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Henry Schein Reports First Quarter 2025 Financial Results

Henry Schein Reports First Quarter 2025 Financial Results

Business Wire05-05-2025

MELVILLE, N.Y.--(BUSINESS WIRE)--Henry Schein, Inc. (Nasdaq: HSIC), the world's largest provider of health care solutions to office-based dental and medical practitioners, today reported financial results for the first quarter ended March 29, 2025.
'We are pleased with our first quarter financial results as well as the momentum we are seeing heading into the second quarter and remain confident in the fundamentals of our business,' said Stanley M. Bergman.
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'We are pleased with our first quarter financial results as well as the momentum we are seeing heading into the second quarter and remain confident in the fundamentals of our business,' said Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein.
'We are advancing our BOLD+1 Strategic Plan, which has been refreshed for 2025 to 2027, with our team focused on growing the distribution business through increasing operational efficiency and enhancing customer experience, growing our dental and medical specialty businesses and corporate brand products, and further developing our digital footprint and digital solutions. We remain committed to our long-term financial goal of high-single-digit to low-double-digit earnings growth by continuing to successfully execute against this strategy,' Mr. Bergman added.
First Quarter 2025 Financial Results
Total net sales for the quarter were $3.2 billion:
Constant currency total net sales increased 1.4% compared with the first quarter of 2024. Excluding the impact of personal protective equipment (PPE) and COVID test kits, constant currency sales growth was 2.0%.
As-reported total net sales decreased 0.1% due to a stronger U.S. dollar versus the first quarter of last year.
Global Distribution and Value-Added Services sales for the quarter increased 0.8% in constant currencies compared with the first quarter of 2024, and increased 1.5% excluding the impact of PPE and COVID test kits. As-reported sales decreased 0.7%. The main components include:
Global Dental Distribution merchandise sales for the quarter increased 0.4% in constant currencies compared with the first quarter of 2024, and increased 0.9% excluding the impact of PPE and COVID test kits. Monthly sales growth accelerated throughout the quarter after a slow start in January primarily as a result of weather-related events in the U.S. As-reported sales decreased 2.1%.
Global Dental Distribution equipment sales for the quarter decreased 2.4% in constant currencies compared with the first quarter of 2024. Sales growth was impacted by a deferral of sales from the fourth quarter of 2023 to the first quarter of 2024, resulting in a more difficult year-over-year comparison. Adjusting for this, global dental equipment sales growth in constant currencies was approximately flat to prior year. As-reported sales decreased 4.5%.
Global Medical Distribution sales for the quarter increased 3.0% in constant currencies compared with the first quarter of 2024, and increased 4.4% excluding the impact of PPE and COVID test kits, reflecting increased patient traffic to physician offices, strong growth in our home solutions business and growth from acquisitions. As-reported sales increased 2.9%.
Global Specialty Products sales for the quarter increased 4.3% in constant currencies compared with the first quarter of 2024, reflecting continued growth in implant and biomaterial sales and acquisition growth. As-reported sales increased 2.0%.
Global Technology sales for the quarter increased 3.4% in constant currencies compared with the first quarter of 2024. Strong sales growth in practice management systems, including Dentrix Ascend and Dentally cloud-based solutions, as well as in revenue cycle management products, was partially offset by lower sales of certain legacy products that are being sunset. As-reported sales increased 2.9%.
First-quarter sales growth is detailed in Exhibit A 1.
GAAP net income 2 for the quarter was $110 million, or $0.88 per diluted share 4, and compares with first-quarter 2024 GAAP net income of $93 million, or $0.72 per diluted share.
Non-GAAP net income 2 for the quarter was $143 million, or $1.15 per diluted share 4, and compares with first-quarter 2024 non-GAAP net income of $143 million, or $1.10 per diluted share.
Adjusted EBITDA 3 for the quarter was $259 million and compares with first-quarter 2024 Adjusted EBITDA of $255 million.
Restructuring Plan
During the first quarter of 2025, the Company recorded $25 million in restructuring costs and expects to achieve annual run-rate savings at the high end of its $75 million to $100 million goal by the end of 2025.
Share Repurchases
During the first quarter of 2025, the Company repurchased approximately 2.3 million shares of its common stock at an average price of $71.58 per share, for a total of $161 million. The impact of these share repurchases on first-quarter diluted EPS was immaterial.
At the end of the quarter, Henry Schein had $718 million authorized and available for future stock repurchases.
2025 Financial Guidance
Henry Schein today maintained its financial guidance for 2025. Guidance is for current continuing operations as well as acquisitions that have closed and does not include the impact of restructuring and integration expenses, amortization expense of acquired intangible assets, the insurance claim recovery associated with the cybersecurity incident and costs associated with shareholder advisory matters. This guidance also assumes that foreign currency exchange rates remain generally consistent with current levels and that additional tariffs will not be introduced.
2025 non-GAAP diluted EPS attributable to Henry Schein, Inc. is unchanged and is expected to be $4.80 to $4.94, reflecting growth of 1% to 4% compared with 2024 non-GAAP diluted EPS of $4.74.
2025 total sales growth is unchanged and is expected to be approximately 2% to 4% over 2024.
2025 Adjusted EBITDA 3 growth is unchanged and is expected to increase mid-single digits compared with 2024.
Adjustments to 2025 GAAP Net Income and Diluted EPS
The Company is providing guidance for 2025 diluted EPS on a non-GAAP basis and for 2025 Adjusted EBITDA, as noted above. The Company is not providing a reconciliation of its 2025 non-GAAP diluted EPS guidance to its projected 2025 diluted EPS prepared on a GAAP basis, or its 2025 Adjusted EBITDA guidance to net income prepared on a GAAP basis. This is because the Company is unable to provide without unreasonable effort an estimate of restructuring costs related to an ongoing initiative to drive operating efficiencies, including the corresponding tax effect, which will be included in the Company's 2025 diluted EPS and net income, prepared on a GAAP basis. The inability to provide this reconciliation is due to the uncertainty and inherent difficulty of predicting the occurrence, magnitude, financial impact and timing of related costs.
Management does not believe these items are representative of the Company's underlying business performance. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.
First-Quarter 2025 Conference Call Webcast
The Company will hold a conference call to discuss first-quarter 2025 financial results today, beginning at 8:00 a.m. Eastern time. Individual investors are invited to listen to the conference call through Henry Schein's website by visiting https://investor.henryschein.com/webcasts. In addition, a replay will be available beginning shortly after the call has ended for a period of one week.
The Company will be posting slides that provide a summary of its first-quarter 2025 financial results on its website at https://www.henryschein.com/us-en/Corporate/investor-presentations.aspx.
About Henry Schein, Inc.
Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With approximately 25,000 Team Schein Members worldwide, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. Our Business, Clinical, Technology and Supply Chain solutions help office-based dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental laboratories, government and institutional health care clinics, as well as other alternate care sites.
Henry Schein operates through a centralized and automated distribution network, with a selection of more than 300,000 branded products and Henry Schein corporate brand products in our main distribution centers.
A FORTUNE 500 Company and a member of the S&P 500® index, Henry Schein is headquartered in Melville, N.Y., and has operations or affiliates in 33 countries and territories. The Company's sales reached $12.7 billion in 2024, and have grown at a compound annual rate of approximately 11.2 percent since Henry Schein became a public company in 1995.
For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein, Instagram.com/HenrySchein, and @HenrySchein on X.
Cautionary Note Regarding Forward-Looking Statements and Use of Non-GAAP Financial Information
In accordance with the 'Safe Harbor' provisions of the Private Securities Litigation Reform Act of 1995, we provide the following cautionary remarks regarding important factors that, among others, could cause future results to differ materially from the forward-looking statements, expectations and assumptions expressed or implied herein. All forward-looking statements made by us are subject to risks and uncertainties and are not guarantees of future performance. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance and achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
These statements include total sales growth, EPS and Adjusted EBITDA guidance and are generally identified by the use of such terms as 'may,' 'could,' 'expect,' 'intend,' 'believe,' 'plan,' 'estimate,' 'forecast,' 'project,' 'anticipate,' 'to be,' 'to make' or other comparable terms. A fuller discussion of our operations, financial condition and status of litigation matters, including factors that may affect our business and future prospects, is contained in documents we have filed with the United States Securities and Exchange Commission, or SEC, including our Annual Report on Form 10-K, and will be contained in all subsequent periodic filings we make with the SEC. These documents identify in detail important risk factors that could cause our actual performance to differ materially from current expectations.
Risk factors and uncertainties that could cause actual results to differ materially from current and historical results include, but are not limited to: our dependence on third parties for the manufacture and supply of our products and where we manufacture products, our dependence on third parties for raw materials or purchased components; risks relating to the achievement of our strategic growth objectives; risks related to the Strategic Partnership Agreement with KKR Hawaii Aggregator L.P. entered into in January 2025; our ability to develop or acquire and maintain and protect new products (particularly technology products) and services and utilize new technologies that achieve market acceptance with acceptable margins; transitional challenges associated with acquisitions, dispositions and joint ventures, including the failure to achieve anticipated synergies/benefits, as well as significant demands on our operations, information systems, legal, regulatory, compliance, financial and human resources functions in connection with acquisitions, dispositions and joint ventures; certain provisions in our governing documents that may discourage third-party acquisitions of us; adverse changes in supplier rebates or other purchasing incentives; risks related to the sale of corporate brand products; risks related to activist investors; security risks associated with our information systems and technology products and services, such as cyberattacks or other privacy or data security breaches (including the October 2023 incident); effects of a highly competitive (including, without limitation, competition from third-party online commerce sites) and consolidating market; changes in the health care industry; risks from expansion of customer purchasing power and multi-tiered costing structures; increases in shipping costs for our products or other service issues with our third-party shippers, and increases in fuel and energy costs; changes in laws and policies governing manufacturing, development and investment in territories and countries where we do business; general global and domestic macro-economic and political conditions, including inflation, deflation, recession, unemployment (and corresponding increase in under-insured populations), consumer confidence, sovereign debt levels, ongoing wars, fluctuations in energy pricing and the value of the U.S. dollar as compared to foreign currencies, changes to other economic indicators and international trade agreements; the threat or outbreak of war, terrorism or public unrest (including, without limitation, the war in Ukraine, the Israel-Gaza war and other unrest and threats in the Middle East and the possibility of a wider European or global conflict); changes to laws and policies governing foreign trade, tariffs and sanctions, including the current imposition of additional new tariffs by the U.S. on numerous countries, retaliatory tariffs and potential for additional retaliatory tariffs; greater restrictions on imports and exports; supply chain disruption; geopolitical wars; failure to comply with existing and future regulatory requirements, including relating to health care; risks associated with the EU Medical Device Regulation; failure to comply with laws and regulations relating to health care fraud or other laws and regulations; failure to comply with laws and regulations relating to the collection, storage and processing of sensitive personal information or standards in electronic health records or transmissions; changes in tax legislation, changes in tax rates and availability of certain tax deductions; risks related to product liability, intellectual property and other claims; risks associated with customs policies or legislative import restrictions; risks associated with disease outbreaks, epidemics, pandemics (such as the COVID-19 pandemic), or similar wide-spread public health concerns and other natural or man-made disasters; risks associated with our global operations; litigation risks; new or unanticipated litigation developments and the status of litigation matters; our dependence on our senior management, employee hiring and retention, increases in labor costs or health care costs, and our relationships with customers, suppliers and manufacturers; and disruptions in financial markets. The order in which these factors appear should not be construed to indicate their relative importance or priority.
We caution that these factors may not be exhaustive and that many of these factors are beyond our ability to control or predict. Accordingly, any forward-looking statements contained herein should not be relied upon as a prediction of actual results. We undertake no duty and have no obligation to update forward-looking statements except as required by law.
Included within the press release are non-GAAP financial measures that supplement the Company's Consolidated Statements of Income prepared under generally accepted accounting principles (GAAP). These non-GAAP financial measures adjust the Company's actual results prepared under GAAP to exclude certain items. In the schedule attached to the press release, the non-GAAP measures have been reconciled to and should be considered together with the Consolidated Statements of Income. Management believes that non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance and allow for greater transparency with respect to key metrics used by management in operating our business. The impact of certain items that are excluded include integration and restructuring costs, and amortization of acquisition-related assets, because the amount and timing of such charges are significantly impacted by the timing, size, number and nature of the acquisitions we consummate and occur on an unpredictable basis. These non-GAAP financial measures are presented solely for informational and comparative purposes and should not be regarded as a replacement for corresponding, similarly captioned, GAAP measures.
1 See Exhibit A for details of sales growth. Internal sales growth is calculated from total net sales using constant foreign currency exchange rates and excludes sales from acquisitions.
2 See Exhibit B for a reconciliation of GAAP net income and diluted EPS to non-GAAP net income and diluted EPS.
3 See Exhibit C for a reconciliation of GAAP net income to Adjusted EBITDA.
4 References to diluted EPS refer to diluted EPS attributable to Henry Schein, Inc.
(TABLES TO FOLLOW)
HENRY SCHEIN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in millions, except share data)
March 29,
December 28,
2025
2024
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
127
$
122
Accounts receivable, net of allowance for credit losses of $81 and $78
1,578
1,482
Inventories, net
1,842
1,810
Prepaid expenses and other
490
569
Total current assets
4,037
3,983
Property and equipment, net
556
531
Operating lease right-of-use assets
294
293
Goodwill
3,956
3,887
Other intangibles, net
1,028
1,023
Investments and other
609
501
Total assets
$
10,480
$
10,218
LIABILITIES, REDEEMABLE NONCONTROLLING INTERESTS AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
908
$
962
Bank credit lines
867
650
Current maturities of long-term debt
56
56
Operating lease liabilities
77
75
Accrued expenses:
Payroll and related
243
303
Taxes
160
139
Other
606
618
Total current liabilities
2,917
2,803
Long-term debt
1,968
1,830
Deferred income taxes
135
102
Operating lease liabilities
256
259
Other liabilities
485
387
Total liabilities
5,761
5,381
Redeemable noncontrolling interests
765
806
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.01 par value, 1,000,000 shares authorized,
none outstanding
-
-
Common stock, $0.01 par value, 480,000,000 shares authorized,
122,243,683 outstanding on March 29, 2025 and
124,155,884 outstanding on December 28, 2024
1
1
Additional paid-in capital
-
-
Retained earnings
3,626
3,771
Accumulated other comprehensive loss
(317
)
(379
)
Total Henry Schein, Inc. stockholders' equity
3,310
3,393
Noncontrolling interests
644
638
Total stockholders' equity
3,954
4,031
Total liabilities, redeemable noncontrolling interests and stockholders' equity
$
10,480
$
10,218
Expand
HENRY SCHEIN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in millions)/(unaudited)
March 29,
March 30,
2025
2024
Cash flows from operating activities:
Net income
$
113
$
98
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization
73
73
Impairment charge on intangible assets
1
-
Non-cash restructuring charges
1
1
Stock-based compensation expense
5
8
Provision for losses on trade and other accounts receivable
2
5
Provision for (benefit from) deferred income taxes
(7
)
2
Equity in earnings of affiliates
(3
)
(3
)
Distributions from equity affiliates
2
2
Changes in unrecognized tax benefits
2
2
Other
(27
)
(6
)
Changes in operating assets and liabilities, net of acquisitions:
Accounts receivable
(74
)
190
Inventories
(14
)
74
Other current assets
75
41
Accounts payable and accrued expenses
(112
)
(290
)
Net cash provided by operating activities
37
197
Cash flows from investing activities:
Purchases of property and equipment
(31
)
(41
)
Payments related to equity investments and business acquisitions,
net of cash acquired
(51
)
(20
)
Proceeds from loan to affiliate
-
1
Capitalized software costs
(12
)
(9
)
Other
(5
)
(3
)
Net cash used in investing activities
(99
)
(72
)
Cash flows from financing activities:
Net change in bank credit lines
215
-
Proceeds from issuance of long-term debt
150
90
Principal payments for long-term debt
(15
)
(60
)
Proceeds from issuance of stock upon exercise of stock options
1
1
Payments for repurchases and retirement of common stock
(161
)
(75
)
Payments for taxes related to shares withheld for employee taxes
(12
)
(7
)
Distributions to noncontrolling shareholders
(4
)
(6
)
Payments for contingent consideration
(12
)
-
Acquisitions of noncontrolling interests in subsidiaries
(73
)
(94
)
Net cash provided by (used in) financing activities
89
(151
)
Effect of exchange rate changes on cash and cash equivalents
(22
)
14
Net change in cash and cash equivalents
5
(12
)
Cash and cash equivalents, beginning of period
122
171
Cash and cash equivalents, end of period
$
127
$
159
Expand
Exhibit A - First Quarter Sales
Henry Schein, Inc.
2025 First Quarter
Sales Summary
(in millions)
(unaudited)
Constant Currency Growth
Q1 2025
Q1 2024
Local Internal Growth
Acquisition Growth
Total Constant Currency Growth
Foreign Exchange Impact
Total Sales Growth
U.S. Distribution and Value-Added Services
Merchandise
$
591
$
592
-0.2
%
0.0
%
-0.2
%
0.0
%
-0.2
%
Equipment
187
205
-8.9
%
0.0
%
-8.9
%
0.0
%
-8.9
%
Value-Added Services
45
52
-15.7
%
2.3
%
-13.4
%
0.0
%
-13.4
%
Total Dental
823
849
-3.3
%
0.2
%
-3.1
%
0.0
%
-3.1
%
Medical
1,030
998
2.0
%
1.2
%
3.2
%
0.0
%
3.2
%
Total U.S. Distribution and Value-Added Services
1,853
1,847
-0.4
%
0.7
%
0.3
%
0.0
%
0.3
%
International Distribution and Value-Added Services
Merchandise
594
618
0.2
%
0.9
%
1.1
%
-5.0
%
-3.9
%
Equipment
197
197
2.9
%
1.4
%
4.3
%
-4.2
%
0.1
%
Value-Added Services
7
4
1.3
%
69.8
%
71.1
%
-12.4
%
58.7
%
Total Dental
798
819
0.8
%
1.4
%
2.2
%
-4.8
%
-2.6
%
Medical
25
27
-4.1
%
0.0
%
-4.1
%
-3.5
%
-7.6
%
Total International Distribution and Value-Added Services
823
846
0.7
%
1.3
%
2.0
%
-4.8
%
-2.8
%
Global Distribution and Value-Added Services
Global Merchandise
1,185
1,210
0.0
%
0.4
%
0.4
%
-2.5
%
-2.1
%
Global Equipment
384
402
-3.2
%
0.8
%
-2.4
%
-2.1
%
-4.5
%
Global Value-Added Services
52
56
-14.4
%
7.2
%
-7.2
%
-0.9
%
-8.1
%
Global Dental
1,621
1,668
-1.3
%
0.8
%
-0.5
%
-2.4
%
-2.9
%
Global Medical
1,055
1,025
1.8
%
1.2
%
3.0
%
-0.1
%
2.9
%
Total Global Distribution and Value-Added Services
2,676
2,693
-0.1
%
0.9
%
0.8
%
-1.5
%
-0.7
%
Global Specialty Products
367
360
0.3
%
4.0
%
4.3
%
-2.3
%
2.0
%
Global Technology
162
157
3.4
%
0.0
%
3.4
%
-0.5
%
2.9
%
Eliminations
(37
)
(38
)
n/a
n/a
n/a
n/a
n/a
Total Global
$
3,168
$
3,172
0.2
%
1.2
%
1.4
%
-1.5
%
-0.1
%
Note: Prior period amounts have been reclassified to conform to the current period presentation.
Expand
Exhibit B
Henry Schein, Inc.
2025 First Quarter
to non-GAAP net income and diluted EPS attributable to Henry Schein, Inc.
(in millions, except per share data)
(unaudited)
First Quarter
%
2025
2024
Growth
Net income attributable to Henry Schein, Inc.
$
110
$
93
17.7
%
Diluted EPS attributable to Henry Schein, Inc.
$
0.88
$
0.72
22.2
%
Non-GAAP Adjustments, net of tax and attribution to noncontrolling interests
Restructuring costs (1)
$
17
$
7
Acquisition intangible amortization (2)
27
28
Cyber incident-insurance proceeds, net of third-party advisory expenses (3)
(15
)
4
Change in contingent consideration (4)
(2
)
11
Costs associated with shareholder advisory matters (5)
6
-
Non-GAAP adjustments to net income
$
33
$
50
Non-GAAP adjustments to diluted EPS
$
0.27
$
0.38
Non-GAAP net income attributable to Henry Schein, Inc.
$
143
$
143
0.5
%
Non-GAAP diluted EPS attributable to Henry Schein, Inc.
$
1.15
$
1.10
4.5
%
Management believes that non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance and allow for greater transparency with respect to key metrics used by management in operating our business. These non-GAAP financial measures are presented solely for informational and comparative purposes and should not be regarded as a replacement for corresponding, similarly captioned, GAAP measures. Net income growth rates are based on actual values and may not recalculate due to rounding. Amounts may not sum due to rounding.
Expand
(2)
Acquisition Intangible Amortization
The following table presents details of amortization of acquired intangible assets:
First Quarter
2025
2024
Acquisition intangible amortization - pre-tax, as reported
$
43
$
46
Income tax benefit
(10
)
(11
)
Amount attributable to noncontrolling interests
(6
)
(7
)
Acquisition intangible amortization, net
$
27
$
28
Expand
(3)
Represents cyber insurance proceeds, net of one time professional and other fees related to remediation of our Q4 2023 cyber incident. During Q1 2025, we received insurance proceeds of $20 million ($15 million, net of taxes) under this policy representing the remaining insurance recovery of losses related to the cyber incident.
(4)
Represents a change in the fair value of contingent consideration of $2 million ($2 million, net of taxes) and $15 million ($11 million, net of taxes) recorded during Q1 2025 and Q1 2024, respectively, related to our acquisitions.
(5)
Represents costs associated with shareholder advisory matters of $8 million ($6 million, net of taxes) recorded during Q1 2025.
Expand
Exhibit C
Henry Schein, Inc.
2025 First Quarter
(in millions)
(unaudited)
First Quarter
2025
2024
Net income attributable to Henry Schein, Inc. (GAAP)
$
110
$
93
Income attributable to noncontrolling interests
3
5
Net income (GAAP)
113
98
Definitional adjustments:
Interest income
(6
)
(5
)
Interest expense
35
30
Income taxes
35
32
Depreciation and amortization
73
73
Non-GAAP adjustments:
Restructuring costs
25
10
Cyber incident-insurance proceeds, net of third-party advisory expenses
(20
)
5
Impairment of intangible assets
1
-
Change in contingent consideration
(2
)
15
Costs associated with shareholder advisory matters
8
-
Other adjustments:
Equity in earnings of affiliates, net of tax
(3
)
(3
)
Adjusted EBITDA (non-GAAP)
$
259
$
255
Adjusted EBITDA is a non-GAAP measure that we calculate in the manner reflected on Exhibit C. We define Adjusted EBITDA as net income, excluding (i) net income attributable to noncontrolling interests, (ii) interest income and expense, (iii) income taxes, (iv) depreciation and amortization, (v) restructuring costs, (vi) cyber incident-insurance proceeds, net of third-party advisory expenses, (vii) impairment of intangible assets, (viii) change in contingent consideration, (ix) costs associated with shareholder advisory matters, and (x) equity in earnings of affiliates, net of tax. Amounts may not sum due to rounding.
Expand

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$4.8M for unfinished work: Attorney General pledges accountability for Lexington Blue roofing

LEXINGTON, Ky. (FOX 56) — A court order has mandated the roofing company, Lexington Blue, to immediately cease operations. An investigation into the company was opened by Attorney General Russell Coleman after learning that the company allegedly accepted $4.8 million for more than 300 projects, and the majority went unfinished. RELATED | Kentucky roofing company facing lawsuit after allegedly going out of business with unfinished paid projects lined up More than 70 of its clients have filed complaints, the attorney general's office said. According to the Lexington Blue website, the company had to close due to 'extraordinary and unforeseen challenges, including unrelenting internal disruptions and attempts to sabotage our operations, including, but not limited to, negative press and reviews.' 'We are constantly on guard against predatory organizations that try to take advantage of Kentuckians, and we will hold these bad actors accountable,' Coleman said. 'We're sending a strong message to scammers that they will face serious consequences when they operate within our Commonwealth.' $4.8M for unfinished work: Attorney General pledges accountability for Lexington Blue roofing Kentucky man killed in tornado remembered for his hard work, kind heart: 'He wanted to give back' Study shows Kentucky among the poorest states The court order will prevent Lexington Blue and its operators from transferring or liquidating assets and freeze the defendant's corporate and personal accounts. Coleman encourages anyone affected by the company to contact the office here or by calling (888)432-9257. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors
2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors

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2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors

SAN FRANCISCO and SUZHOU, China, June 2, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, updated the clinical data of IBI354 (HER2 monoclonal antibody-camptothecin derivative conjugate) in advanced solid tumors at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI354 has demonstrated promising anti-tumor efficacy and favorable safety profiles across multiple solid tumors. It not only holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity" for tumor types such as ovarian cancer and breast cancer, but also validates the advantages of Innovent's ADC technology platform. The results of IBI354 lays the foundation for the subsequent development of Innovent's next-generation of bispecific ADCs and dual-payload ADCs, marking a milestone in Innovent's next-generation "IO+ADC" oncology development strategy. The data presented is from a Phase 1/2 clinical study (NCT05636215) aimed at evaluating the safety, tolerability, and preliminary efficacy of IBI354 in participants with advanced solid tumors. As of March 24, 2025, a total of 368 participants with advanced solid tumors were enrolled and received different doses of IBI354 monotherapy, the median follow-up duration was 11.5 months (range: 0.7-19.6), the median treatment duration was 27.0 weeks (range: 3.1-81.3) and 74 (20.1%) pts were still on treatment. The tumor types including 178 with breast cancer, 92 with ovarian cancer, 38 with colorectal cancer, and 60 with other tumors. IBI354 monotherapy demonstrated excellent safety profile The dosage was escalated to 18mg/kg, with no DLT events observed. The most common treatment-related adverse events (TRAEs) were anemia, nausea, and white blood cell count decreased. The incidence of interstitial lung disease (ILD) was only 1.9%, all were grade 1-2. Overall, 27.4% of patients experienced TRAEs ≥ grade 3, 17.7% experienced TRAEs leading to dose interruption, 2.7% experienced TRAEs leading to dose reduction and 1.6% experienced TRAEs leading to discontinuation, with no TRAEs leading to death. IBI354 monotherapy showed promising efficacy signals in multiple tumor types In HER2-positive breast cancer cohort (n= 88, treated at 6~15mg/kg, the median prior treatment lines was 4), the confirmed objective response rate (ORR) and the disease control rate (DCR) were 59.1% and 90.9%, respectively. In 9 mg/kg Q3W subgroup (n=29), the ORR and the DCR were 72.4% and 89.7%, respectively. The median progression-free survival (PFS) was 14.1 months (95% CI: 8.3-not calculable [NC]) with events of 48.3%. The median overall survival (OS) was immature with events of 3.4%. In ovarian cancer cohort (n=92, treated at 2~12mg/kg, the median prior treatment lines was 3), the cORR was 41.2% and the DCR was 82.0%. In the 12mg/kg Q3W subgroup (n=40), the cORR reached 55.0% and the DCR was 90.0%. In participants with HER2 1+ (n=27), the ORR reached 55.6% and the DCR was 88.9%. As of the data cutoff date, the median follow-up time was 11.9 months, and the median PFS was 7.1 months (95% CI: 5.2−10.8) in 12mg/kg Q3W dose group. The median OS was not mature with events in 14 (34.1%) pts and a 12-month OS rate of 63.9% (95% CI: 45.0−77.8). Professor Qi Zhou, Chief Physician at the Gynecologic Oncology Center of Chongqing University Affiliated Cancer Hospital and the Principal Investigator of the gynecologic oncology cohort study, stated, "The treatment of platinum-resistant recurrent ovarian cancer is difficult and the prognosis is poor, threatening the life and health of women. Extending PFS and OS in platinum-resistant recurrent ovarian cancer patients remains a clinical challenge for gynecological oncologists. ADC drugs provide a new direction for overcoming resistance mechanisms by precisely delivering cytotoxic agents. HER2, as a validated solid tumor target, has made breakthroughs in breast and gastric cancer fields, while the novel ADC drug IBI354 shows broad-spectrum antitumor activity through unique design in HER2 low-expression (IHC 1+) platinum-resistant ovarian cancer. In the Phase 1 study with a dose of 12mg/kg Q3W, IBI354 demonstrated an ORR of 55.0% and DCR of 90.0%, with a median PFS reaching 7.1 months. The safety profile was very good without common severe interstitial lung disease or ocular toxicity seen in other ADCs. These results significantly outperform traditional chemotherapy regimens, suggesting its potential breakthrough efficacy in the platinum-resistant population. The Phase 3 study of IBI354 in platinum-resistant ovarian cancer (HeriCare-Ovarian01) has been initiated, and I am looking forward to the results, as well as the further validation of the long-term benefits for patients receiving IBI354." Doctor Charlotte Rose Lemech from Scientia Clinical Research Ltd, Australia, stated: "Breast cancer is one of the most common malignant tumors among women globally and remains a leading cause of cancer-related deaths. The amplification or overexpression of HER2 (human epidermal growth factor receptor 2) is recognized as a key driver in the development, progression, and metastasis of breast cancer, with approximately 15%-20% of breast cancer patients exhibiting HER2 overexpression. ADCs have become the new standard treatment for later line HER2 positive breast cancer. In this Phase 1 study, IBI354 has demonstrated encouraging efficacy and safety data, achieving high ORR and DCR especially in 9 mg/kg Q3W subgroup. Long term survival was also achieved with the median PFS of 14.1 months. IBI354 also differentiates itself from other HER2 targeted therapies with its safety profile. The incidence of interstitial lung disease was extremely low and most of the hematological toxicity and gastrointestinal adverse events were mild to moderate and can be effectively managed with standard supportive care. This favorable safety profile enhances the clinical application potential of IBI354 and we look forward to IBI354 achieving more breakthroughs in the field of breast cancer treatment." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "With the rapid development of ADC drugs in the field of tumor treatment, Innovent is steadily advancing its strategic layout in the ADC field. At this year's ASCO conference, we update the safety and efficacy data of IBI354 across various advanced solid tumors. These clinical results not only confirm the potential therapeutic value of IBI354 but also demonstrating Innovent's innovative strength and technological advantages in ADC drug development. The phase 3 study of IBI354 in platinum-resistant ovarian cancer has been initiated, and more clinical studies are also planned. We will continue to invest in next-generation ADC molecules, aiming to address unmet clinical needs and bring patients with more effective and safer treatment options." About IBI354 (Anti-HER2 Antibody-Camptothecin Derivative Conjugate) IBI354 is an innovative HER2-targeted antibody–camptocinin derivative conjugate developed by Innovent's proprietary SoloTx ADC platform. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Innovent Biologics is conducting clinical studies to assess the efficacy and safety of IBI354 for multiple advanced solid tumors. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit or follow Innovent on Facebook and LinkedIn. Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s). (2)Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. View original content: SOURCE Innovent Biologics Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI343 (Novel Anti-CLDN18.2 ADC) From the Phase 1 Clinical Study in Patients with Advanced Pancreatic Cancer
ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI343 (Novel Anti-CLDN18.2 ADC) From the Phase 1 Clinical Study in Patients with Advanced Pancreatic Cancer

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ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI343 (Novel Anti-CLDN18.2 ADC) From the Phase 1 Clinical Study in Patients with Advanced Pancreatic Cancer

SAN FRANCISCO and SUZHOU, China, June 2, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, updated the Phase 1 study results of IBI343, a novel anti-CLDN18.2 ADC, for the treatment of advanced pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. With extended follow-up and more mature data on progression-free survival (PFS) and overall survival (OS), IBI343 has demonstrated promising therapeutic efficacy in patients with CLDN18.2-positive advanced pancreatic cancer. These encouraging results suggest the potential of IBI343 in this challenging-to-treat malignancy. Supported by these robust clinical findings, IBI343 has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA). Concurrently, the Phase 1 clinical trial of IBI343 is also being conducted in the United States, where the drug candidate has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). Pancreatic cancer is one of the most aggressive malignancies worldwide. Most patients are diagnosed in the middle and late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than 10%1. According to the GLOBOCAN 2022 statistics2, there are approximately 510,000 new cases and 467,000 deaths globally from pancreatic cancer each year, with China accounting for 120,000 new cases and 110,000 deaths annually. This Phase 1/1b study is a multi-regional, dose escalation and expansion clinical trial (NCT05458219). Preliminary data were presented at ASCO 2025 and ESMO Asia 2024 and the updated results from the study's dose-expansion cohort were presented at the 2025 ASCO as follows: As of March 14, 2025, a total of 83 patients with pancreatic cancer had received at least one dose of IBI343 with a median follow-up time of 11.1 months. As the data cutoff date, in patients with CLDN18.2 1+2+3+≥60% expression treated at the 6mg/kg dose (N=44), the confirmed overall objective response rate (cORR) was 22.7% and the disease control rate (DCR) was 81.8%. The median progression-free survival (mPFS) was 5.4 months, and the median overall survival (mOS) was 9.1 months. Among them, 17 patients had received only one line of prior treatment, achieving a mPFS of 5.4 months and a mOS of 12.1 months; and 18 patients had received two lines of prior treatment, the mPFS was 5.3 months and the mOS was 9.1 months. The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals. 98.8% of the patients experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, and white blood cell count decreased. Notably, no ≥ grade 3 nausea and vomiting occurred. Professor Xianjun Yu from Fudan University Cancer Hospital, said, "Pancreatic cancer is one of the most malignant tumors of the digestive tract. Most patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only about 10%1. Currently, chemotherapy is still the main first- and second-line treatment for advanced pancreatic cancer. The clinical options for second-line treatment are particularly limited, with a chemotherapy response rate of only 6-16%, median progression free survival of 2 to 5 months, and a median survival of approximately 6 to 9 months3, representing an urgent clinical need. With longer follow-up, the mature PFS and OS data from the latest IBI343 update demonstrate promising therapeutic potential, suggesting a breakthrough in this difficult-to-treat malignancy." Dr. Hui Zhou, Senior Vice President of Innovent, said, "We are pleased to present an oral update on IBI343's clinical data at this year's ASCO conference. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate to show encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. We hope to continue advancing the clinical trials of IBI343 for pancreatic cancer patients. Innovent will leverage its unique strengths in R&D innovation and clinical translation to develop a new generation of globally competitive oncology - focused innovative pipeline to benefit patients worldwide.." About IBI343(Anti-CLDN18.2 ADC) IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect". As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancer. The Phase 3 trial of IBI343 for advanced gastric / gastroesophageal junction adenocarcinoma is now recruiting patients. The relevant indication has been included in China's NMPA breakthrough therapy list. IBI343's Phase 1 trial for advanced pancreatic ductal adenocarcinoma is enrolling patients in an multi-regional study. This indication has received Fast Track designation from the FDA and been included in the NMPA's BTD list. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit or follow Innovent on Facebook and LinkedIn. Statement: 1. Innovent Biologics does not recommend the use of unapproved drugs/indications. 2. Ramucirumab injection (Ciranza®), selpercatinib capsules (Ritu®) and pirtobrutinib tablets (Capra®) were developed by Eli Lilly and Company Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References 1 Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33. doi: 10.3322/caac.21708. 2 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. 3 Jemal A, Bray F, Center MM, et al. Global cancer stastics. CA Cancer J Clin, 2011, 61(2): 69-90. View original content: SOURCE Innovent Biologics

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