{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-020146","form_type":"8-K","ticker":"KYNB","cik":"0000921299","company_name":"KYNTRA BIO, INC.","filed_at":"2024-02-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:27.299969+00:00","generated_at":"2026-06-05T16:21:30.095617+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FibroGen FY23 rev $147.8M (+5% YoY), net loss $284.2M; guides China roxadustat $300-340M","bullets":["Full year 2023 total revenue $147.8M, up 5% YoY; net loss $284.2M ($2.92 per share), narrower than $293.7M loss in 2022.","Roxadustat net sales in China (FibroGen share) $100.9M in FY23, up 22% YoY; total China sales including JDE $284.1M (+36% YoY) driven by 41% volume growth.","Cash and equivalents $248.1M, with runway into 2026 after $120M annual cost reduction.","Pipeline: topline data from two pamrevlumab pancreatic cancer trials expected in 2Q 2024; Phase 1 FG-3246 data in mCRPC in 1Q 2024.","Guidance: FY 2024 FibroGen net product revenue $120-135M; total roxadustat China sales $300-340M; potential CIA approval in China mid-2024 with $10M milestone."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-020146","json":"https://secwatch.observer/filing/0000950170-24-020146.json","markdown":"https://secwatch.observer/filing/0000950170-24-020146.md","text":"https://secwatch.observer/filing/0000950170-24-020146.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/921299/000095017024020146/0000950170-24-020146-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/921299/000095017024020146/fgen-20240226.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T16:21:30.095617+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[{"claim_id":"6b43732dafbc05cd724b679160c1e5fae8eb50ae","claim":"KYNTRA BIO, INC. reported year ended December 31, 2023 results: revenue $147.8 million, net income Net loss for the year was $284.2 million, or $2.92 net loss per basic and diluted share, EPS $2.92 net loss per basic and diluted share.","evidence_excerpt":"2024 • FibroGen regains rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea • FY 2023 total net revenue of $147.8 million, an increase of 5% year over year • Robust roxadustat volume growth of 41% in China in FY 2023 compared to FY 2022 • Successful execution of cost reduction plan; $248.1 million","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/921299/000095017024020146/0000950170-24-020146-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"year ended December 31, 2023"},{"label":"Revenue","value":"$147.8 million"},{"label":"Net income","value":"Net loss for the year was $284.2 million, or $2.92 net loss per basic and diluted share"},{"label":"EPS","value":"$2.92 net loss per basic and diluted share"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"},{"claim_id":"90d899f8dd2f5411b5690954b9e24dca5ca7d3cf","claim":"KYNTRA BIO, INC. reported quarter ended December 31, 2023 results: revenue $27.1 million, net income Net loss for the fourth quarter of 2023 was $56.2 million, or $0.57 net loss per basic and diluted share, EPS $0.57 net loss per basic and diluted share.","evidence_excerpt":"full year roxadustat net sales in China 1 by FibroGen and the JDE to range between $300 million to $340 million. Financial: • Total revenue for the fourth quarter of 2023 was $27.1 million, as compared to $34.4 million for the fourth quarter of 2022. Reduction primarily driven by the change in net product revenue assumptions under U.S. GAAP and drug product revenue","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/921299/000095017024020146/0000950170-24-020146-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"quarter ended December 31, 2023"},{"label":"Revenue","value":"$27.1 million"},{"label":"Net income","value":"Net loss for the fourth quarter of 2023 was $56.2 million, or $0.57 net loss per basic and diluted share"},{"label":"EPS","value":"$0.57 net loss per basic and diluted share"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"},{"claim_id":"d7c25c66fd4963fe2d6cc967365788d158f004a0","claim":"KYNTRA BIO, INC. reported 2024 results: revenue between $120 million to $135 million. Guidance reaffirmed.","evidence_excerpt":"For 2024, we anticipate FibroGen’s full year net product revenue under U.S. GAAP to range between $120 million to $135 million, representing full year roxadustat net sales in China 1 by FibroGen and the JDE to range between $300 million to $340 million.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/921299/000095017024020146/0000950170-24-020146-index.htm","confidence":0.85,"family_label":"Earnings Releases","details":[{"label":"Period","value":"2024"},{"label":"Revenue","value":"between $120 million to $135 million"},{"label":"Guidance","value":"reaffirmed"},{"label":"Result","value":"guidance update"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}