Silexion Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Silexion Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update




Silexion Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Throughout the year, the Company reported significant positive preclinical findings for SIL204 across eight KRAS mutations and four cancer types, including first evidence of activity in gastric cancer, reinforcing broad therapeutic potential

During the fourth quarter, Silexion achieved key clinical readiness milestones including completing two-species toxicology studies, written Scientific Advice from Germany’s BfArM, and submission of Phase 2/3 clinical trial application to the Ministry of Health in Israel for SIL204 in locally advanced pancreatic cancer

The Company remains on track to initiate Phase 2/3 clinical trial in the first half of 2026, with Israel regulatory feedback anticipated by the end of Q1 2026

Grand Cayman, Cayman Islands, March 17, 2026 (GLOBE NEWSWIRE) — Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage, oncology-focused biotechnology company, today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on recent business developments.

Recent Milestones & Business Highlights

Expanding Preclinical Validation Across KRAS-Driven Cancers: Throughout 2025, Silexion generated additional preclinical data supporting the broad therapeutic potential of SIL204. In human KRAS-mutated cancer cell line models, SIL204 demonstrated very high inhibition levels of cancer cell growth across multiple models and showed activity against eight distinct KRAS mutations: G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D. Preclinical efficacy was observed across four cancer types, including pancreatic, colorectal, lung, and gastric cancers. In orthotopic pancreatic cancer models, systemic administration of SIL204 resulted in significant reductions in primary tumor growth and metastatic spread to secondary organs.

Completion of Toxicology Studies and Clinical Trial Infrastructure Build-Out: In the fourth quarter of 2025, the Company completed two-species GLP toxicology studies for SIL204, supporting planned regulatory submissions and Phase 2/3 clinical readiness. During the year, Silexion also announced it has engaged AMS Advanced Medical Services GmbH as contract research organization (CRO) for its planned Phase 2/3 program and advanced manufacturing and operational partnerships to support scaled clinical execution.

Regulatory Advancement Toward Phase 2/3 Initiation: Silexion received written Scientific Advice from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) regarding the design of its planned Phase 2/3 clinical trial. The Company subsequently submitted its Phase 2/3 clinical trial application to the Ministry of Health in Israel for SIL204 in locally advanced pancreatic cancer and anticipates receiving initial regulatory feedback in the first quarter of 2026. The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of the first quarter of 2026, with additional regulatory filings across the European Union planned in early 2027.

Strengthened Financial Position and Nasdaq Compliance: During 2025, the Company raised over $18.6 million in aggregate gross proceeds through public offerings and warrant exercises transactions. In September 2025, Nasdaq confirmed that Silexion had regained full compliance with Listing Rules 5550(a)(2) and 5550(b)(1), securing continued listing on the Nasdaq Capital Market.

Phase 2/3 Clinical Trial Planned for the Second Quarter of 2026: The planned Phase 2/3 clinical study is expected to begin in the second quarter of 2026 and will include an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. The study is designed to evaluate SIL204’s dual-route administration approach in combination with standard chemotherapy in patients with locally advanced pancreatic cancer.

Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: “We made meaningful progress during the fourth quarter and throughout 2025 as we executed across scientific, operational, and regulatory priorities to advance SIL204 toward the clinic. With our toxicology package completed, written Scientific Advice from Germany, and the submission of our Phase 2/3 clinical trial application in Israel, we believe we are well-positioned to continue advancing toward our planned Phase 2/3 clinical program initiation in 2026. We remain focused on disciplined execution as we work to bring an RNAi-based approach to patients with KRAS-driven cancers.”

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: “During 2025, we strengthened our financial position while maintaining a determined operating approach. We ended the year with approximately $6.0 million in cash and cash equivalents, and we believe our capital structure and focus on clinical progress support our planned development and regulatory and clinical milestones as we advance SIL204.”

Financial Results for the Three Months Ended December 31, 2025

  • Research and development (“R&D”) expenses for the three months ended December 31, 2025, were approximately $3.4 million, compared to approximately $0.9 million for the same period in 2024.This quarter-over-quarter increase primarily reflected the Company’s continued progression toward clinical readiness, including increased development and external program execution activities.
  • General and administrative (“G&A”) expenses for the three months ended December 31, 2025, were approximately $1.0 million, compared to approximately $1.0 million for the same period in 2024.
  • Net loss for the three months ended December 31, 2025, was approximately $4.4 million, compared to approximately $1.7 million in the same period of 2024.

Financial Results for the Year Ended December 31, 2025:

  • R&D expenses for the year ended December 31, 2025, were $7.1 million, compared to $5.8 million for the year ended December 31, 2024. The increase was primarily driven by higher subcontractor and consultant expenses related to GMP production batches of the active pharmaceutical ingredient (API) and formulation development intended to support initiation of the planned human clinical trial expected in the second quarter of 2026, partially offset by the absence of non-cash share-based compensation expenses recognized in the prior-year period in connection with grants issued during the August 2024 Business Combination.
  • G&A expenses for the year ended December 31, 2025, were $4.5 million, compared to $6.8 million for the year ended December 31, 2024.The decrease primarily reflecting the absence of significant non-cash share-based compensation expenses and transaction costs recognized in the prior-year period in connection with grants issued during the August 2024 Business Combination, partially offset by higher professional services costs including director compensation, legal and other expenses associated with the transition to a public company subsequent to the Closing of the Business Combination, and more.
  • Net loss for the year ended December 31, 2025, was $11.9 million, compared to a net loss of $16.5 million for the year ended December 31, 2024.

Balance Sheet Highlights:

  • As of December 31, 2025, the Company had cash and cash equivalents of $6.0 million, compared to $1.2 million as of December 31, 2024. The Company believes that its current cash balance will support in its continued advancement toward the initiation of Phase 2/3 clinical trial expected in the second quarter of 2026.
  • Total shareholders’ equity was $2.6 million as of December 31, 2025, compared to a capital deficiency of $(4.0) million as of December 31, 2024. During 2025, the Company completed multiple financing transactions, including approximately $11.0 million in gross proceeds from public offerings in January and September, approximately $2.6 million from warrant exercises, and approximately $5.0 million from warrant exercise inducement transactions (before related issuance costs).

About Silexion Therapeutics
Silexion Therapeutics is a pioneering clinical stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: https://silexion.com

Notice Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, Including, for example, statements regarding the development of SIL204; the timing, content, outcome, and review of regulatory submissions and interactions with regulatory authorities in Israel, Germany, the European Union, and other jurisdictions; the timing, initiation, design, and conduct of the planned Phase 2/3 clinical trial (including the timing of patient enrollment and dosing) and any other clinical studies; the timing and results of additional preclinical, toxicology, manufacturing, and operational readiness activities; the potential therapeutic benefits, mutation coverage, and clinical utility of SIL204 and any future product candidates across multiple cancer types; Silexion’s business strategy and development plans; Silexion’s ability to raise additional capital and its future capital requirements; and Silexion’s ability to maintain its Nasdaq listing, are forward-looking statements. These forward-looking statements are generally identified by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion’s ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion’s strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion’s future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion’s ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.

Company Contact:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com

Investor Relations
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com

SILEXION THERAPEUTICS CORP
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)

  December 31
  2025 2024
Assets    
CURRENT ASSETS:    
Cash and cash equivalents $5,991 $1,187
Restricted cash 27 35
Prepaid expenses 570 966
Other current assets 49 62
TOTAL CURRENT ASSETS 6,637 2,250
     
NON-CURRENT ASSETS:    
Restricted cash 57 48
Long-term deposit and other non-current assets 84 5
Property and equipment, net 25 30
Operating lease right-of-use asset 412 530
TOTAL NON-CURRENT ASSETS 578 613
TOTAL ASSETS $7,215 $2,863
     


SILEXION THERAPEUTICS CORP
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)

  December 31
  2025 2024
Liabilities and shareholders’ equity (capital deficiency)    
CURRENT LIABILITIES:    
Trade payables $787 $929
Current maturities of operating lease liability 182 158
Employee related obligations 879 642
Accrued expenses and other accounts payable 910 788
Private warrants to purchase ordinary shares (including $* and $1 due to related party, as of December 31, 2025 and December 31, 2024, respectively) * 2
Underwriters Promissory Note – 1,004
TOTAL CURRENT LIABILITIES 2,758 3,523
     
NON-CURRENT LIABILITIES:    
Long-term operating lease liability 286 368
Related Party Promissory Note 1,568 2,961
TOTAL NON-CURRENT LIABILITIES $1,854 $3,329
TOTAL LIABILITIES $4,612 $6,852
     
COMMITMENTS AND CONTINGENT LIABILITIES (Note 7)    
SHAREHOLDERS’ EQUITY (CAPITAL DEFICIENCY): Ordinary shares ($0.0135 par value per share, 9,000,000 and 1,481,482 shares authorized as of December 31, 2025 and December 31, 2024, respectively; 3,126,651 and 123,290** shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively) 42 2
Additional paid-in capital 57,727 39,263
Accumulated deficit (55,166) (43,254)
TOTAL SHAREHOLDERS’ EQUITY (CAPITAL DEFICIENCY) $2,603 $(3,989)
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY (CAPITAL DEFICIENCY) $7,215 $2,863

All share amounts have been retroactively adjusted to reflect a 1-for-15 reverse share split as discussed in Note 1(e) of the Company’s financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2025
* Represents an amount less than $1
** Net of 28 treasury shares held by the Company as of December 31, 2024


SILEXION THERAPEUTICS CORP
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share data)

  Year ended December 31
  2025 2024
OPERATING EXPENSES:    
Research and development (including $0 and $1,796 from related party, for the year ended December 31, 2025 and December 31, 2024, respectively) $7,140 $5,815
General and administrative (including $134 and $2,972 from related party, for the years ended December 31, 2025 and December 31, 2024, respectively) 4,492 6,756
TOTAL OPERATING EXPENSES 11,632 12,571
OPERATING LOSS 11,632 12,571
Financial expenses (income), net (including $232 and $(1,249) from related party, for the years ended December 31, 2025 and December 31, 2024, respectively) 277 3,938
LOSS BEFORE INCOME TAX $11,909 $16,509
INCOME TAX 3 10
NET LOSS FOR THE YEAR $11,912 $16,519
     
Attributable to:    
Equity holders of the Company 11,912 16,443
Non-controlling interests – 76
  $11,912 $16,519
LOSS PER ORDINARY SHARE, BASIC AND DILUTED* $8.96 $394.94
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE*: 1,329,515 41,635

* All share amounts have been retroactively adjusted to reflect a 1-for-15 reverse share splits as discussed in Note 1(e) of the Company’s financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2025

Compass Health Invites Community to “Camp Out” for Youth Behavioral Health

Compass Health Invites Community to “Camp Out” for Youth Behavioral Health




Compass Health Invites Community to “Camp Out” for Youth Behavioral Health

Annual fundraiser supports programs for children, youth, and families across Northwest Washington

EVERETT, Wash., March 17, 2026 (GLOBE NEWSWIRE) — For fifteen years, Compass Health has hosted therapeutic camps that help youth across Northwest Washington build confidence, strengthen social skills, and experience the joy of the outdoors.

Now, the community is invited to share in that same spirit of connection and fun at The Great Compass Health Camp Out, the organization’s annual fundraiser supporting its child, youth, and family programs. The event, which takes place April 17, 2026, at 6 p.m. at Thomas Family Farm in Snohomish, will be an evening inspired by the joys of the camp experience. The event is for guests 21 and older. Tickets are available online here.

“Our camps are about more than just outdoor fun,” said Tom Sebastian, CEO of Compass Health. “They give kids a chance to try new things, develop friendships, and experience the kind of connection that can change the trajectory of their lives. The Camp Out will celebrate those moments while supporting the broader network of child, youth, and family programs at Compass Health that serve young people and their families year-round.”

The Great Compass Health Camp Out marks the return of Compass Health’s signature annual fundraiser following the organization’s decision to reimagine its longstanding gala, previously known as the Building Communities of Hope Gala.

With a fresh format and a relaxed, camp-inspired atmosphere, this year’s event will feature nostalgic games and activities, classic camp treats, and opportunities to hear firsthand about the broad impact of Compass Health’s youth programs, which serve more than 6,000 Northwest Washington community members every year.

An event highlight will be the Mission Moment, a fireside-style conversation between Compass Health CEO Tom Sebastian and individuals who have directly benefited from the organization’s child, youth, and family programs, including a client, a caregiver, and a peer counselor. Together, they will share firsthand perspectives on how these programs support young people and families and the difference they are making in communities across the region.

Additionally, guests will be able to enjoy arcade favorites like Pac-Man, test their skills at Skee-Ball and mini golf, capture memories at the Camp Out photo booth, and purchase event-branded merchandise, including custom-pressed T-shirts and sweatshirts. The evening will feature a raffle and a raise-the-paddle fundraising opportunity, led by longtime host Fred Northrup Jr.

“Across the communities we serve, we continue to see youth behavioral health needs growing, and time and again we hear from community members asking how they can help,” said Tom Kozaczysnki, chief advancement officer at Compass Health. “The Camp Out is a chance to turn that goodwill into action – an evening for people to come together, have fun, and help ensure essential programs remain available to the young people and families who need them most.”

The Great Compass Health Camp Out is a key funding source for Compass Health’s child, youth, and family services, including programs that support young people struggling with behavioral health challenges and family chemical dependency issues. Benefiting programs are:

  • Child and Family Outpatient Programs, which provide an array of counseling and support services to children, youth, and families that may have emotional and/or behavioral health challenges.
  • Children’s Intensive Services / Wraparound with Intensive Services (WISe), which supports children and their families in the least restrictive environment by honoring the family’s voice, choice, strengths, and natural supports.
  • Camp Outside the Box, a camp specifically designed for children and youth in the WISe program that gives them a chance to participate in fun summer activities while also practicing their social skills with other kids in the program.
  • The Child Advocacy Program (CAP), a program that provides therapeutic services to children and adolescents who have experienced physical or sexual abuse or witnessed a violent crime.
  • YGo Youth Mobile Crisis Outreach Program, which meets youth where they are, whether at home, school, or other community settings, and provides crisis stabilization and short-term support for up to eight weeks.
  • Camp Mariposa, a year-round addiction prevention and mentoring program for youth affected by substance use disorder of a family member that offers fun, traditional camp activities combined with education and support sessions led by mental health professionals and trained adult mentors.

The event is supported by the generosity of many organizations, including FRANSiS, Kaiser Permanente, and BNB Builders. Sponsorship opportunities are still available for companies looking to connect with like-minded community members invested in mental health.

At a time when behavioral health providers across Washington are facing uncertainty due to proposed Medicaid cuts, community support plays a critical role in sustaining these vital programs and services.

“This year is Compass Health’s 125th anniversary, and it’s fitting that we’re celebrating by returning to where our mission began – supporting children and families,” added Sebastian. “For more than a century, we’ve been committed to making sure young people in our communities have access to the care and support they need to thrive, and that commitment remains as strong as ever. We’re grateful for everyone who stands alongside us to support the next chapter of this work for generations to come.”

To learn more about The Great Compass Health Camp Out and purchase tickets, visit www.compasshealth.org/tgcco/. Tickets for the event close Tuesday, April 3.

About Compass Health:   
Compass Health is Northwest Washington’s behavioral healthcare leader. A community-based healthcare agency, Compass Health integrates behavioral health and medical care services to form a key section of the community safety net and serve clients and others in need of care and support. From comprehensive mental health treatment to crisis prevention and intervention, supportive housing, children’s services, community education and much more, the non-profit organization serves people of all ages throughout Snohomish, Skagit, Island, San Juan, and Whatcom counties.   
  
Media Contacts:   
McKenzie Morgan 
Firmani + Associates Inc.   
Compasshealth@firmani.com   
(702) 580-8687   
  
Sarah Forster 
Compass Health   
Sarah.forster@compassh.org 
(306) 728-8288

Virbac: 2025 annual results

Virbac: 2025 annual results




Virbac: 2025 annual results

A robust adjusted EBIT margin² of 16.3% at CERS, driven by solid organic revenue growth of 7.9%

  • Solid 2025 dynamic with annual revenue up +7.9% at CERS; with strong momentum in key categories and countries. Volume/mix effect of ~+5%, completed by price increase of ~+3%
  • Adjusted EBIT (before amortization of assets arising from acquisitions) margin of 16.3% at CERS despite:
    • temporary shutdown of an antigen’s production site and higher inventory write-offs in FY25
    • partially offset by a solid underlying performance on sales prices and product mix and;
    • improving operating expense to revenue ratio. 
  • Consolidated net income increased by +3.2% and amounts to €150.5m
  • Strong cash generation of €93 million funded the Thyronorm acquisition while maintaining a relatively stable net debt at €172.8 million compared to €168.5 million at the end of 2024
  • 2026 guidance: (incl. Thyronorm acquisition impact) : revenue growth expected to be between 5.5% and 7.5% at constant rates and scope. Adjusted recurring operating income1 expected around 17%
in  €m FY25 FY24 Évolution
       
Revenues 1 464.7 1 397.4 4.8 %
Change at constant exchange rates1     8.7 %
Change at constant exchange rates and scope1     7.9 %
EBIT Adjusted (before amortizations2) 234.4 231.8 1.1%
as a % of revenue 16.0% 16.6% (0.6)p.p
as a % of revenue at constant rates 16.5% na na
as a % of revenue at constant exchange rates and scope 16.3% na na
Amortization of intangible assets from acquisitions (4.8) (4.3) 10.8 %
EBIT Adjusted 229.7 227.5 0.9 %
Non-recurring (expenses) and income (3.5) (10.4) (66.1)%
EBIT 226.1 217.1 4.2 %
Consolidated net income 150.5 145.8 3.2 %
       
Other financial indicators      
Shareholders’ equity – Group share 1 125.2 1 043.1 7.9 %
Net debt3 172.8 168.5 2.5 %
Operating cash flow before interest and taxes4 289.1 280.3 3.1 %
       

1Change at constant exchange rates and scope corresponds to organic sales growth, excluding exchange rate variations by calculating the indicator for the current and prior periods using identical exchange rates (the exchange rate used is that of the prior period), and excluding material changes in scope by calculating the indicator for the current period based on the prior period’s consolidation scope. This change is calculated on the actual scope, including scope impacts from acquisitions (Sasaeah company), for which the relevant indicator is calculated using the prior period’s exchange rate.

²EBIT Adjusted (before amortizations) corresponds  to “recurring operating income before amortization of assets arising from acquisitions”.

³Net debt corresponds to current (€105.9 million) and non-current (€150.4 million) financial liabilities, as well as the lease liability related to the application of IFRS 16 (€39.0 million), less cash and cash equivalents (€122.5 million) as published in the statement of financial position.

⁴Operating cash flow corresponds to the EBIT adjusted before amortizations of asset arising from acquisitions (€234.4 million) restated for depreciation & provisions (€56.4m – amortizations from acquisitions adjusted), non-cash items (€1.2m), impacts related to disposals (€1.1m) and other non-current income & expenses (-€4.1m).

The financial statements have been audited by the statutory auditors and were reviewed by the Board of Directors on March 17, 2026. The financial statements and the detailed presentation of the annual results are available on the corporate.virbac.com website.

Paul Martingell, Chief Executive Officer statement: 

“Our 2025 performance perfectly illustrates the resilience and agility of the Virbac teams and model. We delivered solid organic growth of 7.9% and maintained a robust adjusted EBIT margin of 16.3% (at constant exchange rates and scope), despite some temporary headwinds. This financial strength, characterized by a strong cash generation power and low debt, has allowed us to accelerate our strategic investments: we reached record levels in R&D to support future innovations as well as in Capex to bolster our industrial transformation. The acquisition of Thyronorm further highlights our ability to seize targeted external growth opportunities to complete our portfolio in high unmet need areas. In the face of a continued unstable external environment, we enter 2026 with confidence. Our diverse portfolio and the exceptional commitment of our teams allow us to look forward with confidence and to continue our mission of advancing animal health.”

Full year 2025 sales by geography

For the full year 2025, revenue reached €1,465 million, compared to €1,397 million in 2024, representing an overall increase of +4.8%. Excluding currency effects, revenue delivered significant growth of +8.7%. At constant exchange rates and scope, growth for FY25 stands at +7.9%. The acquisition of Sasaeah (Japan, April 2024) contributed +0.8 percentage points to growth. The acquisition of Mopsan (Türkiye, Dec 2024) contributed +0.4 points; however, this impact was not excluded from the constant scope calculation as it was deemed non-material.

  • Europe (+7.5% at CERS): This strong organic growth was driven by positive momentum across all segments and geographies within the region. The Companion Animal business grew by 7.8%, supported primarily by our petfood, dermatology, and reproduction ranges. Meanwhile, the Farm Animal segment also recorded an 8.2% increase; this was largely due to the response to the bluetongue virus (BTV) epidemic and the solid performance of core ruminant products, though these gains were partially tempered by production delays impacting our antibiotic ranges.
  • North America (+14.7% at CERS): The region once again delivered an exceptional performance, spearheaded by the Companion Animal segment (+24.2% at CERS). This growth was propelled by the combined success of new launches (specifically Ursolyx and Zenifel) and strong results from our core business, particularly in the dental, dermatology, and specialty ranges (mobility and behavior). However, this was partially counterbalanced by a decline in our contract manufacturing business (-33.5%), which faced delayed orders. It is worth noting that, excluding the impact of distributor destocking/restocking, organic growth for the region would stand at ~+12%. 
  • Latin America (+7.4% at CERS): The Companion Animal segment posted a 13.0% increase at CERS, with Mexico (+19%) and Colombia (+23%) acting as the primary engines of growth. This performance was built on the success of our petfood, vaccine, dermatology, and nutritional portfolios. The Farm Animal segment also increased, driven by results in Brazil (+14.3%), Colombia (+33.4%), and Mexico (+4.8%). The main contributors to this segment were cattle vaccines, antibiotics, antiparasiticides, and nutritional products, partially offset by a downturn in Chile (-9.6%), where our aquaculture activities faced intensified competitive pressure. 
  • IMEA (+9.5% at CERS): The zone delivered solid progress across all geographies, spearheaded by the Farm Animal segment (+10%). This strong growth was primarily sustained by our ruminant portfolio, with a particularly strong contribution from our nutritional products. Meanwhile, the Companion Animal segment also recorded a robust increase of +6.8%. 
  • Far East Asia (+3.3% at CERS): The zone achieved growth across all geographies, except in Vietnam due to the swine fever epidemic. The Companion Animal segment grew +5.2%, supported by our specialty and antiparasiticides ranges. The scope effect from the acquisition of Sasaeah (completed in April 2024) contributed an additional 9.6 pt to the zone’s growth for the year.
  • Pacific (+0.1% at CERS): The zone remained stable compared to the previous year. Australia recorded a slight decline (-1.6%), impacted by increasing competition and destocking activities at major distributors; however, a recovery was observed in the second half of the year, driven by improved market conditions, normalized inventory levels, and sustained demand in the Companion Animal segment. Conversely, New Zealand closed the year with solid growth of +5.7%, supported by the extension of our nutritional product range and increasing sales of antibiotics.

Full year 2025 results

EBIT Adjusted (before amortizations2) stood at €234.4 million in FY25 compared to €231.8 million in FY24
The actual margin reached 16.0% in FY25 compared to 16.6% in FY24. After adjusting for a currency effect of -0.5 point and a scope effect of +0.2 point, the margin at constant exchange rate and scope amounts to 16.3% in FY25. The performance in 2025 is explained by a decrease in the gross margin (-0.7 point) and by controlled operating and R&D expenses (+0.1 point).

  • The decline in gross margin, beyond the impact of exchange rate is primarily attributable to two factors: a temporary production interruption for one of the Group’s antigens due to facility maintenance, with operations having since resumed and higher level of inventory write-offs compared to last year. However, this was partially offset by a very solid underlying performance fueled by favorable sales prices and product mix.  
  • Operating expenses were managed efficiently in 2025 leading to the reduction of the ratio to revenues of 0.2 point.
  • R&D expenses grew in value as expected but stayed relatively stable in ratio to revenues at ca. 7.9% in FY25 due to the strong revenue growth (0.1 point).

Consolidated net income amounts to €150.5 million, an increase of 3.2% compared to 2024

  • Amortization charges on intangible assets from acquisitions increased from €4.3 million to €4.8 million, a rise mainly due to the integration of Mopsan (acquired in Dec24) and to a lesser extent Sasaeah (acquired in Apr24).
  • Non recurring income and expenses stand at €3.5 million in 2025 and are mainly composed of provisions for depreciation of assets no longer in use (€2.4m) and one-off operational expenses mainly related to M&A activities (€1.8m).
  • Net financial expense increased to €8.6 million, compared to €9.3 million in 2024, and mainly consists of a foreign exchange loss of €4.1 million, supplemented by a cost of financial debt of €4.3 million. The foreign exchange loss is due to the appreciation of the euro against unhedged exposures, particularly to the Chilean peso (-€2.2 million) and, to a lesser extent, the Mexican peso (-€1.9 million).
  • Corporate income tax increased to €67.2 million compared to €62.5 million in 2024 in line with the level of activity. The effective tax rate has slightly increased to ~26.5% vs 25.5% in 2024 essentially linked to a country mix effect.
  • Net income – Group share stands at €150.9 million, an increase of 3.9% compared to the previous year (€145.3 million).

Net debt as of Dec25, stands at €172.8 million relatively stable compared to Dec24 (€168.5m)
The operating cash flow before interest and taxes increased to 289m€. The capex spending amounted to 102m€ essentially linked to our industrial transformation including a few new sites being built to support the future growth of the group. Working capital requirements benefited from an improvement in our inventory and contributed positively to the net free cash flow. All of these elements resulted in a solid cash generation of €93 million at constant exchange rates and scope, which enabled the €107.8* million acquisition of Thyronorm in December 2025, leaving a relatively stable net debt level at the end of 2025 compared to 2024.

Key events of the period

  • Paul Martingell is appointed CEO of Virbac Group, Effective September 1, 2025
  • Virbac continues to execute its “programmatic M&A” strategy with the recent acquisition of Thyronorm. Thyronorm (~€27M in-market annual revenue) is a specialty product to treat feline hyperthyroidism, a condition affecting more than 10% of older cats. This addition complements the existing portfolio and is expected to be accretive to sales and EBITDA margin from Year 1. Virbac will distribute directly in the UK, Australia, and NZ (under Thyronorm) and in the US (under Felanorm). In Europe, distribution will transition from partners (Boehringer Ingelheim, Elanco) to Virbac over the coming years.

*Note: The €107.8m Thyronorm acquisition amount includes an €11.5m escrow payment. In accordance with our reporting standards, this is classified under other working capital rather than as a direct M&A investment.

Guidance 2026

For the year 2026, we currently anticipate at constant rate and scope :

  • A revenue growth between 5.5% and 7.5%
  • A ratio of “current operating income before amortization of assets resulting from acquisitions” (Ebit adjusted) to “revenue” around 17%
  • Our cash generation should be around ~+€80m

In line with our reporting standards, the Thyronorm acquisition is included within the 2026 organic perimeter (constant scope) due to its materiality level. Consequently, the provided guidance accounts for Thyronorm’s contribution to both total revenue (~+1 pt of growth) and expected operating income (~+0.5 Ebit adjusted). As previously disclosed the direct impact of US tariffs is estimated as of today at approximately US$4 million annually. This impact is fully integrated into our 2026 outlook.

Finally, at the next shareholders’ meeting, a net dividend per share of €1.45 will be recommended for distribution for the 2025 fiscal year.

ANALYSTS’ PRESENTATION – VIRBAC

We will hold an analysts meeting on Wednesday, March 18, 2026 at 2:00 p.m. (Paris time – CET)
in the Sainte-Cécile auditorium, 8 rue Sainte-Cécile, 75009 Paris (France)

Participants may arrive 15 minutes before the start of the meeting.

You may also attend the meeting using the webcast (audio + slides) available via the link below.

Information for participants:

Webcast access link: bit.ly/3Pc4jdM

This access link is available on the corporate.virbac.com site, under the heading “Public releases.” This link allows participants to  
access the live and/or archived version of the webcast.

You will be able to ask questions via chat (text) directly during the webcast or after watching the replay via the following email 
address: finances@virbac.com.

 About Virbac – Caring for animals together

At Virbac, we are constantly exploring new ways to prevent, diagnose and treat the majority of animal pathologies. We develop care, hygiene and nutrition products to offer complete solutions to veterinarians, farmers and pet owners around the world. Our purpose: advancing the health of animals with those who care for them every day, so we can all live better together.

More information on corporate.virbac.com

ANNEXES

  1. Income statement of the period
in €k 2025 2024   Variance
       
Net sales 1 464 677 1 397 380 4.8%
       
Raw materials and consumables used  -487 964  -456 117  
External expenses  -281 242  -262 223  
Personnel expenses  -398 936  -383 213  
Taxes and duties  -18 545  -17 404  
Depreciation and provisions  -55 074  -51 192  
Other operating income and expenses   11 505   4 592  
       
Current operating profit before depreciation of assets arising from acquisitions 234 422 231 822 1.1%
       
Depreciations of intangible assets arising from acquisitions  -4 765  -4 325  
       
Operating profit from ordinary activities 229 657 227 497 0.9%
       
Other non-recurring income and expenses  -3 525  -10 422  
       
Operating profit 226 132 217 075 4.2%
       
Financial income and expense  -8 627  -9 282  
       
Profit before tax 217 505 207 793 4.7%
       
Income tax expense  -67 242  -62 478  
       
Share in earnings – Equity method   188   467  
       
Net income of consolidated entities   150 451   145 782 3.2%
attributable to owners of the parent company   150 887   145 290 3.9%
attributable to non-controlling interests  -436   492 -188.7%
       
  1. Statement of financial position
en €k   Dec25   Dec24
     
Goodwill   356 055   276 633
Intangible assets   231 080   251 237
Tangible assets   424 129   397 537
Right of use   37 623   36 861
Other financial assets   45 123   12 993
Share in companies accounted for by the equity method   3 374   4 511
Deferred tax assets   24 891   24 628
Non-current assets   1 122 276   1 004 401
     
Inventories and work in progress   378 791   404 166
Trade receivables   201 154   196 081
Other financial assets   3 668   4 312
Other receivables   85 777   89 931
Cash and cash equivalents   122 500   149 631
Current assets   791 891   844 120
     
Assets classified as held for sale   –   –
     
Assets   1 914 167   1 848 522
     
Share capital   10 488   10 488
Reserves attributable to the owners of the parent company   1 114 702   1 032 628
Equity attributable to the owners of the parent company   1 125 190   1 043 116
     
Non-controlling interests  -208   286
     
Equity 1 124 982 1 043 402
     
Deferred tax liabilities   50 408   57 233
Provisions for employee benefits   21 153   20 358
Other provisions   7 901   8 899
Lease obligations   27 646   26 552
Other financial liabilities   150 410   222 088
Other payables   15 358   5 430
Non-current liabilities   272 876   340 560
     
Other provisions   1 371   776
Trade payables   170 842   174 574
Lease obligations   11 325   11 550
Other financial liabilities   105 881   57 977
Other payables   226 890   219 683
Current liabilities   516 309   464 560
     
Liabilities   1 914 167   1 848 522

  1. Statement of cash flow
en €k 2025 2024
     
Consolidated result for the period 150 451 145 782
     
Elimination of share from companies’ profit accounted for by the equity method  -188  -467
Elimination of depreciations & provisions   60 590   57 352
Elimination of deferred tax change  -3 188  -4 584
Elimination of gains and losses on disposals   1 107   2 451
Other income and expenses with no cash impact  -20 735   5 517
     
Net cash flow 188 037 206 052
     
Net financial interests paid   4 269   4 727
Income tax accrued for the period   70 945   67 510
     
Net cash flow before financial interests & income tax 263 252 278 289
     
Effect of net change in inventories   4 204  -20 890
Effect of net change in trade receivables  -15 735  -4 892
Effect of net change in trade payables   11 925   4 076
Income tax paid  -77 866  -44 891
Effect of net change in other receivables and payables   13 210  -7 472
Effect of change in working capital requirements  -64 261  -74 069
     
Net cash flow generated by operating activities 198 990 204 220
     
Acquisitions of intangible assets  -9 904  -11 193
Acquisitions of tangible assets  -92 236  -69 246
Disposals of intangible and tangible assets   124   274
Change in financial assets  -1 266   2 934
Change in debts relative to acquisitions  -576  -3 485
Acquisitions of subsidiaries or activities  -95 697  -348 436
Disposals of subsidiaries or activities   –   –
Dividends received   925   463
Net cash flow allocated to investing activities  -198 629  -428 689
     
Dividends paid to the owners of the parent company  -12 148  -11 054
Dividends paid to the non-controlling interests  -4  -4
Change in treasury shares   –   –
Transactions between the Group and owners of non-controlling interests   –  -17 492
Increase/decrease of capital   –   –
Cash investments   –   –
Debt issuance   159 385   273 632
Repayments of debt  -140 071  -89 291
Repayments of lease obligation  -12 697  -12 479
Net financial interests paid  -4 269  -4 727
Net cash flow from financing activities  -9 803   138 585
     
Change in cash position  -9 442  -85 884
  1. Reconciliation tables for alternative performance indicators
    1. Net Debt 
in €k Dec25 Dec24
     
Loans   248 694   265 344
Bank overdrafts   1 165   3 567
Accrued interests not yet matured   38   27
Lease obligation [IFRS16]   38 971   38 102
Employee profit sharing   1 719   945
Currency and interest rate derivatives   809   5 835
Other   3 866   4 346
Other financial liabilities   295 262   318 166
     
Cash   99 932   104 945
Cash equivalents   22 568   44 685
Cash & cash equivalents   122 500   149 631
     
Net financial debt   172 762   168 536
    1. Operating cash flow before interest and taxes
in €k 2025 2024
     
Current operating profit before depreciation
of assets arising from acquisitions
234 422 231 822
     
Elimination of depreciations & provisions 56 414 51 166
Elimination of gains and losses on disposals 1 107 2 451
Other income & expenses with no cash impact 1 230 466
     
Current operating cash flow 293 173 285 905
     
Other non-current income & expenses -4 113 -5 637
     
Operating cash flow   289 060   280 268

Attachment

Naturonel Launches Made-in-USA Herbal Supplements to Support Metabolic Wellness

Naturonel Launches Made-in-USA Herbal Supplements to Support Metabolic Wellness




Naturonel Launches Made-in-USA Herbal Supplements to Support Metabolic Wellness

New line of plant-based dietary supplements tested for purity and potency now available to consumers nationwide.

Naturonel Image

Naturonel Image

PRINCETON, N.J., March 17, 2026 (GLOBE NEWSWIRE) — Naturonel, a wellness brand focused on herbal nutrition and metabolic wellness, announced the launch of its new line of plant-based dietary supplements manufactured in the United States and third-party tested for purity and potency.

As consumers increasingly seek transparent, responsibly manufactured wellness products, Naturonel’s newest supplements are designed to support everyday health, balanced energy, and metabolic wellness through carefully blended botanical ingredients, vitamins, and minerals.

“We are excited to officially launch this line of supplements to meet growing consumer demand for high-quality, plant-based wellness products,” said a spokesperson for Naturonel. “Our focus is on transparency, responsible manufacturing, and formulas that reflect both traditional herbal knowledge and modern quality standards.”

Made in the USA with a Focus on Quality

All Naturonel products are manufactured in U.S. facilities following Good Manufacturing Practice (GMP) standards. Each formula undergoes third-party testing to verify purity and potency, giving consumers confidence in the products they choose for daily wellness.

Herbal Inspiration Meets Modern Nutrition

Drawing from long-standing herbal wellness traditions, Naturonel combines botanical ingredients with vitamins and minerals to support metabolic balance and overall vitality. The supplements reflect both traditional herbal knowledge and current nutritional research, appealing to wellness-conscious consumers.

Product Availability

The newly launched supplements are available nationwide and can be purchased through the Naturonel website www.naturonel.com as well as Amazon product listings for convenience and accessibility.

Looking Ahead

Naturonel plans to continue expanding its supplement line with additional formulations designed to support a wide range of wellness needs. The company also emphasizes consumer education around ingredient sourcing, formulation, and quality standards.

About Naturonel

Naturonel is a wellness brand dedicated to developing dietary supplements inspired by herbal traditions and supported by modern nutritional science. Naturonel products are manufactured in the United States and third-party tested for purity and potency, with formulas designed to support metabolic wellness, balanced energy, and everyday vitality.

Media Contact:
Naturonel
800-430-5241
Email: hello@naturonel.com
Website: www.naturonel.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/036af245-1f4f-44ce-afa4-7678099d7b0e

National Survey Finds Only 58% of U.S. Correctional Facilities Offer Medications for Opioid Use Disorder

National Survey Finds Only 58% of U.S. Correctional Facilities Offer Medications for Opioid Use Disorder




National Survey Finds Only 58% of U.S. Correctional Facilities Offer Medications for Opioid Use Disorder

  • Jails outpace prisons in offering MOUD, but regional disparities and limited treatment access persist across the U.S.
  • Qualitative feedback points to need for greater reentry support, housing, care coordination, and provider training

RICHMOND, Va., March 17, 2026 (GLOBE NEWSWIRE) — Indivior Pharmaceuticals Inc. (Nasdaq: INDV) announced results from a cross-sectional survey published in the Journal of Correctional Health Care that reveal critical gaps in the availability of medications for opioid use disorder (MOUD) across U.S. correctional facilities.

Funded by Indivior and conducted in partnership with the National Commission on Correctional Health Care (NCCHC), the study surveyed 212 jails, prisons, and detention centers. Findings indicate that just 58% offer at least one FDA-approved MOUD and stark disparities in treatment access exist across regions and facility types.

The study found that jails were more than twice as likely to provide MOUD compared to prisons and that facilities in the West had over three-fold higher odds of offering MOUD than those in the Midwest. Regional disparities persist, with facilities in the South, Midwest and rural areas reporting the greatest uncertainty about care delivery. Despite increasing awareness of the benefits of MOUD, the South reports the lowest rates of treatment access, with fewer than 10% of diagnosed individuals receiving treatment. Midwest facilities report moderate levels of treatment for diagnosed individuals, some below 10%, while others report between 20%–29%.

“This study reinforces the urgent need to integrate evidence-based care into jails and prisons,” said Christian Heidbreder, PhD, Chief Scientific Officer at Indivior. “To truly address the opioid crisis, we must ensure continuity of care, expand access to medications for opioid use disorder, and eliminate the stigma that prevents people from receiving treatment during and after incarceration.”

Correctional settings are among the most critical intervention points for opioid use disorder (OUD) treatment: An estimated 17% of individuals in state prisons and 19% of those in jails meet the criteria for OUD.1 Research shows that individuals in their first two weeks post-release from incarceration face overdose mortality rates that are up to 40 times higher than the national average.2 MOUD treatment during incarceration can significantly reduce these risks and improve treatment retention.3

“With renewed national attention on strengthening addiction treatment and recovery, our study underscores both the opportunities and the challenges ahead,” said Vanessa Procter, Executive Vice President, Corporate Affairs at Indivior. “We’re encouraged to see recovery rising on the federal agenda, and these data offer a roadmap for expanding life‑saving care inside jails and prisons. Improving continuity of care—from incarceration to community—is not a partisan issue. It’s a public health imperative, and the evidence shows what works.”

_____________________________

1 Medications for Opioid Use Disorder Save Lives | The National Academies Press
2 Opioid Overdose Mortality Among Former North Carolina Inmates: 2000-2015, Table 1. (Graph: Maddy Troilo, 2018)
3 Medication for opioid use disorder service delivery in carceral facilities: update and summary report | Health & Justice | Full Text

In addition to quantitative findings, the survey captured qualitative insights from correctional health professionals on ideal infrastructure to support reentry and reduce reincarceration.

Respondents identified five critical areas for improving MOUD continuity and outcomes:

  • Access to long-acting injectables and telehealth: Respondents called for greater investment in cost-effective medications, including funding for injectable treatments like extended-release buprenorphine and extended-release naltrexone, as well as telemedicine partnerships to extend care into rural settings.
  • Continuity of care and transition services: Respondents emphasized the importance of pre-release planning and providing a warm handoff from incarceration to community-based MOUD services.
  • Housing and employment: Respondents highlighted the role of transitional housing, job training, and financial stability in sustaining recovery.
  • Comprehensive MOUD treatment approaches: Respondents advocated for “medical homes” that combine MOUD with mental health care, infectious disease treatment, and social support.
  • Community support networks: Respondents pointed to the value of peer mentorship, recovery organizations, and community-based programs to promote engagement post-release and reduce re-incarceration.

Despite growing recognition of MOUD as the standard of care for OUD, many facilities cited persistent barriers to implementation, including stigma, abstinence-only philosophies, lack of provider training, limited budgets, and geographic disparities in healthcare infrastructure.

The full survey findings are available here: Medications for Opioid Use Disorder in Correctional Facilities: A 2022 Cross-Sectional Survey of Health Care Staff

About Indivior
As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine — developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities, we are powering recovery and renewing hope. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

For Further Information

Investors:
Jason Thompson Indivior Pharmaceuticals
Tel: 804-402-7123
E-mail: jason.thompson@indivior.com

Media:
Cassie France-Kelly Indivior Pharmaceuticals
Tel: 804-594-0836
E-Mail: Indiviormediacontacts@indivior.com

Personalized Keto Made Easy: How Ketoway Supports Consistent Results and Healthy Habits

Personalized Keto Made Easy: How Ketoway Supports Consistent Results and Healthy Habits




Personalized Keto Made Easy: How Ketoway Supports Consistent Results and Healthy Habits

Ketoway Helps Users Achieve Lasting Keto Success with Personalized Meal Plans, Guided Workouts, and Transparent Customer Support

NEW YORK, March 17, 2026 (GLOBE NEWSWIRE) — Ketoway is a personalized keto-diet app designed to deliver real, sustainable results through structured guidance, simple planning, and ongoing support. By combining tailored meal plans, light workouts, and progress tracking, it removes guesswork and helps users stay consistent with a low-carb lifestyle.

What Is Ketoway and How It Works
After a short onboarding quiz, Ketoway creates a customized program based on individual goals, preferences, and daily routine. Users receive a clear meal plan, easy-to-follow recipes, and guided workouts that fit into busy schedules. This structured approach makes keto accessible for beginners while still being effective for experienced users.

Proven Effectiveness Through Structure
Ketoway focuses on long-term results rather than quick fixes. Built-in trackers for weight, hydration, steps, and fasting provide a full picture of daily habits, helping users stay accountable and motivated. Combined with lifestyle challenges and educational content, the app supports steady progress, improved energy, and better overall wellness.

Clear Billing and Full Transparency
Ketoway stands out with straightforward, transparent billing practices. Subscription details, pricing, and renewal terms are clearly presented before purchase, so users know exactly what to expect. Managing or canceling a subscription is simple, ensuring full control without hidden conditions – an important factor for trust and user confidence.

Reliable and Responsive Customer Support
Customer support is a key strength of Ketoway. Users can expect fast, helpful, and friendly assistance with any questions related to plans, billing, or app features. This responsive customer support system ensures users stay focused on their progress rather than dealing with technical or account issues.

Ketoway Reviews From the Keto Community
Reddit users describe Ketoway as a keto app that truly sticks. Many highlight that the biggest advantage is eliminating decision fatigue – opening the app each day to find clearly defined meals and light workouts without having to guess what comes next. The built-in trackers support accountability, while guided workouts and lifestyle challenges make keto-diet approachable, manageable, and sustainable.

For those seeking a structured, practical, and lasting approach to a keto lifestyle, Ketoway provides a clear path to real results. A personalized plan can be started today, turning keto into a simple, consistent, and effective routine.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/29e89794-47d5-4f95-a416-7e46d7b1a3b7

CONTACT: evita.anilionyte@flmng.ai 

SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas




SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

RANCHO CORDOVA, Calif., March 17, 2026 (GLOBE NEWSWIRE) — SK pharmteco today announced the successful conclusion of a regulatory inspection of its small molecule North America facility in La Porte, Texas.

The U.S. Food and Drug Administration (FDA) carried out a general inspection of the site from February 9 to February 12, 2026. After a thorough review of the facility’s quality systems and manufacturing operations, the FDA completed the inspection without issuing a Form 483. This “No Action Indicated” (NAI) status confirms that the site complies with the highest regulatory standards.

“The successful completion of this FDA inspection directly reflects the commitment to excellence and strong quality culture of our La Porte team,” said Kalen Minvielle, Head of Small Molecule, North America. “Maintaining an NAI status is a significant achievement that continues to highlight the strength of our systems and disciplined approach to building quality into every step of the process. It ensures our customers can continue to rely on SK pharmteco for secure, compliant, and uninterrupted manufacturing of life-enhancing medicines.”

The general inspection included thorough tours of the warehouse, manufacturing plant, and analytical laboratories. Inspectors conducted an in-depth review of the site’s procedural rigor, assessing batch records, Corrective and Preventive Actions (CAPAs), deviation and Out-of-Specification (OOS) investigations, and change controls. The agency also confirmed the integrity of the site’s equipment qualifications, purified water systems, and process and cleaning validations.

SK pharmteco actively partners with the FDA in the pursuit of excellence and continuous improvement. For example, the company recently participated in the FDA Quality Management Maturity (QMM) program, an initiative that recognizes drug manufacturers with advances beyond compliance and a culture of continuous improvement and reliability.

This successful inspection reinforces SK pharmteco’s global reputation for operational excellence in both small molecules and viral vectors, as well as its dedication to meeting the stringent requirements of regulatory agencies worldwide.

About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and South Korea. The company’s core capabilities center on small molecules, peptides, and viral vectors, providing the specialized expertise needed to bring complex therapies to market. Through these pillars, SK pharmteco supports biopharmaceutical partners of all sizes with comprehensive development and manufacturing solutions worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.

Contact:
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com

SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas




SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

RANCHO CORDOVA, Calif., March 17, 2026 (GLOBE NEWSWIRE) — SK pharmteco today announced the successful conclusion of a regulatory inspection of its small molecule North America facility in La Porte, Texas.

The U.S. Food and Drug Administration (FDA) carried out a general inspection of the site from February 9 to February 12, 2026. After a thorough review of the facility’s quality systems and manufacturing operations, the FDA completed the inspection without issuing a Form 483. This “No Action Indicated” (NAI) status confirms that the site complies with the highest regulatory standards.

“The successful completion of this FDA inspection directly reflects the commitment to excellence and strong quality culture of our La Porte team,” said Kalen Minvielle, Head of Small Molecule, North America. “Maintaining an NAI status is a significant achievement that continues to highlight the strength of our systems and disciplined approach to building quality into every step of the process. It ensures our customers can continue to rely on SK pharmteco for secure, compliant, and uninterrupted manufacturing of life-enhancing medicines.”

The general inspection included thorough tours of the warehouse, manufacturing plant, and analytical laboratories. Inspectors conducted an in-depth review of the site’s procedural rigor, assessing batch records, Corrective and Preventive Actions (CAPAs), deviation and Out-of-Specification (OOS) investigations, and change controls. The agency also confirmed the integrity of the site’s equipment qualifications, purified water systems, and process and cleaning validations.

SK pharmteco actively partners with the FDA in the pursuit of excellence and continuous improvement. For example, the company recently participated in the FDA Quality Management Maturity (QMM) program, an initiative that recognizes drug manufacturers with advances beyond compliance and a culture of continuous improvement and reliability.

This successful inspection reinforces SK pharmteco’s global reputation for operational excellence in both small molecules and viral vectors, as well as its dedication to meeting the stringent requirements of regulatory agencies worldwide.

About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and South Korea. The company’s core capabilities center on small molecules, peptides, and viral vectors, providing the specialized expertise needed to bring complex therapies to market. Through these pillars, SK pharmteco supports biopharmaceutical partners of all sizes with comprehensive development and manufacturing solutions worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.

Contact:
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com

Standard Process Launches SP Children’s® ProSynbiotic

Standard Process Launches SP Children’s® ProSynbiotic




Standard Process Launches SP Children’s® ProSynbiotic

A Whole Food-Based Synbiotic Designed to Support Digestive Regularity, Gut Balance, and Immune Health in Children

Standard Process SP Children's ProSynbiotic

PALMYRA, Wis., March 17, 2026 (GLOBE NEWSWIRE) — Standard Process, a leader in whole food-based nutritional solutions, today announced the launch of SP Children’s® ProSynbiotic. The gentle, clinically-backed, whole food-based synbiotic is formulated to support digestive comfort, microbiome balance, and immune health in children three years of age and up as a daily supplement or when needs arise for gastrointestinal (GI) support.

“Most children aren’t consuming adequate amounts of fiber, prebiotics, and beneficial microbes, and it’s an increasingly difficult feat for parents to get what they need in the modern diet landscape,” says Weston Bussler, Nutrition Science PhD and Product Development Manager, Standard Process. “Our ProSynbiotic makes it easy to deliver fiber-packed whole foods, and in a kid-approved format designed and tested at our Nutrition Innovation Center, to provide the nutritional components critical for GI and immune health.”

Standard Process developed SP Children’s® ProSynbiotic to directly meet these needs with a carefully selected blend of probiotics, prebiotics, and whole food-based fiber without added sugars, artificial flavors, or sweeteners. The flavorless powder comes in convenient single-serve sticks, making it easy to mix into food or beverages without altering taste, an important consideration for picky eaters.

Why Now? Children’s Health and The Standard American Diet

Children face health implications of the Standard American Diet (SAD). NCHS data reports approximately 60% of children’s daily calories come from ultra-processed foods (UPF), contributing to widespread nutrient inadequacy. 95% of Americans, for example, don’t come close to consuming 25 grams of recommended daily fiber, which can contribute to digestive issues like constipation and poor gut health.

Numerous factors influence children’s dietary habits, including social determinants, access, convenience, marketing tactics, and autonomy to choose their own foods- contributing to health implications taking root early. Standard Process aims to close the gap through nutrition education and equipping health care practitioners, including chiropractors, nutritionists, nurse practitioners, among others, with science-backed supplement solutions.

Ingredients You Can Trust

  • SP Children’s® ProSynbiotic delivers clinically studied probiotic strains, including Lactobacillus acidophilus DDS-1™ and Bifidobacterium lactis UABla-12™, alongside the yeast Saccharomyces boulardii, to help support microbial balance and healthy bowel movements.
  • The formula is complemented by whole food-based fibers from ingredients such as Royal Ancient Oats™, green banana flour, chicory root, apple pectin, and organic beets to nourish beneficial bacteria and promote digestive regularity.
  • Gluten-free, vegan and contains no stevia, xylitol, silica, citric acid, or added sugars.

Where To Find

ABOUT STANDARD PROCESS

Founded in 1929, Standard Process is a fourth-generation, family-owned company committed to transforming lives through whole food nutrition. Partnering with health care practitioners, we provide science-based nutritional solutions grounded in certified organic agriculture and a systems-based approach to whole-person health.

Standard Process Contact:
Nicole McSwain, Marketing Communications Specialist
nmcswain@standardprocess.com

Media Contact:
Laura Bastardi, MWW Health
Standardprocess@MWW.com

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent disease.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9938bebc-a267-4be5-8fbb-3cff7394f730

Standard Process Launches SP Children’s® ProSynbiotic

Standard Process Launches SP Children’s® ProSynbiotic




Standard Process Launches SP Children’s® ProSynbiotic

A Whole Food-Based Synbiotic Designed to Support Digestive Regularity, Gut Balance, and Immune Health in Children

Standard Process SP Children's ProSynbiotic

PALMYRA, Wis., March 17, 2026 (GLOBE NEWSWIRE) — Standard Process, a leader in whole food-based nutritional solutions, today announced the launch of SP Children’s® ProSynbiotic. The gentle, clinically-backed, whole food-based synbiotic is formulated to support digestive comfort, microbiome balance, and immune health in children three years of age and up as a daily supplement or when needs arise for gastrointestinal (GI) support.

“Most children aren’t consuming adequate amounts of fiber, prebiotics, and beneficial microbes, and it’s an increasingly difficult feat for parents to get what they need in the modern diet landscape,” says Weston Bussler, Nutrition Science PhD and Product Development Manager, Standard Process. “Our ProSynbiotic makes it easy to deliver fiber-packed whole foods, and in a kid-approved format designed and tested at our Nutrition Innovation Center, to provide the nutritional components critical for GI and immune health.”

Standard Process developed SP Children’s® ProSynbiotic to directly meet these needs with a carefully selected blend of probiotics, prebiotics, and whole food-based fiber without added sugars, artificial flavors, or sweeteners. The flavorless powder comes in convenient single-serve sticks, making it easy to mix into food or beverages without altering taste, an important consideration for picky eaters.

Why Now? Children’s Health and The Standard American Diet

Children face health implications of the Standard American Diet (SAD). NCHS data reports approximately 60% of children’s daily calories come from ultra-processed foods (UPF), contributing to widespread nutrient inadequacy. 95% of Americans, for example, don’t come close to consuming 25 grams of recommended daily fiber, which can contribute to digestive issues like constipation and poor gut health.

Numerous factors influence children’s dietary habits, including social determinants, access, convenience, marketing tactics, and autonomy to choose their own foods- contributing to health implications taking root early. Standard Process aims to close the gap through nutrition education and equipping health care practitioners, including chiropractors, nutritionists, nurse practitioners, among others, with science-backed supplement solutions.

Ingredients You Can Trust

  • SP Children’s® ProSynbiotic delivers clinically studied probiotic strains, including Lactobacillus acidophilus DDS-1™ and Bifidobacterium lactis UABla-12™, alongside the yeast Saccharomyces boulardii, to help support microbial balance and healthy bowel movements.
  • The formula is complemented by whole food-based fibers from ingredients such as Royal Ancient Oats™, green banana flour, chicory root, apple pectin, and organic beets to nourish beneficial bacteria and promote digestive regularity.
  • Gluten-free, vegan and contains no stevia, xylitol, silica, citric acid, or added sugars.

Where To Find

ABOUT STANDARD PROCESS

Founded in 1929, Standard Process is a fourth-generation, family-owned company committed to transforming lives through whole food nutrition. Partnering with health care practitioners, we provide science-based nutritional solutions grounded in certified organic agriculture and a systems-based approach to whole-person health.

Standard Process Contact:
Nicole McSwain, Marketing Communications Specialist
nmcswain@standardprocess.com

Media Contact:
Laura Bastardi, MWW Health
Standardprocess@MWW.com

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent disease.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9938bebc-a267-4be5-8fbb-3cff7394f730