UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark one)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact name of registrant as specified in its charter)
| ||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices and zip code)
(
(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 |
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.
Indicate by check mark whether the registrant has submitted electronically, if any, 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).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer | ☐ | Accelerated Filer | ☐ | |
☒ | 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 registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.
Class of Common Stock |
| Outstanding Shares as of August 8, 2022 |
Common Stock Class A, $0.0001 par value | ||
Common Stock, $0.0001 par value |
JOURNEY MEDICAL CORPORATION
Quarterly Report on Form 10-Q
TABLE OF CONTENTS
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 19 | ||
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i
PART I. FINANCIAL INFORMATION
Item 1. Unaudited Condensed Consolidated Financial Statements
JOURNEY MEDICAL CORPORATION
Unaudited Condensed Consolidated Balance Sheets
(Dollars in thousands except for share and per share amounts)
| June 30, |
| December 31, | |||
2022 | 2021 | |||||
ASSETS |
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Current assets |
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Cash and cash equivalents |
| $ | |
| $ | |
Accounts receivable, net of reserves |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Intangible assets, net |
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Operating lease right-of-use asset, net |
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Other assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
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Accounts payable | $ | | $ | | ||
Due to related party |
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Accrued expenses |
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Accrued interest | | — | ||||
Income taxes payable |
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Line of credit | — | | ||||
Deferred cash payment (net of discount of $ | | — | ||||
Installment payments – licenses, short-term |
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Operating lease liabilities |
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Total current liabilities |
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Term loan (net of debt discount of $ | | — | ||||
Installment payments – licenses, long-term |
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Total liabilities |
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Commitments and contingencies (Note 15) |
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Stockholders’ equity |
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Common stock, $ |
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Common stock - Class A, $ |
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Additional paid-in capital |
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Accumulated deficit |
| ( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
JOURNEY MEDICAL CORPORATION
Unaudited Condensed Consolidated Statements of Operations
(Dollars in thousands except for share and per share amounts)
| Three-Month Periods Ended |
| Six-Month Periods Ended | |||||||||
June 30, | June 30, | |||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||
Revenue: | ||||||||||||
Product revenue, net | $ | | $ | | $ | | $ | | ||||
Other revenue | | — | | — | ||||||||
Total Revenue | | | | | ||||||||
Operating expenses |
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Cost of goods sold – product revenue |
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Research and development |
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Research and development - licenses acquired |
| — |
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| — |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
| ( |
| ( |
| ( |
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Other expense |
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Interest income |
| ( |
| — |
| ( |
| - | ||||
Interest expense | | | | | ||||||||
Change in fair value of derivative liability |
| — |
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| — |
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Total other expense |
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Loss before income taxes |
| ( |
| ( |
| ( |
| ( | ||||
Income tax (benefit) expense |
| ( |
| ( |
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| ( | ||||
Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net loss per common share: | ||||||||||||
Basic and diluted | ( | ( | ( | ( | ||||||||
Weighted average number of common shares: |
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Basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
JOURNEY MEDICAL CORPORATION
Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity
(Dollars in thousands except for share amounts)
Six-Month Period Ended June 30, 2022
Total | |||||||||||||||||||
| Common Stock |
| Common Stock A | Additional | (Accumulated | Shareholders’ | |||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Paid-in Capital |
| Deficit) |
| Equity | ||||||
Balance as of December 31, 2021 | | $ | | | $ | | $ | | $ | ( | $ | | |||||||
Share-based compensation | — |
| — | — |
| — |
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| — |
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Exercise of stock options for cash | | — | — | — | | — | | ||||||||||||
Issuance of common stock for vested restricted stock units | | — | — | — | — | — | — | ||||||||||||
Net loss | — |
| — | — |
| — |
| — |
| ( |
| ( | |||||||
Balance as of June 30, 2022 | | $ | | | $ | | $ | | $ | ( | $ | |
Three-Month Period Ended June 30, 2022
Total | |||||||||||||||||||
Common Stock | Common Stock A | Additional | (Accumulated | Shareholders’ | |||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Paid-in Capital |
| Deficit) |
| Equity | ||||||
Balance as of March 31, 2022 | | | ( | $ | | ||||||||||||||
Share-based compensation |
| — |
| — |
| — |
| — |
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| — |
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Exercise of stock options for cash |
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| — |
| — |
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Issuance of common stock for vested restricted stock units |
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| — |
| — |
| — |
| — |
| — |
| — | |||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||
Balance as of June 30, 2022 |
| | $ | |
| | $ | | $ | | $ | ( | $ | |
Six-Month Period Ended June 30, 2021
Retained | |||||||||||||||||||
Earnings | Total | ||||||||||||||||||
| Common Stock |
| Common Stock A | Additional | (Accumulated | Shareholders’ | |||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Paid-in Capital |
| Deficit) |
| Equity (Deficit) | ||||||
Balance as of December 31, 2020 | | $ | — | | $ | | $ | | $ | | $ | | |||||||
Share-based compensation | — |
| — | — |
| — |
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| — |
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Exercise of options for cash | | — | — | — | | — | | ||||||||||||
Contribution of capital – extinguishment of related party payable | — |
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| — |
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Net loss | — |
| — | — |
| — |
| — |
| ( |
| ( | |||||||
Balance as of June 30, 2021 | | $ | — | | $ | | $ | | $ | ( | $ | ( |
Three-Month Period Ended June 30, 2021
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| Retained |
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Earnings | Total | ||||||||||||||||||
| Common Stock | Common Stock A | Additional | (Accumulated | Shareholders’ | ||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Paid-in Capital |
| Deficit) |
| Equity (Deficit) | ||||||
Balance as of March 31, 2021 | | $ | — |
| | $ | | $ | | $ | | $ | | ||||||
Share-based compensation | — |
| — |
| — |
| — |
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Contribution of capital – extinguishment of related party payable | — |
| — |
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Net loss | — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Balance as of June 30, 2021 | | $ | — |
| | $ | | $ | | $ | ( | $ | ( |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
JOURNEY MEDICAL CORPORATION
Unaudited Condensed Consolidated Statements of Cash Flows
(Dollars in thousands)
| Six-Month Periods | |||||
Ended June 30, | ||||||
| 2022 |
| 2021 | |||
Cash flows from operating activities |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Bad debt recoveries |
| ( |
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Non-cash interest expense |
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Amortization of debt discount |
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Amortization of acquired intangible assets |
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Amortization of operating lease right-of-use assets |
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Share-based compensation |
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Deferred taxes provision |
| — |
| ( | ||
Extinguishment of related party income tax payable | — | | ||||
Change in fair value of derivative liability |
| — |
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Research and development-licenses acquired, expense |
| — |
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Changes in operating assets and liabilities: |
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Accounts receivable | ( | ( | ||||
Inventory |
| ( |
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Prepaid expenses and other current assets |
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Other assets |
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Accounts payable |
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Related party expenses |
| ( |
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Accrued expenses |
| ( |
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Accrued interest | | — | ||||
Income tax payable |
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| ( | ||
Lease liabilities | ( | ( | ||||
Net cash used in operating activities |
| ( |
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Cash flows from investing activities |
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Acquired intangible assets |
| ( |
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Net cash used in investing activities | ( | — | ||||
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Cash flows from financing activities |
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Proceeds from the exercise of stock options |
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Payment of license installment note payable |
| ( |
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Proceeds from convertible preferred shares |
| — |
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Payment of debt issuance costs associated with convertible preferred shares |
| ( |
| ( | ||
Proceeds from EWB term-loan, net of discount | | — | ||||
Repayment of line of credit | ( | — | ||||
Offering costs for the issuance of common stock - initial public offering |
| ( |
| — | ||
Net cash provided by financing activities |
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Net change in cash |
| ( |
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Cash at the beginning of the period |
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Cash at the end of the period | $ | | $ | | ||
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Supplemental disclosure of cash flow information: | ||||||
Cash paid for interest | $ | | $ | — | ||
Cash paid for income taxes | $ | — | $ | | ||
Supplemental disclosure of non-cash financing and investing activities: | ||||||
Deferred payment for asset acquisition | $ | | ||||
Unpaid debt offering cost | $ | — | $ | | ||
Unpaid deferred offering cost | $ | — | $ | | ||
Derivative warrant liability associated with convertible preferred shares | $ | — | $ | | ||
Extinguishment of related party payable relates to deferred tax assets | $ | — | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
JOURNEY MEDICAL CORPORATION
Notes to Unaudited Condensed Consolidated Financial Statements
NOTE 1. ORGANIZATION AND PLAN OF BUSINESS OPERATIONS
Journey Medical Corporation (collectively “Journey” or the “Company”) was formed on July 18, 2014. The Company is a commercial-stage pharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions. The Company’s current product portfolio includes
As of June 30, 2022 and December 31, 2021, the Company was a subsidiary of Fortress Biotech, Inc. (“Fortress” or “Parent”).
All dollar amounts discussed in these Notes to Unaudited Condensed Consolidated Financial Statements are in thousands of U.S. dollars, except for per share amounts, and unless otherwise indicated.
Liquidity and Capital Resources
At June 30, 2022, the Company had $
On November 16, 2021, the Company completed an initial public offering (collectively the “Journey IPO” or “IPO”) of its Common Stock, par value $
Prior the Company’s IPO, the Company’s operations were primarily financed through a working capital note from Fortress, referred to herein as the “Fortress Note,” cash generated by operations and cash raised in the Company’s private offering of
The Company has access to a $
The Company regularly evaluates market conditions, its liquidity profile, and various financing alternatives for opportunities to enhance its capital structure. The Company may seek to raise capital through debt or equity financings to expand its product portfolio. If such funding is not available or not available on terms acceptable to the Company, the Company’s current plans for expansion of its product portfolio will be curtailed.
5
NOTE 2. BASIS OF PRESENTATION
Basis of Presentation and Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual consolidated financial statements prepared in accordance with GAAP have been condensed or omitted. These unaudited interim condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. The Company’s unaudited interim condensed consolidated financial statements include the accounts of the Company and the accounts of the Company’s wholly-owned subsidiary, JG Pharma, Inc. All intercompany balances and transactions have been eliminated.
Emerging Growth Company
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s unaudited interim condensed consolidated financial statements upon adoption. Under the Jumpstart Our Business Startups Act of 2012, as amended, the Company meets the definition of an emerging growth company and elected the extended transition period for complying with new or revised accounting standards, which delays the adoption of these accounting standards until they would apply to private companies.
Use of Estimates
The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates made by management include provisions for product returns, coupons, rebates, chargebacks, discounts, allowances and distribution fees paid to certain wholesalers, inventory realization and useful lives of amortizable intangible assets. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in
NOTE 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company’s significant accounting policies are described in Note 2 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. (the “2021 Form 10-K”).
Recently Issued Accounting Pronouncements
During the three-month period ended June 30, 2022, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the 2021 Form 10-K that affect the Company’s present or future results of operations, overall financial condition, liquidity or disclosures.
6
NOTE 4. INVENTORY
The Company’s inventory consists of the following:
| June 30, |
| December 31, | |||
($’s in thousands) | 2022 | 2021 | ||||
Raw materials | $ | | $ | | ||
Work-in-process |
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| — | ||
Finished goods |
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Inventory at cost | | | ||||
Inventory reserves | | — | ||||
Total Inventories | $ | | $ | |
NOTE 5. ASSET ACQUISITION
On January 12, 2022, the Company acquired two United States Food and Drug Administration (“FDA”) approved topical minocycline products, Amzeeq® (minocycline) topical foam,
The Vyne Product Acquisition also provides for contingent net sales milestone payments, on a product by product basis. In the first calendar year in which annual sales reach each of $
The following table summarizes the aggregate consideration transferred for the assets acquired by the Company in connection with the Vyne Product Acquisition:
| Aggregate | ||
Consideration | |||
($’s in thousands) |
| Transferred | |
Consideration transferred to Vyne at closing | $ | | |
Fair Value of deferred cash payment due January 2023 |
| | |
Transaction costs |
| | |
Total consideration transferred at closing | $ | |
The fair value of the deferred cash payment is being accreted to the $
The following table summarizes the assets acquired in the Vyne Product Acquisition:
| Assets | ||
($’s in thousands) | Recognized | ||
Inventory | $ | | |
Identifiable Intangibles: |
|
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Amzeeq Intangible |
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Zilxi Intangible |
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Fair value of net identifiable assets acquired | $ | |
7
The intangible assets were valued using an income approach, while the inventory was valued using a final sales value less cost to dispose approach.
NOTE 6. INTANGIBLES
The Company’s finite-lived intangible assets consist of acquired intangible assets.
The gross carrying amount and accumulated amortization of intangible assets as of June 30, 2022 and December 31, 2021 are summarized as follows:
| June 30, 2022 | |||||||||||
Estimated | ||||||||||||
Useful | Gross | |||||||||||
Lives | Carrying | Accumulated | Intangible | |||||||||
($’s in thousands) |
| (Years) |
| Value |
| Amortization |
| Assets, Net | ||||
Amortizable intangible assets: |
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Ceracade® | $ | | $ | ( | $ | — | ||||||
Luxamend® |
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| |
| ( |
| — | |||||
Targadox® |
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| ( |
| — | |||||
Ximino® |
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| ( |
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Exelderm® |
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| ( |
| — | |||||
Accutane® |
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| ( |
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Amzeeq® |
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| ( |
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Zilxi® |
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| ( |
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| ( | | |||||||
Non-amortizable intangible assets: |
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Anti-itch product (1) |
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| — |
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Total intangible assets | $ | | $ | ( | $ | |
| December 31, 2021 | |||||||||||
Estimated | ||||||||||||
Useful | Gross | |||||||||||
Lives | Carrying | Accumulated | Intangible | |||||||||
($’s in thousands) |
| (Years) |
| Value |
| Amortization |
| Assets, Net | ||||
Amortizable intangible assets: |
|
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| ||||||||
Ceracade® | $ | | $ | ( | $ | — | ||||||
Luxamend® |
|
| |
| ( |
| — | |||||
Targadox® |
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| ( |
| — | |||||
Ximino® |
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| ( |
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Exelderm® |
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| ( |
| — | |||||
Accutane® |
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| ( |
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| ( | | |||||||
Non-amortizable intangible assets: |
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Anti-itch product (1) |
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| — |
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Total intangible assets | $ | | $ | ( | $ | |
The Company’s amortization expense for the three-month periods ended June 30, 2022 and 2021 was $
8
Future amortization of the Company’s intangible assets is as follows:
| Total | ||
($’s in thousands) |
| Amortization | |
Remainder of 2022 | $ | | |
December 31, 2023 | | ||
December 31, 2024 |
| | |
December 31, 2025 |
| | |
December 31, 2026 |
| | |
Thereafter |
| | |
Subtotal | $ | | |
Asset not yet placed in service |
| | |
Total | $ | |
NOTE 7. LICENSES/PRODUCTS ACQUIRED
On June 29, 2021, the Company entered a license, collaboration, and assignment agreement (the “DFD-29 Agreement”) to obtain the global rights for the development and commercialization of a late-stage development modified release oral minocycline for the treatment of rosacea (“DFD-29”) with Dr. Reddy’s Laboratories, Ltd (“DRL”). Pursuant to the terms and conditions of the DFD-29 Agreement, the Company paid $
Additionally, the Company is required to fund and oversee the Phase 3 clinical trials approximating $
The technology licensed has not reached technological feasibility and has no alternative future use. The licenses purchased by the Company require substantial completion of research and development, and regulatory and marketing approval efforts in order to reach technological feasibility. Accordingly, costs incurred in obtaining the license were charged to research and development expense.
On March 31, 2021, the Company executed an Asset Purchase Agreement (the “Qbrexza Agreement”) with Dermira, Inc., a subsidiary of Eli Lilly and Company (“Dermira”). The Company acquired the rights to Qbrexza® (glycoprronium), a prescription cloth towelette to treat primary axillary hyperhidrosis in patients
9
The purchase price of $
On July 29, 2020, the Company entered into a license and supply agreement for Accutane® (“Accutane Agreement”) with DRL. Pursuant to the Accutane Agreement, the Company agreed to pay $
NOTE 8. FAIR VALUE MEASUREMENTS
Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Observable inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
| June 30, 2022 | |||||||||||
($’s in thousands) |
| Level 1 |
| Level 2 |
| Level 3 |
| Total | ||||
Assets |
|
|
|
| ||||||||
Cash and cash equivalents | $ | | $ | — | $ | — | $ | | ||||
Total | $ | | $ | — | $ | — | $ | |
| December 31, 2021 | |||||||||||
($’s in thousands) |
| Level 1 |
| Level 2 |
| Level 3 |
| Total | ||||
Assets |
|
|
|
| ||||||||
Cash and cash equivalents | $ | | $ | — | $ | — | $ | | ||||
Total | $ | | $ | — | $ | — | $ | |
The Company did not carry any level 2 or level 3 assets or liabilities at June 30, 2022, December 31, 2021.
10
NOTE 9. RELATED PARTY AGREEMENTS
Shared Services Agreement with Fortress
On November 12, 2021, the Company and Fortress entered into an arrangement to share the cost of certain legal, finance, regulatory, and research and development employees (the “Shared Services Agreement”). Fortress’ Executive Chairman and Chief Executive Officer is the Executive Chairman of the Company. Under the terms of the Shared Services Agreement, the Company will reimburse Fortress for the salary and benefit costs associated with these employees based upon actual hours worked on Journey-related projects following the completion of the IPO. In addition, the Company reimburses Fortress for various payroll related costs and selling, general and administrative costs. For the three-month periods ended June 30, 2022 and 2021, Fortress employees have provided services to the Company, and the Company recorded related expense of approximately $
Fortress Income Tax
At June 30, 2022,
Additionally, see Note 19 below for a discussion of income taxes.
NOTE 10. ACCRUED EXPENSES
The components of the Company’s accrued expenses at June 30, 2022 and December 31, 2021, were as follows:
| June 30, |
| December 31, | |||
($’s in thousands) | 2022 | 2021 | ||||
Accrued expenses and other short-term liabilities: |
|
|
|
| ||
Accrued coupons and rebates | $ | | $ | | ||
Accrued compensation |
| |
| | ||
Accrued royalties payable | | | ||||
Return reserve |
| |
| | ||
Accrued Inventory |
| |
| | ||
Accrued research and development |
| |
| | ||
Accrued legal, accounting and tax Income taxes payable |
| |
| | ||
Accrued marketing and advertising | — | | ||||
Other |
| |
| | ||
Total accrued expenses | $ | | $ | |
11
NOTE 11. INSTALLMENT PAYMENTS — LICENSES
The following tables show the balances of the Company’s installment payments – licenses for the periods presented:
| June 30, 2022 | ||||||||
($’s in thousands) |
| Short-Term |
| Long-Term |
| Total | |||
Installment payments - licenses | $ | | $ | | $ | | |||
Less: imputed interest |
| ( |
| ( |
| ( | |||
Sub-total installment payments - licenses | | | |
| December 31, 2021 | ||||||||
($’s in thousands) |
| Short-Term |
| Long-Term |
| Total | |||
Installment payments - licenses | $ | | $ | | $ | | |||
Less: imputed interest |
| ( |
| ( |
| ( | |||
Sub-total installment payments - licenses | | | |
NOTE 12. OPERATING LEASE OBLIGATIONS
The Company leases
At June 30, 2022 the Company’s operating lease liability was as follows:
($’s in thousands) |
|
| |
Remainder of 2022 | $ | | |
Less: present value discount |
| ( | |
Operating lease liabilities | $ | |
The following table summarizes quantitative information about the Company’s operating leases:
| |||||||||||||
Three-Month Periods Ended | Six-Month Periods Ended | ||||||||||||
|
| June 30, | June 30, | ||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||||
Lease cost : | |||||||||||||
Operating lease cost | $ | |
| $ | | $ | | $ | |
| |||
Variable lease cost |
| |
| |
| |
| |
| ||||
Total lease cost |
| |
| |
| |
| |
| ||||
Other information: |
|
|
|
|
| ||||||||
Operating cash flows from operating leases | $ | $ | | $ | | $ | | ||||||
Weighted-average remaining lease term - operating leases |
|
|
|
| |||||||||
Weighted-average discount rate - operating leases |
| | % |
| | % |
| | % |
| | % |
NOTE 13. DEBT
Line of Credit
The Company had no outstanding short-term borrowings at June 30, 2022. The Company, through a loan facility agreement entered into with EWB has access to a $
12
Long-Term Debt
The Company’s long-term debt at June 30, 2022 reflects approximately $
On January 12, 2022, the Company entered into a third amendment of the loan and security agreement with EWB (the “Amendment”), which increased the borrowing capacity of the Company’s revolving line of credit to $
The Company accounted for the Amendment as a debt modification. The remaining unamortized debt issuance costs related to the original revolving facility together with any lender fees and direct third-party costs incurred in connection with the entry into the Amendment are considered associated with the new arrangement. The fees allocated to the revolving line are amortized over the new
NOTE 14. INTEREST EXPENSE
Interest expense consisted of the following:
| Three-month periods ended | Six-month periods ended | ||||||||||
June 30, | June 30, | |||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||
Interest payments on EWB term loan | $ | | $ | — | $ | | $ | — | ||||
Imputed Interest on acquired intangible assets | | | | | ||||||||
Amortization/Accretion | | — | | — | ||||||||
Fees on convertible preferred shares | — | | — | | ||||||||
Conversion premium 1 |
| — |
| |
| — |
| | ||||
Interest payable on convertible preferred shares |
| — |
| |
| — |
| | ||||
EWB Fees | — | | — | | ||||||||
Total Interest Expense | $ | | $ | | $ | | $ | |
1 The conversion premium relates to the
NOTE 15. COMMITMENTS AND CONTINGENCIES
License Agreements
The Company has undertaken to make contingent milestone payments to the licensors of its portfolio of drug products and candidates. In addition, the Company is required to pay royalties to such licensors based on a percentage of net sales of each drug candidate following regulatory marketing approval. For additional information on future milestone payments and royalties, see Note 7.
13
NOTE 16. STOCKHOLDERS’ EQUITY
Common Stock
The Company’s Second Amended and Restated Certificate of Incorporation authorizes the Company to issue
Voting Rights
Each holder of Common Stock is entitled to
Each holder of Class A Common Stock is entitled to a number of votes that is equal to
Dividends
The holders of the Company’s outstanding shares of Common Stock and Class A Common Stock are entitled to receive dividends, if any, as may be declared from time to time by the Company’s Board of Directors out of legally available funds.
Liquidation
In the event of the Company’s liquidation, dissolution or winding up, holders of Common Stock and Class A Common Stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of the Company’s debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of Preferred Stock.
Rights and Preference
Holders of the Company’s Common Stock and Class A Common Stock have no preemptive, conversion or subscription rights, and there is no redemption or sinking fund provisions applicable to either the Common Stock or the Class A Common Stock. The rights, preferences and privileges of the holders of Common Stock and Class A Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of the Company’s Preferred Stock that are or may be issued.
In March 2021, the Company commenced an offering of
The Company completed
14
Following the payment of placement agent fees of $
NOTE 17. SHARE-BASED COMPENSATION
In 2015, the Company’s Board of Directors adopted, and stockholders approved, the Journey Medical 2015 Stock Plan (the “Plan”) authorizing the Company to grant up to
Total compensation cost charged against operations related to the above plan for the three-month periods ended June 30, 2022 and 2021 was $
Stock Options
The following table summarizes the Company’s stock option activities:
Weighted | ||||||||||
|
| Weighted |
|
| average | |||||
Number | average | Aggregate | remaining | |||||||
of | exercise | intrinsic | contractual | |||||||
| Shares |
| price |
| value |
| life (years) | |||
Outstanding options at December 31, 2021 | | $ | | $ | | |||||
Granted | | | | |||||||
Exercised | ( | | | — | ||||||
Forfeited | ( | | | — | ||||||
Expired | ( | | | — | ||||||
Outstanding options at June 30, 2022 |
| | $ | | $ | |
| |||
Options vested and exercisable at June 30, 2022 |
| | $ | | $ | |
|
For the three and six-month periods ended June 30, 2022, the Company issued
Restricted Stock Units
For the three and six-month periods ended June 30, 2022, the Company issued
15
of 2021. At June 30, 2022, approximately
The following table summarizes the activity related to the Company’s RSUs for the six-month period ended June 30, 2022:
| Weighted | ||||
average | |||||
Number of | grant | ||||
| shares |
| price | ||
Unvested balance at December 31, 2021 |
| | $ | | |
Granted |
| |
| | |
Vested | ( | | |||
Forfeited | ( | | |||
Unvested balance at June 30, 2022 | | $ | |
NOTE 18. REVENUES FROM CONTRACTS AND SIGNIFICANT CUSTOMERS
Disaggregation of Net Revenues
The Company’s net product revenues are summarized as follows:
| Three-Month Periods Ended |
| Six-Month Periods Ended | |||||||||
June 30, | June 30, | |||||||||||
($ in thousands) |
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||
Qbrexza® | $ | | $ | | $ | | $ | | ||||
Accutane® |
| |
| |
| |
| | ||||
Amzeeq | | — | | — | ||||||||
Targadox® | | | | | ||||||||
Ximino® | | | | | ||||||||
Zilxi | | — | | — | ||||||||
Exelderm® |
| |
| |
| |
| | ||||
Other branded revenue |
| — |
| — |
| — |
| | ||||
Total product revenues | $ | | $ | | $ | | $ | |
The above table includes the authorized generic product within the line items for Targadox®, Ximino® and Exelderm®.
Significant Customers
For the three and six-month periods ended June 30, 2022 and 2021, there were no customers that accounted for more than 10% of the Company’s total gross product revenue.
At June 30, 2022,
Other Revenue
| Three-Month Periods Ended |
| Three-Month Periods Ended | |||||||||
June 30, |
| June 30, | ||||||||||
($ in thousands) |
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||
Other revenue |
| |
| — | |
| — | |||||
Total other revenue | $ | | $ | — | $ | | $ | — |
16
Other revenue for the three-month period ended June 30, 2022 reflects a net $
Other revenue for the six-month period ended June 30, 2022 includes a net $
NOTE 19. INCOME TAXES
The Company records income taxes using the asset and liability method. Deferred income tax assets and liabilities are recognized for the future tax effects attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases, and operating loss and tax credit carryforwards. The Company establishes a valuation allowance if management believes it is more likely than not that the deferred tax assets will not be recovered based on an evaluation of objective verifiable evidence. Management has considered the Company’s history of book and tax income and losses incurred since inception, and the other positive and negative evidence, and has concluded that it is more likely than not that the Company will not realize the benefits of the net deferred tax assets as of June 30, 2022.
For the three-month periods ended June 30, 2022 and 2021, the Company’s income tax benefit was
As of June 30, 2022, the Company had
NOTE 20. NET INCOME PER COMMON SHARE
The Company accounts for and discloses net earnings (loss) per share using the treasury stock method. Net earnings (loss) per common share, or basic earnings (loss) per share, is computed by dividing net earnings (loss) by the weighted-average number of common shares outstanding. Net earnings (loss) per common share assuming dilutions, or diluted earnings (loss) per share, is computed by reflecting the potential dilution from the exercise of in-the-money stock options, and non-vested restricted stock units.
The Company’s basic and diluted weighted-average number of common shares outstanding for the three and six-month periods ended June 30, 2022 and 2021 were as follows:
| Three-month periods ended |
| Six-month periods ended | |||||
June 30, | June 30, | |||||||
2022 |
| 2021 | 2022 |
| 2021 | |||
Basic | | | | | ||||
Common stock equivalents: | ||||||||
Unvested restricted stock units/awards |
| | |
| | | ||
Stock Options |
| | |
| | | ||
Diluted | | |
| | |
The Company’s Common Stock equivalents, including unvested restricted stock and options have been excluded from the computation of diluted loss per share for the three and six-month periods ended June 30, 2022, and 2021, as the effect would be to reduce the loss per share. Therefore, the weighted average Common Stock outstanding used to calculate both basic and diluted income loss per share is the same for the three and six-month periods ended June 30, 2022, and 2021.
17
NOTE 21. Subsequent Event
On August 2, 2022, the Company elected to execute its option to borrow the additional $
18
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes included elsewhere in this Form 10-Q. Our unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP. The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies. We use words such as “expect,” “anticipate,” “intend,” “believe,” “may,” “plan,” “seek,” “could,” “would,” “should,” “will” or similar language to identify forward-looking statements, but not all-forward looking statements include these words. All forward-looking statements included in this document are based on information available to us on the date hereof and we assume no obligation to update any such forward-looking statements. For such forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Our business and financial performance are subject to substantial risks and uncertainties. Actual results could differ materially from those projected in, or implied by, the forward-looking statements. In evaluating our business, you should carefully consider the information set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Form 10-K”). As used below, the words “we,” “us” and “our” refer to Journey Medical Corporation and its consolidated subsidiary.
Overview
We are a commercial-stage pharmaceutical company founded in July 2014 that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions. Our current portfolio includes nine branded and three authorized generic prescription drugs for dermatological conditions that are actively marketed in the U.S. We are managed by experienced life science executives with a track record of creating value for their stakeholders and bringing novel medicines to the market, enabling patients to experience increased quality of life and physicians and other licensed medical professionals to provide better care for their patients. We aim to acquire rights to future products by licensing or otherwise acquiring an ownership interest in, funding the research and development of, and eventually commercializing, dermatological products through our exclusive field sales organization.
On November 16, 2021, we completed an initial public offering (“IPO”) of our Common Stock, which resulted in net proceeds of approximately $30.6 million, after deducting underwriting discounts and other offering costs.
We expect our expenses will increase for the foreseeable future as we pursue business development opportunities, commercialize, and market new products and incur additional costs associated with operating as a public company. To date, our business has not been materially impacted by COVID-19; however, depending on the extent of the ongoing pandemic, it is possible that our business, financial condition and results of operations could be materially and adversely affected by COVID-19 in the future. Our cash and cash equivalents balance was $38.1 million at June 30, 2022.
Recent Highlights
Clinical Developments
On March 14, 2022, we dosed the first patient in our Phase 3 clinical trial evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the treatment of Rosacea. In addition, the published phase 2 clinical data showed that DFD-29 had approximately double the efficacy compared to Doxycycline capsules 40 mg, on reducing total inflammatory lesions and Investigator’s Global Assessment treatment success. The Phase 3 trials encompass two multicenter, randomized, double-blind, parallel-group, active and placebo-controlled clinical trials and will each enroll up to 320 adult patients with moderate to severe papulopustular rosacea (“PPR”). One trial is enrolling patients in the United States and the other is enrolling in the United States and Europe. The patients are being randomized in a 3:3:2 ratio to DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg), Oracea® (Doxycycline capsules 40 mg) or placebo once daily for 16 weeks. The primary objective of the studies is to evaluate the safety, efficacy and tolerability of DFD-29 compared to placebo for the treatment of PPR. The secondary objective is to evaluate the safety, efficacy and tolerability of DFD-29 compared to Oracea® (Doxycycline capsules 40 mg). Enrollment in the phase 3 studies reached 43%, and screening of patients in Europe has commenced. Looking ahead, we expect to announce topline data from the phase 3 program in the first half of 2023, with a New Drug Application (“NDA”) filing expected in the second half of 2023.
19
Critical Accounting Polices and Uses of Estimates
Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States. Applying these principles requires our judgment in determining the appropriateness of acceptable accounting principles and methods of application in diverse and complex economic activities. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of revenues, expenses, assets and liabilities, and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and other assumptions that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
For a discussion of our critical accounting estimates, see the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section in the 2021 Form 10-K. There were no material changes in our critical accounting estimates or accounting policies from December 31, 2021.
Accounting Pronouncements
During the three-month period ended June 30, 2022, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the 2021 Form 10-K that are expected to materially affect the Company’s present or future financial statements.
Smaller Reporting Company Status
We are a “smaller reporting company,” meaning that the market value of our shares held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company as long as either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 million. As a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in the 2021 Form 10-K, have reduced disclosure obligations regarding executive compensation and certain other matters, and smaller reporting companies are permitted to delay adoption of certain recent accounting pronouncements discussed in Note 2 to our consolidated financial statements in this report on Form 10-Q.
20
Results of Operations
The following table summarizes our results of operations for the three-month periods ended June 30, 2022 and 2021:
Comparison of the Three-Month Periods Ended June 30, 2022 and 2021
Three-Month Periods Ended |
| |||||||||||
June 30, | Change | |||||||||||
($ in thousands, except per share data) |
| 2022 |
| 2021 |
| $ |
| % | ||||
Revenue: | ||||||||||||
Product revenue, net |
| $ | 18,235 |
| $ | 15,288 | $ | 2,947 | 19 | % | ||
Other revenue | 56 | — | 56 | 100 | % | |||||||
Total revenue | 18,291 | 15,288 | 3,003 | 20 | % | |||||||
Operating expenses |
|
|
|
|
|
| ||||||
Cost of goods sold - product revenue |
| 7,633 |
| 7,484 | 149 | 2 | % | |||||
Research and development |
| 2,609 |
| 29 | 2,580 | N/A | ||||||
Research and development - licenses acquired |
| — |
| 13,743 | (13,743) | (100) | % | |||||
Selling, general and administrative |
| 15,191 |
| 7,795 | 7,396 | 95 | % | |||||
Total operating expenses |
| 25,433 |
| 29,051 | (3,618) | (12) | % | |||||
Loss from operations |
| (7,142) |
| (13,763) | 6,621 | (48) | % | |||||
Other expense |
|
|
|
|
| |||||||
Interest income |
| (4) |
| — | (4) | 100 | % | |||||
Interest expense | 454 | 1,342 | (888) | (66) | % | |||||||
Change in fair value of derivative liability |
| — |
| 182 | (182) | (100) | % | |||||
Total other expense |
| 450 |
| 1,524 | (1,074) | (70) | % | |||||
Loss before income taxes |
| (7,592) |
| (15,287) | 7,695 | (50) | % | |||||
Income tax benefit |
| (64) |
| (3,422) | 3,358 | (98) | % | |||||
Net Loss | $ | (7,528) | $ | (11,865) | $ | 4,337 | (37) | % |
21
Revenues
Net product revenue
The following table reflects our net product revenue for the three-month periods ended June 30, 2022 and 2021:
Three-Month Periods Ended |
| |||||||||||
June 30, | Change | |||||||||||
($ in thousands) |
| 2022 |
| 2021 |
| $ |
| % | ||||
Qbrexza® | $ | 6,111 | $ | 4,568 | $ | 1,543 | 34 | % | ||||
Accutane® | 5,200 | 1,945 | 3,255 | 167 | % | |||||||
Amzeeq | 1,265 | — | 1,265 | 100 | % | |||||||
Targadox® | 2,756 | 5,727 | (2,971) | (52) | % | |||||||
Ximino® |
| 1,035 |
| 1,312 | (277) | (21) | % | |||||
Zilxi | 555 | — | 555 | 100 | % | |||||||
Exelderm® |
| 1,313 |
| 1,736 | (423) | (24) | % | |||||
Other branded revenue |
| — |
| — | — | 100 | % | |||||
Total net product revenues | $ | 18,235 | $ | 15,288 | $ | 2,947 | 19 | % |
Total net product revenues increased $2.9 million, or 19%, to $18.2 million for the three-month period ended June 30, 2022, from $15.3 million for the three-month period ended June 30, 2021. Net revenue growth from period-to-period is primarily due to growth from Qbrexza®, launched during the second quarter of 2021, and growth ramp up in Accutane®, launched late in the first quarter of 2021. In addition, the increase from period-to-period is driven by incremental net revenues as a result of our newly launched product acquisitions of Amzeeq® and Zilxi® from Vyne in January 2022. Offsetting the increase is a decrease in revenue of Targadox® and its authorized generic, Doxycycline, as a result of continued generic competition, Ximino® and its generic Minocycline, and Exelderm® and its generic Sulconazole, due to product shortages from the contract manufacturer in the second quarter. These shortages were resolved in July 2022 and inventory is now available for sale. Accordingly, we expect that product revenue for these items will be higher in future quarters. The above table includes the authorized generic product within the line items for Targadox®, Ximino® and Exelderm®.
Other revenue
Other revenue for the three-month period ended June 30, 2022 reflects a net $55,514 royalty payment from our exclusive out-licensing partner in Japan, Maruho Co., Ltd (“Maruho”) for sales of Rapifort® Wipes 2.5% (Japanese equivalent to U.S. FDA approved Qbrexza®), for the treatment of primary axillary hyperhidrosis. Manufacturing and marketing approval for this product was obtained in February 2022, and accordingly we expect Maruho to continue to make royalty payments to us in future fiscal quarters as its sales in Japan continue.
Gross-to-Net Sales Accruals
We record gross-to-net sales accruals for chargebacks, distributor service fees, prompt pay discounts, sales returns, coupons, managed care rebates, government rebates, and other allowances customary to the pharmaceutical industry. For a discussion of our gross-to-net sales accruals, see Critical Accounting Estimates and Significant Accounting Policies in the 2021 Form 10-K.
22
Gross-to-net sales accruals and the balance in the related allowance accounts for the three-month periods ended June 30, 2022, and 2021 were as follows:
| Chargebacks |
|
|
|
|
| ||||||||||||
and | Managed | |||||||||||||||||
Distributor | Care | Gov’t | ||||||||||||||||
($’s in thousands) | Service Fees | Returns | Coupons | Rebates | Rebates | Total | ||||||||||||
Balance as of March 31, 2022 | $ | 1,386 | $ | 3,151 | $ | 6,660 | $ | 2,635 | $ | 1,026 | $ | 14,858 | ||||||
Current provision related to sales in the current period |
| 2,304 |
| 1,170 |
| 30,912 |
| 6,543 |
| 752 |
| 41,681 | ||||||
Checks/credits issued to third parties |
| (2,290) |
| (1,594) |
| (35,073) |
| (5,987) |
| (560) |
| (45,504) | ||||||
Reclassifications between liability accounts |
| — |
| — |
| — |
| — |
| — |
| — | ||||||
Balance as of June 30, 2022 | $ | 1,400 | $ | 2,727 | $ | 2,499 | $ | 3,191 | $ | 1,218 | $ | 11,035 |
Chargebacks | ||||||||||||||||||
and | Managed | |||||||||||||||||
Distributor | Care | Gov’t | ||||||||||||||||
($’s in thousands) |
| Service Fees |
| Returns |
| Coupons |
| Rebates |
| Rebates |
| Total | ||||||
Balance as of March 31, 2021 | $ | — | $ | 4,029 | $ | 10,123 | $ | 784 | $ | — | $ | 14,936 | ||||||
Current provision related to sales in the current period | — | 1,414 | 35,510 | 1,397 | — | 35,931 | ||||||||||||
Checks/credits issued to third parties | — | (1,029) | (30,421) | (1,099) | — | (30,159) | ||||||||||||
Reclassifications between liability accounts |
| — |
| (2,315) |
| 2,315 |
| — |
| — |
| — | ||||||
Balance as of June 30, 2021 | $ | — | $ | 2,099 | $ | 17,527 | $ | 1,082 | $ | — | $ | 20,708 |
We have established provisions for chargebacks resulting from the launch of our new products noted above. Included in the reserve for chargebacks and distributor service fees are provisions for prompt pay discounts.
Our provision for returns was $2.7 million at June 30, 2022, compared to $2.1 million at June 30, 2021. The increase is mainly due to incremental provisions resulting from our newly launched products, Accutane®, launched late in the first quarter of 2021, and Qbrexza®, acquired during the second quarter of 2021, and the acquisition of Amzeeq® and Zilxi® from Vyne in January 2022.
The provision for coupons was $2.5 million at June 30, 2022 compared to $17.5 million at June 30, 2021. The decrease is mainly due to the timing of payments from June 30, 2021.
Managed care and government rebate provisions combined were $3.2 million and $1.2 million, respectively, at June 30, 2022 compared to $1.1 million and zero, respectively at June 30, 2021. The increase is due to incremental provisions resulting from our newly launched products, Accutane®, launched late in the first quarter of 2021, and Qbrexza®, acquired during the second quarter of 2021, and the acquisition of Amzeeq® and Zilxi® from Vyne in January 2022 and to a lesser extent a greater portion of sales qualifying for managed care rebates.
23
Cost of Goods Sold
Cost of goods sold increased by $0.1 million, or 2%, to $7.6 million for the three-month period ended June 30, 2022, from $7.5 million for the three-month period ended June 30, 2021. The increase is primarily due to higher product cost of goods sold of $0.8 million driven by our increased net product sales from period-to-period, increased amortization of $0.3 million related to our acquired intangible assets, due to the acquisition of Amzeeq® and Zilxi® from Vyne in January 2022, costs of approximately $0.2 million related to product validation and stability testing for Amzeeq® and Zilxi® and a $0.1 million increase in FDA manufacturing fees from the prior-year quarter. The increases are partially offset by a $1.0 million decrease in product cost of goods sold as the three-month period ended June 30, 2021 included an inventory step-up of $1.2 million for inventory units sold related to the acquired finished goods of Qbrexza® in 2021. The three-month period ended June 30, 2022 includes $0.2 million, non-cash, step up for inventory units sold related to the acquired finished goods for Ameeq® and Zilxi®. Further offsetting the above increases is a $0.3 million decrease in product royalties substantially driven by a decrease in Targadox® royalties as a result of decreased sales from generic competition.
Research and Development
Research and Development expense increased to $2.6 million for the three-month period ended June 30, 2022, from $29,000 for the three-month period ended June 30, 2021. The increase is related to clinical trial expenses to develop our DFD-29 product, for which dosing began in March 2022. We expect these expenses to increase as patients are fully enrolled in the trials.
Research and Development - licenses acquired
Research and development - licenses acquired decreased $13.7 million or 100% from the three-month period ended June 30, 2021. The prior year quarter reflects the acquisition of our development stage asset from DRL for $10.0 million and the fair value of the contingent payment due DRL of $3.7 million.
Selling, General and Administrative
Selling, general and administrative expenses increased $7.4 million, or 95%, to $15.2 million for the three-month period ended June 30, 2022, from $7.8 million for the three-month period ended June 30, 2021. The increase is primarily attributable to the expansion of our salesforce, marketing expense related to our expanded product portfolio, and compliance and other costs associated with being a public company.
Interest Expense
Interest expense decreased $0.9 million to $0.5 million for the three-month period ended June 30, 2022, from $1.3 million for the three-month period ended June 30, 2021. The prior year quarter includes dividends and interest on our convertible preferred shares that converted into common stock upon the closing of our IPO in November 2021.
Income tax benefit
Our income tax benefit decreased $3.4 million to $0.1 million for the three-month period ended June 30, 2022, from $3.4 million for the three-month period ended June 30, 2021. During the three month-periods ended June 30, 2022 and 2021 our income taxes reflected an income tax benefit of $64,000, and $3.4 million, respectively, resulting in an effective tax rate of 0.85% and 23.68%, respectively. The decrease in our income tax benefit is due to changes in unfavorable permanent book-tax differences and a full valuation allowance against the Company’s deferred tax.
24
The following table summarizes our results of operations for the six-month periods ended June 30, 2022 and 2021:
Comparison of the Six-Month Periods Ended June 30, 2022 and 2021
Six-Month Periods Ended |
| |||||||||||
| June 30, |
| Change |
| ||||||||
($in thousands, except per share data) | 2022 |
| 2021 | $ |
| % |
| |||||
Revenue: |
| |
| |
|
|
|
| ||||
Product revenue, net | $ | 39,031 | $ | 26,007 | $ | 13,024 |
| 50 | % | |||
Other revenue |
| 2,556 |
| — |
| 2,556 |
| 100 | % | |||
Total Product revenue |
| 41,587 |
| 26,007 |
| 15,580 |
| 60 | % | |||
Operating expenses |
|
|
|
|
|
|
|
| ||||
Cost of goods sold - product revenue |
| 15,836 |
| 11,392 |
| 4,444 |
| 39 | % | |||
Research and development |
| 3,875 |
| 29 |
| 3,846 |
| N/A | ||||
Research and development - licenses acquired |
| — |
| 13,743 |
| (13,743) |
| (100) | % | |||
Selling, general and administrative |
| 29,906 |
| 14,021 |
| 15,885 |
| 113 | % | |||
Total operating expenses |
| 49,617 |
| 39,185 |
| 10,432 |
| 27 | % | |||
Loss from operations |
| (8,030) |
| (13,178) |
| 5,148 |
| (39) | % | |||
Other expense |
|
|
|
|
|
|
|
| ||||
Interest income |
| (7) |
| — |
| (7) |
| 100 | % | |||
Interest expense |
| 843 |
| 1,563 |
| (720) |
| (46) | % | |||
Change in fair value of derivative liability |
| — |
| 182 |
| (182) |
| (100) | % | |||
Total other expense |
| 836 |
| 1,745 |
| (909) |
| (52) | % | |||
Loss before income taxes |
| (8,866) |
| (14,923) |
| 6,057 |
| (41) | % | |||
Income tax expense (benefit) |
| 40 |
| (3,326) |
| 3,366 |
| (101) | % | |||
Net Loss | $ | (8,906) | $ | (11,597) | $ | 2,691 |
| (23) | % |
Revenues
Net product revenue
The following table reflects our net product revenue for the six-month periods ended June 30, 2022 and 2021:
Six-Month Periods Ended |
| |||||||||||
| June 30, |
| Change |
| ||||||||
($ in thousands) |
| 2022 |
| 2021 |
| $ |
| % |
| |||
Qbrexza® | $ | 13,487 | $ | 4,568 | $ | 8,919 |
| 195 | % | |||
Accutane® |
| 10,107 |
| 2,141 |
| 7,966 |
| 372 | % | |||
Amzeeq |
| 4,731 |
| — |
| 4,731 |
| 100 | % | |||
Targadox® |
| 5,390 |
| 12,926 |
| (7,536) |
| (58) | % | |||
Ximino® |
| 2,002 |
| 3,413 |
| (1,411) |
| (41) | % | |||
Zilxi |
| 1,297 |
| — |
| 1,297 |
| 100 | % | |||
Exelderm® |
| 2,017 |
| 2,953 |
| (936) |
| (32) | % | |||
Other branded revenue |
| — |
| 6 |
| (6) |
| (100) | % | |||
Total net product revenues | $ | 39,031 | $ | 26,007 | $ | 13,024 |
| 50 | % |
25
Total net product revenues increased $13.0 million, or 50%, to $39.0 million for the six-month period ended June 30, 2022, from $26.0 million for the six-month period ended June 30, 2021. Our revenue growth from period-to-period is primarily due to incremental revenues from Qbrexza®, launched during the second quarter of 2021, and the growth Accutane®, launched late in the first quarter of 2021. In addition, the increase from period-to-period is driven by incremental net revenues as a result of our newly launched products due to the acquisition of Amzeeq® and Zilxi® from Vyne in January 2022. Offsetting the increase is a decrease in Targadox® and its authorized generic, Doxycycline, as a result of generic competition, Ximino® and its authorized generic Minocycline, and Exelderm and its authorized generic Sulconazole, due to product shortages from the contract manufacturer in the second quarter, which shortages were eliminated in July 2022, and a decrease in our product, Ximino®, primarily driven by increased promotional emphasis from our salesforce to Accutane®, and increased pressure from generic competition. The above table includes the authorized generic product within the line items for Targadox®, Ximino® and Exelderm®.
Other revenue
Other revenue for the three-month period ended June 30, 2022 reflects a net $2.5 million milestone payment to us from our exclusive out-licensing partner in Japan. In February 2022, Maruho received manufacturing and marketing approval in Japan for Rapifort® Wipes 2.5% (Japanese equivalent to U.S. FDA approved Qbrexza®), for the treatment of primary axillary hyperhidrosis, triggering the net payment. The net payment reflects a milestone payment of $10.0 million to us from Maruho, offset by a $7.5 million payment to Dermira, Inc., pursuant to the terms of the asset purchase agreement between us and Dermira under which we acquired QBREXZA. In conjunction with the terms list above, both transactions were completed in March of 2021. We acquired global rights to Qbrexza® from Dermira in 2021.
Gross-to-Net Sales Accruals
We record gross-to-net sales accruals for chargebacks, distributor service fees, prompt pay discounts, sales returns, coupons, managed care rebates, government rebates, and other allowances customary to the pharmaceutical industry. For a discussion of our gross-to-net sales accruals, see Critical Accounting Estimates and Significant Accounting Policies in the 2021 Form 10-K.
Gross-to-net sales accruals and the balance in the related allowance accounts for the three-month periods ended June 30, 2022, and 2021 were as follows:
| Chargebacks |
|
|
|
|
|
| |||||||||||
and | Managed | |||||||||||||||||
Distributor | Care | Gov’t | ||||||||||||||||
($’s in thousands) |
| Service Fees |
| Returns |
| Coupons |
| Rebates |
| Rebates |
| Total | ||||||
Balance as of December 31, 2021 | $ | 1,610 | $ | 3,240 | $ | 4,992 | $ | 3,492 | $ | 690 | $ | 14,024 | ||||||
Current provision related to sales in the current period | 4,489 |
| 2,290 |
| 66,529 |
| 10,234 |
| 1,756 |
| 85,298 | |||||||
Checks/credits issued to third parties | (4,699) |
| (2,803) |
| (69,022) |
| (10,535) |
| (1,228) |
| (88,287) | |||||||
Reclassifications between liability accounts | — |
| — |
| — |
| — |
| — |
| — | |||||||
Balance as of June 30, 2022 | $ | 1,400 | $ | 2,727 | $ | 2,499 | $ | 3,191 | $ | 1,218 | $ | 11,035 |
Chargebacks | ||||||||||||||||||
and | Managed | |||||||||||||||||
Distributor |
| Care | Gov’t | |||||||||||||||
($’s in thousands) |
| Service Fees |
| Returns |
| Coupons |
| Rebates |
| Rebates |
| Total | ||||||
Balance as of December 31, 2020 | $ | — | $ | 2,580 | $ | 12,769 | $ | 100 | $ | — | $ | 15,449 | ||||||
Current provision related to sales in the current period |
| — |
| 1,428 |
| 68,591 |
| 2,275 |
| — |
| 72,294 | ||||||
Checks/credits issued to third parties |
| — |
| (1,594) |
| (64,148) |
| (1,293) |
| — |
| (67,035) | ||||||
Reclassifications between liability accounts |
| — |
| (315) |
| 315 |
| — |
| — |
| — | ||||||
Balance as of June 30, 2021 | $ | — | $ | 2,099 | $ | 17,527 | $ | 1,082 | $ | — | $ | 20,708 |
26
We have established provisions for chargebacks resulting from the launch of our new products noted above. Included in the reserve for chargebacks and distributor service fees are provisions for prompt pay discounts.
Our provision for returns was $2.7 million at June 30, 2022, compared to $2.1 million at June 30, 2021. The increase is mainly due to incremental provisions resulting from our newly launched products, Accutane®, launched late in the first quarter of 2021, and Qbrexza®, acquired during the second quarter of 2021, and the acquisition of Amzeeq® and Zilxi® from Vyne in January 2022.
The provision for coupons was $2.5 million at June 30, 2022 compared to $17.5 million at June 30, 2021. The decrease is mainly due to the timing of payments from June 30, 2021.
Managed care and government rebate provisions combined were $3.2 million and $1.2 million, respectively, at June 30, 2022 compared to $0.8 million and zero, respectively at June 30, 2021. The increase is due to incremental provisions resulting from our newly launched products, Accutane®, launched late in the first quarter of 2021, and Qbrexza®, acquired during the second quarter of 2021, and the acquisition of Amzeeq® and Zilxi® from Vyne in January 2022 and to a lesser extent, a greater portion of sales qualifying for managed care rebates.
Cost of Goods Sold
Cost of goods sold increased by $4.4 million, or 39%, to $15.8 million for the six-month period ended June 30, 2022, from $11.4 million for the six-month period ended June 30, 2021. The increase is primarily due to higher product cost of goods sold of $2.5 million driven by our increased net product sales from period-to-period, $4.0 million in increased royalties due to incremental revenues from Qbrexza®, launched during the second quarter of 2021, and Accutane®, launched late in the first quarter of 2021, increased amortization of $0.7 million related to our acquired intangible assets, due to the acquisition of Amzeeq® and Zilxi® from Vyne in January 2022, costs of approximately $0.3 million related to product validation and stability testing for Amzeeq® and Zilxi® and a $0.3 million increase in FDA manufacturing fees from the prior period. The increases are partially offset by a $0.9 million decrease in product cost of goods sold as the six-month period ended June 30, 2021 included an inventory step-up of $1.2 million for inventory units sold related to the acquired finished goods of Qbrexza® in 2021. The three-month period ended June 30, 2022, includes $0.3 million step up for inventory units sold related to the acquired finished goods for Amzeeq® and Zilxi®. Further offsetting the above increases is a $2.6 million decrease in product royalties substantially driven by a decrease in Targadox® royalties as a result of decreased sales from generic competition.
Research and Development
Research and Development expense increased to $3.9 million for the six-month period ended June 30, 2022 from $29,000 for the six-month period ended June 30, 2021. The increase is related to clinical trial expenses to develop our DFD-29 product, for which dosing began in March 2022. We expect these expenses to increase as patients are fully enrolled in the trials.
Research and Development - licenses acquired
Research and development expenses and research and development - licenses acquired decreased $13.7 million or 100% from the three-month period ended June 30, 2021. The prior year quarter reflects the acquisition of our development stage asset from DRL for $10.0 million and the fair value of the contingent payment due DRL of $3.7 million.
Selling, General and Administrative
Selling, general and administrative expenses increased $15.9 million, or 113%, to $29.9 million for the six-month period ended June 30, 2022, from $14.0 million for the six-month period ended June 30, 2021. The increase is primarily attributable to the expansion of our salesforce, marketing expense related to our expanded product portfolio, legal expenses and compliance and other costs associated with being a public company.
Interest Expense
Interest expense decreased $0.7 million to $0.8 million for the six-month period ended June 30, 2022, from $1.6 million for the six-month period ended June 30, 2021. The prior year includes dividends and interest on our convertible preferred shares that converted into common stock upon the closing of our IPO in November 2021.
27
Income tax expense (benefit)
Income taxes changed by $3.4 million from an income tax benefit of $3.3 million for the six-month period ended June 30, 2021, to an income tax expense of $40,000 for the six-month period ended June 30. For the six-month period ended June 30, 2022, we recorded income tax expense of $40,000 thousand, resulting in an effective income tax rate of (0.45%). For the six-month period ended June 30, 2021, our income taxes reflected an income tax benefit of $3.3 million, resulting in an effective income tax rate of 23.61%. The change in income taxes from period-to period are due to changes in unfavorable permanent book-tax differences and a full valuation allowance against the Company’s deferred tax assets.
Liquidity and Capital Resources
At June 30, 2022, we had $38.1 million in cash and cash equivalents as compared to $49.1 million at December 31, 2021.
On November 16, 2021, we completed an IPO of our Common Stock, which resulted in net proceeds of approximately $30.6 million, after deducting underwriting discounts and other offering costs.
Prior to our IPO, our operations were primarily financed through a working capital note from Fortress Biotech, Inc. (“Fortress”), referred to herein as the “Fortress Note,” cash generated by operations and cash raised in our private offering of our 8% Cumulative Convertible Class A Preferred Stock (“Class A Preferred Stock”). In connection with the closing of our IPO on November 16, 2021, we issued 2,231,346 shares of Common Stock resulting from the conversion of all of the Class A Preferred Stock. In addition, the Fortress Note was converted into 1,610,467 shares of Journey Common Stock at our IPO price of $10.00 per share.
On January 12, 2022, we entered into the third Amendment of our loan and security agreement with EWB (the “Amendment). Pusuant to the credit facility with East West Bank (“EWB”), as amended by the Amendment, and as further amended, we have access to a $30.0 million borrowing facility, which includes a $10.0 revolving line of credit (with zero outstanding on June 30, 2022) and a $20.0 million term loan, both maturing on January 12, 2026. In January 2022, we borrowed $15.0 million against the term loan, of which $15.1 million in principal and accrued interest is outstanding as of June 30, 2022. Through June 12, 2023, we have the option to borrow an additional $5.0 million under another term loan facility. We elected to execute this option on August 2, 2022. See note 21, Subsequent Events, to our condensed consoldiated financial statements for the quarterly period ended June 30, 2022. For the next twelve months from the issuance of the financial statements included elsewhere in this Quarterly Report on Form 10-Q, we will be able to fund our operations through a combination of existing cash and cash equivalents, cash generated from operations and borrowing under the EWB credit facility. We were in compliance with all applicable financial covenants under the EWB borrowing facility at June 30, 2022. The $10.0 million revolving line of credit is available to us without any restrictions, other than certain customary and ordinary closing conditions.
We expect our expenses will increase substantially for the foreseeable future as we pursue business development opportunities, commercialize, and market new products and incur additional costs associated with operating as a public company. To date, our business has not been materially impacted by COVID-19; however, depending on the extent of the ongoing pandemic, it is possible that our business, financial condition and results of operations could be materially and adversely affected by COVID-19 in the future. Additionally, the Federal Reserve has raised and is expected to continue to raise the federal funds interest rate throughout 2022 in its effort to take action against domestic inflation. Because our borrowings under the facility with EWB bear interest at a floating rate, rising interest rates affect the amount of the regular payments we are required to make to EWB. Accordingly, we may experience materially higher borrowing costs in future fiscal quarters than we historically have to date. We may require additional financing to pursue both development stage and commercial opportunities. In addition, we anticipate increased commercialization expenses related to the launch of new products, as well as increased costs related to development and regulatory approval of potential development stage product acquisitions, including DFD-29. As we continue to expand our product portfolio, we may need to fund possible future operating losses, and, if deemed appropriate, establish or secure through additional third-party manufacturing for our products, and expanded sales and marketing capabilities related to recent product acquisitions. For the next twelve months from the issuance of the financial statements included in this report, we will be able to fund our operations through a combination of existing cash and cash equivalents, cash generated from operations and the EWB borrowing facility. Our failure to raise capital as and when needed would have a material adverse impact on our financial condition and our ability to pursue our business strategies.
28
Cash Flows for the Three-Month Periods Ended June 30, 2022 and 2021
Six-month periods ended | |||||||||
June 30, | Increase | ||||||||
($’s in thousands) |
| 2022 |
| 2021 |
| (Decrease) | |||
Net cash used in operating activities | $ | (2,416) | $ | (6,077) | $ | (3,661) | |||
Net cash used in investing activities |
| (20,000) |
| — |
| 20,000 | |||
Net cash provided by financing activities |
| 11,477 |
| 10,007 |
| 1,470 | |||
Net change in cash and cash equivalents | (10,939) | 3,930 | (14,869) |
Operating Activities
Net cash used in operating activities decreased by $3.7 million, to $2.4 million for the six-month period ended June 30, 2022, from $6.1 million for the six-month period ended June 30, 2021. The decrease is primarily attributable to the change in the Company’s net loss of $2.7 million, the change in working capital components of $1.0 million, an increase in share-based compensation of $1.5 million and the change in deferred taxes of $3.4 million. These increases in cash generated are offset by research and development licenses acquired in the prior year of $3.7 million and the $1.0 million change in related party expenses.
Investing Activities
Net cash used in investing activities incrementally increased by $20.0 million due to the cash payment made to Vyne for the Vyne Product Acquisition made during the six-month period ended June 30, 2022.
Financing Activities
Net cash provided by financing activities increased $1.5 million, to $11.5 for the three-month period ended June 30, 2022, from $10.0 million for the six-month period ended June 30, 2021. The most substantial portion of the increase is related to $14.8 million in net proceeds from our EWB term loan, which was used to facilitate the Vyne Product Acquisition and an $0.8 million decrease in payments of the installment notes related to our previously acquired products. In addition, proceeds from the exercise of stock options were higher that the comparative period by approximately $0.1 million. These increases are offset by the $0.8 million repayment of our EWB line of credit drawn in 2021, cash payments of $0.4 associated with IPO offering costs and the net proceeds of $13.0 million from our convertible preferred shares in 2021.
Material Cash Requirements
In the normal course of business, we enter into contractual obligations that contain cash requirements of which the most significant to date include the following:
● | Our loan and security agreement with EWB was recently amended to increase the borrowing capacity of our revolving line of credit to $10.0 million and to add a term loan not to exceed $20.0 million. Both the revolving line of credit and the term loan mature on January 12, 2026. On January 12, 2022, we borrowed $15.0 million against the first tranche of the term loan to facilitate the Vyne Product Acquisition. The Company is permitted to elect to borrow the additional $5.0 million under the second tranche through June 12, 2023. The term loans bear interest at a floating rate equal to 1.73% above the prime rate and interest is payable monthly. The term loan contains an interest-only payment period through January 12, 2024, with an extension through July 12, 2024 if certain covenants are met, after which the outstanding balance of each term loan is payable in equal monthly installments of principal, plus all accrued interest, through the term loan maturity date. We may prepay all or any part of the term loan without penalty or premium, but may not re-borrow any amount, once repaid. Any outstanding borrowing |
29
against the revolving line of credit bears interest at a floating rate equal to 0.70% above the prime rate. Based on the amount currently outstanding under the EWB facility and current interest rates, we expect to make the following payments: |
Payments by Period | ||||||||||||||||||
Remainder | ||||||||||||||||||
| Total |
| of 2022 |
| 2023 |
| 2024 |
| 2025 |
| 2026 | |||||||
($’s in thousands) | ||||||||||||||||||
Interest | $ | 2,836 | $ | 497 | $ | 986 | $ | 942 | $ | 409 | $ | 2 | ||||||
Principle |
| 15,000 | — | — |
| 4,167 |
| 10,000 |
| 833 | ||||||||
Total | $ | 17,836 | $ | 497 | $ | 986 | $ | 5,109 | $ | 10,409 | $ | 835 |
Should we elect to make further borrowings under the EWB facility, we would expect to repay additional amounts in each year until maturity.
● | Pursuant to the Vyne Product Acquisition, upon the one (1)-year anniversary of the closing, which is January 2023, we will pay to Vyne a $5.0 million payment in completion of our contractual purchase price. Upon the achievement of net sales milestones with respect to the products purchased in the Vyne Product Acquisition, we are also required to pay contingent consideration consisting of a one-time payment, per product, of $10 million, $20 million, $30 million, $40 million and $50 million upon each product reaching annual sales of $100 million, $200 million, $300 million, $400 million and $500 million, respectively. Each required payment must only be paid one time following the first achievement of the applicable annual sales milestone amount. |
● | On June 29, 2021, we entered into a license, collaboration, and assignment agreement (the “DFD-29 Agreement”) to obtain the global rights for the development and commercialization of a late-stage development modified release oral minocycline for the treatment of rosacea (“DFD-29”) with Dr. Reddy’s Laboratories, Ltd (“DRL”). Pursuant to the terms and conditions of the DFD-29 Agreement, we paid an upfront payment of $10.0 million. Additional contingent regulatory and commercial milestone payments totaling up to $158.0 million are also payable. Royalties ranging from ten percent to twenty percent are payable on net sales of the product. Additionally, we are required to fund and oversee the Phase 3 clinical trials approximating $24.0 million, based upon the current development plan and budget. |
● | We are contractually obligated to make installment milestone payments on our acquired licenses as follow: |
Payments by Period | ||||||||||||
Remainder | ||||||||||||
Product |
| Total |
| of 2022 |
| 2023 |
| 2024 | ||||
| ($’s in thousands) | |||||||||||
Ximino | $ | 5,000 | $ | 2,000 | $ | 1,500 | $ | 1,500 | ||||
Accutane |
| 2,000 |
| 1,000 |
| 1,000 |
| — | ||||
Total | $ | 7,000 | $ | 3,000 | $ | 2,500 | $ | 1,500 |
● | We are contractually obligated to make sales-based royalty payments to Dermira, Inc. (Qbrexza®), Sun Pharmaceutical Industries (Exelderm® and Ximino®) and PuraCap Caribe (Targadox®). Due to the contingent nature of these obligations, the amounts of these payments cannot be reasonably predicted. |
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness, as of June 30, 2022, of the design and operation of our disclosure controls and procedures, as such term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e). Based on this evaluation, our principal executive
30
officer and principal financial officer have concluded that, as of such date, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
No change in internal control over financial reporting occurred during the most recent quarter with respect to our operations, which materially affected, or is reasonable likely to materially affect, our internal controls over financial reporting.
Part II. Other Information
Item 1. Legal Proceedings.
Upon the March 31, 2021 closing of our acquisition of Qbrexza® from Dermira, Inc., a subsidiary of Eli Lilly and Company (“Dermira”), we became substituted for Dermira as the plaintiff in U.S. patent litigation commenced by Dermira on October 21, 2020 in the U.S. District Court of Delaware (the “Perrigo Patent Litigation”) against Padagis Israel Pharmaceuticals Ltd. (F/K/A Perrigo Israel Pharmaceuticals Ltd.) (“Padagis”) alleging infringement of certain patents covering Qbrexza (the “Qbrexza Patents”), which are included among the proprietary rights to Qbrexza that we acquired from Dermira. The Perrigo Patent Litigation was initiated following the submission by Padagis, in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), of an Abbreviated New Drug Application (“ANDA”). The ANDA seeks approval to market a generic version of Qbrexza prior to the expiration of the Qbrexza Patents and alleges that the Qbrexza Patents are invalid. Journey is seeking, among other relief, an order that the effective date of any FDA approval of Perrigo’s ANDA be no earlier than the expiration of the patents listed in the Orange Book, the latest of which expires on February 28, 2033 and such further and other relief as the court may deem appropriate. Perrigo is subject to a 30-month stay preventing it from selling a generic version, but that stay is set to expire on March 9, 2023. Trial in the Perrigo Patent Litigation was scheduled for September 19, 2022.
Upon completion of our acquisition of Amzeeq® and Zilxi® from VYNE in January 2022, we became substituted for VYNE Therapeutics, Inc. (“VYNE”) as the plaintiff in U.S. patent litigation commenced by VYNE on August 9, 2021 in the U.S. District Court of Delaware (the “Padagis Patent Litigation”) against Padagis alleging infringement of certain patents covering Amzeeq® (the “Amzeeq® Patents”), which are included among the proprietary rights to Amzeeq® that were acquired from VYNE. The Padagis Patent Litigation was initiated following the submission by Padagis, in accordance with the procedures set out in the Hatch-Waxman Act, of an ANDA. The ANDA seeks approval to market a generic version of Amzeeq® prior to the expiration of the Amzeeq® Patents and alleges that the Amzeeq® Patents are invalid. Padagis is subject to a 30-month stay preventing it from selling a generic version, but that stay is set to expire on December 30, 2023. Journey is seeking, among other relief, an order that the effective date of any United States Food and Drug Administration approval of Padagis’ ANDA be no earlier than the expiration of the patents listed in the Orange Book, the latest of which expires on September 8, 2037, and such further and other relief as the court may deem appropriate. Trial in the Padagis Patent Litigation was scheduled for July 10, 2023.
On May 2, 2022, the Company filed a complaint against Padagis alleging infringement of certain patents covering Zilxi® (the “Zilxi® Patents”), which are included among the proprietary rights to Zilxi® that were acquired from VYNE. This litigation was initiated following the submission by Padagis, in accordance with the procedures set out in the Hatch-Waxman Act, of an ANDA. The ANDA seeks approval to market a generic version of Zilxi® prior to the expiration of the Zilxi® Patents and alleges that the Zilxi® Patents are invalid. Padagis is subject to a 30-month stay which prevents Padagis from selling a generic version. The stay is set to expire on October 6, 2024. Journey is seeking, among other relief, an order that the effective date of any FDA approval of Padagis’ ANDA be no earlier than the expiration of the patents listed in the Orange Book, the latest of which expires on October 1, 2030, and such further and other relief as the court may deem appropriate.
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In May 2022, we announced that we entered into three separate settlement agreements (the “Settlement Agreements”) with Padagis for the above-reference patent infringement lawsuits that we filed to enforce the patents covering Qbrexza®, Amzeeq®, and Zilxi®. Pursuant to the terms of the Settlement Agreements, Padagis is prohibited from launching generic versions of QBREXZA®, Amzeeq® and Zilxi® until August 15, 2030, July 1, 2031, and April 1, 2027, respectively. Each of the aforementioned litigations were dismissed on May 19, 2022.
Item 1A. Risk Factors.
Not Applicable.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the period covered by this report, we have not sold any equity securities in transactions that were not registered under the Securities Act, and we nor our affiliates have purchased any equity securities issued by us. We have not furnished information under this item to the extent that such information previously has been included in our Annual Report on Form 10-K or in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
None.
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Item 6. Exhibits
Exhibit No. |
| Description |
3.1 | ||
3.2 | ||
4.1 | ||
4.2 | ||
10.1 | ||
10.2 | ||
31.1 | ||
31.2 | ||
32.1 | ||
32.2 | ||
101 | The following financial information from the Company’s quarterly report on Form 10-Q for the period ended June 30, 2022, formatted in Inline Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations, (iii) the Condensed Consolidated Statement of Stockholders’ Equity, (iv) the Condensed Consolidated Statements of Cash Flows, and (v) Notes to the Condensed Consolidated Financial Statements (filed herewith).** | |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).** |
* Filed herewith.
** Furnished herewith.
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SIGNATURES
Pursuant to the requirements of the Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Journey Medical Corporation | ||
(Registrant) | ||
Date: August 9, 2022 | By: | /s/ Claude Maraoui |
Claude Maraoui | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) |
Date: August 9, 2022 | By: | /s/ Ernest De Paolantonio |
Ernest De Paolantonio | ||
Chief Financial Officer | ||
(Principal Financial Officer) |
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