RINVOQ® Receives Its Sixth U.S. FDA Approval

RINVOQ is now approved as the first and only oral JAK inhibitor for adults with active non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is the first and only JAK inhibitor approved for both active ankylosing spondylitis (AS) and nr-axSpA ^1-3
In a clinical study, RINVOQ delivered rapid and meaningful disease control based on patients achieving ASAS40 vs. placebo, as well as significant improvement in signs and symptoms of nr-axSpA at week 14 ^1,2

ABBVie (NYSE: ABBV) today announces that the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. This additional indication follows the FDA approval of RINVOQ in April of this year for adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions. 1

Experience the full interactive Multichannel News Release here:
https://www.multivu.com/players/English/9092951-abbvie-fda-active-non-radiographic-axial-spondyloarthritis/

Nr-axSpA is a chronic, progressive inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness, and cannot be detected by x-ray. ^5,6 Nr-axSpA and AS are two sub-types of a broader condition called axial spondyloarthritis. Approximately five percent of patients with nr-axSpA will progress to AS after five years, and 19 percent will progress after ten years. ⁷

"This latest FDA approval of RINVOQ in active nr-axSpA provides a new oral, once-daily treatment option for patients who historically have had limited treatment options for this painful, chronic disease," said Thomas Hudson , M.D., senior vice president, research and development, chief scientific officer, AbbVie. "RINVOQ is now approved to treat patients across the spectrum of axial spondyloarthritis. This further underscores AbbVie's commitment to advancing the standards of care for patients living with these diseases."

The FDA approval decision is supported by data from the Phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of RINVOQ in adults with active nr-axSpA. Among patients who received RINVOQ 15 mg, nearly half achieved an ASAS40* response, the primary endpoint, at week 14 compared to placebo (44.9 percent vs. 22.3 percent respectively). ^1,2 ASAS40 responses were observed as early as two weeks in nr-axSpA patients treated with RINVOQ. The safety profile in patients with nr-axSpA treated with RINVOQ 15 mg was consistent with the safety profile in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. ¹

"Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, RINVOQ demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications," said Atul Deodhar , M.D., professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and lead investigator of the SELECT-AXIS 2 nr-axSpA trial. "Today's FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease."

"There are limited treatment options for people living with nr-axSpA, a condition that can pose many challenges for patients and significantly impact their quality of life as their symptoms persist despite treatment," said Cassie Shafer , chief executive officer, Spondylitis Association of America (SAA). "This approval of RINVOQ is a tremendous step forward in providing our patient community with another option to help them reach their treatment goals, and to find relief."

This FDA approval marks the sixth indication for RINVOQ in the United States across chronic immune-mediated diseases, including four in rheumatology. ¹

Additional study results include the following:

Improvement in nr-axSpA Signs & Symptoms at Week 14 ^1,2

In the SELECT-AXIS 2 nr-axSpA trial, patients receiving RINVOQ 15 mg experienced greater improvements at week 14 compared to placebo in the individual components of the ASAS composite index, including total back pain, patient global assessment of disease activity, morning stiffness, and physical function. Multiplicity-controlled endpoints included total back pain and Bath Ankylosing Spondylitis Disease Activity Index (BASFI).

A significantly greater mean decrease from baseline in Total Back Pain (-2.91 change from baseline) compared to those receiving placebo (-2.00). ²
A significantly greater improvement in physical function (-2.61 change from baseline) as assessed by mean change from baseline in BASFI compared to patients on placebo (-1.47). ²

*ASAS40 is a composite index that measures disease activity. ² To achieve an ASAS40 response, a patient's disease activity must have improved by at least 40%, as well as improved by two units (on a 0 to 10 scale) in at least three of four disease areas assessed, and the remaining area must not have gotten worse, including back pain, patient global assessment of disease activity, physical function, and morning stiffness. ²

Other Health-Related Outcomes

Patients treated with RINVOQ 15 mg showed significant improvements in health-related quality of life as measured by Ankylosing Spondylitis Quality of Life (ASQoL) compared to placebo at Week 14.

Safety Considerations

RINVOQ may cause serious side effects, including:
Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.
Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers.
Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor.
Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
Tears in the stomach or intestines; changes in certain laboratory test results.

For more information about RINVOQ, visit RINVOQ.com .

Patient Access & Support
AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to $5 per month for eligible, commercially insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ at no charge to those who qualify. For more details, please visit AbbVie.com/myAbbVieAssist .

About SELECT-AXIS 2 trial program ⁴
SELECT-AXIS 2 was conducted as a master study protocol that contains two standalone studies with randomization, data collection, analysis and reporting conducted independently. The Phase 3, randomized, placebo-controlled, double-blind studies are evaluating the efficacy and safety of RINVOQ compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA), including bDMARD-IR AS (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT04169373).

In the clinical trial, the primary endpoint was the percentage of subjects achieving an ASAS40 response after 14 weeks of treatment with RINVOQ versus placebo.

About RINVOQ ^® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. ¹ The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

In the U.S., RINVOQ 15 mg is approved for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers; adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers; adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers and adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. ¹ RINVOQ 45 mg is approved for use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers as an induction therapy once daily for 8 weeks. The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dosage needed to maintain response. RINVOQ 15 mg once daily can also be initiated in adults and children 12 years of age and older weighing at least 40 kg with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other system drug products, including biologics or when use of those therapies is inadvisable. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. ^4,8-14

U.S. Uses and Important Safety Information About RINVOQ ^® (upadacitinib) ¹

RINVOQ is a prescription medicine used to treat:

Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and whose eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended.

RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

What is the most important information I should know about RINVOQ?

RINVOQ may cause serious side effects, including:

Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

What should I tell my HCP BEFORE starting RINVOQ?

Tell your HCP if you:

Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:

Fever, sweating, or chills
Shortness of breath
Warm, red, or painful skin or sores on your body
Muscle aches
Feeling tired
Blood in phlegm
Diarrhea or stomach pain
Cough
Weight loss
Burning when urinating or urinating more often than normal

Have TB or have been in close contact with someone with TB.
Are a current or past smoker.
Have had a heart attack, other heart problems, or stroke.
Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

Medicines for fungal or bacterial infections
Rifampicin or phenytoin
Medicines that affect your immune system

If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I do or tell my HCP AFTER starting RINVOQ?

Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse
Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:

Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
Pain or discomfort in your arms, back, neck, jaw, or stomach
Shortness of breath with or without chest discomfort
Breaking out in a cold sweat
Nausea or vomiting
Feeling lightheaded
Weakness in one part or on one side of your body
Slurred speech

Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:

Swelling
Pain or tenderness in one or both legs
Sudden unexplained chest or upper back pain
Shortness of breath or difficulty breathing

Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are the other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.

A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.
These are not all the possible side effects of RINVOQ.

How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide .

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, and women's health, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter, Facebook , LinkedIn or Instagram .

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

*Dr. Atul Deodhar , M.D., is a researcher/consultant for AbbVie.

US-RNQR-221074

References:

RINVOQ ^® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
Deodhar A, Van den Bosch F, Poddubnyy D, et al. U Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet . 2022;400:369–79. doi:10.1016/S0140-6736(22)01212-0.
van der Heijde D, Baraliakos X, Sieper J, et al. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomized, placebo-controlled phase 3 trial. Ann Rheum Dis . 2022;0:1–9. doi:10.1136/annrheumdis-2022-222608.
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373 . Accessed October 21, 2022 .
Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet 2017; 390: 73–84.
Deodhar AA, Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care . 2019;25:S319-S330.
Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475. PMID: 29227352; PMCID: PMC5811203.
A study comparing upadacitinib (ABT-494) to placebo and to adalimumab in adults with rheumatoid arthritis who are on a stable dose of methotrexate and who have an inadequate response to methotrexate (SELECT-COMPARE). ClinicalTrials.gov identifier: NCT02629159. Accessed October 21, 2022 . https://www.clinicaltrials.gov/ct2/show/NCT02629159
A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635 . Accessed on October 21, 2022 .
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649 . Accessed on October 21, 2022 .
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202 . Accessed: October 21, 2022 .
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400 . Accessed on October 21, 2022 .
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397 . Accessed: October 21, 2022 .
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898 . Accessed: October 21, 2022 .

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Health Canada Approves AbbVie's RINVOQ® for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

- Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered rapid and meaningful disease control, meeting the primary endpoint of ASAS40 response at week 14 versus placebo ¹ - RINVOQ is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in Canada ^{1, 2, 3}

AbbVie (NYSE: ABBV), today announced that Health Canada has approved RINVOQ ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.

News Provided by Canada Newswire via QuoteMedia

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Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
“For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
“Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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AMGEN TO PRESENT AT THE 2024 UBS GLOBAL HEALTHCARE CONFERENCE

Amgen (NASDAQ:AMGN) will present at the 2024 UBS Global Healthcare Conference at 10:15 a.m. PT on Wednesday Nov. 13, 2024. Peter Griffith executive vice president and chief financial officer at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

News Provided by PR Newswire via QuoteMedia

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Q3 FY24 Quarterly Report and Appendix 4C: First Positive Operating Cash Flow Quarter Underpinned by Strong Financial and Operational Performance

US-focused Hydration solutions company, The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte USA” or “the Company”) is pleased to provide the following update on its operational and financial performance for the three-month period ended 30 September 2024 (the “quarter”).

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AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2024.

"Strong growth in sales and earnings this quarter reflects the momentum we're building throughout our business. We continue to invest heavily in our rapidly advancing pipeline, with a focus on delivering innovative therapies across our core therapeutic areas," said Robert A. Bradway , chairman and chief executive officer.

News Provided by PR Newswire via QuoteMedia

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Abstract Title	Presentation Details All times CDT
Crohn's Disease
Efficacy and Safety of Upadacitinib for the Treatment of Fistulas and Fissures in Patients with Crohn's Disease	Oral Presentation #947 AGA IBD: Real World Data and Clinical Trials to Guide Care (Research Forum) May 9, 2023 8:30 – 8:45 AM
Upadacitinib Improves Endoscopic Outcomes in Patients with Moderate to Severely Active Crohn's Disease Irrespective of Previous Failure to Respond to Biologics or Conventional Therapies	Oral Presentation #1031 AGA Controlled Clinical Trials in IBD (Research Forum) May 9, 2023 11:00 – 11:15 AM
Delayed Clinical Responders in Patients with Crohn's Disease Receiving Upadacitinib Therapy	Poster #Tu1705 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Upadacitinib Pharmacokinetic and Exposure-Response Relationships in Subjects with Crohn's Disease - Analyses of Phase 3 Studies	Poster #Tu1733 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Additional Risankizumab Treatment Is Effective in Patients with Moderately to Severely Active Crohn's Disease Who Did Not Achieve CDAI Clinical Response with the Initial 12 Week Induction Treatment: Results From the ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1710 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Long-Term Efficacy and Safety of Risankizumab Treatment in Patients with Moderately to Severely Active Crohn's Disease: 104-Week Results from the FORTIFY Study	Poster #Tu1730 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Safety Profile of Risankizumab in Crohn's Disease Patients by Age: Post-hoc Analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1717 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Functional Constipation
Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: a Phase 3 Pivotal Randomized Placebo-Controlled Trial	Oral Presentation: #145 AGA Pediatric Functional and Motility Disorders (Research Forum) May 6, 2023 10:15 – 10:30 AM
Time to Response of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Data from a Phase 3 Randomized Placebo-Controlled Trial	Poster #Mo2008 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Efficacy of Linaclotide in Treating Symptoms of Incomplete Evacuation and Straining in Pediatric Patients with Functional Constipation	Poster #Mo2007 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Long-term Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Interim Analysis of an Open Label, Phase 3, Extension Trial	Poster #Mo2016 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Safety of Linaclotide in Pediatric Patients with Functional Constipation: A Pooled Analysis of Placebo-Controlled, Randomized Controlled Trials	Poster #Mo2015 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Exocrine Pancreatic Insufficiency
Development, Generalizability of a Clinical Screening Tool for Exocrine Pancreatic Insufficiency (EPI) in Patients with Definite Chronic Pancreatitis	Poster #Mo1419 AGA Exocrine Pancreatic Diseases and Diabetes (Poster Session) May 8, 2023 12:30 – 1:30 PM
Disease State
Patients with Crohn's Disease and Ulcerative Colitis Cycle Through Multiple Medications Prior To Starting Advanced Therapy: A Retrospective Study	Poster #Sa1814 May 6, 2023 12:30 – 1:30 PM
Food Security in Hispanics with IBD: A Barrier to Dietary Management	Poster #EP141 AGA Diet and IBD (ePoster section) May 6, 2023 9:30 AM – 4:00 PM
Incidence Rates of Gastrointestinal Perforation Among Patients with Inflammatory Bowel Disease: Real-world Evidence from a Large US Nationwide Claims Database	Poster #Su1769 IBD: Diagnostics in IBD (Poster Section) May 7, 2023 12:30 – 1:30 PM

$Millions, except percentages	Q3 '24			Q3 '23	YOY Δ
	U.S.	ROW	TOTAL	TOTAL	TOTAL
Repatha ^®	$ 281	$ 286	$ 567	$ 406	40 %
EVENITY ^®	289	110	399	307	30 %
Prolia ^®	683	362	1,045	986	6 %
BLINCYTO ^®	237	90	327	220	49 %
Vectibix ^®	132	150	282	252	12 %
KYPROLIS ^®	238	140	378	349	8 %
LUMAKRAS ^® /LUMYKRAS ^™	53	45	98	52	88 %
XGEVA ^®	373	168	541	519	4 %
Nplate ^®	345	111	456	419	9 %
IMDELLTRA ^™	36	—	36	—	N/A
MVASI ^®	136	59	195	213	(8 %)
TEZSPIRE ^®	269	—	269	161	67 %
Otezla ^®	460	104	564	567	(1 %)
Enbrel ^®	817	8	825	1,035	(20 %)
AMJEVITA ^® /AMGEVITA ^™	28	138	166	152	9 %
TEPEZZA ^®(1)	482	6	488	—	N/A
KRYSTEXXA ^®(1)	310	—	310	—	N/A
UPLIZNA ^®(1)	74	32	106	—	N/A
TAVNEOS ^®	74	6	80	37	*
Ultra-Rare products ⁽¹⁾	180	8	188	—	N/A
EPOGEN ^®	33	—	33	50	(34 %)
Aranesp ^®	105	232	337	323	4 %
Parsabiv ^®	32	38	70	95	(26 %)
Neulasta ^®	84	26	110	124	(11 %)
Other products ⁽²⁾	228	53	281	281	— %
Total product sales	$ 5,979	$ 2,172	$ 8,151	$ 6,548	24 %

N/A = not applicable
*Change in excess of 100%
⁽¹⁾ Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ^® , PROCYSBI ^® , ACTIMMUNE ^® , QUINSAIR ^® and BUPHENYL ^®
⁽²⁾ Consists of (i) Aimovig ^® , RIABNI ^® , KANJINTI ^® , AVSOLA ^® , NEUPOGEN ^® , IMLYGIC ^® , BEKEMV ^™ , Corlanor ^® , WEZLANA ^™ /WEZENLA ^™ and Sensipar ^® /Mimpara ^™ , where Biosimilars total $148 million in Q3 '24 and $104 million in Q3 '23; and (ii) Horizon-acquired products including RAYOS ^® and PENNSAID ^®

$Millions, except percentages	GAAP			Non-GAAP
	Q3 '24	Q3 '23	YOY Δ	Q3 '24	Q3 '23	YOY Δ
Cost of Sales	$ 3,310	$ 1,806	83 %	$ 1,454	$ 1,137	28 %
% of product sales	40.6 %	27.6 %	13.0 pts	17.8 %	17.4 %	0.4 pts
Research & Development	$ 1,450	$ 1,079	34 %	$ 1,440	$ 1,070	35 %
% of product sales	17.8 %	16.5 %	1.3 pts	17.7 %	16.3 %	1.4 pts
Selling, General & Administrative	$ 1,625	$ 1,353	20 %	$ 1,565	$ 1,293	21 %
% of product sales	19.9 %	20.7 %	(0.8) pts	19.2 %	19.7 %	(0.5) pts
Other	$ 71	$ 644	(89 %)	$ —	$ —	N/A
Total Operating Expenses	$ 6,456	$ 4,882	32 %	$ 4,459	$ 3,500	27 %

Operating Margin
operating income as % of product sales	25.1 %	30.9 %	(5.8) pts	49.6 %	52.0 %	(2.4) pts

Tax Rate	8.7 %	11.1 %	(2.4) pts	13.4 %	16.1 %	(2.7) pts

pts: percentage points
N/A = not applicable

$Billions, except shares	Q3 '24	Q3 '23	YOYΔ
Operating Cash Flow	$ 3.6	$ 2.8	$ 0.8
Capital Expenditures	$ 0.3	$ 0.2	$ 0.0
Free Cash Flow	$ 3.3	$ 2.5	$ 0.8
Dividends Paid	$ 1.2	$ 1.1	$ 0.1
Share Repurchases	$ 0.0	$ —	$ 0.0
Average Diluted Shares (millions)	542	538	4

Note: Numbers may not add due to rounding

$Billions	9/30/24	12/31/23	YTD Δ
Cash and Investments	$ 9.0	$ 10.9	$ (1.9)
Debt Outstanding	$ 60.4	$ 64.6	$ (4.2)

Note: Numbers may not add due to rounding

Amgen Inc.
Consolidated Statements of Income - GAAP
(In millions, except per-share data)
(Unaudited)
	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Revenues:
Product sales	$ 8,151	$ 6,548	$ 23,310	$ 19,077
Other revenues	352	355	1,028	917
Total revenues	8,503	6,903	24,338	19,994

Operating expenses:
Cost of sales	3,310	1,806	9,746	5,339
Research and development	1,450	1,079	4,240	3,250
Selling, general and administrative	1,625	1,353	5,218	3,905
Other	71	644	187	874
Total operating expenses	6,456	4,882	19,391	13,368

Operating income	2,047	2,021	4,947	6,626

Other income (expense):
Interest expense, net	(776)	(759)	(2,408)	(2,054)
Other income, net	1,830	685	1,288	2,431

Income before income taxes	3,101	1,947	3,827	7,003

Provision for income taxes	271	217	364	1,053

Net income	$ 2,830	$ 1,730	$ 3,463	$ 5,950

Earnings per share:
Basic	$ 5.27	$ 3.23	$ 6.45	$ 11.12
Diluted	$ 5.22	$ 3.22	$ 6.40	$ 11.06

Weighted-average shares used in calculation of earnings per share:
Basic	537	535	537	535
Diluted	542	538	541	538

Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)
	September 30,	December 31,
	2024	2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$ 9,011	$ 10,944
Trade receivables, net	7,317	7,268
Inventories	7,362	9,518
Other current assets	3,076	2,602
Total current assets	26,766	30,332

Property, plant and equipment, net	6,156	5,941
Intangible assets, net	28,920	32,641
Goodwill	18,658	18,629
Other noncurrent assets	10,383	9,611
Total assets	$ 90,883	$ 97,154

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities	$ 16,768	$ 16,949
Current portion of long-term debt	3,544	1,443
Total current liabilities	20,312	18,392

Long-term debt	56,854	63,170
Long-term deferred tax liabilities	1,711	2,354
Long-term tax liabilities	2,280	4,680
Other noncurrent liabilities	2,199	2,326
Total stockholders' equity	7,527	6,232
Total liabilities and stockholders' equity	$ 90,883	$ 97,154

Shares outstanding	538	535

Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars in millions)
(Unaudited)
	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
GAAP cost of sales	$ 3,310	$ 1,806	$ 9,746	$ 5,339
Adjustments to cost of sales:
Acquisition-related expenses (a)	(1,856)	(668)	(5,546)	(2,008)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	(1)	—	(36)
Total adjustments to cost of sales	(1,856)	(669)	(5,546)	(2,044)
Non-GAAP cost of sales	$ 1,454	$ 1,137	$ 4,200	$ 3,295

GAAP cost of sales as a percentage of product sales	40.6 %	27.6 %	41.8 %	28.0 %
Acquisition-related expenses (a)	(22.8)	(10.2)	(23.8)	(10.5)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	0.0	0.0	(0.2)
Non-GAAP cost of sales as a percentage of product sales	17.8 %	17.4 %	18.0 %	17.3 %

GAAP research and development expenses	$ 1,450	$ 1,079	$ 4,240	$ 3,250
Adjustments to research and development expenses:
Acquisition-related expenses (b)	(10)	(9)	(60)	(27)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	—	—	(17)
Total adjustments to research and development expenses	(10)	(9)	(60)	(44)
Non-GAAP research and development expenses	$ 1,440	$ 1,070	$ 4,180	$ 3,206

GAAP research and development expenses as a percentage of product sales	17.8 %	16.5 %	18.2 %	17.0 %
Acquisition-related expenses (b)	(0.1)	(0.2)	(0.3)	(0.1)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	0.0	0.0	(0.1)
Non-GAAP research and development expenses as a percentage of product sales	17.7 %	16.3 %	17.9 %	16.8 %

GAAP selling, general and administrative expenses	$ 1,625	$ 1,353	$ 5,218	$ 3,905
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (c)	(60)	(47)	(255)	(138)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	(13)	—	(13)
Total adjustments to selling, general and administrative expenses	(60)	(60)	(255)	(151)
Non-GAAP selling, general and administrative expenses	$ 1,565	$ 1,293	$ 4,963	$ 3,754

GAAP selling, general and administrative expenses as a percentage of product sales	19.9 %	20.7 %	22.4 %	20.5 %
Acquisition-related expenses (c)	(0.7)	(0.8)	(1.1)	(0.7)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	(0.2)	0.0	(0.1)
Non-GAAP selling, general and administrative expenses as a percentage of product sales	19.2 %	19.7 %	21.3 %	19.7 %

GAAP operating expenses	$ 6,456	$ 4,882	$ 19,391	$ 13,368
Adjustments to operating expenses:
Adjustments to cost of sales	(1,856)	(669)	(5,546)	(2,044)
Adjustments to research and development expenses	(10)	(9)	(60)	(44)
Adjustments to selling, general and administrative expenses	(60)	(60)	(255)	(151)
Certain net charges pursuant to our restructuring and cost-savings initiatives (d)	—	(16)	4	(183)
Certain other expenses (e)	(71)	(628)	(191)	(691)
Total adjustments to operating expenses	(1,997)	(1,382)	(6,048)	(3,113)
Non-GAAP operating expenses	$ 4,459	$ 3,500	$ 13,343	$ 10,255



	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
GAAP operating income	$ 2,047	$ 2,021	$ 4,947	$ 6,626
Adjustments to operating expenses	1,997	1,382	6,048	3,113
Non-GAAP operating income	$ 4,044	$ 3,403	$ 10,995	$ 9,739

GAAP operating income as a percentage of product sales	25.1 %	30.9 %	21.2 %	34.7 %
Adjustments to cost of sales	22.8	10.2	23.8	10.7
Adjustments to research and development expenses	0.1	0.2	0.3	0.2
Adjustments to selling, general and administrative expenses	0.7	1.0	1.1	0.8
Certain net charges pursuant to our restructuring and cost-savings initiatives (d)	0.0	0.2	0.0	1.0
Certain other expenses (e)	0.9	9.5	0.8	3.7
Non-GAAP operating income as a percentage of product sales	49.6 %	52.0 %	47.2 %	51.1 %

GAAP interest expense, net	$ (776)	$ (759)	$ (2,408)	$ (2,054)
Adjustments to interest expense, net:
Interest expense on acquisition-related debt (f)	—	332	—	788
Non-GAAP interest expense, net	$ (776)	$ (427)	$ (2,408)	$ (1,266)

GAAP other income, net	$ 1,830	$ 685	$ 1,288	$ 2,431
Adjustments to other income, net
Interest income and other expenses on acquisition-related debt (f)	—	(313)	—	(607)
Net gains from equity investments (g)	(1,608)	(170)	(693)	(1,305)
Total adjustments to other income, net	(1,608)	(483)	(693)	(1,912)
Non-GAAP other income, net	$ 222	$ 202	$ 595	$ 519

GAAP income before income taxes	$ 3,101	$ 1,947	$ 3,827	$ 7,003
Adjustments to income before income taxes:
Adjustments to operating expenses	1,997	1,382	6,048	3,113
Adjustments to interest expense, net	—	332	—	788
Adjustments to other income, net	(1,608)	(483)	(693)	(1,912)
Total adjustments to income before income taxes	389	1,231	5,355	1,989
Non-GAAP income before income taxes	$ 3,490	$ 3,178	$ 9,182	$ 8,992

GAAP provision for income taxes	$ 271	$ 217	$ 364	$ 1,053
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	228	271	1,007	442
Other income tax adjustments (i)	(33)	23	(44)	6
Total adjustments to provision for income taxes	195	294	963	448
Non-GAAP provision for income taxes	$ 466	$ 511	$ 1,327	$ 1,501

GAAP tax as a percentage of income before taxes	8.7 %	11.1 %	9.5 %	15.0 %
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	5.6	4.2	5.4	1.6
Other income tax adjustments (i)	(0.9)	0.8	(0.4)	0.1
Total adjustments to provision for income taxes	4.7	5.0	5.0	1.7
Non-GAAP tax as a percentage of income before taxes	13.4 %	16.1 %	14.5 %	16.7 %

GAAP net income	$ 2,830	$ 1,730	$ 3,463	$ 5,950
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect	161	960	4,348	1,547
Other income tax adjustments (i)	33	(23)	44	(6)
Total adjustments to net income	194	937	4,392	1,541
Non-GAAP net income	$ 3,024	$ 2,667	$ 7,855	$ 7,491

Note: Numbers may not add due to rounding

(a)		The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions.

(b)		For the three months ended September 30, 2024, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions. For the nine months ended September 30, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three and nine months ended September 30, 2023, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions.

(c)		For the three and nine months ended September 30, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition.

(d)		For the three and nine months ended September 30, 2023, the adjustments related primarily to separation costs associated with our restructuring plan initiated in early 2023.

(e)		For the three and nine months ended September 30, 2024, the adjustments related primarily to impairment charges for in-process R&D assets and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. For the three and nine months ended September 30, 2023, the adjustments related primarily to a net impairment charge for AMG 340.

(f)		For the three and nine months ended September 30, 2023, the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our acquisition of Horizon.

(g)		For the three and nine months ended September 30, 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. For the three and nine months ended September 30, 2023, the adjustments related primarily to our Neumora Therapeutics, Inc. and BeiGene equity fair value adjustments, respectively.

(h)		The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and nine months ended September 30, 2024, was 58.6% and 18.8%, respectively, compared to 22.0% and 22.2% for the corresponding periods of the prior year.

(i)		The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings.

Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)

	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 3,571	$ 2,760	$ 6,719	$ 7,933
Net cash (used in) provided by investing activities	(210)	(262)	(644)	885
Net cash (used in) provided by financing activities	(3,651)	(2,005)	(8,008)	18,294
(Decrease) increase in cash and cash equivalents	(290)	493	(1,933)	27,112
Cash and cash equivalents at beginning of period	9,301	34,248	10,944	7,629
Cash and cash equivalents at end of period	$ 9,011	$ 34,741	$ 9,011	$ 34,741


	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 3,571	$ 2,760	$ 6,719	$ 7,933
Capital expenditures	(257)	(248)	(725)	(863)
Free cash flow	$ 3,314	$ 2,512	$ 5,994	$ 7,070

Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP diluted EPS guidance	$ 8.71	—	$ 9.56
*Known adjustments to arrive at non-GAAP:**
Acquisition-related expenses (a)	11.33	—	11.38
Net gains from equity investments		(1.01)
Other		0.12
Non-GAAP diluted EPS guidance	$ 19.20	—	$ 20.00

Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP tax rate guidance	9.0 %	—	10.5 %
Tax rate of known adjustments discussed above	4.5 %	—	5.0 %
Non-GAAP tax rate guidance	14.0 %	—	15.0 %

RINVOQ® Receives Its Sixth U.S. FDA Approval

1. Bright Minds Biosciences (CSE:DRUG)

2. Medicenna (TSX:MDNA)

3. ME Therapeutics Holdings (CSE:METX)

4. Cardiol Therapeutics (TSX:CRDL)

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