Incyte Backs Out of Immuno-Oncology Pact With Agenus

 

The partnership dates back to 2015, when Incyte paid $60 million upfront for access to four checkpoint programs, including TIM-3, LAG-3, OX40 and GITR.

Incyte has formally terminated its yearslong partnership with Agenus, giving the Massachusetts-based biotech all rights over certain immuno-oncology programs.

The decision, which Agenus announced in an SEC filing on Tuesday, is part of what Incyte terms a “strategic portfolio reprioritization.” Agenus will again have full rights over its LAG-3 and TIM-3 programs, for which the biotech will weigh its options moving forward, “including internal development and potential new partnerships.”

Incyte and Agenus first inked their partnership in January 2015. For $60 million upfront—$25 million in cash and $35 million in equity investments—Incyte bought access to Agenus’ proprietary Retrocyte Display platform, as well as checkpoint modulator inhibitor programs targeting TIM-3, LAG-3, GITR and OX40.

The agreement, which included up to $350 million in various milestones across the four initial programs, also provided both parties the option to jointly nominate and advance additional targets. Incyte upped its investment in Agenus in February 2017, taking full charge of the GITR and OX40 programs, with Agenus being entitled to royalties.

Over the years, however, Incyte has been slowly been distancing itself from the biotech. In its SEC filing on Tuesday, Agenus revealed that Incyte had axed the OX40 program effective October 2023, followed by the termination of GITR and another undisclosed asset in May 2024. Incyte then announced the discontinuation of LAG-3 and TIM-3 in July 2024.

The formal termination of the partnership took effect Feb. 4.

Incyte earlier this week released its fourth-quarter and full-year earnings report, touting a 16% year-on-year increase in quarterly revenue to $1.18 billion. Its Q4 performance surpassed analyst expectations, which pegged earnings at $1.14 billion. Leading its sales figures was the oral kinase inhibitor Jakafi, which brought in $773 million in the quarter, topping the consensus of $747 million.

Opzelura, which shares an active ingredient with Jakafi but is formulated as a cream, made $162 million in the quarter, coming ahead of the expected $151 million.

Incyte is looking at several key catalysts in 2025, chief of which is the Phase III readout for its small molecule JAK1 blocker povorcitinib in hidradenitis suppurativa. Pivotal data from that trial are expected in the first half of this year.

“This will be the first pivotal readout for povo, which many investors view as one potential avenue to replace revenues after Jakafi [loss of exclusivity],” which is expected in December 2028, analysts at Truist Securities wrote in a Feb. 10 note.

https://www.biospace.com/business/incyte-backs-out-of-immuno-oncology-pact-with-agenus

Tenet results, outlook

 Tenet’s Outlook for full year 2025 (consolidated and by segment) follows.

CONSOLIDATED ($ in millions, except per share amounts)	FY 2025 Outlook
Net operating revenues	$20,600 to $21,000
Net income available to Tenet common stockholders	$1,040 to $1,185
Adjusted EBITDA	$3,975 to $4,175
Adjusted EBITDA margin	19.3% to 19.9%
Diluted income per common share	$10.95 to $12.47
Adjusted net income	$1,115 to $1,220
Adjusted diluted earnings per share	$11.74 to $12.84
Equity in earnings of unconsolidated affiliates	$265 to $275
Depreciation and amortization	$805 to $835
Interest expense	$795 to $805
Income tax expense5	$420 to $465
Net income available to NCI	$910 to $960
Weighted average diluted common shares	~95 million
Net cash provided by operating activities	$2,500 to $2,850
Adjusted net cash provided by operating activities	$2,600 to $2,900
Capital expenditures	$700 to $800
Free cash flow	$1,800 to $2,050
Adjusted free cash flow	$1,900 to $2,100
NCI cash distributions	$750 to $800

Ambulatory Segment ($ in millions)	FY 2025 Outlook
Net operating revenues	$4,850 to $5,000
Adjusted EBITDA	$1,915 to $1,985
NCI	$760 to $790
Adjusted EBITDA less NCI	$1,155 to $1,195
Changes versus prior year6:
Same-facility system-wide revenue	Up 3.0% to 6.0%
Hospital Segment ($ in millions)	FY 2025 Outlook
Net operating revenues	$15,750 to $16,000
Adjusted EBITDA	$2,060 to $2,190
NCI	$150 to $170
Changes versus prior year6:
Inpatient admissions	Up 2.0% to 3.0%
Adjusted admissions	Up 2.0% to 3.0%

Management’s Webcast Discussion of Results

Tenet management will discuss the Company’s fourth quarter 2024 results in a webcast scheduled for 10:00 a.m. Eastern Time (9:00 a.m. Central Time) on February 12, 2025. Investors can access the webcast through the Company’s website at www.tenethealth.com/investors.

The slide presentation associated with the webcast referenced above, a copy of this earnings press release, and a related supplemental financial disclosures document will be available on the Company’s Investor Relations website on February 12, 2025.

https://www.businesswire.com/news/home/20250212977320/en

Alkermes results, outlook

 —    Total Revenues of $1.56 Billion in 2024; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year —

—    GAAP Net Income from Continuing Operations of $372 Million and Diluted GAAP Earnings per Share from Continuing Operations of $2.20 for 2024 —

—    ALKS 2680 Phase 2 Studies in Narcolepsy Type 1 and Type 2 Ongoing With Data Expected in H2 2025 —

Financial Expectations for 2025

All line items are according to GAAP, except as otherwise noted.

In millions		2025 Expectations
Total Revenues		$1,340 – $1,430
VIVITROL Net Sales		$440 – $460
ARISTADAi Net Sales		$335 – $355
LYBALVI Net Sales		$320 – $340
Cost of Goods Sold		$185 – $205
R&D Expenses		$305 – $335
SG&A Expenses		$655 – $685
GAAP Net Income a		$175 – $205
EBITDA		$215 – $245
Adjusted EBITDA		$310 – $340
Effective Tax Rate		~17%

a Expected 2025 weighted average basic share count of approximately 165.5 million shares outstanding and a weighted average diluted share count of approximately 169.5 million shares outstanding.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Wednesday, Feb. 12, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website.

https://www.prnewswire.co.uk/news-releases/alkermes-plc-reports-financial-results-for-the-fourth-quarter-and-year-ended-dec-31-2024-and-provides-financial-expectations-for-2025-302373974.html

Biogen Revenue And EPS Beat, Warns Lower 2025 Revenue, Inks R&D Funding Pact With Royalty

 On Wednesday, Biogen Inc (NASDAQ:BIIB) reported fourth-quarter adjusted EPS of $3.44, up 17%, beating the consensus of $3.35.

The company reported sales of $2.46 billion, up 2% year over on constant currency and 3% on a reported basis, beating the consensus of $2.40 billion.

Multiple sclerosis revenue of $1.07 billion decreased by 8% (down 9% on constant currency). The multiple sclerosis drug Tysabri sales were down to $415.4 million from $464.7 million.

Rare disease revenue increased 13% year over year (up 15% on constant currency) to $535.3 million. Spinraza's revenue increased to $421.4 million from $412.6 million a year ago.

Revenues from Skyclarys, acquired via Reata acquisition, reached $102.2 million during the quarter.

In Alzheimer's disease, Biogen said Leqembi fourth quarter global in-market sales of approximately $87 million, including U.S. in-market sales of approximately $50 million, representing good continued sequential growth.

Postpartum depression drug Zurzuvae's fourth-quarter sales reached $22.9 million.

Guidance: Biogen forecasts a full year 2025 adjusted EPS of $15.25-$16.25 versus a consensus of $16.34.

Revenue is expected to decline by a mid-single-digit percentage for 2025 compared to 2024 as further declines in multiple sclerosis product revenues are expected to be partially offset by increases in revenue from product launches.

For 2025, as compared to 2024, Biogen expects the operating margin percentage to remain relatively flat.

The Fit for Growth program is expected to generate approximately $1 billion of gross savings and $800 million net of reinvestment by the end of 2025.

Since the program was initiated in 2023, approximately $400 million of net savings have been achieved, and Biogen expects to realize the balance by the end of 2025.

Biogen expects combined Non-GAAP R&D and SG&A expenses to total approximately $3.9 billion in 2025.

Royalty Pharma plc (NASDAQ:RPRX) agreed to provide Biogen with R&D funding of up to $250 million for litifilimab for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

Litifilimab is currently in Phase 3 trials for SLE and CLE, with results expected between 2026 and 2027.

https://finance.yahoo.com/news/biogen-q4-earnings-revenue-eps-143947087.html

AnaptysBio achieves ‘highest ever’ results in Phase II rheumatoid arthritis trial

 AnaptysBio’s Phase IIb trial of its rheumatoid arthritis (RA) treatment, rosinilimab, has seen some patients achieve the ‘highest ever’ responses at week 14, with 69% of patients achieving low disease activity.

The US-based company has announced results from its randomised RENOIR trial examining the safety and tolerability of rosnilimab (NCT06041269) in patients with moderate-to-severe RA who have until now been on conventional disease-modifying drugs.

The study achieved its primary endpoint in eliciting a mean change from baseline using the 28-Joint Disease Activity Score (DAS28-CRP) as a system of measurement, seeing statistical significance over placebo.

While the primary endpoint sought to establish safety and efficacy, secondary endpoints tracked disease progression via the mean baseline clinical disease activity index (CDAI) scale to achieve low disease activity (LDA).

Patients were split into four arms, receiving 100mg, 400mg and 600mg of rosnilimab or a placebo. Results saw not only statistical significance but also numerical significance across all dose ranges. By the end of week 14, the company stated that 69% of patients achieved LDA, the next best result besides full remission.

Anaptys president Daniel Faga said: “We are excited about these trial results and the impact they could have on patients living with RA. Rosnilimab is safe and well tolerated with the highest ever reported CDAI low disease activity at three months that, to date, is sustained and potentially deepening over six months.

“These findings are further supported by objective translational data and surpass our target product profile in the $20bn US RA market."

Faga added that in Q2 2025, the company intends to report full six-month data and additional translational data it anticipates will further substantiate rosnilimab’s impact on restoring healthy immune homeostasis in RA and additional diseases such as ulcerative colitis (UC).

https://finance.yahoo.com/news/anaptysbio-achieves-highest-ever-results-172232114.html

Inovio Results from Phase 1/2 Study of INO-3107 for Recurrent Respiratory Papillomatosis

 Data shows that INO-3107 induced new populations of T cells in the blood that traveled to airway tissue and were associated with clinical benefit as measured by reduced need for surgeries

https://www.prnewswire.com/news-releases/clinical-and-immunological-results-from-phase-12-study-of-ino-3107-as-a-treatment-for-recurrent-respiratory-papillomatosis-published-in-nature-communications-302374685.html

GRAIL, Quest to Provide Multi-Cancer Early Detection Test

  GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced the initial phase of a program to improve provider access to GRAIL's Galleri® multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest's Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year.

https://www.prnewswire.com/news-releases/grail-and-quest-diagnostics-provide-grails-galleri-multi-cancer-early-detection-mced-test-through-the-quest-diagnostics-test-ordering-system-302374174.html