– Achieved $5.8 Million in Total Revenue in the Fourth Quarter of 2021, Including $4.4 Million in Net Revenue from Sales of COSELA™ (trilaciclib) –
– Completed Hiring, Training, and Deployment of G1’s COSELA Sales Team –
– Announced That Initial Results from Phase 3 Trial of Trilaciclib in Colorectal Cancer (PRESERVE 1) Are Now Expected Early in the First Quarter of 2023 –
– Initiated Two New Phase 2 Trials to Confirm the Immune-Based Mechanism of Action (MOA) of Trilaciclib and to Help Clarify the Potential Synergistic Effects of Trilaciclib and an Antibody-Drug Conjugate (ADC) –
– Management to Host Webcast and Conference Call today at 8:30 AM ET –
RESEARCH TRIANGLE PARK, N.C., Feb. 23, 2022 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the fourth quarter and full year ended December 31, 2021.
“2021 was an important foundational year for G1; but I expect 2022 to be a year of strong execution across the Company and value creation for our shareholders and the people living with cancer we seek to serve,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “I’m very excited with the quality and experience of the members of our new COSELA sales team, who are already hired and fully deployed across the U.S., leveraging our exceptional reimbursement coverage, working to convert high intention-to-use into actual usage and uptake by promoting COSELA with prescribing oncologists and fostering clinical advocacy – all with the goal of rapidly improving COSELA usage and adoption in 2022. Further, we expect to provide initial results from three clinical trials in the second half of this year, including the ADC combination, MOA, and bladder cancer Phase 2 trials, with pivotal colorectal cancer trial data expected soon thereafter, early in the first quarter of 2023. We remain confident in the potential for COSELA in its first indication and, as our pipeline evolves, look forward to delivering on our goal of improving the lives of as many people living with cancer as possible.”
Fourth Quarter 2021 and Recent Highlights
Financial
Commercial
Clinical
Medical
Fourth Quarter and Full Year 2021 Financial Results
As of December 31, 2021, cash and cash equivalents totaled $221.2 million, compared to $207.3 million as of December 31, 2020. On November 1, 2021, G1 and Hercules Capital amended Hercules’ loan terms to provide total commitments of $150.0 million, of which $100.0 million was fully available as of amendment closing. To date, G1 has drawn $75.0 million on this facility. An additional $25.0 million of debt facility is currently available but not yet drawn.
Total revenues for the fourth quarter of 2021 were $5.8 million, including $4.4 million in net product sales of COSELA and license revenue of $1.4 million. This license revenue is primarily related to clinical trial reimbursements from EQRx and Simcere. Total revenues for the full-year 2021 were $31.5 million, consisting of license revenue of $20.4 million and net product revenue of $11.1 million from sales of COSELA.
Operating expenses for the fourth quarter of 2021 were $43.4 million, compared to $40.6 million for the fourth quarter of 2020. GAAP operating expenses include stock-based compensation expense of $5.2 million for the fourth quarter of 2021, compared to $4.8 million for the fourth quarter of 2020. Operating expenses for the full-year 2021 were $173.9 million, compared to $141.8 million for the prior year. Stock-based compensation expense for the full-year 2021 was $22.3 million, compared to $18.8 million for the prior year.
Cost of goods sold expense for the fourth quarter of 2021 were $0.4 million compared to $0 for the fourth quarter of 2020. The increase is related to the Company’s period costs for the sales of COSELA, including third-party logistics costs for the sales of COSELA, inventory overhead costs, and personnel costs. Cost of goods sold expense for the full-year 2021 were $2.0 million.
Research and development (R&D) expenses for the fourth quarter of 2021 were $19.8 million, compared to $16.4 million for the fourth quarter of 2020. The increase in R&D expenses was primarily due to an increase in clinical trial spend, which is partially offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug product to support clinical trials. R&D expenses for the full-year 2021 were $76.2 million, compared to $73.3 million for the prior year.
Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2021 were $23.2 million, compared to $24.3 million for the fourth quarter of 2020. The decrease in SG&A expenses was largely due to a decrease in spend on commercialization activities and medical affairs, partially offset by an increase in personnel costs due to increases in headcount. SG&A expenses for the full-year 2021 were $95.7 million, compared to $68.5 million for the prior year.
The net loss for the fourth quarter of 2021 was $40.0 million, compared to $25.3 million for the fourth quarter of 2020. Net loss for the full-year 2021 was $148.4 million, compared to a net loss of $99.3 million for the prior year. The basic and diluted net loss per share for the fourth quarter of 2021 was $(0.94) compared to $(0.67) for the fourth quarter of 2020. The basic and diluted net loss per share for the full-year 2021 was $(3.54) compared to $(2.62) for the full-year 2020.
Financial Guidance
G1 also expects its current financial position to be sufficient to fund its operations and capital expenditures into 2024.
Webcast and Conference Call
G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the fourth quarter and full year 2021 ended December 31, 2021. The live call may be accessed by dialing (866) 763-6020 (domestic) or (409) 216-0626 (international) and entering the conference code: 5256086. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.
About COSELA™ (trilaciclib) for Injection
COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.
Indication
COSELA™ (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating trilaciclib in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.
G1 Therapeutics™ and the G1 Therapeutics logo and COSELA™ and the COSELA logo are trademarks of G1 Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to expectations for the commercial launch of COSELA (trilaciclib), the therapeutic potential of COSELA (trilaciclib), our ability to generate data to maximize trilaciclib’s applicability to future treatment paradigms, and our reliance on partners to develop licensed products. In addition, COSELA (trilaciclib) may fail to achieve the degree of market acceptance for commercial success, and the impact of pandemics such as COVID-19 (coronavirus), are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete a successful commercial launch for COSELA (trilaciclib); the company’s ability to complete clinical trials for, obtain approvals for and commercialize additional indications of COSELA and any of its product candidates other than COSELA (trilaciclib); the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
G1 Therapeutics Contacts:
Jen Moses
Chief Financial Officer
919-930-8506
jmoses@g1therapeutics.com
Will Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com
Rebecca Levine
Director, Corporate Communications and Public Relations
(919) 667-8711
rlevine@g1therapeutics.com
G1 Therapeutics, Inc.
Balance Sheet Data
(in thousands)
December 31, |
December 31, | ||||||
2021 | 2020 | ||||||
Cash and cash equivalents | $ | 221,186 | $ | 207,306 | |||
Working capital | $ | 215,952 | $ | 192,949 | |||
Total assets | $ | 254,094 | $ | 228,552 | |||
Accumulated deficit | $ | (584,459 | ) | $ | (436,107 | ) | |
Total stockholders’ equity | $ | 143,541 | $ | 177,351 | |||
G1 Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
Three months ended December 31, | Twelve months ended December 31, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues: | |||||||||||||||
Product sales, net | $ | 4,403 | $ | – | $ | 11,120 | $ | – | |||||||
License revenue | 1,393 | 16,546 | 20,356 | 45,285 | |||||||||||
Total revenues | 5,796 | 16,546 | 31,476 | 45,285 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of goods sold | 374 | – | 2,016 | – | |||||||||||
Research and development | 19,790 | 16,374 | 76,225 | 73,271 | |||||||||||
Selling, general and administrative | 23,218 | 24,260 | 95,692 | 68,490 | |||||||||||
Total operating expenses | 43,382 | 40,634 | 173,933 | 141,761 | |||||||||||
Loss from operations | (37,586 | ) | (24,088 | ) | (142,457 | ) | (96,476 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 8 | 30 | 43 | 952 | |||||||||||
Interest expense | (2,058 | ) | (756 | ) | (4,667 | ) | (1,778 | ) | |||||||
Other income (expense) | (138 | ) | (54 | ) | (346 | ) | (542 | ) | |||||||
Total other income (expense), net | (2,188 | ) | (780 | ) | (4,970 | ) | (1,368 | ) | |||||||
Loss before income taxes | (39,774 | ) | (24,868 | ) | (147,427 | ) | (97,844 | ) | |||||||
Income tax expense | 246 | 479 | 925 | 1,410 | |||||||||||
Net loss | $ | (40,020 | ) | $ | (25,347 | ) | $ | (148,352 | ) | $ | (99,254 | ) | |||
Net loss per share, basic and diluted | $ | (0.94 | ) | $ | (0.67 | ) | $ | (3.54 | ) | $ | (2.62 | ) | |||
Weighted average common shares outstanding, basic and diluted | 42,544,321 | 38,053,609 | 41,943,417 | 37,878,026 | |||||||||||
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