U.S. FDA Approves QULIPTA® for Adults With Chronic Migraine

QULIPTA ^® now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic
Expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities
Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment
AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of QULIPTA ® (atogepant) for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine. 1

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9120951-abbvie-qulipta-migraine/

"Since September 2021 , QULIPTA has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on QULIPTA to significantly reduce their migraine days," said Roopal Thakkar , senior vice president, chief medical officer, AbbVie. "This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including QULIPTA as a preventive treatment for both episodic and chronic migraine; BOTOX ^® (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and UBRELVY ^® (ubrogepant), an acute treatment for migraine attacks."

QULIPTA's expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period. ² The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19. ³ The trial also demonstrated that treatment with QULIPTA resulted in statistically significant improvements in all six secondary endpoints. ³ This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine. ⁴ These efficacy results are consistent with those in the ADVANCE episodic migraine trial. ⁵

"The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe and effective treatment option in a convenient, once-daily pill," said Peter McAllister , M.D., Director of the New England Center for Neurology and Headache. "QULIPTA's data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine."

QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety profile of QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness. ⁶

"For years, I felt hopeless and struggled to find a treatment that not only reduced the number of migraine attacks but could also help reduce how often migraine impacted my daily activities like taking my kids to school or practices," said Latoya Lawrence , a patient who has lived with migraine for more than 20 years. "After I started taking QULIPTA for my episodic migraine, I wasn't as worried about when my next migraine attack might strike. I'm glad people living with chronic migraine now have a treatment option that has the potential to make a substantial impact on their lives."

About the Phase 3 PROGRESS Clinical Trial

The Phase 3 PROGRESS clinical trial evaluated the safety, tolerability and efficacy of oral QULIPTA 60mg once daily (QD) for the preventive treatment of chronic migraine. ⁷ The patient population for the study included patients with a diagnosis of chronic migraine for at least one year, and greater than or equal to 15 headache days with greater than or equal to eight migraine days in the 28 days prior to randomization. ⁷ The primary endpoint measured the reduction from baseline in mean monthly migraine days compared to placebo across a 12-week treatment period. ⁷

Key secondary endpoints across the 12-week treatment period included: change from baseline in mean monthly headache days; change from baseline in mean monthly acute medication use days; proportion of participants with at least a 50% reduction in mean monthly migraine days; and change from baseline in Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score at Week 12. The MSQ v2.1 is a questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past four weeks. Key secondary endpoints also included change from baseline in Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities and Physical Impairment domain scores. The AIM-D is a novel questionnaire designed to evaluate difficulty with performance of daily activities and physical impairment due to migraine.

About QULIPTA ^® (atogepant)

QULIPTA ^® is approved by the U.S. Food and Drug Administration (FDA) and is available in the United States for the preventive treatment of migraine in adults. QULIPTA is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is approved for the preventive treatment of chronic migraine.

IMPORTANT SAFETY INFORMATION

Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA.

Before taking QULIPTA ^® (atogepant) tablets, tell your healthcare provider about all your medical conditions, including if you:

Have kidney problems or are on dialysis
Have liver problems
Are pregnant or plan to become pregnant. It is not known if QULIPTA will harm your unborn baby
Are breastfeeding or plan to breastfeed. It is not known if QULIPTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking QULIPTA

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines.

QULIPTA can cause serious allergic (hypersensitivity) reactions, like anaphylaxis, that can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash.

The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA.

Please see QULIPTA full Prescribing Information .

INDICATIONS
BOTOX ^® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used:

To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken
To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older
To treat increased muscle stiffness in people 2 years of age and older with spasticity
To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older

BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

It is not known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION
BOTOX 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:

Problems swallowing, speaking, or breathing, due to weakening of associated muscles, 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; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing.

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.

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

Do not receive BOTOX if you are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc ^® (rimabotulinumtoxinB), Dysport ^® (abobotulinumtoxinA), or Xeomin ^® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not receive BOTOX for the treatment of urinary incontinence if you have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate catheterization posttreatment, if required, should be considered for treatment.

Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics.

Adult patients treated for overactive bladder due to a neurologic disease: In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).

Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection than those with spinal cord injury.

The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported, including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued.

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 typical doses of BOTOX.

Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX.

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX for their blepharospasm, especially in people with certain nerve disorders. BOTOX may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX.

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).

Tell your doctor about all your medical conditions, including if you have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX 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 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 in the past.

Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc ^® , Dysport ^® , or Xeomin ^® 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; take aspirin-like products or blood thinners.

Other side effects of BOTOX include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include UTI and painful urination. In children being treated for urinary incontinence, other side effects include UTI and bacteria in the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder on your own after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

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

Please see BOTOX ^® full Product Information , including Boxed Warning and Medication Guide .

About UBRELVY ^® (ubrogepant)
UBRELVY ^® is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY ^® is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.

What is UBRELVY ^® (ubrogepant)?
UBRELVY is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY is not used to prevent migraine headaches.

IMPORTANT SAFETY INFORMATION
Do not take UBRELVY if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, or itraconazole, or if you are allergic to UBRELVY or any of its ingredients.

Before taking UBRELVY, tell your healthcare provider about all your medical conditions, including if you:

Have liver problems
Have kidney problems
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines.

UBRELVY may cause serious side effects, including allergic reactions. Most reactions happened within hours after taking UBRELVY and were not serious. Some reactions may occur days after taking UBRELVY. Call your healthcare provider or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing.

The most common side effects of UBRELVY are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY.

Please see UBRELVY full Prescribing Information .

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

About Migraine and Chronic Migraine

Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea. ⁸ It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age. ^9-12

People living with chronic migraine experience headaches or migraine for 15 or more days per month, with at least eight of those days associated with migraine. ¹³ It is differentiated from episodic migraine, which is characterized by 0-14 headache days per month, ¹⁴ by its more debilitating disease profile including greater prevalence of comorbid conditions as well as higher frequency of headache and migraine days. ^14-16 Individuals with chronic migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life. This results in substantial societal and familial burden. ^17-21 Significant direct and indirect costs are also associated with chronic migraine, leading to economic burden for patients and healthcare systems. ^22-24

About AbbVie in Migraine

AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine to help patients living with this debilitating disease.

QULIPTA ^® (atogepant) is FDA-approved for the preventive treatment of migraine in adults. It is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. Since its initial approval for the preventive treatment of episodic migraine in September 2021 , QULIPTA has been prescribed for nearly 200,000 patients.
BOTOX ^® (onabotulinumtoxinA) is the first FDA-approved, preventive treatment for adult patients with chronic migraine. Since FDA approval in 2010, more than 5 million BOTOX ^® treatments given to more than 850,000 people living with chronic migraine.
UBRELVY ^® (ubrogepant) is the first FDA-approved CGRP treatment for the acute treatment of migraine attacks in adults. Since its approval in December 2019 , UBRELVY ^® has been prescribed for nearly 750,000 patients. It can be used in patients across the entire spectrum of migraine and regardless of other treatments (acute or preventive) they may be on or have tried.

At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives.

About AbbVie in Neuroscience

At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies in neurological and psychiatric disorders, including bipolar I disorder, cervical dystonia, major depressive disorder, migraine, Parkinson's disease, post-stroke spasticity, schizophrenia and others along with a robust pipeline.

We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts , and our Neuroscience Discovery site in Ludwigshafen, Germany , where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people's lives.

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 gastroenterology, 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 , Instagram , YouTube and LinkedIn .

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 and uses of future or conditional verbs, 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 expressed or implied 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," of AbbVie's 2022 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
AbbVie. Data on File: ABVRRTI73750
Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137?term=NCT03855137&draw=2&rank=1 . Accessed on March 15, 2023 .
AbbVie. Data on File: ABVRRTI73750
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03777059 .
QULIPTA™ (atogepant) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137 .
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. PMID: 35281991; PMCID: PMC8904749.
Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., & Katsarava, Z. Migraine is first cause of disability in under 50s: Will health politicians now take notice? J Headache Pain. 2018;19:17.
AbbVie. Data on File: ABVRRTI73750
Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92.
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92.
Buse DC, Manack A, Serrano DC, et al. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry. 2010;81:428-432.
Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7) 563-578.
Blumenfeld A, Varon S, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301-315.
Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia. 2011;31:837-850.
Buse DC, Scher AI, Dodick DW, et al. Impact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO Study. Mayo Clin Proc . 2016;91:596-611.
Buse DC, Powers SW, Gelfand AA, et al. Adolescent perspectives on the burden of a parent's migraine: results from the CaMEO study. Headache. 2018;58:512-524.
Buse DC, Murray S, Dumas PK, et al. Life with migraine, effect on relationships, career and finances, and overall health and well-being results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Cephalalgia. 2018;38(Suppl 1):9-10.
Messali A, Sanderson JC, Blumenfeld AM, et al. Direct and indirect costs of chronic and episodic migraine in the United States : a web-based survey. Headache. 2016;56:306-322.
Sanderson JC, Devine EB, Lipton RB, et al. Headache-related health resource utilization in chronic and episodic migraine across six countries. J Neurol Neurosurg Psychiatry. 2013;84:1309-1317.
Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: Results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301-315.

Pharmaceutical

View original content: https://www.prnewswire.com/news-releases/us-fda-approves-qulipta-atogepant-for-adults-with-chronic-migraine-301799554.html

SOURCE AbbVie

News Provided by PR Newswire via QuoteMedia

AbbVie ABBV Biotech Investing

ABBV

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

Keep reading...Show less

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."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

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.

Keep reading...Show less

AMGEN ANNOUNCES WEBCAST OF 2024 FIRST QUARTER FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced that it will report its first quarter 2024 financial results on Thursday, May 2, 2024 after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET . Participating in the call from Amgen will be Robert A. Bradway chairman and chief executive officer, and other members of Amgen's senior management team.

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

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	Q1 '24			Q1 '23	YOY Δ
	US	ROW	TOTAL	TOTAL	TOTAL
Repatha ^®	$ 273	$ 244	$ 517	$ 388	33 %
Prolia ^®	657	342	999	927	8 %
EVENITY ^®	236	106	342	254	35 %
BLINCYTO ^®	153	91	244	194	26 %
Vectibix ^®	120	127	247	233	6 %
KYPROLIS ^®	234	142	376	358	5 %
LUMAKRAS ^® /LUMYKRAS ^™	53	29	82	74	11 %
XGEVA ^®	366	195	561	536	5 %
Nplate ^®	190	127	317	362	(12 %)
MVASI ^®	105	97	202	202	— %
TEZSPIRE ^®	173	—	173	96	80 %
Otezla ^®	293	101	394	392	1 %
Enbrel ^®	561	6	567	579	(2 %)
AMJEVITA ^® /AMGEVITA ^™	30	138	168	164	2 %
TEPEZZA ^® **	419	5	424	—	N/A
KRYSTEXXA ^® **	235	—	235	—	N/A
UPLIZNA ^® **	70	10	80	—	N/A
TAVNEOS ^®	45	6	51	23	*
Ultra rare products**	166	3	169	—	N/A
EPOGEN ^®	41	—	41	60	(32 %)
Aranesp ^®	100	249	349	355	(2 %)
Parsabiv ^®	65	40	105	91	15 %
Neulasta ^®	87	31	118	249	(53 %)
Other products***	301	56	357	309	16 %
Total product sales	$ 4,973	$ 2,145	$ 7,118	$ 5,846	22 %

*Change in excess of 100%
**Horizon-acquired products, and the Ultra rare products consist of RAVICTI ^® , PROCYSBI ^® , ACTIMMUNE ^® , BUPHENYL ^® , and QUINSAIR ^®
***Consists of (i) KANJINTI ^® , Aimovig ^® , RIABNI ^® , Corlanor ^® , NEUPOGEN ^® , AVSOLA ^® , IMLYGIC ^® , Sensipar ^® /Mimpara ^™ , BEKEMV ^™ , and WEZLANA ^™ /WEZENLA ^™ , where Biosimilars total $176 million in Q1 '24 and $121 million in Q1 '23; and (ii) Horizon-acquired products including RAYOS ^® , PENNSAID ^® , and DUEXIS ^®
N/A = not applicable

$Millions, except percentages	GAAP			Non-GAAP
	Q1 '24	Q1 '23	YOY Δ	Q1 '24	Q1 '23	YOY Δ
Cost of Sales	$ 3,200	$ 1,720	86 %	$ 1,340	$ 1,016	32 %
% of product sales	45.0 %	29.4 %	15.6 pts	18.8 %	17.4 %	1.4 pts
Research & Development	$ 1,343	$ 1,058	27 %	$ 1,317	$ 1,044	26 %
% of product sales	18.9 %	18.1 %	0.8 pts	18.5 %	17.9 %	0.6 pts
Selling, General & Administrative	$ 1,808	$ 1,258	44 %	$ 1,712	$ 1,224	40 %
% of product sales	25.4 %	21.5 %	3.9 pts	24.1 %	20.9 %	3.2 pts
Other	$ 105	$ 148	(29 %)	$ —	$ —	N/A
Total Operating Expenses	$ 6,456	$ 4,184	54 %	$ 4,369	$ 3,284	33 %

Operating Margin
operating income as % of product sales	13.9 %	32.9 %	(19.0) pts	43.2 %	48.3 %	(5.1) pts

Tax Rate	(66.2) %	17.5 %	(83.7) pts	15.4 %	17.8 %	(2.4) pts

pts: percentage points
N/A = not applicable

$Billions, except shares	Q1 '24	Q1 '23	YOY Δ
Operating Cash Flow	$ 0.7	$ 1.1	$ (0.4)
Capital Expenditures	$ 0.2	$ 0.3	$ (0.1)
Free Cash Flow	$ 0.5	$ 0.7	$ (0.3)
Dividends Paid	$ 1.2	$ 1.1	$ 0.1
Share Repurchases	$ —	$ —	$ —
Average Diluted Shares (millions)	536	538	(2)

Note: Numbers may not add due to rounding

$Billions	3/31/24	12/31/23	YTD Δ
Cash and Investments	$ 9.7	$ 10.9	$ (1.2)
Debt Outstanding	$ 64.0	$ 64.6	$ (0.6)

Note: Numbers may not add due to rounding

Amgen Inc. Consolidated Statements of (Loss) Income - GAAP (In millions, except per-share data) (Unaudited)

	Three months ended March 31,
	2024	2023
Revenues:
Product sales	$ 7,118	$ 5,846
Other revenues	329	259
Total revenues	7,447	6,105

Operating expenses:
Cost of sales	3,200	1,720
Research and development	1,343	1,058
Selling, general and administrative	1,808	1,258
Other	105	148
Total operating expenses	6,456	4,184

Operating income	991	1,921

Other income (expense):
Interest expense, net	(824)	(543)
Other (expense) income, net	(235)	2,064

(Loss) income before income taxes	(68)	3,442

Provision for income taxes	45	601

Net (loss) income	$ (113)	$ 2,841

(Loss) earnings per share:
Basic	$ (0.21)	$ 5.32
Diluted	$ (0.21)	$ 5.28

Weighted-average shares used in calculation of (loss) earnings per share:
Basic	536	534
Diluted	536	538

Amgen Inc. Consolidated Balance Sheets - GAAP (In millions)

	March 31,	December 31,
	2024	2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$ 9,708	$ 10,944
Trade receivables, net	6,776	7,268
Inventories	8,724	9,518
Other current assets	2,821	2,602
Total current assets	28,029	30,332

Property, plant and equipment, net	6,002	5,941
Intangible assets, net	31,372	32,641
Goodwill	18,570	18,629
Other noncurrent assets	9,007	9,611
Total assets	$ 92,980	$ 97,154

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities	$ 15,755	$ 16,949
Current portion of long-term debt	3,959	1,443
Total current liabilities	19,714	18,392

Long-term debt	60,061	63,170
Long-term deferred tax liabilities	1,862	2,354
Long-term tax liabilities	3,964	4,680
Other noncurrent liabilities	2,357	2,326
Total stockholders' equity	5,022	6,232
Total liabilities and stockholders' equity	$ 92,980	$ 97,154

Shares outstanding	536	535

Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited)

	Three months ended March 31,
	2024	2023
GAAP cost of sales	$ 3,200	$ 1,720
Adjustments to cost of sales:
Acquisition-related expenses (a)	(1,860)	(669)
Certain net charges pursuant to our restructuring and cost savings initiatives	—	(35)
Total adjustments to cost of sales	(1,860)	(704)
Non-GAAP cost of sales	$ 1,340	$ 1,016

GAAP cost of sales as a percentage of product sales	45.0 %	29.4 %
Acquisition-related expenses (a)	(26.2)	(11.4)
Certain net charges pursuant to our restructuring and cost savings initiatives	0.0	(0.6)
Non-GAAP cost of sales as a percentage of product sales	18.8 %	17.4 %

GAAP research and development expenses	$ 1,343	$ 1,058
Adjustments to research and development expenses:
Acquisition-related expenses (b)	(26)	(14)
Non-GAAP research and development expenses	$ 1,317	$ 1,044

GAAP research and development expenses as a percentage of product sales	18.9 %	18.1 %
Acquisition-related expenses (b)	(0.4)	(0.2)
Non-GAAP research and development expenses as a percentage of product sales	18.5 %	17.9 %

GAAP selling, general and administrative expenses	$ 1,808	$ 1,258
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (b)	(96)	(34)
Non-GAAP selling, general and administrative expenses	$ 1,712	$ 1,224

GAAP selling, general and administrative expenses as a percentage of product sales	25.4 %	21.5 %
Acquisition-related expenses (b)	(1.3)	(0.6)
Non-GAAP selling, general and administrative expenses as a percentage of product sales	24.1 %	20.9 %

GAAP operating expenses	$ 6,456	$ 4,184
Adjustments to operating expenses:
Adjustments to cost of sales	(1,860)	(704)
Adjustments to research and development expenses	(26)	(14)
Adjustments to selling, general and administrative expenses	(96)	(34)
Certain net charges pursuant to our restructuring and cost savings initiatives (c)	1	(141)
Certain other expenses (d)	(106)	(7)
Total adjustments to operating expenses	(2,087)	(900)
Non-GAAP operating expenses	$ 4,369	$ 3,284


	Three months ended March 31,
	2024	2023
GAAP operating income	$ 991	$ 1,921
Adjustments to operating expenses	2,087	900
Non-GAAP operating income	$ 3,078	$ 2,821

GAAP operating income as a percentage of product sales	13.9 %	32.9 %
Adjustments to cost of sales	26.2	12.0
Adjustments to research and development expenses	0.4	0.2
Adjustments to selling, general and administrative expenses	1.3	0.6
Certain net charges pursuant to our restructuring and cost savings initiatives (c)	0.0	2.5
Certain other expenses (d)	1.4	0.1
Non-GAAP operating income as a percentage of product sales	43.2 %	48.3 %

GAAP interest expense, net	$ (824)	$ (543)
Adjustments to interest expense, net:
Interest expense on acquisition-related debt (e)	—	123
Non-GAAP interest expense, net	$ (824)	$ (420)

GAAP other (expense) income, net	$ (235)	$ 2,064
Adjustments to other (expense) income, net
Interest income and other expenses on acquisition-related debt (e)	—	(6)
Net losses (gains) from equity investments (f)	510	(1,853)
Total adjustments to other (expense) income, net	510	(1,859)
Non-GAAP other income, net	$ 275	$ 205

GAAP (loss) income before income taxes	$ (68)	$ 3,442
Adjustments to (loss) income before income taxes:
Adjustments to operating expenses	2,087	900
Adjustments to interest expense, net	—	123
Adjustments to other (expense) income, net	510	(1,859)
Total adjustments to (loss) income before income taxes	2,597	(836)
Non-GAAP income before income taxes	$ 2,529	$ 2,606

GAAP provision for income taxes	$ 45	$ 601
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (g)	359	(117)
Other income tax adjustments (h)	(15)	(19)
Total adjustments to provision for income taxes	344	(136)
Non-GAAP provision for income taxes	$ 389	$ 465

GAAP tax as a percentage of income before taxes	(66.2) %	17.5 %
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (g)	82.2	1.0
Other income tax adjustments (h)	(0.6)	(0.7)
Total adjustments to provision for income taxes	81.6	0.3
Non-GAAP tax as a percentage of income before taxes	15.4 %	17.8 %

GAAP net (loss) income	$ (113)	$ 2,841
Adjustments to net (loss) income:
Adjustments to (loss) income before income taxes, net of the income tax effect	2,238	(719)
Other income tax adjustments (h)	15	19
Total adjustments to net (loss) income	2,253	(700)
Non-GAAP net income	$ 2,140	$ 2,141

Note: Numbers may not add due to rounding

Amgen Inc. GAAP to Non-GAAP Reconciliations (In millions, except per-share data) (Unaudited)

The following table presents the computations for GAAP and non-GAAP diluted earnings per share:

	Three months ended March 31, 2024		Three months ended March 31, 2023
	GAAP	Non-GAAP	GAAP	Non-GAAP
Net (loss) income	$ (113)	$ 2,140	$ 2,841	$ 2,141

Shares (Denominator):
Weighted-average shares for basic (loss) earnings per share	536	536	534	534
Effect of dilutive securities (i)	—	5	4	4
Weighted-average shares for diluted (loss) earnings per share (i)	536	541	538	538

Diluted (loss) earnings per share	$ (0.21)	$ 3.96	$ 5.28	$ 3.98


(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 March 31, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three months ended March 31, 2023, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions.

(c)		For the three months ended March 31, 2023, the adjustments related primarily to separation costs associated with our restructuring plan initiated in early 2023.

(d)		For the three months ended March 31, 2024, the adjustments related primarily to a net impairment charge for an in-process R&D asset and changes in contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. For the three months ended March 31, 2023, the adjustments related to changes in contingent consideration liabilities.

(e)		For the three months ended March 31, 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.

(f)		For the three months ended March 31, 2024 and 2023, the adjustments related primarily to our BeiGene, Ltd. equity fair value adjustment.

(g)		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, this results in a tax impact at the U.S. marginal tax rate for certain adjustments, including the majority of amortization of intangible assets and certain gains and losses on our investments in equity securities, whereas the tax impact of other adjustments, including the amortization of acquired inventory 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 months ended March 31, 2024, was 13.8% compared to 14.0% for the corresponding period of the prior year.

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

(i)		During periods of net loss, diluted loss per share is equal to basic loss per share as the anti-dilutive effect of potential common shares is disregarded.

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

	Three months ended March 31,
	2024	2023
Net cash provided by operating activities	$ 689	$ 1,064
Net cash (used in) provided by investing activities	(217)	1,358
Net cash (used in) provided by financing activities	(1,708)	21,509
(Decrease) increase in cash and cash equivalents	(1,236)	23,931
Cash and cash equivalents at beginning of period	10,944	7,629
Cash and cash equivalents at end of period	$ 9,708	$ 31,560


	Three months ended March 31,
	2024	2023
Net cash provided by operating activities	$ 689	$ 1,064
Capital expenditures	(230)	(344)
Free cash flow	$ 459	$ 720

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

GAAP diluted EPS guidance	$ 7.15	—	$ 8.40
*Known adjustments to arrive at non-GAAP:**
Acquisition-related expenses (a)	10.98	—	11.03
Net losses from equity investments		0.74
Other		0.08
Non-GAAP diluted EPS guidance	$ 19.00	—	$ 20.20

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

GAAP tax rate guidance	9.5 %	—	11.0 %
Tax rate of known adjustments discussed above	5.0 %	—	5.5 %
Non-GAAP tax rate guidance	15.0 %	—	16.0 %

U.S. FDA Approves QULIPTA® for Adults With Chronic Migraine

1. ME Therapeutics Holdings (CSE:METX)

2. Cardiol Therapeutics (TSX:CRDL)

3. Medicenna (TSX:MDNA)

Latest News

Latest Press Releases

Related News

TOP STOCKS