Silence Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Highlights

On August 7, 2025 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, reported its financial results for the second quarter ended June 30, 2025, and reviewed recent business highlights (Press release, Silence Therapeutics, AUG 7, 2025, View Source [SID1234654955]).

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"The updated data we presented at EHA (Free EHA Whitepaper) this past quarter were highly encouraging and supportive of the therapeutic potential of divesiran as a first-in-class siRNA in PV," said Craig Tooman, President and Chief Executive Officer at Silence. "The SANRECO Phase 2 trial of divesiran in PV patients continues to progress towards full enrollment this year and remains our top priority."

Rhonda Hellums, Silence’s Chief Financial Officer, said, "We are continuing to prioritize investments in key areas where we see the highest potential to deliver near term value, including ensuring the successful completion of the SANRECO Phase 2 trial enrollment by year-end. We ended the quarter with approximately $114.2 million in cash and cash equivalents and short-term investments and are reiterating our cash runway guidance into 2028."

Second Quarter 2025 & Recent Business Highlights

Divesiran for Polycythemia Vera (PV)


Presented updated data from the SANRECO Phase 1 study at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Annual Congress, further supporting divesiran’s compelling therapeutic profile, including:


Additional data showing that treatment with divesiran led to durable hematocrit control (<45%) and essentially eliminated the need for phlebotomies in the targeted population.


Divesiran increased hepcidin and ferritin, resulting in elevation of iron body content and improved iron deficiency.


Divesiran was well tolerated with no dose-limiting toxicities.


Exceeded 50% enrollment in the Phase 2 portion of the SANRECO trial and remain on-track to complete enrollment by year-end 2025.

Zerlasiran for Cardiovascular Disease


Completed core Phase 3 readiness activities, including manufacturing and supply scale up. We continue to be in dialogues with potential third-party partners for Phase 3 development of zerlasiran as well as potential future commercialization activities.

Other R&D Updates


Advanced extra-hepatic cell targeting of siRNA where we are seeing promising initial preclinical activity in mice models. As a result, we are prioritizing our extra-hepatic activities and have decided to pause initiating a Phase 1 study of SLN548, our wholly owned siRNA for complement-mediated diseases.

Collaborations


A Phase 1 study of our siRNA product candidate, SLN312, which is licensed to AstraZeneca, is ongoing.

Second Quarter 2025 Financial Highlights


Cash Position: Cash and cash equivalents, and short-term investments of $114.2 million as of June 30, 2025, which are expected to fund our operational plans into 2028.


Research & Development Expenses: R&D expenses were $17.6 million for the quarter ended June 30, 2025, as compared to $13.8 million for the quarter ended June 30, 2024. The increase in R&D expenses was primarily driven by the advancement of our clinical trials and an increase in contract manufacturing activities.


General & Administrative Expenses: G&A expenses were $5.1 million for the quarter ended June 30, 2025, as compared to $7.0 million for the quarter ended June 30, 2024. The decrease in G&A expenses was primarily due to a reduction in reporting and compliance requirements, as well as our efforts to increase operating efficiencies.


Net Loss: Net loss was $27.4 million for the quarter ended June 30, 2025, as compared to $19.8 million for the quarter ended June 30, 2024.

Merck Delivers Profitable Organic Growth Amid Strong Currency Headwinds

On August 7, 2025 Merck, a leading science and technology company, reported its organic growth. Despite ongoing geopolitical uncertainties, Group net sales in the second quarter of 2025 increased by 2.0% organically compared with the year-earlier quarter, while EBITDA pre rose by 4.6% organically (Press release, Merck KGaA, AUG 7, 2025, View Source [SID1234654881]). Process Solutions within the Life Science business sector recorded another very strong quarter, while sales of Healthcare’s blockbuster drugs Mavenclad and Erbitux saw very strong growth. In addition, the Semiconductor Materials business within Electronics continued to grow, fueled by strong demand for AI technologies.

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Strong negative foreign exchange effects, especially the weakening of the U.S. dollar against the euro, weighed on net sales and EBITDA pre. Group net sales declined by 1.8% to € 5.3 billion due to negative foreign exchange effects of 4.2%. Negative foreign exchange also impacted EBITDA pre by 7.2%, leading to an overall decrease by 3.1% to € 1.5 billion. As a result, the EBITDA pre margin of 27.8% was 0.4 percentage points lower than the year-earlier period. Earnings per share pre amounted to € 2.02 compared with € 2.20 in the year-earlier quarter.

"We have delivered solid underlying sales and earnings growth," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "Yes, currency effects are taking their toll. But by standing on three pillars – Life Science, Healthcare and Electronics – we are, as a Group, better able to withstand the geopolitical, economic and currency swings that are buffeting companies around the world. Meanwhile, our recently completed acquisition of SpringWorks Therapeutics underlines our conviction that cutting-edge technology, including through strategically savvy acquisitions and partnerships, is key to securing future growth."

Life Science accelerates underlying growth

Process Solutions recorded yet another strong quarter, significantly driving growth for Life Science. Overall, net sales of the business sector rose organically by 3.7%. This growth was mostly offset by foreign exchange effects, leading to net sales growth of 0.4% to € 2.3 billion in the second quarter of 2025. EBITDA pre grew organically by 3.7%, primarily thanks to higher net sales. However, negative foreign exchange and portfolio effects resulted in a decline of 1.3% to € 646 million.

Process Solutions, which offers solutions for the entire pharmaceutical production value chain, saw an organic net sales increase of 11.5%. This marked the business unit’s second consecutive double-digit quarterly increase and its best sales performance in two years. During the Covid-19 pandemic, customers had substantially increased their inventories, resulting in a post-pandemic drop in demand. However, order intake has risen very strongly again, with the book-to-bill ratio comfortably above 1 in the second quarter of 2025.

The Science & Lab Solutions unit, which offers products and services for pharmaceutical, biotechnology and academic research, faced challenging market conditions in the United States in particular, with ongoing uncertainty surrounding funding for scientific research. While overall spending on pharmaceutical research remained restrained, the company saw some encouraging signs from pharma and biotech customers. Net sales growth was organically flat (+/–0.0%), an improvement on an organic decline of 2.5% in the first quarter of 2025.

Challenging market conditions, in particular early-stage biotech funding, continued to weigh on the Life Science Services business unit, which offers customers services as a contract development and manufacturing organization (CDMO) of medications as well as testing services. Net sales declined by 8.2% organically.

Blockbusters fuel Healthcare growth

Growth in Healthcare was mainly driven by two blockbuster drugs Erbitux and Mavenclad and the Cardiovascular, Metabolism & Endocrinology franchise. Net sales of the business sector as a whole grew by 3.6% organically compared with the previous year; however, negative foreign exchange effects led to a decline of 1.6% to € 2.1 billion. EBITDA pre grew organically by 20.0%, primarily as a result of temporarily reduced spending on research and development, a favorable product mix, strong commercial execution, and continued cost discipline. Despite negative foreign exchange effects in the double-digit percentage range, EBITDA pre rose 8.8% to € 783 million.

Net sales of Erbitux increased organically by 10.9% thanks to increased demand. The drug is a treatment for metastatic colorectal cancer as well as cancer of the head and neck. Bavencio, used to treat a type of bladder cancer, saw weaker demand as other treatment options are now available for this indication. Net sales declined by 12.1% organically. Overall, net sales of the Oncology franchise grew by 3.9% organically.

Mavenclad, which is used to treat multiple sclerosis, achieved strong organic growth of 20.7% because of increased demand in the United States and Europe. With net sales of € 307 million, Mavenclad delivered record quarterly sales. The multiple sclerosis drug Rebif recorded an organic net sales decline of 26.1%, in line with the global interferon market. Net sales of the Neurology & Immunology franchise grew by 2.6% organically.

The Cardiovascular, Metabolism & Endocrinology franchise achieved organic net sales growth of 4.7%. This franchise includes the diabetes medicine Glucophage, the beta-blocker Concor, the thyroid medicine Euthyrox, and Saizen, which is primarily used to treat various growth hormone disorders. All therapeutic areas contributed to the positive organic sales development.

In the Fertility franchise, Pergoveris achieved 20.5% organic net sales growth supported by its differentiated profile. The drug stimulates the production and release of egg cells. Gonal-f, a hormone treatment for infertility, saw an organic net sales decline of 12.5% amid high year-earlier comparables. The franchise’s overall net sales declined by 3.4% organically.

Going forward, SpringWorks Therapeutics will also contribute to the growth of Merck. Merck completed the acquisition of this U.S.-based biopharmaceutical company for US$ 3.4 billion (approximately € 3 billion) on July 1, 2025. With SpringWorks’ portfolio, Merck is expanding its rare tumor business. On July 18, 2025, the European Commission granted conditional approval for Ezmekly (mirdametinib). Developed by SpringWorks, it is used for the treatment of symptomatic, inoperable plexiform neurofibromas.

Electronics sees continued demand for semiconductor materials

The decline in Delivery Systems & Services has been sharper than anticipated, with already committed customer capital projects being delayed further. AI demand is driving the continued growth of materials needed for advanced nodes – the latest semiconductor manufacturing processes that allow for smaller feature sizes. The Semiconductor Materials business continued to deliver low single-digit organic growth for the second quarter against a strong comparable period.

Net sales of Electronics declined by 7.4% to € 886 million (organically: –5.6%) amid negative foreign exchange effects of –3.5%. Excluding foreign exchange effects, the second quarter saw the highest quarterly revenue for Semiconductor Materials since 2022, reflecting the sixth quarter of sequential growth. EBITDA pre declined by 47.6% to € 134 million (organically: –41.3%) due mainly to one-time effects including a purchase price allocation (PPA) adjustment and a provision for potential customer claims as a result of a non-quality-related problem caused by a supplier.

Sales in Optronics were around stable with the acquisition contribution from Unity‑SC more than offsetting lower sales for liquid crystals and OLED materials and foreign exchange headwinds. Demand for metrology and inspection, highly precise measurement and testing equipment for semiconductor manufacturing, increased year-on-year with strong demand from the field of Artificial Intelligence. Organically, overall net sales declined by 5.3%.

Net sales in Surface Solutions declined organically by 6.4% due to low demand, especially in cosmetics. Merck closed the divestment of the business unit on July 31, 2025. By divesting Surface Solutions, the company is positioning its Electronics business sector even more strongly as a provider of semiconductor solutions.

Merck refines 2025 guidance

Merck refined its existing guidance for the full year. The company narrowed the expected organic sales growth range for the Group to 2% to 5% (previously 2% to 6%). For EBITDA pre, Merck raised its guidance and now expects organic growth of 4% to 8% (previously 2% to 7%). This change was driven by positive guidance adjustments for Life Science and Healthcare as well as high cost discipline in all business sectors.

For Life Science, Merck now expects organic net sales growth of 3% to 6% (previously 2% to 6%) and organic EBITDA pre growth of 3% to 7% (previously 1% to 7%). For Healthcare, the range for expected organic net sales growth was narrowed to 3% to 5% (previously 2% to 6%). Merck now expects EBITDA pre for Healthcare to grow organically by 9% to 13% (previously 4% to 10%). For Electronics, the company’s smallest business sector, the new guidance reflects the one-time effects arising in the second quarter. Organic net sales are expected to decline by –5% to –1% (previously +1% to +6%), and organic EBITDA pre by –15% to –7% (previously –3% to +8%).

Overview of the key figures for Q2 2025

Merck Group

Key figures

€ million

Q2 2025

Q2 2024

Change

Net sales

5,255

5,352

-1.8%

Operating result (EBIT)1

891

792

12.4%

Margin (% of net sales)1

17.0%

14.8%

EBITDA2

1,348

1,472

-8.5%

Margin (% of net sales)1

25.6%

27.5%

EBITDA pre1

1,462

1,509

-3.1%

Margin (% of net sales)1

27.8%

28.2%

Profit after income tax

655

605

8.3%

Earnings per share (€)

1.50

1.40

7.1%

Earnings per share pre (€)1

2.02

2.20

-8.2%

Operating cash flow

567

861

-34.2%

Net financial debt1, 3

7,973

7,155

11.4%

Number of employees4

63,160

62,176

1.6%

1 Not defined by IFRS Accounting Standards (IFRS).

2 Not defined by IFRS Accounting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation,
amortization, impairment losses, and reversals of impairment losses.

3 Figures for the reporting period ending on June 30, 2025, prior-year figures as of December 31, 2024.

4 Figures for the reporting period ending on June 30, 2025, prior-year figures as of June 30, 2024. This figure refers to all employees at sites of fully consolidated entities.

Merck Group

Net sales by business sector

€ million

Q2 2025

Share

Organic
growth1

Exchange
rate effects1

Acquisitions/
divestments1

Total change

Q2 2024

Share

Life Science

2,267

43%

3.7%

-3.6%

0.3%

0.4%

2,258

42%

Healthcare

2,102

40%

3.6%

-5.2%

0.0%

-1.6%

2,137

40%

Electronics

886

17%

-5.6%

-3.5%

1.7%

-7.4%

957

18%

Merck Group

5,255

100%

2.0%

-4.2%

0.4%

-1.8%

5,352

100%

1 Not defined by IFRS Accounting Standards (IFRS).

Life Science

Net sales by business unit

€ million

Q2 2025

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q2 2024

Share

Science & Lab Solutions

1,150

51%

0.0%

-3.7%

0.2%

-3.5%

1,192

53%

Process Solutions

945

42%

11.5%

-3.4%

0.4%

8.4%

871

38%

Life Science Services

172

8%

-8.2%

-3.4%

0.0%

-11.5%

194

9%

Life Science

2,267

100%

3.7%

-3.6%

0.3%

0.4%

2,258

100%

1 Not defined by IFRS Accounting Standards (IFRS).

Healthcare

Net sales by major product lines/products

€ million


Q2 2025


Share


Organic
growth1


Exchange rate effects1


Total change


Q2 2024


Share

Oncology


485


23%


3.9%


-5.0%


-1.1%


490


23%

thereof: Erbitux


288


14%


10.9%


-6.6%


4.3%


276


13%

thereof: Bavencio


158


8%


-12.1%


-2.8%


-14.9%


186


9%

Neurology & Immunology


425


20%


2.6%


-4.6%


-2.0%


434


20%

thereof: Mavenclad


307


15%


20.7%


-5.4%


15.3%


266


12%

thereof: Rebif


119


6%


-26.1%


-3.2%


-29.3%


168


8%

Fertility


366


17%


-3.4%


-5.8%


-9.1%


403


19%

thereof: Gonal-f


186


9%


-12.5%


-5.6%


-18.1%


227


11%

thereof: Pergoveris


84


4%


20.5%


-6.1%


14.4%


73


3%

Cardiovascular, Metabolism and Endocrinology


741


35%


4.7%


-5.4%


-0.7%


746


35%

thereof: Glucophage


235


11%


4.3%


-5.4%


-1.1%


238


11%

thereof: Concor


154


7%


1.0%


-3.4%


-2.4%


158


7%

thereof: Euthyrox


155


7%


6.3%


-6.1%


0.2%


155


7%

thereof: Saizen


99


5%


9.7%


-7.8%


1.9%


97


5%

Other


84


4%


64


3%

Healthcare


2,102


100%


3.6%


-5.2%


-1.6%


2,137


100%

1 Not defined by IFRS Accounting Standards (IFRS).

Electronics

Net sales by business unit

€ million

Q2 2025

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q2 2024

Share

Semiconductor Solutions

603

68%

-5.6%

-3.7%

-0.1%

-9.3%

665

69%

Optronics

189

21%

-5.3%

-3.4%

9.0%

0.3%

188

20%

Surface Solutions

94

11%

-6.4%

-2.9%

0.0%

-9.3%

104

11%

Electronics

886

100%

-5.6%

-3.5%

1.7%

-7.4%

957

100%

1 Not defined by IFRS Accounting Standards (IFRS).

Forecast

Forecast for FY 2025

€ million

Net sales

EBITDA pre1

Operating cash flow

Merck Group

~20,500 to 21,700
Organic +2% to +5%
Foreign exchange effect -5% to -2%
Portfolio ~0%

~5,900 to 6,300
Organic +4% to +8%
Foreign exchange effect -6% to -3%
Portfolio -2% to -1%

~3,600 to 4,000

Life Science

~8,800 to 9,300
Organic +3% to +6%
Foreign exchange effect -5% to -2%

~2,500 to 2,700
Organic +3% to +7%
Foreign exchange effect -5% to -2%

Healthcare

~8,500 to 8,900
Organic +3% to +5%
Foreign exchange effect -5% to -2%
Portfolio ~+2%

~2,900 to 3,100
Organic +9% to +13%
Foreign exchange effect -9% to -6%
Portfolio -3% to -2%

Electronics

~3,300 to 3,600
Organic -5% to -1%
Foreign exchange effect -5% to -2%
Portfolio ~-3%

~700 to 900
Organic -15% to -7%
Foreign exchange effect -6% to -3%
Portfolio -3% to -1%

Corporate and Other

n/a

~-350 to -400

Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent

On August 6, 2025 Lantheus Holdings, Inc. ("Lantheus") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent filed by its affiliate, Aphelion. The FDA has set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (PDUFA).

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This NDA acceptance builds on the success of Lantheus’ market-leading PSMA PET imaging agent, PYLARIFY, which has demonstrated high diagnostic performance and meaningful impact on clinical decision making. If approved, we expect that this new formulation will offer an efficacy consistent with the market-leading PSMA PET agent, PYLARIFY, which has demonstrated an 86% median true-positive rate based on three independent readers in a study of patients with recurrent prostate cancer based on rising PSA after therapy.1

"We are pleased the FDA accepted Aphelion’s NDA for the new piflufolastat F 18 formulation, which we expect will improve patient access due to a significant increase in the number of doses per batch," said Brian Markison, CEO, Lantheus. "This formulation is a natural next step in our commitment to advancing PSMA imaging. There is a growing burden of prostate cancer in the U.S. and a clear need for accurate and early detection. Building on PYLARIFY’s proven performance and accuracy, Lantheus is well-positioned for continued leadership in prostate cancer imaging."

This new formulation optimizes the manufacturing process and is expected to increase batch size by ~50%, allowing Lantheus to serve significantly more patients while maintaining the same high standards that has made PYLARIFY the trusted choice for providers. The new formulation increases the radioactive concentration of the agent and has the potential to expand patient access in new geographic locations.

"We have reached a key milestone and delivered on our commitment to advance prostate cancer imaging through sustainable innovation," said Paul Blanchfield, President, Lantheus. "By enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader healthcare system’s ability to deliver timely diagnostic imaging."

About Prostate Cancer

In the U.S., prostate cancer is the second most frequently diagnosed cancer and fifth-leading cause of cancer-related deaths among men globally. For 2025, estimates suggest nearly 315,000 new cases and more than 35,000 deaths.2 Projections indicate a significant increase in prostate cancer incidence, with annual cases expected to nearly double to 2.9 million by 2040.3 This is largely attributed to aging populations and increased life expectancy, particularly in low- and middle-income countries where healthcare access and early detection may be limited.

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.3-9

PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states, Puerto Rico and Washington, D.C.

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, AUG 6, 2025, View Source [SID1234662959])

Novo Nordisk’s sales increased by 16% in Danish kroner and by 18% at constant exchange rates to DKK 154.9 billion in the first six months of 2025

On August 6, 2025 Novo Nordisk reported the company’s sales increased by 16% in Danish kroner and by 18% at constant exchange rates to DKK 154.9 billion in the first six months of 2025 (Press release, Novo Nordisk, AUG 6, 2025, View Source [SID1234655576]).

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Half-Year Financial Report 2025

On August 6, 2025 Bayer reported its second quarter 2025 financial results (Presentation, Bayer, AUG 6, 2025, View Source [SID1234655500]).

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