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RVL Pharmaceuticals plc - Quarter Report: 2022 June (Form 10-Q)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended June 30, 2022

OR

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

For the transition period from           to

Commission file number 001-38709

RVL Pharmaceuticals plc

(Exact name of registrant as specified in its charter)

Ireland

   

Not Applicable

(State or other jurisdiction of

(I.R.S. Employer

incorporation or organization)

Identification No.)

400 Crossing Boulevard

Bridgewater, NJ 08807

(Address of principal executive offices)

(Zip Code)

(908) 809-1300

(Registrant’s telephone number, including area code)

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Ordinary shares, $0.01 nominal value per share

RVLP

Nasdaq Global Select Market

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

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

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

Large accelerated filer

Accelerated filer

Non-accelerated filer  

Smaller reporting company  

Emerging growth company  

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

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

There were 99,149,955 ordinary shares ($0.01 nominal value per share) outstanding as of August 10, 2022.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, including the section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations," contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy and plans and our objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "plan," "should," "estimate," "continue," "anticipate," "intend," "expect" and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short- and long-term business operations and objectives and financial needs. Examples of forward-looking statements include, among others, statements we make regarding: our intentions, beliefs or current expectations concerning, among other things, future operations; future financial performance, trends and events, particularly relating to sales of Upneeq; U.S. Food and Drug Administration, or the FDA, and other regulatory applications, approvals and actions; the continuation of historical trends; our ability to manage costs and service our debt; and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs.

We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following:

Due to our dependence on one product, Upneeq, our business could be materially adversely affected if Upneeq does not perform as well as expected.
Our business may be adversely affected by the ongoing coronavirus outbreak.
Upneeq may fail to achieve market acceptance by clinicians and patients, or others in the medical community, and the market opportunity for Upneeq may be smaller than we estimate.
If we are unable to successfully commercialize Upneeq, or develop new products, on a timely or cost effective basis, our operating results will suffer.
Our profitability depends on our customers’ willingness to pay the price we charge for Upneeq. If we decide to lower the price we charge for Upneeq our profitability could materially suffer.
Our marketing and sales expenditures may not result in the commercial success of Upneeq.
There is no certainty that we will be able to get FDA approval of arbaclofen extended release (“ER”) and no certainty that we will be able to realize any value for arbaclofen ER if we decide to license or divest the product.
We expend a significant amount of resources on research and development, including milestones on in licensed products, which may not lead to successful product introductions.
If we are unable to maintain our sales, marketing and distribution capabilities, or establish additional capabilities if and when necessary, we may not be successful in commercializing Upneeq.
We depend to a large extent on third-party suppliers and distributors for Upneeq, including Nephron Pharmaceuticals, and if such suppliers and distributors are unable to supply raw materials for manufacture and deliver Upneeq in a timely manner, or are unable to manufacture Upneeq at a scale sufficient to meet demand, it could have material adverse effect on our business, financial position and results of operations.
If Upneeq does not produce the intended effects, our business may suffer.

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Failures of or delays in clinical trials are common and have many causes, and such failures or delays could result in increased costs to us and could prevent or delay our ability to obtain regulatory approval and commence product sales for new products.
The drug regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
We are, and will continue to be in the future, a party to legal proceedings that could result in adverse outcomes.
Other factors that are described in Part 1, Item 1A "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the U.S. Securities and Exchange Commission (“SEC”) on March 30, 2022.

The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date hereof. You should not rely upon forward-looking statements as predictions of future events. We cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Except as required by applicable law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or to changes in our expectations.

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Page

PART I. FINANCIAL INFORMATION

ITEM 1. Financial Statements (unaudited).

5

Unaudited Condensed Consolidated Balance Sheets – June 30, 2022 and December 31, 2021

5

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss – Three and Six Months Ended June 30, 2022 and 2021

6

Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity – Three and Six Months Ended June 30, 2022 and 2021

7

Unaudited Condensed Consolidated Statements of Cash Flows – Three and Six Months Ended June 30, 2022 and 2021

8

Notes to Unaudited Condensed Consolidated Financial Statements

9

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

21

ITEM 3. Quantitative and Qualitative Disclosures About Market Risk.

31

ITEM 4. Controls and Procedures.

31

PART II. OTHER INFORMATION

ITEM 1. Legal Proceedings.

32

ITEM 1A. Risk Factors.

32

ITEM 6. Exhibits.

33

SIGNATURES

34

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PART I – FINANCIAL INFORMATION

Item 1.Financial Statements (unaudited).

RVL PHARMACEUTICALS PLC

Unaudited Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

    

June 30, 2022

    

December 31, 2021

    

Assets

 

  

 

  

 

Current assets:

 

  

 

  

 

Cash and cash equivalents

$

27,413

$

40,444

Other receivables

 

1,833

 

2,133

Inventories, net

 

528

 

838

Prepaid expenses and other current assets

 

9,287

 

12,901

Financial commitment asset

1,128

3,063

Total current assets

 

40,189

 

59,379

Property, plant and equipment, net

 

713

 

866

Operating lease assets

871

1,368

Indefinite-lived intangible assets

 

27,210

 

27,210

Goodwill

 

55,847

 

55,847

Total assets

$

124,830

$

144,670

Liabilities and Shareholders' Equity

 

  

 

  

Current liabilities:

 

  

 

  

Trade accounts payable

$

5,437

$

3,777

Accrued liabilities

 

11,947

 

13,077

Current portion of debt

607

2,409

Current portion of obligations under finance leases

1

5

Current portion of lease liability

552

839

Income taxes payable - current portion

 

11

 

1

Total current liabilities

 

18,555

 

20,108

Long-term debt (measured at fair value and representing $55,000 of aggregate unpaid principal)

 

42,900

 

43,800

Warrant liability

4,273

3,220

Long-term portion of lease liability

349

592

Income taxes payable - long term portion

 

68

 

66

Deferred taxes

 

174

 

151

Total liabilities

 

66,319

 

67,937

Commitments and contingencies (see Note 11)

 

  

 

  

Shareholders' equity:

 

  

 

  

Ordinary shares ($0.01 nominal value, 400,000,000 shares authorized, 83,617,567 and 83,297,567 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively)

836

833

Preferred shares ($0.01 nominal value, 40,000,000 shares authorized, no shares issued and outstanding)

Euro deferred shares (€1.00 nominal value, 25,000 shares authorized, no shares issued and outstanding)

Additional paid in capital

594,132

591,730

Accumulated deficit

(536,457)

(517,530)

Accumulated other comprehensive income

 

 

1,700

Total shareholders' equity

 

58,511

 

76,733

Total liabilities and shareholders' equity

$

124,830

$

144,670

See accompanying notes to unaudited condensed consolidated financial statements.

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RVL PHARMACEUTICALS PLC

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2022

    

2021

    

2022

    

2021

    

  

  

  

  

Net product sales

$

8,448

$

1,482

$

14,392

$

2,255

Royalty revenue

 

 

28

 

 

190

Licensing revenue

 

 

10,000

 

15,500

 

10,000

Total revenues

 

8,448

 

11,510

 

29,892

 

12,445

Cost of goods sold

 

2,227

709

 

4,371

 

1,388

Gross profit

 

6,221

 

10,801

 

25,521

 

11,057

Selling, general and administrative expenses

 

20,169

21,047

 

44,003

 

37,999

Research and development expenses

 

1,176

2,052

 

2,038

 

4,256

Impairment of intangible assets

7,880

7,880

Total operating expenses

 

21,345

 

30,979

 

46,041

 

50,135

Operating loss before gain on sales of product rights, net

 

(15,124)

 

(20,178)

 

(20,520)

 

(39,078)

Gain on sales of product rights, net

5,636

Operating loss

(15,124)

(20,178)

(20,520)

(33,442)

Interest expense and amortization of debt discount

 

978

494

 

1,963

 

1,015

Change in fair value of debt and interest expense

(740)

304

Change in fair value of warrants

(3,455)

1,053

Other non-operating (income) expense, net

 

(78)

1,202

 

(5,115)

 

1,193

Total other non-operating (income) expense

 

(3,295)

 

1,696

 

(1,795)

 

2,208

Loss before income taxes

 

(11,829)

 

(21,874)

 

(18,725)

 

(35,650)

Income tax expense, continuing operations

 

277

 

94

 

202

 

90

Loss from continuing operations

(12,106)

(21,968)

(18,927)

(35,740)

Income from discontinued operations before income taxes

4,454

9,153

Income tax expense, discontinued operations

 

 

213

 

 

752

Income from discontinued operations, net of tax

4,241

8,401

Net loss

$

(12,106)

$

(17,727)

$

(18,927)

$

(27,339)

Change in fair value of debt due to change in credit risk, net of tax

(1,700)

Comprehensive loss

$

(12,106)

$

(17,727)

$

(20,627)

$

(27,339)

(Loss) earnings per ordinary share:

Basic and diluted, continuing operations

$

(0.14)

$

(0.35)

$

(0.23)

$

(0.57)

Basic and diluted, discontinued operations

0.07

0.13

Basic and diluted

$

(0.14)

$

(0.28)

$

(0.23)

$

(0.44)

Weighted average ordinary shares outstanding:

 

  

 

 

  

 

Basic and diluted

 

83,580,906

62,767,400

 

83,535,655

62,723,011

See accompanying notes to unaudited condensed consolidated financial statements.

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RVL PHARMACEUTICALS PLC

Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity

(In thousands, except share data)

  

  

  

  

Accumulated

  

other

Ordinary shares

Additional

Accumulated

comprehensive

Total

Shares

Amount

paid in capital

deficit

income (loss)

shareholders' equity

Balance at January 1, 2021

62,545,832

$

625

$

548,070

$

(452,610)

$

(2,229)

$

93,856

Share compensation

173,299

2

1,309

1,311

Net loss

(9,612)

(9,612)

Payments for taxes related to the net share settlement of equity awards

(358)

(358)

Balance at March 31, 2021

62,719,131

$

627

$

549,021

$

(462,222)

$

(2,229)

$

85,197

Share compensation

128,931

1

1,232

1,233

Net loss

(17,727)

(17,727)

Payments for taxes related to the net share settlement of equity awards

(249)

(249)

Balance at June 30, 2021

62,848,062

$

628

$

550,004

$

(479,949)

$

(2,229)

$

68,454

Balance at January 1, 2022

83,297,567

$

833

$

591,730

$

(517,530)

$

1,700

$

76,733

Share compensation

217,844

2

1,326

1,328

Net loss

(6,821)

(6,821)

Payments for taxes related to the net share settlement of equity awards

(57)

(57)

Change in credit risk associated with fair value of debt

(1,700)

(1,700)

Balance at March 31, 2022

83,515,411

$

835

$

592,999

$

(524,351)

$

$

69,483

Share compensation

102,156

1

1,207

1,208

Net loss

(12,106)

(12,106)

Payments for taxes related to the net share settlement of equity awards

(74)

(74)

Balance at June 30, 2022

83,617,567

$

836

$

594,132

$

(536,457)

$

$

58,511

See accompanying notes to unaudited condensed consolidated financial statements.

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RVL PHARMACEUTICALS PLC

Unaudited Condensed Consolidated Statements of Cash Flows

(In thousands)

Six Months Ended June 30, 

    

2022

    

2021

Cash Flows from Operating Activities:

 

  

 

  

Net loss from continuing operations

$

(18,927)

$

(35,740)

Net income from discontinued operations

8,401

Net loss

(18,927)

(27,339)

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

 

 

Depreciation and amortization

 

180

 

7,914

Share compensation

2,418

2,409

Change in fair value of debt

(2,600)

Change in fair value of warrants

1,053

Impairment of intangible assets

7,880

Deferred income tax benefit

 

23

 

267

(Gain) loss on sale of fixed and leased assets

(94)

1,244

Gain on sale of product rights, net

(5,636)

Amortization of deferred financing and loan origination fees

1,935

552

Write off of deferred financing and loan origination fees

37

Change in operating assets and liabilities:

 

 

Other receivables

 

300

 

3,875

Inventories, net

 

310

 

1,606

Prepaid expenses and other current assets

 

3,614

 

(1,004)

Trade accounts payable

 

1,659

 

(1,004)

Accrued and other current liabilities

 

(1,151)

 

(5,209)

Net cash used in operating activities

 

(11,280)

 

(14,408)

Cash Flows from Investing Activities:

 

  

 

Proceeds from product rights disposal

7,300

Proceeds from sale of fixed and leased assets

94

25

Purchases of property, plant and equipment

(27)

(1,398)

Net cash provided by investing activities

 

67

 

5,927

Cash Flows from Financing Activities:

 

  

 

  

Payments on finance lease obligations

 

(4)

(27)

Payments on insurance financing loan

 

(1,802)

Payments for taxes related to net share settlement of share-based awards

(131)

(607)

Proceeds from issuance of ordinary shares under ESPP

119

139

Debt repayments

(5,300)

Net cash used in financing activities

 

(1,818)

 

(5,795)

Net change in cash and cash equivalents

 

(13,031)

 

(14,276)

Cash and cash equivalents, beginning of period

 

40,444

114,053

Cash and cash equivalents, end of period

$

27,413

$

99,777

See accompanying notes to unaudited condensed consolidated financial statements.

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements

Note 1. Organization and Nature of Operations

RVL Pharmaceuticals plc, an Irish public limited company, together with its subsidiaries (the “Company”), is a specialty pharmaceutical company focused on the development and commercialization of products that target markets with underserved patient populations. In July 2020, the Company received regulatory approval from the FDA for RVL-1201, or Upneeq, (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or droopy or low-lying eyelids in adults. Upneeq was commercially launched in September 2020 to a limited number of eye care professionals with commercial operations expanded in 2021 among ophthalmology, optometry and oculoplastic specialties. In February 2022, Upneeq was commercially expanded into the medical aesthetics market.

On August 27, 2021, the Company closed the divestiture of its portfolio of branded and non-promoted products and its Marietta, Georgia, manufacturing facility (the “Legacy Business”) to certain affiliates of Alora Pharmaceuticals (“Alora”) for $111 million in cash upon closing, subject to certain adjustments, and up to $60 million in additional contingent milestone payments. Pursuant to the agreement the Company retained the rights to Upneeq and to arbaclofen extended release (“ER”) tablets which is under development for the treatment of spasticity in multiple sclerosis.

With the divestiture of the Legacy Business the Company’s commercial operations are conducted by its wholly-owned subsidiaries, RVL Pharmaceuticals, Inc. (“RVL Pharmaceuticals”) and RVL Pharmacy, LLC, (“RVL Pharmacy”). RVL Pharmacy operates pharmacy operations dedicated to the processing and fulfillment of prescriptions for Upneeq.

Unless otherwise indicated or required by the context, references throughout to “RVL,” or the “Company,” refer to the Company’s continuing operations following the sale of the Legacy Business to Alora.

Note 2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation—The accompanying unaudited condensed consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and under the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. In management’s opinion, the interim financial data presented herein includes all adjustments (consisting solely of normal, recurring adjustments) that are necessary for a fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. The operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2022 or any period thereafter. The accompanying condensed consolidated balance sheet data as of December 31, 2021 was derived from the audited consolidated financial statements.

Management believes that the disclosures included herein are adequate to make the information presented not misleading in any material respect when read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2021. Those audited consolidated financial statements include a summary of our significant accounting policies, updates to which are included in this Note 2.

Discontinued Operations—Upon divestiture of a business, the Company classifies such business as a discontinued operation, if the divested business represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results. The results of businesses that have qualified as discontinued operations have been presented as such for all reporting periods. Results of discontinued operations include all revenues and expenses directly derived from such businesses; general corporate overhead is not allocated to discontinued operations. Reclassification changes to the accompanying unaudited condensed consolidated statement of cash flows have been made to conform to the current period presentation.

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

The divestiture of the Legacy Business qualifies as a discontinued operation and therefore has been presented as such. See Note 4, Discontinued Operations, for more information.

Use of Estimates—The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported throughout the financial statements. Actual results could differ materially from those estimates.

Supplemental Cash Flow Disclosures—Supplemental cash flow disclosures are as follows (in thousands):

Six Months Ended June 30, 

2022

    

2021

Cash paid for:

Interest

$

2,931

$

5,349

Income taxes

$

142

$

1,913

Recently Issued Accounting Standards

In August 2020, the FASB issued Accounting Standards Update 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The standard requires entities to provide expanded disclosures about the terms and features of convertible instruments and amends certain guidance related to the computation of earnings per share for convertible instruments and contracts on an entity’s own equity. The standard, which allows entities to adopt the guidance through either a modified or fully retrospective method of transition, becomes effective for the Company, as a smaller reporting company, for fiscal years beginning after December 15, 2023, with early adoption permitted. The Company is currently assessing the impact of adoption of ASU 2020-06.

There are no other recently issued accounting standards that are expected to have a material impact to the Company’s financial position or results of operations upon adoption.

Note 3. Liquidity

At June 30, 2022, the Company had cash and cash equivalents of $27.4 million, an accumulated deficit of $536.5 million, and total long-term debt with aggregate principal maturities of $55.0 million, with such maturities commencing in March 2024 and extending through October 2026 (see Note 8). In addition, the Company’s primary indebtedness contains various restrictive covenants including minimum liquidity and minimum quarterly product sales requirements. For the six months ended June 30, 2022 and 2021, the Company incurred net losses from continuing operations of $18.9 million and $35.7 million, respectively. For the six months ended June 30, 2022 and 2021, the Company used $11.3 million and $14.4 million, respectively, in cash for operating activities.

The divestiture of the Legacy Business in 2021 resulted in the loss of substantially all the Company’s revenue generating assets. The Company’s current business plan is focused on the continued launch and commercialization of Upneeq, which has and will continue to diminish the Company’s cash flows in at least the near term. The Company will require additional capital to fund its operating needs, including the expanded commercialization of Upneeq and other activities. The Company expects to continue to incur significant expenditures and sustained operating losses in the future.

Management of the Company does not believe that current sources of liquidity will be sufficient to fund the Company’s planned expenditures and meet its obligations for at least 12 months following the date the accompanying unaudited condensed consolidated financial statements are issued without raising additional funding. As a result, there is a

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

substantial doubt as to the Company’s ability to operate as a going concern. The Company’s ability to continue as a going concern will require it to obtain additional funding, generate positive cash flow from operations and/or enter into strategic alliances or sell assets.

Management’s plans to address these conditions include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or is entirely within its control, (i) raise funds through additional sales of ordinary shares, through equity sales agreements with brokers/dealers or other public or private equity financings, (ii) raise funds through borrowings under existing debt facilities and/or convertible debt, and/or (iii) raise non-dilutive funds through product collaborations and/or to partner or sell a portion or all rights to any of the Company’s assets.

In August 2022, the Company raised an aggregate of $43.9 million, comprised of $23.9 million in aggregate gross proceeds from the private placement of ordinary shares and, concurrently, $20.0 million from the issuance of second tranche Senior Secured Notes (see Note 16), to enhance liquidity in furtherance of certain of management’s plans as described above.

There can be no assurance that the Company will receive cash proceeds from any of these potential sources or, to the extent cash proceeds are received, such proceeds would be sufficient to support its current operating plan for at least the next 12 months from the date the accompanying unaudited condensed consolidated financial statements are issued. The sale of additional equity or convertible debt securities may result in dilution to the Company’s shareholders. If the Company raises additional funds through the issuance of debt securities or preferred shares, these securities could provide for rights senior to those of its ordinary shares and could contain covenants that would further restrict its operations. Additional funds may not be available when the Company needs them, on terms that are acceptable to it, or at all.

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which assumes the realization of assets and settlement of liabilities in the normal course of business, and therefore do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern.

Note 4. Discontinued Operations

On August 27, 2021, the Company announced the closing of the divestiture of its Legacy Business to certain affiliates of Alora for $111 million in cash upon closing, subject to certain adjustments, and up to $60 million in additional contingent milestone payments. During the six months ended June 30, 2022, the Company received an aggregate of $5.0 million in cash from Alora related to contingent milestone payments earned in connection with the sale of the Legacy Business, such income was recognized and classified within other non-operating income, net in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss.

The Company has determined the divestiture of the Legacy Business represents a strategic shift that will have a major effect on its business and therefore met the criteria for classification as discontinued operations. Accordingly, the Legacy Business is reported as discontinued operations in accordance with Accounting Standards Codification 205-20, Discontinued Operations. The results of operations from the Legacy Business are classified as discontinued operations in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss. Applicable amounts in prior periods have been recast to conform to this discontinued operations presentation. The Company recognized a gain on the sale of the Legacy Business upon closing.

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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

The following table presents the results of discontinued operations (in thousands):

Three Months Ended

Six Months Ended

June 30, 2021

June 30, 2021

Total revenues

$

23,289

    

$

46,234

Cost of goods sold (inclusive of depreciation and amortization)

 

12,235

 

25,045

Selling, general and administrative expenses

 

2,426

 

4,396

Research and development expenses

1,744

2,850

Income from operations

 

6,884

 

13,943

Interest expense and amortization of debt discount

 

2,465

4,904

Other non-operating income, net

 

(35)

(114)

Income from discontinued operations before provision for income taxes

 

4,454

 

9,153

Income tax expense

213

752

Income from discontinued operations, net of tax

$

4,241

$

8,401

The following table presents the significant non-cash items and purchase of property, plant and equipment for the discontinued operations that are included in the accompanying unaudited condensed consolidated statements of cash flows (in thousands):

Three Months Ended

Six Months Ended

Cash flows from operating activities:

June 30, 2021

June 30, 2021

Depreciation and amortization

$

3,274

$

6,583

Share compensation

101

204

Cash flows from investing activities:

Purchases of property, plant and equipment

$

912

$

1,226

Note 5. Revenues

The Company’s performance obligations are to provide its pharmaceutical products based upon purchase orders from customers. The performance obligation is satisfied at a point in time, typically upon delivery, when the customer obtains control of the pharmaceutical product. The Company collects payments in advance from its customers.

The following table presents disaggregated revenues from contracts with customers (in thousands):

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2022

    

2021

    

2022

    

2021

    

Net product sales - Upneeq

$

8,448

 

$

1,482

$

14,392

$

2,255

Royalty revenue

 

 

28

 

190

Licensing revenue

 

 

10,000

 

15,500

10,000

Total revenues

$

8,448

$

11,510

$

29,892

$

12,445

On July 28, 2020, the Company entered into a License Agreement with Santen Pharmaceutical Co. Ltd (“Santen”), granting Santen exclusive development, registration, and commercialization rights to RVL-1201 in Japan, China, and other Asian countries as well as Europe, the Middle East and Africa (“EMEA”) countries (the “License Agreement”). Under the License Agreement the Company is entitled to certain development and regulatory milestone payments. The Company is also entitled to royalty payments on net sales of RVL-1201 in Santen commercialization territories.

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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

During the three and six months ended June 30, 2021, the Company received a $10.0 million milestone payment from Santen which was recognized as license revenue as all performance obligations were met.

On March 29, 2022, RVL Pharmaceuticals entered into the First Amendment to License Agreement (the “Amendment”) with Santen, amending the License Agreement. Under the terms of the Amendment, effective March 31, 2022, RVL Pharmaceuticals became entitled to receive an upfront cash payment of $15.5 million, and the remaining developmental and regulatory cash milestone payments, were removed. Pursuant to the terms of the Amendment, new developmental and regulatory cash milestone payments with an aggregate value of up to $1.0 million will be payable to RVL Pharmaceuticals. In addition, the territories were expanded to include additional EMEA countries and Canada, and during the first five years following the effective date of the Amendment, Santen was granted an option to expand the territories to include Russia, subject to additional upfront and milestone payments of $2.0 million and $1.0 million, respectively. Further, under the terms of the Amendment, if RVL Pharmaceuticals desires to enter into an agreement to license certain rights related to the License Agreement to a third party in Russia, then Santen will have a right to exercise an option to expand the territories to include Russia or to match the terms of the agreement with the third party.

During the six months ended June 30, 2022, the Company recognized $15.5 million in license revenue from Santen under the Amendment as all performance obligations were met.

When the Company receives consideration from a customer, or such consideration is unconditionally due from a customer prior to the transfer of products to the customer under the terms of a contract, the Company records a contract liability. The Company classifies contract liabilities as deferred revenue. The Company had deferred revenue of $0.9 million at June 30, 2022 and an immaterial amount at December 31, 2021 (see Note 7).

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 generally does not incur costs to obtain or fulfill contracts meeting the capitalization criteria under ASC Topic 340, Other Assets and Deferred Costs. The Company had no contract assets at June 30, 2022 or December 31, 2021.

The following table presents the various adjustments recognized against gross product sales (in thousands):

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2022

    

2021

    

2022

    

2021

Gross product sales

$

8,538

$

1,483

$

14,565

$

2,256

Less provisions for:

 

 

 

Chargebacks

 

(2)

 

(1)

 

(3)

(1)

Discounts and allowances

 

(88)

 

 

(170)

Net product sales

$

8,448

$

1,482

$

14,392

$

2,255

Note 6. Other Receivables

Other receivables result primarily from payroll retention credits and other miscellaneous activities.

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

Note 7. Accrued Liabilities

The following table presents the components of accrued liabilities (in thousands):

    

June 30, 

    

December 31,

2022

2021

Accrued expenses and other liabilities

$

5,313

$

7,897

Accrued compensation

4,101

4,504

Accrued royalties

 

1,079

 

200

Deferred revenue

 

931

 

67

Accrued research and development

523

409

Total accrued liabilities

$

11,947

$

13,077

Note 8. Financing Arrangements

The following table presents the components of long-term debt and financing obligations (in thousands):

    

June 30, 

December 31,

2022

2021

Senior Secured Notes (measured at fair value)

$

42,900

$

43,800

Note payable — insurance financing

 

607

 

2,409

Total debt and financing obligations

 

43,507

 

46,209

Less: current portion of debt

 

(607)

 

(2,409)

Long-term debt

$

42,900

$

43,800

The following table presents the aggregation of principal maturities of long-term debt and financing obligations (in thousands):

Year Ending December 31,

    

Debt Obligations

Remainder of 2022

$

607

2023

 

2024

 

11,000

2025

11,000

2026

33,000

Total future minimum payments

55,607

Less: current portion of debt principal

(607)

Non-current portion of debt principal

$

55,000

Senior Secured Notes

On October 1, 2021, the Company entered into a note purchase agreement (the “Note Purchase Agreement”) with, among others, Athyrium Opportunities IV Acquisition 2 LP (“Purchaser”) providing for the issuance of senior secured notes in three separate tranches (the “Senior Secured Notes”). On October 12, 2021, the Company issued $55.0 million first tranche notes, a portion of the proceeds of which, together with the proceeds from a concurrent underwritten equity offering, were used to repay in full the obligations under a prior credit agreement.

Prior to October 12, 2022, upon satisfaction of certain conditions, including a minimum net product sales target for Upneeq over a specified period of time, the Company may request second tranche notes of up to $20.0 million. Prior to October 12, 2023, the Company may request third tranche notes of up to $25.0 million, in the sole discretion of the Purchaser.

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

The Senior Secured Notes bear interest at an annual rate of 9.0% plus adjusted three-month LIBOR, with a LIBOR floor of 1.50% and LIBOR cap of 3.00%, payable in cash quarterly in arrears. At June 30, 2022, the interest rate applicable to the Senior Secured Notes was 10.5%. Effective July 1, 2022, the interest rate applicable to the Senior Secured Notes was approximately 11.3%.

In addition, the restrictive covenants in the Note Purchase Agreement require the Company to comply with certain minimum liquidity requirements and minimum quarterly product sales requirements. At any time, the Company is required to maintain unrestricted cash and cash equivalents greater than or equal to $15.0 million, and, as of the end of each fiscal quarter, it is required to maintain consolidated Upneeq net product sales greater than or equal to specified quarterly thresholds (currently at $4.0 million for the quarter ending June 30, 2022, and increasing in $1.0 million increments each quarter thereafter until the quarter ending June 30, 2024, for which quarter and all subsequent quarters the threshold is $12.0 million). At June 30, 2022, the Company was in compliance with all conditions of the Note Purchase Agreement.

During the year ended December 31, 2021, the Company incurred aggregate debt issuance costs of $2.1 million related

to the Senior Secured Notes, $1.5 million and $0.6 million of which were recognized as financial commitment assets

underlying the first and second tranche notes, respectively.

The Company elected the fair value option of accounting on the Senior Secured Notes upon issuance and, accordingly, a proportionate amount of related debt issuance costs were immediately written off. The Company’s residual financial commitment asset related to the undrawn second tranche notes, is being amortized over the relevant one-year commitment period. During the three and six months ended June 30, 2022, the Company recognized $0.9 million and $1.9 million, respectively, of amortization expense from the second tranche financial commitment asset with such expense being recorded within interest expense and amortization of debt discount in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss. At June 30, 2022 and December 31, 2021, the second tranche financial commitment asset had a carrying value of $1.1 million and $3.1 million, respectively, and was recorded within current assets in the accompanying unaudited condensed consolidated balance sheets. If the second tranche notes are drawn within the one-year commitment period, the Company will expense the remaining balance under the fair value option of accounting.

On a recurring basis, changes in fair value of Senior Secured Notes will be presented in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss at each reporting period (see Note 13).

In the six months ended June 30, 2022, the Company obtained waivers from the Purchaser of mandatory repayments of an aggregate of $5.0 million in principal of the Senior Secured Notes as otherwise required under the Note Purchase Agreement, in exchange for a consent fee of $0.2 million, resulting in net retained proceeds of $4.8 million.

In August 2022, the Company entered into an amendment to the Note Purchase Agreement (Note 16).

Prior Credit Agreement

Prior to October 12, 2021, the Company was party to a Credit Agreement, dated February 3, 2016 and as amended from

time-to-time, under which an aggregate principal amount of $327.5 million of secured term loans were previously issued

(the “Prior Term Loans”) and that provided for revolving credit commitments up to $50.0 million (the “Prior Revolving

Facility,” and together with the Prior Term Loans, the “Prior Credit Agreement”).

During the three and six months ended June 30, 2021, pursuant to the terms of the Prior Credit Agreement, the Company exercised its right to cure a shortfall in certain financial covenants which resulted in the mandatory prepayment of $5.3 million against the Prior Term Loans. During the three and six months ended June 30, 2021, the Company wrote off an

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

immaterial amount of debt issuance costs relating to such prepayment, with the related expense classified within other non-operating gain or loss in the unaudited condensed consolidated statements of operations and comprehensive loss.

Note 9. Share-Based Compensation

The following table presents the components of share-based compensation expense (in thousands):

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2022

    

2021

    

2022

    

2021

Share options

$

442

$

122

$

992

$

223

Performance stock units

228

453

Restricted stock units

723

763

1,339

1,492

Employee share purchase plan

44

18

87

37

Total share-based compensation expense

$

1,209

$

1,131

$

2,418

$

2,205

At June 30, 2022, aggregate unrecognized share compensation expense related to unvested awards was $5.4 million which is expected to be recognized over a weighted-average remaining service period of 1.59 years.

Note 10. Earnings (Loss) Per Ordinary Share

The following potentially dilutive securities have been excluded from the weighted average ordinary shares outstanding in the computation of diluted earnings (loss) per share because the impact of including them would have been anti-dilutive:

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2022

    

2021

    

2022

    

2021

Performance and restricted stock units

1,057,158

2,149,329

1,057,158

2,149,329

Share options to purchase ordinary shares

5,414,496

2,666,696

5,414,496

2,666,446

Warrants to purchase ordinary shares

16,100,000

16,100,000

Ordinary shares to be purchased through employee stock purchase plan

271,571

23,322

271,571

23,322

Note 11. Commitments and Contingencies

Legal Proceedings

The Company is a party in legal proceedings and potential claims arising from time to time in the ordinary course of its business. The amount, if any, of ultimate liability with respect to such matters cannot be determined. Despite the inherent uncertainties of litigation, management of the Company believes that the ultimate disposition of such proceedings and exposures will not have a material adverse impact on the financial condition, results of operations, or cash flows of the Company.

On February 16, 2018, the Company received FDA approval for its amantadine extended release tablets under the trade name Osmolex ER and filed a Complaint for Declaratory Judgment of Noninfringement of certain patents owned by Adamas Pharmaceuticals, Inc., who filed counterclaims against the Company. On December 2, 2020, the Company entered into an agreement to settle the litigation with Adamas, under which both parties agreed to drop their respective claims relating to the patent litigation, and Adamas agreed to acquire the global rights to Osmolex ER from the Company for $7.5 million. The sale of the global rights to Osmolex ER closed in January 2021 and a gain of $5.6 million was recorded in the unaudited condensed consolidated statements of operations and comprehensive loss under gain on sale of product rights, net.

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

Note 12. Income Taxes

The following table presents the relationship between income tax expense or benefit from continuing operations and income or loss before income taxes from continuing operations (dollars in thousands):

Three Months Ended June 30, 

Six Months Ended June 30, 

2022

    

2021

2022

    

2021

Loss before income taxes, continuing operations

$

(11,829)

$

(21,874)

$

(18,725)

$

(35,650)

Income tax expense, continuing operations

277

94

202

90

Effective income tax rate

(2.34)

%

(0.43)

%

(1.08)

%

(0.25)

%

Income tax expense or benefit in the quarterly periods is based upon the estimated income or loss for the full year. The composition of the income or loss in different jurisdictions and adjustments, if any, in the applicable quarterly periods influences the periodic expense or benefit.

The relationship between pre-tax income or loss and income tax expense or benefit is greatly affected by the impact of losses for which management cannot claim a tax benefit, non-deductible expenses, and other items that increase tax expense without a relationship to income, such as withholding taxes and changes with respect to uncertain tax positions. The change in the effective income tax rate in the three and six months ended June 30, 2022 when compared to the three and six months ended June 30, 2021, is primarily related to our recognition of individually minor tax expenses during the respective periods.

Note 13. Financial Instruments and Fair Value Measurements

The Company’s financial instruments subject to fair value measurements include cash and cash equivalents, other receivables, trade accounts payable, accrued liabilities, long-term debt and warrant liabilities.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

Financial Assets— Cash and cash equivalents, generally consisting of investments in interest-bearing money market accounts, are measured at fair value on a recurring basis using Level 1 measurements. Fair value inputs for these investments are considered Level 1 measurements within the fair value hierarchy because money market account fair values are known and observable through daily published floating net asset values. The fair value of the Company’s cash and cash equivalents, being the same as their carrying value, were $27.4 million and $40.4 million at June 30, 2022 and December 31, 2021, respectively.

Financial Liabilities— The Senior Secured Notes, a material component of long-term debt (see Note 8), and our warrant liabilities, a material component of total liabilities have each been measured and carried at fair value since their issuance in October 2021. Such instruments represent financial liabilities whose measurement contains significant unobservable inputs, which management considers to be Level 3 measurements under the fair value hierarchy.

The Company uses a discounted cash flow technique, an income-based approach, to determine the fair value of the Senior Secured Notes. This technique relies upon an assumption of pricing the Senior Secured Notes to their maturity (without mandatory or voluntary prepayments) and incorporates inputs such as contractual repayment terms, maturity, and discount rate. The most significant unobservable input for the Senior Secured Notes is the discount rate which is estimated by performing a yield analysis that relies upon the discount rate observed in the initial issuance of the Senior Secured Notes as well as certain benchmark debt instruments with observable pricing from which conclusions are drawn on the change in the discount rate from period to period.

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

The Company uses the Black-Scholes Merton option-pricing model to value the warrants. This model incorporates transaction details such as the Company’s stock price, contractual terms, maturity, risk free rates, and volatility. The most significant unobservable input for the warrant liabilities is volatility. Given the limited trading volume and period of time the Company’s stock has been traded in an active market, the expected volatility is estimated by taking the average historical price volatility for industry peers, consisting of several public companies in the Company’s industry that are similar in size, stage, or financial leverage, over a period of time commensurate to the expected term of the warrants.

The following tables show financial liabilities subject to fair value measurement on a recurring basis and related information on fair values, valuation techniques and unobservable inputs (dollars in thousands):

At June 30, 2022

Financial Instrument

Fair Value

Valuation Technique

Unobservable Inputs

Senior Secured Notes

$

(42,900)

Income Approach - DCF

Discount rate

21.0

%

Term (in years)

4.3

Warrants

$

(4,273)

Black-Scholes Merton

Equity volatility

62.5

%

Term (in years)

2.8

At December 31, 2021

Financial Instrument

Fair Value

Valuation Technique

Unobservable Inputs

Senior Secured Notes

$

(43,800)

Income Approach - DCF

Discount rate

17.9

%

Term (in years)

4.8

Warrants

$

(3,220)

Black-Scholes Merton

Equity volatility

65.0

%

Term (in years)

3.3

The following table shows changes in the fair value of financial liabilities subject to Level 3 fair value measurements on a recurring basis (in thousands):

Senior Secured Notes

Warrants

Balance, At December 31, 2021

$

(43,800)

$

(3,220)

Cash payments for interest

2,904

-

Fair value adjustments through earnings (inclusive of related accrued interest expense)

(304)

(1,053)

Fair value adjustments through accumulated other comprehensive income or loss

(1,700)

-

Balance, At June 30, 2022

$

(42,900)

$

(4,273)

Changes in the fair value of debt that is accounted for at fair value, inclusive of related accrued interest expense, are presented as gains or losses in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss under change in fair value of debt and interest expense. The portion of total changes in fair value of debt attributable to changes in instrument-specific credit risk are determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes and are presented as a component of comprehensive income or loss in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss.

No financial liabilities were subject to fair value measurements on a recurring basis prior to October 2021.

Assets and Liabilities for Which Fair Value is Only Disclosed

The carrying amounts for other receivables, trade accounts payable, accrued liabilities and the residual amounts of long-term debt not otherwise measured at fair value on a recurring basis approximate their relative fair values due to their short-term nature with relevant inputs considered Level 2 measurements within the fair value hierarchy.

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RVL PHAMACEUTICALS PLC

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

Note 14. Restructuring Expenses

In April 2022, as part of an initiative to refine the Company’s go to market strategy, the Company recognized an aggregate of $1.9 million in expenses primarily associated with employee severance benefits that were classified in selling, general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss.

In April 2021, the Company curtailed operations and implemented workforce reductions in its research and development subsidiary in Buenos Aires, Argentina. These restructuring activities were associated with the Company’s plans to reduce expenses and better align business activities with the Company’s then-current corporate strategy. As a result, the Company recognized $4.5 million of restructuring expenses in the three and six months ended June 30, 2021. The restructuring expenses consisted of $3.2 million one-time employee related termination benefits and $1.3 million of asset disposal costs related to leasehold improvements at the Buenos Aires location. Of the $4.5 million of restructuring expenses, $2.0 million were recognized in selling, general and administrative expenses, $1.2 million were recognized in research and development expenses, and $1.3 million of asset disposal costs were recognized in non-operating expenses.

Note 15. Indefinite-Lived Intangible Assets

Subsequent to the divestiture of the Legacy Business in 2021, the Company retained the rights to arbaclofen ER tablets (see Note 1) which is under development for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis for which the Company has completed Phase III clinical trials and for which the Company is exploring opportunities to divest, out-license or otherwise partner with a third party to monetize its net investment (see Note 3).

At June 30, 2022 and December 31, 2021, the Company held indefinite-lived intangible assets for the right to develop and sell arbaclofen ER that had a gross carrying value of $64.0 million, aggregate impairment losses of $36.8 million and a net carrying amount of $27.2 million.

Based on the results of quantitative impairment assessments performed relative to arbaclofen ER, an In-Process Research and Development project-based intangible asset, we recognized an impairment charge of $7.9 million during the three and six months ended June 30, 2021, related to delays in anticipated commercialization of the product candidate, if approved. No such impairments were recognized in the three or six months ended June 30, 2022.

Note 16. Subsequent Events

Debt Financing

On August 4, 2022, (the “Effective Date”), the Company entered into an amendment to the Note Purchase Agreement (the “Amendment”) with, among others, certain purchasers party thereto, including Athyrium Opportunities IV Co-Invest 1 LP (“New Purchaser”) and Athyrium Opportunities IV Acquisition LP, as administrative agent, which Amendment amends the Note Purchase Agreement, dated October 1, 2021 (see Note 8).

The Amendment provides, among other things, for the waiver of the second tranche minimum net product sales target condition and, upon the satisfaction of certain other funding conditions, the issuance of the second tranche notes in an aggregate principal amount equal to $20.0 million, which occurred on August 8, 2022. Furthermore, the New Purchaser committed to purchase certain third tranche notes in an aggregate principal amount of up to $25.0 million at any time after the Effective Date but prior to April 15, 2023, upon the satisfaction of certain conditions, including a minimum net product sales target for Upneeq over a specified period of time.

Under the Amendment, the Company will continue to have the option to voluntarily prepay the Senior Secured Notes upon the satisfaction of certain conditions and with each such prepayment being accompanied by, as applicable, (i) a

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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

make-whole premium, (ii) an exit fee of 2% of the principal amount of the notes prepaid, (iii) certain other fees, indemnities and expenses and (iv) all accrued interest on the principal amount of the notes being so prepaid. Further, the Amendment provides for the reset of the date from which the make-whole premium is applicable with respect to the first tranche notes. Specifically, the make-whole premium start date with respect to the first tranche notes will change from October 12, 2021, to either (A) March 1, 2022, if the third tranche notes are not issued or (B) the date on which the second tranche notes were issued (i.e., August 8, 2022), if the third tranche notes are issued. The make-whole premium with respect to (x) the second tranche notes, will continue to apply from the second tranche notes issuance date (i.e., August 8, 2022) and (y) the third tranche notes, will continue to apply from the third tranche notes issuance date, if issued.

Additionally, the Amendment provides for the replacement of a LIBOR-based interest rate under the existing Note Purchase Agreement with a Term SOFR-based interest rate. After September 30, 2022 with respect to the first tranche notes, and on or after August 8, 2022 with respect to the second tranche notes, such notes will bear interest at a rate per annum equal to 9.0% plus adjusted three-month Term SOFR, with a floor of 1.50% and cap of 3.00%, payable in cash quarterly in arrears. All notes require minimum quarterly amortization payments beginning on March 31, 2024 and will mature five years following the date of issuance of the first tranche notes (i.e., October 12, 2026).

Equity Financing

As a condition to the effectiveness of the Amendment, on August 4, 2022, the Company entered into a series of share subscription agreements (collectively, the “Share Subscription Agreements”) with Athyrium Opportunities IV Co-Invest 2 LP (“Athyrium”), Avista Healthcare Partners, L.P. (“Avista”), Brian Markison, Chief Executive Officer, and James Schaub, Executive Vice President and Chief Operating Officer, (together, the “Equity Purchasers”) pursuant to which the Company sold and issued to the Equity Purchasers, in a private placement (the “Private Placement”), an aggregate of 15,451,612 ordinary shares of the Company, nominal value $0.01 per share (the “Ordinary Shares”), at a purchase price of $1.55 per Ordinary Share, the closing market trading price on August 4, 2022.

Pursuant to the Share Subscription Agreements, the closing of the Private Placement occurred on August 8, 2022. The Company issued and allotted (i) 6,451,612 Ordinary Shares to Athyrium; (ii) 8,000,000 Ordinary Shares to Avista; (iii) 850,000 Ordinary Shares to Brian Markison; and (iv) 150,000 Ordinary Shares to James Schaub, for aggregate gross proceeds to the Company of approximately $23.9 million, before deducting offering expenses payable by the Company. The Share Subscription Agreements also provide the Equity Purchasers with certain registration rights.

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

The statements in the discussion and analysis regarding industry outlook, our expectations regarding the performance of our business and the forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the risks and uncertainties described in “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” You should read the following discussion together with our audited consolidated financial statements, and related notes thereto, appearing in our Annual Report on Form 10-K and our unaudited condensed consolidated financial statements, and related notes thereto, appearing elsewhere in this Quarterly Report on Form 10-Q. Our actual results may differ materially from those contained in or implied by any forward-looking statements. This discussion and analysis is based upon the historical financial statements of RVL Pharmaceuticals plc and subsidiaries. All references to years, unless otherwise noted, refer to our fiscal years, which end on December 31.

Overview

We are a specialty pharmaceutical company focused on the development and commercialization of products that target markets with underserved patient populations. In July 2020, we received regulatory approval from the FDA for RVL-1201, or Upneeq, (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or droopy or low-lying eyelids in adults. Upneeq was commercially launched in September 2020 to a limited number of eye care professionals with commercial operations expanded in 2021 among ophthalmology, optometry and oculoplastic specialties. In February 2022, Upneeq was commercially expanded into the medical aesthetics market. We believe Upneeq is the first non-surgical treatment option approved by the FDA for acquired blepharoptosis.

On August 27, 2021, we announced the closing of the divestiture of our portfolio of branded and non-promoted products and our Marietta, Georgia, manufacturing facility (the “Legacy Business”) to certain affiliates of Alora Pharmaceuticals (“Alora”) for $111 million in cash upon closing, subject to certain adjustments, and up to $60 million in additional contingent milestone payments (the “Transaction”). Pursuant to the Transaction, we retained the rights to Upneeq and to arbaclofen extended release (“ER”) tablets. As a result, our business is now primarily focused on the commercialization and development of Upneeq. Following the Transaction, on January 17, 2022 we formally changed our name to RVL Pharmaceuticals plc.

With the divestiture of the Legacy Business, our commercial operations are conducted by our wholly-owned subsidiaries, RVL Pharmaceuticals, Inc. and RVL Pharmacy, LLC (“RVL Pharmacy”). RVL Pharmacy operates pharmacy operations dedicated to the processing and fulfillment of prescriptions for Upneeq.

Arbaclofen ER is under development for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis for which we have completed Phase III clinical trials and for which we are exploring opportunities to divest, out-license or otherwise partner with a third party to monetize our net investment.

Business Update Regarding COVID-19

The COVID-19 pandemic has adversely affected global economies, financial markets and the overall environment in which we do business as further described in Part II, Item 1A, “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2021.

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Results of Operations

Comparison of Three Months Ended June 30, 2022 and 2021

Financial Operations Overview

The following table presents revenues and expenses for the periods indicated (dollars in thousands):

Three Months Ended June 30, 

 

    

2022

    

2021

    

% Change

 

Net product sales

$

8,448

$

1,482

 

470

%

Royalty revenue

 

 

28

 

(100)

%

Licensing revenue

 

 

10,000

 

(100)

%

Total revenues

 

8,448

 

11,510

 

(27)

%

Cost of goods sold

 

2,227

 

709

 

214

%

Gross profit

6,221

10,801

 

(42)

%

Gross profit percentage

 

74

%  

 

94

%  

Selling, general and administrative expenses

 

20,169

 

21,047

 

(3)

%

Research and development expenses

 

1,176

 

2,052

 

(43)

%

Impairment of intangible assets

 

 

7,880

 

(100)

%

Total operating expenses

 

21,345

 

30,979

 

(30)

%

Operating loss

(15,124)

(20,178)

(24)

%

Interest expense and amortization of debt discount

 

978

 

494

 

98

%

Change in fair value of debt and interest expense

(740)

NM

%

Change in fair value of warrants

(3,455)

NM

%

Other non-operating (income) expense, net

 

(78)

 

1,202

 

(107)

%

Total other non-operating (income) expense

 

(3,295)

 

1,696

 

(294)

%

Loss before income taxes

 

(11,829)

 

(21,874)

 

(45)

%

Income tax expense, continuing operations

 

277

 

94

 

198

%

Loss from continuing operations

(12,106)

(21,968)

(44)

%

Income from discontinued operations before income taxes

4,454

(100)

%

Income tax expense, discontinued operations

213

(100)

%

Income from discontinued operations, net of tax

4,241

(100)

%

Net loss

$

(12,106)

$

(17,727)

 

(30)

%

NM-Not Meaningful

Revenue

The following table presents total revenues for the periods indicated (dollars in thousands):

Three Months Ended June 30, 

    

2022

    

2021

    

% Change

Net product sales - Upneeq

$

8,448

$

1,482

470

%

Royalty revenue

28

(100)

%

Licensing revenue

 

 

10,000

 

(100)

%

Total revenues

$

8,448

$

11,510

 

(27)

%

Total Revenues — Total revenues decreased by $3.1 million to $8.4 million in the three months ended June 30, 2022, as compared to $11.5 million in the three months ended June 30, 2021, primarily due to the absence of licensing revenue from Santen during the 2022 period, partially offset by a $6.9 million year over year increase in net product sales of Upneeq.

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Net Product Sales — Net product sales, relating entirely to sales of Upneeq, increased by $6.9 million to $8.4 million in the 2022 period, as compared to $1.5 million in the 2021 period. The increase in net product sales was primarily attributable to a year over year increase in sales volume reflecting expanded commercialization into eyecare markets and, effective February 2022, the medical aesthetics market.

Royalty and Licensing Revenue — Royalty and licensing revenue decreased by $10.0 million during the 2022 period, due to $10.0 million recognized under our license agreement with Santen, relating to our achievement of a regulatory milestone in the 2021 period. Refer to Note 5, “Revenues” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our License Agreement with Santen.

Cost of Goods Sold and Gross Profit Percentage

The following table presents a breakdown of total cost of goods sold for the periods indicated (dollars in thousands):

Three Months Ended June 30, 

    

2022

    

2021

    

% Change

Royalty expense

 

$

751

 

$

84

 

794

%

Depreciation expense

 

14

 

13

 

8

%

Other costs of goods sold

 

1,462

 

612

 

139

%

Total costs of goods sold

$

2,227

$

709

 

214

%

Total cost of goods sold increased $1.5 million in the three months ended June 30, 2022 to $2.2 million, as compared to $0.7 million in the three months ended June 30, 2021. The year over year increase in cost of goods sold was primarily driven by $0.9 million in higher product costs for Upneeq due to higher sales volume and by $0.7 million relating to increased royalties and contingent milestone payments due under an intellectual property license agreement, each attributable to sales of Upneeq.

Gross profit percentage decreased to 74% in the three months ended June 30, 2022, as compared to 94% in the 2021 period, largely due to an absence of licensing revenue from Santen during the 2022 period. Excluding licensing revenues, gross profit percentage from net product sales was 52% in the 2021 period.

Selling, General and Administrative Expenses

Selling, general and administrative expenses decreased $0.8 million in the three months ended June 30, 2022 to $20.2 million, as compared to $21.0 million in the three months ended June 30, 2021. The year over year decrease in selling, general and administrative expenses was primarily driven by approximately $1.1 million in lower legal and other professional fees and $0.6 million in lower marketing expenses for Upneeq partially offset by $1.0 million in higher net compensation and training costs relating to our expanded salesforce.

Selling, general and administrative expenses include various restructuring related expenditures, including severance, of $1.9 million and $2.0 million in the three months ended June 30, 2022 and 2021, respectively, and non-cash share-based compensation expenses of $1.0 million and $0.9 million in the three months ended June 30, 2022 and 2021, respectively. Refer to Notes 14, “Restructuring Expenses,” and 9, “Share-Based Compensation,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

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Table of Contents

Research and Development Expenses

The following table summarizes our research and development (“R&D”) expenses incurred for the periods indicated (dollars in thousands):

Three Months Ended June 30, 

    

2022

    

2021

    

% Change

Arbaclofen ER

$

86

$

221

(61)

%

RVL-1201 (Upneeq)

183

397

(54)

%

Other research and development

 

907

 

1,434

(37)

%

Total research and development expenses

$

1,176

$

2,052

(43)

%

R&D expenses decreased by $0.9 million in the three months ended June 30, 2022 to $1.2 million, as compared to $2.1 million in the three months ended June 30, 2021. The year over year decrease in R&D expenses primarily reflects $1.2 million in restructuring expenses unique to the 2021 period.

R&D expenses include non-cash share-based compensation expenses of $0.2 million in each of the three months ended June 30, 2022 and 2021.

Impairment of Intangible Assets

Based on the results of quantitative impairment assessments performed relative to arbaclofen ER, an In-Process Research and Development project-based intangible asset, we recognized impairment charges of $7.9 million in the three months ended June 30, 2021, related to delays in anticipated commercialization of the product candidate, if approved. No such impairments were recognized in the three months ended June 30, 2022.

Refer to Note 15, “Indefinite-Lived Intangible Assets,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our prior year impairment.

Interest Expense and Amortization of Debt Discount

Interest expense and amortization of debt discount increased by $0.5 million in the three months ended June 30, 2022 to $1.0 million, as compared to $0.5 million in the three months ended June 30, 2021. The year over year increase is attributable to our recognition of $0.9 million of amortization expense from the second tranche financial commitment asset, unique to the 2022 period, partially offset by the absence of interest expense in the 2022 period.

Beginning in the fourth quarter of 2021, our recognition of interest expense on our Senior Secured Notes is classified within the separate caption titled “Change in fair value of debt and interest expense” pursuant to our elections related to fair value accounting (see “Change in Fair Value of Debt and Interest Expense and Change in Fair Value of Warrants” section below).

Refer to Note 8, “Financing Arrangements,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our indebtedness.

Change in Fair Value of Debt and Interest Expense and Change in Fair Value of Warrants

Changes in the fair value of our Senior Secured Notes and warrants, each issued in October 2021, resulted in gains of $0.7 million and $3.5 million, respectively, in the three months ended June 30, 2022. Changes in the fair value of our Senior Secured Notes includes $1.4 million of related interest expense.

Refer to Note 13, “Financial Instruments and Fair Value Measurements,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our recurring fair value measurements.

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Other Non-operating (Income) Expense, Net

Other non-operating (income) expense, net was less than $0.1 million of income and $1.2 million of expense in the three months ended June 30, 2022 and 2021, respectively. Non-operating expense in the 2021 period was primarily attributable to $1.3 million of asset disposal costs recognized under a restructuring program.

Refer to Note 14, “Restructuring Expenses,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Income Tax Expense

The following table summarizes our income tax expense from continuing operations and the resultant effective income tax rate for the periods indicated (dollars in thousands):

Three Months Ended June 30, 

2022

    

2021

Loss before income taxes, continuing operations

$

(11,829)

$

(21,874)

Income tax expense, continuing operations

277

94

Effective income tax rate

(2.34)

%

(0.43)

%

The change in the effective income tax rate in the three months ended June 30, 2022 when compared to the three months ended June 30, 2021, is primarily related to our recognition of individually minor tax expense during the respective periods.

Refer to Note 12, “Income Taxes,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on income taxes.

Discontinued Operations

For the three months ended June 30, 2021 we recognized income from discontinued operations, net of tax of $4.2 million.

Comparison of Six Months Ended June 30, 2022 and 2021

Financial Operations Overview

The following table presents revenues and expenses for the periods indicated (dollars in thousands):

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Table of Contents

Six Months Ended June 30, 

 

    

2022

    

2021

    

% Change

 

Net product sales

$

14,392

$

2,255

 

538

%

Royalty revenue

 

 

190

 

(100)

%

Licensing revenue

 

15,500

 

10,000

 

55

%

Total revenues

 

29,892

 

12,445

 

140

%

Cost of goods sold

 

4,371

 

1,388

 

215

%

Gross profit

25,521

11,057

 

131

%

Gross profit percentage

 

85

%  

 

89

%  

Selling, general and administrative expenses

 

44,003

 

37,999

 

17

%

Research and development expenses

 

2,038

 

4,256

 

(52)

%

Impairment of intangible assets

7,880

(100)

%

Total operating expenses

 

46,041

 

50,135

 

(8)

%

Gain on sales of product rights, net

5,636

(1)

%

Operating loss

(20,520)

(33,442)

(38)

%

Interest expense and amortization of debt discount

 

1,963

 

1,015

 

93

%

Change in fair value of debt and interest expense

304

NM

%

Change in fair value of warrants

1,053

NM

%

Other non-operating (income) expense, net

 

(5,115)

 

1,193

 

(529)

%

Total other non-operating (income) expense

 

(1,795)

 

2,208

 

(181)

%

Loss before income taxes

 

(18,725)

 

(35,650)

 

(47)

%

Income tax expense, continuing operations

 

202

 

90

 

128

%

Loss from continuing operations

(18,927)

(35,740)

(46)

%

Income from discontinued operations before income taxes

9,153

(100)

%

Income tax expense, discontinued operations

752

(100)

%

Income from discontinued operations, net of tax

8,401

(100)

%

Net loss

$

(18,927)

$

(27,339)

 

(30)

%

NM-Not Meaningful

Revenue

The following table presents total revenues for the periods indicated (dollars in thousands):

Six Months Ended June 30, 

 

    

2022

    

2021

    

% Change

 

Net product sales - Upneeq

$

14,392

$

2,255

538

%

Royalty revenue

 

 

190

 

(100)

%

Licensing revenue

 

15,500

 

10,000

 

55

%

Total revenues

$

29,892

$

12,445

 

140

%

Total Revenues — Total revenues increased by $17.5 million to $29.9 million in the six months ended June 30, 2022, as compared to $12.4 million in the six months ended June 30, 2021, primarily due to a $5.5 million increase in licensing revenue from Santen and further attributable to a $12.1 million year over year increase in net product sales of Upneeq.

Net Product Sales — Net product sales, relating entirely to sales of Upneeq, increased by $12.1 million to $14.4 million in the 2022 period, as compared to $2.3 million in the 2021 period. The increase in net product sales was primarily attributable to a year over year increase in sales volume reflecting expanded commercialization into eyecare markets and, effective February 2022, the medical aesthetics market.

Royalty and Licensing Revenue — Royalty and licensing revenue increased by $5.3 million during the 2022 period, primarily due to changes in milestone revenues recognized under our license agreement with Santen. Refer to Note 5, “Revenues” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our License Agreement with Santen.

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Table of Contents

Cost of Goods Sold and Gross Profit Percentage

The following table presents a breakdown of total cost of goods sold for the periods indicated (dollars in thousands):

Six Months Ended June 30, 

 

    

2022

    

2021

    

% Change

 

Royalty expense

 

$

1,469

 

$

143

927

%

Depreciation expense

 

28

 

29

 

(3)

%

Other costs of goods sold

 

2,874

 

1,216

 

136

%

Total costs of goods sold

$

4,371

$

1,388

 

215

%

Total cost of goods sold increased $3.0 million in the six months ended June 30, 2022 to $4.4 million, as compared to $1.4 million in the six months ended June 30, 2021. The year over year increase in cost of goods sold was primarily driven by $1.7 million in higher product costs for Upneeq due to higher sales volume and by $1.3 million relating to increased royalties and contingent milestone payments due under an intellectual property license agreement, each attributable to sales of Upneeq.

Gross profit percentage decreased to 85% in the six months ended June 30, 2022, as compared to 89% in the 2021 period, largely due to licensing revenue from Santen recognized during each period. Excluding licensing revenues, gross profit percentage from net product sales was 70% and 38% in the 2022 and 2021 periods, respectively.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased $6.0 million in the six months ended June 30, 2022 to $44.0 million, as compared to $38.0 million in the six months ended June 30, 2021. The year over year increase in selling, general and administrative expenses was primarily influenced by $7.8 million in higher net compensation and training costs primarily for our expanded salesforce and $0.7 million in transactional fees unique to the 2022 period, partially offset by approximately $2.2 million in lower legal and other professional fees and $0.7 million in lower restructuring related expenditures.

Selling, general and administrative expenses include various restructuring-related expenditures, including severance, of $1.9 million and $2.7 million in the six months ended June 30, 2022 and 2021, respectively, and non-cash share-based compensation expenses of $2.1 million and $1.9 million in the six months ended June 30, 2022 and 2021, respectively. Refer to Notes 14, “Restructuring Expenses,” and 9, “Share-Based Compensation,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Research and Development Expenses

The following table summarizes our R&D expenses incurred for the periods indicated (dollars in thousands):

Six Months Ended June 30, 

 

    

2022

    

2021

    

% Change

 

Arbaclofen ER

$

138

$

605

(77)

%

RVL-1201 (Upneeq)

208

594

(65)

%

Other research and development

 

1,692

 

3,057

(45)

%

Total research and development expenses

$

2,038

$

4,256

(52)

%

R&D expenses decreased by $2.3 million in the six months ended June 30, 2022 to $2.0 million, as compared to $4.3 million in the six months ended June 30, 2021. The year over year decrease in R&D expenses primarily reflects $1.0 million in lower personnel costs, $0.8 million in lower project spending and $1.2 million in restructuring expenses unique to the 2021 period.

R&D expenses include non-cash share-based compensation expenses of $0.3 million in each of the six months ended June 30, 2022 and 2021.

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Table of Contents

Impairment of Intangible Assets

Based on the results of quantitative impairment assessments performed relative to arbaclofen ER, an In-Process Research and Development project-based intangible asset, we recognized impairment charges of $7.9 million in the six months ended June 30, 2021, related to delays in anticipated commercialization of the product candidate, if approved. No such impairments were recognized in the six months ended June 30, 2022.

Refer to Note 15, “Indefinite-Lived Intangible Assets,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our prior year impairment.

Gain on Sale of Product Rights, Net

On December 2, 2020, we entered into an agreement to settle certain litigation. Under the terms of the agreement, we agreed to convey the global rights to Osmolex ER for $7.5 million. The sale of the global rights to Osmolex ER closed in January 2021 resulting in our recognition of a $5.6 million gain.

Interest Expense and Amortization of Debt Discount

Interest expense and amortization of debt discount increased by $1.0 million in the six months ended June 30, 2022 to $2.0 million as compared to $1.0 million in the six months ended June 30, 2021. The year over year increase is attributable to our recognition of $1.9 million of amortization expense from the second tranche financial commitment asset, unique to the 2022 period, partially offset by the absence of interest expense in the 2022 period.

Beginning in the fourth quarter of 2021, our recognition of interest expense on our Senior Secured Notes is classified within the separate caption titled “Change in fair value of debt and interest expense” pursuant to our elections related to fair value accounting (see “Change in Fair Value of Debt and Interest Expense and Change in Fair Value of Warrants” section below).

Refer to Note 8, “Financing Arrangements,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our indebtedness.

Change in Fair Value of Debt and Interest Expense and Change in Fair Value of Warrants

Changes in the fair value of our Senior Secured Notes and warrants, each issued in October 2021, resulted in losses of $0.3 million and $1.1 million, respectively, in the six months ended June 30, 2022. Changes in the fair value of our Senior Secured Notes includes $2.9 million of related interest expense.

Refer to Note 13, “Financial Instruments and Fair Value Measurements,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our recurring fair value measurements.

Other Non-operating (Income) Expense, Net

Other non-operating (income) expense, net was $5.1 million of income and $1.2 million of expense in the six months ended June 30, 2022 and 2021, respectively. Non-operating income in the 2022 period was primarily attributable to our receipt of an aggregate of $5.0 million in cash from Alora related to contingent milestone payments earned in connection with the sale of the Legacy Business. Non-operating expense in the 2021 period was primarily attributable to $1.3 million of asset disposal costs recognized under a restructuring program.

Refer to Note 4, “Discontinued Operations,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on the Alora contingent milestone payments.

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Income Tax Expense

The following table summarizes our income tax expense from continuing operations and the resultant effective income tax rate for the periods indicated (dollars in thousands):

Six Months Ended June 30, 

2022

    

2021

Loss before income taxes, continuing operations

$

(18,725)

$

(35,650)

Income tax expense, continuing operations

202

90

Effective income tax rate

(1.08)

%

(0.25)

%

The change in effective income tax rate in the six months ended June 30, 2022 when compared to the six months ended June 30, 2021, is primarily related to our recognition of individually tax expenses items during the respective periods.

Refer to Note 12, “Income Taxes,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on income taxes.

Discontinued Operations

For the six months ended June 30, 2021 we recognized income from discontinued operations, net of tax of $8.4 million.

Liquidity and Capital Resources

Our principal sources of liquidity are cash and cash equivalents and borrowings available under our Note Purchase Agreement, dated October 1, 2021, with Athyrium Opportunities IV Acquisition LP, as administrative agent, and Athyrium Opportunities IV Acquisition 2 LP, as the Purchaser. At June 30, 2022, we had cash and cash equivalents of $27.4 million and total debt obligations with aggregate principal amounts of $55.6 million including an aggregate principal amount of $55.0 million of long-term debt, the maturities of which commence in March 2024 and extend through October 2026. Our primary uses of cash are to fund operating expenses, including commercialization costs associated with Upneeq, capital expenditures, and debt service payments.

The Note Purchase Agreement provides for the issuance of the notes to the Purchaser in an aggregate principal amount of up to $100.0 million in three separate tranches. The first tranche of notes was issued in an aggregate principle amount equal to $55.0 million on October 12, 2021. At any time after October 12, 2021 but prior to the first anniversary thereof, upon the satisfaction of certain conditions, including a minimum liquidity requirement and minimum net product sales target for Upneeq, we may request the issuance of the second tranche notes in an aggregate principal amount of up to $20.0 million. At any time after October 12, 2021 but prior to the second anniversary thereof, we may request the issuance of the third tranche notes in an aggregate principal amount of up to $25.0 million, which shall be funded in the sole discretion of the Purchaser. The minimum net product sales target for Upneeq is $4.0 million for the quarter ending June 30, 2022, and increasing in $1.0 million increments each quarter thereafter until the quarter ending June 30, 2024, for which quarter and all subsequent quarters the threshold is $12.0 million. The minimum liquidity requirement under the Note Purchase Agreement requires us to maintain, at any time, unrestricted cash and cash equivalents greater than or equal to $15.0 million.

As of June 30, 2022, the interest rate on our Senior Secured Notes was 10.5%.

Going Concern

At June 30, 2022, we had cash and cash equivalents of $27.4 million, an accumulated deficit of $536.5 million, and total long-term debt with aggregate principal maturities of $55.0 million, with such maturities commencing in March 2024 and extending through October 2026. In addition, our primary indebtedness contains various restrictive covenants including minimum liquidity and minimum quarterly product sales requirements. For the six months ended June 30, 2022 and 2021, we incurred net losses from continuing operations of $18.9 million and $35.7 million, respectively. For

29

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the six months ended June 30, 2022 and 2021, we used $11.3 million and $14.4 million, respectively, in cash for operating activities.

The divestiture of the Legacy Business in 2021 resulted in the loss of substantially all of our revenue generating assets. Our current business plan is focused on the continued launch and commercialization of Upneeq, which has and will continue to diminish our cash flows in at least the near term. We will require additional capital to fund our operating needs, including the expanded commercialization of Upneeq and other activities. We expect to continue to incur significant expenditures and sustained operating losses in the future.

Our management does not believe that current sources of liquidity will be sufficient to fund our planned expenditures and meet our obligations for at least 12 months following the date the accompanying unaudited condensed consolidated financial statements are issued without raising additional funding. As a result, there is a substantial doubt as to our ability to operate as a going concern. Our ability to continue as a going concern will require us to obtain additional funding, generate positive cash flow from operations and/or enter into strategic alliances or sell assets.

Our plans to address these conditions include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or is entirely within our control, (i) raise funds through additional sales of ordinary shares, through equity sales agreements with brokers/dealers or other public or private equity financings, (ii) raise funds through borrowings under existing debt facilities and/or convertible debt, and/or (iii) raise non-dilutive funds through product collaborations and/or to partner or sell a portion or all rights to any of our assets.

In August 2022, we raised an aggregate of $43.9 million, comprised of $23.9 million in aggregate gross proceeds from the private placement of ordinary shares and, concurrently, $20.0 million from the issuance of second tranche senior secured notes, to enhance liquidity in furtherance of certain of our plans as described above. Refer to Note 16, “Subsequent Events,” of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our most recent financing arrangements.

There can be no assurance that we will receive cash proceeds from any of these potential sources or, to the extent cash proceeds are received, such proceeds would be sufficient to support our current operating plan for at least the next 12 months from the date the accompanying unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q are issued. The sale of additional equity or convertible debt securities may result in dilution to our shareholders. If we raise additional funds through the issuance of debt securities or preferred shares, these securities could provide for rights senior to those of our ordinary shares and could contain covenants that would further restrict our operations. Additional funds may not be available when we need them, on terms that are acceptable to us, or at all.

The accompanying unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q have been prepared on a going concern basis, which assumes the realization of assets and settlement of liabilities in the normal course of business, and therefore do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.

Cash Flows

The following table provides information regarding our cash flows, including our continuing operations and discontinued operations, for the periods indicated (in thousands):

Six Months Ended June 30, 

    

2022

    

2021

    

$ Change

    

Net cash used in operating activities

$

(11,280)

$

(14,408)

$

3,128

Net cash provided by investing activities

 

67

5,927

 

(5,860)

Net cash used in financing activities

 

(1,818)

(5,795)

 

3,977

Net decrease in cash and cash equivalents

$

(13,031)

$

(14,276)

$

1,245

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Net cash from operating activities

Cash flows from operating activities are primarily driven by earnings from operations (excluding the impact of non-cash items), the timing of cash receipts and disbursements related to accounts receivable and accounts payable and the timing of inventory transactions and changes in other working capital amounts. Net cash used in operating activities was $11.3 million in the six months ended June 30, 2022, and net cash used in operating activities was $14.4 million for the six months ended June 30, 2021.

The overall lower cash used in operating activities during the 2022 period, was primarily a result of a favorable change in net cash used to fund working capital assets and liabilities partially offset by lower net income after considering non-cash adjustments as compared to the 2021 period.

Net cash from investing activities

Net cash provided by investing activities was less than $0.1 million and $5.9 million in the six months ended June 30, 2022 and 2021, respectively. The year over year change in investing cash flows is primarily attributable to proceeds of $7.3 million from the sale of Osmolex product rights in January 2021 unique to the 2021 period, partially offset by significantly lower purchases of property, plant and equipment in the 2022 period.

Net cash from financing activities

Net cash used in financing activities was $1.8 million and $5.8 million in the six months ended June 30, 2022 and 2021, respectively. The year over year change in financing cash flows largely reflects the prepayment of $5.3 million of term loans under a prior credit agreement unique to the 2021 period, partially offset by new payments made under an insurance financing arrangement unique to the 2022 period. Refer to Note 8, “Financing Arrangements,” of our unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our indebtedness.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

There have been no significant changes to the disclosures about market risk included in our Annual Report on Form 10-K for the year ended December 31, 2021.

Item 4. Controls and Procedures.

Our principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2022, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective.

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Changes in internal control over financial reporting

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

PART II - OTHER INFORMATION

Item 1. Legal Proceedings.

The information under the caption entitled “Legal Proceedings” set forth in Note 11, “Commitments and Contingencies,” in the accompanying notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q is incorporated herein by reference.

Item 1A. Risk Factors.

There have been no material changes from the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2021.

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Item 6. Exhibits.

EXHIBIT 10.1

First Amendment to Note Purchase Agreement, dated August 4, 2022, by and among Osmotica Pharmaceutical Corp., the Guarantors party thereto, the Purchasers party thereto and Athyrium Opportunities IV Acquisition LP, as the Administrative Agent

EXHIBIT 10.2

Share Subscription Agreement, dated August 4, 2022, by and between RVL Pharmaceuticals plc and Avista Healthcare Partners, L.P.

EXHIBIT 10.3

Share Subscription Agreement, dated August 4, 2022, by and between RVL Pharmaceuticals plc and Athyrium Opportunities IV Co-Invest 2 LP

EXHIBIT 10.4

Share Subscription Agreement, dated August 4, 2022, by and between RVL Pharmaceuticals plc and Brian Markison

EXHIBIT 10.5

Share Subscription Agreement, dated August 4, 2022, by and between RVL Pharmaceuticals plc and James Schaub

EXHIBIT 31.1

-

Principal Executive Officer and Principal Financial Officer Certification Pursuant to Securities Exchange Act Rules 13a—14 and 15d—14 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

EXHIBIT 32.1

-

Principal Executive Officer and Principal Financial Officer Certification Pursuant to 18 U.S.C. Section 1350 as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

EXHIBIT 101.INS

-

Inline XBRL Instance Document.

EXHIBIT 101.SCH

-

Inline XBRL Taxonomy Extension Schema Document.

EXHIBIT 101.CAL

-

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

EXHIBIT 101.DEF

-

Inline XBRL Taxonomy Extension Definition Linkbase Document.

EXHIBIT 101.LAB

-

Inline XBRL Taxonomy Extension Label Linkbase Document.

EXHIBIT 101.PRE

-

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

EXHIBIT 104

Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.)

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SIGNATURES

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

RVL Pharmaceuticals plc

Dated:  August 11, 2022

By:

/s/ Brian Markison

Brian Markison

Chief Executive Officer and Principal Financial Officer

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