Henry Schein Reports First Quarter 2025 Financial Results

Henry Schein Reports First Quarter 2025 Financial Results




Henry Schein Reports First Quarter 2025 Financial Results

  • First-quarter 2025 GAAP diluted EPS of $0.88, growth of 22% compared to the first quarter of 2024
  • First-quarter 2025 non-GAAP diluted EPS of $1.15, growth of 4.5% compared to the first quarter of 2024
  • Maintains guidance for 2025 non-GAAP diluted EPS of $4.80 to $4.94, mid-single digit 2025 Adjusted EBITDA growth, and sales growth of 2% to 4%
  • Repurchased $161 million of common stock, or approximately 2.3 million shares

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, 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 A1.

  • GAAP net income2 for the quarter was $110 million, or $0.88 per diluted share4, and compares with first-quarter 2024 GAAP net income of $93 million, or $0.72 per diluted share.
  • Non-GAAP net income2 for the quarter was $143 million, or $1.15 per diluted share4, and compares with first-quarter 2024 non-GAAP net income of $143 million, or $1.10 per diluted share.
  • Adjusted EBITDA3 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 EBITDA3 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 STATEMENTS OF INCOME

(in millions, except share and per share data)

(unaudited)

 

 

Three Months Ended

 

March 29,

 

March 30,

 

2025

 

2024

 

 

 

 

 

 

Net sales

$

3,168

 

 

$

3,172

 

Cost of sales

 

2,168

 

 

 

2,160

 

Gross profit

 

1,000

 

 

 

1,012

 

Operating expenses:

 

 

 

 

 

Selling, general and administrative

 

738

 

 

 

791

 

Depreciation and amortization

 

62

 

 

 

61

 

Restructuring costs

 

25

 

 

 

10

 

Operating income

 

175

 

 

 

150

 

Other income (expense):

 

 

 

 

 

Interest income

 

6

 

 

 

5

 

Interest expense

 

(35

)

 

 

(30

)

Other, net

 

(1

)

 

 

2

 

Income before taxes, equity in earnings of affiliates and noncontrolling interests

 

145

 

 

 

127

 

Income taxes

 

(35

)

 

 

(32

)

Equity in earnings of affiliates, net of tax

 

3

 

 

 

3

 

Net income

 

113

 

 

 

98

 

Less: Net income attributable to noncontrolling interests

 

(3

)

 

 

(5

)

Net income attributable to Henry Schein, Inc.

$

110

 

 

$

93

 

 

 

 

 

 

 

Earnings per share attributable to Henry Schein, Inc.:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

0.89

 

 

$

0.72

 

Diluted

$

0.88

 

 

$

0.72

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

Basic

 

123,776,073

 

 

 

128,720,661

 

Diluted

 

124,848,221

 

 

 

129,769,580

 

 

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

 

 

 

 

 

 

 

 

HENRY SCHEIN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in millions)/(unaudited)

 

 

Three Months Ended

 

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

 

 

Exhibit A – First Quarter Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Henry Schein, Inc.

2025 First Quarter

Sales Summary

(in millions)

(unaudited)

Q1 2025 over Q1 2024

           

 

 

 

 

 

 

 

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.

Contacts

Investors
Ronald N. South

Senior Vice President and Chief Financial Officer

ronald.south@henryschein.com
(631) 843-5500

Graham Stanley

Vice President, Investor Relations and Strategic Financial Project Officer

graham.stanley@henryschein.com
(631) 843-5500

Media

Tim Vassilakos

Executive Director, Global Corporate Communications

timothy.vassilakos@henryschein.com
(516)-510-0926

Read full story here

Aurinia Pharmaceuticals to Release First Quarter 2025 Financial and Operational Results on May 12, 2025

Aurinia Pharmaceuticals to Release First Quarter 2025 Financial and Operational Results on May 12, 2025




Aurinia Pharmaceuticals to Release First Quarter 2025 Financial and Operational Results on May 12, 2025

ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that it will release first quarter 2025 financial and operational results before markets open on May 12, 2025.


Aurinia’s management team will host a conference call and webcast at 8:30 AM ET that day to review these results and provide a general business update. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170 / +1 201-493-6756. A replay of the webcast will be available on Aurinia’s website.

About Aurinia

Aurinia Pharmaceuticals is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) inhibitor for the potential treatment of autoimmune diseases.

Contacts

Media & Investor Inquiries:
Andrea Christopher

Corporate Communications & Investor Relations

Aurinia Pharmaceuticals Inc.

achristopher@auriniapharma.com

General Investor Inquiries:
ir@auriniapharma.com

Mammoth Biosciences Announces Nomination of MB-111 as First Development Candidate and Appoints Genetic Medicines Veteran Bob D. Brown to Board of Directors

Mammoth Biosciences Announces Nomination of MB-111 as First Development Candidate and Appoints Genetic Medicines Veteran Bob D. Brown to Board of Directors




Mammoth Biosciences Announces Nomination of MB-111 as First Development Candidate and Appoints Genetic Medicines Veteran Bob D. Brown to Board of Directors

MB-111 is a potential first-in-class in vivo ultracompact CRISPR therapy for Familial Chylomicronemia Syndrome and Severe Hypertriglyceridemia

Dr. Brown brings deep expertise in nucleic acid drug development as Mammoth advances its lead program, MB-111, to IND-enabling stage and continues to build a leading company in genetic medicines

BRISBANE, Calif.–(BUSINESS WIRE)–#CRISPRMammoth Biosciences, Inc., a biotechnology company harnessing its proprietary next-generation CRISPR gene editing platform to create potential one-time curative therapies, today announced the nomination of its first clinical development candidate, MB-111, and the appointment of biotechnology industry veteran, Bob D. Brown, Ph.D., to its Board of Directors.


MB-111 utilizes CasPhi — an ultracompact CRISPR in vivo gene editing system that is less than half the size of first-generation, Cas9-based systems — encapsulated in a lipid nanoparticle for delivery to the liver after IV administration. MB-111 has the potential to be a first-in-class, one-time treatment for patients with very high triglycerides including familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG).

MB-111 is designed to permanently disrupt the expression of the APOC3 gene in the liver, and thus to reduce expression of ApoC-III protein. ApoC-III is a critical driver of lipid metabolism and disrupting its production has been shown to reduce plasma triglycerides in patients with pathologically elevated levels, including those with FCS and SHTG. These patients suffer from recurrent episodes of acute pancreatitis, leading to frequent hospitalizations, as well as an increased risk of cardiovascular disease. Mammoth Biosciences is on track to initiate IND-enabling studies this year.

“The nomination of our lead program as a development candidate is a major milestone for Mammoth and the gene editing field, as well as the first proof point of the therapeutic potential of our novel ultracompact CRISPR systems and gene editing technologies,” said Trevor Martin, Ph.D., co-founder and Chief Executive Officer of Mammoth Biosciences. “The preclinical data on MB-111 is compelling, and we’re excited about its potential to be a first-in-class genetic cure for debilitating diseases such as FCS and SHTG. We believe Dr. Brown’s extensive drug discovery and development experience, and track record of building leading companies in siRNA and antisense oligonucleotide therapeutics across rare and chronic diseases will be invaluable to our goal of increasing the number of patients who can derive benefit from Mammoth Biosciences’ genetic medicines.”

Dr. Bob D. Brown brings over 30 years of experience in multidisciplinary biotechnology research and drug development, including in the US and ex-US jurisdictions. Most recently, Dr. Brown served as Chief Scientific Officer and Executive Vice President of R&D at Dicerna Pharmaceuticals, an RNAi-focused therapeutics company that was acquired by Novo Nordisk. At Novo, he served as President and Head of the Dicerna Transformation Research Unit and SVP. During his time at Dicerna, he led the discovery and early clinical development of numerous genetic medicines, including nedosiran for the treatment of primary hyperoxaluria, RG6346 for the treatment of chronic hepatitis B, belcesiran for the treatment of alpha-1 antitrypsin deficiency, and several other drug candidates now in the clinical development pipelines of large pharmaceutical companies.

Prior to Dicerna, Dr. Brown held various positions at Genta, a clinical-stage antisense oligonucleotide therapeutics company, most recently as its Vice President of Research and Technology. Previously, he was a co-founder and Vice President of R&D of Oasis Biosciences, which was acquired by Gen-Probe. Dr. Brown is an inventor or co-inventor of more than 85 issued US patents, and earned a Ph.D. in molecular biology from the University of California, Berkeley and B.S. degrees in chemistry and biology from the University of Washington, Seattle.

“I’m honored to join Mammoth Biosciences at such a pivotal moment, as CRISPR technology stands ready to transform healthcare and redefine the future of medicine,” said Dr. Brown. “I look forward to working with the exceptional Mammoth Biosciences team to harness the power of their groundbreaking platform to tackle some of the most pressing medical challenges and improve patients’ lives. Drawing on my experiences in drug discovery and clinical development, I aim to help advance Mammoth Biosciences’ ultracompact CRISPR gene editing therapies—starting with MB-111—toward clinical application.”

About Mammoth Biosciences

Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop potential long-term curative therapies for patients with life-threatening and debilitating diseases. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact systems are designed to be more specific and enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, reverse transcriptase editing, and epigenetic editing. The company is building out its wholly owned pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology platform. Mammoth Biosciences’ deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the promise of CRISPR technologies.

Contacts

Media Contact:
Mohana Ray

Email: Mammoth.PR@hdmz.com
Phone: 312-506-5210

InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA

InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA




InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA

 

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the New Drug Application (NDA) of zurletrectinib for the treatment of patients with advanced solid tumors harboring NTRK gene fusions recently. Priority review is one of the key policies introduced by the CDE to accelerate drug approval.

In the registrational trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “We are delighted that zurletrectinib has been granted priority review. Zurletrectinib has demonstrated outstanding efficacy and a favorable safety profile. We anticipate it will provide better treatment options for eligible patients with solid tumors earlier.”

Zurletrectinib is a pan-TRK inhibitor developed by InnoCare. British Journal of Cancer, part of leading science journal Nature, published a paper entitled “Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents”1.

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%2. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed in China each year. There are significant unmet clinical needs in this area due to lack of effective treatment options.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

 

1 British Journal of Cancer volume 131, pages 601–610 (2024)

2 Cocco, E., Scaltriti, M., and Drilon, A. (2018). NTRK fusion-positive cancers and TRK inhibitor therapy. Nature Reviews Clinical Oncology 15, 731-747.

 

Contacts

Media
Chunhua Lu

86-10-66609879

chunhua.lu@innocarepharma.com

Investors
86-10-66609999

ir@innocarepharma.com

InfuSystem to Report First Quarter 2025 Financial Results on May 8, 2025

InfuSystem to Report First Quarter 2025 Financial Results on May 8, 2025




InfuSystem to Report First Quarter 2025 Financial Results on May 8, 2025

Investor Conference Call to be held 9:00 a.m. Eastern Time

ROCHESTER HILLS, Mich.–(BUSINESS WIRE)–InfuSystem Holdings, Inc. (NYSE American: INFU) (“InfuSystem” or the “Company”), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, announced today it will issue first quarter 2025 financial results on Thursday, May 8, 2025, before the market opens.

The Company will also conduct a conference call for all interested parties on Thursday, May 8, 2025 at 9:00 a.m. Eastern Time to discuss its financial results.


To participate in this call, please dial (833) 366-1127 or (412) 902-6773, or listen via a live webcast, which is available in the Investors section of the Company’s website at https://ir.infusystem.com/. A replay of the call will be available by visiting https://ir.infusystem.com/ for the next 90 days or by calling (877) 344-7529 or (412) 317-0088, replay access code 6704669 through Thursday, May 15, 2025.

About InfuSystem Holdings, Inc.

InfuSystem Holdings, Inc. (NYSE American: INFU), is a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers. INFU services are provided under a two-platform model. The lead platform is Patient Services, providing the last-mile solution for clinic-to-home healthcare where the continuing treatment involves complex durable medical equipment and services. The Patient Services segment is comprised of Oncology, Pain Management and Wound Therapy businesses. The second platform, Device Solutions, supports the Patient Services platform and leverages strong service orientation to win incremental business from its direct payer clients. The Device Solutions segment is comprised of direct payer rentals, pump and consumable sales, and biomedical services and repair. Headquartered in Rochester Hills, Michigan, the Company delivers local, field-based customer support and also operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada.

Contacts

Joe Dorame, Joe Diaz & Robert Blum

Lytham Partners, LLC

602-889-9700

StatLab Activates New U.S. Manufacturing Capabilities to Secure Supply for Domestic Pathology Labs

StatLab Activates New U.S. Manufacturing Capabilities to Secure Supply for Domestic Pathology Labs




StatLab Activates New U.S. Manufacturing Capabilities to Secure Supply for Domestic Pathology Labs

Strategic investments reinforce supply chain resilience and streamline U.S. production of essential diagnostic supplies.




MCKINNEY, Texas–(BUSINESS WIRE)–StatLab Medical Products (“StatLab”), a leading global innovator of pathology supplies, today announced the launch of new U.S.-based manufacturing capabilities, advancing its multi-year “in-region, for-region” strategy to ensure reliable, scalable production of critical reagents for pathology labs nationwide. The latest milestone—insourcing injection-molded prefill containers—further strengthens StatLab’s position as one of the top U.S. manufacturers of formalin prefills, producing nearly 100 million units annually, while increasing supply chain reliability for labs amid ongoing global uncertainty.

StatLab has a long history of manufacturing StatClick™ formalin prefills, but by becoming the first in its industry to vertically integrate container and lid production in-house, it is increasing control and reducing supply chain risk for this essential product used in operating rooms and labs every day across the U.S. In addition to bringing injection molding for prefill containers in-house, StatLab will also begin blow molding gallon bottles in Q2. Production capacity for cassettes continues to grow as well, with new injection molding cells added at the Arlington facility to meet strong U.S. demand.

“At StatLab, it is in our DNA to invest ahead of the need,” said Sung-Dae Hong, CEO of StatLab. “As one of the market leaders for essential pathology consumables, insourcing key containers for the products we make, including gallon bottles and prefills, empowers us to control quality and protect our customers against external market forces.”

In another proactive move to support customers through challenging market conditions, StatLab has announced it will currently absorb any tariff-related fees associated with products manufactured in its European facilities when selling directly to U.S. laboratories. These products include PiSmart cassette and slide printers, KT microscope slides, and KT coverglass. By leveraging its U.S. and European manufacturing capabilities, StatLab is able to offer consumables for the full pathology workflow protected from tariff impact, empowering domestic customers to focus more on patient care.

“Delivering stability for our customers, especially in times of volatility, is part of the trust we build every day,” continued Hong. “We recognize the importance of predictable pricing and reliable access to the essential supplies labs need for accurate diagnoses.”

About StatLab Medical Products

StatLab Medical Products has been dedicated to helping anatomic pathology laboratories provide the best possible patient care since 1976. Today, with the strength of our united brands and locations around the globe, we’re innovating pathology essentials, together. We offer an extensive portfolio of self-manufactured consumables and pathology equipment, developed and produced across nine manufacturing sites in the United States, United Kingdom, and Europe. Our global operational footprint — powered by over 750 mission-driven colleagues — enables an “in-region, for-region” manufacturing strategy, delivering a resilient, dependable supply chain and high-quality solutions. With a customer-centric approach at our core, we bring reliability, innovation, and quality to every interaction. Learn more at StatLab.com.

Contacts

Jessica Baer

jbaer@statlab.com
630-346-1659

IFF Completes Divestiture of Pharma Solutions Business Unit

IFF Completes Divestiture of Pharma Solutions Business Unit




IFF Completes Divestiture of Pharma Solutions Business Unit

NEW YORK–(BUSINESS WIRE)–IFF (NYSE: IFF) today announced that it has successfully completed the previously announced divestiture of its Pharma Solutions business unit to Roquette.


“The completion of our Pharma Solutions divestiture represents a significant milestone for IFF as we delivered our targeted net debt to credit-adjusted EBITDA of below 3.0x,” said Erik Fyrwald, IFF CEO. “This is an important step as it allows us to focus on our core strategy – capitalizing on the exciting growth opportunities within our key businesses – as we maximize long-term value for our shareholders. We’d like to thank our Pharma Solutions colleagues for their unwavering commitment and their dedication to exceptional customer service. We wish them continued success as they find a new home with Roquette.”

Welcome to IFF

At IFF (NYSE: IFF), we make joy through science, creativity and heart. As the global leader in flavors, fragrances, food ingredients, health and biosciences, we deliver groundbreaking, sustainable innovations that elevate everyday products—advancing wellness, delighting the senses and enhancing the human experience. Learn more at iff.com, LinkedIn, Instagram and Facebook.

© 2025 by International Flavors & Fragrances Inc. IFF is a Registered Trademark. All Rights Reserved.

Contacts

Media Relations:

Paulina Heinkel

332.877.5339

Media.request@iff.com

Investor Relations:

Michael Bender

212.708.7263

Investor.Relations@iff.com

BIOQUAL Announces the retirement of Dr. Mark G. Lewis as President and CEO of the company

BIOQUAL Announces the retirement of Dr. Mark G. Lewis as President and CEO of the company




BIOQUAL Announces the retirement of Dr. Mark G. Lewis as President and CEO of the company

The Company Also Announces the Appointment of Dr. Hanne Andersen Elyard, BIOQUAL’s President and Chief Science Officer

ROCKVILLE, Md.–(BUSINESS WIRE)–BIOQUAL, Inc. www.bioqual.com BIOQ(Pinksheets):

Dr. Mark Lewis will be retiring as President of BIOQUAL effective May 31, 2025, and is succeeded by Dr. Hanne Andersen Elyard, BIOQUAL’s Chief Science Officer. Dr. Lewis will remain as Chairman of the Board of Directors. Dr. Lewis joined BIOQUAL as Senior Scientist in August 2003. He became the Executive Vice President in October 2008 and served in that capacity until he became President and CEO in 2010.

“The entire BIOQUAL team is excited and honored to have Hanne assume the role of President of BIOQUAL and to continue driving and growing our contract research program,” shared Mark Lewis, President and Chief Executive Officer of BIOQUAL. “Working alongside Hanne for over eighteen years, I remain impressed by her expertise in client contract and business operations capabilities and am confident that through her leadership our company will continue its successful operations.”

Hanne Andersen Elyard received her PhD in microbiology from the Louisiana State University Health Sciences Center in 2000. She was a postdoctoral fellow in the AIDS Vaccine Program, SAIC-Frederick, Inc. from 2001 until 2005. In January 2006 she joined BIOQUAL as a staff scientist, was promoted to Research Director in 2010, promoted to Vice President of Science in 2018 and subsequently she was promoted to Chief Scientific Officer in 2022. She has authored or co-authored more than 105 peer-reviewed scientific publications.

Forward Looking Information

Statements herein that are not descriptions of historical facts are forward-looking and subject to risks and uncertainties. The forward-looking statements are neither promises nor guarantees, and one should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including risks relating to the ability to continue to extend current government contracts; the Company’s ability to obtain new government or commercial contracts; continued demand for the use of animal models in scientific research; the Company’s ability to obtain sufficient numbers of animal models; the availability of adequate numbers of employees; the Company’s ability to perform under its contracts in accordance with the requirements of the contracts; the actual costs incurred in performing the Company’s contracts and its ability to manage its costs, including its capital expenditures; dependence on third parties; future capital needs; the ability to fund its capital needs through the use of its cash on hand and line of credit; and the future availability and cost of financing/capital sources to the Company.

Contacts

Mark G. Lewis, Ph.D., CEO (240-404-7654)

Scholar Rock Appoints David L. Hallal as Chief Executive Officer; Also Announces Addition of Three Key Leaders to Scale for Next Phase of Growth

Scholar Rock Appoints David L. Hallal as Chief Executive Officer; Also Announces Addition of Three Key Leaders to Scale for Next Phase of Growth




Scholar Rock Appoints David L. Hallal as Chief Executive Officer; Also Announces Addition of Three Key Leaders to Scale for Next Phase of Growth

  • David Hallal has served as Chairman of the Board of Directors since 2017; ensures seamless transition ahead of global launch of apitegromab for Spinal Muscular Atrophy
  • Jay Backstrom, M.D., to serve as strategic advisor as part of planned transition, continuing to work closely with executive team and Board of Directors
  • Akshay Vaishnaw, M.D., Ph.D., appointed to newly created role of President of R&D; has served as Board member since 2019
  • R. Keith Woods appointed to newly created role of Chief Operating Officer with focus on evolution to fully integrated global commercial operations
  • Vikas Sinha appointed Chief Financial Officer
  • Company to host Conference Call today at 8:30 AM ET

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, announced today that David Hallal has been appointed Chief Executive Officer succeeding Jay Backstrom, M.D. David Hallal has served as Chairman of the Board at Scholar Rock since 2017 and just prior to that spent more than a decade as CEO, COO, and CCO of Alexion building and leading the company’s 50-country operating platform. As part of this planned transition, Dr. Backstrom will serve as a strategic advisor, working closely with the company’s executive team and Board of Directors.


Scholar Rock also announced today the addition of three leaders with unparalleled experience and success in building global organizations focused on developing and commercializing life-changing therapies.

  • Akshay Vaishnaw, M.D., Ph.D., has been named President of R&D; he was formerly President of Alnylam.
  • R. Keith Woods has been appointed Chief Operating Officer and will focus on evolving the organization into a fully integrated global enterprise; he was formerly COO of argenx.
  • Vikas Sinha is joining as Chief Financial Officer; he was formerly CFO of Alexion and ElevateBio.

“On behalf of the Board, we are deeply grateful to Jay for his leadership over the past three years – driving us through the highly successful apitegromab global Phase 3 program and now into the US and European regulatory processes for marketing authorization,” said Mr. Hallal. “As Board Chair, I have been continuously collaborating with Jay to accelerate Scholar Rock’s evolution into a global biotech leader. These efforts will be amplified by the immediate addition of Akshay, Keith and Vikas – three operators that have built and led some of the most successful biotech companies in our industry. Together, we are committed to realizing Scholar Rock’s global ambitions to bring apitegromab to SMA patients around the world.”

“It has been an honor to lead the incredible team at Scholar Rock over the past several years. I am very proud of all we have achieved – from advancing apitegromab through a successful, pivotal Phase 3 study and on the path to becoming a commercial company,” said Dr. Backstrom. “With the BLA now accepted under priority review and the anticipated launch later this year, this is the right moment for our leadership transition. I’m grateful for the close partnership over the years with David and Akshay as board members, and I look forward to continuing our collaboration on behalf of the SMA community to bring our highly innovative apitegromab, the world’s first muscle targeted treatment, to patients and families living with the impact of this severe and progressive disease.”

Conference Call Information

Management will discuss the new leadership appointments via conference call on April 28, 2025 at 8:30 am ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the Scholar Rock website at http://investors.scholarrock.com. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. An archived replay of the webcast will be available on the Company’s website for approximately 90 days.

About Apitegromab

Apitegromab is an investigational fully human monoclonal antibody inhibiting myostatin activation by selectively binding the pro- and latent forms of myostatin in the skeletal muscle. It is the first muscle-targeted treatment candidate in spinal muscular atrophy (SMA) to demonstrate clinical success in a pivotal phase 3 trial. Myostatin, a member of the TGFβ superfamily of growth factors, is expressed primarily by skeletal muscle cells, and the absence of its gene is associated with an increase in muscle mass and strength in multiple animal species, including humans. Scholar Rock believes that its highly selective targeting of pro- and latent forms of myostatin with apitegromab may lead to a clinically meaningful improvement in motor function in patients with SMA. The U.S. Food and Drug Administration (FDA) has granted Fast Track, Orphan Drug and Rare Pediatric Disease designations, and the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) and Orphan Medicinal Product designations, to apitegromab for the treatment of SMA. Apitegromab has not been approved for any use by the FDA or any other regulatory agency.

About SMA

Spinal muscular atrophy (SMA) is a rare, genetic neuromuscular disease that afflicts an estimated 30,000 to 35,000 people in the United States and Europe. The disease is characterized by the loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk, and progressive muscle weakness. While there has been progress in the development of therapeutics that address the loss of motor neurons, there continues to be a high unmet need for therapies that directly address the progressive muscle weakness that leads to loss of motor function in SMA.

About Scholar Rock

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily. The company is named for the visual resemblance of a scholar rock to protein structures. Over the past decade, Scholar Rock has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about our approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Availability of Other Information About Scholar Rock

Investors and others should note that we communicate with our investors and the public using our company website www.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly known as Twitter) and LinkedIn. The information that we post on our website or on X (formerly known as Twitter) or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Scholar Rock® is a registered trademark of Scholar Rock, Inc.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, the timing and results of regulatory submissions, the therapeutic potential of apitegromab, its transition to a fully integrated global commercial enterprise and launch of apitegromab and the anticipated impact of the management transition described herein. The use of words such as “may,” “might,” “could,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, without limitation, whether the results from the Phase 3 SAPPHIRE trial will be sufficient to support regulatory approval, that preclinical and clinical data, including the results from the Phase 2 or Phase 3 clinical trial of apitegromab, are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidates; information provided or decisions made by regulatory authorities; competition from third parties that are developing products for similar uses; Scholar Rock’s ability to obtain, maintain and protect its intellectual property; Scholar Rock’s dependence on third parties for development and manufacture of product candidates including, without limitation, to supply any clinical trials; and Scholar Rock’s ability to manage expenses and to obtain additional funding when needed to support its business activities and establish and maintain strategic business alliances and new business initiatives, and our ability to continue as a going concern; as well as those risks more fully discussed in the section entitled “Risk Factors” in Scholar Rock’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

Contacts

Rushmie Nofsinger

Scholar Rock

ir@scholarrock.com
media@scholarrock.com
857-259-5573

Cynthia Clayton

Clayton Bio Communications

cynthia@claytonbiocomms.com
617-852-7735

Compass Pathways to Announce First Quarter Financial Results on May 8, 2025

Compass Pathways to Announce First Quarter Financial Results on May 8, 2025




Compass Pathways to Announce First Quarter Financial Results on May 8, 2025

Compass management will host a conference call at 8:00 am ET (1:00 pm UK)

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the first quarter ended March 31, 2025, and provide an update on recent developments, on May 8, 2025.

Compass management will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025.

A live webcast of the call will be available on the Compass Pathways website at: First Quarter 2025 Financial Results. The webcast will be archived for 30 days.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.

Contacts

Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com, +1 484 432 0041

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324