UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
For the quarterly period ended
OR
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) |
(Zip Code) |
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(Registrant’s Telephone Number, Including Area Code)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
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 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 the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of May 6, 2024, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was
GYRE THERAPEUTICS, INC.
TABLE OF CONTENTS
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PART I. FINANCIAL INFORMATION |
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Item 1. |
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Condensed Consolidated Balance Sheets as of March 31, 2024 (unaudited) and December 31, 2023 |
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Notes to the Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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39 |
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Gyre Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
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March 31, 2024 |
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December 31, 2023 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term bank deposits |
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— |
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Accounts and note receivables, net |
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Other receivables from GNI |
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Inventories, net |
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Prepaid assets |
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Other current assets |
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Total current assets |
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Property and equipment, net |
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Long-term receivable from GCBP |
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Intangible assets, net |
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Right-of-use assets |
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Land use rights, net |
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Deferred tax assets |
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Long-term certificates of deposit |
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Other assets, noncurrent |
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Total assets |
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$ |
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$ |
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Liabilities, convertible preferred stock, and equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Deferred revenue |
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Due to related parties |
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CVR excess closing cash payable |
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Accrued expenses and other current liabilities |
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Income tax payable |
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Operating lease liabilities, current |
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Total current liabilities |
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Operating lease liabilities, noncurrent |
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Deferred government grants |
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CVR derivative liability, noncurrent |
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Warrant liability, noncurrent |
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Other noncurrent liabilities |
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Total liabilities |
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Convertible Preferred Stock, $ |
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— |
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Stockholders’ equity: |
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Common stock, $ |
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Additional paid-in capital |
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Statutory reserve |
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Accumulated deficit |
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( |
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( |
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Accumulated other comprehensive loss |
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( |
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Total Gyre stockholders’ equity (deficit) |
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( |
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Noncontrolling interest |
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Total equity |
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Total liabilities, convertible preferred stock, and equity |
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$ |
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$ |
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2
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Gyre Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Revenues |
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$ |
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$ |
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Operating expenses: |
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Cost of revenues |
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Selling and marketing |
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Research and development |
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General and administrative |
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Total operating expenses |
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Income from operations |
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Other income (expense), net: |
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Interest income, net |
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Other income |
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Change in fair value of warrant liability |
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— |
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Other expenses |
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( |
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( |
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Income before income taxes |
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Provision for income taxes |
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( |
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Net income |
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Net income attributable to noncontrolling interest |
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Net income attributable to common stockholders |
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$ |
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$ |
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Net income per share attributable to common stockholders: |
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Basic |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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Weighted average shares used in calculating net income per |
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Basic |
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Diluted |
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Other comprehensive income: |
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Net income |
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$ |
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$ |
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Foreign currency translation adjustments |
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( |
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Comprehensive income |
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Net income attributable to noncontrolling interest |
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Foreign currency translation adjustments attributable to noncontrolling interest |
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( |
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Comprehensive income attributable to noncontrolling interest |
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Comprehensive income attributable to common stockholders |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Gyre Therapeutics, Inc.
Condensed Consolidated Statements of Convertible Preferred Stock and Equity
(In thousands, except share amounts)
(Unaudited)
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Convertible |
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Common Stock |
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Additional |
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Statutory |
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Accumulated Other Comprehensive |
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Total Gyre |
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Non-controlling |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Reserve |
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Accumulated Deficit |
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Loss |
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(Deficit) Equity |
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Interest |
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Equity |
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Balance at December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock options exercised |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Convertible preferred stock conversion |
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( |
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( |
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— |
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— |
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— |
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— |
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Foreign currency translation adjustments |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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( |
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( |
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Net income |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Balance at March 31, 2024 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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$ |
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$ |
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Convertible |
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Common Stock |
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Additional |
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Statutory |
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Retained Earnings |
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Accumulated Other Comprehensive |
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Total Gyre |
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Non-controlling |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Reserve |
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(Loss) Income |
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Equity |
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Interest |
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Equity |
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Balance at December 31, 2022 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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$ |
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Foreign currency translation adjustments |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net income |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Balance at March 31, 2023 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Gyre Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Operating Activities |
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Net income |
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$ |
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$ |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Stock-based compensation |
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— |
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Equity in loss of unconsolidated affiliate |
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— |
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Depreciation and amortization |
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Noncash lease expense |
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Amortization of land use rights |
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Deferred income taxes, net |
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( |
) |
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( |
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Bad debt expense and other non-cash items |
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( |
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( |
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Accrued interest on certificates of deposit |
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( |
) |
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( |
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Change in fair value of long-term receivable |
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( |
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— |
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Change in fair value of derivative liabilities |
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— |
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Change in fair value of warrant liability |
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( |
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— |
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Loss on disposal of property and equipment |
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— |
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Changes in operating assets and liabilities: |
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Accounts and note receivables |
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Inventories |
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( |
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Prepaid and other assets |
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( |
) |
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( |
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Income tax payable |
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Accounts payable |
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( |
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Other noncurrent liabilities |
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( |
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( |
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Due to related parties |
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( |
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( |
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Accrued expenses and other liabilities |
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( |
) |
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Operating lease liabilities |
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( |
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( |
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Net cash provided by operating activities |
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Investing Activities |
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Acquisition of intangible assets |
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— |
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( |
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Purchase of certificates of deposit |
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( |
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( |
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Purchase of property and equipment |
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( |
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( |
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Proceeds from sale of equipment |
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— |
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Net cash used in investing activities |
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( |
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( |
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Financing Activities |
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Proceeds from the exercise of stock options |
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— |
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Net cash provided by financing activities |
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— |
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Effect of exchange rate changes on cash and cash equivalents |
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( |
) |
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Net (decrease) increase in cash and cash equivalents |
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( |
) |
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Cash and cash equivalents at beginning of the period |
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Cash and cash equivalents at end of the period |
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$ |
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$ |
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Supplemental Disclosure of Non-Cash Financing and Investing Activities: |
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Convertible preferred stock conversion |
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$ |
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$ |
— |
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Non-cash acquisition of property and equipment through prepaid conversion |
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$ |
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$ |
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Supplemental Disclosure of Cash Flow Information: |
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Cash paid for income taxes |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Gyre Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. |
Nature of Operations and Liquidity |
Description of Business
Gyre Therapeutics, Inc. (the “Company,” “Gyre,” or the “combined company”), formerly known as Catalyst Biosciences, Inc. (“Catalyst”), is a biopharmaceutical company originally incorporated in Delaware on March 7, 1997 under the name Targacept, Inc. Catalyst was a biopharmaceutical company with expertise in protease engineering. Prior to ceasing research and development activities in March 2022, Catalyst had several protease assets that were designed to address unmet medical needs in disorders of the complement or coagulation systems.
On October 30, 2023, the Company consummated the transactions (the “Contributions”) contemplated by the Business Combination Agreement as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”), which were accounted for as a reverse asset acquisition and a purchase of noncontrolling interest in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”). Continent Pharmaceuticals Inc. (“CPI”) was treated as the accounting acquirer of the reverse asset acquisition and is presented as the predecessor for post-acquisition financial reporting purposes. CPI holds an indirect controlling interest in Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd., “Gyre Pharmaceuticals”), a commercial-stage biopharmaceutical company registered and established in the People’s Republic of China (“PRC”) in 2002.
After consummation of the Contributions, the immediate holding company of CPI became Gyre. The Company holds in aggregate a
Liquidity
For the three months ended March 31, 2024, the Company had net income of $
2. |
Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying condensed consolidated financial statements include the accounts of the Company and its controlled subsidiaries. All intercompany accounts and transactions among consolidated entities were eliminated upon consolidation. The condensed consolidated financial statements have been prepared in accordance with GAAP and following the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s condensed consolidated financial information. These condensed consolidated results of operations and cash flows for any interim period are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or for any other future annual or interim period.
The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the consolidated financial statements filed with the Annual Report.
7
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, allowance of doubtful accounts, long-term receivable, contingent value right (“CVR”) derivative liability, warrant liability, allowance for credit losses, reserves for excess or obsolete inventory, operating lease right-of-use assets and liabilities, recognition of research and development expenses to the appropriate financial reporting period based on the progress of the research and development projects, income taxes, stock-based compensation and useful lives of property and equipment and intangibles with definite lives. The Company bases its estimates on various assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Risks and Uncertainties
The Company is subject to a number of risks associated with companies at a similar stage, including dependence on key individuals, competition from larger and established companies, uncertainty of clinical results, ability to obtain adequate financing to support growth, the ability to attract and retain additional qualified personnel to manage the anticipated growth of the Company, and general economic conditions.
Concentration of Credit Risk
In May 2015, a new Deposit Insurance System (“DIS”) managed by the People’s Bank of China was implemented by the Chinese government. Deposits in the licensed banks in mainland China are protected by DIS, up to a limit of Chinese Renminbi (“RMB”)
Accounts receivable are typically unsecured and are derived from product sales. The Company manages credit risk related to the accounts receivable through ongoing monitoring of outstanding balances and limiting the amount of credit extended based upon payment history and creditworthiness. Historically, the Company has collected receivables from customers within the credit terms with no significant credit losses incurred.
Concentration of Customer Risk
For the three months ended March 31, 2024 and 2023, the Company had one customer, Sinopharm Group Co., Ltd. (“Sinopharm”), who accounted for approximately
Foreign Currency Risk
The RMB is not a freely convertible currency. The State Administration for Foreign Exchange, under the authority of the People’s Bank of China, controls the conversion of RMB into other currencies. The value of the RMB is subject to changes in central government policies and to international economic and political developments affecting supply and demand in the China Foreign Exchange Trading System market.
8
March 31, 2024, in the amount of $
Accounting Pronouncements Recently Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Improvements to Reportable Segment Disclosures (Topic 280). This ASU updates reportable segment disclosure requirements by requiring disclosures of significant reportable segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and included within each reported measure of a segment’s profit or loss. This ASU also requires disclosure of the title and position of the individual identified as the CODM and an explanation of how the CODM uses the reported measures of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources. The amendments in this ASU are effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company
New Accounting Pronouncements – Issued But Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures (Topic 740). The ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is permitted. This ASU will result in the required additional disclosures being included in the Company’s consolidated financial statements, once adopted. The Company plans to adopt ASU 2023-09 and related updates as of January 1, 2025. The Company will assess the impact of adoption of this standard on its consolidated financial statements.
3. |
Fair Value Measurements and Financial Instruments |
For a description of the fair value hierarchy and the Company’s fair value methodology, see Note 2 – Summary of Significant Accounting Policies in the Annual Report. There were no significant changes in these methodologies during the three months ended March 31, 2024. As of March 31, 2024, the Company’s highly liquid money market funds are included within cash equivalents.
The following tables present the fair value hierarchy for assets and liabilities measured at fair value on a recurring basis as of March 31, 2024 and December 31, 2023 (in thousands):
|
|
March 31, 2024 |
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|
Level 1 |
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|
Level 2 |
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|
Level 3 |
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Total |
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||||
Financial assets: |
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|
|
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|
|
|
|
|
|
|
|
||||
Money market funds(1) |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Long-term receivable from GCBP |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Total financial assets |
|
$ |
|
|
$ |
— |
|
|
$ |
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|
$ |
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|||
|
|
|
|
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||||
Financial liabilities: |
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|
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|
|
|
||||
CVR derivative liability, noncurrent |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
Warrant liability, noncurrent |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Total financial liabilities |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
9
|
|
December 31, 2023 |
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|||||||||||||
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|
Level 1 |
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|
Level 2 |
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|
Level 3 |
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|
Total |
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds(1) |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Long-term receivable from GCBP |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Total financial assets |
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
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|
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|
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|
||||
Financial liabilities: |
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|
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|
|
|
|
|
|
|
|
||||
CVR derivative liability |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
Warrant liability, noncurrent |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Total financial liabilities |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
The carrying amounts of cash, accounts and note receivables, net, other receivables, accounts payable, due to related parties, CVR excess closing cash payable, and accrued liabilities approximate their fair values due to the short-term maturity of these instruments.
During the three months of March 31, 2024 and the year ended December 31, 2023, there were
Long-term Receivables and Derivative Liabilities
Concurrent with the signing of the Business Combination Agreement on December 26, 2022, Catalyst and the Rights Agent (as defined in the CVR Agreement) executed a contingent value rights agreement (the “CVR Agreement”), as amended on
The long-term receivable and the corresponding CVR derivative liability, noncurrent relate to the asset purchase agreement with GC Biopharma Corp. (“GCBP”). The fair value of this long-term receivable and derivative liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The estimated fair value of the long-term receivable and CVR derivative liability, noncurrent was determined based on the anticipated amount and timing of projected cash flows to be received from GCBP pursuant to the GCBP asset purchase agreement discounted to their present values using an estimated discount rate of
Warrant Liability
In October 2023, Catalyst entered into a Securities Purchase Agreement for a private placement with GNI USA (the “Private Placement”). The Private Placement closed immediately following the Contributions, on October 30, 2023. Upon closing of the Private Placement, the Company issued
10
The Preferred Stock Warrants are freestanding financial instruments classified as a warrant liability on the Company’s condensed consolidated balance sheet. The Preferred Stock Warrants are revalued in each reporting period with the change in fair value recorded as change in fair value of warrant liability in other income (expense), net on the condensed consolidated statement of operations and comprehensive income.
The fair value of the warrant liability is estimated based on the Black-Scholes option pricing model using the following weighted-average assumptions:
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Share price |
$ |
|
|
$ |
|
||
Exercise price |
$ |
|
|
$ |
|
||
Dividend yield |
|
— |
% |
|
|
— |
% |
Risk-free interest |
|
% |
|
|
% |
||
Term (years) |
|
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|
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|
||
Expected volatility |
|
% |
|
|
% |
||
The following table sets forth the changes in the estimated fair value of the Company’s Level 3 financial assets and liabilities (in thousands):
|
|
Long-term receivable |
|
|
CVR derivative |
|
|
Warrant |
|
|||
|
|
from GCBP |
|
|
liability, noncurrent |
|
|
liability |
|
|||
Balance at December 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Changes in fair value |
|
|
|
|
|
|
|
|
( |
) |
||
Balance at March 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Cash equivalents consisted of the following (in thousands):
March 31, 2024 |
|
Amortized |
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
||||
Money market funds (cash equivalents) |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Total financial assets |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Classified as: |
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|
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|
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|
||||
Cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
Total financial assets |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
December 31, 2023 |
|
Amortized |
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
||||
Money market funds (cash equivalents) |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Total financial assets |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Classified as: |
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|
|
|
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|
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|
||||
Cash and cash equivalents |
|
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|
|
|
|
|
|
|
|
$ |
|
||||
Total financial assets |
|
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|
|
|
|
|
|
|
|
$ |
|
||||
11
4. |
Balance Sheet Components |
Inventories, net
Inventories, net of reserves of $
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in progress |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
Inventories, net |
|
$ |
|
|
$ |
|
||
The provision for inventory and write-downs for the periods ended March 31, 2024 and December 31, 2023 were immaterial.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Accrued payroll and welfare |
$ |
|
|
$ |
|
||
Accrued expenses - selling expenses |
|
|
|
|
|
||
Supplier reimbursement |
|
|
|
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|
||
Accrued sales discount |
|
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||
Accrued expenses - general and administrative |
|
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|
||
Accrued professional services |
|
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||
Accrued expenses - research and development |
|
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|
||
Deferred government grants |
|
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|
||
Employee reimbursement |
|
|
|
|
|
||
Other accrued liabilities |
|
|
|
|
|
||
Accrued expenses and other current liabilities |
$ |
|
|
$ |
|
||
Accounts and Note Receivables, Net
Accounts and note receivables, net consisted of the following (in thousands):
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Accounts receivable |
|
$ |
|
|
$ |
|
||
Note receivable |
|
|
|
|
|
|
||
Allowance for credit losses |
|
|
( |
) |
|
|
( |
) |
Allowance and note receivables, net |
|
$ |
|
|
$ |
|
||
Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Buildings |
|
$ |
|
|
$ |
|
||
Construction in progress |
|
|
|
|
|
|
||
Machinery and electronic devices |
|
|
|
|
|
|
||
Furniture and fixtures |
|
|
|
|
|
|
||
Motor vehicles |
|
|
|
|
|
|
||
Property and equipment, gross |
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
12
5. |
Intangible Assets |
The gross carrying amounts and accumulated amortization of the Company’s intangible assets with determinable lives as of March 31, 2024 and December 31, 2023 were as follows (in thousands):
|
|
March 31, 2024 |
|
|||||||||
|
|
Gross carrying amount |
|
|
Accumulated amortization |
|
|
Intangible assets, net |
|
|||
Intangible assets with finite lives: |
|
|
|
|
|
|
|
|
|
|||
Technological know-how |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Computer software |
|
|
|
|
|
( |
) |
|
|
|
||
Total intangible assets |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
December 31, 2023 |
|
|||||||||
|
|
Gross carrying amount |
|
|
Accumulated amortization |
|
|
Intangible assets, net |
|
|||
Intangible assets with finite lives: |
|
|
|
|
|
|
|
|
|
|||
Technological know-how |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Computer software |
|
|
|
|
|
( |
) |
|
|
|
||
Total intangible assets |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Intangible assets are carried at cost less accumulated amortization and impairment, if applicable, and the amortization expense is recorded in operating expenses. The weighted average amortization period for the intangible assets as of March 31, 2024 is
Amortization expense was $
|
|
Estimated amortization expense |
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Thereafter |
|
|
|
|
Total |
|
$ |
|
|
6. |
Revenue |
The Company’s product revenues were mainly generated from the sale of ETUARY. Sales of ETUARY accounted for
Sales of Pharmaceutical Products
The Company generates revenue mostly through sales of ETUARY and certain generic drugs. The distributors were the Company’s direct customers, and sales to distributors accounted for
Product returns to date have not been significant and the Company has not considered it necessary to record a reserve for product returns. The Company’s product revenues were recognized at a point in time when the underlying product was delivered to the customer, which was when the customer obtained control of the product. Revenue from sales of pharmaceutical products was $
13
The Company’s sales by product categories for the three months ended March 31, 2024 and 2023 are as follows (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Sales of Pharmaceutical Products |
|
$ |
|
|
$ |
|
||
Total |
|
$ |
|
|
$ |
|
||
7. |
Leases |
Operating Leases
Gyre Pharmaceuticals’ corporate headquarters, a
The Company also has multiple short-term leased properties used as offices and employee dormitories. The Company recorded a total of $
As of March 31, 2024, the Company recorded an aggregate right-of-use asset of $
For the three months ended March 31, 2024 and 2023, the Company’s operating lease expense was $
Supplemental cash flow information related to operating leases was as follows (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Cash paid for amounts included in the measurement of lease liabilities |
|
$ |
|
|
$ |
|
||
The present value assumptions used in calculating the present value of the lease payments were as follows:
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Weighted-average remaining lease term |
|
|
|
|
||||
Weighted-average discount rate |
|
|
% |
|
|
% |
||
As of March 31, 2024, undiscounted future minimum payments under the Company’s operating leases were as follows (in thousands):
|
|
Amount |
|
|
Remaining in 2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
Total undiscounted lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Total lease liabilities |
|
|
|
|
Less: current portion of lease liabilities |
|
|
( |
) |
Lease liabilities, net of current portion |
|
$ |
|
|
14
The Company is required to maintain security deposits of $
Land Use Rights
As of March 31, 2024, the Company held land use rights for two land parcels in Beijing’s Shunyi District, expiring in 2053, and in Cangzhou, Hebei Province, expiring from 2067 to 2071. These parcels, with a combined area of approximately
8. |
Stockholders’ Equity |
Common Stock
Common stock reserved for future issuance is as follows:
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Options issued and outstanding |
|
|
|
|
|
|
||
Preferred Stock Warrants issued and outstanding |
|
|
|
|
|
|
||
Convertible Preferred Stock issued and outstanding |
|
|
— |
|
|
|
|
|
Total common stock reserved |
|
|
|
|
|
|
||
2021 ATM Program
On October 15, 2021, Catalyst entered into an Equity Distribution Agreement (the “ATM Agreement”) with Piper Sandler & Co. (“Piper Sandler”) as sales agent, pursuant to which the Company may offer and sell, from time to time, through Piper Sandler, shares of the Company’s common stock, par value of $
Sales of shares of common stock under the ATM Program may be made pursuant to the registration statement on Form S-3 (File No. 333-253874), which was declared effective by the SEC on May 3, 2021, and a related prospectus supplement filed with the SEC on October 15, 2021. For the three months ended March 31, 2024 and 2023,
Restricted Net Assets
Under PRC laws and regulations, Gyre Pharmaceuticals is subject to restrictions on foreign exchange and cross-border cash transfers, including to parent companies and U.S. stockholders. The ability to distribute earnings to the parent companies and U.S. stockholders is also limited. Current PRC regulations permit Gyre Pharmaceuticals to pay dividends to BJContinent Pharmaceuticals Limited (“BJC”) only out of its accumulated profits as determined in accordance with PRC accounting standards and regulations. Amounts restricted include paid-in capital and the statutory reserves of Gyre Pharmaceuticals. The aggregate amounts of restricted capital and statutory reserves of the relevant subsidiaries not available for distribution were $
Statutory Reserve
Gyre Pharmaceuticals is required to set aside at least
15
Company may allocate a portion of after-tax profits based on PRC accounting standards to a discretionary reserve fund.
There were
9. |
Convertible Preferred Stock |
In December 2022, Catalyst issued an aggregate of
In October 2023, immediately following the closing of the Contributions, the Company issued
In November 2023, GNI USA provided notice to the Company to convert its
10. |
Stock Based Compensation |
2023 Omnibus Incentive Plan
The 2023 Omnibus Incentive Plan was approved by Catalyst’s stockholders in August 2023 and ratified by Gyre’s board of directors (the “Board”) in October 2023. The 2023 Omnibus Incentive Plan became effective on October 30, 2023. The 2023 Omnibus Incentive Plan permits the Company to issue up to
The following table summarizes stock option activity considering the conversion of Gyre Pharmaceuticals options to Gyre options to purchase shares of Gyre common stock upon completion of the Contributions:
|
|
Number of Shares |
|
|
Weighted- |
|
|
Weighted- |
|
|||
Outstanding — December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
Options granted |
|
|
|
|
$ |
|
|
|
|
|||
Options exercised |
|
|
( |
) |
|
$ |
|
|
|
|
||
Options forfeited and cancelled |
|
|
( |
) |
|
$ |
|
|
|
|
||
Outstanding — March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|||
Exercisable — March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|||
16
Valuation Assumptions
The Company estimated the fair value of stock options granted using the Black-Scholes option-pricing formula and a single option award approach. Due to its limited relevant historical data, the Company estimated its volatility considering a number of factors, including the use of the volatility of comparable public companies. The expected term of options granted under the 2023 Omnibus Incentive Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited relevant history. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. This fair value is being amortized ratably over the requisite service periods of the awards, which is generally the vesting period.
Since
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Three Months Ended March 31, |
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2024 |
|
|
2023 |
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|
|
|
|
|
|
|
Risk-free interest rate (%) |
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|
% |
|
n/a |
|
Expected option life (in years) |
|
|
|
|
n/a |
|
Expected dividend yield (%) |
|
|
— |
% |
|
n/a |
Volatility (%) |
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|
% |
|
n/a |
|
Weighted average share price of the Company (USD per share) |
|
$ |
|
|
n/a |
|
Total stock-based compensation expense recognized was as follows (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
General and administrative |
|
$ |
|
|
$ |
— |
|
|
Total stock-based compensation expense |
|
$ |
|
|
$ |
— |
|
|
As of March 31, 2024, the Company had an unrecognized stock-based compensation expense of $
11. |
Net Income per Share (“EPS”) Attributable to Common Stockholders |
The dilutive effect of outstanding stock options and warrants is calculated using the treasury stock method. Stock options and warrants are anti-dilutive and excluded from the diluted EPS attributable to common stock calculation if the exercise price exceeds the average market price of the common shares.
17
The following table sets forth the computation of EPS attributable to common stockholders, basic and diluted (in thousands, except share and per share data):
|
|
Three Months Ended March 31, |
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|||||
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|
2024 |
|
|
2023 |
|
||
Numerator: |
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||
Net income |
|
$ |
|
|
$ |
|
||
Less: Allocation of undistributed earnings to noncontrolling interest |
|
|
|
|
|
|
||
Net income attributable to common stockholders - basic |
|
$ |
|
|
$ |
|
||
Less: Change in fair value of warrant liability |
|
|
|
|
|
— |
|
|
Net income attributable to common stockholders - diluted |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Denominator: |
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Basic common shares outstanding: |
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||
Weighted average common shares outstanding |
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||
Weighted average shares used in calculating net income per share attributable to common stockholders, basic |
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||
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||
Dilutive potential common shares: |
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||
Weighted average of common stock options |
|
|
|
|
|
|
||
Weighted average of Convertible Preferred Stock (as converted) |
|
|
|
|
|
— |
|
|
Weighted average of Preferred Stock Warrants (as converted) |
|
|
|
|
|
— |
|
|
Weighted average shares used in calculating net income per share attributable to common stockholders, diluted |
|
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||
|
|
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|
||
Net income per share attributable to common stockholders: |
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|
|
|
|
|
||
Basic |
|
$ |
|
|
$ |
|
||
Diluted |
|
$ |
|
|
$ |
|
||
Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:
|
|
As of March 31, |
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|||||
|
|
2024 |
|
|
2023 |
|
||
Options to purchase common stock |
|
|
|
|
|
— |
|
|
Total |
|
|
|
|
|
— |
|
|
12. |
Commitments and Contingencies |
Contingent Value Rights Agreement
Each CVR under the CVR Agreement entitles the holder to receive (i) certain cash payments from the net proceeds related to the disposition of Catalyst’s legacy assets, (ii)
In February 2023, Catalyst sold its legacy rare bleeding disorder program to GCBP. As a result, the Company distributed the net cash proceeds received from the GCBP asset sale of $
18
on the condensed consolidated balance sheet. Refer to Note 3 — Fair Value Measurements and Financial Instruments for additional information regarding the CVR derivative liability and GCBP asset sale.
On October 30, 2023, pursuant to the CVR Agreement, the Company recorded a $
Litigation and Legal Matters
The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company’s condensed consolidated financial statements.
In April 2023, separate stockholders of Catalyst filed lawsuits in the Delaware Chancery Court, captioned Bushansky v. Catalyst Biosciences, Inc., et al and Scott v. Catalyst Biosciences, Inc., et al., alleging Catalyst violated its fiduciary duties under Delaware Law by failing to disclose purportedly material information regarding the proposed Business Combination Agreement. In February 2024, both lawsuits were dismissed with prejudice and the Company reimbursed the stockholders for their legal and other expenses related to the litigation in the aggregate amount of $
Purchasing Commitments
Property and Equipment
The Company’s commitments related to purchase of property and equipment contracted but not yet reflected in the condensed consolidated financial statements were $
F351
In September 2020, Gyre Pharmaceuticals entered into an intellectual property (“IP”) transfer agreement (the “F351 Transfer Agreement”) with GNI Japan and certain of its wholly owned subsidiaries (the “GNI Group” or “GNI”). According to the F351 Transfer Agreement, Gyre Pharmaceuticals acquired the exclusive right to use Hydronidone IP rights in mainland China and the right of first offer for the global IP rights (the “F351 IP Rights”).
Under the F351 Transfer Agreement, in exchange for the F351 IP Rights, Gyre Pharmaceuticals is obligated to pay GNI Group $
Research and Development Programs
In addition to the F351 program, as of March 31, 2024, the Company has committed to allocate $
13. |
Income Taxes |
During the three months ended March 31, 2024 and 2023, the Company recorded the following income tax provision (in thousands) and effective tax rate:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Income tax provision |
|
$ |
|
|
$ |
|
||
Effective tax rate |
|
|
% |
|
|
% |
||
19
The change of effective tax rate for the three months ended March 31, 2024 and 2023 was primarily due the consummation of the Contributions in October 2023.
As of March 31, 2024, after consideration of certain limitations (see below), the Company had approximately $
If the Company experiences a greater than 50% aggregate change in ownership over a three-year period (a Section 382 ownership change), utilization of its pre-change NOL carryforwards are subject to annual limitation under Section 382 of the Internal Revenue Code (California has similar provisions). The annual limitation is determined by multiplying the value of the Company’s stock at the time of such ownership change by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the NOL carryforwards before utilization. The Company determined that ownership changes under Section 382 occurred on December 31, 2007, August 20, 2015, April 13, 2017, February 15, 2018, February 18, 2020, and December 26, 2022. Approximately $
14. |
Related Party Transactions |
Research and Development with GNI
Other Receivables from GNI
As of March 31, 2024 and December 31, 2023, the Company had recorded $
15. |
Employee Benefit Plans |
Mainland China Contribution Plan
Pursuant to relevant PRC regulations, the Company is required to make contributions to various defined contribution plans organized by municipal and provincial PRC governments. The contribution for each employee is based on a percentage of the employee’s current compensation as required by the local government. The contributions are charged to profit or loss as they become payable in accordance with the rules of the central pension scheme. The total contributions for such employee benefits were $
Defined-Contribution Savings Plan
In the U.S., the Company maintains a defined-contribution savings plan pursuant to Section 401(k) of the Internal Revenue Code of 1986, as amended. The plan is available to employees who meet the minimum age and length of service requirements. The contributions made during the three months ended March 31, 2024 were immaterial.
16. |
Segment Information |
The Company is a consolidated entity comprised of
20
availability of separate financial information, and overall materiality considerations. All Gyre’s operations are within the U.S., while all of Gyre Pharmaceuticals’ operations are in mainland China.
Gyre Pharmaceuticals
Gyre Pharmaceuticals has one major commercial drug product, ETUARY, and several product candidates in pre-clinical and clinical development. Gyre Pharmaceuticals’ product revenues are mainly generated from the sale of ETUARY and certain generic drugs. Gyre Pharmaceuticals primarily sells its pharmaceutical products to distributors in the PRC, who ultimately sell the products to hospitals, other medical institutions and pharmacies. Gyre Pharmaceuticals also generates revenue from license agreements. However, the license agreements did not generate any revenue for the three months ended March 31, 2024 or 2023.
Gyre
Gyre is a biopharmaceutical company focused on the development and commercialization of F351 for the treatment of non-alcoholic steatohepatitis-associated liver fibrosis in the United States. Other than the IP associated with F351 in the U.S., Gyre has no other product candidates since the Company sold all of its legacy IP assets prior to the closing of the Contributions. Subsequent to the closing of the Contributions, Gyre has not generated any revenue.
Other
Other represents the financial information from other subsidiaries, consisting of mainly CPI, GNI HK, and Continent Pharmaceuticals U.S., Inc. During the year ended December 31, 2023, prior to the Contributions, CPI divested almost all of its assets other than its
Segment information for the three months ended March 31, 2024 and 2023 is as follows (in thousands):
|
|
Three Months Ended March 31, 2024 |
|
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|
|
Gyre Pharmaceuticals |
|
|
Gyre |
|
|
Other |
|
|
Consolidated |
|
||||
Revenues |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Cost of revenues |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Gross profit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Operating expenses excluding cost of revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Research and development |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
General and administrative |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Total operating expenses excluding cost of revenues |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Income (loss) from operations |
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Supplemental disclosure of stock-based compensation expense: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Stock-based compensation total |
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
March 31, 2024 |
|
|||||||||||||
|
|
Gyre Pharmaceuticals |
|
|
Gyre |
|
|
Other |
|
|
Consolidated |
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
21
The table below only includes cash outflows for the purchase of property and equipment and excludes non-cash activities.
|
|
Three Months Ended March 31, 2024 |
|
|||||||||||||
|
|
Gyre Pharmaceuticals |
|
|
Gyre |
|
|
Other |
|
|
Consolidated |
|
||||
Purchase of property and equipment |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
|
|
Three Months Ended March 31, 2023 |
|
|||||||||||||
|
|
Gyre Pharmaceuticals |
|
|
Gyre |
|
|
Other |
|
|
Consolidated |
|
||||
Revenues |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Cost of revenues |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Gross profit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Operating expenses excluding cost of revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Research and development |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
General and administrative |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|||
Total operating expenses excluding cost of revenues |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|||
Income (loss) from operations |
|
$ |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Supplemental disclosure of stock-based compensation expense: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation total |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
December 31, 2023 |
|
|||||||||||||
|
|
Gyre Pharmaceuticals |
|
|
Gyre |
|
|
Other |
|
|
Consolidated |
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The table below only includes cash outflows for the purchase of property and equipment and excludes non-cash activities.
|
|
Three Months Ended March 31, 2023 |
|
|||||||||||||
|
|
Gyre Pharmaceuticals |
|
|
Gyre |
|
|
Other |
|
|
Consolidated |
|
||||
Purchase of property and equipment |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
17. |
Subsequent Events |
Lease Agreement
In April 2024, the Company entered into a lease arrangement to lease
22
Jiangsu Wangao Agreement
In May 2024, Gyre Pharmaceuticals entered into an agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. (the “Jiangsu Wangao Agreement”), effective from May 7, 2024 to May 6, 2035. Pursuant to the Jiangsu Wangao Agreement, Gyre Pharmaceuticals obtained the drug registration certificate for and became the marketing authorization holder of nintedanib, a kinase inhibitor for the treatment of idiopathic pulmonary fibrosis, within the PRC. The total minimum payments under the Jiangsu Wangao Agreement are RMB
23
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
In this Quarterly Report on Form 10-Q (this “Quarterly Report”), unless otherwise specified, references to “we,” “our,” “us” and “our company” refer to Gyre Therapeutics, Inc. and our majority indirectly owned subsidiary, Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd.) (“Gyre Pharmaceuticals”). The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and related notes that appear in this Quarterly Report and with the audited consolidated financial statements and related notes that are included as part of our Annual Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”).
In addition to historical information, this Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”). Forward-looking statements are identified by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially” “predict,” “should,” “will,” or the negative of these terms or similar expressions. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. For example, forward-looking statements include any statements regarding: the strategies, prospects, plans, expectations or objectives of management for future operations or the distribution of cash to Company stockholders, the benefits that may be derived from product candidates or the commercial or market opportunity in any target indication, our ability to protect intellectual property rights, our anticipated operations, financial position, revenues, costs or expenses, future economic conditions or performance, and statements of belief and any assumptions underlying any of the foregoing. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in this report in Part II, Item 1A — “Risk Factors,” and in Part I - Item 1A – “Risk Factors” in the Annual Report. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this Report, speak only as of their date, and we undertake no obligation to update or revise these statements in light of future developments. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.
Overview
We are a financially-sustainable pharmaceutical company with a record of financial success that develops and commercializes small-molecule anti-inflammatory and anti-fibrotic drugs targeting organ diseases, focusing specifically on organ fibrosis. Fibrotic diseases represent a large patient population with significant unmet medical needs. Fibrosis involves a complex, multi-stage process with multiple pathways. While there are numerous potential targets for anti-fibrotic therapy, both established and emerging, addressing a single molecular pathway may not be sufficient to prevent, halt, or reverse fibrosis.
Our strategy is to use our experience in the successful development and commercialization of ETUARY® (Pirfenidone) to expand into new indications and develop similar drug candidates. Pirfenidone, the first anti-fibrotic drug approved for idiopathic pulmonary fibrosis (“IPF”) in Japan, the European Union, the United States, and the People’s Republic of China (“PRC”), is a small molecule drug that inhibits the synthesis of Transforming Growth Factor (“TGF”)-ß1, Tumor Necrosis Factor (“TNF”)-α, and other fibrosis and inflammation modulators. We have obtained approval for ETUARY (pirfenidone) in the PRC for IPF.
Gyre Pharmaceuticals successfully advanced Pirfenidone from research and development (“R&D”) to commercialization in the PRC for the treatment of IPF. ETUARY’s annual sales have consistently grown each year, reaching $112.1 million in 2023. In addition to IPF, Pirfenidone is undergoing three additional Phase 3 clinical trials for Connective Tissue Disease-associated Interstitial Lung Disease to broaden its indications and market: sclerosis-related interstitial lung disease, dermatomyositis-related interstitial lung disease and pneumoconiosis.
F351, our lead development candidate in both the United States and the PRC, is a structural derivative of ETUARY (Pirfenidone). It is a new oral chemical entity with an anti-fibrotic, TGF-ß1-targeting mechanism of action, for which we hold patents in major markets. Studies suggest that F351 and its major metabolites have minimal drug-drug interaction risks. Despite potential efficacy in IPF, we are prioritizing F351 for the treatment of liver fibrosis due to the large potential addressable market and significant unmet need.
24
Gyre Pharmaceuticals has completed a Phase 2 trial of F351 in the PRC for Chronic Hepatitis B (“CHB”)-associated liver fibrosis. The Phase 2 trial showed that F351 was well-tolerated without notable toxicity and patients treated showed statistically-significant improvement of liver fibrosis, with the best efficacy results achieved at 270 mg/day dosing. Based on these results, a confirmatory Phase 3 trial is ongoing in the PRC with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one grade after taking F351 in combination with Entecavir. The enrollment of 248 patients for the confirmatory Phase 3 trial has been completed, with last patient out expected in 2024 and clinical results expected by early 2025.
In the United States, we have completed a Phase 1 clinical trial of F351 in healthy volunteers. We are preparing an investigational new drug (an “IND”) application and expect to submit it in late 2024. Following results from the PRC Phase 3 trial in CHB-associated liver fibrosis and pending approval of our IND, we expect to initiate a Phase 2a trial to evaluate F351 for the treatment of non-alcoholic steatohepatitis-associated liver fibrosis in 2025.
In parallel, we are also conducting a randomized, double-blind, placebo-controlled Phase 2 clinical trial in the PRC to assess the safety and efficacy of F573, a caspase inhibitor for the treatment of acute/acute on-chronic liver failure.
Business Combination Agreement
On December 26, 2022, Catalyst Biosciences, Inc., a Delaware corporation (“Catalyst”) entered into a Business Combination Agreement, as amended on March 29, 2023 and August 30, 2023 (the “Business Combination Agreement”) with GNI USA, Inc., a Delaware corporation (“GNI USA”), GNI Japan, GNI Hong Kong Limited (“GNI HK”), Shanghai Genomics, Inc., a company organized under the laws of the PRC (collectively with GNI USA, GNI Japan and GNI HK, the “Contributors,” and each a “Contributor”), certain individuals and Continent Pharmaceuticals Inc., a Cayman Islands company limited by shares (“CPI”). On October 30, 2023 (the “Effective Time”), the Contributions (as defined below) became effective and Catalyst acquired an indirect controlling interest in Gyre Pharmaceuticals.
Pursuant to the Business Combination Agreement, at the Effective Time of the Contributions:
As a result of the GNI USA Contributions, Gyre directly and indirectly holds 100% of CPI’s shares. Through Gyre’s ownership of CPI, prior to the Minority Holder Contributions, Gyre held a 56.0% indirect interest in Gyre Pharmaceuticals. Upon completion of the Minority Holder Contributions, Gyre obtained additional indirect interests in Gyre Pharmaceuticals and holds, in aggregate, a 65.2% indirect interest in Gyre Pharmaceuticals. Each share of Common Stock and option to purchase Common Stock that was issued and outstanding at the Effective Time remained issued and outstanding, and such shares and options were unaffected by the Contributions.
At the Effective Time, Gyre Pharmaceuticals terminated its 2021 Stock Incentive Plan (the “2021 Plan”) and the options (the “Gyre Pharmaceuticals Options”) outstanding under the 2021 Plan were terminated and replaced with options granted under a subplan for Chinese participants under the Gyre 2023 Omnibus Incentive Plan (the “2023 Omnibus Incentive Plan”) that are substantially similar in all material respects to the Gyre Pharmaceuticals Options previously outstanding under the 2021 Plan.
The majority shareholder of Gyre Pharmaceuticals is BJContinent Pharmaceuticals Limited (“BJC”). The immediate holding company of BJC is CPI. Immediately following the GNI USA Contributions, the immediate holding company of CPI is Gyre. The majority stockholder of Gyre is GNI USA, which is indirectly wholly owned by GNI Japan.
25
The GNI USA Contributions were treated as an asset acquisition under U.S. generally accepted accounting principles, with CPI treated as the accounting acquirer and presented as the predecessor for post-acquisition reporting purposes. Since Catalyst is the legal acquirer, the GNI USA Contributions were accounted for as a reverse asset acquisition. This determination was based upon the terms of the Business Combination Agreement and other factors including that, immediately following the GNI USA Contributions: (i) GNI USA (as the parent company of CPI immediately prior to the GNI USA Contributions) owns a substantial majority of the voting power of the combined company; (ii) GNI USA has the ability to control the board of directors of the combined company; and (iii) senior management of Gyre Pharmaceuticals and GNI USA hold a majority of the key positions in senior management of the combined company. Immediately prior to the closing of the GNI USA Contributions, Catalyst did not meet the definition of a business because Catalyst did not have an organized workforce that significantly contributed to its ability to create output, and substantially all of its fair value was concentrated in in-process research and development (“IPR&D”).
As of the closing date of the GNI USA Contributions, the net assets of Catalyst were recorded at their acquisition-date relative fair values in the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report and the reported operating results prior to the GNI USA Contributions are those of CPI.
The Minority Holder Contributions were treated as an equity transaction, where we obtained additional indirect interests in and maintained our control over Gyre Pharmaceuticals.
Contingent Value Rights Agreement
Concurrent with the signing of the Business Combination Agreement on December 26, 2022, Catalyst and the Rights Agent (as defined in the CVR Agreement) executed a contingent value rights agreement (the “CVR Agreement”), as amended on March 29, 2023, pursuant to which each CVR Holder, excluding GNI Japan and GNI HK, received one contractual contingent value right (a “CVR”) issued by the Company for each share of Catalyst common stock held by such holders. Each CVR entitles the CVR Holder thereof to receive certain cash payments in the future. For additional information, see Note 12 — Commitments and Contingencies to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report.
Private Placement and Securities Purchase Agreement
On October 27, 2023, we entered into the Securities Purchase Agreement for a private placement with GNI USA (the “Private Placement”). Pursuant to the Securities Purchase Agreement, GNI USA agreed to purchase (i) 811 shares of Convertible Preferred Stock and (ii) warrants to purchase up to 811 shares of Convertible Preferred Stock (the “Preferred Stock Warrants”) for an aggregate purchase price of $5.0 million. The Private Placement closed immediately after the closing of the Contributions.
The Preferred Stock Warrants are exercisable at an exercise price of $4,915.00 per share of Convertible Preferred Stock and expire on October 30, 2033. In January 2024, all shares of Convertible Preferred Stock were converted into Gyre common stock. The Preferred Stock Warrants issued are considered freestanding financial instruments and classified as a liability.
26
Jiangsu Wangao Agreement
In May 2024, Gyre Pharmaceuticals entered into an agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. (the “Jiangsu Wangao Agreement”), effective from May 7, 2024 to May 6, 2035. Pursuant to the Jiangsu Wangao Agreement, Gyre Pharmaceuticals obtained the drug registration certificate for and became the marketing authorization holder of nintedanib, a kinase inhibitor for the treatment of idiopathic pulmonary fibrosis, within the PRC. The total minimum payments under the Jiangsu Wangao Agreement are RMB 35.0 million, or approximately $4.8 million, based on the May 7, 2024 spot exchange rate. This includes an upfront transfer fee of RMB 15.0 million, or approximately $2.1 million, payable in three installments, and subsequent low- to mid-single-digit royalty payments over eight years following the commencement of sales. Additionally, Gyre Pharmaceuticals will bear the costs associated with relocating the production site to a designated location and will cover all expenses related to the manufacturing process.
Financial Operations Overview
During the three months ended March 31, 2024, we had net income of $9.9 million and net income attributable to common stockholders of $7.5 million. For the three months ended March 31, 2023, we had net income of $4.2 million and a net income attributable to common stockholders of $2.2 million. As of March 31, 2024, we had an accumulated deficit of $78.0 million and cash and cash equivalents of $29.8 million. As of December 31, 2023, we had an accumulated deficit of $85.5 million and cash and cash equivalents of $33.5 million.
Components of Results of Operations
Revenues
Sales of Pharmaceutical Products
We generate revenue primarily through sales of ETUARY and certain generic drugs in the PRC. Distributors are our direct customers, and sales to distributors accounted for 100.0% of the revenue from ETUARY. Such distributors sell ETUARY to certain outlets, including hospitals and other medical institutions, as well as pharmacies.
Operating Expenses
Cost of Revenue
Cost of revenue mainly consists of cost of sales representing direct and indirect costs incurred to bring the product to saleable condition. Cost of sales primarily consists of (i) raw material costs; (ii) staff costs for production employees; (iii) depreciation and amortization related to property and equipment and intangible assets used in production; (iv) taxes and surcharges; (v) transportation costs; and (vi) miscellaneous other costs.
Selling and Marketing Expenses
Selling and marketing expenses primarily relate to selling and marketing our product ETUARY in the PRC and consist of expenses incurred from hosting academic conferences, seminars and symposia; promotional expenses associated with market education on ETUARY for its use in hospitals; and staff costs primarily consisting of salaries and benefits for in-house marketing and promotion staff.
Research and Development Expenses
Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services used in research and development are initially deferred and capitalized in prepaid and other current assets. The capitalized amounts are then expensed as the related goods are delivered or services are performed, or until it is no longer expected that the goods or services will be delivered.
Research and development costs consist primarily of costs related to the pre-clinical and clinical development of our product candidates, which include payroll and other personnel-related expenses, laboratory supplies and reagents, contract research and development services for pre-clinical research and clinical trials, materials, and consulting costs, as well as allocations of facilities, depreciation and other overhead costs.
27
General and Administrative Expenses
General and administrative expenses consist of (i) accounting, IT, legal, administrative, and other internal service staff costs; (ii) stock-based compensation representing share options granted to our functional employees; (iii) professional service fees, primarily for legal and accounting services; and (iv) other miscellaneous expenses.
Other Income (Expense), Net
Interest Income, Net
Interest income consists primarily of interest earned on our certificates of deposit. Interest income is recognized on an accrual basis using the effective interest method by applying the rate that exactly discounts the estimated future cash receipts over the expected life of the financial instrument or a shorter period, when appropriate, to the net carrying amount of the financial asset.
Other Income
Other income consists mostly of government grants. Government grants are recognized at their fair value where there is reasonable assurance that the grant will be received, and all attaching conditions will be complied with. When the grant relates to an expense item, it is recognized as income on a systematic basis over the periods that the costs, for which it is intended to compensate, are expensed. Where the grant relates to an asset, the fair value is credited to a deferred income account and is released to profit or loss over the expected useful life of the relevant asset by equal annual installments or deducted from the carrying amount of the asset and released to profit or loss by way of a reduced depreciation charge.
Change in Fair Value of Warrant Liability
In connection with the Private Placement, we issued the Preferred Stock Warrants, which are freestanding financial instruments classified as warrant liability since the underlying securities are contingently redeemable upon the occurrence of events which are outside of our control. The Preferred Stock Warrants are recorded at fair value upon issuance and are subject to remeasurement at the end of each reporting period, with any change in fair value recognized in our statements of operations as other (income) expense.
Other Expenses
Other expenses consists of any non-operating costs, such as loss from equity method investments.
Provision for Income Taxes
Provision for income taxes are comprised primarily of current income tax provision, mainly attributable to the profitable Gyre Pharmaceuticals operations in the PRC, and deferred income tax provision, mainly including deferred tax recognized for temporary differences in relation to research and development tax credit and net operating loss carryforwards for U.S. tax purposes, deemed income inclusions from controlled foreign corporations for U.S. tax purposes, and fixed and intangible assets, net of valuation allowances.
28
Results of Operations
The following table summarizes our results of operations for the periods presented (in thousands, except percentage change):
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|||||||
|
|
2024 |
|
|
2023 |
|
|
Change ($) |
|
|
Change (%) |
|
||||
Revenues |
|
$ |
27,172 |
|
|
$ |
24,931 |
|
|
$ |
2,241 |
|
|
|
9 |
% |
Cost of revenues |
|
|
979 |
|
|
|
1,125 |
|
|
|
(146 |
) |
|
|
(13 |
)% |
Gross profit |
|
|
26,193 |
|
|
|
23,806 |
|
|
|
2,387 |
|
|
|
10 |
% |
Operating expenses excluding cost of revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing |
|
|
12,542 |
|
|
|
12,768 |
|
|
|
(226 |
) |
|
|
(2 |
)% |
Research and development |
|
|
2,182 |
|
|
|
2,635 |
|
|
|
(453 |
) |
|
|
(17 |
)% |
General and administrative |
|
|
3,398 |
|
|
|
1,739 |
|
|
|
1,659 |
|
|
|
95 |
% |
Total operating expenses excluding cost of revenues |
|
|
18,122 |
|
|
|
17,142 |
|
|
|
980 |
|
|
|
6 |
% |
Income from operations |
|
|
8,071 |
|
|
|
6,664 |
|
|
|
1,407 |
|
|
|
21 |
% |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income, net |
|
|
328 |
|
|
|
184 |
|
|
|
144 |
|
|
|
78 |
% |
Other income |
|
|
109 |
|
|
|
66 |
|
|
|
43 |
|
|
|
65 |
% |
Change in fair value of warrant liability |
|
|
4,288 |
|
|
|
— |
|
|
|
4,288 |
|
|
* |
|
|
Other expenses |
|
|
(315 |
) |
|
|
(643 |
) |
|
|
328 |
|
|
|
(51 |
)% |
Income before income taxes |
|
|
12,481 |
|
|
|
6,271 |
|
|
|
6,210 |
|
|
|
99 |
% |
Provision for income taxes |
|
|
(2,546 |
) |
|
|
(2,054 |
) |
|
|
(492 |
) |
|
|
24 |
% |
Net income |
|
|
9,935 |
|
|
|
4,217 |
|
|
|
5,718 |
|
|
|
136 |
% |
Net income attributable to noncontrolling interest |
|
|
2,403 |
|
|
|
1,973 |
|
|
|
430 |
|
|
|
22 |
% |
Net income attributable to common stockholders |
|
$ |
7,532 |
|
|
$ |
2,244 |
|
|
$ |
5,288 |
|
|
|
236 |
% |
*Not meaningful
Comparison of the Three Months Ended March 31, 2024 and 2023
Revenues
Revenues for the three months ended March 31, 2024 and 2023 were $27.2 million and $24.9 million, respectively. The increase was primarily due to a $2.2 million increase in pharmaceutical product sales, driven by enhanced marketing and sales initiatives in regions of the PRC where sales were previously lower in the first quarter of 2023.
Cost of Revenues
Cost of revenues for the three months ended March 31, 2024 and 2023 was $1.0 million and $1.1 million, respectively. The decrease was primarily driven by a decrease in raw material costs mainly due to the stoppage loss that occurred at the Cangzhou factory in 2023.
Selling and Marketing Expenses
Selling and marketing expenses decreased by $0.2 million, or 2%, for the three months ended March 31, 2024 compared to the three months ended March 31, 2023. The decrease was primarily driven by a $1.8 million decrease in conference costs due to a decrease in conference activity, offset by a $1.5 million increase in staff costs due to an increase in staff headcount.
29
Research and Development Expenses
The table below details our costs for research and development for the periods presented (in thousands, except percentage change):
|
|
Three Months Ended March 31, |
|
|
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
Change ($) |
|
|
Change (%) |
|
||||
Direct program expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical trials |
|
$ |
353 |
|
|
$ |
832 |
|
|
$ |
(479 |
) |
|
|
(58 |
)% |
Materials and utilities |
|
|
502 |
|
|
|
538 |
|
|
|
(36 |
) |
|
|
(7 |
)% |
Pre-clinical research |
|
|
149 |
|
|
|
255 |
|
|
|
(106 |
) |
|
|
(42 |
)% |
Indirect expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel-related costs |
|
|
976 |
|
|
|
791 |
|
|
|
185 |
|
|
|
23 |
% |
Facilities, depreciation and other |
|
|
202 |
|
|
|
219 |
|
|
|
(17 |
) |
|
|
(8 |
)% |
Total research and development expenses |
|
$ |
2,182 |
|
|
$ |
2,635 |
|
|
$ |
(453 |
) |
|
|
(17 |
)% |
Research and development expenses decreased by $0.5 million, or 17%, for the three months ended Month 31, 2024 compared to the three months ended March 31, 2023. The decrease was primarily driven by a $0.5 million decrease in clinical trials expenses, as well as by a $0.1 million decrease in pre-clinical research expenses. The latter is a result of several research and development projects advancing to the clinical trials stage or reaching the application phase in 2023. This overall decrease was partially offset by a $0.2 million increase in research and development payroll costs due to increased headcount.
General and Administrative Expenses
General and administrative expenses increased by $1.7 million, or 95%, for the three months ended March 31, 2024 compared to the three months ended March 31, 2023. The increase was primarily driven by a $1.2 million increase in payroll expenses, with $1.0 million attributable to Gyre Pharmaceuticals and $0.2 million attributable to Gyre, due to an increase in staff. Additionally, there was a $0.6 million increase in miscellaneous expenses, including $0.2 million attributable to Gyre Pharmaceuticals and $0.3 million attributable to Gyre, primarily related to general office expenses.
Other Income (Expense), Net
Interest income increased by $0.1 million, or 78%, for the three months ended March 31, 2024 compared to the three months ended March 31, 2023, primarily due to additional investments in certificates of deposit.
Change in fair value of warrant liability was $4.3 million for the three months ended March 31, 2024, and was related to the remeasurement of the Preferred Stock Warrants liability.
Other expenses decreased by $0.3 million, or 51%, for the three months ended March 31, 2024 compared to the three months ended March 31, 2023. The decrease was primarily due to a $0.3 million loss from equity method investments, recorded during the three months ended March 31, 2023, but not during the three months ended March 31, 2024, because CPI had divested nearly all of its assets except for its indirect ownership interest in Gyre Pharmaceuticals in October 2023.
Provision for Income Taxes
Provision for income taxes was $2.5 million and $2.1 million for the three months ended March 31, 2024 and 2023, respectively. The increase was primarily attributable to a higher profit from Gyre Pharmaceuticals’ operations.
Recent Accounting Pronouncements
Refer to Note 2 – Summary of Significant Accounting Policies to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for more information about recent accounting pronouncements.
30
Liquidity and Capital Resources
Sources of Liquidity
As of March 31, 2024, we had cash and cash equivalents of $29.8 million, short-term bank deposits of $7.6 million and long-term certificates of deposit of $23.1 million, which are available to fund operations, and an accumulated deficit of $78.0 million. Our net income during the three months ended March 31, 2024 was $9.9 million, while cash provided by operating activities was $2.9 million. We believe that our existing cash and cash equivalents, cash flows from operations, and access to capital markets will be sufficient to fund our operating activities and obligations for at least 12 months following the filing date of this Quarterly Report.
Future Funding Requirements
We expect to use cash flows from operations to meet our current and future financial obligations, including funding our operations, and capital expenditures. Our ability to make these payments depends on our future performance, which will be affected by financial, business, economic, regulatory, and other factors, many of which we cannot control. Factors that may affect financing requirements include, but are not limited to:
Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies.
The following table summarizes our cash flows for the periods presented (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Cash Flow Data: |
|
|
|
|
|
|
||
Net cash provided by operating activities |
|
$ |
2,884 |
|
|
$ |
10,417 |
|
Net cash used in investing activities |
|
|
(7,220 |
) |
|
|
(7,648 |
) |
Net cash provided by financing activities |
|
|
658 |
|
|
|
— |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(46 |
) |
|
|
200 |
|
Net change in cash and cash equivalents |
|
$ |
(3,724 |
) |
|
$ |
2,969 |
|
31
Cash Flows from Operating Activities
Cash provided by operating activities for the three months ended March 31, 2024 was $2.9 million, reflecting our net income of $9.9 million, offset by non-cash items of $4.3 million primarily related to the change in fair value of warrant liability of $4.3 million. Additionally, cash provided by operating activities reflected changes in net operating assets and liabilities of $2.8 million.
Cash provided by operating activities for the three months ended March 31, 2023 was $10.4 million, reflecting our net income of $4.2 million and additional positive non-cash items impact of $0.2 million. Additionally, cash provided by operating activities reflected changes in net operating assets and liabilities of $6.0 million.
Cash Flows from Investing Activities
Cash used in investing activities for the three months ended March 31, 2024 was $7.2 million, which consisted of $7.0 million in purchases of certificates of deposit and $0.2 million in purchases of property and equipment, partially offset by $0.1 million proceeds from sale of equipment.
Cash used in investing activities for the three months ended March 31, 2023 was $7.6 million, which consisted of $5.8 million in purchases of certificates of deposit and $1.7 million in purchases of property and equipment.
Cash Flows from Financing Activities
Cash provided by financing activities for the three months ended March 31, 2024 was $0.7 million due to proceeds from the exercise of stock options.
Restricted Net Assets
Under PRC laws and regulations, Gyre Pharmaceuticals is subject to restrictions on foreign exchange and cross-border cash transfers, including to parent companies and U.S. stockholders. The ability to distribute earnings to the parent companies and U.S. stockholders is also limited. Current PRC regulations permit Gyre Pharmaceuticals to pay dividends to BJC only out of its accumulated profits as determined in accordance with PRC accounting standards and regulations. Amounts restricted include paid-in capital and the statutory reserves of Gyre Pharmaceuticals. The aggregate amounts of restricted capital and statutory reserves of the relevant subsidiaries not available for distribution were $64.3 million as of March 31, 2024 and December 31, 2023. We do not expect the restrictions described above to have a material impact on our ability to meet our cash obligations.
Contractual Obligations and Other Commitments
Leases
We have entered into lease arrangements in (1) San Diego, California for our headquarters, which expires on the last day of the 38th full calendar month beginning on or after November 11, 2023, and (2) the PRC, for office and laboratory spaces through August 2024. As of March 31, 2024, our fixed lease payment obligations were $0.3 million, with $0.1 million payable within 12 months.
Other Contractual Obligations and Commitments
In June 2021, we entered into a transfer agreement with Nanjing Healthnice Pharmaceutical Technology Co., Ltd. (“Nanjing Healthnice”), an independent third party, pursuant to which Nanjing Healthnice agreed to transfer to us the avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia and all relevant technologies, complete any research or trials and transfer to us all materials necessary for the application of marketing approval by CDE. Upon the completion of the transfer, we expect that we will be approved by NMPA as the marketing authorization holder of the avatrombopag maleate tablets. In exchange, we will pay a total of approximately $2.3 million upon certain milestones (e.g., the completion of bioequivalence study, or the registration application to CDE) being met. We have completed the bioequivalence study and received CDE acceptance on August 1, 2022, and as of March 31, 2024, we have made total payments of approximately $1.8 million.
In September 2022, we entered into a transfer agreement with New Jiyuan (Beijing) Pharmaceutical Technology Co., Ltd. (“New Jiyuan”), an independent third party, pursuant to which New Jiyuan agreed to transfer to us the
32
minocycline hydrochloride foam for the treatment of moderate to severe acne and all relevant technologies, complete product development and transfer to us all materials necessary for the application of marketing approval of CDE. Upon the completion of the transfer, we expect that we will be approved by NMPA as the marketing authorization holder of the minocycline hydrochloride foam. In exchange, we will pay a total amount of $1.0 million and the payments will be made by installments conditioned upon certain milestones (e.g., the completion of bioequivalence study, or the registration application to CDE) being met. Process verification has been completed. As of March 31, 2024, we have made total payments of approximately $0.7 million.
In December 2022, we entered into a transfer agreement with Hangzhou Baicheng Pharmaceutical Technology Co., Ltd. and Zhejiang CDMO Pharmaceutical Co., Ltd., an independent third party, pursuant to which Baicheng agreed to transfer to us the acetylcysteine injection for the treatment of respiratory diseases with excessive thick mucus discharge and all relevant technologies, assist us in completing any research, trial and other required procedures and transfer to us all materials necessary for the application of marketing approval of CDE. Upon the completion of this transfer agreement, we expect that we will be approved by NMPA as the marketing authorization holder of the acetylcysteine injection. We have received CDE acceptance on January 8, 2024. As of March 31, 2024, we have made payments totaling approximately $0.5 million under this agreement. Upon receiving the CDE’s final approval, we will make an additional $40,000 in payments.
Research and Development Programs
As of March 31, 2024, we have committed to allocate $25.8 million toward future research and development activities for various programs.
Property and Equipment
Our commitments related to the purchase of property and equipment contracted but not yet reflected in the unaudited consolidated condensed financial statements were $2.0 million as of March 31, 2024 and are expected to be incurred within one year.
Critical Accounting Policies and Estimates
There have been no significant changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in our Annual Report.
Smaller Reporting Company Status
We are a “smaller reporting company” as defined in the Exchange Act. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
33
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company, as defined by Rule 12b-2 under the Securities and Exchange Act of 1934 and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of March 31, 2024, our management, with the participation and supervision of our principal executive officer and our principal financial officer, evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were effective as of March 31, 2024 to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
34
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are currently not a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors, and there can be no assurances that favorable outcomes will be obtained.
ITEM 1A. RISK FACTORS
You should carefully consider the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report, which could materially affect our business, financial position, or future results of operations. The risks described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial position, or future results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC. There have been no material changes from the risk factors disclosed in Part I, Item 1A, “Risk Factors” in our Annual Report.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Trading Arrangements
None of our directors or executive officers
35
ITEM 6. EXHIBITS
The exhibits filed or furnished as part of this Quarterly Report are set forth below.
Exhibit Number |
|
Exhibit Title |
Form |
File No. |
Incorporated by reference Exhibit No. |
Filing Date |
|
|
|
|
|
|
|
2.1(a)†# |
|
8-K |
000-51173 |
2.1 |
Dec. 27, 2022 |
|
|
|
|
|
|
|
|
2.1(b) |
|
8-K |
000-51173 |
2.2 |
Mar. 30, 2023 |
|
|
|
|
|
|
|
|
2.2(a)# |
|
8-K |
000-51173 |
2.2 |
Dec. 27, 2022 |
|
|
|
|
|
|
|
|
2.2(b) |
|
8-K |
000-51173 |
2.1 |
Mar. 30, 2023 |
|
|
|
|
|
|
|
|
2.2(c) |
|
8-K |
000-51173 |
2.1 |
Aug. 31, 2023 |
|
|
|
|
|
|
|
|
3.1 |
|
Fourth Amended and Restated Certificate of Incorporation of the Company. |
S-8 |
333-133881 |
4.1 |
May 8, 2006 |
|
|
|
|
|
|
|
3.2 |
|
8-K |
000-51173 |
3.1 |
Aug. 20, 2015 |
|
|
|
|
|
|
|
|
3.3 |
|
8-K |
000-51173 |
3.1 |
Feb. 10, 2017 |
|
|
|
|
|
|
|
|
36
3.4 |
|
8-K |
000-51173 |
3.1 |
Oct. 30, 2023 |
|
|
|
|
|
|
|
|
3.5 |
|
8-K |
000-51173 |
3.3 |
Oct. 30, 2023 |
|
|
|
|
|
|
|
|
3.6(a) |
|
10-Q |
000-51173 |
3.1 |
Aug. 3, 2017 |
|
|
|
|
|
|
|
|
3.6(b) |
|
10-K |
000-51173 |
3.6(b) |
Mar. 27, 2024 |
|
|
|
|
|
|
|
|
3.7(a) |
|
8-K |
000-51173 |
3.1 |
Dec. 27, 2022 |
|
|
|
|
|
|
|
|
3.7(b) |
|
8-K |
000-51173 |
3.2 |
Oct. 30, 2023 |
|
|
|
|
|
|
|
|
3.8(a) |
|
8-K |
000-51173 |
3.1 |
June 20, 2023 |
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3.8(b) |
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8-K |
000-51173 |
3.1 |
Aug. 31, 2023 |
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4.1 |
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10-K |
000-51173 |
4.4 |
Mar. 9, 2016 |
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4.2 |
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10-K |
000-51173 |
4.6 |
Mar. 9, 2016 |
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4.3 |
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Form of Warrant to Purchase Series X Convertible Preferred Stock. |
8-K |
000-51173 |
4.1 |
Oct. 30, 2023 |
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31.1* |
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37
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pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2* |
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32.1** |
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32.2** |
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101.INS* |
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Inline XBRL (extensible Business Reporting Language) Instance Document |
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101.SCH* |
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Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Document |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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* Filed herewith.
** Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act.
† The annexes, schedules, and certain exhibits to this Exhibit have been omitted pursuant to Item 601(a)(5).
# Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) the Company customarily and actually treats that information as private or confidential and (ii) the information was not material.
38
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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GYRE THERAPEUTICS, INC. |
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Date: May 13, 2024 |
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/s/ Han Ying, Ph.D. |
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Han Ying, Ph.D. |
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Chief Executive Officer |
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(Principal Executive Officer) |
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Date: May 13, 2024 |
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/s/ Ruoyu Chen |
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Ruoyu Chen |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
39
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a) AND 15d-14(a) OF THE SECURITIES EXCHANGE ACT
OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Han Ying, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Gyre Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 13, 2024 |
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/s/ Han Ying, Ph.D. |
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Han Ying, Ph.D. Chief Executive Officer and Director (Principal Executive Officer) |
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Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a) AND 15d-14(a) OF THE SECURITIES EXCHANGE ACT
OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Ruoyu Chen, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Gyre Therapeutics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 13, 2024 |
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/s/ Ruoyu Chen |
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Ruoyu Chen Chief Financial Officer (Principal Financial and Accounting Officer) |
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Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Gyre Therapeutics, Inc. (the “Company”) for the period ended March 31, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Han Ying, hereby certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: May 13, 2024 |
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/s/ Han Ying, Ph.D. |
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Han Ying, Ph.D. |
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Chief Executive Officer and Director (Principal Executive Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Note: A signed original of this written statement required by § 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Gyre Therapeutics, Inc. (the “Company”) for the period ended March 31, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Ruoyu Chen, hereby certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: May 13, 2024 |
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/s/ Ruoyu Chen |
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Ruoyu Chen |
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Chief Financial Officer (Principal Financial and Accounting Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Note: A signed original of this written statement required by § 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.