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Syndax Announces FDA Approval of Revuforj® (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation
Prnewswire· 2024-11-15 22:29
Core Insights - The FDA has approved Revuforj® (revumenib) as the first menin inhibitor for treating relapsed or refractory acute leukemia with a KMT2A translocation in patients aged one year and older [1][2][3] - The approval is based on positive data from the AUGMENT-101 clinical trial, demonstrating a 21% complete remission rate among treated patients [2][3] - Syndax Pharmaceuticals is preparing to launch Revuforj and is committed to advancing its development for KMT2A-rearranged acute leukemias and mutant NPM1 AML [2][8] Efficacy and Safety - In the AUGMENT-101 trial, 104 patients were evaluated, with a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 21% [2] - The median duration of CR+CRh was 6.4 months, and the median time to CR or CRh was 1.9 months [2] - The safety evaluation involved 135 patients, with common adverse reactions including hemorrhage (53%), nausea (51%), and infection (41%) [3][18] Market Availability - Revuforj tablets (110 mg and 160 mg) are expected to be available for order in the U.S. in November 2024, with 25 mg tablets anticipated in early 2025 [4] - An oral solution of revumenib will be available through an expanded access program for patients weighing less than 40 kg prior to the commercial availability of the 25 mg tablets [4] Company Commitment - Syndax has established SyndAccess™, a program providing personalized support and financial assistance to U.S. patients prescribed Revuforj [5] - The company is focused on removing barriers to access for patients and enhancing support resources [5] Future Developments - Revumenib is also in development for treating R/R acute myeloid leukemia (AML) with a nucleophosmin 1 mutation (mNPM1), with ongoing trials in combination with standard-of-care agents [8][9] - The company is conducting multiple clinical trials across the treatment landscape for KMT2A-rearranged acute leukemia and mNPM1 AML [8][22]
Kennametal Named Among Top of Caterpillar Inc's 2024 Indirect Suppliers
Prnewswire· 2024-11-13 12:00
PITTSBURGH, Nov. 13, 2024 /PRNewswire/ -- Kennametal Inc. (NYSE: KMT) is proud to announce that it has been recognized as one of Caterpillar Inc's top indirect suppliers in 2024. This prestigious recognition reflects Kennametal's continued dedication to delivering innovative solutions, productivity improvements and outstanding customer and applications engineering support. Key drivers of this recognition include Kennametal's exceptional support in the successful launch of the Cat C27B and C32 cylinder head ...
Syndax: Fall On NPM1m AML Data Of Revumenib Creates Buy Opportunity
Seeking Alpha· 2024-11-12 21:34
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...
Kennametal to Attend UBS Global Industrials and Transportation Conference
Prnewswire· 2024-11-12 12:00
PITTSBURGH, Nov. 12, 2024 /PRNewswire/ -- Kennametal Inc. (NYSE: KMT) announced today that they will attend the UBS Global Industrials and Transportation Conference in Manalapan, Florida.Details of the conference are as follows:             When:      Tuesday, December 3, 2024             Attendees: Patrick Watson, Vice President and Chief Financial Officer Michael Pici, Vice President, Investor Relations About KennametalWith over 85 years as an industrial technology leader, Kennametal In ...
Kennametal's Q1 Earnings Surpass Estimates, Revenues Decline Y/Y
ZACKS· 2024-11-07 17:35
Kennametal Inc. (KMT) reported first-quarter fiscal 2025 (ended Sept. 30, 2024) adjusted earnings of 29 cents per share, which beat the Zacks Consensus Estimate of 25 cents. The bottom line decreased 29.3% from the year-ago figure.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.KMT’s Revenue DetailsKennametal’s revenues were $481.9 million, which decreased 2% from the year-ago quarter’s figure. Organic sales declined 2% year over year. Business days had a positive impact of 1%. Curr ...
Kennametal(KMT) - 2025 Q1 - Earnings Call Transcript
2024-11-06 20:49
Financial Data and Key Metrics Changes - Sales decreased by 2% year-over-year, with adjusted EBITDA margin at 14.3%, down from 16.6% in the prior year [11][13][28] - Adjusted EPS decreased to $0.29 from $0.41 in the prior year quarter [13][29] - Cash from operating activities increased to $46 million from $26 million in the prior year [43] - Free operating cash flow improved to $21 million from negative $3 million in the prior year [14][43] Business Line Data and Key Metrics Changes - Infrastructure sales increased by 1% organically, while metal cutting sales decreased by 4% [11][32] - Aerospace and Defense grew by 13%, while Energy grew by 2%; other markets like Transportation, General Engineering, and Earthworks experienced declines of 2%, 3%, and 6% respectively [11][40] Market Data and Key Metrics Changes - Asia Pacific sales increased by 2% on a constant currency basis, while EMEA declined by 1% and the Americas declined by 2% [11] - In the U.S., metal cutting growth was 3%, slightly below the overall market [18] Company Strategy and Development Direction - The company is focused on driving above-market growth through innovative product launches and operational initiatives [10][20] - Continued emphasis on primary working capital management and strong cash flow generation [10][15] - The company aims to optimize inventory levels and reduce primary working capital as a percentage of sales [44][70] Management's Comments on Operating Environment and Future Outlook - Management noted that fiscal '25 has started unevenly, with worsening market conditions in EMEA and soft industrial production in the U.S. [8][9] - The outlook for Q2 sales is projected between $480 million and $500 million, with expectations of a slight recovery in the second half of the year [47][50] - Management remains optimistic about long-term growth driven by global megatrends despite short-term challenges [54] Other Important Information - The company continues its share repurchase program, buying back $15 million worth of shares during the quarter [14][45] - Adjusted effective tax rate increased to 25.1% year-over-year, influenced by geographical mix and discrete items [29] Q&A Session Summary Question: Margin assumptions for Q2 - Management expects margins to be flattish from Q1 to Q2, with some benefits from the resolution of a tax dispute and the end of certain expenses [56][57] Question: Recovery in organic growth - Management anticipates slight recovery in industrial production and oil rig counts, with confidence in aerospace and defense growth [58][59] Question: Trends in Asia Pacific - Despite pressure in construction and mining, overall APAC markets are expected to remain stable and slightly improve [63] Question: Operating margins in the second half - Seasonal uptick in volumes is expected to drive margin performance in the second half, with Q4 typically being the higher margin quarter [65] Question: Inventory relative to demand - The company aims to reduce inventory levels, with production slightly below demand to optimize working capital [70] Question: Near-term trends - Industrial production and oil and gas are expected to remain stable, with continued pressure in transportation and mining construction [76] Question: Price cost dynamics - Tungsten prices have remained stable, and the company is confident in achieving 2% price realization [77][78] Question: Impact of Fed rate cuts - Lower rates are expected to be constructive, but historical lag periods suggest several quarters before significant demand changes [81][82] Question: Restructuring savings - Restructuring savings in the quarter were $5 million, with an annualized run rate of $35 million [85] Question: Metal cutting margins - Metal cutting margins were impacted by significant volume reductions and temporary costs from trade shows [86] Question: Market share gains in Europe - The company expects to maintain market share gains despite near-term pressures, supported by ongoing project wins [90][92] Question: Implications of recent political events - Management is monitoring industrial production and consumer confidence as potential impacts of new policies and tariffs [94][96]
Kennametal (KMT) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates
ZACKS· 2024-11-06 15:35
Core Insights - Kennametal (KMT) reported revenue of $481.95 million for the quarter ended September 2024, reflecting a year-over-year decline of 2.1% and an EPS of $0.29 compared to $0.41 a year ago [1] - The reported revenue exceeded the Zacks Consensus Estimate of $480.69 million by 0.26%, while the EPS surprised positively by 16.00% against the consensus estimate of $0.25 [1] Revenue Performance - Total Sales in the Infrastructure segment were $185.05 million, surpassing the three-analyst average estimate of $179.62 million, with a year-over-year change of +0.4% [3] - Total Sales in the Metal Cutting segment were $296.90 million, slightly below the three-analyst average estimate of $301.08 million, showing a year-over-year decline of -3.7% [3] Operating Income - Corporate Operating Income was reported at -$0.53 million, better than the estimated loss of -$0.70 million by three analysts [3] - Proforma Operating Income for the Infrastructure segment was $12.71 million, exceeding the average estimate of $11.41 million [3] - Proforma Operating Income for the Metal Cutting segment was $24.47 million, also above the average estimate of $23.26 million [3] Stock Performance - Kennametal's shares have returned +7.1% over the past month, outperforming the Zacks S&P 500 composite's +0.7% change [4] - The stock currently holds a Zacks Rank 5 (Strong Sell), indicating potential underperformance relative to the broader market in the near term [4]
Kennametal (KMT) Surpasses Q1 Earnings and Revenue Estimates
ZACKS· 2024-11-06 13:40
Kennametal (KMT) came out with quarterly earnings of $0.29 per share, beating the Zacks Consensus Estimate of $0.25 per share. This compares to earnings of $0.41 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 16%. A quarter ago, it was expected that this engineered products maker would post earnings of $0.44 per share when it actually produced earnings of $0.49, delivering a surprise of 11.36%.Over the last four quarters, the ...
Kennametal(KMT) - 2025 Q1 - Quarterly Results
2024-11-06 11:52
Sales Performance - Sales for the first quarter of fiscal 2025 were $482 million, a decrease of 2% from $492 million in the prior year quarter, reflecting an organic sales decline of 2% and an unfavorable currency exchange effect of 1%[2] - Total sales for the quarter were $481,948 thousand, a decline of 2.7% from $492,476 thousand in the prior year[18] - Metal Cutting segment sales were $297 million, a decrease of 4% from $308 million in the prior year quarter, while Infrastructure segment sales increased by 0.4% to $185 million[6] - Metal Cutting segment sales were $296,900 thousand, down from $308,229 thousand, indicating a decrease of 3.9% year-over-year[24] - Infrastructure segment sales increased slightly to $185,048 thousand from $184,247 thousand, showing a growth of 0.4%[24] - Organic sales growth for Metal Cutting declined by 4%, while Infrastructure saw a growth of 1%, resulting in a total decline of 2%[31] - The foreign currency exchange effect contributed to a 2% decline in Metal Cutting sales and a 1% decline overall[31] - The business days effect positively impacted total sales by 1%[31] Financial Performance - Operating income was $36 million, representing a margin of 7.5%, compared to $45 million and a margin of 9.2% in the prior year quarter[4] - Net income for the three months ended September 30, 2024, was $23,466 thousand, down from $30,369 thousand in the same period of 2023, representing a decrease of 22.5%[16] - Operating income decreased to $36,027 thousand for the quarter, down 20.2% from $45,118 thousand in the same quarter of 2023[18] - The company reported an adjusted operating margin of 7.6% for the quarter, compared to 9.9% in the same quarter of the previous year[22] - The effective tax rate for the quarter was 25.2%, up from 21.0% in the prior year quarter, primarily due to prior year adjustments and geographical mix[4] Earnings and Cash Flow - Earnings per diluted share (EPS) were $0.28, down from $0.37 in the prior year quarter, while adjusted EPS was $0.29 compared to $0.41 in the prior year quarter[1] - Year-to-date net cash flow from operating activities was $46 million, up from $26 million in the prior year period, with free operating cash flow of $21 million compared to negative $3 million in the prior year[4] - Free Operating Cash Flow (FOCF) for the three months ended September 30, 2024, was $21,091 thousand, compared to a negative FOCF of $(3,040) thousand in the prior year[28] - Management considers FOCF an important indicator of cash generating capability for dividends, debt repayment, and strategic initiatives[27] Shareholder Returns - The company returned approximately $31 million to shareholders, including $15 million in share repurchases and $16 million in dividends[1] - The company paid cash dividends of $15,582 thousand to shareholders during the quarter, slightly down from $15,935 thousand in the previous year[16] Future Outlook - The outlook for the second quarter of fiscal 2025 anticipates sales between $480 million and $500 million, with adjusted EPS expected to be between $0.20 and $0.30[5] - Annual sales are expected to be between $2.0 billion and $2.1 billion, with adjusted EPS projected to be between $1.30 and $1.70[5] Restructuring and Cost Management - The company achieved incremental year-over-year restructuring savings of approximately $5 million, contributing to an annualized run rate pretax savings of approximately $35 million[2] - Restructuring and related charges amounted to $2,539 thousand for Metal and $1,155 thousand for Infrastructure[26] Assets and Liabilities - Total assets increased to $2,521,929 thousand as of September 30, 2024, compared to $2,503,758 thousand on June 30, 2024, reflecting a growth of 0.73%[14] - Total current liabilities decreased to $398,386 thousand from $415,961 thousand, a reduction of 4.2%[14] - Cash and cash equivalents at the end of the period were $119,588 thousand, a decrease from $127,971 thousand at the beginning of the period, reflecting a decline of 6.5%[16] Capital Expenditures - Capital expenditures for the period were $24,748 thousand, down from $31,799 thousand in the previous year[28]
Kennametal Announces Fiscal 2025 First Quarter Results
Prnewswire· 2024-11-06 11:30
Core Insights - Kennametal Inc. reported fiscal 2025 first quarter results with sales of $482 million, a decrease of 2% from $492 million in the prior year quarter, and earnings per diluted share (EPS) of $0.28 compared to $0.37 in the prior year quarter [1][3][17] Financial Performance - Strong cash flow from operations was $46 million compared to $26 million in the prior year, with free operating cash flow of $21 million compared to negative $3 million in the prior year [1][7][26] - Operating income was $36 million, representing a 7.5% margin, down from $45 million and a 9.2% margin in the prior year quarter [5][17] - The effective tax rate for the quarter was 25.2%, up from 21.0% in the prior year quarter [6][23] Shareholder Returns - The company returned approximately $31 million to shareholders, including $15 million in share repurchases and $16 million in dividends [1][8] - A quarterly cash dividend of $0.20 per share was declared, payable on November 26, 2024 [12] Segment Performance - Metal Cutting sales decreased 4% to $297 million, with operating income of $24 million and an 8.0% margin [10][23] - Infrastructure sales increased 0.4% to $185 million, with operating income of $13 million and a 6.9% margin [11][23] Outlook - For the second quarter of fiscal 2025, sales are expected to be between $480 million and $500 million, with adjusted EPS anticipated to be between $0.20 and $0.30 [9] - Annual sales are projected to be between $2.0 billion and $2.1 billion, with adjusted EPS expected to be between $1.30 and $1.70 [9]