AbbVie Reports Third-Quarter 2022 Financial Results

Reports Third-Quarter Diluted EPS of $2.21 on a GAAP Basis, an Increase of 24.2 Percent; Adjusted Diluted EPS of $3.66 , an Increase of 29.3 Percent; These Results Include an Unfavorable Impact of $0.02 Per Share related to Acquired IPR&D and Milestones Expense ¹

Delivers Third-Quarter Net Revenues of $14.812 Billion , an Increase of 3.3 Percent on a Reported Basis and 5.4 Percent Operationally

Third -Quarter Global Net Revenues from the Immunology Portfolio Were $7.651 Billion , an Increase of 14.6 Percent on a Reported Basis, or 16.4 Percent on an Operational Basis; U.S. Humira Net Revenues Were $4.956 Billion , an Increase of 7.4 Percent; Internationally, Humira Net Revenues Were $603 Million , a Decrease of 25.9 Percent on a Reported Basis, or 16.8 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.397 Billion ; Global Rinvoq Net Revenues Were $695 Million

Third -Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.650 Billion , a Decrease of 11.7 Percent on a Reported Basis, or 9.9 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $1.135 Billion , a Decrease of 17.4 Percent , with U.S. Net Revenues of $849 Million and International Profit Sharing of $286 Million ; Global Venclexta Net Revenues Were $515 Million

Third -Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.672 Billion , an Increase of 6.7 Percent on a Reported Basis, or 8.3 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $699 Million ; Vraylar Net Revenues Were $554 Million

Third -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.301 Billion , an Increase of 4.0 Percent on a Reported Basis, or 8.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $637 Million ; Global Juvederm Net Revenues Were $352 Million

Confirms Midpoint of 2022 Adjusted Diluted EPS Guidance Range and Narrows Range from $13.76 - $13.96 to $13.84 - $13.88 , which Includes an Unfavorable Impact of $0.25 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Third Quarter 2022

Announces 2023 Dividend Increase of 5.0 Percent, Beginning with Dividend Payable in February 2023

ABBVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2022 .

"We continue to see strong momentum from our key immunology assets, Skyrizi and Rinvoq, and this performance – combined with strength from other growth drivers within our diverse portfolio – has mitigated the impact of temporary economic headwinds on our aesthetics products to deliver another quarter of strong results," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Based upon our performance and confidence in AbbVie's long-term outlook, we are once again meaningfully raising our dividend."

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.

Third -Quarter Results

Worldwide net revenues were $14.812 billion , an increase of 3.3 percent on a GAAP basis, or 5.4 percent on an operational basis.
Global net revenues from the immunology portfolio were $7.651 billion , an increase of 14.6 percent on a reported basis, or 16.4 percent on an operational basis.

Global Humira net revenues of $5.559 billion increased 2.5 percent on a reported basis, or 3.9 percent on an operational basis. U.S. Humira net revenues were $4.956 billion , an increase of 7.4 percent. Internationally, Humira net revenues were $603 million , a decrease of 25.9 percent on a reported basis, or 16.8 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $1.397 billion , an increase of 75.4 percent on a reported basis, or 78.3 percent on an operational basis.
Global Rinvoq net revenues were $695 million , an increase of 53.5 percent on a reported basis, or 59.3 percent on an operational basis.

Global net revenues from the hematologic oncology portfolio were $1.650 billion , a decrease of 11.7 percent on a reported basis, or 9.9 percent on an operational basis.

Global Imbruvica net revenues were $1.135 billion , a decrease of 17.4 percent, with U.S. net revenues of $849 million and international profit sharing of $286 million .
Global Venclexta net revenues were $515 million , an increase of 4.5 percent on a reported basis, or 11.3 percent on an operational basis.

Global net revenues from the neuroscience portfolio were $1.672 billion , an increase of 6.7 percent on a reported basis, or 8.3 percent on an operational basis.

Global Botox Therapeutic net revenues were $699 million , an increase of 8.2 percent on a reported basis, or 10.0 percent on an operational basis.
Vraylar net revenues were $554 million , an increase of 20.2 percent.
Global Ubrelvy net revenues were $160 million .

Global net revenues from the aesthetics portfolio were $1.301 billion , an increase of 4.0 percent on a reported basis, or 8.1 percent on an operational basis.

Global Botox Cosmetic net revenues were $637 million , an increase of 16.9 percent on a reported basis, or 21.6 percent on an operational basis.
Global Juvederm net revenues were $352 million , a decrease of 0.6 percent on a reported basis, or an increase of 5.3 percent on an operational basis.

On a GAAP basis, the gross margin ratio in the third quarter was 66.1 percent. The adjusted gross margin ratio was 85.4 percent.

On a GAAP basis, selling, general and administrative (SG&A) expense was 22.3 percent of net revenues. The adjusted SG&A expense was 20.9 percent of net revenues.

On a GAAP basis, research and development (R&D) expense was 10.9 percent of net revenues. The adjusted R&D expense was 10.8 percent of net revenues.

Acquired IPR&D and milestones expense was 0.3 percent of net revenues.

On a GAAP basis, the operating margin in the third quarter was 31.1 percent. The adjusted operating margin was 53.4 percent.

Net interest expense was $497 million .

On a GAAP basis, the tax rate in the quarter was 10.2 percent. The adjusted tax rate was 12.9 percent.

Diluted EPS in the third quarter was $2.21 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.66 . These results include an unfavorable impact of $0.02 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 U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. The approval is supported by data from the SELECT-AXIS 2 clinical trial, in which Rinvoq delivered rapid and meaningful disease control as well as significant improvement in signs and symptoms of nr-axSpA. This approval marks the sixth FDA approved indication for Rinvoq in chronic immune-mediated diseases.

AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Skyrizi (risankizumab) 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 positive opinion is based on results from three Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. If the CHMP recommendation is accepted by the European Commission (EC), this would mark the third indication for Skyrizi in the European Union. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

At the United European Gastroenterology (UEG) Week 2022, AbbVie shared 17 abstracts, including seven oral presentations, from a broad range of studies in inflammatory bowel disease (IBD). Highlights included final analyses from the U-ACHIEVE Phase 3 maintenance study of Rinvoq in moderately to severely active ulcerative colitis (UC), data from the U-EXCEL Phase 3 study evaluating the efficacy and safety of Rinvoq as induction therapy for use in adults with moderately to severely active CD as well as data evaluating Skyrizi for use in patients with moderate to severe CD.

At the American College of Gastroenterology (ACG) Annual Scientific Meeting, AbbVie presented 26 abstracts that illustrate AbbVie's commitment to providing research and innovative solutions that support patients with high disease burden and unmet need. Key presentations focused on the treatment of moderate to severe CD, including late-breaking Phase 3 data from the Rinvoq 52 week maintenance trial, as well as efficacy and safety outcomes from the Skyrizi pivotal clinical program.

At the European Academy of Dermatology and Venereology (EADV) Congress, AbbVie presented 23 abstracts from across its dermatology portfolio that underscore AbbVie's commitment to advancing research in dermatology for people living with immune-mediated skin diseases such as psoriasis (PsO), psoriatic arthritis (PsA), atopic dermatitis (AD) and vitiligo. Presentations included long-term efficacy and safety results, including real-world data, from studies of Skyrizi in moderate to severe PsO and active PsA as well as data from the largest-of-its-kind study that demonstrate the real-world burden of AD.

AbbVie announced that the FDA approved the use of Imbruvica (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. The approval marks the first approved treatment option for children with cGVHD under 12 years of age and the only Bruton's tyrosine kinase inhibitor (BTKi) treatment for a pediatric patient population. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.

At the International Parkinson and Movement Disorder Society's (MDS) International Congress, ABBVie presented 13 abstracts across multiple disease states that highlighted ABBVie's continued commitment to advancing the management of movement disorders. Highlights included results from the Phase 3 M15-736 trial evaluating the continuous subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) in people with advanced Parkinson's disease (PD) as well as data on the real-world efficacy of Botox (onabotulinumtoxinA) for the treatment of spasticity and treatment of cervical dystonia.

At the Migraine Trust International Symposium (MTIS), AbbVie shared 13 abstracts, including 4 oral presentations, from a wide range of studies across its migraine portfolio that underscore AbbVie's leadership and commitment to people living with migraine. Highlights included Phase 3 PROGRESS study results evaluating Qulipta (atogepant) for the preventive treatment of chronic migraine as well as data from studies evaluating Botox and Ubrelvy (ubrogepant) in the treatment of migraine.

Allergan Aesthetics announced that the FDA approved Juvederm Volux XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. Juvederm Volux XC is the first and only hyaluronic acid (HA) filler to receive FDA approval for jawline definition.

At the American Society for Dermatologic Surgery (ASDS), Allergan Aesthetics shared data from across its facial injectables, body contouring and skincare portfolio that highlighted Allergan Aesthetics' continued commitment to advancing aesthetic medicine. Highlights included analyses of 15 years of post-marketing surveillance data that demonstrated the global reported rate of delayed-onset nodules associated with dermal fillers on the Vycross technology platform is low, as well as results from three clinical studies showcasing a customizable platform with patent-pending LTN Complex, to address the appearance of facial hyperpigmentation.

AbbVie announced the acquisition of DJS Antibodies (DJS), a biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins. The acquisition includes DJS' lead program DJS-002, a potential first-in-class LPAR1 antagonist antibody in preclinical studies for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases as well as the company's proprietary HEPTAD platform.

Full-Year 2022 Outlook

AbbVie is confirming the midpoint of its full-year 2022 adjusted diluted EPS guidance range and narrowing the range from $13.76 - $13.96 to $13.84 - $13.88 , which includes an unfavorable impact of $0.25 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2022. The company's 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2022, as both cannot be reliably forecasted.

Company Declares Dividend Increase of 5.0 Percent

AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.41 per share to $1.48 per share beginning with the dividend payable on February 15, 2023 to shareholders of record as of January 13, 2023 . This reflects an increase of approximately 5.0 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by 270 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

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 third-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, 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, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to promptly and effectively integrate Allergan's business, 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 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 September 30, 2022 (Unaudited)
				% Change vs. 3Q21
	Net Revenues (in millions)			Reported			Operational ^a
	U.S.	Int'l.	Total	U.S.	Int'l.	Total	Int'l.	Total
NET REVENUES	$11,763	$3,049	$14,812	4.3 %	(0.4) %	3.3 %	9.6 %	5.4 %

Immunology	6,682	969	7,651	18.5	(6.3)	14.6	5.6	16.4
Humira	4,956	603	5,559	7.4	(25.9)	2.5	(16.8)	3.9
Skyrizi	1,221	176	1,397	79.8	50.1	75.4	70.0	78.3
Rinvoq	505	190	695	44.7	82.9	53.5	>100.0	59.3

Hematologic Oncology	1,108	542	1,650	(17.7)	3.9	(11.7)	10.3	(9.9)
Imbruvica ^b	849	286	1,135	(23.5)	7.6	(17.4)	7.6	(17.4)
Venclexta	259	256	515	9.2	0.1	4.5	13.2	11.3

Aesthetics	760	541	1,301	(7.4)	25.6	4.0	37.4	8.1
Botox Cosmetic	370	267	637	4.1	41.0	16.9	54.5	21.6
Juvederm Collection	125	227	352	(21.9)	16.9	(0.6)	27.7	5.3
Other Aesthetics	265	47	312	(13.1)	(0.8)	(11.4)	8.3	(10.2)

Neuroscience	1,464	208	1,672	8.6	(5.0)	6.7	6.3	8.3
Botox Therapeutic	584	115	699	9.2	3.6	8.2	14.2	10.0
Vraylar	554	—	554	20.1	n/a	20.2	n/a	20.2
Duodopa	22	88	110	(4.9)	(15.0)	(13.1)	(2.6)	(3.0)
Ubrelvy	160	—	160	(1.4)	n/a	(1.4)	n/a	(1.4)
Qulipta	62	—	62	n/m	n/a	n/m	n/a	n/m
Other Neuroscience	82	5	87	(50.5)	10.2	(49.0)	14.1	(48.9)

Eye Care	362	261	623	(38.1)	(9.1)	(28.6)	1.3	(25.2)
Lumigan/Ganfort	59	62	121	(4.4)	(18.7)	(12.2)	(8.7)	(6.7)
Alphagan/Combigan	37	36	73	(58.2)	(8.9)	(43.0)	2.9	(39.4)
Restasis	132	10	142	(56.7)	(30.7)	(55.6)	(37.7)	(55.9)
Other Eye Care	134	153	287	3.7	(2.7)	0.1	9.1	6.6

Other Key Products	788	202	990	5.5	(19.4)	(0.7)	(9.1)	1.9
Mavyret	190	193	383	3.5	(20.6)	(10.2)	(10.3)	(4.4)
Creon	336	—	336	8.5	n/a	8.5	n/a	8.5
Linzess/Constella	262	9	271	3.4	16.0	3.8	25.8	4.1


^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/a = not applicable
n/m = not meaningful

AbbVie Inc. Key Product Revenues Nine Months Ended September 30, 2022 (Unaudited)

				% Change vs. 9M21
	Net Revenues (in millions)			Reported			Operational ^a
	U.S.	Int'l.	Total	U.S.	Int'l.	Total	Int'l.	Total
NET REVENUES	$33,521	$9,412	$42,933	5.3 %	(0.7) %	3.9 %	6.7 %	5.6 %

Immunology	17,922	3,077	20,999	16.4	(2.2)	13.3	6.6	14.8
Humira	13,613	2,045	15,658	6.5	(20.9)	1.9	(14.3)	3.0
Skyrizi	3,081	508	3,589	78.6	59.3	75.6	75.1	78.1
Rinvoq	1,228	524	1,752	38.0	>100.0	54.5	>100.0	59.3

Hematologic Oncology	3,325	1,621	4,946	(14.5)	10.7	(7.6)	15.6	(6.3)
Imbruvica ^b	2,585	868	3,453	(19.4)	6.3	(14.2)	6.3	(14.2)
Venclexta	740	753	1,493	8.1	16.2	12.1	27.3	17.5

Aesthetics	2,489	1,557	4,046	0.6	15.1	5.8	23.1	8.6
Botox Cosmetic	1,232	741	1,973	20.0	27.9	22.8	36.8	26.0
Juvederm Collection	420	686	1,106	(12.3)	9.9	0.3	17.6	4.6
Other Aesthetics	837	130	967	(13.4)	(12.8)	(13.4)	(7.2)	(12.7)

Neuroscience	4,175	643	4,818	15.2	(1.1)	12.8	7.9	14.2
Botox Therapeutic	1,641	350	1,991	13.1	6.5	11.9	15.0	13.5
Vraylar	1,473	—	1,473	18.9	n/a	18.9	n/a	18.9
Duodopa	72	279	351	(2.4)	(9.8)	(8.4)	—	(0.5)
Ubrelvy	483	—	483	31.0	n/a	31.0	n/a	31.0
Qulipta	106	—	106	n/m	n/a	n/m	n/a	n/m
Other Neuroscience	400	14	414	(18.3)	10.3	(17.6)	13.1	(17.5)

Eye Care	1,265	846	2,111	(26.9)	(3.5)	(19.0)	5.4	(16.0)
Lumigan/Ganfort	186	205	391	(7.1)	(10.8)	(9.0)	(2.9)	(4.8)
Alphagan/Combigan	161	111	272	(40.8)	(5.1)	(30.0)	4.9	(27.0)
Restasis	518	38	556	(41.3)	(10.1)	(39.9)	(2.8)	(39.6)
Other Eye Care	400	492	892	6.3	0.9	3.3	10.1	8.5

Other Key Products	2,245	623	2,868	4.5	(16.9)	(1.0)	(8.6)	1.2
Mavyret	562	599	1,161	0.9	(17.5)	(9.5)	(9.1)	(4.7)
Creon	941	—	941	9.0	n/a	9.0	n/a	9.0
Linzess/Constella	742	24	766	2.0	3.2	2.0	9.6	2.2


^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/a = not applicable
n/m = not meaningful

AbbVie Inc. Consolidated Statements of Earnings (Unaudited)

(in millions, except per share data)	Third Quarter Ended September 30		Nine Months Ended September 30
	2022	2021	2022	2021
Net revenues	$ 14,812	$ 14,342	$ 42,933	$ 41,311
Cost of products sold	5,022	4,390	13,244	13,126
Selling, general and administrative	3,304	3,083	11,843	9,089
Research and development ^a	1,614	1,661	4,720	5,095
Acquired IPR&D and milestones ^a	40	402	454	719
Other operating expense, net	229	500	57	432
Total operating costs and expenses	10,209	10,036	30,318	28,461

Operating earnings	4,603	4,306	12,615	12,850

Interest expense, net	497	585	1,568	1,813
Net foreign exchange loss	36	12	108	35
Other expense (income), net	(330)	21	427	2,284
Earnings before income tax expense	4,400	3,688	10,512	8,718
Income tax expense	448	508	1,139	1,214
Net earnings	3,952	3,180	9,373	7,504
Net earnings attributable to noncontrolling interest	3	1	10	6
Net earnings attributable to AbbVie Inc.	$ 3,949	$ 3,179	$ 9,363	$ 7,498

Diluted earnings per share attributable to AbbVie Inc.	$ 2.21	$ 1.78	$ 5.24	$ 4.19

Adjusted diluted earnings per share ^b	$ 3.66	$ 2.83	$ 10.18	$ 8.75

Weighted-average diluted shares outstanding	1,776	1,777	1,777	1,776


^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 $12 million for the three months and $162 million for the nine months ended September 30, 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.

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

1. Specified items impacted results as follows:

	Quarter Ended September 30, 2022
(in millions, except per share data)	Earnings		Diluted
	Pre-tax	After-tax ^a	EPS
As reported (GAAP)	$ 4,400	$ 3,949	$ 2.21
Adjusted for specified items:
Intangible asset amortization	2,024	1,673	0.94
Intangible asset impairment	770	604	0.34
Acquisition and integration costs	348	348	0.20
Change in fair value of contingent consideration	(214)	(218)	(0.12)
Litigation matters	110	94	0.05
Other	58	78	0.04
As adjusted (non-GAAP)	$ 7,496	$ 6,528	$ 3.66

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs include costs related to the Allergan acquisition. 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 September 30, 2022 included acquired IPR&D and milestones expense of $40 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.02 to both diluted EPS and adjusted diluted EPS.

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

	Quarter Ended September 30, 2022
(in millions)	Cost of products sold	SG&A	R&D	Other operating expense, net	Other expense (income), net
As reported (GAAP)	$ 5,022	$ 3,304	$ 1,614	$ 229	$ (330)
Adjusted for specified items:
Intangible asset amortization	(2,024)	—	—	—	—
Intangible asset impairment	(770)	—	—	—	—
Acquisition and integration costs	(22)	(91)	(6)	(229)	—
Change in fair value of contingent consideration	—	—	—	—	214
Litigation matters	—	(110)	—	—	—
Other	(39)	(14)	(1)	—	(4)
As adjusted (non-GAAP)	$ 2,167	$ 3,089	$ 1,607	$ —	$ (120)


3. The adjusted tax rate for the third quarter of 2022 was 12.9 percent, as detailed below:

			Quarter Ended September 30, 2022
(dollars in millions)			Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)			$ 4,400	$ 448	10.2 %
Specified items			3,096	517	16.7 %
As adjusted (non-GAAP)			$ 7,496	$ 965	12.9 %

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

1. Specified items impacted results as follows:

	Quarter Ended September 30, 2021
(in millions, except per share data)	Earnings		Diluted
	Pre-tax	After-tax ^a	EPS
As reported (GAAP)	$ 3,688	$ 3,179	$ 1.78
Adjusted for specified items:
Intangible asset amortization	1,904	1,585	0.88
Acquisition and integration costs	176	166	0.09
Change in fair value of contingent consideration	98	98	0.06
Other	48	29	0.02
As adjusted (non-GAAP)	$ 5,914	$ 5,057	$ 2.83

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs reflect Allergan-related integration costs. Other primarily includes restructuring charges associated with streamlining global operations and COVID-19 related expenses.

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 September 30, 2021 included acquired IPR&D and milestones expense of $402 million on a pre-tax and $396 million on an 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 $0.50 to both diluted EPS and adjusted diluted EPS.

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

	Quarter Ended September 30, 2021
(in millions)	Cost of products sold	SG&A	R&D	Other expense (income), net
As reported (GAAP)	$ 4,390	$ 3,083	$ 1,661	$ 21
Adjusted for specified items:
Intangible asset amortization	(1,904)	—	—	—
Acquisition and integration costs	(49)	(105)	(22)	—
Change in fair value of contingent consideration	—	—	—	(98)
Other	(24)	(17)	(7)	—
As adjusted (non-GAAP)	$ 2,413	$ 2,961	$ 1,632	$ (77)

3. The adjusted tax rate for the third quarter of 2021 was 14.5 percent, as detailed below:

		Quarter Ended September 30, 2021
(dollars in millions)		Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)		$ 3,688	$ 508	13.8 %
Specified items		2,226	348	15.6 %
As adjusted (non-GAAP)		$ 5,914	$ 856	14.5 %

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

1. Specified items impacted results as follows:

	Nine Months Ended September 30, 2022
(in millions, except per share data)	Earnings		Diluted
	Pre-tax	After-tax ^a	EPS
As reported (GAAP)	$ 10,512	$ 9,363	$ 5.24
Adjusted for specified items:
Intangible asset amortization	5,728	4,794	2.69
Intangible asset impairment	770	604	0.34
Acquisition and integration costs	595	567	0.32
Change in fair value of contingent consideration	647	657	0.37
Pylera divestiture	(172)	(126)	(0.07)
Litigation matters	2,497	2,021	1.13
Other	281	295	0.16
As adjusted (non-GAAP)	$ 20,858	$ 18,175	$ 10.18

^a Represents net earnings attributable to AbbVie Inc.

Acquisition and integration costs 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. 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 nine months ended September 30, 2022 included acquired IPR&D and milestones expense of $454 million on a pre-tax and $439 million on an after-tax basis, representing an unfavorable impact of $0.25 to both diluted EPS and adjusted diluted EPS.

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

	Nine Months Ended September 30, 2022
(in millions)	Cost of products sold	SG&A	R&D	Other operating expense, net	Other expense (income), net
As reported (GAAP)	$ 13,244	$ 11,843	$ 4,720	$ 57	$ 427
Adjusted for specified items:
Intangible asset amortization	(5,728)	—	—	—	—
Intangible asset impairment	(770)	—	—	—	—
Acquisition and integration costs	(84)	(263)	(19)	(229)	—
Change in fair value of contingent consideration	—	—	—	—	(647)
Pylera divestiture	—	—	—	172	—
Litigation matters	—	(2,497)	—	—	—
Other	(160)	(107)	(7)	—	(7)
As adjusted (non-GAAP)	$ 6,502	$ 8,976	$ 4,694	$ —	$ (227)

3. The adjusted tax rate for the first nine months of 2022 was 12.8 percent, as detailed below:

			Nine Months Ended September 30, 2022
(dollars in millions)			Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)			$ 10,512	$ 1,139	10.8 %
Specified items			10,346	1,534	14.8 %
As adjusted (non-GAAP)			$ 20,858	$ 2,673	12.8 %

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

1. Specified items impacted results as follows:

	Nine Months Ended September 30, 2021
(in millions, except per share data)	Earnings		Diluted
	Pre-tax	After-tax ^a	EPS
As reported (GAAP)	$ 8,718	$ 7,498	$ 4.19
Adjusted for specified items:
Intangible asset amortization	5,912	4,929	2.77
Acquisition and integration costs	535	427	0.23
Change in fair value of contingent consideration	2,447	2,445	1.38
Litigation matters	107	86	0.05
Other	319	255	0.13
As adjusted (non-GAAP)	$ 18,038	$ 15,640	$ 8.75

^a Represents net earnings attributable to AbbVie Inc.

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

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 nine months ended September 30, 2021 included acquired IPR&D and milestones expense of $719 million on a pre-tax and $696 million on an 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 $0.67 to both diluted EPS and adjusted diluted EPS.

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

	Nine Months Ended September 30, 2021
(in millions)	Cost of products sold	SG&A	R&D	Other operating expense, net	Other expense (income), net
As reported (GAAP)	$ 13,126	$ 9,089	$ 5,095	$ 432	$ 2,284
Adjusted for specified items:
Intangible asset amortization	(5,912)	—	—	—	—
Acquisition and integration costs	(172)	(275)	(88)	—	—
Change in fair value of contingent consideration	—	—	—	—	(2,447)
Litigation matters	—	(107)	—	—	—
Other	(65)	(50)	(287)	68	15
As adjusted (non-GAAP)	$ 6,977	$ 8,657	$ 4,720	$ 500	$ (148)

3. The adjusted tax rate for the first nine months of 2021 was 13.3 percent, as detailed below:

			Nine Months Ended September 30, 2021
(dollars in millions)			Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)			$ 8,718	$ 1,214	13.9 %
Specified items			9,320	1,178	12.6 %
As adjusted (non-GAAP)			$ 18,038	$ 2,392	13.3 %

View original content: https://www.prnewswire.com/news-releases/abbvie-reports-third-quarter-2022-financial-results-301661927.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 Third-Quarter 2022 Financial Results

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