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 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the second quarter ended June 30, 2025 (Press release, Delcath Systems, AUG 6, 2025, View Source [SID1234654861]).

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Second Quarter 2025 Financial Results

Total revenue of $24.2 million, compared with $7.8 million in the second quarter of 2024
HEPZATO KIT revenue of $22.5 million, compared to $6.6 million in the second quarter of 2024
CHEMOSAT revenue of $1.7 million, compared to $1.2 million in the second quarter of 2024
Gross margins of 86%, compared to 80% in the second quarter of 2024
Net income of $2.7 million, compared to a net loss of $13.7 million in the second quarter of 2024
Non-GAAP positive adjusted EBITDA in the second quarter of $9.8 million, compared to a loss of $0.8 million in the second quarter of 2024
Cash provided by operations of $7.3 million in the quarter
Cash and investments of $81.0 million as of June 30, 2025
Business Highlights

Activated three new U.S. centers in the second quarter, which brings the current total to 20 active centers, with an additional 10 centers accepting referrals
Announced its intention to enter into a Medicaid National Drug Rebate Agreement (NDRA) to expand patient access beginning July 1, 2025
Received authorization from the European Union and United Kingdom regulatory authorities for the clinical study of Melphalan for Injection/Hepatic Delivery System in patients with refractory metastatic colorectal cancer with liver dominant disease
"The consistent utilization of HEPZATO at treating sites and continued positive feedback from treating physicians has increased our confidence in HEPZATO’s long term growth prospects," said Gerard Michel, Chief Executive Officer of Delcath. "Physicians are sharing positive results, which is expanding interest at sites not yet activated as well as interest in participating in the future development of HEPZATO. With growing physician engagement and a strong financial outlook, the company is well prepared to pursue additional indications for HEPZATO."

2025 Full Year Financial Guidance
The Company updates its financial outlook for fiscal year 2025:

Total CHEMOSAT and HEPZATO KIT revenue to be in the range of $93 to $96 million, an increase of more than 150% over 2024
Gross margins in the range of 83% to 85%
Positive adjusted EBITDA and cashflow in each quarter of 2025
Second Quarter 2025 Results
Total revenue for the quarter ending June 30, 2025 was $24.2 million compared to $7.8 million for the same period in the prior year. Revenue in the quarter includes sales of $22.5 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending June 30, 2025, were $6.9 million compared to $3.4 million for the same period in the prior year. The increase is primarily due to costs associated with expanding the clinical team including the share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer and Phase 2 clinical trial in metastatic breast cancer. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter ended June 30, 2025, were $11.4 million compared to $6.8 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses.

Net income for the quarter ended June 30, 2025 was $2.7 million compared to net loss of $13.7 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended June 30, 2025 was $9.8 million compared to adjusted EBITDA loss of $0.8 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of June 30, 2025, the Company had $81.0 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Wednesday, August 6, 2025
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=fbe0333159

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

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 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, and Freenome, a biotechnology company pioneering an early cancer detection platform, reported they have entered into an agreement under which Exact Sciences will acquire exclusive rights in the United States to current and future versions of Freenome’s blood-based, single indication, colorectal cancer (CRC) screening tests (Press release, Exact Sciences, AUG 6, 2025, View Source [SID1234654862]).

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Complete findings from the prospective PREEMPT study were recently published in JAMA, a high-quality peer-reviewed journal. U.S. Census adjusted results as reported in JAMA show Freenome’s first version test achieved sensitivities of 81% for CRC and 14% for advanced precancerous lesions (APL) at specificity of 90%. The Freenome team recently submitted the last module of the pre-market application to the FDA. Freenome then plans to submit a supplement to the FDA for its next-generation test once final clinical validation data are available.

"This exclusive license expands our leadership in cancer screening with the addition of blood-based options," said Kevin Conroy, Chairman & CEO. "Cologuard Plus is the most accurate guideline-included non-invasive colorectal cancer screening test. We’re now able to offer a complementary blood-based option to the over 50 million unscreened Americans, supported by our broad commercial reach, ExactNexus technology platform, and deep relationships with health systems and payers."

"The test performance represents an important step toward closing the screening gap in the United States," said Aaron Elliott, Ph.D., Chief Executive Officer at Freenome. "Exact Sciences brings the scale, reach, and proven track record to maximize its impact and deliver this technology to patients faster and with greater certainty."

In addition, Exact Sciences shared initial results from an internal version of its CRC blood test, showing sensitivities of 73% for CRC and 14% for APL at 90% specificity. These results do not include the additional marker class presented at the ESMO (Free ESMO Whitepaper) 2024 congress. Internal testing and evaluation of the assay are ongoing.

Transaction terms and additional information

Under the terms of the agreement, Freenome will receive $75 million in cash payable by November 2025. Additional potential payments of up to $700 million are based on the achievement of certain milestones for Freenome’s blood-based CRC screening tests, including:

$100M upon first-line FDA approval for the first version test
$100M upon first-line FDA approval for the next-generation test contingent on performance benchmarks such as ≥19% APL sensitivity and ≥83% overall CRC sensitivity, provided a reduced payment would be payable for certain performance levels below such benchmarks
$500M if rated as a first-line A or B test in the United States Preventive Services Taskforce (USPSTF) guidelines or meeting certain payer contracted coverage requirements, provided a reduced payment would be payable based on second-line A or B USPSTF guidelines inclusion
Freenome may be eligible to receive royalty rates ranging from 0% to 10% based on the test’s profitability and subject to customary royalty stacking provisions. If certain criteria are not met, Exact Sciences will have the right to terminate the agreement.

Exact Sciences committed $20M annually over the next three years in joint R&D development expenses leveraging the technology.

Exclusivity is subject to receipt of FDA approval and expiration or termination of the applicable Hart-Scott-Rodino waiting period. Prior to the exclusive license, Exact Sciences can co-exclusively commercialize a lab-developed version of the test.

Additionally, Exact Sciences agreed to purchase from Freenome a senior convertible note with an aggregate principal amount of $50M with a 5.0% coupon rate due in 2030.

On August 6, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the Company generated revenue of $811 million for the second quarter ended June 30, 2025, compared to $699 million for the same period of 2024 (Press release, Exact Sciences, AUG 6, 2025, View Source [SID1234654863]).

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"The Exact Sciences team continues to build momentum, advancing our mission through earlier detection," said Kevin Conroy, chairman and CEO. "In the second quarter, we delivered answers to more patients than ever driven by strong momentum behind the successful launch of Cologuard Plus, powerful commercial execution, and exceptional customer satisfaction. This progress strengthens our platform and enables us to deliver better outcomes for patients."

Second quarter 2025 financial results

For the three-month period ended June 30, 2025, as compared to the same period of 2024 (where applicable):

Total revenue was $811 million, an increase of 16% on a reported and core revenue basis
Screening revenue was $628 million, an increase of 18%
Precision Oncology revenue was $183 million, an increase of 9%
Gross margin was 69%, and adjusted gross margin was 72%
Net loss was $1 million, or $0.01 per share, an improvement of $15 million and $0.08 per share, respectively
Adjusted EBITDA was $138 million, an increase of $28 million or 26%, and adjusted EBITDA margin was 17%, an increase of 130 basis points
Operating cash flow was $89 million and free cash flow was $47 million,
Cash, cash equivalents, and marketable securities were $858 million at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

Platform and pipeline advancements

In April 2025, Exact Sciences launched the Oncodetect test, its molecular residual disease and recurrence monitoring test. Oncodetect identifies residual disease up to two years earlier than imaging, the current standard of care. The Company recently received Medicare coverage through the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) for serial use in patients with stage II, III and resectable stage IV colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings over a five-year period.

In September 2025, Exact Sciences plans to launch its Cancerguard multi-cancer screening test as a laboratory-developed test. The Company plans to bring the test to patients through its large commercial organization and unique ExactNexus technology platform.

In August 2025, Exact Sciences acquired exclusive rights to the current and future versions of Freenome’s blood-based colorectal cancer screening tests as well as the underlying technology for colorectal cancer, subject to customary regulatory approvals. Additionally, the Company announced initial study results from the pivotal BLUE-C study for an internal version of its blood-based colorectal cancer screening test.

2025 outlook

The Company has updated its full-year 2025 revenue and adjusted EBITDA guidance:

Prior guidance

August 6 update

Change at midpoint

Y/Y growth rate

Total revenue

$3.070 – $3.120 billion

$3.130 – $3.170 billion

$55.0 million

14%

Screening

$2.390 – $2.425 billion

$2.440 – $2.470 billion

$47.5 million

17%

Precision Oncology

$680 – $695 million

$690 – $700 million

$7.5 million

6%

Adjusted EBITDA

$425 – $455 million

$455 – $475 million

$25.0 million

44%

Second-quarter 2025 conference call & webcast

Company management will host a conference call and webcast on Wednesday, August 6, 2025, at 5 p.m. ET to discuss second-quarter 2025 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608. A replay of the webcast will be available at exactsciences.com. The webcast, conference call, and replay are open to all interested parties.