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European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
GlobeNewswire News Room· 2024-11-04 12:00
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chron ...
Avnet(AVT) - 2025 Q1 - Quarterly Report
2024-10-31 21:48
Financial Performance - Sales for the first quarter of fiscal 2025 were $5.60 billion, a decrease of $731.5 million, or 11.6%, compared to $6.34 billion in the same quarter last year[70]. - Adjusted operating income for the first quarter of fiscal 2025 was $168.9 million, a decrease of $92.8 million, or 35.4% year over year[81]. - Gross profit for the first quarter of fiscal 2025 was $140.7 million, down 18.8% from the first quarter of fiscal 2024[73]. - Operating income for the first quarter of fiscal 2025 was $142.2 million, a decrease of $111.5 million, or 44.0%, year over year[81]. - The gross profit margin decreased by 97 basis points to 10.8% for the first quarter of fiscal 2025[74]. - The company's net income for Q1 fiscal 2025 was $59.0 million, or $0.66 per share, down from $209.3 million, or $2.25 per share in Q1 fiscal 2024[87]. Expenses and Costs - SG&A expenses decreased by $48.5 million, or 10.0%, from the first quarter of fiscal 2024[76]. - Restructuring, integration, and other expenses totaled $26.4 million in the first quarter of fiscal 2025, compared to $7.1 million in the same period last year[79]. Tax and Income - The effective tax rate for the first quarter of fiscal 2025 was 21.1%, compared to 24.0% in the first quarter of fiscal 2024[68]. - The effective tax rate decreased to 21.1% in Q1 fiscal 2025 from 24.0% in Q1 fiscal 2024, with income tax expenses of $15.8 million compared to $66.2 million[86]. Cash Flow and Borrowings - Net cash provided by operating activities increased by $147.6 million year-over-year to $106.3 million in Q1 fiscal 2025, compared to a cash outflow of $41.3 million in Q1 fiscal 2024[88]. - The company reported net borrowings of $15.7 million in Q1 fiscal 2025, a significant decrease from $151.4 million in the same period of the prior year[89]. - Cash and cash equivalents stood at $267.5 million as of September 28, 2024, down from $310.9 million as of June 29, 2024[95]. - The company generated $837.6 million in cash flows from operating activities over the trailing four fiscal quarters ended September 28, 2024[96]. - The company had a total borrowing capacity of $2.20 billion under its Credit Facility and Securitization Program, with $768.6 million of borrowings outstanding as of September 28, 2024[98]. - Approximately 56% of the company's debt bears interest at a fixed rate, while 44% bears interest at variable rates[106]. Shareholder Returns - The company repurchased $100.0 million of common stock in Q1 fiscal 2025, compared to $24.3 million in the same period of the prior year[89]. - The company paid cash dividends of $0.33 per share, totaling $28.9 million in Q1 fiscal 2025, compared to $0.31 per share, or $28.3 million in Q1 fiscal 2024[101]. Sales Outlook - The company expects sales in the second quarter of fiscal 2025 to be down 4% to up 2% compared to the first quarter of fiscal 2025[65]. - Sales in the Asia region increased by 6.2% year over year, contrasting with declines in the Americas and EMEA regions[70].
Avnet Q1 Earnings Beat: Will Strong Sales View Lift the Stock?
ZACKS· 2024-10-31 14:11
Core Insights - Avnet (AVT) reported better-than-expected results for the first quarter of fiscal 2025, with earnings of 92 cents per share, surpassing the Zacks Consensus Estimate of 85 cents and management's guidance of 80-90 cents per share. However, this represents a 42.9% decline year over year due to decreased revenues [1][4]. Financial Performance - Revenues for the fiscal first quarter were $5.6 billion, exceeding the high end of the company's guidance of $5.25-$5.55 billion and the Zacks Consensus Estimate of $5.41 billion. Year-over-year, revenues declined by 11.6% [2][4]. - The Electronic Components segment's revenues decreased by 11.1% year over year but increased by 1.3% sequentially to $5.26 billion, while Farnell sales fell 17.6% year over year and 7.5% sequentially to $347.1 million [5]. - From a regional perspective, sales increased by 6.2% in Asia to $2.61 billion, but declined by 27.7% in EMEA to $1.67 billion and by 15.5% in the Americas to $1.33 billion [6]. Operating Metrics - Adjusted operating income was $168.9 million, down 35.4% year over year. The operating income for the Electronic Components segment fell 27.8% to $197 million, while Farnell's operating income dropped 88.9% to $2 million [6]. - The adjusted operating margin shrank by 112 basis points to 3% from the year-ago quarter, with the Electronic Components segment's margin contracting by 86 basis points to 3.8% and Farnell's margin declining by 366 basis points to 0.5% [7]. Balance Sheet and Cash Flow - As of September 30, 2024, Avnet had cash and cash equivalents of $267.5 million, down from $310.9 million at the end of the previous quarter. Long-term debt remained flat at $2.43 billion [8]. - The company generated nearly $106.3 million in cash from operational activities during the fiscal first quarter [8]. Shareholder Returns and Future Guidance - In the quarter, Avnet repurchased approximately $100 million worth of shares, representing more than 2% of shares outstanding, and returned $28.9 million to shareholders in dividends [9]. - For the second quarter of fiscal 2025, Avnet anticipates revenues in the range of $5.4-$5.7 billion, with non-GAAP earnings expected between 80-90 cents per share [9].
Avnet(AVT) - 2025 Q1 - Earnings Call Transcript
2024-10-30 20:09
Financial Data and Key Metrics Changes - The company achieved sales of over $5.6 billion and adjusted EPS of $0.92, both exceeding the high end of guidance [5][24] - Sales decreased by 12% year-over-year but increased by 1% sequentially [24][25] - Gross margin was 10.8%, down 97 basis points year-over-year and 72 basis points sequentially [26] - Adjusted operating income was $169 million with an adjusted operating margin of 3% [29] Business Line Data and Key Metrics Changes - Electronic Components sales declined 11% year-over-year but increased 1% sequentially [25] - Farnell sales decreased 18% year-over-year and 8% sequentially [26][15] - The Asia region saw a 14% sequential increase and a 6% year-over-year increase in sales, driven by strength in server and data center markets [12][25] Market Data and Key Metrics Changes - EMEA sales declined 28% year-over-year, while Americas sales decreased 16% [25] - Demand in aerospace and defense increased sequentially in EMEA but remained flat year-over-year [13] - The global book-to-bill ratio remains below parity, with Asia showing the strongest ratio [7] Company Strategy and Development Direction - The company is focusing on cost control and managing working capital while preparing for market recovery [6][18] - There is an emphasis on improving the Farnell business under new leadership, with restructuring efforts underway [15][17] - The company is optimistic about future growth opportunities in AI-related projects and the overall market recovery [21][22] Management's Comments on Operating Environment and Future Outlook - Management believes the market correction may continue for another quarter or two, with expectations for modest improvement in the second half of fiscal 2025 [55][74] - The company is seeing some positive indicators, including a return to year-on-year growth in Asia and an increase in turns business [22][75] - Management remains confident in the company's ability to adapt and thrive through market changes [23] Other Important Information - The company generated over $100 million in cash flow from operations during the quarter [5] - Inventory levels increased due to foreign currency exchange rates, but the company aims to reduce inventory days to the 80s by the end of the fiscal year [33][34] - The quarterly dividend was increased by approximately 6% to $0.33 per share, and share buyback authorization was expanded to $600 million [37][38] Q&A Session Summary Question: Understanding Asia's Return to Year-over-Year Growth - Management noted that growth in Asia is not solely driven by data center opportunities but includes increases in consumer, communication, and industrial sectors [42][43] Question: Farnell's Future and EBIT Target - Management expressed confidence in Farnell's model returning to double-digit EBIT, despite current challenges [44][45] Question: Market Correction Outlook - Management believes the market correction may last another quarter or two, with expectations for improvement in early 2025 [55] Question: Impact of WT Micro Acquisition - Management refrained from commenting on competitive dynamics but acknowledged the potential for synergies [57] Question: Operating Margin Impact from FX and Mix - Management indicated that FX had a 150 to 200 basis point impact on margins, with a focus on returning to double-digit margins over time [58][59] Question: Guidance for December Quarter - Management anticipates modest regional growth in December, despite typical seasonal declines in Europe [63][64] Question: Inventory Management - Management acknowledged the need to reduce inventory levels while also seizing market opportunities [68][71] Question: End Market Exposure - Management provided rough estimates of end market exposure, indicating a diversified customer base across various sectors [79][80]
Avnet(AVT) - 2025 Q1 - Earnings Call Presentation
2024-10-30 16:27
Avnet First Quarter Fiscal Year 2025 Financial Results /\VNET October 30, 2024 Safe Harbor Statement This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, with respect to the financial condition, results of operations, and business of the Company. You can find many of these statements by looking for words like "believes," "projected", "plans," "expects," "anticipates," ...
Here's What Key Metrics Tell Us About Avnet (AVT) Q1 Earnings
ZACKS· 2024-10-30 14:35
Core Insights - Avnet reported $5.6 billion in revenue for the quarter ended September 2024, reflecting a year-over-year decline of 11.6% and an EPS of $0.92 compared to $1.61 a year ago, with a revenue surprise of +3.68% over the Zacks Consensus Estimate of $5.41 billion and an EPS surprise of +8.24% over the consensus estimate of $0.85 [1] Financial Performance Metrics - Sales for Farnell were $347.10 million, below the average estimate of $364.55 million, representing a year-over-year decline of 17.6% [3] - Sales for Electronic Components reached $5.26 billion, exceeding the average estimate of $5.04 billion, with a year-over-year change of -11.1% [3] - Operating income for Electronic Components was $197.40 million, surpassing the estimated $177.78 million [3] - Operating income for Farnell was $1.90 million, significantly lower than the average estimate of $13.23 million [3] - Corporate expenses reported an operating loss of -$30.30 million, slightly worse than the estimated loss of -$29.47 million [3] Stock Performance - Avnet's shares have returned +1.9% over the past month, compared to the Zacks S&P 500 composite's +1.8% change, with a current Zacks Rank of 3 (Hold), indicating potential performance in line with the broader market [4]
Avnet (AVT) Q1 Earnings and Revenues Surpass Estimates
ZACKS· 2024-10-30 14:10
Avnet (AVT) came out with quarterly earnings of $0.92 per share, beating the Zacks Consensus Estimate of $0.85 per share. This compares to earnings of $1.61 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of 8.24%. A quarter ago, it was expected that this distributor of electronic components would post earnings of $0.95 per share when it actually produced earnings of $1.22, delivering a surprise of 28.42%. Over the last four quar ...
Avnet(AVT) - 2025 Q1 - Quarterly Results
2024-10-30 12:05
Exhibit 99.1 Avnet Reports First Quarter 2025 Financial Results First quarter sales of $5.6 billion and diluted EPS of $0.66 Adjusted diluted EPS of $0.92 Cash flow from operations of $838 million over past four quarters PHOENIX – October 30, 2024 – Avnet, Inc. (Nasdaq: AVT) today announced results for its first quarter ended September 28, 2024. "In the first quarter, our sales and earnings exceeded the upper end of our guidance range led by a return to growth in our Asia region. We continue to focus on imp ...
European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
GlobeNewswire News Room· 2024-10-10 09:01
Core Insights - Alvotech has received acceptance from the European Medicines Agency (EMA) for the Marketing Authorization Application of AVT03, a biosimilar candidate to Prolia® and Xgeva® (denosumab), marking a significant step towards patient access in Europe [1][2] - The company aims to leverage its end-to-end biosimilars platform to enhance access to affordable biologic medicines [1] - Alvotech has partnered with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA for the commercialization of AVT03 in Europe, with each partner holding semi-exclusive rights [1] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines [7] - The company has already approved and marketed two biosimilars, targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [8] - Alvotech has established a network of strategic commercial partnerships across various global markets, including the US, Europe, and Asia [8] Product Details - AVT03 is a human monoclonal antibody that targets the RANK ligand, reducing bone resorption and cancer-induced bone destruction [5] - The European market for denosumab is valued at approximately US$1 billion, indicating significant potential for biosimilar competition to enhance patient access [3][4] - In 2019, the direct cost of osteoporotic fractures in the EU, Switzerland, and the UK was estimated at US$63 billion, highlighting the economic burden of osteoporosis [4] Clinical Study Results - Alvotech announced positive topline results from a confirmatory patient study for AVT03, demonstrating clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis [2] - The AVT03-GL-C01 study met its primary endpoints, as did two additional studies comparing AVT03 to Prolia and Xgeva in healthy adult participants [2]
European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
GlobeNewswire News Room· 2024-08-15 08:30
The approvals process is anticipated to be completed in the third quarter of 2025 REYKJAVIK, Iceland and LONDON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accept ...