Company Overview - SpringWorks Therapeutics (SWTX) shares increased by 9% to close at $44.93, following a notable trading volume that exceeded typical levels, contrasting with an 11.3% loss over the past four weeks [1] - The rise in stock price is linked to growing investor optimism regarding the company's lead product, Ogsiveo (nirogacestat), which is approved for treating Desmoid tumors and has seen rapid uptake since its late 2023 approval [2] Financial Performance - The company is expected to report a quarterly loss of $0.79 per share, reflecting a year-over-year increase of 33.1%, while revenues are projected to be $64.19 million, marking a 205.5% increase from the same quarter last year [3] - The consensus EPS estimate for SpringWorks has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - SpringWorks Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Pharming Group N.V. Sponsored ADR (PHAR), saw a 3.8% increase in its stock price, closing at $8.58, despite a -5.8% return over the past month [4] - Pharming Group's consensus EPS estimate for the upcoming report has also remained unchanged at -$0.25, representing a 31.6% decline from the previous year [5]

智通财经APP获悉，据《华尔街日报》最新报道，德国默克集团(Merck KGaA)当前非常接近达成一项大 约35亿美元的协议，收购癌症以及罕见病药物知名开发商 SpringWorks Therapeutics(SWTX.US)，消息传 出后 SpringWorks 股价盘中触及当日最高点，截至周四收盘SpringWorks股价涨幅高达9%。 据了解，SpringWorks 拥有首款获 FDA 批准的专门治疗肢端纤维瘤(desmoid tumor)药物 Ogsiveo (nirogacestat)，预计年峰值销售潜力可达 10 亿美元级别。SpringWorks 旗下产品管线还包括泛素激活酶 抑制剂 mirdametinib 等针对 NTRK、BRAF 罕见肿瘤项目，非常契合德国默克在精准肿瘤领域"补短 板"需求。 此外，德国默克旗下的对于业绩增长至关重要的免疫检查点抑制剂 Bavencio销售额增速放缓，旗下多 发性硬化药 Mavenclad 则将于本十年末迎来所谓的"专利悬崖"，SpringWorks旗下的产品管线可提供后 续增长引擎。通过并购，德国默克还可获得 SpringWorks 在美国市场的商业与临 ...

2月份，两家公司正在进行深入谈判，默克随后证实了这一消息。自那以来，SpringWorks的股价已经下 跌了17%。媒体报道默克接近达成交易的消息后，SpringWorks股价收盘上涨9%，交易最早可能于下周 一完成。该股2月份的交易价接近60美元。 巴克莱分析师Emily Field表示，该交易可能加速默克的增长，特别是在其抗癌药物Bavencio销售放缓， 多发性硬化症治疗药物Mavenclad面临专利到期的情况下。 智通财经APP获悉，德国默克公司周四表示，以约35亿美元收购美国SpringWorks Therapeutics(SWTX.US)的谈判已进入后期阶段，该交易可能使默克获得最近批准的一种罕见疾病药 物，并扩大其实验性癌症治疗产品组合。默克表示，两家公司正在就每股约47美元的价格进行谈判，根 据计算，该公司的估值约为35亿美元。 默克在一份声明中表示，尚未做出最终决定，也没有达成具有法律约束力的协议。收购SpringWorks将 成为这家德国医疗保健和科技集团近年来最大的制药交易之一，推动其正在进行的建立癌症治疗业务的 努力。2015年，默克同意以170亿美元收购美国实验室设备供应商Sigma ...

Core Viewpoint - SpringWorks Therapeutics reported a wider loss per share in Q4 2024 compared to estimates, despite a significant increase in total revenues driven by the successful launch of its product Ogsiveo [1][2][6]. Financial Performance - The company incurred a loss of $1.04 per share in Q4 2024, exceeding the Zacks Consensus Estimate of a loss of 72 cents, and improved from a loss of $1.44 per share in the same quarter last year [1]. - Total revenues for Q4 2024 reached $61.5 million, surpassing the Zacks Consensus Estimate of $60 million, and significantly up from $5.4 million in the year-ago quarter [2]. - For the full year 2024, SpringWorks generated revenues of $191.6 million, compared to $5.4 million in the previous year, with a loss of $3.48 per share, an improvement from a loss of $5.15 per share in the prior year [6]. Product Development and Market Position - Ogsiveo became the first approved product in SpringWorks' portfolio and the first drug approved for treating desmoid tumors, with net product revenues increasing nearly 24.7% sequentially in Q4 due to strong demand [2][3]. - The FDA approved Ogsiveo in November 2023 for adult patients with progressing desmoid tumors, and the company aims to establish it as the standard of care [2][4]. - The marketing authorization application for Ogsiveo is under review with the European Medicines Agency (EMA), with potential approval expected in 2025 [7]. Research and Development - Research and development expenses in Q4 totaled $60.2 million, a 37.7% increase from the previous year, attributed to higher drug manufacturing costs and ongoing clinical studies [4]. - Selling, general, and administrative expenses reached $77.1 million, up approximately 28.9% year-over-year, primarily due to costs associated with the launch of Gomekli [5]. Stock Performance - Following the earnings announcement, SpringWorks shares rose by 7.5% on February 20, and the stock has increased by 22.1% over the past year, contrasting with an 8.3% decline in the industry [3].

YANCOAL AUSTRALIA LTD | ADDRESS: | Level 18, Tower 2, 201 Sussex Street, | | --- | --- | | | Sydney NSW 2000 | | PHONE: | 61 2 8583 5300 | | FAX: | 61 2 8583 5399 | | WEBSITE: | www.yancoal.com.au | 20 February 2025 ASX Release: 2024 Financial Results Presentation Authorised for lodgement by the Board of Yancoal Australia Investor Relations Contact: Brendan Fitzpatrick, GM Investor Relations Email: Brendan.Fitzpatrick@yancoal.com.au Additional information about the company can be found at www.yancoal.com.au ...

Company Performance - SpringWorks Therapeutics reported a quarterly loss of $1.04 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.72, representing an earnings surprise of -44.44% [1] - The company posted revenues of $61.55 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 2.52%, and showing significant growth from $5.45 million in the same quarter last year [2] - Over the last four quarters, SpringWorks has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - SpringWorks Therapeutics shares have increased approximately 54.3% since the beginning of the year, significantly outperforming the S&P 500's gain of 4.5% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.73 on revenues of $64.18 million, and for the current fiscal year, it is -$2.05 on revenues of $332.27 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which SpringWorks belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5][6]

Financial Performance - OGSIVEO generated net sales of $172.0 million in 2024, up from $5.4 million in 2023[549]. - The company recorded net product revenue of $172.0 million for the year ended December 31, 2024, compared to $5.4 million for the year ended December 31, 2023, reflecting a significant increase of $166.6 million[593]. - Total revenue for 2024 was $191,589 thousand, compared to $5,447 thousand in 2023, indicating a substantial growth[661]. - The net loss for 2024 was $258,131 thousand, an improvement from a net loss of $325,104 thousand in 2023[661]. - The company reported a net loss of $258.1 million for the year ended December 31, 2024, an improvement from a net loss of $325.1 million in 2023, and $277.4 million in 2022[671]. Cash and Securities - The company had cash, cash equivalents, and marketable securities of $461.9 million as of December 31, 2024, down from $662.6 million in 2023[558]. - Cash used in operating activities was $175.6 million in 2024, down from $222.8 million in 2023, indicating improved cash flow management[621]. - The company had cash, cash equivalents, and marketable securities totaling $461.9 million, down from $662.6 million as of December 31, 2023[680]. - The company’s accumulated deficit reached $1.2 billion as of December 31, 2024, compared to $895.0 million as of December 31, 2023[679]. - The company had no outstanding debt as of December 31, 2024[643]. Operating Expenses - Total operating expenses increased to $469.7 million for the year ended December 31, 2024, up from $348.5 million in 2023, representing a 35% increase[593]. - Research and development expenses rose to $200.5 million in 2024, an increase of $50.0 million or 33% compared to $150.5 million in 2023[593]. - Selling, general and administrative expenses were $256.7 million for the year ended December 31, 2024, a 30% increase from $197.6 million in 2023[593]. - The total equity-based compensation expense for 2024 was $109,140,000, compared to $94,534,000 in 2023, indicating a year-over-year increase of approximately 15.4%[737]. Regulatory Approvals and Product Development - GOMEKLI was approved by the FDA on February 11, 2025, for treating NF1-PN, with commercialization starting in the same month[550]. - The FDA approved OGSIVEO in November 2023, leading to revenue generation from sales starting in December 2023[578]. - The company anticipates ongoing regulatory reviews for nirogacestat and mirdametinib, with decisions expected in 2025[551]. - The company began capitalizing inventory for OGSIVEO upon its FDA approval in November 2023[692]. Collaborations and Agreements - The company has entered into a license agreement with Rappta Therapeutics for a portfolio of PP2A activators, with an upfront payment of $13 million and potential future milestones totaling up to $235 million[565]. - The company terminated its collaboration agreement with GSK, effective December 3, 2024, but will continue to support ongoing clinical trials[552]. - The company entered into several clinical trial collaboration agreements to evaluate nirogacestat in combination with BCMA-directed therapies[571]. Future Outlook - The company expects to continue incurring significant expenses related to the commercialization of OGSIVEO and GOMEKLI, as well as ongoing clinical development[560]. - The company anticipates achieving profitability in the first half of 2026, indicating a long-term outlook for financial recovery[614]. - The company expects research and development expenses to continue increasing as it invests in product candidates and preclinical programs[583]. Assets and Liabilities - Total assets decreased to $587,276 thousand in 2024 from $725,788 thousand in 2023, indicating a reduction in overall financial resources[659]. - The company's total accrued expenses increased to $86,012,000 in 2024, up from $65,569,000 in 2023, reflecting a significant rise in accrued compensation and benefits[736]. - The company's property and equipment, net, rose to $19,680,000 in 2024 from $17,943,000 in 2023, showing an increase of about 9.7%[731]. Stock Options and Compensation - The company had 12,818,963 stock options outstanding, with a weighted average exercise price of $35.90 and an intrinsic aggregate value of $105,568,481[742]. - The total unrecognized compensation expense related to unvested stock options was $100.2 million, expected to be recognized over approximately 2.2 years[743]. - The total restricted stock awards compensation expense for the year ended December 31, 2024, was $2.2 million, with 11,101 unvested shares outstanding at year-end[744].

Financial Performance - SpringWorks Therapeutics, Inc. achieved preliminary U.S. net product revenue of $61.5 million for Q4 2024 and $172.0 million for the fiscal year ended December 31, 2024[4] - The company's total preliminary cash, cash equivalents, and marketable securities amounted to $461.9 million as of December 31, 2024[4] Audit Status - The financial information provided is unaudited and preliminary, with ongoing audits that may result in changes[5]

Core Insights - SpringWorks Therapeutics reported strong financial results for the fourth quarter and full year 2024, achieving U.S. net product revenues of $61.5 million and $172.0 million for OGSIVEO® (nirogacestat) respectively [1][6] - The company received FDA approval for GOMEKLI™ (mirdametinib) for treating symptomatic NF1-PN in both adults and pediatric patients, marking a significant milestone in its product offerings [1][6] - As of December 31, 2024, SpringWorks had a cash position of $461.9 million, indicating a solid financial foundation for future growth [1][6] Financial Performance - OGSIVEO net product revenues were $61.5 million in Q4 2024 and $172.0 million for the full year 2024, a substantial increase compared to previous periods [6][19] - Selling, General and Administrative (SG&A) expenses rose to $77.1 million for Q4 2024 and $256.7 million for the full year, up from $59.8 million and $197.6 million in 2023, primarily due to commercial readiness activities for GOMEKLI and OGSIVEO [7][19] - Research and Development (R&D) expenses increased to $60.2 million in Q4 2024 and $200.5 million for the full year, compared to $43.7 million and $150.5 million in 2023, driven by higher external costs related to clinical trials and drug manufacturing [7][19] - The net loss attributable to common stockholders was $77.3 million, or $1.04 per share, for Q4 2024, and $258.1 million, or $3.48 per share, for the full year, showing improvement from the previous year's losses [7][19] Product Development and Pipeline - The company is advancing a diversified pipeline, including ongoing studies for nirogacestat in various indications, with initial data from a Phase 2 trial expected in the first half of 2025 [2][6] - A Marketing Authorization Application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), with potential launch in Germany anticipated in mid-2025 [6][19] - GOMEKLI is now available through a specialty pharmacy network in the U.S., and an MAA for mirdametinib is also under review with the EMA [6][19] Strategic Outlook - The CEO expressed confidence in the company's ability to serve the desmoid tumor community and emphasized the importance of the recent FDA approval of GOMEKLI for expanding treatment options [2][6] - SpringWorks is committed to global expansion of its medicines and aims to develop important therapeutic advances for underserved patient populations [2][6]

Core Insights - SpringWorks Therapeutics has received FDA approval for GOMEKLI™ (mirdametinib), the first and only treatment for both adults and children with neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) [1][2][11] - The approval is based on positive results from the Phase 2b ReNeu trial, which demonstrated significant tumor volume reductions and a manageable safety profile [3][4][5] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with GOMEKLI being its second FDA approval in less than 18 months [2][21] - The company is also advancing a diverse portfolio of novel targeted therapy product candidates for solid tumors and hematological cancers [21] Product Details - GOMEKLI is an oral MEK inhibitor approved for patients aged 2 years and older with symptomatic NF1-PN not amenable to complete resection [11][21] - The drug is available in 1 mg and 2 mg capsules, as well as a 1 mg tablet for oral suspension, and is expected to be available through specialty pharmacies within two weeks [7][21] Clinical Trial Results - The ReNeu trial enrolled 114 patients (58 adults and 56 pediatric patients) and achieved a confirmed objective response rate (ORR) of 41% in adults and 52% in children [3][4] - The median best percentage change in target PN volume was -41% in adults and -42% in children, with 88% of adults and 90% of children showing a response lasting at least 12 months [3][5] Market Need - NF1 affects approximately 100,000 individuals in the U.S., with about 40,000 living with NF1-PN, highlighting a significant unmet need for effective treatment options [2][9] - Prior to GOMEKLI, there were no approved medications for NF1-PN, making this approval a critical advancement for patients [2][5] Regulatory Status - GOMEKLI was granted a rare pediatric disease priority review voucher by the FDA and has previously received Orphan Drug and Fast Track designations [4][5] - The Marketing Authorization Application for GOMEKLI is under review by the European Medicines Agency (EMA), with a decision expected in 2025 [8]