On October 29, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the quarter and the half year ended September 30, 2021 (Press release, Dr Reddy’s, OCT 29, 2021, View Source [SID1234592180]).

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The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS). COVID portfolio We continue to play our role in the fight against Covid-19 by acting proactively to bring multiple preventive and curative treatment options, including a vaccine. Our major Covid-19 products launched till now include Sputnik V vaccine, Remdesivir, Avigan (Favipiravir) and 2-deoxy-D-glucose (2-DG). We have commercialized all these products in India and some of these products in overseas markets.

Currently, we are conducting clinical trials for Sputnik Light, Molnupiravir and are also developing several other covid drugs for treatment ranging from mild to severe conditions. Revenue Analysis Global Generics (GG) Revenues from GG segment at Rs. 47.4 billion:

 Year-on-year growth of 19% and sequential quarter growth of 15% was driven by covid portfolio, new product launches and base business volume traction across key markets. However, this was offset partly by price erosion in some of our products. North America Revenues from North America at Rs. 18.9 billion:
 Year-on-year growth of 3% and sequential quarter growth of 9%, driven by launch and scale up of new products and increase in volumes of certain of our existing products, which was offset by price erosion in some molecules. 

During this quarter, we launched 4 new products. These were Chlordiazepoxide Hydrochloride + Clidinium Bromide Capsules in the US and Lenalidomide capsules, Ertapenem injection and Dasatinib tablets in Canada.  We filed two new ANDAs during the quarter. As of 30th September 2021, cumulatively 93 generic filings are pending for approval with the USFDA (90 ANDAs and 3 NDAs under 505(b)(2) route). Out of these 93 pending filings, 46 are Para IVs and we believe 23 have ‘First to File’ status. Europe Revenues from Europe at Rs. 4.1 billion. Year-on-year growth of 10% and sequential quarter growth of 4% was primarily on account of volume traction in base business and new product launches across our markets, which was partially offset by price erosion. India Revenues from India at Rs. 11.4 billion:

 Year-on-year growth of 25% and sequential quarter growth of 8% was primarily driven by increase in sales volumes of our existing products, including from our Covid portfolio, contribution from new product launches and increase in sales price of our existing products.
 We launched two new products during the quarter. These were Melotryp and Baricax. 5 Emerging Markets Revenues from Emerging Markets at Rs. 13.0 billion. Year-on-year growth of 50% and sequential quarter growth of 42%:  Revenues for Russia at Rs. 5.7 billion. Year-on-year growth of 44% and sequential quarter growth of 63% was on account of increase in volumes and sales prices in our existing products and new products launches. We have launched biosimilar bevacizumab in Russia during the quarter.
 Revenues from other CIS countries and Romania at Rs. 2.2 billion. Year-on-year growth of 9% and sequential quarter growth of 51% was driven by primarily by new product launches. While sequential quarter growth was supported by increase in sales volumes and prices of certain of our existing products, year-on-year growth was offset partly on account of reduction in volumes and price erosion in some of our existing products.

 Revenues from Rest of World (RoW) territories at Rs. 5.1 billion. Year-on-year growth of 90% and sequential growth of 22% was driven by covid portfolio, new products and volume traction in our base business, partially offset by a reduction in sales price of some of our products. Pharmaceutical Services and Active Ingredients (PSAI) Revenues from PSAI at Rs. 8.4 billion with a year-on-year decline of 2% and sequential quarter growth of 11%.  While there has been growth from covid portfolio, there was a decline in some of our other products due to lower traction in the volumes and further there has been decrease in sales price for some of our products.

 During the quarter we filed two DMFs in the US. Proprietary Products (PP) & Others Revenues from PP & Others at Rs. 1.8 billion. Year-on-year growth of 195% and sequential quarter growth of 238% was primarily on account of recognition of a license fee associated with the sale of our U.S. and Canada territory rights for ELYXYB (celecoxib oral solution) 25 mg/ml, to BioDelivery Sciences International, Inc.Income Statement Highlights:  Gross profit margin for the quarter at 53.4%:-Decreased by ~50 bps over previous year majorly on account of price erosion and lower export benefits partially offset by leverage benefit on manufacturing overheads.-Increased by ~120 bps sequentially, driven majorly by leverage benefit on manufacturing overheads partially offset by price erosion.-Gross profit margin for GG and PSAI business segments are at 56.9% and 25.9% respectively.

 Selling, general & administrative (SG&A) expenses at Rs. 16.0 billion, increased by 22% on a yearon-year basis and by 6% sequentially. This increase was in line with the business growth and primarily attributable to royalty on sales, annual increments, investments in sales & marketing of our key brands and investments in digitalization.  Research & development (R&D) expenses at Rs. 4.5 billion. As % to revenues – Q2 FY22: 7.7% | Q1 FY22: 9.2% | Q2 FY21: 8.9%. We continue our focus on investing in R&D to build a healthy pipeline of new products across our markets including development of products in our biosimilars and generics businesses.

 Other operating income at Rs. 1.7 billion compared to Rs. 149 million in Q2 FY21. The increase was on account of recognition of income towards sale of all of our rights relating to our anti-cancer agent E7777 (denileukin diftitox) to Citius Pharmaceuticals, Inc.  Net Finance income at Rs. 319 million compared to Rs. 237 million in Q2 FY21.  Profit before Tax at Rs. 12.7 billion, increased by 47% year-on-year and by 71% sequentially.  Profit after Tax at Rs. 9.9 billion. The effective tax rate is 21.8% for the quarter.  Diluted earnings per share is at Rs. 59.65. Other Highlights:  EBITDA is at Rs. 15.6 billion and the EBITDA margin is 27.0%.  Capital expenditure is at Rs. 3.6 billion.  Free cash flow is at Rs. 830 million.  Net debt for the company is at Rs. 2.7 billion as on September 30, 2021

. Consequently, net debt to equity ratio is 0.015. 7 Earnings Call Details (05:30 pm IST, 08:00 am EDT, Oct 29, 2021) The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

On October 29, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that its third quarter 2021 financial results will be released after market close on Monday, November 8, 2021 (Press release, Coherus Biosciences, OCT 29, 2021, View Source [SID1234592179]). Starting at 5 p.m. ET, Coherus’ management team will host a conference call and webcast to discuss financial results and provide a general business update.

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After releasing third quarter financial results, the Company will post them on the Coherus website at View Source

Conference Call Information

Webcast: View Source

Please dial-in 15 minutes early to ensure a timely connection to the call.

On October 29, 2021 Alphamab Oncology (stock code: 9966.HK) reported, a pivotal clinical study of PD-L1/CTLA-4 bispecific antibody KN046 in China (ENREACH-LUNG-02) recently completed the first drug administration (Press release, Alphamab, OCT 29, 2021, View Source [SID1234592178]).

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ENREACH-LUNG-02 is a multi-center, open-label, randomized-controlled phase II/III clinical study. Phase III study is planned to be carried out in about 50 research centers, recruiting about 486 patients, with OS and PFS as co-primary endpoints. To evaluate the efficacy of KN046 combined with lenvatinib versus docetaxel in patients with advanced NSCLC who have progressed on anti-PD-(L)1 treatment.

The principal investigator Professor Caicun Zhou, Director of the Department of Oncology from Shanghai Pulmonary Hospital Affiliated to Tongji University, commented, "In recent years, major progress has been made in lung cancer treatment, especially immunotherapies have brought significant clinical benefits to patients. However, there is still no effective option for PD-(L)1 refractory NSCLC patients. Through ENREACH-LUNG-02 study, we look forward to bringing new treatment options to these patients with huge unmet needs."

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism CTLA-4 domain fused with a PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg（suppress tumor immunity） clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown promising data in terms of survival for patients. Alphamab Oncology has received FDA clearance to enter later stage trials of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.

On October 29, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported two new academic collaborations with Columbia University and Mount Sinai (Icahn Mount Sinai) to translate cutting-edge research discoveries into potential therapies for patients with genetic diseases and genetically driven cancers (Press release, BridgeBio, OCT 29, 2021, View Source [SID1234592174]).

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"Columbia University and Mount Sinai are known for bringing together some of the most talented scientists to develop breakthroughs for patients. By partnering with these world-class research institutions, we are hopeful that together we will be able to help patients in need," said BridgeBio founder and CEO Neil Kumar, Ph.D.

BridgeBio has initiated 25 collaborations with leading institutions around the world that are focused on providing therapeutic options to patients with unmet need as quickly and safely as possible. To learn more about some of the institutions BridgeBio is proud to partner with, please visit Our Partners page.

Collaborating with academic institutions to identify early discoveries is a core pillar of BridgeBio’s efforts to reach patients more quickly. The goal of these collaborations is to revolutionize the relationships between drug development companies and biomedical research institutions by moving away from one-off interactions in favor of engaging and creative partnerships.

More than two-thirds of BridgeBio’s 30+ pipeline programs have come from partnerships with academic institutions and research centers. For example, BridgeBio’s clinical trial of encaleret, which is being investigated for the treatment of autosomal dominant hypocalcemia type 1 (ADH1), has been enabled by a Cooperative Research and Development Agreement with the National Institute for Dental and Craniofacial Research at the National Institutes of Health. BridgeBio’s investigational medicine acoramidis, which is being developed for the treatment of transthyretin (TTR) amyloidosis (ATTR), originated in a lab at Stanford University. BridgeBio partnered with the Stanford researchers and advanced acoramidis from the lab to Phase 3 clinical development in less than three years.

With a diverse pipeline encompassing investigational therapies in Mendelian diseases, precision cardiorenal, precision oncology and gene therapy, BridgeBio provides the insights and support needed to rapidly progress therapeutic research from labs to clinical development. BridgeBio intends to develop similar long-term partnerships based on trust, engagement, science and respect to support its mission of developing potentially life-changing medicines for patients with genetic diseases and cancers as quickly and safely as possible.

On October 29, 2021 AbbVie (NYSE:ABBV) reported that financial results for the third quarter ended September 30, 2021 (Press release, AbbVie, OCT 29, 2021, View Source [SID1234592173]).

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"We continue to deliver excellent results, with balanced performance across our portfolio driving double-digit operational sales and EPS growth," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Based upon our strong momentum, we are increasing our full-year 2021 EPS guidance. We remain highly confident in AbbVie’s long-term outlook and are once again raising our dividend, which has grown over 250 percent since inception."

Third-Quarter Results

Worldwide net revenues were $14.342 billion, an increase of 11.2 percent on a GAAP basis. Adjusted net revenues increased 11.3 percent on a reported basis, or 10.8 percent on an operational basis.
Global net revenues from the immunology portfolio were $6.674 billion, an increase of 15.3 percent on a reported basis, or 14.9 percent on an operational basis.
Global Humira net revenues of $5.425 billion increased 5.6 percent on a reported basis, or 5.2 percent on an operational basis. U.S. Humira net revenues were $4.613 billion, an increase of 10.1 percent. Internationally, Humira net revenues were $812 million, a decrease of 14.6 percent on a reported basis, or 16.7 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $796 million.
Global Rinvoq net revenues were $453 million.
Global net revenues from the hematologic oncology portfolio were $1.866 billion, an increase of 8.4 percent on a reported basis, or 8.1 percent on an operational basis.
Global Imbruvica net revenues were $1.374 billion, an increase of 0.3 percent, with U.S. net revenues of $1.109 billion and international profit sharing of $265 million.
Global Venclexta net revenues were $492 million, an increase of 40.1 percent on a reported basis, or 38.7 percent on an operational basis.
Global net revenues from the neuroscience portfolio were $1.566 billion, an increase of 25.5 percent on a reported basis, or 25.0 percent on an operational basis.
Global Botox Therapeutic net revenues were $645 million, an increase of 23.4 percent on a reported basis, or 22.5 percent on an operational basis.
Vraylar net revenues were $461 million, an increase of 29.0 percent on a reported and operational basis.
Global Ubrelvy net revenues were $162 million.
Global net revenues from the aesthetics portfolio were $1.251 billion, an increase of 29.3 percent on a reported basis, or 27.7 percent on an operational basis.
Global Botox Cosmetic net revenues were $545 million, an increase of 38.5 percent on a reported basis, or 36.9 percent on an operational basis.
Global Juvederm net revenues were $354 million, an increase of 29.1 percent on a reported basis, or 26.6 percent on an operational basis.
On a GAAP basis, the gross margin ratio in the third quarter was 69.4 percent. The adjusted gross margin ratio was 83.2 percent.
On a GAAP basis, selling, general and administrative expense was 21.5 percent of net revenues. The adjusted SG&A expense was 20.6 percent of net revenues.
On a GAAP basis, research and development expense was 11.7 percent of net revenues. The adjusted R&D expense was 11.4 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the third quarter was 30.0 percent. The adjusted operating margin was 51.1 percent.
On a GAAP basis, net interest expense was $585 million.
On a GAAP basis, the tax rate in the quarter was 13.8 percent. The adjusted tax rate was 12.6 percent.
Diluted EPS in the third quarter was $1.78 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.33.

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

Recent Events

AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. The recommended dose of Rinvoq for AD in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents and adults 65 years and older. The approval is supported by data from one of the largest registrational Phase 3 programs in AD evaluating Rinvoq monotherapy or with topical corticosteroids. This milestone marks the fourth EC-approved indication for Rinvoq.
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 active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). The positive opinion is based on data from two pivotal Phase 3 studies which evaluated the efficacy and safety of Skyrizi in adults with active PsA. If the CHMP recommendation is accepted by the EC, this will mark the second 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.
AbbVie announced that it submitted applications to the U.S. Food and Drug Administration (FDA) and EMA seeking approval for Rinvoq (45 mg (induction dose) and 15 mg and 30 mg (maintenance dose)) for the treatment of adults with moderately to severely active ulcerative colitis (UC). The applications are supported by data from two Phase 3 induction studies and one maintenance study. In these studies, significantly more patients treated with Rinvoq achieved the primary and all secondary endpoints compared to placebo. The safety results of Rinvoq, including the 45 mg dose as induction therapy, in these studies were generally consistent with the known safety profile of Rinvoq, with no new important safety risks observed.
AbbVie announced that it submitted an application to the FDA seeking approval for Skyrizi (600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) for the treatment of patients 16 years and older with moderate to severe Crohn’s disease (CD). The submission is supported by three pivotal Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response as both induction and maintenance therapy. The overall safety findings in these pivotal studies were generally consistent with the known safety profile of Skyrizi.
AbbVie announced positive top-line results from two studies of the Phase 3 SELECT-AXIS 2 clinical trial evaluating the efficacy and safety of Rinvoq in patients with active ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA). In Study 1, Rinvoq (15 mg, once daily) met the primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 at week 14 versus placebo (45 percent compared to 18 percent) in patients with AS who have had an inadequate response to biologic DMARD therapy. All ranked secondary endpoints were also met. In Study 2, Rinvoq (15 mg, once daily) met the primary endpoint of ASAS40 at week 14 versus placebo (45 percent compared to 23 percent) and met the first 12 of 14 ranked secondary endpoints in patients with nr-axSpA. Across both studies, safety data were consistent with SELECT-AXIS 1, previous Phase 3 studies in other indications and the known safety profile of Rinvoq, with no new risks identified. Full results from the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
At the United European Gastroenterology (UEG) Week, AbbVie shared 13 abstracts including 7 live presentations that reinforced AbbVie’s commitment to advancing research in inflammatory bowel disease (IBD). Highlights included new results from the 52-week Phase 3 maintenance studies evaluating the efficacy and safety of Skyrizi in patients with CD and Rinvoq in patients with UC.
At the European Academy of Dermatology and Venereology (EADV) Congress, AbbVie shared 27 abstracts from across its dermatology portfolio that underscored AbbVie’s commitment to advancing standards of care in dermatology for people living with serious skin diseases. Highlights included new analyses from the Phase 3 Rinvoq AD clinical trial program as well as new long-term efficacy and safety data from the KEEPsAKE 1 and KEEPsAKE 2 trials evaluating Skyrizi in adults with PsA treated through 52 weeks.
AbbVie announced that Skyrizi is now available in the U.S. as a single-dose 150 mg injection for the treatment of adults with moderate to severe plaque psoriasis (PsO). Previously two 75 mg injections per dose, Skyrizi 150 mg is now administered with one injection per dose via either a prefilled pen or syringe every 12 weeks following two starter doses.
AbbVie announced that the FDA approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The approval is supported by data from a robust clinical program evaluating the efficacy, safety and tolerability of Qulipta in nearly 2,000 patients who experienced 4 to 14 migraine days per month including the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b/3 study and the Phase 3 long-term safety study. AbbVie is the only pharmaceutical company to offer three treatments across the full spectrum of migraine to help patients living with this debilitating disease.
At the International Headache Congress (IHC) 2021, AbbVie presented data showcasing its migraine portfolio and shared a total of 23 abstracts including 2 oral presentations and 1 abstract lecture. Highlights included results from an open-label, multicenter extension to the pivotal Phase 3 ADVANCE trial evaluating the safety and tolerability of oral Qulipta for the preventive treatment of migraine, data from the observational cross-sectional UNIVERSE study highlighting the real-world effectiveness and patient satisfaction of Ubrelvy (ubrogepant) in acute migraine as well as results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluating the use of Botox (onabotulinumtoxinA) for chronic migraine.
AbbVie announced ABBV-951 (foslevodopa/foscarbidopa) met the primary endpoint in a pivotal Phase 3 trial in patients with advanced Parkinson’s Disease (PD). Patients who received the continuous 24 hours/day subcutaneous infusion of ABBV-951 showed statistically significant increases in "On" time without troublesome dyskinesia, compared to oral levodopa/carbidopa, after 12 weeks. A significant reduction in "Off" time was also observed. Systemic adverse events were generally consistent with the well-established safety profile of levodopa/carbidopa medications and infusion site adverse events were mostly non-serious and mild or moderate in severity. Data from this head-to-head superiority study will be a key component of global regulatory submissions and full results will be presented at a future medical meeting or submitted for publication in a peer-reviewed journal.
At the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021, AbbVie presented more than 20 abstracts showcasing AbbVie’s continued focus on advancing the management of movement disorders. Highlights included final results from PROviDE, a long-term, real-world study, evaluating the effectiveness of Duodopa (levodopa-carbidopa intestinal gel) in patients with advanced PD as well as additional data on the long-term, real-world use of Botox in patients with spasticity and cervical dystonia.
AbbVie and REGENXBIO announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery as well as in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery. Under the terms of the agreement, AbbVie will pay REGENXBIO a $370 million upfront payment with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones. The transaction is expected to close by the end of 2021, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.
Full-Year 2021 Outlook

AbbVie is raising its GAAP diluted EPS guidance for the full-year 2021 from $6.04 to $6.14 to $6.29 to $6.33. AbbVie is raising its adjusted diluted EPS for the full-year 2021 from $12.52 to $12.62 to $12.63 to $12.67. The company’s 2021 adjusted diluted EPS guidance excludes $6.34 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

Company Declares Dividend Increase of 8.5 Percent

AbbVie is announcing today that its board of directors declared an increase in the company’s quarterly cash dividend from $1.30 per share to $1.41 per share beginning with the dividend payable on February 15, 2022 to shareholders of record as of January 14, 2022. This reflects an increase of approximately 8.5 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 more than 250 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.