AbbVie Reports First-Quarter 2023 Financial Results

Reports First-Quarter Diluted EPS of $0.13 on a GAAP Basis, a Decrease of 94.8 Percent; Adjusted Diluted EPS of $2.46 , a Decrease of 22.2 Percent; These Results Include an Unfavorable Impact of $0.08 Per Share related to Acquired IPR&D and Milestones Expense

Delivers First-Quarter Net Revenues of $12.225 Billion , a Decrease of 9.7 Percent on a Reported Basis and 8.3 Percent on an Operational Basis

First -Quarter Global Net Revenues from the Immunology Portfolio Were $5.587 Billion , a Decrease of 9.0 Percent on a Reported Basis, or 7.8 Percent on an Operational Basis; Global Humira Net Revenues Were $3.541 Billion ; Global Skyrizi Net Revenues Were $1.360 Billion ; Global Rinvoq Net Revenues Were $686 Million

First -Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.416 Billion , a Decrease of 14.0 Percent on a Reported Basis, or 12.9 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $878 Million ; Global Venclexta Net Revenues Were $538 Million

First -Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.695 Billion , an Increase of 13.9 Percent on a Reported Basis, or 15.0 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $719 Million ; Global Vraylar Net Revenues Were $561 Million

First -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.300 Billion , a Decrease of 5.4 Percent on a Reported Basis, or 2.0 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $659 Million ; Global Juvederm Net Revenues Were $355 Million

Raises 2023 Adjusted Diluted EPS Guidance Range from $10.62 - $11.02 to $10.72 - $11.12 , which Includes an Unfavorable Impact of $0.08 Per Share Related to Acquired IPR&D and Milestones Expense Incurred During the First Quarter 2023

AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2023 .

"This year is off to an excellent start, with first-quarter revenues and EPS ahead of our expectations, driven by strong commercial execution across all areas of our diversified portfolio," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "These balanced results give us confidence to increase our full-year guidance and we see numerous opportunities for key assets to drive compelling long-term growth."

First -Quarter Results

Worldwide net revenues were $12.225 billion , a decrease of 9.7 percent on a reported basis, or 8.3 percent on an operational basis.

Global net revenues from the immunology portfolio were $5.587 billion , a decrease of 9.0 percent on a reported basis, or 7.8 percent on an operational basis.

Global Humira net revenues of $3.541 billion decreased 25.2 percent on a reported basis, or 24.3 percent on an operational basis. U.S. Humira net revenues were $2.948 billion , a decrease of 26.1 percent. Internationally, Humira net revenues were $593 million , a decrease of 20.3 percent on a reported basis, or 14.8 percent on an operational basis.
Global Skyrizi net revenues were $1.360 billion , an increase of 44.7 percent on a reported basis, or 46.3 percent on an operational basis.
Global Rinvoq net revenues were $686 million , an increase of 47.5 percent on a reported basis, or 51.2 percent on an operational basis.

Global net revenues from the hematologic oncology portfolio were $1.416 billion , a decrease of 14.0 percent on a reported basis, or 12.9 percent on an operational basis.

Global Imbruvica net revenues were $878 million , a decrease of 25.2 percent, with U.S. net revenues of $638 million and international profit sharing of $240 million .
Global Venclexta net revenues were $538 million , an increase of 13.7 percent on a reported basis, or 17.5 percent on an operational basis.

Global net revenues from the neuroscience portfolio were $1.695 billion , an increase of 13.9 percent on a reported basis, or 15.0 percent on an operational basis.

Global Botox Therapeutic net revenues were $719 million , an increase of 17.1 percent on a reported basis, or 18.7 percent on an operational basis.
Global Vraylar net revenues were $561 million , an increase of 31.3 percent.
Global Ubrelvy net revenues were $152 million , an increase of 10.0 percent.

Global net revenues from the aesthetics portfolio were $1.300 billion , a decrease of 5.4 percent on a reported basis, or 2.0 percent on an operational basis.

Global Botox Cosmetic net revenues were $659 million , an increase of 2.9 percent on a reported basis, or 5.8 percent on an operational basis.
Global Juvederm net revenues were $355 million , a decrease of 13.4 percent on a reported basis, or 7.4 percent on an operational basis.

On a GAAP basis, the gross margin ratio in the first quarter was 67.4 percent. The adjusted gross margin ratio was 84.2 percent.

On a GAAP basis, selling, general and administrative (SG&A) expense was 24.9 percent of net revenues. The adjusted SG&A expense was 24.4 percent of net revenues.

On a GAAP basis, research and development (R&D) expense was 18.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

Acquired IPR&D and milestones expense was 1.2 percent of net revenues.

On a GAAP basis, the operating margin in the first quarter was 22.6 percent. The adjusted operating margin was 45.0 percent.

Net interest expense was $454 million .

On a GAAP basis, the tax rate in the quarter was 49.3 percent. The adjusted tax rate was 13.7 percent.

Diluted EPS in the first quarter was $0.13 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46 . These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.

^{Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.}

Recent Events

AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib, 45 mg induction dose, 15 mg and 30 mg maintenance doses) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. The approval is based on results from three studies in which Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This is the seventh approved indication for Rinvoq in the European Union (EU).

AbbVie announced positive top-line results from INSPIRE, a Phase 3 induction study, showing Skyrizi (risankizumab, 1200 mg intravenous (IV), at weeks 0, 4 and 8) met the primary endpoint of clinical remission at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis (UC). Safety results in this study were consistent with the known safety profile of Skyrizi, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

AbbVie announced positive top-line results from a Phase 2 study of Rinvoq (30 mg, once daily), given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), in patients with moderately to severely active systemic lupus erythematosus (SLE). The study met the primary endpoint of SLE Responder Index (SRI-4) with a steroid dose of less than or equal to 10 mg per day at week 24 in patients with moderately to severely active SLE. Based on these results, AbbVie intends to advance its clinical program of Rinvoq in SLE to Phase 3.

At the Congress of European Crohn's and Colitis Organisation (ECCO), AbbVie presented 24 abstracts, including four oral presentations, two digital oral presentations and 18 posters from a broad range of studies across its inflammatory bowel disease (IBD) portfolio. Highlights included data from the ADVANCE, MOTIVATE and FORTIFY studies highlighting efficacy outcomes and clinical response in patients receiving Skyrizi for treatment of moderately to severely active CD, sub-analyses from the U-EXCEL, U-EXCEED and U-ENDURE studies evaluating Rinvoq for the treatment of moderately to severely active CD and analyses evaluating Rinvoq for the treatment of UC.

At the 2023 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented more than 20 abstracts showcasing the strength of its dermatology portfolio. Notable presentations included late-breaking data that demonstrated Skyrizi improved plaque psoriasis (PsO) signs and symptoms among moderate to severe PsO patients that previously had a suboptimal response to IL-17 inhibitor therapy; abstracts assessing long-term outcomes of Skyrizi in patients with active psoriatic arthritis (PsA); subgroup analyses of outcomes in adults and adolescents with atopic dermatitis (AD) from three Phase 3 trials assessing the efficacy and safety of Rinvoq across 52 weeks; and results from a Phase 2 study evaluating the efficacy and safety of Rinvoq in moderate-to-severe hidradenitis suppurativa (HS).

AbbVie announced that it intends to voluntarily withdraw the U.S. accelerated Imbruvica (ibrutinib) approvals for patients with mantle cell lymphoma (MCL) who received at least one prior therapy and patients with marginal zone lymphoma (MZL) who require systemic therapy and received at least one prior anti-CD20-based therapy. This voluntary action was due to requirements related to the accelerated approval status granted by the U.S. Food and Drug Administration (FDA) for MCL and MZL. Other approved indications for Imbruvica in the U.S. were not affected by this withdrawal and Imbruvica's established clinical profile in other approved indications is unchanged. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.

Recent Events (Continued)

AbbVie announced that the FDA approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. The expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval is 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 announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL did not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible.

AbbVie and Capsida Biotherapeutics Inc. (Capsida) announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. The collaboration builds on the partnership announced in 2021. Under the expanded collaboration, AbbVie's extensive capabilities will be paired with Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs.

Full-Year 2023 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2023 from $10.62 - $11.02 to $10.72 - $11.12 , which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2023. The company's 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2023, as both cannot be reliably forecasted.

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 or LinkedIn .

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the call will be available after 11:00 a.m. Central time .

Non-GAAP Financial Results

Financial results for 2023 and 2022 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.

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 Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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.

AbbVie Inc. Key Product Revenues Quarter Ended March 31, 2023 (Unaudited)

				% Change vs. 1Q22
	Net Revenues (in millions)			Reported			Operational ^a
	U.S.	Int'l.	Total	U.S.	Int'l.	Total	Int'l.	Total
NET REVENUES	$9,201	$3,024	$12,225	(11.1) %	(5.2) %	(9.7) %	0.9 %	(8.3) %

Immunology	4,536	1,051	5,587	(10.8)	(0.6)	(9.0)	6.3	(7.8)
Humira	2,948	593	3,541	(26.1)	(20.3)	(25.2)	(14.8)	(24.3)
Skyrizi	1,139	221	1,360	45.9	38.5	44.7	47.7	46.3
Rinvoq	449	237	686	44.4	53.7	47.5	64.9	51.2

Hematologic Oncology	903	513	1,416	(18.2)	(5.5)	(14.0)	(2.2)	(12.9)
Imbruvica ^b	638	240	878	(27.0)	(19.7)	(25.2)	(19.7)	(25.2)
Venclexta	265	273	538	15.7	11.8	13.7	19.2	17.5

Aesthetics	777	523	1,300	(8.1)	(1.1)	(5.4)	7.8	(2.0)
Botox Cosmetic	409	250	659	(0.7)	9.4	2.9	17.5	5.8
Juvederm Collection	122	233	355	(17.9)	(10.9)	(13.4)	(1.4)	(7.4)
Other Aesthetics	246	40	286	(13.6)	3.6	(11.5)	12.7	(10.4)

Neuroscience	1,463	232	1,695	15.0	7.5	13.9	15.0	15.0
Botox Therapeutic	587	132	719	17.5	15.5	17.1	24.2	18.7
Vraylar	560	1	561	31.2	n/m	31.3	n/m	31.3
Duodopa	25	93	118	6.5	(4.3)	(2.2)	1.7	2.6
Ubrelvy	150	2	152	9.0	n/m	10.0	n/m	10.0
Qulipta	66	—	66	>100.0	n/m	>100.0	n/m	>100.0
Other Neuroscience	75	4	79	(56.7)	6.9	(55.2)	12.6	(55.1)

Eye Care	319	289	608	(35.7)	5.0	(21.2)	11.0	(19.0)
Ozurdex	39	76	115	16.1	3.2	7.3	10.3	12.2
Lumigan/Ganfort	63	67	130	(6.8)	(7.2)	(7.0)	(2.7)	(4.7)
Alphagan/Combigan	28	43	71	(59.4)	16.9	(33.3)	24.2	(30.8)
Restasis	79	13	92	(66.5)	20.4	(62.8)	25.1	(62.6)
Other Eye Care	110	90	200	22.9	10.3	16.9	16.3	19.8

Other Key Products	727	201	928	5.5	(7.4)	2.4	(1.1)	3.9
Mavyret	171	193	364	1.2	(8.1)	(4.0)	(1.8)	(0.5)
Creon	305	—	305	6.3	n/m	6.3	n/m	6.3
Linzess/Constella	251	8	259	7.7	11.9	7.8	17.8	8.0


^a	"Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.
^b	Reflects profit sharing for Imbruvica international revenues.
n/m = not meaningful

AbbVie Inc. Consolidated Statements of Earnings (Unaudited)

(in millions, except per share data)	First Quarter Ended March 31
	2023	2022
Net revenues	$ 12,225	$ 13,538
Cost of products sold	3,986	4,052
Selling, general and administrative	3,039	3,127
Research and development	2,292	1,497
Acquired IPR&D and milestones	150	145
Other operating income	(10)	—
Total operating costs and expenses	9,457	8,821

Operating earnings	2,768	4,717

Interest expense, net	454	539
Net foreign exchange loss	35	25
Other expense (income), net	1,804	(776)
Earnings before income tax expense	475	4,929
Income tax expense	234	436
Net earnings	241	4,493
Net earnings attributable to noncontrolling interest	2	3
Net earnings attributable to AbbVie Inc.	$ 239	$ 4,490

Diluted earnings per share attributable to AbbVie Inc.	$ 0.13	$ 2.51

Adjusted diluted earnings per share ^a	$ 2.46	$ 3.16

Weighted-average diluted shares outstanding	1,776	1,778

^a Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.

AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited)

1. Specified items impacted results as follows:

			Quarter Ended March 31, 2023
(in millions, except per share data)			Earnings		Diluted
			Pre-tax	After-tax ^a	EPS
As reported (GAAP)			$ 475	$ 239	$ 0.13
Adjusted for specified items:
Intangible asset amortization			1,948	1,646	0.93
Intangible asset impairment			710	629	0.35
Acquisition and integration costs			61	55	0.03
Change in fair value of contingent consideration			1,872	1,822	1.02
Other			17	(6)	—
As adjusted (non-GAAP)			$ 5,083	$ 4,385	$ 2.46

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs primarily reflect integration costs related to the Allergan acquisition.

Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2023 included acquired IPR &D and milestones expense of $150 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.08 to both diluted EPS and adjusted diluted EPS.

2. The impact of the specified items by line item was as follows:

	Quarter Ended March 31, 2023
(in millions)	Cost of products sold	SG&A	R&D	Other operating income	Other expense (income), net
As reported (GAAP)	$ 3,986	$ 3,039	$ 2,292	$ (10)	$ 1,804
Adjusted for specified items:
Intangible asset amortization	(1,948)	—	—	—	—
Intangible asset impairment	(80)	—	(630)	—	—
Acquisition and integration costs	(15)	(44)	(2)	—	—
Change in fair value of contingent consideration	—	—	—	—	(1,872)
Other	(12)	(11)	(3)	10	(1)
As adjusted (non-GAAP)	$ 1,931	$ 2,984	$ 1,657	$ —	$ (69)


3. The adjusted tax rate for the first quarter of 2023 was 13.7 percent, as detailed below:

			Quarter Ended March 31, 2023
(dollars in millions)			Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)			$ 475	$ 234	49.3 %
Specified items			4,608	462	10.0 %
As adjusted (non-GAAP)			$ 5,083	$ 696	13.7 %

AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited)

1. Specified items impacted results as follows:

		Quarter Ended March 31, 2022
(in millions, except per share data)		Earnings		Diluted
		Pre-tax	After-tax ^a	EPS
As reported (GAAP)		$ 4,929	$ 4,490	$ 2.51
Adjusted for specified items:
Intangible asset amortization		1,855	1,565	0.88
Acquisition and integration costs		138	121	0.07
Change in fair value of contingent consideration		(748)	(746)	(0.42)
Litigation matters		184	148	0.08
Other		64	63	0.04
As adjusted (non-GAAP)		$ 6,422	$ 5,641	$ 3.16

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs reflect integration costs related to the Allergan acquisition. Other primarily includes restructuring charges associated with streamlining global operations.

Reported GAAP earnings and adjusted non-GAAP earnings for the first quarter of 2022 included acquired IPR&D and milestones expense of $145 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.08 to both diluted EPS and adjusted diluted EPS.

2. The impact of the specified items by line item was as follows:

	Quarter Ended March 31, 2022
(in millions)	Cost of products sold	SG&A	R&D	Other expense (income), net
As reported (GAAP)	$ 4,052	$ 3,127	$ 1,497	$ (776)
Adjusted for specified items:
Intangible asset amortization	(1,855)	—	—	—
Acquisition and integration costs	(34)	(93)	(11)	—
Change in fair value of contingent consideration	—	—	—	748
Litigation matters	—	(184)	—	—
Other	(60)	2	(6)	—
As adjusted (non-GAAP)	$ 2,103	$ 2,852	$ 1,480	$ (28)


3. The adjusted tax rate for the first quarter of 2022 was 12.1 percent, as detailed below:

		Quarter Ended March 31, 2022
(dollars in millions)		Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)		$ 4,929	$ 436	8.8 %
Specified items		1,493	342	22.9 %
As adjusted (non-GAAP)		$ 6,422	$ 778	12.1 %

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SOURCE AbbVie

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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 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

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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	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 %

AbbVie Reports First-Quarter 2023 Financial Results

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