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Appili Therapeutics Announces Alignment with FDA on Development Requirements for ATI-1801 Topical Antiparasitic Product NDA Submission
GlobeNewswire News Room· 2024-10-31 11:15
Core Insights - Appili Therapeutics has received positive feedback from the FDA regarding the development strategy for ATI-1801, a topical formulation of paromomycin for treating cutaneous leishmaniasis, which is a significant step towards submitting a New Drug Application (NDA) [1][2][8] Development Strategy - The FDA's agreement on the proposed strategy allows Appili to utilize key results from previous clinical trials, including a successful Phase 3 study, to expedite the NDA submission process [2][3] - The strategy includes developing an in-vitro release test (IVRT) method and manufacturing a new reference standard to support the scientific bridge to prior studies, which will facilitate a quicker NDA submission [2] Product Information - ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis and is being evaluated for eligibility for a priority review voucher (PRV) [4] - The product has demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies, offering a non-invasive treatment option that can be administered in an outpatient setting [8] Transaction Details - Appili has entered into an arrangement agreement with Aditxt Inc. for the acquisition of all issued and outstanding Class A common shares of the Company, providing shareholders with immediate value [5][6] - Under the terms of the transaction, shareholders will receive US$ 0.0467 in cash and a fractional share of Aditxt common stock [5][6] Shareholder Engagement - Shareholders are encouraged to vote their shares ahead of the special meeting scheduled for November 6, 2024, to discuss the transaction [7]
ATI's Earnings Miss Estimates in Q3, Revenues Increase Y/Y
ZACKS· 2024-10-30 12:10
ATI Inc. (ATI) recorded a third-quarter 2024 profit of $82.7 million or 57 cents per share compared with the year-ago quarter's $90.2 million or 62 cents. ATI posted adjusted earnings of 60 cents, down 6% from the yearago quarter figure of 64 cents. The bottom line missed the Zacks Consensus Estimate of 66 cents. Find the latest EPS estimates and surprises on Zacks Earnings Calendar. The company's third-quarter net sales were $1,051.2 million, missing the Zacks Consensus Estimate of $1,127.4 million. Net sa ...
ATI(ATI) - 2024 Q3 - Earnings Call Transcript
2024-10-29 16:09
ATI Inc (NYSE:ATI) Q3 2024 Results Conference Call October 29, 2024 8:30 AM ET Company Participants David Weston - Vice President of Investor Relations Kim Fields - President, CEO & Director Don Newman - Executive VP of Finance & CFO Conference Call Participants Richard Safran - Seaport Research Partners Andre Madrid - BTIG David Strauss - Barclays Phil Gibbs - KeyBanc Capital Markets Timna Tanners - Wolfe Research Seth Seifman - JPMorgan Scott Deuschle - Deutsche Bank Operator Hello, everyone, and welcome ...
Allegheny Technologies (ATI) Q3 Earnings and Revenues Lag Estimates
ZACKS· 2024-10-29 13:46
Allegheny Technologies (ATI) came out with quarterly earnings of $0.60 per share, missing the Zacks Consensus Estimate of $0.66 per share. This compares to earnings of $0.55 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -9.09%. A quarter ago, it was expected that this maker of steel and specialty metals would post earnings of $0.58 per share when it actually produced earnings of $0.60, delivering a surprise of 3.45%.Over the ...
ATI(ATI) - 2024 Q3 - Quarterly Results
2024-10-29 11:36
[Executive Summary & Financial Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Financial%20Highlights) [Q3 2024 Performance Overview](index=1&type=section&id=Q3%202024%20Performance%20Overview) ATI Inc. reported Q3 2024 sales of **$1.05 billion**, marking its ninth consecutive quarter with sales exceeding **$1 billion**, with net income attributable to ATI at **$82.7 million** or **$0.57** per share, driven significantly by aerospace & defense markets representing **62%** of sales - Q3 2024 marks the ninth consecutive quarter with sales in excess of **$1 billion**[3](index=3&type=chunk) - Aerospace & defense represented **62%** of Q3 2024 sales[3](index=3&type=chunk) | Metric | Q3 2024 ($ millions) | Q2 2024 ($ millions) | Sequential Change | Q3 2023 ($ millions) | Y-O-Y Change | | :---------------------------------------- | :------------------- | :------------------- | :---------------- | :------------------- | :----------- | | Sales | $1,051.2 million | $1,095.3 million | (4)% | $1,025.6 million | 2% | | Net income attributable to ATI | $82.7 million | $81.9 million | 1% | $90.2 million | (8)% | | Earnings per share | $0.57 | $0.58 | (2)% | $0.62 | (8)% | | Adjusted net income attributable to ATI* | $85.9 million | $86.0 million | —% | $94.2 million | (9)% | | Adjusted earnings per share* | $0.60 | $0.60 | —% | $0.64 | (6)% | | ATI adjusted EBITDA* | $185.7 million | $182.6 million | 2% | $162.6 million | 14% | [Non-GAAP Adjustments](index=1&type=section&id=Non-GAAP%20Adjustments) Q3 2024 adjusted results exclude **$4.3 million** in pre-tax charges, primarily for start-up and transaction-related costs, while prior periods included inventory write-downs, start-up costs, and unplanned outages - Q3 2024 adjusted results exclude pre-tax charges of **$4.3 million**, primarily consisting of **$2.5 million** in start-up costs and **$1.7 million** for transaction-related costs[5](index=5&type=chunk) - Q2 2024 adjusted results excluded pre-tax charges of **$5.4 million**, including **$5.5 million** for inventory write-downs related to European restructuring and **$1.8 million** for start-up costs, partially offset by **$1.9 million** in credits from lower severance reserves[5](index=5&type=chunk)[6](index=6&type=chunk) - Q3 2023 adjusted results excluded **$4.2 million** in pre-tax charges related to start-up costs and an unplanned outage, partially offset by restructuring credits[6](index=6&type=chunk) [Management Commentary](index=2&type=section&id=Management%20Commentary) [CEO's Remarks on Q3 Performance and Strategy](index=2&type=section&id=CEO's%20Remarks%20on%20Q3%20Performance%20and%20Strategy) CEO Kimberly A. Fields noted Q3 results showed year-over-year growth in sales and EBITDA but fell short of expectations due to industry-wide challenges, while the company focuses on operational efficiency, deleveraging, and returning cash to shareholders - Q3 results reflected year-over-year growth in sales and EBITDA but fell short of expectations due to a slowing aircraft production ramp, supply chain work stoppage, unplanned outages, and transportation issues from Hurricane Helene[7](index=7&type=chunk) - Consolidated adjusted EBITDA margin increased **100 basis points** sequentially[8](index=8&type=chunk) - The company announced the early redemption of 2025 Convertible Notes and a new **$700 million** share repurchase authorization, demonstrating commitment to deleveraging and returning cash to shareholders[8](index=8&type=chunk) [Segment Operating Results](index=2&type=section&id=Segment%20Operating%20Results) [High Performance Materials & Components (HPMC)](index=2&type=section&id=High%20Performance%20Materials%20%26%20Components%20(HPMC)) HPMC segment sales decreased **2%** sequentially to **$552.4 million**, primarily due to lower sales in medical and general industrial markets, offset by increased demand for next-generation commercial jet engine products, with segment EBITDA at **$123.2 million** or **22.3%** of sales | Metric | Q3 2024 ($ millions) | Q2 2024 ($ millions) | Q3 2023 ($ millions) | | :----------------- | :------------------- | :------------------- | :------------------- | | Sales | $552.4 million | $562.0 million | $539.5 million | | Segment EBITDA | $123.2 million | $113.8 million | $117.2 million | | % of Sales | 22.3% | 20.2% | 21.7% | - HPMC sales decreased **2%** sequentially, primarily due to lower sales to medical and general industrial markets, partially offset by increased demand for next-generation commercial jet engine products[9](index=9&type=chunk) - Aerospace & defense sales represented **86%** of total HPMC sales in Q3 2024, up from **85%** in Q2 2024[9](index=9&type=chunk) [Advanced Alloys & Solutions (AA&S)](index=2&type=section&id=Advanced%20Alloys%20%26%20Solutions%20(AA%26S)) AA&S segment sales decreased **7%** sequentially to **$498.8 million**, mainly due to lower aerospace & defense and specialty energy sales, partially offset by higher electronics end market sales, with segment EBITDA at **$73.6 million** or **14.8%** of sales | Metric | Q3 2024 ($ millions) | Q2 2024 ($ millions) | Q3 2023 ($ millions) | | :----------------- | :------------------- | :------------------- | :------------------- | | Sales | $498.8 million | $533.3 million | $486.1 million | | Segment EBITDA | $73.6 million | $87.5 million | $61.5 million | | % of Sales | 14.8% | 16.4% | 12.7% | - AA&S sales decreased **7%** sequentially, driven by lower aerospace & defense (commercial airframe products) and specialty energy sales, partially offset by higher electronics end market sales[10](index=10&type=chunk) - Overall aerospace & defense sales were **36%** of total AA&S sales in Q3 2024[11](index=11&type=chunk) [Corporate Financials & Capital Management](index=3&type=section&id=Corporate%20Financials%20%26%20Capital%20Management) [Corporate Expenses and Other Items](index=3&type=section&id=Corporate%20Expenses%20and%20Other%20Items) Restructuring and other charges in Q3 2024 totaled **$4.3 million**, primarily from start-up and transaction costs, while corporate expenses decreased to **$13.4 million** due to lower incentive compensation, and the effective tax rate increased to **24.6%** - Restructuring and other charges for Q3 2024 were **$4.3 million**, primarily **$2.5 million** in start-up costs and **$1.7 million** in transaction-related costs[12](index=12&type=chunk) - Corporate expenses decreased to **$13.4 million** in Q3 2024 from **$19.4 million** in Q2 2024, mainly due to lower incentive compensation costs[12](index=12&type=chunk) - Closed operations and other income was **$2.3 million** in Q3 2024, including a **$3.7 million** gain from the sale of oil & gas rights[12](index=12&type=chunk) - The effective tax rate for Q3 2024 was **24.6%**, an increase from **22.8%** in Q2 2024, primarily due to lower discrete tax benefits[12](index=12&type=chunk) [Cash Flow and Liquidity](index=3&type=section&id=Cash%20Flow%20and%20Liquidity) Cash provided by operating activities was **$24 million** for Q3 2024, with managed working capital increasing to **40.0%** of sales, and the company redeemed **$291.4 million** of convertible notes, maintaining strong liquidity with **$407 million** cash on hand - Cash provided by operating activities was **$24 million** for Q3 2024[12](index=12&type=chunk) - Managed working capital as a percent of sales increased to **40.0%** in Q3 2024 from **35.5%** in Q2 2024[12](index=12&type=chunk) - The company redeemed **$291.4 million** of **3.5%** Convertible Senior Notes due 2025 by issuing **18.8 million shares** and received **$76 million** from the associated capped call[12](index=12&type=chunk) - Cash on hand at September 29, 2024, was **$407 million**, with approximately **$551 million** available under the ABL credit facility and no significant debt maturities until Q4 2025[12](index=12&type=chunk)[13](index=13&type=chunk) [Capital Allocation](index=4&type=section&id=Capital%20Allocation) ATI's Board of Directors authorized a **$700 million** share repurchase program, under which the company repurchased **$40
ATI Announces Third Quarter 2024 Results
Prnewswire· 2024-10-29 11:30
Ninth consecutive quarter with sales in excess of $1 billion Q3 2024 sales of $1.05 billion Q3 2024 net income attributable to ATI of $82.7 million, or $0.57 per share Aerospace & defense represent 62% of Q3 2024 sales Full year 2024 guidance updated Non-GAAP Information* Q3 adjusted net income attributable to ATI of $85.9 million, or $0.60 per share Q3 2024 ATI adjusted EBITDA of $185.7 million, or 17.7% of sales, up 100 basis points sequentially DALLAS, Oct. 29, 2024 /PRNewswire/ -- ATI Inc. (NYSE: ATI) r ...
ATI Physical Therapy to Announce Third Quarter 2024 Financial Results
Prnewswire· 2024-10-21 16:00
BOLINGBROOK, Ill., Oct. 21, 2024 /PRNewswire/ -- ATI Physical Therapy, Inc. – ("ATI" or the "Company") (NYSE: ATIP), a nationally recognized outpatient physical therapy provider in the United States, today announced that it will release third quarter 2024 financial results on Monday, November 4, 2024, after the market closes. In conjunction, the company will host a conference call to review results at 5 p.m. ET on the same day. Conference Call Details Management will host a conference call at 5 p.m. Eastern ...
Appili Therapeutics Presents Update on ATI-1701 Biodefense Vaccine Candidate at IDWeek™ 2024
GlobeNewswire News Room· 2024-10-17 11:15
ATI-1701 provides full protection against lethal tularemia in animal models after one year Company to provide update on tularemia vaccine candidate ATI-1701 and present new data on efficacy Presentation scheduled for 3:15 pm ET on October 17, 2024 HALIFAX, Nova Scotia, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced t ...
Allegheny Technologies (ATI) Exceeds Market Returns: Some Facts to Consider
ZACKS· 2024-10-16 23:21
In the latest market close, Allegheny Technologies (ATI) reached $63.02, with a +0.75% movement compared to the previous day. The stock's change was more than the S&P 500's daily gain of 0.47%. Meanwhile, the Dow gained 0.79%, and the Nasdaq, a tech-heavy index, added 0.28%. Prior to today's trading, shares of the maker of steel and specialty metals had gained 1.15% over the past month. This has lagged the Basic Materials sector's gain of 6.97% and the S&P 500's gain of 3.48% in that time. Analysts and inve ...
Allegheny Technologies (ATI) Stock Declines While Market Improves: Some Information for Investors
ZACKS· 2024-10-09 23:20
The latest trading session saw Allegheny Technologies (ATI) ending at $62.83, denoting a -1.83% adjustment from its last day's close. The stock's performance was behind the S&P 500's daily gain of 0.71%. Elsewhere, the Dow gained 1.03%, while the tech-heavy Nasdaq added 0.6%.Coming into today, shares of the maker of steel and specialty metals had gained 7.51% in the past month. In that same time, the Basic Materials sector gained 5.75%, while the S&P 500 gained 6.41%.Market participants will be closely foll ...