Gilead Sciences and Arcus Biosciences Expand Partnership to Include Research Programs in Inflammation

Gilead to Have Early Option to Exclusively License Drug Candidates Against up to Four Targets for Inflammatory Diseases –

– Expanded Research Collaboration May Result in up to $1 Billion in Option Fees and Milestone Payments by Gilead to Arcus –

Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced that the companies have expanded the previously announced research collaboration focused on oncology to include therapies for the treatment of inflammatory diseases. The expanded collaboration builds upon Gilead's growing presence in inflammatory disease and serves as a step towards broadening Arcus' capabilities and portfolio beyond oncology and into inflammation.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230513005022/en/

"We are pleased to build upon Gilead's efforts in inflammation with the expansion of our strategic collaboration with Arcus," said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. "Gilead is committed to accessing innovative approaches to address the significant unmet medical needs across a range of inflammatory conditions, and this expanded collaboration with Arcus underscores that commitment. Arcus is an excellent partner with clear strengths in discovery and development, and we believe this partnership will significantly accelerate our progress in developing transformative new therapies for inflammatory diseases."

"Since its founding, Arcus has been creating and developing therapeutic interventions that can modulate the immune system to treat cancer. Through this expansion of our partnership with Gilead, we can combine our research expertise in immunology and small molecule drug discovery with Gilead's strong clinical experience in inflammation," said Terry Rosen, Ph.D., Chief Executive Officer, Arcus. "Our two companies have a strong, broad and productive relationship and together, we aspire to advance innovative new therapies for patients in need. The research collaboration facilitates much earlier alignment between Gilead and Arcus on our discovery and development activities, while enabling Arcus to expand into inflammation in a capital-efficient manner."

Under the terms of the expanded collaboration, Arcus will receive an upfront payment of $35 million and will initiate research programs against up to four targets jointly selected by the parties that are applicable to inflammatory diseases. Gilead may exercise an option to license each program at two separate, prespecified time points. If Gilead exercises its option at the earlier time point for the first two target programs, Arcus would be eligible to receive up to $420 million in option and milestone payments and tiered royalties for each optioned program. For any other option exercise by Gilead for the four target programs, the parties would have rights to co-develop and share global development costs and to co-commercialize and share profits in the United States for optioned programs.

Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Arcus is expected to reduce Gilead's GAAP and non-GAAP 2023 EPS by $0.02.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry partners, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and A2a/A2b receptors) and HIF-2a. For more information about Arcus Biosciences' clinical and preclinical programs, please visit www.arcusbio.com .

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Arcus Forward-Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the development of current and future programs, including programs with targets applicable to inflammatory diseases; future option fees, milestone and royalty payments under the expanded partnership; and Arcus' election to equally share global development costs and U.S. profits for any program optioned by Gilead. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause our actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: dependence on the collaboration with Gilead for the successful development and commercialization of Arcus' investigational products; difficulties associated with the management of the collaboration activities or expanded clinical programs; Arcus' ability to scale its operations to successfully develop inflammation programs; the inherent uncertainty associated with pharmaceutical product development and clinical trials; delays in Arcus' clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; and changes in the competitive landscape for Arcus' programs. Risks and uncertainties facing Arcus are described more fully in its quarterly report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 28, 2023. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties, and other factors, including the risk that Gilead may not realize the potential benefits of this expanded research collaboration with Arcus, including advancing new therapies for inflammatory diseases; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's revenues and earnings; the ability of the parties to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that regulatory authorities may not approve such applications in the anticipated timelines or at all; the possibility that the parties may make a strategic decision to terminate the collaboration, including the research programs in inflammatory diseases, at any time; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc., and Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Gilead Contacts:

Jacquie Ross, Investors
investor_relations@gilead.com

Meaghan Smith, Media
Public_affairs@gilead.com

Arcus Contacts:

Pia Banerjee, Investors
pbanerjee@arcusbio.com , (617) 459-2006

Holli Kolkey, Media
hkolkey@arcusbio.com , (650) 922-1269

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CHMP Adopts Positive Opinion Recommending Hepcludex®  for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

CHMP Adopts Positive Opinion Recommending Hepcludex® for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

--   If Granted by the European Commission, Hepcludex will Become the Only Approved Treatment for HDV in the EU --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex ® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.

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Gilead Sciences Announces First Quarter 2023 Financial Results

Product Sales Excluding Veklury Increased 15% Year-Over-Year to $5.7 billion

Biktarvy Sales Increased 24% Year-Over-Year to $2.7 billion

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CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.

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Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

  • Covid-19 has proven to be the "great revealer" of disparities in healthcare

  • Contakt World (CSE: HELP) and Satcher Health Leadership Institute, Morehouse School of Medicine executed a strategic collaboration in October 2020
  • Health Equity Tracker, supported by Google.org, Gilead Sciences (Nasdaq: GILD), Annie E. Casey Foundation, and CDC Foundation, is now operational
  • Contakt World's SaaS Platform, Smart Health RM, will help drive de-identified data to Health Equity Tracker to improve health equity and reduce disparities of care

Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.

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HOOKIPA Advances HIV and HBV Vaccine Research with Gilead

HOOKIPA Pharma (NASDAQ:HOOK) announced that it has made progress in its collaboration with Gilead Sciences (NASDAQ:GILD) for arenavirus-based therapeutics intended to support cures for chronic Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.

As quoted in the press release:

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BOTOX® Cosmetic  Continues its Mission of Empowering Entrepreneurs Through "The Confidence Project"

BOTOX® Cosmetic Continues its Mission of Empowering Entrepreneurs Through "The Confidence Project"

  • BOTOX ® Cosmetic Will Provide 250 Entrepreneurs with Access to New Resources and Opportunities and Will Award 20 Grants Worth $20,000 Each to Support Business Goals.
  • By 2030, BOTOX ® Cosmetic Pledges to Empower 50,000 Entrepreneurs, Helping to Close the Confidence Gap.

- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced BOTOX ® Cosmetic's continued commitment to closing the Confidence Gap with the introduction of The Confidence Project: Empowering Women Entrepreneurs . The one & only BOTOX ® Cosmetic invites business owners to apply for this year's program starting today through May 9, 2025 at 11:59pm PT .

BOTOX® Cosmetic (onabotulinumtoxinA) Continues its Mission of Empowering Entrepreneurs Through

Women entrepreneurs continue to break barriers in the business world, with increasing efforts to close the Confidence Gap. When women founders are supported by mentors and have access to capital, they become agents of change. Seventy-one percent of businesswomen said their mentor was influential in their career advancement, with many using their income to uplift their families and community. 1

Since 2023, BOTOX ® Cosmetic has provided a total of $1 million dollars in grant funding across more than 40 founders, along with coaching and networking opportunities. This year, BOTOX ® Cosmetic is expanding to reach more founders by providing 250 entrepreneurs with access to The Confidence Project. Through a partnership with Hello Alice, an online platform that helps businesses launch and grow, each of the 250 entrepreneurs will participate in an intensive "Boostcamp" program, which will provide participants with skill-building, mentorship resources, and exclusive networking opportunities. After completing the course, they will leverage their newfound skills to pitch their business to a panel of aesthetic entrepreneurs, as well as key business leaders from Allergan Aesthetics and Hello Alice, for a chance to receive one of 20 $20,000 grants from BOTOX ® Cosmetic.

"BOTOX ® Cosmetic is committed to being a catalyst for confidence, whether that be by pursuing education, aesthetic treatment, or your entrepreneurial goals. Through The Confidence Project, we pledge to continue to uplift founders who've invested so much in their businesses," said Nicole Katz , Vice President, Customer Engagement and Corporate Affairs at Allergan Aesthetics. "We know when women have access to resources and capital, there's no limit to what they can achieve. We look forward to getting to know this year's cohort of founders and how they found the confidence to pursue their dreams."

"Our mission at Hello Alice is to help entrepreneurs access the funding, mentorship, and resources they need to succeed. BOTOX ® Cosmetic's The Confidence Project provides a powerful opportunity for women entrepreneurs to scale their businesses and create lasting change," said Elizabeth Gore , Co-Founder and President of Hello Alice. "Our partnership with BOTOX ® Cosmetic aims to foster long-term growth, confidence, and leadership for future generations of women in business, by investing in their success today."

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact . Applicants must agree to the official rules of the grant program and submissions must be received by May 9, 2025 , at 11:59pm PT . The 250 women entrepreneurs selected to participate in the Hello Alice Boostcamp will be announced in July, and the 20 grant recipients will be announced in October 2025 .

For more information on The Confidence Project, visit www.botoxcosmetic.com/realimpact and follow @botoxcosmetic on Instagram and YouTube .

About Allergan Aesthetics  
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com .

About AbbVie  
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn   ,   Facebook , Instagram , X (formerly Twitter) , and YouTube .

Approved Uses  
BOTOX ® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.

IMPORTANT SAFETY INFORMATION

BOTOX ® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX ® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX ® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, and/or platysma bands.

BOTOX ® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX ® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX ® Cosmetic if you are allergic to any of the ingredients in BOTOX ® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing, from standard doses of BOTOX ® Cosmetic.

Tell your doctor about all your medical conditions, including surgery or plans to have surgery on your face, trouble raising your eyebrows, drooping eyelids, any other abnormal facial change, are pregnant or plan to become pregnant (it is not known if BOTOX ® Cosmetic can harm your unborn baby), or are breastfeeding or plan to (it is not known if BOTOX ® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, or Letybo in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; or take aspirin-like products or blood thinners.

Other side effects of BOTOX ® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes.

For more information, refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan Aesthetics at 1-800-678-1605.

Please see BOTOX ® Cosmetic full Prescribing Information , including Boxed Warning and Medication Guide .

References:

  1. Barbara Kurshan. Forbes.com. Purpose-Driven Women: Unleash Your Potential Through Mentorship. 2023 https://www.forbes.com/sites/barbarakurshan/2023/06/13/purpose-driven-women-unleash-your-potential-through-mentorship/

© 2025 AbbVie. All rights reserved. BOTOX Cosmetic and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates.

Contacts:

Investors:
Liz Shea
Liz.Shea@AbbVie.com
(847) 935-2211

Media:
Ember Garrett
Ember.Garrett@allergan.com
(714) 246-3525

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact.

Allergan Aesthetics (PRNewsfoto/AbbVie)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/botox-cosmetic-onabotulinumtoxina-continues-its-mission-of-empowering-entrepreneurs-through-the-confidence-project-302444121.html

SOURCE AbbVie

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Details of the event are as follows:
Date: Wednesday, May 7, 2025
Time: 1:30 p.m. ET

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RINVOQ® Receives U.S. FDA Approval for Giant Cell Arteritis

RINVOQ (upadacitinib) is now the first and only oral Janus Kinase (JAK) inhibitor approved for the treatment of GCA in adults Also known as temporal arteritis, GCA is the most common vasculitis affecting adults in Western countries 2 This marks the ninth approved indication for RINVOQ in the U.S., across rheumatology, gastroenterology, and dermatology 1

NORTH CHICAGO, Ill. , April 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). 1 This comes after the European Commission recently granted marketing authorization of RINVOQ for the treatment of GCA in adult patients.

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Details of the oral presentation are as follows:

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Binding Commitments Received for A$1.0 Million under Convertible Note Placement

Nutritional Growth Solutions Limited (ASX:NGS) ("NGS" or "the Company"), is pleased to announce that it has received binding commitments for the issue of 1,000,000 convertible notes (Placement CNs), to be issued at $1.00 each (CN Placement).

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AbbVie Reports First-Quarter 2025 Financial Results

AbbVie Reports First-Quarter 2025 Financial Results

  • Reports First-Quarter Diluted EPS of $0.72 on a GAAP Basis, a Decrease of 6.5 Percent; Adjusted Diluted EPS of $2.46 , an Increase of 6.5 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense
  • Delivers First-Quarter Net Revenues of $13.343 Billion , an Increase of 8.4 Percent on a Reported Basis or 9.8 Percent on an Operational Basis
  • First   -Quarter Global Net Revenues from the Immunology Portfolio Were $6.264 Billion , an Increase of 16.6 Percent on a Reported Basis, or 18.1 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $3.425 Billion ; Global Rinvoq Net Revenues Were $1.718 Billion ; Global Humira Net Revenues Were $1.121 Billion
  • First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.282 Billion , an Increase of 16.1 Percent on a Reported Basis, or 17.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $765 Million ; Global Botox Therapeutic Net Revenues Were $866 Million ; Combined Global Ubrelvy and Qulipta Net Revenues Were $433 Million
  • First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.633 Billion , an Increase of 5.8 Percent on a Reported Basis, or 7.5 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $738 Million ; Global Venclexta Net Revenues Were $665 Million ; Global Elahere Net Revenues Were $179 Million
  • First   -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.102 Billion , a Decrease of 11.7 Percent on a Reported Basis, or 10.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $556 Million ; Global Juvederm Net Revenues Were $231 Million
  • Raises 2025 Adjusted Diluted EPS Guidance Range from $11.99 - $12.19 to $12.09 - $12.29 , which Includes an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2025

- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025 .

"AbbVie's first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael , chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term."

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