Utz Brands(UTZ) - 2026 Q4 - Annual Results
2026-01-12 11:59
https://files.reportify.cc/m Utz Brands, Inc. Announces Preliminary Fourth Quarter and Fiscal Year 2025 Results Hanover, PA, January 12, 2026 (BUSINESS WIRE) – Utz Brands, Inc. (NYSE: UTZ) ("Utz" or the "Company"), a leading U.S. manufacturer of branded Salty Snacks and a small-cap growth and value Staples equity, today announced preliminary estimated Net Sales and Adjusted EBITDA results for the fourth quarter and fiscal year 2025 and provided a balance sheet update. The Company expects to report fourth qu ...
US Foods(USFD) - 2025 Q4 - Annual Results
2026-01-12 11:55
Financial Guidance - US Foods Holding Corp. reaffirmed its fiscal year 2025 guidance previously announced on November 6, 2025[4] Upcoming Events - The company will participate in the 28th Annual ICR Conference in Orlando on January 12, 2026[4] Investor Information - The press release regarding the financial results is available on the company's Investor Relations page[5]
Regeneron(REGN) - 2025 Q4 - Annual Results
2026-01-12 11:48
Financial Performance - Regeneron reported Q4 2025 U.S. net sales of $1.1 billion, reflecting a year-over-year growth of 27%[6] - EYLEA HD and EYLEA global net sales reached $4.9 billion in the U.S. branded anti-VEGF category, maintaining a strong market position[6] - Dupixent global net sales increased to $754 million in Q4 2025, with a 27% year-over-year growth[6] - Capital returned to shareholders in 2025 totaled $3.8 billion, including $3.4 billion in share repurchases and $0.4 billion in dividends[6] - Approximately $1.5 billion remains under the current share repurchase program as of December 31, 2025[6] Research and Development - The company has 45 clinical programs across six core therapeutic areas, providing a robust foundation for future growth[4] - The company has internally discovered 14 therapies that have been approved, indicating strong R&D productivity[4] - Regeneron is leveraging the world's largest DNA and proteomics-linked healthcare database to enhance drug discovery and development[4] - The company is a leader in human antibodies and is pioneering bispecifics, siRNA, gene editing, and AAV gene therapy[4] - Estimated Non-GAAP R&D expense for 2026 is projected to be approximately $6.5 billion, with formal financial guidance to be provided at Q4 2025 earnings[6] - The internal R&D spend is aligned with the biopharma industry average of 43% of commercial cash flow, while external business development spend is at 27%[8] Market Opportunities - The global market opportunity across key therapeutic categories is projected to exceed $200 billion annually by 2030[9] - The estimated worldwide market sales for Geographic Atrophy in 2025 is approximately $1.1 billion, with a CAGR of about 34% from 2025 to 2030[15] - The U.S. treatment landscape shows approximately 30,000 patients in 1L (NDMM) and 17,000 patients in 2L, indicating significant market potential[14] Clinical Trials and Approvals - Positive Phase 3 results were demonstrated in allergy programs for cat (FelD1) and birch (BetV1) allergies, with registration-enabling studies set to begin in 2026[11] - The company is advancing a long-acting, fully-human IL-13 & IL-4 antibodies development plan, with first-in-human trials expected in 1H 2026[11] - The company anticipates pivotal data from the 1L metastatic melanoma trial for FIANLIMAB + LIBTAYO in 1H 2026, aiming to transform treatment paradigms[12] - Cemdisiran monotherapy reported the best MG-ADL improvement among C5 inhibitors, with FDA submission planned for Q1 2026 and decision expected by Q4 2026/Q1 2027[15] - The company is conducting 4 registrational studies for Lynozyfic, with 100% of evaluable patients achieving MRD-negativity in HRSMM and 1L multiple myeloma[14] - The anticipated pivotal data for the combination approach in PNH is expected in Q4 2026/Q1 2027[12] - The company is on track for FDA submission for gMG in Q1 2026, with pivotal data expected in Q4 2026/Q1 2027[12] - Regeneron is initiating trials for its investigational drug candidates in the anticoagulation market, with data expected in 2029 for one trial and 2028 for another[16] - Initiated additional Phase 3 trials in multiple myeloma and precursor conditions expected in 2026[19] - Reported results from Phase 3 trial in PNH anticipated in Q4 2026/Q1 2027[19] - Reported initial Phase 2 data in advanced NSCLC expected in 2026[19] - Initiated clinical program for atopic dermatitis with NDA submission for gMG in Q1 2026[19] - FDA decision for genetic hearing loss expected in 2026[19] - Reported interim results from lead-in cohort of Phase 3 trial in GA expected in 2026[19] - Initiated Phase 3 program in obesity with and without T2D expected in 2026[19] - Reported additional data from proof-of-concept data of combination of semaglutide and trevogrumab in obesity expected in 2026[19] - FDA decision for BP expected in Q1 2026[19] - Initiated clinical program for olatopratide and pralutamide expected in 2026[19] Strategic Focus - Regeneron expects to continue delivering growth through leadership in key therapeutic categories[6] - The company is focused on integrating genetics, proteomics, and big data to maintain competitive advantages in the market[4] - The company is prioritizing a combination approach with Praluent (PCSK9) to achieve over 50% LDL lowering along with weight loss[12] - Regeneron aims to achieve over 50% LDL lowering in combination therapies, which will be administered via weekly injections[17] - The anticoagulation market remains underpenetrated, with less than 50% of eligible patients receiving therapy due to safety concerns[16] - Regeneron is exploring preclinical solutions for muscle preservation in obesity treatment[17] Financial Commitments - $6 billion is committed to U.S. manufacturing and R&D infrastructure expansion over the coming years[6]
Duolingo(DUOL) - 2025 Q4 - Annual Results
2026-01-12 11:46
slide1 US-DOCS\166734234.2 Duolingo, Inc. 5900 Penn Avenue Pittsburgh, PA 15206 Main Office: 412-567-6602 January 9, 2026 Gillian Munson Employment Terms Dear Gillian: Duolingo, Inc., a Delaware corporation (the "Company"), is pleased to offer you employment in the exempt position of Chief Financial Officer, in which you will be responsible for such duties as are normally associated with such position or as otherwise determined by your supervisor to the extent not materially inconsistent with your title and ...
NioDevelopments .(NB) - 2026 Q2 - Quarterly Results
2026-01-12 11:31
Financial Performance - The net loss for the three months ended December 31, 2025, was $0.8 million, or $0.02 per share, compared to a net loss of $0.5 million, or $0.01 per share, for the same period in 2024[6] - For the six months ended December 31, 2025, the net loss was $43.4 million, or $0.44 per share, compared to a net loss of $2.5 million, or $0.06 per share, for the same period in 2024[6] - The adjusted net loss for the three months ended December 31, 2025, was $5.3 million, or $0.06 per share, compared to an adjusted net loss of $1.9 million, or $0.05 per share, for the prior-year period[6] - The adjusted net loss for the six months ended December 31, 2025, was $13.6 million, or $0.15 per share, compared to an adjusted net loss of $3.3 million, or $0.08 per share, for the prior-year period[6] - Operating cash outflows for the six-month period totaled $7.6 million, primarily due to expenditures associated with the Elk Creek drilling program and feasibility study updates[7] Cash Position - As of December 31, 2025, NioCorp had a record cash balance of $307 million, following significant derisking of the Elk Creek Critical Minerals Project[3] Project Developments - The U.S. Department of Defense awarded Elk Creek Resources Corp. up to $10 million to support activities related to the Elk Creek Critical Minerals Project[3] - NioCorp completed an infill drilling campaign and closed on the acquisition of scandium alloy manufacturing assets during the reporting period[3] - The company is developing a critical minerals project expected to produce niobium, scandium, and titanium, with potential for rare earth production[14] Risks and Uncertainties - NioCorp faces significant risks including trade policies, inflationary pressures, and climate change impacts that may affect its operations[18] - The company acknowledges the speculative nature of mineral exploration and development, which includes risks of diminishing reserves and resources[18] - NioCorp's management emphasizes the possibility of cost overruns and unanticipated expenses in development programs[18] - There are concerns regarding the management of the water balance at the Elk Creek Project site and land reclamation requirements[18] - The company has not secured insurance covering all of its operations, which poses additional risks[18] - NioCorp warns that actual results may materially differ from projections if risks or uncertainties materialize[19] - The company does not undertake any obligation to update forward-looking statements unless required by law[20] Reporting and Compliance - NioCorp plans to file its unaudited interim condensed consolidated financial statements for the three- and six-month periods ended December 31, 2025, by February 16, 2026[8]
USANA Health Sciences(USNA) - 2025 Q4 - Annual Results
2026-01-12 11:29
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K _____________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): January 12, 2026 3838 West Parkway Boulevard Salt Lake City, Utah 84120 (Address of principal executive offices, Zip Code) Registrant's telephone number, including area code: (801) 954-7100 Check the appropriate box below if the Form 8-K filing is intended to simultaneousl ...
Tempus Ai,Inc.(TEM) - 2025 Q4 - Annual Results
2026-01-12 11:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 11, 2026 Tempus AI, Inc. (Exact name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation) 600 West Chicago Avenue Suite 510 Chicago, Illinois 60654 (Address of Principal Executive Offices) (Zip Code) (Commission File Number) Nevada 001-42130 47-49033 ...
Kura Oncology(KURA) - 2025 Q4 - Annual Results
2026-01-12 11:05
Financial Performance - KOMZIFTI™ (ziftomenib) generated $2.1 million in net product revenue during the initial five-week commercial availability period ending December 31, 2025[5]. - Kura Oncology received milestone payments of $195 million under a collaboration agreement with Kyowa Kirin in Q4 2025[5]. - The company reported estimated collaboration revenue (non-cash item) for Q4 2025 between $15 million and $17 million[5]. - As of December 31, 2025, Kura had $667.3 million in cash, cash equivalents, and short-term investments[5]. - Kura's financial results for Q4 2025 are subject to completion of financial closing procedures, and actual results may differ materially from preliminary metrics[31]. Product Development and Approval - KOMZIFTI was granted full FDA approval on November 13, 2025, for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation[7]. - KOMZIFTI™ (ziftomenib) is an FDA-approved oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia[29]. - The company anticipates non-cash collaboration revenue recognition of $45 million to $55 million in 2026[9]. - Kura plans to accelerate U.S. uptake of KOMZIFTI in R/R NPM1-m AML and drive quarter-over-quarter growth in net product revenue[9]. - The company aims to present updated data from the KOMET-007 trial in the first half of 2026[9]. - Kura is expanding ziftomenib to non-AML indications and advancing enrollment in various clinical trials throughout 2026[9]. - The company is excited about delivering meaningful impact for patients throughout 2026 and beyond, supported by a deep pipeline of transformative therapies[4]. - Kura Oncology is focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors[29]. - The company is advancing research in menin inhibition and farnesyl transferase inhibition[29]. Risks and Challenges - Forward-looking statements indicate potential risks affecting Kura's future operations and financial results, including market competition and regulatory approval[32]. - Kura anticipates cash runway and collaboration revenue recognition in 2026, but faces risks related to financing and product development[32]. - The company emphasizes the importance of monitoring for unexpected adverse side effects of its product candidates[32]. - Kura's collaboration with Kyowa Kirin is highlighted as a potential risk factor for future success[32]. - The company is committed to developing safe and effective therapeutics, navigating the complexities of drug commercialization[32]. Investor Relations - Investors and media inquiries can be directed to Greg Mann at Kura Oncology[33].
Veracyte(VCYT) - 2025 Q4 - Annual Results
2026-01-12 11:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 11, 2026 VERACYTE, INC. (Exact name of registrant as specified in its charter) Delaware 001-36156 20-5455398 (State or other jurisdiction of incorporation) Commission File Number (IRS Employer Identification No.) 6000 Shoreline Court, Suite 300, South San Francisco, California 94080 (Ad ...
Guardant Health(GH) - 2025 Q4 - Annual Results
2026-01-12 11:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 11, 2026 GUARDANT HEALTH, INC. (Exact name of registrant as specified in its charter) FORM 8-K (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) 3100 Hanover Street Palo Alto, California 94304 (Address of principal execut ...