On August 6, 2025 Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in generic and biosimilar medicines, reported its financial results for the first half of 2025 (Press release, Sandoz, AUG 6, 2025, View Source [SID1234654880]). Growth in this document is shown at constant currencies (CC)[1] unless stated otherwise.

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FINANCIAL RESULTS

H1 2025 H1 2024 change
USD m
USD m
USD %
CC %
CGR %[2]

Net sales 5,232 5,047 4% 4% 6%
Generics 3,736 3,704 1% 1% 2%
Biosimilars 1,496 1,343 11% 12% 17%

Core EBITDA 1,046 885 18% 20%
Core EBITDA margin (%) 20.0% 17.5%
Core diluted earnings per share (USD) 1.46 1.12 30% 33%
Management free cash flow 503 237 nm[3]

Richard Saynor, Chief Executive Officer of Sandoz, said: "The first half of the year marked another phase of good progress for Sandoz. Strong underlying sales growth was underpinned by the double-digit performance from our biosimilars which, in the second quarter, represented 30% of net sales for the first time, marking a true milestone for the company. Europe and International also performed particularly well, while we launched more important medicines for patients in North America.

"Reflecting this year’s launch program, weighted to the second half, we anticipate an even stronger sales performance in the second half, particularly in North America. Further investments in our biosimilars future, in Slovenia and via the proposed acquisition of Just-Evotec Biologics EU SAS, reflect the latest step in our strategic plan to capitalize on the unprecedented patent-expiries’ opportunity over the next ten years. This will only be enhanced by the effects of regulatory streamlining. It is the combination of the growing platform of opportunities, consistently strong financial results and our unrelenting focus on patients that offers such attractive long-term value for our stakeholders."

FINANCIAL HIGHLIGHTS

H1 2025 net sales of USD 5,232 million:
Up by 4% at CC and USD, with volume growth of 7%; on a CGR basis, H1 net sales grew by 6%
In the second quarter, accelerated growth of 5% at CC and 8% in USD; growth of 7% at CGR
Biosimilars H1 sales up by 12% at CC and 17% at CGR
H1 generics growth of 1% at CC and 2% at CGR
The 10 largest-selling medicines grew by a combined 10% at CC and represented 33% of net sales
A core EBITDA margin in H1 of 20.0%, representing a 2.5 percentage-point year-on-year improvement, primarily driven by operating leverage and the mix of sales
Management free cash flow in H1 of USD 503 million (H1 2024: USD 237 million). Free cash flow of USD 207 million (H1 2024: USD 21 million)
Core diluted earnings per share of USD 1.46 in H1 represented growth of 33% at CC and 30% in USD
Full-year 2025 guidance confirmed: mid-single-digit net-sales growth at CC and a core EBITDA margin of around 21%
BUSINESS HIGHLIGHTS

There were a number of business highlights since the publication of the Q1 2025 sales update.

Biosimilars

The company recently signed a non-binding term sheet with Evotec SE to acquire its Just-Evotec Biologics’ in-house development and manufacturing capabilities in Toulouse, France. The proposed transaction would seamlessly align with the strategic objective of capitalizing on the projected USD 300 billion biosimilar-market opportunity over the next 10 years[4]
Sandoz recently announced the start of construction for a new, state-of-the-art biosimilars production center for sterile product manufacturing in Brnik, Slovenia. This complements ongoing investments in Slovenia, namely a new biosimilar drug-substance production center in Lendava and a biosimilar development center in Ljubljana
Following feedback from major regulatory authorities, Sandoz has decided to streamline the clinical-development programs for its proposed nivolumab and ocrelizumab biosimilars, respectively. The company is winding down the Phase III NivoReach trial for its proposed biosimilar nivolumab. Sandoz is also modifying its Strive-MS integrated Phase I/III trial to become a comparative pharmacokinetic trial for its proposed ocrelizumab biosimilar. The development programs, including comprehensive analytical and clinical pharmacokinetic data, have been designed to align with updated regulatory guidance and confirm biosimilarity to their respective reference medicines, while maintaining the highest scientific and regulatory standards
The aforementioned streamlining reflects ongoing encouraging and favorable regulatory developments for biosimilars and follows Sandoz’s decision earlier in the year to minimize its Phase III trial for its proposed pembrolizumab biosimilar
Launches

Sandoz recently launched Wyost and Jubbonti in the US, the first and only interchangeable denosumab biosimilars. Pyzchiva (ustekinumab) was also launched in the US, including in private label. Finally, a Pyzchiva autoinjector was also rolled out to become the first commercially available ustekinumab biosimilar in a pre-filled pen in Europe
Anticipated biosimilar launches in the second half of the year include Wyost & Jubbonti and Afqlir (aflibercept) in Europe, while the company retains its ambition to launch Tyruko (natalizumab) in the US before the end of the year[5]
FULL-YEAR 2025 GUIDANCE

The company expects further major biosimilar launches this year, while price erosion is expected to return to normalized levels of a low to mid-single-digit percentage. Sandoz continues to anticipate core EBITDA-margin expansion this year to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the company confirms its expectations for 2025:

Net sales to grow at CC by a mid-single-digit percentage
A core EBITDA margin in FY 2025 of around 21%
This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government.

H1 AND Q2 2025 NET SALES

Net sales by business

H1

H1 2025 % of net sales H1 2024 change
USD m USD m USD % CC % CGR %

Generics 3,736 71 3,704 1% 1% 2%
Biosimilars 1,496 29 1,343 11% 12% 17%
Net sales 5,232 100 5,047 4% 4% 6%

Net sales for the first half of 2025 were USD 5,232 million, up by 4% at CC and by 6% at CGR. Volumes grew by 7%, partly offset by price erosion of 3%; the erosion was in line with a full-year assumption of a low to mid-single-digit decline. Net-sales growth was primarily driven by the performance of biosimilars, which continues to benefit from an extensive pipeline and launch program.

Generics overview
Net sales of generics in H1 were USD 3,736 million, reflecting growth of 1% at CC and 2% at CGR. Generics represented 71% of net sales (H1 2024: 73%, Q2 2025: 70%).

Europe net sales of generics grew by 2% at CC in the first half, reflecting the impact of launches in 2024. International net sales of generics declined by 1% at CC; after adjusting for the 2024 divestment of the Sandoz business in China, International net sales of generics grew by 3% at CGR. In North America, generics net-sales growth of 2% at CC benefited from the successful launch of paclitaxel in 2024.

Biosimilars overview
Net sales of biosimilars in H1 of USD 1,496 million reflected growth of 12% at CC and 17% at CGR. Biosimilars represented 29% of total net sales (H1 2024: 27%, Q2 2025: 30%).

Strong Europe biosimilars net-sales growth of 17% at CC benefited from a number of good performances, including recently launched Pyzchiva and Tyruko, while strong International biosimilar net-sales growth of 30% at CC partly reflected the strong contribution from Omnitrope (somatropin). Major biosimilar launches in International in 2025 will all occur in the second half of the year.

North America biosimilar net sales declined by 9% at CC in the half, reflecting the withdrawal of Cimerli in Q1 2025 and the effect of private-label adalimumab pricing; excluding the impact of the 2024 acquisition of Cimerli, North America biosimilar net sales grew by 9%.

Q2

Q2 2025 % of net sales Q2 2024 change
USD m USD m USD % CC % CGR %

Generics 1,927 70 1,835 5% 2% 3%
Biosimilars 825 30 720 15% 12% 20%
Net sales 2,752 100 2,555 8% 5% 7%

Net sales for the second quarter were USD 2,752 million, up by 5% at CC and by 7% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%.

Net sales by region

H1

H1 2025 % of net sales H1 2024 change
USD m USD m USD % CC % CGR %

Europe 2,832 54 2,634 8% 6% 6%
International 1,284 25 1,269 1% 5% 8%
North America 1,116 21 1,144 -2% -1% 4%
Net sales 5,232 100 5,047 4% 4% 6%

Europe overview
Net sales in Europe in H1 were USD 2,832 million, reflecting growth of 6% at CC and CGR. Europe net sales of generics grew by 2% at CC in the first half, with growth in biosimilars of 17% at CC primarily a result of commercial execution and recent launches, including Pyzchiva and Tyruko.

International overview
Net sales in International in H1 were USD 1,284 million, with growth of 5% at CC and 8% at CGR. In the second quarter, International net sales grew by 11% at CC and by 13% at CGR, despite major biosimilar launches this year all coming in H2. Pricing increased in generics during the first half of 2025, with strong International biosimilar net-sales growth of 30% at CC partly a result of the continued good performance from Omnitrope.

North America overview
Net sales in North America in H1 were USD 1,116 million, reflecting a decline of 1% at CC. Growth at CGR however, namely excluding the impact of the acquisition of Cimerli, amounted to 4%. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the aforementioned impact of the Cimerli acquisition. Price erosion was driven by reduced Cimerli sales, private-label adalimumab pricing and Omnitrope.

Q2

Q2 2025 % of net sales Q2 2024 change
USD m USD m USD % CC % CGR %

Europe 1,460 53 1,308 12% 6% 6%
International 694 25 627 11% 11% 13%
North America 598 22 620 -4% -3% 5%
Net sales 2,752 100 2,555 8% 5% 7%

H1 2025 KEY OPERATING AND NON-OPERATING RESULTS

H1 2025 H1 2024 change
USD m USD m USD % CC %

Net sales 5,232 5,047 4% 4%
Gross profit 2,411 2,380 1% 2%
Operating income 602 332 81% 90%
EBITDA 870 576 51% 55%
Net income 377 151 nm nm

Core results

Core gross profit 2,575 2,544 1% 2%
Core gross profit margin (%) 49.2% 50.4%

Core operating income 901 763 18% 20%
Core operating income margin (%) 17.2% 15.1%

Core EBITDA 1,046 885 18% 20%
Core EBITDA margin (%) 20.0% 17.5%

Core net income 635 484 31% 34%
Core diluted earnings per share (USD) 1.46 1.12 30% 33%

Core gross profit amounted to USD 2,575 million (H1 2024: USD 2,544 million), resulting in a core gross profit margin of 49.2% (H1 2024: 50.4%). The favorable product mix from double-digit biosimilars growth, as well as operational improvements, was more than offset by price erosion and inflation on cost of goods sold.

Core EBITDA was USD 1,046 million (H1 2024: USD 885 million), resulting in a core EBITDA margin of 20.0% (H1 2024: 17.5%). The strong increase was primarily driven by leveraging expenses from a growing top line and savings from the transformation program. EBITDA was USD 870 million (H1 2024: USD 576 million). Core adjustments for EBITDA in the first half of 2025 were USD 176 million (H1 2024: USD 309 million). These were mainly driven by separation costs of USD 156 million, costs of rationalization of internal manufacturing sites of USD 54 million and favorable impacts from adjustments for legal costs of USD 28 million.

Core net income was USD 635 million (H1 2024: USD 484 million), mainly driven by higher core operating income and a lower core net financial result, partly offset by higher core income taxes, while the effective tax rate remained broadly unchanged. Core diluted earnings per share were USD 1.46 (H1 2024: USD 1.12). The weighted average number of shares diluted was 435.8 million as of June 30, 2025, versus 432.2 million in the prior-year period.

NET CASH FLOW, NET WORKING CAPITAL AND NET DEBT

H1 2025 H1 2024 change
USD m USD m USD m

Net cash flows from operating activities 523 229 294
Cash flows used for net capex (310) (205) (105)
Free cash flow 207 21 186
Management free cash flow 503 237 266

Sandoz generated net cash flows from operating activities of USD 523 million in the first half of the year (H1 2024: USD 229 million). This was mainly driven by working-capital enhancements through improvements in receivables; inventory levels were stable versus December 2024.

Cash flows used for capital expenditures were USD 310 million (H1 2024: USD 205 million). This included the company’s ongoing investment in Slovenia, namely a new biosimilar drug substance production center in Lendava, a biosimilar development center in Ljubljana and a new production plant in Brnik. It also included separation-related investments in facilities and technology.

Management free cash flow, defined as free cash flow adjusted for one-off items, was USD 503 million (H1 2024: USD 237 million). The increase was mainly driven by a higher core EBITDA. Free cash flow amounted to USD 207 million (H1 2024: USD 21 million). The improvement was mainly due to increased net cash flows from operating activities, partly offset by higher cash flows used for capital expenditures.

Jun 30, 2025 Dec 31, 2024 change
USD m USD m USD m

Net working capital 3,638 3,486 152
Net debt 3,909 3,329 580

Net working capital increased by USD 152 million, largely due to currency-translation effects of USD 305 million, offset by improvements in underlying net working capital.

Non-current financial debt increased by USD 811 million, reflecting the issuance of three bonds in the first half of 2025 of EUR 500 million and CHF 400 million, respectively and currency-translation effects. This was partly offset by the repayment of USD 750 million equivalent in USD and EUR term loans.

Cash and cash equivalents increased by USD 198 million as cash generated from operating activities and proceeds from the issuance of non-current financial debt were partly offset by the repayment of term loans, the annual dividend payment and purchases of property, plant and equipment.

As a result of the above, net debt increased to USD 3.9 billion compared to USD 3.3 billion on December 31, 2024, mainly related to currency-translation effects of USD 422 million.

CONFERENCE CALL

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

NOTES

The performance shown in this announcement covers the six-month period to June 30, 2025 (H1 2025) and the three-month period to June 30, 2025 (Q2 2025), compared to the six-month period to June 30, 2024 (H1 2024) and the three-month period to June 30, 2024 (Q2 2024), respectively. Commentary is based on the performance in H1 2025, unless stated otherwise.

CALENDAR

The company intends to publish its nine-months’ and third-quarter sales update on October 30, 2025.

HALF-YEAR REPORT

Sandoz published its Half-Year Report 2025 today, which can be found here.

[1] Non-IFRS measures are defined in the Supplementary financial information section of the Half-Year Report 2025.
[2] Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the company’s Consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time. In this announcement, adjustments relate to the impact of the 2024 acquisition of US biosimilar Cimerli (ranibizumab) and the 2024 divestment of the Sandoz business in China.
[3] Not meaningful.
[4] Based on March 2025 data from IPD Analytics Evaluate Pharma, covering the period 2026–2035.
[5] Subject to regulatory approval of John Cunningham virus assay and pending litigation.

On August 6, 2025 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, reported financial results for the second quarter 2025 and highlighted recent operational progress (Press release, Zentalis Pharmaceuticals, AUG 6, 2025, View Source [SID1234654876]).

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"This quarter, we continued to execute on our focused strategy to advance the late-stage clinical development of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is no approved treatment option specifically for this biomarker selected population, which comprises approximately 50% of PROC patients," said Julie Eastland, Chief Executive Officer of Zentalis. "We are maintaining momentum with the DENALI Phase 2 clinical trial and remain on track to disclose topline data from DENALI Part 2 by year end 2026."

Business Updates

•Phase 2 DENALI clinical trial remains on track.
◦Enrollment is ongoing in DENALI Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1-positive PROC. DENALI Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule) and 300mg QD 5:2. DENALI Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results, subject to FDA feedback.
◦The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review.

•Completed strategic restructuring announced in January 2025, supporting late-stage clinical development of azenosertib.
◦The Company has operationally completed the restructuring and does not expect to incur further associated related non-recurring expenses.
◦This restructuring prioritizes the late-stage development of azenosertib and extends the Company’s cash runway into late 2027, beyond the Company’s anticipated DENALI Part 2 topline data.

Second Quarter 2025 Financial Results

•Cash, Cash Equivalents and Marketable Securities Position: As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of $303.4 million, which includes $16.8 million representing the June 30, 2025 fair value of Immunome common stock received by the Company from the sale of its ROR1 antibody-drug conjugate (ADC) product candidate and ADC platform to Immunome in October 2024. The Company believes that its existing cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund its operating expenses requirements into late 2027.

•Research and Development Expenses: Research and development (R&D) expenses for the three months ended June 30, 2025 were $27.6 million, compared to $48.4 million for the three months ended June 30, 2024. The decrease of $20.8 million was primarily due to decreases of $15.9 million for clinical expenses, $3.6 million for lab services, $3.4 million for drug manufacturing, $0.6 million related to personnel expenses and $0.4 million of miscellaneous expenses. These decreases were partially offset by an increase in companion diagnostic expense of $3.1 million.

•General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2025 were $8.4 million, compared to $16.7 million during the three months ended June 30, 2024. This decrease of $8.3 million was attributable to a decrease of $6.8 million in personnel expense, $1.1 million related to consulting and $0.4 million miscellaneous expenses.
•Operating Expenses: Total operating expenses were $36.1 million for the three months ended June 30, 2025, compared to $65.1 million for the three months ended June 30, 2024.

About Azenosertib
Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 clinical trial studying azenosertib in platinum-resistant ovarian cancer (PROC) patients. Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule). Interim results from Part 1b were presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. Part 2 is ongoing and is enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff. Part 2 includes Part 2a, a dose confirmation portion evaluating two doses, 300mg 5:2 and 400mg 5:2, and Part 2b, a portion designed to complete enrollment at the selected dose. Part 2, in total, is designed for accelerated approval, pending study outcome and discussions with the U.S. Food and Drug Administration.

On August 6, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the second quarter ended June 30, 2025 and provided recent business and clinical program updates (Press release, Xencor, AUG 6, 2025, View Source [SID1234654875]).

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"Xencor is focused on execution of our clinical studies, evaluating four wholly owned XmAb drug candidates in cancer and advanced autoimmune-driven diseases," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In oncology, these include two T-cell engager (TCE) programs, XmAb819 and XmAb541, which continue to progress through dose-escalation studies. We are on-track to present preliminary safety and efficacy from XmAb819 in advanced clear cell renal cell carcinoma later this year."

"In our autoimmune portfolio, we recently initiated the Phase 2b XENITH-UC study of XmAb942, our potential best-in-class antibody targeting TL1A for inflammatory bowel disease, to rapidly identify a pivotal dose regimen for those with moderately to severely active ulcerative colitis. Also, in June we were granted regulatory authorization to proceed with the proof-of-concept study of plamotamab, our CD20 B-cell depleting TCE, in rheumatoid arthritis. For the remainder of the year, we expect to continue our global rollout of the XENITH-UC and plamotamab studies, and we also remain on-track to start a proof-of-concept study of XmAb657, our novel CD19 B-cell depleting TCE for the treatment of patients with autoimmune disease."

Clinical Program Updates

Oncology

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC). XmAb819 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing ENPP3. Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial dose-escalation data at a medical conference during the fourth quarter of 2025.

XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with advanced solid tumors expressing CLDN6. Like XmAb819, XmAb541 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing CLDN6. A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer, germ cell tumors, and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025.
Autoimmune & Inflammatory Diseases

Plamotamab (CD20 x CD3), a clinical stage, B-cell depleting bispecific T-cell engager for development in rheumatoid arthritis (RA). Xencor is evaluating plamotamab in a Phase 1b/2a proof-of-concept study, for patients with RA have progressed through prior standard-of-care treatment. In June 2025, Xencor received regulatory authorization to proceed with the study.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. In the first half of 2025, Xencor presented initial data from a Phase 1 study of XmAb942 in healthy volunteers. The results showed that XmAb942 was well tolerated at single and multiple doses and had a greater than 71-day half-life, which supports an every 12-week dosing in maintenance. Xencor recently initiated the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy.
Recent Partnership Developments

Incyte Corporation: In June 2025, Incyte announced that Monjuvi was approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma in combination with rituximab and lenalidomide. The approval was based on data from Incyte’s pivotal Phase 3 inMIND trial. Xencor earned a $25 million regulatory milestone payment in addition to non-cash royalty revenue from sales of Monjuvi/Minjuvi for the second quarter of 2025. Monjuvi and Minjuvi are registered trademarks of Incyte.
Additional Corporate Updates

In July, Xencor appointed Raymond Deshaies, Ph.D., to its board of directors. Dr. Deshaies is a pioneering biochemist and cell biologist with more than 25 years of experience in biotechnology and drug development. He recently served as senior vice president of global research at Amgen Inc., where he oversaw all research activities, including the nomination of over 50 clinical candidates, expansion of Amgen’s capabilities for discovering and optimizing multispecific drug candidates, and application of generative protein design to biologics discovery.
Financial Guidance: Based on current operating plans, Xencor expects to end 2025 with between $555 million and $585 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2028.

Financial Results for the Second Quarter Ended June 30, 2025

Cash, cash equivalents and marketable debt securities totaled $663.8 million as of June 30, 2025, compared to $706.7 million as of December 31, 2024.

Revenue for the second quarter ended June 30, 2025 was $43.6 million, compared to $23.9 million for the same period in 2024. Revenue earned in the second quarter of 2025 was primarily milestone revenue from Incyte and non-cash royalty revenue from Alexion and Incyte, compared to the same period in 2024, which was primarily non-cash royalty revenue from Alexion and Incyte and licensing revenue from multiple licensees.

Research and development (R&D) expenses for the second quarter ended June 30, 2025 were $61.7 million, compared to $61.5 million for the same period in 2024. R&D spending for the second quarter of 2025 compared to 2024 reflects increased spending on XmAb819, XmAb541 and XmAb657 (CD19 x CD3), offset by reduced wind-down costs on terminated programs.

General and administrative (G&A) expenses for the second quarter ended June 30, 2025 were $15.1 million, compared to $17.7 million for the same period in 2024. Decreased G&A spending for the second quarter of 2025 compared to 2024 is primarily due to lower stock compensation expense.

Other income (expense), net, for the second quarter ended June 30, 2025 was $2.1 million, compared to $(13.4) million for the same period in 2024. The increase for the second quarter of 2025, compared to 2024, is primarily driven by unrealized gains from marketable equity securities.

Net loss attributable to Xencor for the second quarter ended June 30, 2025 was $30.8 million, or $(0.41) on a fully diluted per share basis, compared to net loss of $67.3 million, or $(1.09) on a fully diluted per share basis, for the same period in 2024.

On August 6, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the second quarter ended June 30, 2025 (Press release, Veracyte, AUG 6, 2025, View Source [SID1234654874]).

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"Testing growth continues to exceed our expectations, driven by Decipher which achieved its thirteenth consecutive quarter of over 25% year-over-year volume growth," said Marc Stapley, Veracyte’s chief executive officer. "This strong result, combined with Afirma volume meeting our expectations and the resolution of the French subsidiary proceedings, has positioned us for incremental investment in our strategic portfolio in the second half of 2025 and beyond, strengthening our confidence in delivering sustained long-term revenue growth. Backed by our differentiated platform and a growing body of clinical evidence, we are deeply committed to improving outcomes for patients around the world."

Key Financial Highlights

For the three-month period ended June 30, 2025, as compared to the same period in 2024:

Increased total revenue by 14% to $130.2 million and testing revenue by 14% to $122.3 million.
Increased total volume by 15% to 44,966 tests and testing volume by 18% to 42,441 tests.
Grew Decipher revenue by 24% to $76.3 million and Afirma revenue by 5% to $43.4 million.
Grew Decipher volume by 28% to approximately 25,500 tests and Afirma volume by 8% to approximately 16,950 tests.
Recorded GAAP net loss of $1.0 million, or (0.8%) of revenue, including $20.5 million of one-time impairment charges, and adjusted EBITDA of $35.8 million, or 27.5% of revenue.
Generated $33.6 million of cash from operations to end the quarter with $320.7 million of cash, cash equivalents, and short-term investments as of June 30, 2025.
Provided full year revenue guidance of $496 million to $504 million; raised testing revenue guidance to $477 million to $483 million or 14% to 15% year-over-year growth.
Key Business Highlights

Kicked off our high risk and metastatic growth strategy with the full launch of Decipher for use in the metastatic population in June, engaging physicians in understanding the utility of Decipher in aiding decision making on treatment intensification.
Demonstrated utility of Decipher Prostate and Decipher Bladder Genomic Classifiers as well as the Decipher GRID research capabilities through 29 abstracts presented and nine new publications.
Supported the presentation of seven different abstracts covering clinical Afirma GSC data and research with Afirma GRID at scientific and medical conferences, and saw the publication of the first study detailing the development and validation of tumor behavior classifiers offered on the Afirma GRID research report, in Frontiers in Endocrinology.
Added to the clinical data demonstrating that Prosigna accurately classifies patients’ risk of recurrence with the presentation of 10-year clinical outcomes data from the OPTIMA Prelim study at ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress.
Completed the French entity restructuring process as it relates to the sale of the Veracyte SAS product manufacturing business and deconsolidation of the Veracyte SAS operations (see below).
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Second Quarter 2025 Financial Results

Total revenue for the second quarter of 2025 was $130.2 million, an increase of 14% compared to $114.4 million reported in the second quarter of 2024. Testing revenue was $122.3 million, an increase of 14% compared to $107.0 million in the second quarter of 2024, driven by our Decipher Prostate and Afirma tests. Product revenue was $3.6 million, a decrease of 8% compared to $3.9 million in the second quarter of 2024. Biopharmaceutical and other revenue was $4.3 million, an increase of 21% compared to $3.6 million in the second quarter of 2024.

Total gross margin for the second quarter of 2025 was 69%, compared to 68% in the second quarter of 2024. Non-GAAP gross margin was 72%, compared to 71% in the second quarter of 2024.

Operating expenses were $95.0 million for the second quarter of 2025 including $20.5 million of impairment given the partial sale and subsequent liquidation proceedings of our French subsidiary. Non-GAAP operating expenses grew 2% to $60.3 million compared to $59.0 million in the second quarter of 2024.

Net loss for the second quarter of 2025 was $1.0 million, a decrease of 117% compared to the second quarter of 2024. Diluted net loss per common share was $0.01, a decrease of $0.08 compared to the second quarter of 2024. Non-GAAP diluted net earnings per common share was $0.44, an increase of $0.14 compared to the second quarter of 2024. Net cash provided by operating activities in the first six months of 2025 was $39.0 million, an improvement of $18.4 million compared to the same period in 2024.

Adjusted EBITDA for the second quarter of 2025 was $35.8 million, an improvement of 49% compared to the second quarter of 2024, representing 27.5% of revenue compared to 21.0% of revenue in the same period of 2024.

Update on Marseille Operations

As previously communicated, on May 7, 2025, the Commercial Court of Marseille opened restructuring proceedings related to Veracyte SAS, Veracyte Inc.’s French subsidiary. These proceedings allowed the court-appointed representative to evaluate opportunities for sale of all or part of the Veracyte SAS business, including Veracyte’s immune-oncology biopharma business, contract IVD development and manufacturing and support for Veracyte’s IVD product development and manufacturing.

On July 16, 2025, the Marseille Commercial Court published a decision approving the sale of the manufacturing operations of Veracyte SAS to Helio Diagnostics SAS. The sale closed on August 1, 2025. Following the sale, the remaining Veracyte SAS assets will continue to be managed by the court-appointed administration until formal liquidation proceedings are opened, at which point the proceeding will be managed solely by a court-appointed judicial liquidator. Given the sale and subsequent liquidation proceedings we took a $20.5 million impairment charge on related assets in Q2 and have deconsolidated the entity as of August 1, 2025, the effective date of the sale.

Management will provide further details on the potential impact to Veracyte’s 2025 financial outlook during the conference call this afternoon.

2025 Financial Outlook

The company is raising full-year 2025 testing revenue guidance to $477 million to $483 million, or 14% to 15% year-over-year growth, from prior guidance of $470 million to $480 million. Adjusting for the impact of the paused Envisia test, the guidance implies 16% to 17% year-over-year testing revenue growth. Given the resolution of the French subsidiary proceedings, the company is initiating full-year 2025 total revenue guidance of $496 million to $504 million, or 11% to 13% year-over-year growth.

Additionally, the company is raising guidance for adjusted EBITDA as a percentage of revenue in 2025 to 23.5% from 22.5%.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA as a percentage of revenue to the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: View Source

On August 6, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported financial results for the quarter ended June 30, 2025 (Press release, Schrodinger, AUG 6, 2025, View Source [SID1234654873]).

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"In a highly dynamic macroenvironment, our ability to deliver solid second quarter results and maintain our 2025 revenue growth guidance is a testament to our strong customer relationships and the demand for proven computational technologies to accelerate molecular discovery," said Ramy Farid, Ph.D., chief executive officer of Schrödinger. "In addition to progressing several collaborative programs in our pipeline, we achieved an important milestone with the presentation of encouraging initial data for our MALT1 inhibitor, SGR-1505, and we expect to report initial data from our other two clinical programs in the fourth quarter."

Earlier this year, Schrödinger presented initial Phase 1 data for SGR-1505 in patients with relapsed/refractory B-cell malignancies. SGR-1505 was observed to be well tolerated and clinically active with responses observed in multiple histologies, including in patients with chronic lymphocytic leukemia and Waldenström macroglobulinemia.

"We are very pleased with the initial Phase 1 SGR-1505 data we presented last month at EHA (Free EHA Whitepaper) and ICML. We are exploring strategic opportunities for SGR-1505 with the goals of accelerating the clinical development of this potential best-in-class molecule and maximizing benefit to patients globally," stated Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships. "In parallel, we plan to complete the Phase 1 package and meet with the FDA later this year to discuss the recommended Phase 2 dose."

Second Quarter 2025 Financial Results
•Total revenue for the second quarter increased 16% to $54.8 million, compared to $47.3 million in the second quarter of 2024.
•Software revenue for the second quarter increased 15% to $40.5 million, compared to $35.4 million in the second quarter of 2024. The increase was primarily due to increases in revenue recognized from hosted contracts and contribution revenue, partially offset by revenue from multi-year on-premise contracts signed in the prior year.
•Drug discovery revenue was $14.2 million for the second quarter, compared to $11.9 million in the second quarter of 2024.
•Software gross margin was 68% for the second quarter, compared to 80% in the second quarter of 2024, primarily reflecting the costs associated with the company’s predictive toxicology initiative.
•Operating expenses were $79.1 million for the second quarter, compared to $84.1 million for the second quarter of 2024. The decrease was due to lower R&D expenses.
•Other income was $10.0 million for the second quarter, which included changes in fair value of equity investments and interest income/expense, compared to other expense of $1.2 million for the second quarter of 2024.
•Net loss for the second quarter was $43.2 million, compared to $54.0 million in the second quarter of 2024.

Three Months Ended
June 30,
2025 2024 % Change
(in millions)
Total revenue $ 54.8 $ 47.3 16%
Software revenue 40.5 35.4 15%
Drug discovery revenue 14.2 11.9 19%
Software gross margin 68 % 80 %
Operating expenses $ 79.1 $ 84.1 (6.0)%
Other income (expense) $ 10.0 $ (1.2) —
Net loss $ (43.2) $ (54.0) —

For the three and six months ended June 30, 2025, Schrödinger reported a non-GAAP net loss of $47.5 million and $94.2 million, compared to a non-GAAP net loss of $48.1 million and $110.5 million for the three and six months ended June 30, 2024. See "Non-GAAP Information" below and the table at the end of this press release for a reconciliation of non-GAAP net loss to GAAP net loss.

2025 Financial Outlook
As of August 6, 2025, Schrödinger updated its expectation for operating expenses and reaffirmed the other aspects of its previously issued financial guidance for the fiscal year ending December 31, 2025:
•Software revenue growth is expected to range from 10% to 15%.
•Drug discovery revenue is expected to range from $45 million to $50 million.
•Software gross margin is expected to range from 74% to 75%.
•Operating expenses in 2025 are now expected to be lower than 2024.
•Cash used for operating activities in 2025 is expected to be significantly lower than cash used for operating activities in 2024.

For the third quarter of 2025, software revenue is expected to range from $36 million to $40 million.
Key Highlights
Proprietary and Collaborative Pipeline
•In June, Schrödinger presented encouraging initial Phase 1 clinical data for SGR-1505, the company’s MALT1 inhibitor in patients with relapsed/refractory B-cell malignancies. These data were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and International Conference on Malignant Lymphoma. Also in June, SGR-1505 received Fast Track Designation from the FDA for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Schrödinger is completing the Phase 1 package and expects to meet with the FDA later this year to discuss the recommended Phase 2 dose. The company is also exploring strategic opportunities to advance the development of SGR-1505.

•Schrödinger is continuing to progress the Phase 1 clinical study of SGR-2921, the company’s CDC7 inhibitor, in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Initial clinical data from this study are expected in the fourth quarter of 2025.

•Schrödinger is continuing to progress the Phase 1 clinical study of SGR-3515, the company’s Wee1/Myt1 co-inhibitor, in patients with advanced solid tumors. Initial clinical data from this study are expected in the fourth quarter of 2025.

•In July, Schrödinger announced an expanded research collaboration with Ajax Therapeutics, a company co-founded by Schrödinger. The expansion adds a new Janus kinase (JAK) target to the collaboration. Under the terms of the amended collaboration agreement, Schrödinger is eligible to receive discovery and development milestones for the new target similar to the terms of the original collaboration agreement. Schrödinger is also eligible to receive sales milestones and single-digit royalties on net sales of any products emerging from the additional target.

Platform
•Scientists at Schrödinger, Sanofi, Galapagos and UCB published an industry perspective on computational hit-finding in the Journal of Medicinal Chemistry. The paper highlights how recent breakthroughs in computational power, AI, and expansive chemical libraries are reshaping virtual screening and hit identification, and emphasizes the importance of accurate physics-based methods, including Schrödinger’s FEP+.

Corporate
•In May, the company completed a review of the organization and implemented several changes to improve its operating expense profile and reduce cash burn, including a reduction in force of approximately 7% of full-time employees, which is expected to reduce operating expenses by approximately $30 million on an annualized basis. Separately, Schrödinger announced the appointment of Richie Jain to chief financial officer, the addition of Mannix Aklian as chief commercial officer, global head of software sales and marketing, and the expansion of Karen Akinsanya’s role to president, head of therapeutics R&D and chief strategy officer, partnerships.

Webcast and Conference Call Information
Schrödinger will host a conference call to discuss its second quarter 2025 financial results on Wednesday, August 6, 2025, at 4:30 p.m. ET. The live webcast can be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source To participate in the live call, please register for the call here. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will receive the dial-in information. The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.