On August 7, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported its financial results for the second quarter of 2025 and provided a corporate update (Press release, Aclaris Therapeutics, AUG 7, 2025, View Source [SID1234654959]).

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"Aclaris is in a period of strong execution throughout the business as we advance our innovative therapies toward our goal of improving therapeutic options for patients with certain I&I diseases," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "For example, the results from the single arm Phase 2a clinical trial of our ITK/JAK3 inhibitor ATI-2138 represent a significant achievement for our ITK franchise by both confirming the strong tolerability profile and mechanism of ATI-2138 in AD ahead of our planned alopecia areata clinical trial and validating ITK as an important therapeutic target. Importantly, with an expected cash runway that funds our operations into the second half of 2028, we have sufficient capital to execute our strategic plan. We are also exploring additional non-dilutive opportunities to extend our cash runway even further."

Second Quarter 2025 Highlights and Recent Updates

Pipeline:

Achieved Primary and Key Secondary Endpoints in Phase 2a Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3: Positive results from this open-label, single arm trial further confirmed the favorable tolerability profile of ATI-2138, demonstrated clinically meaningful improvements from baseline in assessments of disease severity in patients with moderate-to-severe AD receiving low doses of ATI-2138, and validated ITK as a therapeutic target. Overall, these results provide evidence that the contribution of ITK may enable ATI-2138, even at low doses, to achieve efficacy results comparable to approved JAK inhibitors in moderate-to-severe AD, but with improved tolerability and without the significant safety risks typically associated with JAK inhibition. (press release here)
Initiated Dosing in Phase 2 Trial of Potential Best-in-Class Investigational Anti-TSLP Monoclonal Antibody Bosakitug: Patient dosing is ongoing in the randomized, double-blind, placebo-controlled global Phase 2 trial designed to evaluate bosakitug in approximately ninety (90) patients with moderate-to-severe AD. The Company expects to provide top line results in the second half of 2026. (press release here)
Initiated Dosing in Phase 1a/1b Program for Potential Best-in-Class Investigational Bispecific Anti-TSLP/IL-4R Antibody ATI-052: Dosing is ongoing in the randomized, blinded, placebo-controlled Phase 1a portion, designed to evaluate single and multiple ascending doses of ATI-052 in healthy adults. The Phase 1b proof-of-concept portion in up to two indications is expected to follow the Phase 1a portion. Aclaris expects to complete the Phase 1a portion by year-end 2025 and provide top line results in early 2026, followed by top line results from the Phase 1b portion in the second half of 2026. (press release here)

Corporate:

Strong Cash Runway Funds the Company’s Planned Operations into the Second Half of 2028: The Company is assessing potential non-dilutive opportunities to extend the cash runway further.
Provided Update on Senior Leadership: Roland Kolbeck, Ph.D. has been appointed as Chief Scientific Officer, replacing Joe Monahan, Ph.D. who will remain with the Company as Special Scientific Advisor to the Chief Executive Officer through the first quarter of 2026 as part of his planned retirement. (press release here)
Financial Results

Liquidity and Capital Resources

As of June 30, 2025, Aclaris had cash, cash equivalents and marketable securities of $180.9 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2028, without giving effect to any potential business development transactions or financing activities.

Second Quarter 2025 and Year-to-Date 2025

Net loss was $15.4 million for the second quarter of 2025 compared to $11.0 million for the second quarter of 2024. Net loss was $30.5 million for the six months ended June 30, 2025 compared to $27.9 million for the six months ended June 30, 2024.

Total revenue was $1.8 million for the second quarter of 2025 compared to $2.8 million for the second quarter of 2024. Total revenue was $3.2 million for the six months ended June 30, 2025 compared to $5.2 million for the six months ended June 30, 2024. The decrease for both comparison periods was primarily driven by the sale of a portion of royalty payments under the Company’s agreement with Eli Lilly and Company to OCM IP Healthcare Portfolio IP, an investment vehicle for Ontario Municipal Employees Retirement System (OMERS), in July 2024.

Research and development (R&D) expenses were $11.4 million and $23.0 million for the quarter and six months ended June 30, 2025, respectively, compared to $8.8 million and $18.6 million for the corresponding prior year periods. The increases were primarily driven by product candidate manufacturing costs, preclinical development activities, and clinical development expenses associated with the Phase 2 trial in AD for bosakitug and the Phase 1a/1b program for ATI-052. For the six-month comparison period, clinical development expenses associated with the Phase 2a trial in AD for ATI-2138 also contributed to the increase. The increases were partially offset by a reduction in development expenses for zunsemetinib for both comparison periods.

General and administrative (G&A) expenses were $5.4 million for the quarter ended June 30, 2025 compared to $4.8 million for the corresponding prior year period. The increase was primarily driven by higher personnel expenses as a result of higher headcount. G&A expenses were $11.5 million for the six months ended June 30, 2025 compared to $11.6 million for the six months ended June 30, 2024. The decrease was primarily driven by lower personnel expenses as a result of lower termination benefits.

Revaluation of contingent consideration resulted in a $1.5 million charge for the quarter ended June 30, 2025 compared to a $0.2 million charge for the prior year period. The increase was primarily due to changes to the probability of success for certain product candidates and lower discount rates resulting from changes in credit spreads being applied to potential payments during the quarter ended June 30, 2025. For the six months ended June 30, 2025, revaluation of contingent consideration resulted in a charge of $1.8 million compared to $3.0 million for the prior year period. The decrease was primarily due to changes in estimated sales levels and changes to the probability of success for certain product candidates during the six months ended June 30, 2024.

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.

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

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

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