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Chimerix(CMRX) - 2022 Q3 - Quarterly Report

Financial Performance - Total revenue for the nine months ended September 30, 2022, increased to $33.0 million, up from $1.9 million for the same period in 2021, primarily due to international TEMBEXA procurement agreements[168]. - The company recognized $31.9 million in procurement revenue for the nine months ended September 30, 2022, with contract and grant revenue decreasing by 73.9% to $503,000[167]. - The gross profit for the nine months ended September 30, 2022, was $32.6 million, compared to $1.9 million in the same period in 2021, reflecting a significant increase of 1,584.6%[167]. - Operating expenses decreased by 49.1% to $69.1 million for the nine months ended September 30, 2022, compared to $135.8 million for the same period in 2021[167]. - The company reported a net income of $193.1 million for the nine months ended September 30, 2022, compared to a net loss of $133.7 million for the same period in 2021, marking a change of 244.4%[167]. - Total revenues for the three months ended September 30, 2022, reached $32.6 million, a significant increase from $0.1 million for the same period in 2021, primarily due to international TEMBEXA procurement agreements[179]. - The company reported a net income of $241.4 million for the three months ended September 30, 2022, compared to a net loss of $18.6 million for the same period in 2021[179]. Research and Development - Research and development expenses for the nine months ended September 30, 2022, were $52.4 million, an increase of $12.9 million compared to $39.5 million for the same period in 2021[170]. - Research and development expenses included a $15.6 million increase related to ONC201 research and development expenses for the nine months ended September 30, 2022[170]. - Research and development expenses increased to $15.3 million for the three months ended September 30, 2022, compared to $13.8 million for the same period in 2021, reflecting a $1.4 million increase[180]. - The company expects to incur significant research and development expenses as it continues to develop Oncoceutics' lead compound, ONC201, for U.S. regulatory approval[156]. - The ACTION Study for ONC201 aims to enroll 450 patients and is expected to begin site activation in November 2023[130]. - A 50-patient analysis of ONC201 showed an overall response rate of 20% and a median duration of response of 11.2 months[135]. - ONC206 is currently in Phase I dose escalation trials, targeting solid tumors and demonstrating anti-cancer activity in pre-clinical models[136]. Revenue Streams - Chimerix received an upfront cash payment of approximately $238 million from Emergent BioSolutions upon closing the Asset Sale[142]. - The company is eligible for up to approximately $124 million in milestone payments under the BARDA Agreement[142]. - Chimerix can earn a 20% royalty on gross profits from TEMBEXA sales in the U.S. exceeding 1.7 million treatment courses[124]. - The company also expects to receive a 15% royalty on gross profits from TEMBEXA sales outside the U.S.[124]. - A Supply Agreement was established with a third party for TEMBEXA treatment courses, generating approximately $9.3 million in revenue[127]. - The Public Health Agency of Canada awarded a contract valued at approximately CAD $33.0 million ($25.3 million) for TEMBEXA, resulting in $22.6 million of revenue[128]. - The company recorded a net gain of $229.7 million on the sale of exclusive worldwide rights to brincidofovir, including TEMBEXA, for the nine months ended September 30, 2022[176]. Expenses and Liabilities - The company incurred $2.3 million in accounts payable and contract close-out accruals related to the discontinued DSTAT program as of September 30, 2022[157]. - Share-based compensation expense recognized was $3.8 million for the three months ended September 30, 2022, compared to $3.4 million for the same period in 2021[161]. - General and administrative expenses increased to $16.8 million for the nine months ended September 30, 2022, up from $13.4 million in the same period of 2021, representing a $3.4 million increase[173]. - Total operating expenses for the three months ended September 30, 2022, were $20.6 million, an increase from $18.7 million in the same period of 2021, marking a 10.0% increase[178]. Cash Flow and Financial Position - Net cash used in operating activities was $26.9 million for the nine months ended September 30, 2022, a decrease from $65.9 million in the same period of 2021[193]. - The company had approximately $284.6 million available to fund operations as of September 30, 2022, despite an accumulated deficit of $692.5 million[185]. - Net cash provided by investing activities was $298.4 million for the nine months ended September 30, 2022, primarily due to proceeds from the sale of TEMBEXA[195]. - Net cash used by financing activities was $12.7 million for the nine months ended September 30, 2022, primarily due to a $14.0 million payment related to the Oncoceutics acquisition[196]. - The company had net cash provided by financing activities of $112.4 million for the nine months ended September 30, 2021, mainly from $107.8 million in proceeds from the issuance of common stock[196]. Market and Economic Factors - The company does not expect significant effects on operating results or cash flows from a sudden change in market interest rates due to the short-term duration of its investment portfolio[202]. - Inflation has not had a material effect on the company's results of operations for the three and nine months ended September 30, 2022, or September 30, 2021[204]. - The company could be required to pay up to an aggregate of $340.0 million in remaining milestone payments to former Oncoceutics securityholders, contingent upon achieving specified milestones[200]. - The company is required to purchase an additional $2.4 million of DSTAT active pharmaceutical ingredient by December 31, 2023, unless the contract is terminated earlier[199].