Roivant Sciences(ROIV)
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Roivant Sciences(ROIV) - 2021 Q4 - Earnings Call Transcript
2022-06-28 17:38
Financial Data and Key Metrics Changes - As of March 31, 2022, the company reported $2.1 billion in cash and cash equivalents, with a net loss of $291 million for the quarter and an adjusted net loss of $188 million [71][72]. - Research and development expenses were $135 million, while general and administrative expenses were $139 million [71]. Business Line Data and Key Metrics Changes - The commercial launch of VTAMA Cream is ongoing, with strong early prescriptions recorded, although it is still early to forecast its long-term performance [11][12]. - The company has deprioritized certain programs, notably Aruvant in sickle cell disease, to focus on differentiated offerings [14]. Market Data and Key Metrics Changes - The company is focusing on the autoimmune disease market, particularly with the introduction of Priovant, which is developing a dual selective inhibitor of TYK2 and JAK1 [21][27]. - The market opportunity for VTAMA in atopic dermatitis is expected to be significant, with the potential for blockbuster status in multiple indications [11][114]. Company Strategy and Development Direction - The company aims to operate from a strong capital position, maintaining over two years of runway and focusing on cost optimization and portfolio prioritization [13][14]. - The partnership with Pfizer for Priovant is seen as a strategic move to leverage Pfizer's expertise while allowing Roivant to focus on unique indications [82][86]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early demand for VTAMA and the potential for it to become a blockbuster in multiple indications [79][114]. - The company is aware of the high clinical bar for therapies in sickle cell disease and has made the decision to wind down that program to allocate resources more effectively [102][106]. Other Important Information - The company has multiple strategic partnerships that validate its discovery pipeline, including collaborations with Janssen and Blueprint [67]. - Ongoing litigation regarding Genevant's IP portfolio is being monitored, with updates expected as the situation develops [68][70]. Q&A Session Summary Question: Can you discuss the decision for Pfizer to out-license assets to Priovant? - Management indicated that Pfizer remains excited about the program and continues to invest in the Lupus trial alongside Roivant, suggesting a strong partnership dynamic [82][83]. Question: How are script volumes for VTAMA tracking? - Management reported being pleased with early demand and physician feedback, although it is still too early to draw definitive conclusions [79][80]. Question: What factors led to the wind down of the sickle cell program? - The decision was influenced by the high clinical bar for curative therapies in sickle cell disease and the need to allocate resources effectively in the current environment [102][106]. Question: Can you elaborate on the initial physician feedback on the VTAMA label? - Initial feedback has been positive, with excitement and enthusiasm noted among prescribers regarding the label [107]. Question: What is the market opportunity for batoclimab in myasthenia gravis? - Management views the market as large and interesting, with a differentiated development strategy that could provide a competitive edge [110][116]. Question: How does the company view the potential for tapinarof in psoriasis and atopic dermatitis? - The company is optimistic about the readout in atopic dermatitis, supported by compelling Phase II data [113][114]. Question: How does the company approach cash runway and resource allocation? - The company maintains over two years of runway and has flexibility in resource allocation due to a broad portfolio [117].
Roivant Sciences(ROIV) - 2022 Q4 - Annual Report
2022-06-28 11:58
Washington, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40782 ROIVANT SCIENCES LTD. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of in ...
Roivant Sciences(ROIV) - 2022 Q3 - Quarterly Report
2022-02-14 12:27
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40782 ROIVANT SCIENCES LTD. (Exact name of Registrant as specified in its Charter) Bermuda 98-1173944 (State or other jurisdiction of incorp ...
Roivant Sciences (ROIV) Presents At B. Riley Securities Virtual Oncology Conference - Slideshow
2022-01-28 22:59
ROIVANT SCIENCES Oncology Overview January 2022 of Forward-Looking Statements Forward–Looking Statements and Disclaimer This presentation will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies rega ...
Roivant Sciences (ROIV) Presents At 40th Annual J.P. Morgan Virtual Healthcare Conference
2022-01-24 17:06
ROIVANT SCIENCES Overview January 2022 O Forward-Looking Statements Forward–Looking Statements and Disclaimer This presentation will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the ...
Roivant Sciences(ROIV) - 2021 Q2 - Earnings Call Transcript
2021-11-15 18:46
Roivant Sciences Ltd. (NASDAQ:ROIV) Q2 2021 Earnings Conference Call November 15, 2021 8:00 AM ET Company Participants Paul Davis – Head of Communications Matthew Gline – Chief Executive Officer Richard Pulik – Chief Financial Officer Frank Torti – Vant Chair Eric Venker – President and Chief Operating Officer Mayukh Sukhatme – President and Chief Investment Officer Todd Zavodnick – Chief Executive Officer, Dermavant Conference Call Participants Robyn Karnauskas – Truist Securities Douglas Tsao – H.C. Wainw ...
Roivant Sciences(ROIV) - 2021 Q2 - Earnings Call Presentation
2021-11-15 13:33
Financial Results and Business Update for the Quarter Ended September 30, 2021 November 15, 2021 Forward-Looking Statements and Non-GAAP Financial Information Forward–Looking Statements Our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Our forward-looking statements include, but are not limited to, statements regard ...
Roivant Sciences(ROIV) - 2022 Q2 - Quarterly Report
2021-11-15 12:24
FORM 10-Q (Mark One) Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40782 ROIVANT SCIENCES LTD. (Exact name of Registrant as specified in its Charter) Bermuda 98-1173944 (State or other jurisdiction of incor ...
Roivant Sciences(ROIV) - 2022 Q1 - Quarterly Report
2021-09-21 21:27
Financial 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]