Revance(RVNC) - 2022 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the period Item 1. Condensed Consolidated Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining significant accounting policies, revenue recognition, financial instruments, debt, equity, commitments, contingencies, and segment information for the period ended March 31, 2022 Condensed Consolidated Balance Sheets This section presents the company's financial position, detailing assets, liabilities, and equity at specific reporting dates | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Total Assets | $639,546 | $531,163 | | Total Liabilities | $614,005 | $462,692 | | Total Stockholders' Equity | $25,541 | $68,471 | | Cash and cash equivalents | $198,359 | $110,623 | | Short-term investments | $64,231 | $114,448 | | Total current assets | $285,330 | $246,117 | | Total current liabilities | $71,066 | $67,289 | Condensed Consolidated Statements of Operations and Comprehensive Loss This section outlines the company's revenues, expenses, and net loss over the reporting periods | Metric | 3 Months Ended March 31, 2022 (in thousands) | 3 Months Ended March 31, 2021 (in thousands) | Change (in thousands) | % Change | | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------- | :------- | | Total Revenue | $25,261 | $13,299 | $11,962 | 90.0% | | Product revenue | $20,837 | $11,647 | $9,190 | 78.9% | | Collaboration revenue | $3,568 | $1,511 | $2,057 | 136.1% | | Service revenue | $856 | $141 | $715 | 507.1% | | Total operating expenses | $87,482 | $83,311 | $4,171 | 5.0% | | Loss from operations | $(62,221) | $(70,012) | $7,791 | (11.1)% | | Net loss | $(64,342) | $(71,639) | $7,297 | (10.2)% | | Basic and diluted net loss per share | $(0.94) | $(1.08) | $0.14 | (13.0)% | Condensed Consolidated Statements of Stockholders' Equity This section details changes in the company's equity, including additional paid-in capital and accumulated deficit | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Total Stockholders' Equity | $25,541 | $68,471 | | Additional paid-in capital | $1,487,822 | $1,466,369 | | Accumulated deficit | $(1,462,294) | $(1,397,952) | Condensed Consolidated Statements of Cash Flows This section summarizes the cash inflows and outflows from operating, investing, and financing activities | Metric | 3 Months Ended March 31, 2022 (in thousands) | 3 Months Ended March 31, 2021 (in thousands) | | :------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Net cash used in operating activities | $(61,270) | $(74,755) | | Net cash provided by (used in) investing activities | $44,568 | $(38,420) | | Net cash provided by financing activities | $105,313 | $29,044 | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $88,611 | $(84,131) | Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements - The company incurred a net loss of $64.3 million for the three months ended March 31, 2022, and has an accumulated deficit of $1.5 billion, raising substantial doubt about its ability to continue as a going concern[21][22] - The FDA issued a Complete Response Letter (CRL) for DaxibotulinumtoxinA for Injection BLA due to manufacturing facility deficiencies, delaying commercial launch[22] - To mitigate going concern doubt, the company needs to execute its commercial strategy for RHA® Collection, obtain FDA approval for DaxibotulinumtoxinA for Injection to draw on the Second Tranche of debt, and raise additional capital[25] 1. The Company and Summary of Significant Accounting Policies This note describes the company's business and outlines its significant accounting policies - Revance is a commercial-stage biotechnology company focused on DaxibotulinumtoxinA for Injection, RHA® Collection of dermal fillers, and the OPUL™ Relational Commerce Platform[20] - The company reported a net loss of $64.3 million for the three months ended March 31, 2022, and an accumulated deficit of $1.5 billion[21] - The FDA issued a Complete Response Letter (CRL) for DaxibotulinumtoxinA for Injection BLA due to manufacturing facility deficiencies, leading to a delay in commercial launch and raising substantial doubt about the company's ability to continue as a going concern. The BLA was resubmitted in March 2022 and accepted as a Class 2 resubmission with a PDUFA date of September 8, 2022, requiring a reinspection[22][33] 2. Revenue This note details the company's revenue recognition policies and disaggregates revenue by type | Revenue Type | 3 Months Ended March 31, 2022 (in thousands) | 3 Months Ended March 31, 2021 (in thousands) | | :-------------------- | :------------------------------------------ | :------------------------------------------ | | Product Revenue | $20,837 | $11,647 | | Collaboration Revenue | $3,568 | $1,511 | | Service Revenue | $856 | $141 | | Total Revenue | $25,261 | $13,299 | - All product revenue was generated from the sale of the RHA® Collection of dermal fillers[43] - Collaboration revenue increased due to increased development activities for the onabotulinumtoxinA biosimilar program with Viatris[51] - Service revenue increased primarily due to the commercial launch of OPUL™ in October 2021 and a change to gross accounting presentation of revenue[58] 3. Cash Equivalents and Short-Term Investments This note provides a breakdown of cash equivalents and short-term investments by category and fair value | Category | March 31, 2022 (Fair Value, in thousands) | December 31, 2021 (Fair Value, in thousands) | | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Money market funds | $166,585 | $90,355 | | Commercial paper | $34,464 | $87,964 | | U.S. treasury securities | $16,021 | $0 | | Corporate bonds | $13,746 | $26,484 | | Total cash equivalents and available-for-sale securities | $230,816 | $204,803 | 4. Intangible Assets, net This note presents the net carrying amount of intangible assets and related amortization expense | Category | March 31, 2022 (Net Carrying Amount, in thousands) | December 31, 2021 (Net Carrying Amount, in thousands) | Weighted Average Remaining Useful Lives (in years) | | :---------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Distribution rights | $17,514 | $19,535 | 2.2 | | Developed technology | $27,656 | $29,147 | 4.6 | | Customer relationships | $6,008 | $6,652 | 2.3 |