets securing such indebtedness.

 

On the Effective Date, the outstanding 5.50% Notes were cancelled and the 5.50% noteholders received shares of common stock of the Successor Company (or warrants) representing, in the aggregate, 16.1 % of the shares of common stock outstanding as of the Effective Date.  As of September 30, 2019, the 5.50% Notes were no longer outstanding. As of December 31, 2018, a total of $24.7 million in principal amount of the 5.50% Notes remained outstanding.  Refer to Note 3 – Fresh Start Accounting for further details.

 

Former 6.50% Convertible Notes

 

In December 2017, the Company entered into exchange agreements (the “Exchange Agreements”) with certain holders (the “Holders”) of the Company’s 5.50% Notes pursuant to which the Holders agreed to exchange, in the aggregate, approximately $36.4 million of outstanding principal amount of the 5.50% Notes for, in the aggregate, (i) approximately $23.9 million of 6.50% Convertible Senior Notes due 2024 (the “6.50% Notes”) issued by the Company,

24

(ii) a warrant exercisable for 3,500,000 shares of the Company’s common stock at an exercise price of $0.01 per share and (iii) payments, in cash, of all accrued but unpaid interest as of the closing on the 5.50% Notes exchanged in the transaction (the “Exchange”).  At the closing of the Exchange, 2,500,000 warrants were exercised.  The remaining 1,000,000 warrants were exercised in January 2018.

 

On the Effective Date, the outstanding 6.50% Notes were cancelled, and the 6.50% noteholders received shares of common stock of the Successor Company (or warrants) representing, in the aggregate, 15.5% of the shares of common stock outstanding as of the Effective Date.  As of September 30, 2019, the 6.50% Notes were no longer outstanding.  As of December 31, 2018, a total of $23.9 million in principal amount of the 6.50% Notes remained outstanding. Refer to Note 3 – Fresh Start Accounting for further details.

 

9. Leases

 

The Company leases office space, vehicles and office equipment under operating lease arrangements. The leases have initial lease terms ranging from one to five years. Certain of the Company’s leases contain renewal options to extend the lease, which if the Company determined it is reasonably certain to exercise, that renewal option would be included in the total lease term.

 

The Company accounts for its leases in accordance with ASC 842. The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the Company the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the Company has the right to control the use of the identified asset and to obtain substantially all of the economic benefits from using the underlying asset.

 

Right-of-use assets represent the Company’s right to control the use of an explicitly or implicitly identified fixed asset for a period of time and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating leases where the Company is the lessee are included in ROU assets, Other current liabilities and Other long-term liabilities on the Company’s consolidated balance sheets. The lease liabilities are measured at the present value of the unpaid lease payments at the lease commencement date. Key estimates and judgments include how the Company determined the incremental borrowing rate (“IBR”) it uses to present value the unpaid lease payments, the lease term and lease payments.

 

ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its IBR. The Company’s leases do not provide an implicit rate, therefore, management uses its IBR based on the information available at commencement date in determining the present value of lease payments.

.

The lease term for all of the Company’s leases includes the noncancelable period of the lease. Lease payments included in the measurement of the lease asset or liabilities comprised of fixed payments. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

 

The Company recognizes lease expense associated with its short-term leases as an expense on a straight-line basis over the lease term. Variable lease payments are presented in the Company’s consolidated statements of operations in the same line item as expense arising from fixed lease payments for operating leases.

 

25

The following table reflects the components of lease expense as of the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

 

 

Period from

 

 

Period from

 

 

 

Three months

 

 

February 1, 2019

 

 

January 1, 2019

 

 

 

ended

 

 

through

 

 

through

(in thousands)

 

 

March 31, 2020

 

 

March 31, 2019

   

   

January 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease expense:

 

 

 

 

 

 

 

 

 

 

 

 

Fixed lease cost

 

 

$

250

 

 

$

139

 

 

$

69

Total operating lease expense

 

 

$

250

 

 

$

139

 

 

$

69

 

The following table reflects supplemental balance sheet information related to leases as of March 31, 2020:

 

 

 

 

 

 

 

 

 

Successor

(in thousands)

Location in Balance Sheet

    

As of March 31, 2020

Operating leases

 

 

 

 

Operating lease ROU asset

ROU asset - operating lease

 

$

2,479

 

 

 

 

 

Current operating lease liabilities

Other current liabilities

 

 

1,007

Non-current operating lease liabilities

Other liabilities

    

 

1,759

Total operating lease liability

 

 

$

2,766

 

The following table reflects supplement lease term and discount rate information related to leases as of March 31, 2020:

 

 

 

 

 

 

 

 

 

 

Successor

 

 

 

    

As of March 31, 2020

 

 

 

 

 

 

 

Weighted-average remaining lease term

 

 

 

2.70

years

 

 

 

 

 

 

Weighted-average discount rate

 

    

 

8.00%

 

 

The following table reflects supplemental cash flow information related to leases as of the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

Period from

 

 

Period from

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

ended

 

through

 

 

through

(in thousands)

   

March 31, 2020

   

March 31, 2019

   

   

January 31, 2019

 

 

 

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

 

 

 

 

Operating cash flows from operating leases

 

$

317

 

$

211

 

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

Right-of-use assets obtained in exchange for lease obligations:

 

 

 

 

 

 

 

 

 

 

Operating leases

 

$

 —

 

$

 —

 

 

 

2,478

 

26

The following table reflects future minimum lease payments under noncancelable leases as of March 31, 2020:

 

 

 

 

 

(in thousands)

 

 

2020 (excludes the three months ended March 31, 2020)

 

$

956

2021

 

 

1,227

2022

 

 

634

2023

 

 

233

Thereafter

 

 

 —

Total lease payments

 

 

3,050

Less: Imputed interest

 

 

(284)

Total minimum lease payments

 

$

2,766

 

 

10. Stockholders’ Equity

 

Successor

 

Preferred Stock

 

The Successor Company’s certificate of incorporation authorizes it to issue up to 5,000,000 shares of preferred stock with a par value of $0.001 per share. As of March 31, 2020, there were no preferred shares outstanding.

 

Common Stock

 

The Successor Company’s certificate of incorporation authorizes it to issue up to 100,000,000 shares of common stock with a par value of $0.001 per share. As of March 31, 2020, there were 9,591,957 shares issued and outstanding. Outstanding shares were issued to holders of Predecessor first lien obligations and convertible notes claims of 4,774,093 shares and Iroko and its affiliates of 4,586,875 shares.

 

Amended and Restated Charter and Bylaws

 

On February 1, 2019, in accordance with the Plan, the Company’s Fourth Amended and Restated Certificate of Incorporation (as amended and restated, the “A&R Charter”) was filed with the Secretary of State of the State of Delaware, at which time the A&R Charter became effective.  Among other things, the A&R Charter decreased the number of shares of authorized common stock of the Company from 275,000,000 to 100,000,000 and decreases the maximum number of directors that may serve on the Company’s Board of Directors to seven.

 

On the Effective Date, pursuant to the Plan, the Company’s Second Amended and Restated Bylaws (the “A&R Bylaws”) became effective. Among other things, the A&R Bylaws provide for special director nomination procedures, related party transaction approval procedures and independence requirements with respect to certain directors appointed by the Supporting Noteholders pursuant to the Plan (or such directors successors), in each case, for a two-year period following the Effective Date.

 

Effective June 3, 2019, the Company changed its name to Zyla Life Sciences by filing an amendment to the A&R Charter. In addition, the A&R Bylaws were amended to reflect the name change to Zyla Life Sciences and to expressly permit communications between and among stockholders and directors of the Company by means of electronic transmissions.

 

Stockholders’ Agreement

 

On the Effective Date, the Company entered into a stockholders’ agreement (the “Stockholders’ Agreement”) with Iroko and certain of its affiliates. Pursuant to the Stockholders’ Agreement, Iroko and the other stockholder parties agreed to a customary lock-up with respect to their shares of common stock for a period of 90 days following the Effective Date and a customary standstill provision for a period of 24 months following the Effective Date, in each case, subject to certain exceptions. In addition, pursuant to the Stockholders’ Agreement, the stockholder parties are entitled to

27

designate two nominees to the Company’s Board of Directors for so long as such entities hold at least 25% of the equity consideration received on the Effective Date. The Stockholders’ Agreement also provides for customary preemptive rights in favor of the stockholder parties with respect to future issuance of equity securities by the Company, subject to certain exceptions.

 

Warrant Agreements

 

On the Effective Date, the Company entered into warrant agreements (the “Warrant Agreements”) with Iroko, certain of Iroko’s affiliates and certain other parties entitled to receive shares of the Company’s common stock as consideration pursuant to the Purchase Agreement or in satisfaction of certain claims pursuant to the Plan. Pursuant to the Warrant Agreements, the Company issued warrants to purchase up to an aggregate of 4,972,365 shares of the Company’s common stock. The warrants are exercisable at any time at an exercise price of $0.001 per share, subject to certain ownership limitations including, with respect to Iroko and its affiliates, that no such exercise may increase the aggregate ownership of the Company’s outstanding common stock of such parties above 49% of the number of shares of its common stock then outstanding for a period of 18 months.  All of the Company’s outstanding warrants have similar terms whereas under no circumstance may the warrants be net-cash settled. As such, all warrants are equity-classified.

 

Predecessor

 

In connection with the Company’s Plan of Reorganization and emergence from bankruptcy, all equity interests in the Predecessor Company were cancelled, including common stock and equity-based awards.

 

Registration Rights Agreement

 

On the Effective Date, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with Iroko pursuant to which the Company agreed to file with the SEC, upon Iroko’s request at any time following the date which is 180 days following the date on which any equity securities of the Company are accepted for listing on any national securities exchange, a registration statement on Form S-1 or Form S-3, and thereafter to use its commercially reasonable efforts to cause to be declared effective as promptly as practicable, one or more registration statements for the offer and resale of the Company’s common stock held by Iroko and certain of its affiliates. The Registration Rights Agreement contains other customary terms and conditions, including, without limitation, provisions with respect to blackout periods, underwriter cutbacks, reimbursement of expenses and indemnification.

 

11. Fair Value Measurements

 

The Company measures certain assets and liabilities at fair value in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”). ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The guidance in ASC 820 outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company maximizes the use of quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

 

·

Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.

 

·

Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.

 

·

Level 3—Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement.

 

28

Cash equivalents - Cash equivalents primarily consisted of money market funds with overnight liquidity and no stated maturities. The Company classified cash equivalents as Level 1, due to their short-term maturity, and measured the fair value based on quoted prices in active markets for identical assets.

 

Acquisition-related contingent consideration - As of March 31, 2020, the Company had obligations to make contingent payment consideration for future royalties to Iroko based upon annual INDOCIN product net sales over $20.0 million. Pursuant to the Iroko Products Acquisition, the Company recorded the acquisition-date fair value of these contingent liabilities, based on the likelihood of contingent earn-out payments. The earn-out payments are subsequently remeasured to fair value each reporting date.  The Company classified the acquisition-related contingent consideration liabilities to be settled in cash as Level 3, due to the lack of relevant observable inputs and market activity. Changes in assumptions described above could have an impact on the payout of contingent consideration.

 

The following table reflects fair value hierarchy information about each major category of the Company’s financial assets and liabilities measured, at fair value on a recurring basis, for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

Fair Value Measurements as of March 31, 2020

 

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents (money market funds)

 

$

77

 

$

 —

 

$

 —

 

$

77

Total assets

 

$

77

 

$

 —

 

$

 —

 

$

77

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Acquisition-related contingent consideration

 

$

 —

 

$

 —

 

$

20,300

 

$

20,300

Total liabilities

 

$

 —

 

$

 —

 

$

20,300

 

$

20,300

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

Fair Value Measurements as of December 31, 2019

 

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents (money market funds)

 

$

76

 

$

 —

 

$

 —

 

$

76

Total assets

 

$

76

 

$

 —

 

$

 —

 

$

76

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Acquisition-related contingent consideration

 

$

 —

 

$

 —

 

$

17,900

 

$

17,900

Total liabilities

 

$

 —

 

$

 —

 

$

17,900

 

$

17,900

 

The following table reflects a rollforward of our Level 3 liabilities:

 

 

 

 

(in thousands)

 

 

 

 

 

Balance at December 31, 2019

$

17,900

Payments made during the period

 

(1,600)

Change in fair value of contingent consideration

 

4,000

Balance at March 31, 2020

$

20,300

 

The fair value of the contingent consideration was determined on the date of acquisition, January 31, 2019, using an option pricing model under the income approach based on estimated Indocin revenues over 10 years, and discounted to present value at a rate of 15.5%. The fair value of the contingent consideration is remeasured each reporting period, with changes in fair value recorded in the consolidated statements of operations. The valuation inputs utilized to estimate the fair value of the contingent consideration as of March 31, 2020 included a weighted average cost of capital of 17.5% and updated projections of future Indocin revenues. The change in fair value of the contingent consideration during the three months ended March 31, 2020 was due primarily to the passage of time and improved revenue forecasts as there were no other significant changes in the key assumptions during the period.

 

29

12. Net (Loss) Income Per Common Share

 

On the Effective Date the Predecessor Company's equity was cancelled and new equity was issued. Additionally, the Predecessor Company's 5.50% and 6.50% Convertible Notes were cancelled. See Note 10 – Stockholders' Equity and Note 15 – Reorganization Items for further details.

 

Basic net loss per common share excludes dilution for potential common stock issuances and is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period. The 4,972,364 shares of common stock issuable upon the exercise of warrants are included in the number of outstanding shares used for the computation of basic and diluted loss per share.

 

The following table reflects the computation of basic and diluted weighted average shares outstanding and net income (loss) per share for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

Period from

 

 

Period from

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

ended

 

through

 

 

through

 

(in thousands, except share and per share data)

    

March 31, 2020

    

March 31, 2019

    

    

January 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net income (loss) per common share calculation:

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share of common stock—basic and diluted

 

$

(18,239)

 

$

(10,483)

 

 

$

107,240

 

Weighted average common stock outstanding

 

 

14,443,541

 

 

14,333,332

 

 

 

56,547,101

 

Net (loss) income per share of common stock—basic and diluted

 

$

(1.26)

 

$

(0.73)

 

 

$

1.90

 

 

 

13. Stock-Based Compensation

 

Successor

 

2019 Stock-Based Incentive Compensation Plan

 

In March 2019, the Company adopted its 2019 Stock-Based Incentive Compensation Plan (the “2019 Stock Plan”) for the benefit of employees, non-employee directors and consultants of the Company and its subsidiaries and affiliates. The 2019 Stock Plan is designed to attract and retain valued employees, consultants and non-employee directors by offering them a greater stake in the Company’s success and a closer identity with it, and to encourage ownership of the Company’s stock by such persons. Additionally, in March 2020, the Board approved and adopted an amendment to the 2019 Stock Plan increasing the shares available for issuance by 1,300,000 shares and merging the pools of shares reserved for issuance under the 2019 Stock Plan. The 2019 Stock Plan is administered by the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”). In the discretion of the Compensation Committee, the right of a 2019 Stock Plan participant to exercise or receive a grant or settlement of any award, and the timing thereof, may be subject to performance goals as may be specified by the Compensation Committee. Awards granted to executives that are forfeited or otherwise terminate will once again be available for issuance to executives under the 2019 Stock Plan. Similarly, awards granted to persons other than executives that are forfeited or otherwise terminate will once again be available for issuance to persons who are not executives under the Stock Plan. Any award granted under the 2019 Stock Plan, including a common stock award, will be subject to mandatory repayment by the participant to the Company pursuant to the terms of any “clawback” or recoupment policy that is directly applicable to the 2019 Stock Plan and set forth in an award agreement or as required by applicable law.

 

For restricted stock awards and restricted stock units that vest subject to the satisfaction of service requirements, stock-based compensation expense is measured based on the fair value of the award on the date of grant and is recognized as expense on a straight-line basis over the requisite service period.  All of the restricted stock awards and restricted stock units reflected above vest based on performance conditions or over time as stipulated in the individual award agreements. In the event of a change in control, the unvested awards will be accelerated and fully vested immediately prior to the change in control.

 

30

Treatment of Options and Other Equity-Based Awards and Warrants if Proposed Merger Agreement becomes Effective

 

In accordance with terms of the March 16, 2020 Merger Agreement, each outstanding option to purchase shares of the Company’s Common Stock granted under 2019 Stock Plan shall cease to represent a right to acquire shares of Company Common Stock and shall be converted into an option to purchase shares of Parent Common Stock on the same terms and conditions with (1) the number of shares of Parent Common Stock subject to each such option equal to (i) the number of shares of Company Common Stock subject to the corresponding Company option immediately prior to the Merger Effective Time multiplied by (ii) the Exchange Ratio, rounded, if necessary, to the nearest whole share of Parent Common Stock and (2) an exercise price per share (rounded to the nearest whole cent) proportionally adjusted as set forth in the Merger Agreement. Additionally, each outstanding time-based restricted stock unit granted under the 2019 Stock Plan shall be cancelled and Parent shall deliver to each former holder of any such cancelled Company Restricted Stock Unit a number of shares of fully vested Parent Common Stock (rounded to the nearest whole number) equal to the product of (i) the Exchange Ratio, and (ii) the number of shares of Company Common Stock covered by such Company Restricted Stock Unit, subject to reduction for any Taxes withheld pursuant the Merger Agreement. Each outstanding performance-based restricted stock unit granted under the 2019 Stock Plan shall be cancelled and, in exchange therefor, Parent shall deliver to each former holder of each award of Company Performance Stock Units a number of shares of fully vested Parent Common Stock (rounded to the nearest whole number) equal to the product of (i) the Exchange Ratio and (ii) the number of shares of Company Common Stock covered by such Company Performance Stock Unit, subject to reduction for any Taxes withheld pursuant to the Merger Agreement.

 

 

Shares Reserved for Future Issuance Under the 2019 Plan

 

The following table reflects the Company’s shares that are reserved under its 2019 Stock Plan as of March 31, 2020:

 

 

 

 

 

Shares initially reserved under the 2019 Plan

    

2,150,000

 

Additional shares reserved under the 2019 Plan

 

1,300,000

 

Time-based restricted stock units granted under the 2019 Plan

 

(1,420,800)

 

Performance-based restricted stock units granted under the 2019 Plan

 

(509,000)

 

Stock options granted under the 2019 Plan

 

(2,264,450)

 

Stock options forfeited

 

188,500

 

Restricted stock units forfeited

 

827,995

 

Remaining shares available for future grant under the 2019 Plan

 

272,245

 

 

The estimated grant date fair value of the Company’s stock-based awards is amortized ratably over the award’s service periods. The following table reflects stock-based compensation expense recognized for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

 

Period from

 

 

Period from

 

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

 

ended

 

through

 

 

through

 

 

 

    

March 31, 2020

    

March 31, 2019

    

 

January 31, 2019

    

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative

 

$

554

 

$

60

 

 

$

3,466

 

 

Sales and marketing

 

 

12

 

 

 —

 

 

 

436

 

 

Research and development

 

 

 —

 

 

 —

 

 

 

223

 

 

Total stock-based compensation expense

 

$

566

 

$

60

 

 

$

4,125

 

 

 

31

Restricted Stock Awards

 

Time-Based Restricted Stock Unit Award Agreement

 

Time-based restricted stock units granted under the 2019 Stock Plan will be awarded pursuant to a time-based restricted stock unit agreement with the Company. On March 26, 2019, the Compensation Committee approved a form of time-based Restricted Stock Unit Award Agreement (the “Time RSU Agreement”).  The Time RSU Agreement provides for grants of restricted stock units (“RSUs”), with two potential vesting schedules: (i) 1/3 of the RSUs vesting on each of the first three anniversaries of the date of grant; and (ii) 100% of the RSUs vesting on the first anniversary of the date of grant, in each case subject to the participant’s continued employment with the Company through each such anniversary date.  In the event of a change of control (as defined in the 2019 Stock Plan) prior to a termination of the participant’s service, any remaining unvested time-based RSUs will vest and be settled immediately prior to the change of control. 

 

Performance-Based Restricted Stock Unit Award Agreement

 

Performance-based RSUs granted under the 2019 Stock Plan will be awarded pursuant to a performance-based restricted stock unit agreement with the Company. On March 26, 2019, the Compensation Committee approved a form of performance-based Restricted Stock Unit Award Agreement (the “Performance RSU Agreement”). The Performance RSU Agreement provides for grants of RSUs, which only vest if the Company achieves at least 75% of its 2019 Corporate Goals, as set by the Company’s Board of Directors in March 2019, with the exact number of performance-based RSUs vesting pro-rated based on the level of achievement between 75% and 100%. It was determined the 2019 Corporate Goals were attained at a 99% and accordingly the performance-based RSUs vest (i) one with 50% of the performance-based RSUs eligible for issuance on each of March 1, 2020 and March 1, 2021 and (ii) one with 100% of the performance-based RSUs eligible for issuance on March 1, 2020, in each case subject to the participant’s continued employment with the Company through each such anniversary date.  In the event of a change of control (as defined in the 2019 Stock Plan) prior to a termination of the participant’s service, any remaining unvested performance-based RSUs will vest and be settled immediately prior to the change of control.

 

The following table reflects the Company’s restricted stock award (RSU) activity for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average

 

 

 

Number of

 

Grant Date Fair

 

 

    

Shares

    

Value per Share

 

Unvested as of December 31, 2019

 

665,000

 

$

6.07

 

Granted

 

419,800

 

$

1.50

 

Forfeited

 

(1,820)

 

$

6.07

 

Restricted stock units released

 

(212,164)

 

$

6.07

 

Unvested as of March 31, 2020

 

870,816

 

$

3.87

 

 

During the three months ended March 31, 2020, the Compensation Committee of the Company granted time-based restricted stock units to certain executives and directors of the Company. During the three months ended March 31, 2019, the Compensation Committee of the Company granted 511,000 time-based and 509,000 performance-based RSUs to certain executive officers of the Company.

 

As of March 31, 2020, unrecognized stock-based compensation expense related to RSUs under the 2019 Plan was $2.9 million which will be recognized over the weighted-average remaining period of 2.4 years.

 

32

Stock Option Grants

 

The following table reflects the Company’s stock option grant activity for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

Stock Options Outstanding

 

 

    

 

    

 

 

    

Weighted-average

 

 

 

 

 

 

 

 

Remaining

 

 

 

Number of

 

Weighted-Average

 

Contractual

 

 

 

Shares

 

Exercise Price

 

Term (in years)

 

Outstanding as of December 31, 2019

 

534,500

 

$

2.69

 

 

 

Granted

 

1,666,950

 

 

1.62

 

 

 

Exercised

 

 —

 

 

 —

 

 

 

Forfeited or cancelled

 

(125,500)

 

 

2.81

 

 

 

Outstanding as of March 31, 2020

 

2,075,950

 

$

1.82

 

9.8

 

Vested or expected to vest as of March 31, 2020

 

2,075,950

 

$

1.82

 

9.8

 

Exercisable at March 31, 2020

 

 —

 

$

 —

 

 

 

 

The per-share weighted-average grant date fair value of the stock options granted to employees during the three months ended March 31, 2020 was $1.10 per share on the date of grant using the Black-Scholes option pricing model with the weighted average assumptions listed below.  There were no stock options granted during the Successor period February 1, 2019 through March 31, 2019.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months

 

 

 

ended

 

 

    

March 31, 2020

 

 

 

 

 

Risk-free interest rate

 

 

0.80 - 1.71

%

Expected term of options (in years)

 

 

6.00

 

Expected volatility

 

 

80.00

%

Dividend yield

 

 

 —

 

 

The weighted-average valuation assumptions were determined as follows:

·

Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term.

·

Expected term of options: The Company estimated the expected life of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin (“SAB”) No. 107, “Share Based Payments”, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to its lack of sufficient historical data.

·

Expected stock price volatility: The Company estimated the expected volatility based on its actual historical volatility of the Company’s stock price. The Company calculated the historical volatility by using daily closing prices over a period of the expected term of the associated award. A decrease in the expected volatility would have decreased the fair value of the underlying instrument.

·

Expected annual dividend yield: The Company estimated the expected dividend yield based on consideration of its historical dividend experience and future dividend expectations. The Company has not historically declared or paid dividends to stockholders. Moreover, it does not intend to pay dividends in the future, but instead expects to retain any earnings to invest in the continued growth of the business. Accordingly, the Company assumed an expected dividend yield of 0.0%.

 

As of March 31, 2020, there was $2.3 million of total unrecognized stock-based compensation expense related to stock options under the 2019 Stock Plan, which will be recognized over the weighted-average remaining period of 2.7 years.

33

 

Predecessor

 

The Predecessor Company’s common stock was cancelled and new common stock was issued on the Effective Date. Accordingly, the Predecessor Company’s then existing stock-based compensation awards were also cancelled, which resulted in the recognition of any previously unamortized expense on the date of cancellation. Stock-based compensation for the Successor and Predecessor periods are not comparable.

 

The Predecessor Company had granted stock-based awards that were cancelled upon emergence from bankruptcy. In conjunction with the cancellation, the Predecessor Company accelerated the unrecognized stock-based compensation expense and recorded $4.1 million of compensation expense in the period from January 1, 2019 to January 31, 2019.

 

14. Restructuring and Other Charges

 

The following table reflects the Company’s restructuring and other charges for the periods indicated:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

Period from

 

 

Period from

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

ended

 

through

 

 

through

 

(in thousands)

   

March 31, 2020

   

March 31, 2019

   

 

January 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

    

Severance

 

$

284

 

$

 —

 

 

$

776

 

Professional fees

 

 

 —

 

 

 —

 

 

 

23

    

Total restructuring and other costs

 

$

284

 

$

 —

 

 

$

799

 

 

Restructuring and other charges for the Successor three months ended March 31, 2020 reflect severance fees related to the reduction of employees. Restructuring and other charges for Predecessor period January 1, 2019 through January 31, 2019 primarily reflect severance costs related to the closure of the Denmark facility. There were no restructuring and other costs for the period February 1, 2019 through March 31, 2019.

 

15. Reorganization items

 

The following table reflects reorganization items for the periods indicated. See Note 3—Fresh Start Accounting for further details.

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

Period from

 

 

Period from

 

 

February 1, 2019

 

 

January 1, 2019

 

 

through

 

 

through

(in thousands)

 

March 31, 2019

    

    

January 31, 2019

 

 

 

 

 

 

 

 

Professional fees

 

$

 —

 

 

$

2,612

Iroko acquisition related fees

 

 

 —

 

 

 

2,138

Legal fees

 

 

 —

 

 

 

713

Other reorganization expenses

 

 

 —

 

 

 

473

Bankruptcy fees

 

 

606

 

 

 

42

Gain on extinguishment of debt

 

 

 —

 

 

 

(29,976)

Revaluation of assets and liabilities

 

 

 —

 

 

 

(91,171)

Total reorganization items

 

$

606

 

 

$

(115,169)

 

 

34

16. Commitments and Contingencies

 

Legal Proceedings

 

On January 27, 2017 and February 10, 2017, respectively, two putative securities class actions were filed in the U.S. District Court for the Eastern District of Pennsylvania that named as defendants Egalet Corporation and former officers Robert S. Radie, Stanley J. Musial and Jeffrey M. Dayno (the “Officer Defendants” and together with Egalet Corporation, the “Defendants”). These two complaints, captioned Mineff v. Egalet Corp. et al., No. 2:17-cv-00390-MMB and Klein v. Egalet Corp. et al., No. 2:17-cv-00617-MMB, assert securities fraud claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) on behalf of putative classes of persons who purchased or otherwise acquired Egalet Corporation securities between December 15, 2015 and January 9, 2017 and seek damages, interest, attorneys’ fees and other expenses.  On May 1, 2017, the Court entered an order consolidating the two cases (the “Securities Class Action Litigation”) before it, appointing the Egalet Investor Group (consisting of Joseph Spizzirri, Abdul Rahiman and Kyle Kobold) as lead plaintiff and approving their selection of lead and liaison counsel.  On July 3, 2017, the plaintiffs filed their consolidated amended complaint, which named the same Defendants and also asserted claims for purported violations of Sections 10(b) and 20(a) of the Exchange Act.  Plaintiffs brought their claims individually and on behalf of a putative class of all persons who purchased or otherwise acquired shares of Egalet between November 4, 2015 and January 9, 2017 inclusive.  The consolidated amended complaint based its claims on allegedly false and/or misleading statements and/or failures to disclose information about the likelihood that ARYMO ER would be approved for intranasal abuse-deterrent labeling.  The Defendants moved to dismiss the consolidated amended complaint on September 1, 2017 (the “Motion to Dismiss”), the plaintiffs filed their opposition on October 31, 2017, and the Defendants filed their reply on December 8, 2017.  The Court heard oral arguments on the Motion to Dismiss on February 20, 2018 and entered an order pursuant to which the plaintiffs filed a motion for leave to file a second amended complaint on March 6, 2018.  The Defendants responded on March 20, 2018 and the plaintiffs filed their reply on March 27, 2018.  The Court heard oral arguments on the plaintiffs’ motion for leave to file a second amended complaint on July 12, 2018.  On August 2, 2018, the Court granted the Defendants’ Motion to Dismiss and dismissed the Securities Class Action Litigation with prejudice.  On August 31, 2018, plaintiffs filed their notice of appeal with the United States Court of Appeal for the Third Circuit.  On November 7, 2018, the Defendants filed a notice of suggestion of bankruptcy and unopposed motion to stay the appeal as to the Officer Defendants (the appeal was automatically stayed as to the Company upon the Chapter 11 filing).  On February 6, 2019, the Officer Defendants filed a Notice of Lifting of Automatic Stay of Proceedings and Discharge of Subordinated Claims, as plaintiffs’ claim against the Company was extinguished as part of the bankruptcy, which restarted the appellate process.  On April 22, 2019, plaintiffs filed their brief with the United States Court of Appeals for the Third Circuit.  Defendants filed their brief on May 22, 2019 and Plaintiffs filed their reply on June 12, 2019. On April 30, 2020, the Court of Appeals affirmed the District Court’s decision to dismiss the Securities Class Action Litigation.  The Company disputes the allegations in the lawsuit and intend to defend these actions vigorously.  The Company cannot determine the likelihood of, nor can it reasonably estimate the range of, any potential loss, if any, from these lawsuits.

 

On May 1, 2019, the Company was served in a lawsuit entitled International Brotherhood of Electrical Workers Local 728 Family Healthcare Plan v. Allergan, PLC, et al., which was filed in the Philadelphia County Court of Common Pleas (and subsequently coordinated with similar cases and transferred to the Delaware County Court of Common Pleas) on March 29, 2019 in which the Company was named as a defendant.  In the lawsuit, plaintiff alleges that the Company, along with numerous other named defendants, manufactured, promoted, sold and distributed branded and generic opioid pharmaceutical products in the Commonwealth of Pennsylvania, State of Florida and the City of Philadelphia.  Plaintiffs assert that the defendants’ conduct has exacted a financial burden on the plaintiff which has unnecessarily spent considerably more on costs directly attributable to opioid use and over-use in the Commonwealth of Pennsylvania and City of Philadelphia.   On December 18, 2019, Plaintiffs filed a Stipulation of Dismissal, which has not yet been signed by the judge and ordered by the Court as the matter is currently stayed.  The Company cannot determine the likelihood of, nor can it reasonably estimate the range of, any potential loss, if any, from this lawsuit.

 

Cosette Pharmaceuticals Supply Agreement

 

On January 31, 2019, as part of Asset Purchase Agreement to acquire products from Iroko, the Company assumed a Collaborative License, Exclusive Manufacture and Global Supply Agreement with Cosette Pharmaceuticals,

35

Inc. (formerly G&W Laboratories, Inc.) (the “Supply Agreement”) for the manufacture and supply of INDOCIN Suppositories to Zyla for commercial distribution in the United States. The Company is obligated to purchase all of its requirements for INDOCIN Suppositories from Cosette Pharmaceuticals, Inc., and are required to meet minimum purchase requirements for the calendar years 2019 and 2020. The term of the Supply Agreement extends through July 31, 2023, and there are no minimum requirements in any of the other subsequent years. Total commitments to Cosette Pharmaceuticals, Inc are $6.5 million in each of years 2019 and 2020.

 

Catalent Pharma Solutions Commercial Supply Agreement

 

On January 31, 2019, as part of the Iroko Products Purchase Agreement, the Company assumed a Commercial Supply Agreement (“CSA”) with Catalent Pharma Solutions (“Catalent”) for the manufacture of certain SOLUMATRIX products. Based on the CSA, the Company is obligated to purchase certain minimum amounts of manufacturing and product maintenance services on an annual basis for the term of the contract (“Minimum Requirement”) through September 2021. Total commitments to Catalent are $1.0 million through the period ending September 2021.

 

Jubilant HollisterStier Manufacturing and Supply Agreement

On July 30, 2019, the Company entered into a Manufacturing and Supply Agreement (the “Agreement”) with Jubilant HollisterStier LLC (“JHS”) pursuant to which the Company engaged JHS to provide certain services related to the manufacture and supply of SPRIX® (ketorolac tromethamine) Nasal Spray for the Company’s commercial use. Under the Agreement, JHS will be responsible for supplying a minimum of 75% of the Company’s annual requirements of SPRIX through July 30, 2022. The Company has agreed to purchase a minimum number of batches of SPRIX per calendar year from JHS over the term of the Agreement.  Total commitments to JHS are $3.6 million through the period ending July 30, 2022.

 

17. Acquisitions and License and Collaboration Agreements

 

Purchase Agreement with Iroko

 

On October 30, 2018, the Company entered into the Purchase Agreement with Iroko pursuant to which, upon the terms and subject to the conditions set forth therein, the Company acquired certain assets and rights of Iroko, referred to in the Purchase Agreement as the “Transferred Assets,” and assumed certain liabilities of Iroko, referred to in the Purchase Agreement as the “Assumed Liabilities,” including assets related to Iroko’s marketed products, the SOLUMATRIX products under the iCeutica License Agreement and the INDOCIN products. The Iroko Products Acquisition was completed on January 31, 2019.

 

iCeutica License Agreement

 

Pursuant to the Purchase Agreement, on the Effective Date, the Company assumed the rights and obligations of Iroko and its subsidiaries pursuant to the Amended and Restated Nano-Reformulated Compound License Agreement, dated October 30, 2018 (the “iCeutica License”), with iCeutica Inc. and iCeutica Pty Ltd. (collectively, “iCeutica”) to license certain technology and intellectual property related to iCeutica’s SOLUMATRIX® technology, meloxicam and certain other rights of iCeutica.

 

Pursuant to the iCeutica License, iCeutica granted to the Company (as the assignee of Iroko) a sole and exclusive, world-wide right and license under certain iCeutica intellectual property to make, use, sell, offer and import certain products made from the compounds indomethacin, diclofenac, naproxen and meloxicam.  In consideration of the grant of the iCeutica License, the Company is obligated to pay to iCeutica a mid-single digit royalty on all Net Sales of any licensed products, including pro rata portions of any combination products that include a licensed product.

 

The iCeutica License will terminate on a country-by-country basis upon the expiration of the last-to-expire of any licensed patent rights in such country, and otherwise twenty years after the date of the first commercial introduction of a licensed product in such country.  Either party may terminate the license in its entirety if the other party materially breaches the License Agreement, subject to applicable cure periods.  The iCeutica License also contains customary

36

provisions for an agreement of this type related to intellectual property matters, confidentiality, representations and warranties and indemnification.

 

Iroko Royalty Arrangement

 

Pursuant to the Purchase Agreement, on the Effective Date, the Company was also obligated to pay to Iroko a 5% royalty payment on Net Sales of TIVORBEX, ZORVOLEX and the development product acquired on a quarterly basis. In May 2019, the Company agreed to pay approximately $0.8 million to satisfy the royalty payment terminating any obligation for future payments with respect to this agreement.

 

Collaboration and License Agreement with Acura

 

In January 2015, the Company entered into the OXAYDO License Agreement with Acura to commercialize OXAYDO tablets containing Acura’s Aversion Technology. OXAYDO (formerly known as Oxecta®) is currently approved by the FDA for marketing in the United States. in 5 mg and 7.5 mg strengths but was not actively marketed at the time of the OXAYDO License Agreement. Under the terms of the OXAYDO License Agreement, Acura transferred the approved New Drug Application (“NDA”) for OXAYDO to the Company and the Company was granted an exclusive license under Acura’s intellectual property rights for development and commercialization of OXAYDO worldwide in all strengths.

 

Under the OXAYDO License Agreement, Acura will be entitled to a one-time $12.5 million milestone payment when OXAYDO net sales reach a level of $150.0 million in a calendar year.

 

In addition, Acura receives from the Company, a tiered royalty percentage based on sales thresholds.  Based on the Company’s current level of net sales, the royalty percentage payable to Acura is in the mid-single digits; however, the percentage may increase in future years in the event the Company achieves the higher sales thresholds set forth in the License Agreement.   In addition, in any calendar year in which net sales exceed a specified threshold, Acura is entitled receive a double-digit royalty on all OXAYDO net sales in that year. The Company’s royalty payment obligations commenced on the first commercial sale of OXAYDO and expire, on a country-by-country basis, upon the expiration of the last to expire valid patent claim covering OXAYDO in such country (or if there are no patent claims in such country, then upon the expiration of the last valid claim in the U.S.).  Royalties will be reduced upon the entry of generic equivalents, as well for payments required to be made by the Company to acquire intellectual property rights to commercialize OXAYDO, with an aggregate minimum floor.  The term of the Acura license agreement expires, in its entirety, upon the final expiration of any such patent claim in any country. OXAYDO is currently sold in the United States and is covered by six U.S. patents that expire between 2023 and 2025. Patents covering OXAYDO in foreign jurisdictions expire in 2024.  Either the Company or Acura may terminate the license agreement for certain customary reasons, including cause, insolvency or patent challenge. The Company may terminate the license agreement upon 90 days prior written notice.

 

Purchase Agreement with Luitpold

 

In January 2015, the Company entered into and consummated the transactions contemplated by the SPRIX Purchase Agreement with Luitpold (the “SPRIX Purchase Agreement”), pursuant to which the Company acquired certain assets and liabilities associated with SPRIX Nasal Spray and the Company was assigned an exclusive license with Recordati Ireland Ltd. (“Recordati”) for intranasal formulations of ketorolac tromethamine (the “Licensed Product”), the active ingredient in SPRIX Nasal Spray.  The Company is required to pay a fixed, single-digit royalty to Recordati on net sales of the Licensed Product.  The exclusive term of the license agreement expires, on a country-by-country basis, on the later of the final expiration of any patent right in such country that contains a valid claim covering the Licensed Product, or ten years from the date of the first commercial sale of the Licensed Product in such country, and thereafter the Company will retain a non-exclusive, perpetual license in such country. In addition, during the exclusivity period with respect to the United States, Canada and Latin America, the royalty payable to Recordati is decreased if no patent containing a valid claim is in force in the country at the time of sale.  SPRIX Nasal Spray is currently sold in the United States and the patent expired in December 2018 and the first commercial sale of SPRIX Nasal Spray in the United States occurred in May 2011.

37

 

18. Income Taxes

 

The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act was signed into law on March 27, 2020. The CARES Act has significant changes to the U.S. tax law, including a five-year carryback of Net Operating Losses for tax years 2018, 2019, and 2020.  Due to the Company’s historical losses, there is no ability to carryback Net Operating Losses, and the provisions to the law are expected to have no material impact to the Company.

 

The Tax Cuts and Jobs Act (the "Tax Act"), enacted on December 22, 2017, became effective January 1, 2018. The Tax Act had significant changes to U.S. tax law, including the lowering of U.S. corporate income tax rates, implementing a territorial tax system, imposing a one-time transition tax on deemed repatriated earnings of foreign subsidiaries and modified the taxation of other income and expense items.  Due to the valuation allowance on the Company’s deferred tax assets, these provisions do not have any material impact on the Company.

 

The Tax Act contains additional international provisions which may impact the Company prospectively, including the tax on Global Intangible Low-Taxed Income.   The Company does not believe the impact will be material given the historical losses in its international subsidiary and projected future losses.

 

 

 

38

19. Subsequent Events

 

In response to the current business environment as impacted by COVID-19, the Company took several precautionary measures and adjusted its operational needs, including a significant reduction of expenses. As part of these measures, effective April 13, 2020, the base salaries of its management team, including the base salaries of its principal executive officer and other named executive officers, were temporarily reduced. Effective April 13, 2020, each of Todd N. Smith, President and Chief Executive Officer, and Mark Strobeck, Executive Vice President and Chief Operating Officer, took a temporary reduction in their respective base salaries of 50%. Megan Timmins, Senior Vice President, General Counsel and Secretary, and each of the other members of the management team, took a temporary reduction in their base salaries of 30%.

 

On April 13, 2020, the Company announced the taking of certain additional proactive steps designed to mitigate the potential financial and operational impacts of the COVID-19 pandemic. The Company implemented a reduction in force for its territory managers and temporarily reduced the salaries of its remaining territory managers by 30%. In addition, the Company’s home office employees and sales managers, other than the President and Chief Executive Officer and the Executive Vice President and Chief Operating Officer, received a temporary reduction in their base salaries of 30%. The employees on reduced salary will continue to receive employee benefits, including medical, dental and vision benefits.

 

These changes will be reviewed based on future operating conditions and the Company will continue to take appropriate measures to address its changing needs. Although it is difficult to reasonably determine the current impacts of the COVID-19 pandemic at this time, the Company expects the ongoing, global economic impact from the COVID-19 pandemic to have an adverse impact on its financial condition and results of operations. Accordingly, the Company will continue to take reasonable steps, including cost reduction measures, to attempt to mitigate the impact of the COVID-19 pandemic. Assertio granted a waiver in connection with these actions under the Merger Agreement.

 

 

 

ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis of our financial condition and result of operations should be read in conjunction with our 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”).

 

Forward Looking Statements

 

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “potential,” “continue,” “seek to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain, including, but not limited to, risks related to: our ability to continue as a going concern; the impact of our bankruptcy on our business going forward, including with regard to relationships with vendors and customers; the impact of our acquisition of products from Iroko Pharmaceuticals, Inc. (together with its subsidiaries, “Iroko”), including our assumption of related liabilities, potential exposure to successor liability and credit risk of Iroko and its affiliates; our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our current and future indebtedness;  our ability to maintain compliance with the covenants in our debt documents; our ability to obtain additional financing or to refinance our existing indebtedness; the level of commercial success of our products; our ability to execute on our sales and marketing strategy, including developing relationships with customers, physicians, payors and other constituencies; the continued development of our commercialization capabilities, including sales, marketing and market

39

access capabilities; the rate and degree of market acceptance of any of our products and product candidates; the success of competing products that are or become available; the entry of any generic products for SPRIX Nasal Spray, Indocin suppositories or any of our other products; recently enacted and future legislation regarding the healthcare system; the difficulties in obtaining and maintaining regulatory approval of our products and product candidates, and any related restrictions, limitations and/or warnings in the product label under any approval we may obtain; the accuracy of our estimates of the size and characteristics of the potential markets for our products and our ability to serve those markets;

the performance of third parties, including contract research organizations, manufacturers, pharmacy networks, distributors and collaborators; our failure to recruit or retain key personnel, including our executive officers; regulatory developments in the United States and foreign countries; obtaining and maintaining intellectual property protection for our products and product candidates and our proprietary technology; our ability to operate our business without infringing the intellectual property rights of others; our ability to integrate and grow any businesses or products that we may acquire; the success and timing of our preclinical studies and clinical trials; litigation related to opioids and public or legislative pressure on the opioid industry; the outcome of any litigation in which we are or may be involved; the failure or delay of the Merger to be consummated; the termination of the Merger Agreement in circumstances that require us to pay Assertio a termination fee of $3.4 million or reimbursement of out-of-pocket expenses up to $1.75 million; the diversion of management’s attention from our ongoing business operations; the effect of the announcement of the Merger on our business relationships (including, without limitation, partners and customers), operating results and business generally; the obtaining of the requisite consents to the Merger, including, without limitation, the approvals of our and Assertio’s respective stockholders; the spread of epidemic, pandemic, or contagious disease; and general market conditions.

 

You should refer to the “Risk Factors” section of our most recent Annual Report on Form 10-K (which are incorporated herein by reference) and our other filings with the SEC for a discussion of additional important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements.  As a result of these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements included herein or that may be made elsewhere from time to time by, or on behalf of, us.  Furthermore, such forward-looking statements speak only as of the date of this report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

Our Current Business

 

On March 16, 2020, we entered into an the Agreement and Plan of Merger (the “Merger Agreement”) by and among us, Assertio Therapeutics, Inc. (“Assertio”), Alligator Zebra Holdings, Inc. (“Parent”), Zebra Merger Sub, Inc., a wholly-owned subsidiary of Parent (“Merger Sub”) and Alligator Merger Sub, Inc. The Merger Agreement provides that, upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will be merged with and into us, with us continuing as the surviving corporation and a wholly-owned subsidiary of Parent. Pursuant to the terms of the Merger Agreement, at the time the merger is effective, each issued and outstanding share of common stock, par value $0.001 per share, of the Company (the “Common Stock”) (other than Excluded Shares (as defined below) and Dissenting Shares (as defined below)) will be converted into the right to receive 2.5 shares (the “Exchange Ratio”) of common stock, par value $0.0001 per share, of Parent (“Parent Common Stock”). Each share of Common Stock that is held by the Company as treasury stock or that is owned, directly or indirectly, by Parent, the Company, Merger Sub, or any subsidiary of the Company (collectively, “Excluded Shares”), immediately prior to the effective time of the Merger (the “Effective Time”) will cease to be outstanding and will be cancelled and retired and will cease to exist, and no consideration will be delivered in exchange therefor.  “Dissenting Shares” are shares of the Common Stock (other than Excluded Shares) outstanding immediately prior to the Effective Time and held by a holder who is entitled to demand and has properly demanded appraisal for such shares of the Common Stock in accordance with Section 262 of the Delaware General Corporation Law. Consummation of the Merger is subject to certain conditions to closing, including, among others: (1) requisite approvals of our and Assertio’s stockholders; (2) the absence of certain legal impediments to the consummation of the Merger; (3) the approval for listing on the Nasdaq Stock Market of the shares of Parent Common Stock to be issued as Merger consideration, (4) effectiveness of the registration statement on Form S-4 registering the shares of Parent Common Stock and other equity instruments to be issued in the Merger, (5) subject to certain exceptions, the accuracy of the representations, warranties and compliance with the covenants of each party to the Merger Agreement, and (6) Assertio, Parent and their respective Subsidiaries having minimum cash and cash

40

equivalents equal to $25 million in the aggregate (as calculated pursuant to the Merger Agreement).  We are working toward completing the Merger as quickly as possible and currently expect to consummate the merger in the second calendar quarter of 2020.

We are a commercial-stage life science company committed to bringing differentiated products to patients and healthcare providers. We are focused on marketing our portfolio of medicines used both in and outside of the hospital by orthopedic surgeons, gynecologists, neurologists, internists, gastroenterologists, physiatrists, rheumatologists and podiatrists. Our six commercially available products include: SPRIX® (ketorolac tromethamine) Nasal Spray, ZORVOLEX® (diclofenac), INDOCIN® (indomethacin) suppositories, VIVLODEX® (meloxicam), INDOCIN oral suspension and OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII.  VIVLODEX and ZORVOLEX are SOLUMATRIX® Technology non-steroidal anti-inflammatory products. In November 2019, we divested assets related to TIVORBEX® (indomethacin), which was a SoluMatrix product, to a third party, although we continue to supply TIVORBEX tablets to that third party. In January 2020, we amended the terms of the license agreement with iCeutica. To leverage our commercial infrastructure and augment our current product portfolio, we continually seek to acquire additional late-stage product candidates or approved products to develop and/or commercialize.

On January 31, 2019, we completed the acquisition of five marketed non-narcotic, nonsteroidal anti- inflammatory drug (“NSAID”) products from Iroko (the “Iroko Acquisition”). To facilitate this transaction and reorganize our capital structure, in January 2019, we completed proceedings under Chapter 11 of the United States Bankruptcy Code in the District of Delaware. In exchange for the products, Iroko received among other consideration, $45.0 million in principal amount of our 13% senior secured notes and shares of common stock and warrants to purchase common stock of the reorganized Company representing in the aggregate approximately 49% of outstanding common stock at issuance, subject to dilution for shares of common stock issued pursuant to our stock-based incentive compensation plan.  Pursuant to the Chapter 11 plan of reorganization, holders of our then outstanding convertible notes received shares of common stock of the reorganized Company, and holders of our then outstanding senior secured notes received in the aggregate of $20.0 million in cash, $50.0 million in principal amount of our 13% senior secured notes, as well as shares of common stock and warrants to purchase common stock of the reorganized Company representing, in the aggregate, approximately 19.38% of outstanding common stock at issuance, subject to dilution for shares of common stock issued pursuant to our stock-based incentive compensation plan.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

We believe there have been no significant changes in our critical accounting policies and significant judgments and estimates as discussed in our audited consolidated financial statements and the notes thereto for the year ended December 31, 2019, other than as noted below.

 

Goodwill

 

Goodwill is calculated as the excess of the reorganization equity value over the fair value of tangible and identifiable intangible assets pursuant to ASC 852 Reorganizations. Goodwill is not amortized but is tested for impairment at the reporting unit level at least annually or when a triggering event occurs that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net assets are below their carrying amounts. A reporting unit is the same as, or one level below, an operating segment. Our operations are currently comprised of a single, entity wide reporting unit.

 

On March 16, 2020, the Company entered into a Merger Agreement with Assertio whereby Assertio, Parent and their respective Subsidiaries are required to have minimum cash and cash equivalents equal to $25 million in the aggregate (as calculated pursuant to the Merger Agreement) upon closing of the merger with the Company. The execution of the merger agreement triggered the testing of goodwill for impairment and as a result, an impairment charge of $4.8 million was recognized during the three months ended March 31, 2020.

 

41

Acquisition-related contingent consideration 

 

Pursuant to the Iroko Products Acquisition, we have obligations relating to contingent payment consideration for future royalty obligations to Iroko based upon annual INDOCIN product net sales over $20.0 million. We recorded the acquisition-date fair value of these contingent liabilities, based on the likelihood of contingent earn-out payments. The earn-out payments are subsequently remeasured to fair value each reporting date.  The fair value of the acquisition-related contingent consideration is remeasured each reporting period, with changes in fair value recorded in our Consolidated Statements of Operations. The royalty term commenced on the Effective Date and ends on the tenth anniversary of the Effective Date, January 31, 2029.

 

Results of Operations

 

Comparison of the three months ended March 31, 2020 (successor) to the period from February 1, 2019 through March 31, 2019 (Successor) and the period from January 1, 2019 through January 31, 2019 (Predecessor)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

 

 

Period from

 

 

Period from

 

 

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

 

 

ended

 

through

 

 

through

 

 

 

(in thousands)

 

March 31, 2020

   

March 31, 2019

   

 

January 31, 2019

 

Change

Revenue

    

 

 

 

 

 

 

 

 

 

 

 

 

Net product sales

 

$

19,066

 

$

15,810

 

 

$

1,775

 

$

1,481

Total revenue

 

 

19,066

 

 

15,810

 

 

 

1,775

 

 

1,481

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales (excluding amortization of product rights)

 

 

3,444

 

 

12,461

 

 

 

554

 

 

(9,571)

Amortization of product rights

 

 

3,497

 

 

2,332

 

 

 

171

 

 

994

General and administrative

 

 

7,474

 

 

3,365

 

 

 

5,413

 

 

(1,304)

Sales and marketing

 

 

9,972

 

 

5,131

 

 

 

2,773

 

 

2,068

Research and development

 

 

 —

 

 

 5

 

 

 

186

 

 

(191)

Restructuring & other charges

 

 

284

 

 

 —

 

 

 

799

 

 

(515)

Change in fair value of contingent consideration payable

 

 

4,000

 

 

200

 

 

 

 —

 

 

3,800

Impairment of goodwill

 

 

4,830

 

 

 —

 

 

 

 —

 

 

4,830

Total costs and expenses

 

 

33,501

 

 

23,494

 

 

 

9,896

 

 

111

Loss from operations

 

 

(14,435)

 

 

(7,684)

 

 

 

(8,121)

 

 

1,370

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

3,808

 

 

2,193

 

 

 

(52)

 

 

1,667

Other gain

 

 

 —

 

 

 —

 

 

 

(140)

 

 

140

Loss (gain) on foreign currency exchange

 

 

(4)

 

 

 —

 

 

 

 —

 

 

(4)

Total other (income) expense

 

 

3,804

 

 

2,193

 

 

 

(192)

 

 

1,803

Reorganization items

 

 

 —

 

 

606

 

 

 

(115,169)

 

 

114,563

Net (loss) income

 

$

(18,239)

 

$

(10,483)

 

 

$

107,240

 

$

(114,996)

 

 

Net product sales

 

Net product sales increased $1.5 million for the three months ended March 31, 2020 compared to the three months ended March 31, 2019. Net product sales for the three months ended March 31, 2020 consisted of $11.9 million for INDOCIN products, $5.7 million for SPRIX Nasal Spray, $0.9 million for the SOLUMATRIX products, and $0.6 million for OXAYDO.  Net product sales for the three months ended March 31, 2019 consisted of $7.5 million for INDOCIN products, $5.2 million for SPRIX Nasal Spray, $3.8 million for the SOLUMATRIX products, and $1.1 million for OXAYDO.

 

Cost of sales (excluding amortization of product rights)

 

Cost of sales (excluding amortization of product rights) decreased by $9.6 million for the three months ended March 31, 2020 compared to the three months ended March 31, 2019.

42

 

Cost of sales for SPRIX Nasal Spray, OXAYDO, SOLUMATRIX products and INDOCIN products reflects the average cost of inventory shipped to wholesalers and specialty pharmaceutical companies during the three months ended March 31, 2020.

 

Cost of sales for SPRIX Nasal Spray, OXAYDO, SOLUMATRIX products and INDOCIN products reflects the fair value of finished goods inventory for the period from February 1, 2019 to March 31, 2019.

 

Cost of sales for SPRIX Nasal Spray and OXAYDO reflect the average cost of inventory shipped to wholesalers and specialty pharmaceutical companies from January 1, 2019 to January 31, 2019.

 

Amortization of product rights

 

Amortization of product rights increased $1.0 million for the three months ended March 31, 2020 compared to the three months ended March 31, 2019. Amortization of product rights relates to the INDOCIN, OXAYDO and SPRIX Nasal Spray intangible assets. The increase was due to the acquisition on January 31, 2019 of the INDOCIN product rights that were valued at $90.1 million and the increase in the value of the SPRIX Nasal Spray intangible assets to $31.9 million, offset in part by a decrease in the value of OXAYDO, as a result of a Fresh Start Accounting adjustment.

 

General and administrative expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

 

 

Period from

 

 

Period from

 

 

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

 

 

ended

 

through

 

 

through

 

 

 

(in thousands)

 

March 31, 2020

   

March 31, 2019

   

 

January 31, 2019

 

Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Legal, accounting, tax and insurance

 

$

2,664

 

$

599

 

 

$

204

 

$

1,861

Salary and related benefits and employee costs

 

 

2,005

 

 

1,319

 

 

 

839

 

 

(153)

Other professional fees including public company costs

 

 

668

 

 

352

 

 

 

106

 

 

210

Regulatory and related

 

 

651

 

 

490

 

 

 

503

 

 

(342)

Stock compensation

 

 

554

 

 

60

 

 

 

3,466

 

 

(2,972)

Intellectual property

 

 

234

 

 

11

 

 

 

 3

 

 

220

Other general and administrative costs

 

 

698

 

 

534

 

 

 

292

 

 

(128)

Total general and administrative expenses

 

$

7,474

 

$

3,365

 

 

 

5,413

 

$

(1,304)

 

 

General and administrative expenses decreased $1.3 million for the three months ended March 31, 2020 compared to the three months ended March 31, 2019. The decrease was primarily due to lower stock-based compensation expense of $3.0million partially offset by an increase in legal, accounting, tax and insurance expense of $1.9 million. Increased legal is attributed to the pending merger with Assertio. Unamortized stock-based compensation expense of $3.5 million was recognized on January 31, 2019 as a result of the reorganization.

 

43

Sales and marketing expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Successor

 

 

Predecessor

 

 

 

 

 

 

 

Period from

 

 

Period from

 

 

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

 

 

ended

 

through

 

 

through

 

 

 

(in thousands)

 

March 31, 2020

   

March 31, 2019

   

   

January 31, 2019

    

Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Salary and related benefits and employee costs

 

$

5,814

 

$

3,436

 

 

$

1,410

 

$

968

Promotional and marketing programs

 

 

3,086

 

 

1,279

 

 

 

657

 

 

1,150

Other professional fees including consultants

 

 

438

 

 

159

 

 

 

65

 

 

214

Stock compensation

 

 

12

 

 

 —

 

 

 

444

 

 

(432)

Other sales and marketing expenses

 

 

622

 

 

257

 

 

 

197

 

 

168

Total sales and marketing expenses

 

$

9,972

 

$

5,131

 

 

 

2,773

 

$

2,068

 

Sales and marketing expenses increased $2.1 million for the three months ended March 31, 2020 compared to the three months ended March 31, 2019.  The increase was primarily due to higher promotional and marketing program expenses of $1.1 million and higher employee compensation costs of $1.0 million.

 

Research and development expenses

 

Research and development expenses decreased by $0.2 million for the three months ended March 31, 2020 compared to the three months ended March 31, 2019.  This decrease was driven by a discontinuation of costs that did not directly support the growth of our commercial business.

 

Restructuring and other charges

 

Restructuring and other charges of $0.3 million for the three months ended March 31, 2020 reflect costs of severance payments related to the reduction of personnel.

 

Restructuring and other charges of $0.8 million for the three months ended March 31, 2019 reflect costs of severance payments related to the reduction of executive officers and a reduction in force in our Denmark facility in January 2019.

 

Change in fair value of acquisition-related contingent consideration

 

Acquisition-related contingent consideration, which consists of our future royalty obligations to Iroko based upon annual INDOCIN product net sales over $20.0 million, was recorded on the acquisition date, January 31, 2019, at the estimated fair value of the obligation, in accordance with the acquisition method of accounting. The fair value of the acquisition-related contingent consideration is remeasured quarterly. The change in fair value of the acquisition-related contingent consideration during the three months ended March 31, 2020 was $4.0 million and was primarily attributable to higher revenue projections and a decrease in the applicable discount rate.

 

Interest expense

 

Interest expense increased by $1.7 million for the three months ended March 31, 2020 compared to the three months ended March 31, 2019. Interest on Successor debt began on January 31, 2019. The interest expense of $3.8 million for the three months ended March 31, 2020 includes non-cash interest and amortization of debt discount totaling $0.3 million.  The interest expense of $2.1 million for the three months ended March 31, 2019 includes non-cash interest and amortization of debt discount totaling $1.2 million.

 

44

Reorganization items

 

Reorganization items of $114.6 million for the three months ended March 31, 2019 consisted of a gain on the revaluation of assets and liabilities of $91.2 million, a gain on extinguishment of debt of $30.0 million and fees of $6.63 million related to the bankruptcy and Iroko Products Acquisition.

 

Provision (benefit) for income taxes

 

We had no provision nor benefit for income taxes for the three months ended March 31, 2020 and 2019 since we have been in a full valuation allowance for federal and state purposes. 

 

Liquidity and Capital Resources

 

Since our inception, we have incurred net losses and generally negative cash flows from our operations. We incurred net loss of $18.2 million, net loss of $10.5 million and net income of $107.2 million for the three months ended March 31, 2020, the period from February 1, 2019 through March 31, 2019 and the period from January 1, 2019 through January 31, 2019, respectively. Our operating activities provided $5.3 million of cash during the three months ended March 31, 2020, used $16.4 million for the period from February 1, 2019 through March 31, 2019 and provided $0.8 million of cash for the period from January 1, 2019 through January 31, 2019.  At March 31, 2020 we had an accumulated deficit of $64.9 million, a working capital deficit of $32.8 million and cash, cash equivalents and restricted cash totaling $14.9 million.

 

Cash Flows

 

The following table summarizes our cash flows for the three months ended March 31, 2020, the period from February 1, 2019 through March 31, 2019 and the period from January 1, 2019 through January 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

Successor

 

 

Predecessor

 

 

 

 

 

Period from

 

 

Period from

 

 

 

Three months

 

February 1, 2019

 

 

January 1, 2019

 

 

 

ended

 

through

 

 

through

 

 

    

March 31, 2020

   

March 31, 2019

   

 

January 31, 2019

 

Net cash provided by (used in):

 

 

    

 

 

 

 

 

 

    

 

Operating activities

 

$

5,326

 

$

(16,400)

 

 

$

822

 

Investing activities

 

 

(3)

 

 

4,991

 

 

 

 —

 

Financing activities

 

 

(2,815)

 

 

4,775

 

 

 

(19,104)

 

Effect of foreign currency translation on cash

 

 

69

 

 

(26)

 

 

 

 6

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

$

2,577

 

$

(6,660)

 

 

$

(18,276)

 

 

Cash Flows from Operating Activities

 

Net cash provided by operating activities for the three months ended March 31, 2020 of $5.3 million was primarily due to the net loss of $18.2 million.  The net loss was partially offset by non-cash adjustments of $3.7 million related to depreciation and amortization expense, $4.8 million related to impairment of goodwill, and $4.0 million due to the change in fair value of contingent consideration. Net cash inflows from changes in operating assets and liabilities of $9.8 million consisted of an increase in accounts receivable of $5.4 million, an increase in inventory of $1.2 million, offset by an increase in accounts payable of $10.3 million and an increase in accrued expenses of $5.0 million.

 

Net cash used in operating activities for the period from February 1, 2019 through March 31, 2019 was $16.4 million and consisted primarily of a net loss of $10.5 million.  The net loss was partially offset by $2.5 million in depreciation and amortization expense. Net cash outflows from changes in operating assets and liabilities of $9.7 million consisted of an increase in accounts receivable of $35.8 million, offset by decrease in inventory of $10.6 million and an increase in accrued expenses of $12.1 million.

 

45

Net cash provided by operating activities for the period from January 1, 2019 through January 31, 2019 was $0.8 million and consisted primarily of net income of $107.2 million. In addition to net income, there were reorganization items of $121.1 million. Net cash inflows from changes in operating assets and liabilities of $10.4 million primarily consisted of a decrease in accounts receivable of $3.9 million, a decrease in other receivables of $0.7 million and a decrease in accrued expenses of $5.2 million.

 

Cash Flows from Investing Activities

 

Net cash provided by investing activities for the period from February 1, 2019 through March 31, 2019 was $5.0 million and consisted of cash inflows of $2.5 million and $2.5 million for the maturity and sale of investments, respectively. 

 

Cash Flows from Financing Activities

 

Net cash used in financing activities was $2.8 million for the three months ended March 31, 2020 and consisted of payments of contingent consideration and payments on the interim promissory note.

 

Net cash provided by financing activities was $4.8 million for the period from February 1, 2019 through March 31, 2019 and consisted of net proceeds from the Highbridge Credit Agreement, net of principal repayments.

 

Net cash used in financing activities was $19.1 million for the period from January 1, 2019 through January 31, 2019 and consisted of repayments to former 13% Noteholders.

 

Operating and Capital Expenditure Requirements

 

We have not achieved profitability since our inception and we expect to continue to incur net losses for the foreseeable future. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, sales and marketing expenses, manufacturing, commercial infrastructure, legal and other regulatory expense, business development opportunities and general overhead costs, including interest and principal repayments on indebtedness.

   

To date, we have been unable to achieve profitability, and with just our existing products and product candidates, we believe we are unlikely to achieve profitability in the future.

 

Until such time if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements. In order to meet these additional cash requirements, we may seek to sell additional equity or convertible debt securities that may result in dilution to our holders of our common stock. If we issue additional equity, the holders of our common stock will be diluted. The indenture governing the 13% Senior Secured Notes contains covenants that, among other things, restrict our ability to issue additional indebtedness.  Although our ability to issue additional indebtedness is significantly limited by such covenants, if we raise additional funds through the issuance of convertible debt securities, these securities could have rights senior to those of our Successor Zyla common stock and could contain covenants that restrict our operations.  We may also seek to raise additional financing through the issuance of debt which, if available and permitted pursuant to the documents governing the 13% Senior Secured Notes, the Credit Agreement and any other indebtedness we may incur in the future, may involve agreements that include restrictive covenants limiting our ability to take important actions, such as incurring additional debt, making capital expenditures or declaring dividends.  If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.  There can be no assurance that we will be able to obtain additional equity or debt financing on terms acceptable to us, if at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.  In addition, certain agreements we entered into in connection with the consummation of the Iroko Products Acquisition and the Chapter 11 Cases further restrict and limit our ability to raise additional capital, including agreements with respect to pre-emptive rights. Accordingly, our ability to raise additional capital is restricted by these agreements as well.

46

 

Going Concern

 

As of March 31, 2020, we had cash, cash equivalents and restricted cash of $14.9 million. Even though we have emerged from bankruptcy and have funds available under the Credit Agreement, we continue to have significant indebtedness and our ability to continue as a going concern is contingent upon the successful integration of the Iroko Products Acquisition, increasing our revenue, managing our expenses and complying with the terms of our new debt agreements.  We cannot be certain that these initiatives will be successful.

 

Our current debt arrangements with holders of the Series A-1 and Series A-2 Notes as well as the Credit Agreement involve agreements that include minimum liquidity requirements and covenants limiting or restricting our ability to take specific actions. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates, or grant licenses on terms that may not be favorable to us.

 

The unaudited financial statements as of March 31, 2020 have been prepared under the assumption that we will continue as a going concern for the next 12 months. Our ability to continue as a going concern is dependent upon our uncertain ability to successfully integrate the Iroko Products into our business, increasing our revenue, managing our expenses and complying with the terms of our new debt agreements. These unaudited financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Contractual Obligations and Purchase Commitments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

Payments Due By Period

 

 

 

 

 

 

Less than

 

 

 

 

 

 

 

More than

 

 

 

Total

 

1 year

 

1 to 3 years

 

3 to 5 years

 

5 years

 

Operating lease obligations (1)

    

$

3,049

    

$

1,276

    

$

1,657

    

$

116

    

$

 —

 

13% Series A-1 Notes (2)

 

 

72,638

 

 

7,736

 

 

18,803

 

 

46,099

 

 

 —

 

13% Series A-2 Notes (3)

 

 

65,374

 

 

6,963

 

 

16,922

 

 

41,489

 

 

 —

 

Promissory Note (4)

 

 

3,894

 

 

3,894

 

 

 —

 

 

 —

 

 

 —

 

Credit agreement (5)

 

 

6,010

 

 

513

 

 

5,497

 

 

 —

 

 

 —

 

Supply Agreement - Cosette Pharmaceuticals (6)

 

 

6,480

 

 

6,480

 

 

 —

 

 

 —

 

 

 —

 

Supply Agreement - Catalent (7)

 

 

1,000

 

 

500

 

 

500

 

 

 —

 

 

 —

 

Supply Agreement - JHS (8)

 

 

3,600

 

 

1,440

 

 

2,160

 

 

 —

 

 

 —

 

Total

 

$

162,045

 

$

28,802

 

$

45,539

 

$

87,704

 

$

 —

 

 

(1)

Operating lease obligations reflect our obligation to make payments in connection with the leases for our vehicles, office space and office equipment. The vehicle lease expires in June 2023 and the office lease expires on February 28, 2022.

 

(2)

On January 31, 2019, we issued $50.0 million aggregate principal amount of our 13% senior secured notes, designated as Series A-1 Notes, to former holders of First Lien Secured Notes Claims. The Series A-1 Notes are subject to an interest holiday from January 31, 2019 through November 1, 2019. Interest on the Series A-1 notes accrues at a rate of 13% per annum, and is payable semi-annually in arrears on May 1 and November of each year, commencing on May 1, 2019, subject to the interest holiday referred to above.  The stated maturity date of the Series A-1 Notes is January 31, 2024.

 

(3)

On January 31, 2019, we issued $45.0 million aggregate principal amount of our 13% senior secured notes, designated as Series A-2 Notes, to Iroko and certain of its affiliates. Interest on the Series A-2 notes accrues at a rate of 13% per annum, and is payable semi-annually in arrears on May 1 and November of each year, commencing on May 1, 2019. The stated maturity date of the Series A-1 Notes is January 31, 2024.

 

47

(4)

On January 31, 2019, pursuant to the Iroko Products Purchase Agreement, we issued a $4.5 million promissory note to an affiliate of Iroko in respect of certain inventory purchases by Iroko as a result of the Iroko Products Acquisition (the “Interim Promissory Note”). The Interim Promissory Note bears interest at a rate of 8% per annum (payable by way of increasing the principal amount of the Interim Promissory Note on each interest payment date), is subordinate to the Notes, and matures on July 31, 2020.

 

(5)

On March 20, 2019, (the “Closing Date”), we entered into the Credit Agreement with Cantor Fitzgerald Securities as administrative agent and collateral agent certain funds managed by Highbridge Capital Management, LLC, as lenders, which Credit Agreement consists of a $20.0 million revolving line of credit. We drew $5.0 million on the Closing Date and must maintain at least 25% of the commitment amount outstanding at all times.  Advances under the Credit Agreement bear interest at the Company’s option at either the LIBOR Rate (as defined in the Credit Agreement) plus 5.00% or the Base Rate (as defined in the Credit Agreement) plus 4.00%. The Credit Agreement matures on March 20, 2022.

 

(6)

On January 31, 2019, as part of Asset Purchase Agreement to acquire products from Iroko, we assumed a Collaborative License, Exclusive Manufacture and Global Supply Agreement with Cosette Pharmaceuticals, Inc. (formerly G&W Laboratories, Inc.) (the “Supply Agreement”) for the manufacture and supply of INDOCIN Suppositories to Zyla for commercial distribution in the United States. We are obligated to purchase all of our requirements for INDOCIN Suppositories from Cosette Pharmaceuticals, Inc., and are required to meet minimum purchase requirements for the calendar years 2019 and 2020. The term of the Supply Agreement extends through July 31, 2023, and there are no minimum requirements in any of the other subsequent years.

 

(7)

On January 31, 2019, as part of our Iroko Products Purchase Agreement, we assumed a Commercial Supply Agreement (“CSA”) with Catalent Pharma Solutions (“Catalent”) for the manufacture of certain SOLUMATRIX products. Based on the CSA, we are obligated to purchase certain minimum amounts of manufacturing and product maintenance services on an annual basis for the term of the contract (“Minimum Requirement”) through September 2021.

 

(8)

On July 30, 2019, we entered into a Manufacturing and Supply Agreement (the “Agreement”) with Jubilant HollisterStier LLC (“JHS”) for the manufacture and supply of SPRIX® Nasal Spray. Based on the Agreement, we are obligated to purchase certain minimum amounts of manufacturing and supply services on an annual basis for the term of the agreement through July 30, 2022.

 

Off-Balance Sheet Arrangements

 

We did not have, during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

 

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We have limited exposure to market risk related to changes in interest rates. As of March 31, 2020, we had cash, cash equivalents and restricted cash of $14.9 million. As of December 31, 2019, we had cash, cash equivalents and  restricted cash of $12.4 million.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer (“PEO”)/principal financial officer (“PFO”), has evaluated the effectiveness of our disclosure controls and procedures as defined in Rule 13a-15(e) of the

48

Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of the end of the period covered by this Quarterly Report on Form 10-Q.  Based on that evaluation, our management, including our PEO/PFO, concluded that as of March 31, 2020 our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and that such information is accumulated and communicated to our management, including our PEO/PFO, as appropriate to allow timely decisions regarding required disclosure.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during the period from January 1, 2020 through March 31, 2020, which were identified in connection with management’s evaluation required by paragraph (d) of Rules 13a-15 and 15d-15 under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II

 

ITEM 1.  LEGAL PROCEEDINGS

 

Refer to Note 16 - Commitments and Contingencies—Legal Proceedings in the notes to the unaudited consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, which is incorporated into this item by reference.

 

ITEM 1A. RISK FACTORS

 

We are subject to various risks and uncertainties that could have a material impact on our business, financial condition, results of operations and cash flows. The discussion of these risk factors is included in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “Annual Report on Form 10-K”). There were no changes in our Risk Factors from those we previously disclosed in our Annual Report on Form 10-K, other than the following:

 

A terrorism attack, other geopolitical crisis, or widespread outbreak of an illness or other health issue, such as the COVID-19 outbreak, or the perception of their effects, could negatively affect various aspects of Zyla's business, including its workforce and supply chain, which could have a material adverse effect on its financial condition, results of operation or cash flows.

 

       Zyla's operations are susceptible to global events, including acts or threats of war or terrorism, international conflicts, political instability, and natural disasters. The occurrence of any of these events could have an adverse effect on Zyla's business results and financial condition.

 

       Zyla is also susceptible to a widespread outbreak of an illness or other health issue, such as the ongoing COVID-19 outbreak. Outbreaks of epidemic, pandemic, or contagious diseases, such as the COVID-19 virus or, historically, the Ebola virus, Middle East Respiratory Syndrome, Severe Acute Respiratory Syndrome, or the H1N1 virus, could divert medical resources and priorities towards the treatment of that disease. An outbreak of a contagious disease could also negatively disrupt Zyla's business. Business disruptions could include disruptions or restrictions to Zyla's workforce, including Zyla's ability to educate HCPs in person regarding its products, any restrictions on or decline in the use of its products due to the recommendations relating to the treatment of such disease, on its ability to travel or to distribute its products, as well as temporary closures of its facilities or the facilities of its suppliers and their contract manufacturers (and the resulting impact on production or its products), and a reduction in business hours. For example, the ongoing COVID-19 outbreak has required Zyla's sales representatives to work from home and has prevented them from the usual practice of calling on physicians and healthcare providers in person in a healthcare setting. Any disruption of Zyla's suppliers and contract manufacturers or its customers would likely adversely impact its cash flow, sales and operating results. Alternate sources may not be available or may result in delays in shipments to Zyla from its suppliers and subsequently to Zyla's customers. Moreover, if Zyla's customers' businesses are similarly affected or if non-essential

49

medical procedures are delayed, HCPs may not write prescriptions for Zyla's products and/or Zyla's customers might delay or reduce purchases from Zyla. In particular, the ongoing COVID-19 outbreak has caused elective surgeries to be cancelled or postponed and Zyla expects this to impact sales of certain Zyla products that are prescribed for pain management following surgery. If Zyla's operations are curtailed, it may need to seek alternate sources of supply for services and staff, which may be more expensive. In addition, a significant outbreak of epidemic, pandemic, or contagious diseases in the human population could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that could affect demand for Zyla's products, the value of its Common Stock and Zyla's liquidity and access to capital. The extent to which COVID-19 impacts Zyla's operations or those of its third-party partners will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. While Zyla carries insurance for certain business interruption events, it does not carry sufficient business interruption insurance to compensate for all losses that may occur during significant business interruptions. Any losses or damages Zyla incurs could have a material adverse effect on its financial results and its ability to conduct business as expected.

 

ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

Issuer Purchases of Equity Securities 

 

 

 

 

 

Period

(a)

Total Number of Shares (or Units) Purchased

(b)

Average Price Paid per Share (or Unit)

(c)

Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs

(d)

Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs

Month 1

January 1, 2020 – January 31, 2020

N/A

N/A

N/A

N/A

Month 2

February 1, 2020 – February 29, 2020

N/A

N/A

N/A

N/A

Month 3 (1)

March 1, 2020 – March 31, 2020

58,090

$1.55

N/A

N/A

 

Total

58,090

$1.55

N/A

N/A

 

(1)

Consists of shares withheld to pay taxes on behalf of our employees in connection with the vesting of restricted stock units granted under the Company’s Amended and Restated 2019 Stock-Based Incentive Compensation Plan.  These shares may be deemed to be “issuer purchases” of shares.

 

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

50

ITEM 5. OTHER INFORMATION

 

None.

 

51

ITEM 6.  EXHIBITS

 

The following is a list of exhibits filed as part of this Quarterly Report on Form 10-Q. Where so indicated by footnote, exhibits that were previously filed are incorporated by reference. For exhibits incorporated by reference, the location of the exhibit in the previous filing is indicated.

 

 

 

 

Exhibit
Number

    

Description

 

 

 

2.1

 

Debtors’ First Amended Joint Plan of Reorganization, filed with the Court on January 10, 2018 (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 16, 2019).

 

 

 

2.2

 

Order Confirming Debtors’ First Amended Joint Plan of Reorganization, dated January 14, 2018 (incorporated by reference to Exhibit 99.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 16, 2019).

 

 

 

2.3

 

Amendment No. 3 to the Asset Purchase Agreement, dated as of October 30, 2018, by and among Iroko Pharmaceuticals, Inc., Zyla Life Sciences (incorporated by reference to Exhibit 2.1 to Zyla Life Science’s current report on Form 8 K filed with the Securities and Exchange Commission on June 6, 2019).

 

 

 

2.4

 

Agreement and Plan of Merger, dated as of March 16, 2020 by and among Zyla Life Sciences, Alligator Zebra Holdings, Inc., Assertio Therapeutics, Inc., Zebra Merger Sub, Inc. and Alligator Merger Sub, Inc. (incorporated by reference to Exhibit 2.1 to Zyla Life Science’s current report on Form 8-K filed with the Securities and Exchange Commission on March 17, 2020).

 

 

 

3.1

 

Fourth Amended and Restated Certificate of Incorporation of the Company, as amended (incorporated by reference to Exhibit 3.1 to the Company’s current Report on Form 8-K filed with the Securites and Exchange Commission on February 1, 2019).

 

 

 

3.2

 

Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation of Zyla Life Sciences (incorporated by reference to Exhibit 3.1 to Zyla Life Science’s current report on Form 8 K filed with the Securities and Exchange Commission on June 6, 2019).

 

 

 

3.3

 

Second Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 to Egalet Corporation’s current report on Form 8‑K filed with the Securities and Exchange Commission on February 1, 2019).

 

 

 

3.4

 

First Amendment to Second Amended and Restated Bylaws of Zyla Life Sciences (incorporated by reference to Exhibit 3.2 to Zyla Life Science’s current report on Form 8 K filed with the Securities and Exchange Commission on June 6, 2019).

 

 

 

4.1

 

Form of Certificate of Common Stock (incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 29, 2019).

 

 

 

4.2

 

Indenture, dated as of January 31, 2019, among the Company, the Guarantors from time to time party thereto and U.S. Bank National Association, as trustee and collateral agent (incorporated by reference to Exhibit 4.1 to the Registrant’s current report on Form 8-K filed with the Securities and Exchange Commission on February 1, 2019).

 

 

 

4.3

 

Form of Iroko Warrant Agreement (incorporated by reference to Exhibit 4.3 to the Registrant’s current report on Form 8-K filed with the Securities and Exchange Commission on February 1, 2019).

 

 

 

4.4

 

Form of Non-Iroko Warrant Agreement (incorporated by reference to Exhibit 4.4 to the Registrant’s current report on Form 8-K filed with the Securities and Exchange Commission on February 1, 2019).

 

 

 

4.5

 

Promissory Note, dated as of January 31, 2019, by and between the Company and Iroko Pharmaceuticals Inc. (incorporated by reference to Exhibit 4.2 to the Company’s current report on Form 8‑K filed with the Securities and Exchange Commission on February 1, 2019).

 

 

 

52

10.1

 

Form of Consent to First Supplemental Indenture (incorporated by reference to Exhibit 99.1 to Zyla Life Science’s current report on Form 8-K filed with the Securities and Exchange Commission on March 17, 2020).

 

 

 

10.2

 

Second Amended and Restated Nano-Reformulated Compound License Agreement dated January 27, 2020 among iCeutica Inc., iCeutica Pty Ltd., and Zyla Life Sciences US Inc. (incorporated by reference to Exhibit 10.9 to Zyla Life Science’s annual report on Form 10-K filed with the Securities and Exchange Commission on March 26, 2020).*

 

 

 

10.3

 

Amended and Restated 2019 Stock-Based Incentive Compensation Plan, as amended (incorporated by reference to Exhibit 10.27 to Zyla Life Science’s annual report on Form 10-K filed with the Securities and Exchange Commission on March 26, 2020).+

 

 

 

31.1

 

Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934 (filed herewith).

 

 

 

32.1

 

Certification of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).

 

 

 

101.INS

 

XBRL Instance Document (filed herewith).

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document (filed herewith).

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document (filed herewith).

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document (filed herewith).

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document (filed herewith).

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document (filed herewith).

 

 

 

 

 

+Management or compensatory plan or arrangement.

 

 

*Portions of this exhibit have been redacted pursuant to a request for confidential treatment.

 

 

53

EXHIBIT INDEX

 

 

 

 

Exhibit
Number

    

Description

 

 

 

2.1

 

Debtors’ First Amended Joint Plan of Reorganization, filed with the Court on January 10, 2018 (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 16, 2019).

 

 

 

2.2

 

Order Confirming Debtors’ First Amended Joint Plan of Reorganization, dated January 14, 2018 (incorporated by reference to Exhibit 99.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 16, 2019).

 

 

 

2.3

 

Amendment No. 3 to the Asset Purchase Agreement, dated as of October 30, 2018, by and among Iroko Pharmaceuticals, Inc., Zyla Life Sciences (incorporated by reference to Exhibit 2.1 to Zyla Life Science’s current report on Form 8 K filed with the Securities and Exchange Commission on June 6, 2019).

 

 

 

2.4

 

Agreement and Plan of Merger, dated as of March 16, by and among Zyla Life Sciences, Alligator Zebra Holdings, Inc., Assertio Therapeutics, Inc., Zebra Merger Sub, Inc. and Alligator Merger Sub, Inc. (incorporated by reference to Exhibit 2.1 to Zyla Life Science’s current report on Form 8-K filed with the Securities and Exchange Commission on March 17, 2020). 

 

 

 

3.1

 

Fourth Amended and Restated Certificate of Incorporation of the Company, as amended (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed February 1, 2019).

 

 

 

3.2

 

Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation of Zyla Life Sciences (incorporated by reference to Exhibit 3.1 to Zyla Life Science’s current report on Form 8 K filed with the Securities and Exchange Commission on June 6, 2019).

 

 

 

3.3

 

Second Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s current report on Form 8‑K filed with the Securities and Exchange Commission on February 1, 2019).

 

 

 

3.4

 

First Amendment to Second Amended and Restated Bylaws of Zyla Life Sciences (incorporated by reference to Exhibit 3.2 to Zyla Life Science’s current report on Form 8 K filed with the Securities and Exchange Commission on June 6, 2019).

 

 

 

4.1

 

Form of Certificate of Common Stock (incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K filed with the Commission on March 29, 2019).

 

 

 

4.2

 

Indenture, dated as of January 31, 2019, among the Company, the Guarantors from time to time party thereto and U.S. Bank National Association, as trustee and collateral agent (incorporated by reference to Exhibit 4.1 to the Registrant’s current report on Form 8-K filed with the Commission on February 1, 2019).

 

 

 

4.3

 

Form of Iroko Warrant Agreement (incorporated by reference to Exhibit 4.3 to the Registrant’s current report on Form 8-K filed with the Commission on February 1, 2019).

 

 

 

4.4

 

Form of Non-Iroko Warrant Agreement (incorporated by reference to Exhibit 4.4 to the Registrant’s current report on Form 8-K filed with the Commission on February 1, 2019).

 

 

 

4.5

 

Promissory Note, dated as of January 31, 2019, by and between the Company and Iroko Pharmaceuticals Inc. (incorporated by reference to Exhibit 4.2 to the Company’s current report on Form 8K filed with the Securities and Exchange Commission on February 1, 2019).

 

 

 

10.1

 

Form of Consent to First Supplemental Indenture (incorporated by reference to Exhibit 99.1 to Zyla Life Science’s current report on Form 8-K filed with the Securities and Exchange Commission on March 17, 2020).

 

 

 

54

10.2

 

Second Amended and Restated Nano-Reformulated Compound License Agreement dated January 27, 2020 among iCeutica Inc., iCeutica Pty Ltd., and Zyla Life Sciences US Inc. (incorporated by reference to Exhibit 10.9 to Zyla Life Science’s annual report on Form 10-K filed with the Securities and Exchange Commission on March 26, 2020).*

 

 

 

10.3

 

Amended and Restated 2019 Stock-Based Incentive Compensation Plan, as amended (incorporated by reference to Exhibit 10.27 to Zyla Life Science’s annual report on Form 10-K filed with the Securities and Exchange Commission on March 26, 2020).+

 

 

 

31.1

 

Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934 (filed herewith).

 

 

 

32.1

 

Certification of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).

 

 

 

101.INS

 

XBRL Instance Document (filed herewith).

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document (filed herewith).

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document (filed herewith).

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document (filed herewith).

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document (filed herewith).

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document (filed herewith).

 

 

 

 

 

+Management or compensatory plan or arrangement.

 

 

*Portions of this exhibit have been redacted pursuant to a request for confidential treatment.

 

 

55

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) 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.

 

 

 

 

Date: May 14, 2020

 

 

 

 

 

 

ZYLA LIFE SCIENCES

 

 

 

 

By:   

/s/ Todd N. Smith

 

 

Todd N. Smith

 

 

President and Chief Executive Officer and Principal Financial Officer

 

56