AbbVie Reports Full-Year and Fourth-Quarter 2022 Financial Results

Reports Full-Year Diluted EPS of $6.63 on a GAAP Basis, an Increase of 2.8 Percent; Adjusted Diluted EPS of $13.77 , an Increase of 16.4 Percent; These Results Include an Unfavorable Impact of $0.39 Per Share related to 2022 Acquired IPR&D and Milestones Expense ¹

Delivers Full-Year Net Revenues of $58.054 Billion , an Increase of 3.3 Percent on a Reported Basis and 5.1 Percent on an Operational Basis

Full-Year Global Net Revenues from the Immunology Portfolio Were $28.924 Billion , an Increase of 14.4 Percent on a Reported Basis, or 16.0 Percent on an Operational Basis; Global Humira Net Revenues Were $21.237 billion ; Global Skyrizi Net Revenues Were $5.165 Billion ; Global Rinvoq Net Revenues Were $2.522 Billion

Full-Year Global Net Revenues from the Hematologic Oncology Portfolio Were $6.577 Billion , a Decrease of 9.0 Percent on a Reported Basis, or 7.6 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $4.568 Billion ; Global Venclexta Net Revenues Were $2.009 Billion

Full-Year Global Net Revenues from the Neuroscience Portfolio Were $6.528 Billion , an Increase of 10.1 Percent on a Reported Basis, or 11.6 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $2.719 Billion ; Global Vraylar Net Revenues Were $2.038 Billion

Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.333 Billion , an Increase of 1.9 Percent on a Reported Basis, or 5.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.615 Billion ; Global Juvederm Net Revenues Were $1.428 Billion

Reports Fourth-Quarter Diluted EPS of $1.38 on a GAAP Basis, a decrease of 38.9 Percent; Adjusted Diluted EPS of $3.60 , an increase of 16.9 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Fourth-Quarter 2022 Acquired IPR&D and Milestones Expense

Delivers Fourth-Quarter Net Revenues of $15.121 Billion , an Increase of 1.6 Percent on a Reported Basis and 3.8 Percent on an Operational Basis

Provides 2023 Adjusted Diluted EPS Guidance Range of $10.70 to $11.10 , which Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense

ABBVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2022 .

"2022 was another highly productive year capping a decade of outstanding performance. Since our inception, we have built a diverse portfolio of growth products with significant leadership positions, developed a robust pipeline of innovative assets and created a culture of strong execution," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Looking forward, we have a solid foundation which will allow us to absorb the U.S. Humira loss of exclusivity, return to strong top-line growth in 2025 and drive top-tier financial performance over the long term."

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

¹ Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures.

Fourth -Quarter Results

Worldwide net revenues were $15.121 billion , an increase of 1.6 percent on a reported basis, or 3.8 percent on an operational basis.

Global net revenues from the immunology portfolio were $7.925 billion , an increase of 17.5 percent on a reported basis, or 19.5 percent on an operational basis.

Global Humira net revenues of $5.579 billion increased 4.6 percent on a reported, or 6.0 percent on an operational basis. U.S. Humira net revenues were $5.006 billion , an increase of 9.9 percent. Internationally, Humira net revenues were $573 million , a decrease of 26.5 percent on a reported basis, or 16.9 percent on an operational basis.
Global Skyrizi net revenues were $1.576 billion , an increase of 76.1 percent on a reported basis, or 78.9 percent on an operational basis.
Global Rinvoq net revenues were $770 million , an increase of 49.0 percent on a reported basis, or 55.4 percent on an operational basis.

Global net revenues from the hematologic oncology portfolio were $1.631 billion , a decrease of 12.9 percent on a reported basis, or 11.2 percent on an operational basis.

Global Imbruvica net revenues were $1.115 billion , a decrease of 19.5 percent, with U.S. net revenues of $841 million and international profit sharing of $274 million .
Global Venclexta net revenues were $516 million , an increase of 5.7 percent on a reported basis, or 12.2 percent on an operational basis.

Global net revenues from the neuroscience portfolio were $1.710 billion , an increase of 3.4 percent on a reported basis, or 5.1 percent on an operational basis.

Global Botox Therapeutic net revenues were $728 million , an increase of 8.5 percent on a reported basis, or 10.7 percent on an operational basis.
Global Vraylar net revenues were $565 million , an increase of 15.5 percent.
Global Ubrelvy net revenues were $197 million , an increase of 7.7 percent.

Global net revenues from the aesthetics portfolio were $1.287 billion , a decrease of 8.5 percent on a reported basis, or 4.2 percent on an operational basis.

Global Botox Cosmetic net revenues were $642 million , an increase of 2.6 percent on a reported basis, or 7.1 percent on an operational basis.
Global Juvederm net revenues were $322 million , a decrease of 25.4 percent on a reported basis, or 19.0 percent on an operational basis.

On a GAAP basis, the gross margin ratio in the fourth quarter was 72.4 percent. The adjusted gross margin ratio was 86.0 percent.

On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 20.8 percent of net revenues.

On a GAAP basis, research and development (R&D) expense was 11.8 percent of net revenues. The adjusted R&D expense was 11.5 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

Acquired IPR&D and milestones expense was 1.6 percent of net revenues.

On a GAAP basis, the operating margin in the fourth quarter was 36.4 percent. The adjusted operating margin was 52.1 percent.

Net interest expense was $476 million .

On a GAAP basis, the tax rate in the quarter was 16.6 percent. The adjusted tax rate was 13.4 percent.

Diluted EPS in the fourth quarter was $1.38 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.60 . These results include an unfavorable impact of $0.13 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 Skyrizi (risankizumab, 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD) who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The approval is supported by results from three Phase 3 studies in which Skyrizi demonstrated significant improvement in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This approval marks the third indication for Skyrizi in the European Union (EU). Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

At the American College of Rheumatology's (ACR) annual meeting, AbbVie shared 36 abstracts that underscore AbbVie's commitment to advancing research to help more people living with rheumatic diseases. Analyses presented showcased data from the clinical trial programs evaluating Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AS) as well as data evaluating Skyrizi for the treatment of psoriasis (PsO) and PsA.

AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted, for priority review, the Biologics License Application (BLA) for epcoritamab, an investigational subcutaneous bispecific antibody for the treatment of adult patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Additionally, AbbVie announced the European Medicines Agency (EMA) validated AbbVie's Marketing Authorization Application (MAA) for epcoritamab for the treatment of adult patients with r/r diffuse LBCL. Both applications are supported by data from the EPCORE NHL-1 Phase 2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL). Epcoritamab is being co-developed by Genmab and AbbVie.

At the American Society of Hematology (ASH) Annual Meeting, AbbVie presented results from nearly 65 abstracts, including 15 oral presentations, across eight types of cancer. Highlights included four oral presentations evaluating investigational epcoritamab for the treatment of r/r follicular lymphoma (FL), previously untreated FL, r/r diffuse LBCL as well as Richter's syndrome; data from cohort three of the Phase 2 REFINE study evaluating navitoclax in combination with ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (MF); data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating fixed-duration treatment in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) who received the Imbruvica (ibrutinib) + Venclexta (venetoclax) combination regimen. AbbVie also presented multiple abstracts evaluating Venclexta in approved CLL and acute myeloid leukemia (AML) indications and the investigational multiple myeloma (MM) indication. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

AbbVie announced that the FDA approved Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval marks the fourth indication for Vraylar, which is now the first and only dopamine and serotonin partial agonist FDA-approved for the most common forms of depression – as an adjunctive treatment for MDD and the treatment of depressive episodes associated with bipolar I disorder. The approval is supported by clinical data demonstrating the efficacy and well-established tolerability of Vraylar as an adjunctive treatment for MDD with an antidepressant therapy. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc.

At the European Headache Federation Congress (EHC) 2022, AbbVie shared 15 abstracts which underscore its commitment to people living with migraine. Presentations highlighted late-breaking data from the Chronic Migraine Epidemiology and Outcomes - International (CaMEO-I) study, evaluating the frequency and burden of neck pain with headache among people with and without migraine, as well as results from the Phase 3 PROGRESS trial evaluating Qulipta (atogepant) for the preventive treatment of chronic migraine (CM) in patients living in Europe .

AbbVie announced new results from its exploratory NOVA phase 2 dose-ranging study evaluating the efficacy and safety of AGN-151607, a novel investigational neurotoxin for the prevention of postoperative atrial fibrillation (POAF) in cardiac surgery patients, at the American Heart Association Scientific Sessions meeting. The study's primary endpoint was not met for the modified intent-to-treat (mITT) population; however, the data showed relative risk reduction in specific study populations such as coronary artery bypass graft (CABG) patients and patients aged 65 years and older, as well as overall lower rates of rehospitalization within 30 days compared to placebo. Adverse Events (AEs) were numerically similar across all treatment groups.

AbbVie and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, announced an exclusive worldwide collaboration and option to license agreement for HotSpot's discovery-stage interferon regulatory factor 5 (IRF5) inhibitor program for the potential treatment of autoimmune diseases.

AbbVie and Immunome, a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's Discovery Engine.

AbbVie and Anima Biotech, announced a collaboration to discover and develop mRNA biology modulators for three targets across Immunology and Oncology. Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs.

Full-Year 2023 Outlook

AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2023 of $10.70 to $11.10 . The company's 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 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 fourth-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 2022 and 2021 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. Beginning in the first quarter of 2022, the company includes the impact of upfront and milestone payments related to collaborations, licensing agreements, and other asset acquisitions in its reported non-GAAP financial measures. Prior periods have been revised to conform to the current period presentation. 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 2021 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 December 31, 2022 (Unaudited)

				% Change vs. 4Q21
	Net Revenues (in millions)			Reported			Operational ^a
	U.S.	Int'l.	Total	U.S.	Int'l.	Total	Int'l.	Total
NET REVENUES	$ 12,192	$ 2,929	$ 15,121	4.4 %	(8.7) %	1.6 %	1.8 %	3.8 %

Immunology	6,975	950	7,925	22.5	(9.5)	17.5	3.2	19.5
Humira	5,006	573	5,579	9.9	(26.5)	4.6	(16.9)	6.0
Skyrizi	1,403	173	1,576	84.3	29.1	76.1	47.9	78.9
Rinvoq	566	204	770	48.6	50.1	49.0	74.5	55.4

Hematologic Oncology	1,110	521	1,631	(18.7)	2.6	(12.9)	8.8	(11.2)
Imbruvica ^b	841	274	1,115	(24.6)	1.6	(19.5)	1.6	(19.5)
Venclexta	269	247	516	7.7	3.7	5.7	17.0	12.2

Aesthetics	835	452	1,287	(4.7)	(14.8)	(8.5)	(3.4)	(4.2)
Botox Cosmetic	422	220	642	6.4	(4.0)	2.6	8.3	7.1
Juvederm Collection	128	194	322	(28.3)	(23.3)	(25.4)	(12.4)	(19.0)
Other Aesthetics	285	38	323	(5.3)	(21.4)	(7.6)	(11.7)	(6.2)

Neuroscience	1,506	204	1,710	4.7	(5.7)	3.4	7.2	5.1
Botox Therapeutic	614	114	728	9.6	2.8	8.5	16.2	10.7
Vraylar	564	1	565	15.4	n/m	15.5	n/m	15.5
Duodopa	23	84	107	(18.3)	(15.8)	(16.3)	(3.2)	(6.5)
Ubrelvy	197	—	197	7.5	n/m	7.7	n/m	7.7
Qulipta	52	—	52	>100.0	n/m	>100.0	n/m	>100.0
Other Neuroscience	56	5	61	(66.2)	(8.8)	(64.5)	(1.1)	(64.3)

Eye Care	338	252	590	(49.7)	(12.4)	(38.5)	(1.3)	(35.2)
Lumigan/Ganfort	56	67	123	(22.1)	(13.0)	(17.4)	(3.3)	(12.4)
Alphagan/Combigan	41	33	74	(59.4)	(16.2)	(47.4)	(4.5)	(44.1)
Restasis	103	7	110	(70.5)	(49.0)	(69.6)	(45.0)	(69.4)
Other Eye Care	138	145	283	(7.7)	(7.8)	(7.7)	4.5	(1.4)

Other Key Products	791	195	986	(1.5)	(18.4)	(5.4)	(6.2)	(2.6)
Mavyret	193	187	380	(1.8)	(18.8)	(11.0)	(6.5)	(4.4)
Creon	337	—	337	3.0	n/m	3.0	n/m	3.0
Linzess/Constella	261	8	269	(6.5)	(7.5)	(6.6)	2.2	(6.3)


^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. Key Product Revenues Twelve Months Ended December 31, 2022 (Unaudited)

				% Change vs. 12M21
	Net Revenues (in millions)			Reported			Operational ^a
	U.S.	Int'l.	Total	U.S.	Int'l.	Total		Int'l.	Total
NET REVENUES	$ 45,713	$ 12,341	$ 58,054	5.1 %	(2.7) %	3.3 %		5.5 %	5.1 %

Immunology	24,897	4,027	28,924	18.1	(4.0)	14.4		5.7	16.0
Humira	18,619	2,618	21,237	7.4	(22.2)	2.6		(14.9)	3.8
Skyrizi	4,484	681	5,165	80.4	50.4	75.7		67.1	78.3
Rinvoq	1,794	728	2,522	41.2	91.4	52.8		>100.0	58.1

Hematologic Oncology	4,435	2,142	6,577	(15.6)	8.6	(9.0)		13.9	(7.6)
Imbruvica ^b	3,426	1,142	4,568	(20.7)	5.1	(15.5)		5.1	(15.5)
Venclexta	1,009	1,000	2,009	8.0	12.9	10.4		24.6	16.1

Aesthetics	3,324	2,009	5,333	(0.8)	6.7	1.9		15.6	5.1
Botox Cosmetic	1,654	961	2,615	16.2	18.9	17.2		28.8	20.8
Juvederm Collection	548	880	1,428	(16.7)	0.3	(7.0)		8.9	(2.1)
Other Aesthetics	1,122	168	1,290	(11.5)	(14.9)	(12.0)		(8.3)	(11.1)

Neuroscience	5,681	847	6,528	12.3	(2.3)	10.1		7.7	11.6
Botox Therapeutic	2,255	464	2,719	12.1	5.6	10.9		15.3	12.6
Vraylar	2,037	1	2,038	17.9	n/m	17.9		n/m	17.9
Duodopa	95	363	458	(6.7)	(11.3)	(10.4)		(0.8)	(2.0)
Ubrelvy	680	—	680	23.2	n/m	23.3		n/m	23.3
Qulipta	158	—	158	>100.0	n/m	>100.0		n/m	>100.0
Other Neuroscience	456	19	475	(30.5)	4.8	(29.6)		9.0	(29.5)

Eye Care	1,603	1,098	2,701	(33.3)	(5.7)	(24.3)		3.7	(21.2)
Lumigan/Ganfort	242	272	514	(11.0)	(11.3)	(11.2)		(3.0)	(6.8)
Alphagan/Combigan	202	144	346	(45.8)	(7.9)	(34.6)		2.5	(31.5)
Restasis	621	45	666	(49.6)	(20.2)	(48.3)		(13.8)	(48.0)
Other Eye Care	538	637	1,175	2.3	(1.2)	0.4		8.7	5.9

Other Key Products	3,036	818	3,854	2.9	(17.2)	(2.2)		(7.9)	0.1
Mavyret	755	786	1,541	0.2	(17.8)	(9.9)		(8.5)	(4.7)
Creon	1,278	—	1,278	7.3	n/m	7.3		n/m	7.3
Linzess/Constella	1,003	32	1,035	(0.4)	0.3	(0.3)		7.6	(0.1)


^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)	Fourth Quarter Ended December 31		Twelve Months Ended December 31
	2022	2021	2022	2021
Net revenues	$ 15,121	$ 14,886	$ 58,054	$ 56,197
Cost of products sold	4,170	4,320	17,414	17,446
Selling, general and administrative	3,417	3,260	15,260	12,349
Research and development ^a	1,790	1,827	6,510	6,922
Acquired IPR&D and milestones ^a	243	405	697	1,124
Other operating (income) expense, net	(1)	—	56	432
Total operating costs and expenses	9,619	9,812	39,937	38,273

Operating earnings	5,502	5,074	18,117	17,924

Interest expense, net	476	571	2,044	2,384
Net foreign exchange loss	40	16	148	51
Other expense, net	2,021	216	2,448	2,500
Earnings before income tax expense	2,965	4,271	13,477	12,989
Income tax expense	493	226	1,632	1,440
Net earnings	2,472	4,045	11,845	11,549
Net earnings (loss) attributable to noncontrolling interest	(1)	1	9	7
Net earnings attributable to AbbVie Inc.	$ 2,473	$ 4,044	$ 11,836	$ 11,542

Diluted earnings per share attributable to AbbVie Inc.	$ 1.38	$ 2.26	$ 6.63	$ 6.45

Adjusted diluted earnings per share ^b	$ 3.60	$ 3.08	$ 13.77	$ 11.83

Weighted-average diluted shares outstanding	1,778	1,778	1,778	1,777


^a	During the three months ended March 31, 2022, AbbVie changed its classification of development milestone expense associated with licensing and collaboration arrangements in the consolidated statement of earnings. Milestone payments incurred prior to regulatory approval, which were previously included in research and development expense, are now presented as acquired IPR&D and milestones expense. The reclassification decreased research and development expense and increased acquired IPR&D and milestones expense by $162 million for the twelve months ended December 31, 2021 and had no impact on the three months ended December 31, 2021. The company believes this presentation assists users of the financial statements to better understand the total upfront and subsequent development milestone payments incurred to acquire in-process research and development projects. Prior periods have been revised to conform to the current period presentation. The reclassification had no impact on total operating costs and expenses, operating earnings, net earnings, net earnings attributable to AbbVie, Inc., earnings per share, or total equity.

^b	Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Weighted-average diluted shares outstanding includes the effect of dilutive securities.

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

1. Specified items impacted results as follows:

			Quarter Ended December 31, 2022
(in millions, except per share data)			Earnings		Diluted
			Pre-tax	After-tax ^a	EPS
As reported (GAAP)			$ 2,965	$ 2,473	$ 1.38
Adjusted for specified items:
Intangible asset amortization			1,961	1,636	0.92
Acquisition and integration costs			215	199	0.11
Change in fair value of contingent consideration			2,114	2,113	1.19
Income tax items			—	(143)	(0.08)
Other			157	144	0.08
As adjusted (non-GAAP)			$ 7,412	$ 6,422	$ 3.60

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs primarily include costs related to the Allergan acquisition. Income tax items include a benefit of $323 million related to tax law changes partially offset by certain other tax related items. Other primarily includes restructuring charges associated with streamlining global operations.

Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended December 31, 2022 included acquired IPR&D and milestones expense of $243 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.13 to both diluted EPS and adjusted diluted EPS.

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

	Quarter Ended December 31, 2022
(in millions)	Cost of products sold	SG&A	R&D	Other operating income, net	Other expense, net
As reported (GAAP)	$ 4,170	$ 3,417	$ 1,790	$ (1)	$ 2,021
Adjusted for specified items:
Intangible asset amortization	(1,961)	—	—	—	—
Acquisition and integration costs	1	(205)	(11)	—	—
Change in fair value of contingent consideration	—	—	—	—	(2,114)
Other	(99)	(62)	(38)	1	41
As adjusted (non-GAAP)	$ 2,111	$ 3,150	$ 1,741	$ —	$ (52)


3. The adjusted tax rate for the fourth quarter of 2022 was 13.4 percent, as detailed below:

			Quarter Ended December 31, 2022
(dollars in millions)			Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)			$ 2,965	$ 493	16.6 %
Specified items			4,447	498	11.2 %
As adjusted (non-GAAP)			$ 7,412	$ 991	13.4 %

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

1. Specified items impacted results as follows:

		Quarter Ended December 31, 2021
(in millions, except per share data)		Earnings		Diluted
		Pre-tax	After-tax ^a	EPS
As reported (GAAP)		$ 4,271	$ 4,044	$ 2.26
Adjusted for specified items:
Intangible asset amortization		1,806	1,490	0.84
Acquisition and integration costs		(191)	(212)	(0.12)
Change in fair value of contingent consideration		232	232	0.13
Litigation matters		200	167	0.09
Impacts related to tax law changes		—	(265)	(0.15)
Other		41	58	0.03
As adjusted (non-GAAP)		$ 6,359	$ 5,514	$ 3.08

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs reflect a recovery of certain Allergan acquisition-related regulatory fees partially offset by Allergan-related integration costs and Soliton acquisition costs. Other primarily includes COVID-19 related expenses and certain tax related items.

Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reportednon-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended December 31, 2021 included acquired IPR&D and milestones expense of $405 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.23 to both diluted EPS and adjusted diluted EPS.

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

	Quarter Ended December 31, 2021
(in millions)	Cost of products sold	SG&A	R&D	Other expense, net
As reported (GAAP)	$ 4,320	$ 3,260	$ 1,827	$ 216
Adjusted for specified items:
Intangible asset amortization	(1,806)	—	—	—
Acquisition and integration costs	(43)	250	(16)	—
Change in fair value of contingent consideration	—	—	—	(232)
Litigation matters	—	(200)	—	—
Other	(23)	(3)	(13)	(2)
As adjusted (non-GAAP)	$ 2,448	$ 3,307	$ 1,798	$ (18)


3. The adjusted tax rate for the fourth quarter of 2021 was 13.3 percent, as detailed below:

		Quarter Ended December 31, 2021
(dollars in millions)		Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)		$ 4,271	$ 226	5.3 %
Specified items		2,088	618	29.6 %
As adjusted (non-GAAP)		$ 6,359	$ 844	13.3 %

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

1. Specified items impacted results as follows:

			Twelve Months Ended December 31, 2022
(in millions, except per share data)			Earnings		Diluted
			Pre-tax	After-tax ^a	EPS
As reported (GAAP)			$ 13,477	$ 11,836	$ 6.63
Adjusted for specified items:
Intangible asset amortization			7,689	6,430	3.61
Intangible asset impairment			770	604	0.34
Acquisition and integration costs			810	766	0.43
Change in fair value of contingent consideration			2,761	2,770	1.55
Pylera divestiture			(172)	(126)	(0.07)
Litigation matters			2,506	2,028	1.13
Income tax items			—	(26)	(0.02)
Other			429	315	0.17
As adjusted (non-GAAP)			$ 28,270	$ 24,597	$ 13.77

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs primarily include costs related to the Allergan acquisition. Litigation matters primarily include a charge related to a potential settlement of litigation involving Allergan's past sales of opioid products. Income tax items include a benefit of $323 million related to tax law changes partially offset by certain other tax related items. Other primarily includes restructuring charges associated with streamlining global operations.

Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the twelve months ended December 31, 2022 included acquired IPR&D and milestones expense of $697 million on a pre-tax and $682 million on an after-tax basis, representing an unfavorable impact of $0.39 to both diluted EPS and adjusted diluted EPS.

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

	Twelve Months Ended December 31, 2022
(in millions)	Cost of products sold	SG&A	R&D	Other operating expense, net	Other expense, net
As reported (GAAP)	$ 17,414	$ 15,260	$ 6,510	$ 56	$ 2,448
Adjusted for specified items:
Intangible asset amortization	(7,689)	—	—	—	—
Intangible asset impairment	(770)	—	—	—	—
Acquisition and integration costs	(83)	(468)	(30)	(229)	—
Change in fair value of contingent consideration	—	—	—	—	(2,761)
Pylera divestiture	—	—	—	172	—
Litigation matters	—	(2,506)	—	—	—
Other	(259)	(160)	(45)	1	34
As adjusted (non-GAAP)	$ 8,613	$ 12,126	$ 6,435	$ —	$ (279)


3. The adjusted tax rate for the full-year 2022 was 13.0 percent, as detailed below:

			Twelve Months Ended December 31, 2022
(dollars in millions)			Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)			$ 13,477	$ 1,632	12.1 %
Specified items			14,793	2,032	13.7 %
As adjusted (non-GAAP)			$ 28,270	$ 3,664	13.0 %

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

1. Specified items impacted results as follows:

			Twelve Months Ended December 31, 2021
(in millions, except per share data)			Earnings		Diluted
			Pre-tax	After-tax ^a	EPS
As reported (GAAP)			$ 12,989	$ 11,542	$ 6.45
Adjusted for specified items:
Intangible asset amortization			7,718	6,419	3.60
Acquisition and integration costs			344	215	0.12
Change in fair value of contingent consideration			2,679	2,677	1.50
Litigation matters			307	253	0.14
Impacts related to tax law changes			—	(265)	(0.15)
Other			360	313	0.17
As adjusted (non-GAAP)			$ 24,397	$ 21,154	$ 11.83

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs reflect Allergan integration costs, Soliton acquisition costs as well as amortization of the acquisition date fair value step-up for inventory related to the Allergan acquisition partially offset by a recovery of certain Allergan acquisition-related regulatory fees. Other primarily includes the purchase of FDA priority review vouchers from third parties, COVID-19 related expenses, restructuring charges associated with streamlining global operations and certain tax related items.

Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the twelve months ended December 31, 2021 included acquired IPR&D and milestones expense of $1.1 billion on a pre-tax and after-tax basis, as well as other operating expense related to the Calico collaboration of $500 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.90 to both diluted EPS and adjusted diluted EPS.

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

	Twelve Months Ended December 31, 2021
(in millions)	Cost of products sold	SG&A	R&D	Other operating expense, net	Other expense, net
As reported (GAAP)	$ 17,446	$ 12,349	$ 6,922	$ 432	$ 2,500
Adjusted for specified items:
Intangible asset amortization	(7,718)	—	—	—	—
Acquisition and integration costs	(215)	(25)	(104)	—	—
Change in fair value of contingent consideration	—	—	—	—	(2,679)
Litigation matters	—	(307)	—	—	—
Other	(88)	(53)	(300)	68	13
As adjusted (non-GAAP)	$ 9,425	$ 11,964	$ 6,518	$ 500	$ (166)


3. The adjusted tax rate for the full-year 2021 was 13.3 percent, as detailed below:

			Twelve Months Ended December 31, 2021
(dollars in millions)			Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)			$ 12,989	$ 1,440	11.1 %
Specified items			11,408	1,796	15.8 %
As adjusted (non-GAAP)			$ 24,397	$ 3,236	13.3 %

View original content: https://www.prnewswire.com/news-releases/abbvie-reports-full-year-and-fourth-quarter-2022-financial-results-301742639.html

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.

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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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Cardiex Announces Publication of Breakthrough Study Validating Noninvasive Fingertip Photoplethysmography for Central Aortic Pressure Waveform Analysis

- Cardiex Limited (ASX: CDX), a global health technology company focused on cardiovascular diagnostics and arterial health solutions, today announced the publication of a peer-reviewed study validating its innovative method for measuring central aortic pressure—an important indicator of heart health—using a noninvasive fingertip sensor. The study, co-authored by Cardiex's team, was published in the respected journal Pulse.

The study, titled "Validation of Noninvasive Derivation of the Central Aortic Pressure Waveform from Fingertip Photoplethysmography Using a Novel Selective Transfer Function Method," demonstrates that Cardiex's technology can accurately capture key cardiovascular data from a simple fingertip sensor. The method leverages photoplethysmography (PPG)—an optical technique widely used in wearables such as fitness trackers and smartwatches—offering a powerful and accessible tool for advanced heart health monitoring.

Key findings include:

Strong correlation between fingertip sensor measurements and traditional methods, with heart health indicators showing excellent alignment.
The fingertip sensor offers a user-friendly, noninvasive way to measure central aortic pressure parameters without calibration, making heart health monitoring more accessible and comfortable.
Twenty clinically relevant parameters were captured from the converted PPG waveforms, including central systolic blood pressure, central diastolic blood pressure, central pulse pressure, central augmentation pressure, central augmentation index, subendocardial viability, and pulse pressure amplification, amongst others.

Relevance in the Wearable Health Market:

The use of PPG technology in this study is especially significant as the wearable market continues to expand, with consumers seeking more advanced health insights without the need for frequent calibration. Cardiex's innovation aligns with this trend offering consumers the ability to track clinical grade biomarkers in real-time. These biomarkers have applications in various healthcare fields, including cognitive, renal, maternal, metabolic health, and heart failure management. The technology's ease of use and capacity for continuous monitoring place Cardiex at the forefront of the growing wearable health sector, which increasingly prioritizes deeper and more accurate health data.

"This study is a significant validation of Cardiex's technology and its ability to deliver critical heart health insights in a simpler, more convenient way," said Craig Cooper , CEO of Cardiex. "Our PPG-based fingertip technology has the potential to transform heart health monitoring, offering a more accessible option for both patients and healthcare providers. This breakthrough also opens up exciting opportunities for integration into the wearable health tech market, where continuous and noninvasive monitoring is becoming the gold standard."

The study confirms that Cardiex's PPG-based solution can provide valuable cardiovascular data in a comfortable, portable format, paving the way for broader adoption in both medical and consumer-grade wearables.

The full study is now available online in the journal Pulse DOI: 10.1159/000540666.

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SOURCE Cardiex Limited

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TEPEZZA® RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF ACTIVE THYROID EYE DISEASE

Amgen (NASDAQ:AMGN) today announced TEPEZZA ® (JAN: Teprotumumab (Genetical Recombination)) has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare (MHLW).

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling. ¹ There are approximately 25,000 - 35,000 people living with TED in Japan , inclusive of both active and chronic (low CAS) TED. ² TEPEZZA is now the first and only medicine approved in Japan to treat active TED. A separate trial to study the efficacy of TEPEZZA in chronic TED patients in Japan is currently ongoing.

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AMGEN TO HOST CONFERENCE CALL TO DISCUSS NEW TOPLINE DATA IN INFLAMMATION AND RARE DISEASE

Amgen (NASDAQ:AMGN) will host a webcasted call for the investment community at 1:30 p.m. PT on Tuesday, Sept. 24, 2024 to discuss new topline clinical data from the rocatinlimab (AMG 451KHK4083) and UPLIZNA ® (inebilizumab-cdon) Phase 3 programs. Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, and other members of the Amgen team will participate. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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

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Cardiol Therapeutics Announces Completion of the MAvERIC Phase II Study in Recurrent Pericarditis with Results to be Presented at the American Heart Association Scientific Sessions 2024

Full clinical data will be reported in an oral presentation at the premier global event for advancements in cardiovascular science and medicine on November 18, 2024

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced the data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis will be reported in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture that runs from 9:45 a.m. to 11:00 a.m. Central Time, on Monday, November 18th, 2024, at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, Co-Director, Pericardial Diseases Clinic and Associate Professor of Medicine, Department of Cardiovascular Medicine at the Mayo Clinic, will present on behalf of the MAvERIC-Pilot investigators.

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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

PRODUCT NAME	TEPEZZA ^® for Intravenous Infusion 500 mg
Generic Name (JAN)	Teprotumumab (Genetical Recombination)
Indication	Active thyroid eye disease
Precautions related to indications	Hearing disorders (e.g., deafness, hypoacusis, Eustachian tube dysfunction, patulous Eustachian tube, hyperacusis, tinnitus, and tympanic membrane disorder) may occur during treatment with TEPEZZA, and serious and irreversible events have also been reported. Patients eligible for TEPEZZA therapy should be selected based on a thorough understanding of the information provided in "17. Clinical Results," the backgrounds of the patients in the clinical studies, and the results of the studies of the efficacy and safety of TEPEZZA. Clinical studies of the efficacy and safety in patients with mild active thyroid eye disease have not been conducted.
Dose and Administration	The usual adult dosage is 10 mg/kg as teprotumumab (genetical recombination) for the first dose and 20 mg/kg for the second and subsequent doses, administered intravenously every 3 weeks, for a total of 8 infusions.

AbbVie Reports Full-Year and Fourth-Quarter 2022 Financial Results

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