Sandoz delivers strong H1 2026 results, with outstanding biosimilar growth in the second quarter

On August 5, 2026 Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, reported its financial results for the first half of 2026 and net-sales performance for the second quarter of 2026.

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H1 2026 RESULTS

H1 net sales up by 5% at constant currencies (CC) to USD 5,761 million
Anti-infective B2B[1] headwind on net sales of one percentage point at CC. Impact all in Q1
Q2 2026 net sales up by 7% at CC, with all regions contributing to outstanding biosimilar growth of 22% at CC; generics returned to growth of 1% at CC in second quarter
Biosimilars represented record 33% of total net sales in first half (H1 2025: 29%)
Standout North America performance in H1, driven by biosimilar growth of 47% at CC
H1 core EBITDA increased by 15% in USD, resulting in core-EBITDA margin expansion to 20.9%
Full-year 2026 guidance confirmed

USD millions unless indicated otherwise

H1 2026

H1 2025

change %

change CC[2] %

Biosimilars

1,875

1,496

25%

20%

Generics

3,886

3,736

4%

-1%

Net sales

5,761

5,232

10%

5%

Core EBITDA

1,206

1,046

15%

9%

Core-EBITDA margin

20.9%

20.0%

Core diluted earnings per share

USD 1.71

USD 1.46

17%

11%

Management free cash flow

503

503

USD millions unless indicated otherwise

Q2 2026

Q2 2025

change %

change CC %

Biosimilars

1,022

825

24%

22%

Generics

1,983

1,927

3%

1%

Net sales

3,005

2,752

9%

7%

Richard Saynor, Chief Executive Officer of Sandoz, said: "Sandoz delivered excellent progress during the first half of the year, building further momentum across the business and reinforcing the growth trajectory. The sales result in the second quarter was particularly encouraging, driven by an outstanding biosimilar performance. Biosimilars now represent a record one-third of net sales, reflecting our ability to successfully translate innovation into launch execution. We added four additional in-house assets to our industry-leading biosimilars pipeline, taking the total to 36. I was also delighted by more progress made in profitability and cash generation, while we continue to invest in sustainable long-term growth.

"The consistent high-growth profile of our biosimilars reinforces our conviction that Sandoz is uniquely well positioned for the opportunities ahead. Our expanding portfolio and pipeline, combined with an increasingly streamlined regulatory environment and the forthcoming completion of our vertically integrated biosimilars platform, will further strengthen our leadership position. We look forward to sharing our plans to maximise value in our golden decade for biosimilars at our Capital Markets Day in September."

H1 2026 FINANCIAL HIGHLIGHTS

H1 net sales of USD 5.8 billion (H1 2025: USD 5.2 billion), up by 5% at CC
Biosimilar net sales delivered excellent growth of 20% at CC across all regions in the first half, with North America increasing by 47% at CC and recent launches, notably Wyost & Jubbonti (denosumab), performing well
The 10 largest-selling medicines grew by a combined 14% at CC in H1 and represented 35% of net sales
A H1 core-EBITDA margin of 20.9%, reflecting a 90-basis points year-on-year improvement (H1 2025: 20.0%), driven by an improved mix of sales, cost-price savings and operating leverage
Increased capital expenditures (capex) in the first half; management free cash flow, however, remained strong at an unchanged USD 503 million. Free cash flow of USD 337 million (H1 2025: USD 207 million)
Core diluted earnings per share of USD 1.71 in H1 represented growth of 17% in USD

BUSINESS HIGHLIGHTS

Sandoz recently announced that it will host a Capital Markets Day in London on 8 September, focused on ‘maximising Sandoz value in its golden decade for biosimilars’. The Company will also host an analyst and investor site visit in Slovenia on 9-10 November, providing participants with the opportunity to visit the expanding biosimilar development and manufacturing network
In July, it was announced that Sandoz will be included in the Swiss Market Index, Switzerland’s leading blue-chip equity index, effective from 21 September
Sandoz recently advanced from third to second position in terms of gross sales of biosimilar and generic medicines in North America[3]
Marking 80 years of antibiotic manufacturing in Europe and 20 years since the approval of the world’s first biosimilar medicine, Omnitrope (somatropin), Sandoz celebrated these milestones through anniversary events, highlighting its heritage in affordable medicines, leadership in biosimilars and the importance of resilient European-medicines production
A new biosimilar development centre in Ljubljana, Slovenia, was officially opened in June, further strengthening the Company’s in-house development capabilities and supporting its long-term biosimilars growth strateg
Sandoz’s industry-leading biosimilars pipeline expanded during the period by four additional in-house assets, namely through sotatercept, polatuzumab vedotin, burosumab and anifrolumab, bringing the total biosimilars pipeline to 36[4] assets
In July, the Company announced that the Agência Nacional de Vigilância Sanitária granted marketing authorisation for Owozy (semaglutide). This marks the first GLP-1 approval for Sandoz, which the Company will commercialise in Brazil in partnership with Adalvo
The European Commission recently granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening Sandoz’s position in diabetes and expanding access to affordable treatment options for patients across Europe
In June, the US Food and Drug Administration accepted for review two Abbreviated New Drug Applications for proposed generic tirzepatide autoinjectors, marking an important step in advancing the Company’s growing GLP-1 pipeline
Sandoz recently announced that it has entered into a settlement agreement with the leadership of the consortium of 43 US states and territories to resolve all claims brought by the remaining litigating states and territories against the Company concerning alleged anti-competitive conduct in the US market for generic medicines. Sandoz US has also entered into a settlement agreement with the indirect reseller plaintiffs class. When these two settlements will be completed, Sandoz US will have resolved all claims brought by US federal or state governments against the Company stemming from their investigations of the US generic medicine market from more than a decade ago and all the pending class actions related to this legacy matter. The only remaining anti-trust claims against the Company in the US generic antitrust litigation are those brought by individual plaintiffs who opted out of class settlements. These settlements do not affect full-year 2026 guidance or the Sandoz mid-term outlook
The Company’s greenhouse-gas reduction targets were recently validated by the Science Based Targets initiative, including combined Scope 1 and 2 emissions reductions of 42% by 2030 and 63% by 2035, respectively
Several key leadership appointments were announced in the period to support the Company’s next phase of growth, including Pascal Bouye as President, Generics Manufacturing & Supply, Keren Haruvi assuming responsibility for global M&A in addition to her current role and Simon Goeller as Country President, Germany

FULL-YEAR 2026 GUIDANCE

Sandoz anticipates continued growth in 2026, partly reflecting the expected performance of recently launched biosimilars. This growth, alongside a favourable shift in the mix of sales, further operating efficiencies and cost discipline, is expected to result in core-EBITDA margin expansion in 2026.

As a result, the Company confirms its expectations for the year:

Net sales to grow at CC by a mid-to-high single-digit percentage
Core-EBITDA margin expansion of around 100 basis points

This guidance excludes any impacts of unforeseen events or unconfirmed developments, including the potential imposition of new tariffs emanating from the US government.

No material contribution from any potential launch of generic semaglutide is expected in 2026. Partly reflecting short-term market dynamics in Germany and an outstanding biosimilars performance in North America, overall pricing is now expected to decline by a mid-single-digit percentage in 2026, compared with the previous expectation of a low-to-mid single-digit percentage decline.

CONFERENCE CALL

A conference call and webcast for investors and analysts will begin today at 9:30 CET. Details can be found here, with the accompanying presentation here.

(Press release, Sandoz, AUG 5, 2026, View Source [SID1234669670])

Half-Year Financial Report 2026

On August 4, 2026 Bayer reported half-year financial report 2026.

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(Presentation, Bayer, AUG 4, 2026, View Source [SID1234670289])

CUMBERLAND PHARMACEUTICALS REPORTS
COMPANY UPDATE & Q2 2026 FINANCIAL RESULTS

On August 4, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), an innovation-focused biopharmaceutical company, reported its second quarter 2026 financial results and provided an update following the successful closing of its Strategic Transaction with Apotex Health.

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During the second quarter, Cumberland completed a transaction with Apotex Health, the largest Canadian pharmaceutical company, to integrate their branded business. Under the terms of the agreement, Apotex acquired Cumberland’s portfolio of FDA-approved brands and related commercial organization for $100 million in cash at closing, plus an additional $11 million in funding for inventory and transition services.

Following the transaction, Cumberland will transition into a development-stage biopharmaceutical organization focused on advancing differentiated medicines for rare diseases and other areas of significant unmet medical need.

Cumberland returned capital to shareholders through a special cash dividend while retaining sufficient resources to fund its long-term operations, advance its development pipeline and pursue additional strategic opportunities. Cumberland retains its development pipeline of late stage candidates, including four Phase 2 clinical programs, as well as its majority ownership in Cumberland Emerging Technologies.

"The second quarter marked a defining milestone for Cumberland," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "With the successful completion of our Strategic Transaction, we have unlocked substantial value for our shareholders, while positioning Cumberland for its next phase as an innovation-focused biopharmaceutical company. We have strengthened our balance sheet, returned capital to shareholders through a special dividend and remain well-capitalized to advance our pipeline of differentiated product candidates designed to address significant unmet medical needs."

RECENT COMPANY DEVELOPMENTS INCLUDE:

Completion of Strategic Transaction with Apotex
On July 1, 2026, Cumberland announced the closing of its agreement with Apotex to integrate the U.S. branded businesses. Under the terms of the agreement, Apotex acquired Cumberland’s portfolio of FDA-approved brands for $100 million in cash consideration, plus an additional $11 million in funding for inventory and transition services.
The transaction was unanimously approved by Cumberland’s Board of Directors, which was followed by approval from Cumberland’s shareholders, with over 99% of the voting shares in favor of the transaction. Cumberland has retained its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This transaction positions Cumberland to operate as an innovation-focused development-stage biopharmaceutical organization.

Board Declares a Special Dividend

Cumberland’s Board of Directors authorized and declared a special cash dividend of $1.50 per share of the company’s common stock. The dividend was paid on July 31, 2026, to the shareholders of record as of July 23, 2026.
Following the closing of the transaction with Apotex, an analysis by Cumberland’s tax advisors, along with refined financial projections, indicated greater net cash from the transaction than originally projected. Therefore, Cumberland’s Board assessed its future cash needs and evaluated possible alternatives for the excess capital. The Board of Directors determined that after the payout of the special dividend, Cumberland will still have significant liquidity and financial flexibility to fund its long-term product development efforts, with additional reserves available to address any new opportunities.

Updated DMD Results Shared at PPMD Conference

In June 2026, Cumberland presented updated results from its Phase 2 FIGHT DMD clinical trial evaluating ifetroban in patients with Duchenne muscular dystrophy-associated cardiomyopathy at the annual Parent Project Muscular Dystrophy (PPMD) Conference.

The updated data included new blood biomarker findings directionally consistent with heart muscle protection, with increases in markers of cardiac protection and repair and reductions in markers of heart muscle injury and cell damage with ifetroban treatment. These biomarker results reinforce the previously reported improvements in cardiac function, consistent with ifetroban’s ability to slow the progression of DMD-related heart disease. Together, the findings strengthen the case for developing ifetroban as a therapy targeting cardiomyopathy, the leading cause of death in patients with DMD.

Positive Results in Cancer Metastasis Prevention
In collaboration with Vanderbilt Health, Cumberland announced results from a randomized, placebo-controlled Phase 2 study evaluating ifetroban as a potential therapy to inhibit cancer metastasis in patients with Stage I to III malignant solid tumors at high risk of metastatic recurrence. The study met its primary objective of assessing safety and feasibility. Ifetroban was found to be safe and well-tolerated, and no safety signals were identified in markers of blood clotting function.

Although intentionally not powered for efficacy, the study also compared the percentage of patients with distant metastatic recurrence 12 months after completion of therapy in both groups (10 placebo-treated and 18 ifetroban-treated participants) as a prespecified secondary endpoint.
Metastatic recurrence occurred in 3 of 18 patients (17%) receiving ifetroban, compared with 5 of 10 patients (50%) receiving placebo, a difference that did not reach statistical significance (odds ratio 0.21; p=0.09). There were no deaths from distant metastatic disease among patients receiving ifetroban, compared with 3 of 10 patients (30%) receiving placebo (p=0.037). The findings support the continued clinical development of ifetroban as a potential approach to inhibiting the metastatic process, an area of significant unmet medical need.
FINANCIAL RESULTS:
Net Revenue: During the second quarter of 2026, Cumberland reorganized its income statement to classify the revenues and expenses associated with the Apotex transaction as discontinued operations. The ongoing investment in research and development, supported by the remaining general and administrative expenses, resulted in a loss from continuing operations of $3.1 million for the quarter. With the addition of discontinued operations, the net loss for the quarter was $4.1 million.
Balance Sheet: At June 30, 2026, Cumberland had approximately $63 million in total assets, including $4 million in cash and cash equivalents. Liabilities totaled $46 million and total shareholders’ equity was $17 million on June 30, 2026. Cumberland retired its bank line of credit through a payment of $5.2 million at the end of the second quarter.
EARNINGS REPORT CALL:
A conference call will be held today, August 4, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results.
The link to register is View Source
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting: View Source

(Press release, Cumberland Pharmaceuticals, AUG 4, 2026, View Source [SID1234669724])

Remix Therapeutics to Present at 46th Annual Canaccord Genuity Growth Conference

On August 4, 2026 Remix Therapeutics (Remix), Inc., a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, reported Peter Smith, Ph.D., Co-Founder and Chief Executive Officer of Remix, will present a corporate overview at the 46th Annual Canaccord Genuity Growth Conference on Tuesday, August 11, 2026, at 12:30 p.m. ET in Boston.

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The Remix management team will also be hosting one-on-one meetings with investors. For those investors interested in scheduling a meeting, please contact your Canaccord representative.

(Press release, Remix Therapeutics, AUG 4, 2026, View Source [SID1234669689])

SHY Therapeutics Announces the First Patient Has Been Dosed in Phase 1 Clinical Trial Evaluating SHY-ONC6, a Novel, Oral Proteasome Inhibitor for the Treatment of Solid Tumors

On August 4, 2026 SHY Therapeutics ("SHY" or "the Company"), a clinical-stage biotechnology company developing small molecules that non-covalently target ATPases and GTPases and modulate their activity, reported that the first patient has been dosed in Luca-1, the Company’s first-in-human Phase 1 clinical trial evaluating SHY-ONC6, an investigational, novel and potentially first-in-class oral proteasome inhibitor for patients with advanced solid tumors. The Company expects initial Phase 1 data in 2027.

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"SHY-ONC6 targets the ubiquitin-proteasome system, which governs the degradation of damaged or unneeded proteins. Unlike current FDA-approved proteasome inhibitors that target the 20S Core Particle, SHY-ONC6 inhibits the ATPases within the 19S Regulatory Particle of the proteasome, introducing a novel and differentiated mechanism of proteasome inhibition," said Yaron Hadari, Ph.D., SHY’s Chief Executive Officer and Co-Founder.

While treatment with the current FDA approved proteasome inhibitors is limited to hematologic malignancies, SHY-ONC6 is being developed to expand this clinically validated therapeutic approach to solid tumors. Preclinical studies of SHY-ONC6 have demonstrated robust anti-tumor activity and favorable tolerability in multiple in vivo models of solid tumors, with similarly strong activity observed in hematologic malignancy models, supporting potential future development in additional cancer types.

"Dosing the first patient represents an important milestone as SHY advances its first clinical program and validates our strategy of developing differentiated small molecules against high-value ATPase and GTPase targets," said Michael Schmertzler, Executive Chairman and Co-Founder of SHY Therapeutics. "We believe SHY-ONC6 has the potential to expand the clinical utility of proteasome inhibition beyond hematologic cancers, addressing a much broader population of patients with solid tumors, and look forward to generating the first clinical data from the program next year," added Mr. Schmertzler.

The Luca-1 trial is a first-in-human, open-label, multicenter Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SHY-ONC6 in patients with advanced solid tumors. Additional information about the trial is available at ClinicalTrials.gov.

(Press release, SHY Therapeutics, AUG 4, 2026, View Source [SID1234669688])