Roivant Sciences(US:ROIV)2021-09-21 21:27Financial Performance - Revenue for the three months ended June 30, 2021, was $7,735 thousand, compared to $1,576 thousand for the same period in 2020, representing a year-over-year increase of approximately 389%[30] - Net loss attributable to Roivant Sciences Ltd. for the three months ended June 30, 2021, was $82,183 thousand, compared to a net loss of $3,243 thousand for the same period in 2020, indicating a significant increase in losses[30] - Comprehensive loss for the three months ended June 30, 2021, was $103,517 thousand, compared to $8,797 thousand for the same period in 2020, reflecting a substantial increase in comprehensive losses[32] - For the three months ended June 30, 2021, the company reported a net loss of $101.1 million, compared to a net loss of $8.0 million for the same period in 2020, indicating a significant increase in losses[44] - Net loss for the three months ended June 30, 2021, was $101.1 million, compared to a net loss of $8.0 million for the same period in 2020, indicating an increase of $93.1 million[178] Assets and Liabilities - Total current assets decreased from $2,186,995 thousand as of March 31, 2021, to $2,057,609 thousand as of June 30, 2021, a decline of approximately 5.9%[27] - Total liabilities decreased from $527,687 thousand as of March 31, 2021, to $474,865 thousand as of June 30, 2021, a reduction of approximately 10%[27] - Shareholders' equity attributable to Roivant Sciences Ltd. decreased from $1,797,788 thousand as of March 31, 2021, to $1,723,122 thousand as of June 30, 2021, a decline of about 4.1%[27] - Cash and cash equivalents decreased from $2,055,044 thousand as of March 31, 2021, to $1,996,733 thousand as of June 30, 2021, a decrease of about 2.8%[27] - The company had cash and cash equivalents of approximately $2.0 billion as of June 30, 2021, with an accumulated deficit of approximately $2.0 billion[44] Operating Expenses - Research and development expenses increased to $78,626 thousand for the three months ended June 30, 2021, up from $58,734 thousand in the same period of 2020, an increase of about 33.9%[30] - General and administrative expenses increased by $25.6 million to $82.8 million for the three months ended June 30, 2021, compared to $57.1 million for the same period in 2020, mainly due to higher professional fees and personnel-related expenses[183] - Total operating expenses increased by $46.1 million to $162.1 million for the three months ended June 30, 2021, compared to $116.0 million for the same period in 2020[178] Cash Flow - Net cash used in operating activities for the three months ended June 30, 2021, was $141.2 million, compared to $111.2 million for the same period in 2020[44] - Cash flows from investing activities resulted in a net cash outflow of $2.3 million for the three months ended June 30, 2021, compared to a net cash outflow of $25.6 million in the same period in 2020[44] - The company reported net cash provided by financing activities of $10.2 million for the three months ended June 30, 2021, compared to $181.1 million in the same period in 2020[44] Future Expectations - The company expects to incur additional losses in the future to fund operations and product research and development, recognizing the need to raise additional capital[45] - The company intends to raise additional capital through the issuance of equity securities, debt financings, or other sources to implement its business plan[45] - The company expects its existing cash and cash equivalents to be sufficient to fund its committed operating expenses and capital expenditure requirements for at least the next 12 months[45] - The company expects to continue incurring significant operating losses for the foreseeable future and does not anticipate generating product revenue until successful development and regulatory approval of product candidates[194] Investments and Fair Value - The fair value of the Company's investment in Arbutus was $117.7 million as of June 30, 2021, down from $129.4 million as of March 31, 2021, reflecting an unrealized loss of $11.7 million[76] - The fair value of the Company's investment in Sio was $50.7 million as of June 30, 2021, an increase from $48.5 million as of March 31, 2021, with unrealized gains of $2.2 million recognized[78] - The fair value of the Company's additional equity investment was $11.9 million as of June 30, 2021, compared to $11.1 million as of March 31, 2021[79] - The fair value of Level 3 liabilities decreased to $161.1 million as of June 30, 2021, from $217.99 million as of March 31, 2021, reflecting changes in fair value of debt and liability instruments[128] Research and Development - The company has a pipeline of over 30 drug candidates, ranging from early discovery to registration[143] - Research and development expenses are expected to increase as the company advances its product candidates through clinical trials[163] - The company is pursuing the funding of preclinical studies and clinical trials for its product candidates, as well as the manufacturing of drug substances[196] Share-Based Compensation - The company incurred share-based compensation of $19.3 million for the three months ended June 30, 2021, up from $14.3 million in the same period in 2020[44] - Share-based compensation expense related to stock options was approximately $10.3 million for the three months ended June 30, 2021, compared to $7.8 million for the same period in 2020[102] - Share-based compensation expense for the three months ended June 30, 2021, totaled $19.3 million, up from $14.3 million in the same period in 2020, representing a 35% increase[115] Market and Regulatory Developments - The FDA has assigned a PDUFA target action date in the second calendar quarter of 2022 for the NDA filing of Tapinarof for psoriasis[154] - Dermavant entered into a $160.0 million revenue interest purchase and sale agreement for its investigational product tapinarof, conditional on FDA approval[96] - The company has a $3 billion upfront partnership with Sumitomo Dainippon Pharma Co., Ltd.[143]