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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following is a discussion and analysis of the financial condition of AbbVie Inc. (AbbVie or the company) as of March 31, 2022 and December 31, 2021 and the results of operations for the three months ended March 31, 2022 and 2021. This commentary should be read in conjunction with the Condensed Consolidated Financial Statements and accompanying notes appearing in Item 1, “Financial Statements and Supplementary Data.”
EXECUTIVE OVERVIEW
Company Overview
AbbVie is a global, diversified research-based biopharmaceutical company positioned for success with a comprehensive product portfolio that has leadership positions across immunology, oncology, aesthetics, neuroscience and eye care. AbbVie uses 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.
AbbVie's products are generally sold worldwide directly to wholesalers, distributors, government agencies, health care facilities, specialty pharmacies and independent retailers from AbbVie-owned distribution centers and public warehouses. Certain products (including aesthetic products and devices) are also sold directly to physicians and other licensed healthcare providers. In the United States, AbbVie distributes pharmaceutical products principally through independent wholesale distributors, with some sales directly to retailers, pharmacies, patients or other customers. Outside the United States, AbbVie sells products primarily to customers or through distributors, depending on the market served. Certain products are co-marketed or co-promoted with other companies. AbbVie has approximately 50,000 employees. AbbVie operates as a single global business segment.
2022 Strategic Objectives
AbbVie's mission is to discover and develop innovative medicines and products that solve serious health issues today and address the medical challenges of tomorrow while achieving top-tier financial performance through outstanding execution. AbbVie intends to continue to advance its mission in a number of ways, including: (i) maximizing the benefits of a diversified revenue base with multiple long-term growth drivers; (ii) growing revenues by leveraging AbbVie's commercial strength and international infrastructure across therapeutic areas and ensuring strong commercial execution of new product launches; (iii) continuing to invest in and expand its pipeline in support of opportunities in immunology, oncology, aesthetics, neuroscience and eye care as well as continued investment in key on-market products; (iv) expanding operating margins; and (v) returning cash to shareholders via a strong and growing dividend while also reducing debt. In addition, AbbVie anticipates several regulatory submissions and data readouts from key clinical trials in the next 12 months.
Financial Results
The company's financial performance for the three months ended March 31, 2022 included delivering worldwide net revenues of $13.5 billion, operating earnings of $4.7 billion, diluted earnings per share of $2.51 and cash flows from operations of $4.9 billion. Worldwide net revenues grew by 4% on a reported basis and 5% on a constant currency basis, reflecting growth across its immunology, neuroscience and aesthetics portfolios.
Diluted earnings per share was $2.51 for the three months ended March 31, 2022 and included the following after-tax costs: (i) $1.6 billion related to the amortization of intangible assets; (ii) $148 million for charges related to litigation matters; (iii) $145 million for acquired IPR&D and milestones; and (iv) $121 million of acquisition and integration expenses. These costs were partially offset by an after-tax benefit of $746 million related to the change in fair value of contingent consideration liabilities. Additionally, financial results reflected continued funding to support all stages of AbbVie’s pipeline assets and continued investment in AbbVie’s on-market brands.
Following the closing of the Allergan acquisition, AbbVie implemented an integration plan designed to reduce costs, integrate and optimize the combined organization. The integration plan is expected to realize approximately $2.5 billion of annual cost synergies in 2022.
To achieve these integration objectives, AbbVie expects to incur total cumulative charges of approximately $2 billion through 2022. These costs consist of severance and employee benefit costs (cash severance, non-cash severance, including accelerated equity award compensation expense, retention and other termination benefits) and other integration expenses.
2022 Form 10-Q |  | 24 |
Recent Global Events
Russia/Ukraine
In response to the military conflict between Russia and Ukraine, the United States and other North Atlantic Treaty Organization member states, as well as certain non-member states, announced targeted economic sanctions and export controls on Russia and Belarus. These include restrictions on the export and transfer of products containing certain toxins, including Botox, to Russia and Belarus. With the exception of Botox, AbbVie is not prohibited to continue the sale of essential pharmaceutical products to help ensure patients receive an uninterrupted supply of their medicines. In March 2022, AbbVie announced the suspension of operations for all aesthetics products in Russia. In April 2022, AbbVie also announced that all profits from the sales of essential medicines in Russia will be donated to support direct humanitarian relief efforts in Ukraine. While the company’s operations in Russia, Belarus and Ukraine are not significant, if the conflict escalates and results in broader economic and political concerns, AbbVie’s business could be adversely impacted.
Impact of the Coronavirus Disease 2019 (COVID-19)
In response to the ongoing public health crisis posed by COVID-19, AbbVie continues to focus on ensuring the safety of employees. Throughout the pandemic, AbbVie has followed health and safety guidance from state and local health authorities and implemented safety measures for those employees who are returning to the workplace.
AbbVie also continues to closely manage manufacturing and supply chain resources around the world to help ensure that patients continue to receive an uninterrupted supply of their medicines. Clinical trial sites are being monitored locally to protect the safety of study participants, staff and employees. While the impact of COVID-19 on AbbVie's operations to date has not been material, AbbVie continues to experience lower new patient starts in certain products and markets. AbbVie expects this matter could continue to negatively impact its results of operations throughout the duration of the pandemic.
The extent to which COVID-19 may impact AbbVie's financial condition and results of operations remains uncertain and is dependent on numerous evolving factors, including the measures being taken by authorities to mitigate against the spread of COVID-19, the emergence of new variants and the availability and successful administration of effective vaccines.
Research and Development
Research and innovation are the cornerstones of AbbVie’s business as a global biopharmaceutical company. AbbVie’s long-term success depends to a great extent on its ability to continue to discover and develop innovative products and acquire or collaborate on compounds currently in development by other biotechnology or pharmaceutical companies.
AbbVie’s pipeline currently includes approximately 90 compounds, devices or indications in development individually or under collaboration or license agreements and is focused on such important specialties as immunology, oncology, aesthetics, neuroscience and eye care. Of these programs, more than 50 are in mid- and late-stage development.
The following sections summarize transitions of significant programs from mid-stage development to late-stage development as well as developments in significant late-stage and registration programs. AbbVie expects multiple mid-stage programs to transition into late-stage programs in the next 12 months.
Significant Programs and Developments
Immunology
Skyrizi
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In January 2022, AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Skyrizi for the treatment of adults with active psoriatic arthritis (PsA).
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In February 2022, AbbVie announced that the FDA has extended the Prescription Drug User Fee Act action date by three months for Skyrizi for the treatment of moderate to severe Crohn’s disease in patients 16 years.
Rinvoq
*•*In January 2022, AbbVie announced its submission of a supplemental New Drug Application (sNDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Rinvoq for the treatment of adults with active nr-axSpA with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs.
| 2022 Form 10-Q | | 25 |
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In January 2022, AbbVie announced that the FDA approved Rinvoq for the treatment of moderate to severe atopic dermatitis (AD) in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.
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In February 2022, AbbVie was notified that the European Commission (EC) is requesting the EMA to assess safety concerns associated with JAK inhibitor products authorized in inflammatory diseases and to evaluate the impact of these events on their benefit-risk balance. The assessment covers all JAK inhibitors approved for use in inflammatory diseases. The request is for an opinion from the EMA by September 30, 2022.
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In February 2022, AbbVie announced top-line results from its second Phase 3 induction study, U-Excel, for Rinvoq in patients with moderate to severe Crohn’s disease who had an inadequate response or were intolerant to conventional or biologic therapy met the primary and most key secondary endpoints.
*•*In March 2022, AbbVie announced that the FDA approved Rinvoq for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
- In April 2022, AbbVie announced that the FDA approved Rinvoq for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
Oncology
Teliso-V
- In January 2022, AbbVie announced that the FDA granted Breakthrough Therapy Designation to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy.
Imbruvica
- In February 2022, AbbVie submitted an sNDA to the FDA for Imbruvica for the treatment of pediatric and adolescent patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic therapy.
Epcoritamab
- In March 2022, Genmab A/S (Genmab) announced that FDA granted orphan-drug designation to the investigational medicine, epcoritamab (DuoBody-CD3xCD20), for the treatment of follicular lymphoma. Genmab and AbbVie are co-developing epcoritamab and will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
*•*In April 2022, AbbVie and Genmab announced positive topline results from the first cohort of the EPCORE NHL-1 phase 1/2 clinical trial evaluating epcoritamab (DuoBody-CD3xCD20) in patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy. Based on the topline results, the companies will engage global regulatory authorities.
Aesthetics
Juvederm Collection
- In February 2022, AbbVie announced that the FDA approved JUVEDERM VOLBELLA XC for improvement of infraorbital hollows in adults over the age of 21.
BoNTE
- In March 2022, AbbVie initiated three Phase 3 clinical trials to evaluate the efficacy and safety of BoNTE (AGN-151586) for the treatment of glabellar lines.
| 2022 Form 10-Q | | 26 |
Neuroscience
Vraylar
- In February 2022, AbbVie submitted an sNDA to the FDA for Vraylar for the adjunctive treatment of major depressive disorder in patients who are receiving ongoing antidepressant therapy.
Qulipta
- In March 2022, AbbVie announced results from the Phase 3 PROGRESS trial for Qulipta in the preventive treatment of chronic migraine in adults met the primary endpoint and resulted in significant improvements in all secondary endpoints after adjustment for multiple comparisons.
Eye Care
Vuity
- In April 2022, AbbVie announced that the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of Vuity 1.25% in adults with presbyopia met its primary efficacy endpoint.
For a more comprehensive discussion of AbbVie’s products and pipeline, see the company’s Annual Report on Form 10-K for the year ended December 31, 2021.
| 2022 Form 10-Q | | 27 |
RESULTS OF OPERATIONS
Net Revenues
The comparisons presented at constant currency rates reflect comparative local currency net revenues at the prior year’s foreign exchange rates. This measure provides information on the change in net revenues assuming that foreign currency exchange rates had not changed between the prior and current periods. AbbVie believes that the non-GAAP measure of change in net revenues at constant currency rates, when used in conjunction with the GAAP measure of change in net revenues at actual currency rates, may provide a more complete understanding of the company’s operations and can facilitate analysis of the company’s results of operations, particularly in evaluating performance from one period to another.
| Three months ended March 31, | Percent change | |||||||||||||||||||||||||||||||||||||||||||||||||
| At actual currency rates | At constant currency rates | |||||||||||||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | 2022 | 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||
| United States | $ | 10,348 | $ | 9,750 | 6.1 | % | 6.1 | % | ||||||||||||||||||||||||||||||||||||||||||
| International | 3,190 | 3,260 | (2.1) | % | 3.2 | % | ||||||||||||||||||||||||||||||||||||||||||||
| Net revenues | $ | 13,538 | $ | 13,010 | 4.1 | % | 5.4 | % |
| 2022 Form 10-Q | | 28 |
The following table details AbbVie’s worldwide net revenues:
| Three months ended March 31, | Percent change | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| At actual currency rates | At constant currency rates | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | 2022 | 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Immunology | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Humira | United States | $ | 3,993 | $ | 3,907 | 2.2 | % | 2.2 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 743 | 960 | (22.6) | % | (17.9) | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 4,736 | $ | 4,867 | (2.7) | % | (1.8) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Skyrizi | United States | $ | 781 | $ | 481 | 62.3 | % | 62.3 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 159 | 93 | 71.2 | % | 82.9 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 940 | $ | 574 | 63.7 | % | 65.6 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Rinvoq | United States | $ | 311 | $ | 245 | 26.8 | % | 26.8 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 154 | 58 | >100.0 % | >100.0 % | |||||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 465 | $ | 303 | 53.6 | % | 57.3 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Hematologic Oncology | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Imbruvica | United States | $ | 874 | $ | 999 | (12.4) | % | (12.4) | % | ||||||||||||||||||||||||||||||||||||||||||||
| Collaboration revenues | 299 | 269 | 11.0 | % | 11.0 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 1,173 | $ | 1,268 | (7.4) | % | (7.4) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Venclexta | United States | $ | 228 | $ | 225 | 1.7 | % | 1.7 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 245 | 180 | 35.8 | % | 45.2 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 473 | $ | 405 | 16.9 | % | 21.1 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Aesthetics | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Botox Cosmetic | United States | $ | 413 | $ | 305 | 35.5 | % | 35.5 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 228 | 172 | 32.5 | % | 38.6 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 641 | $ | 477 | 34.4 | % | 36.6 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Juvederm Collection | United States | $ | 148 | $ | 123 | 20.1 | % | 20.1 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 262 | 198 | 32.2 | % | 37.7 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 410 | $ | 321 | 27.5 | % | 30.9 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Other Aesthetics | United States | $ | 285 | $ | 300 | (4.9) | % | (4.9) | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 38 | 43 | (9.9) | % | (6.2) | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 323 | $ | 343 | (5.5) | % | (5.0) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Neuroscience | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Botox Therapeutic | United States | $ | 500 | $ | 429 | 16.5 | % | 16.5 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 114 | 103 | 10.7 | % | 17.1 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 614 | $ | 532 | 15.4 | % | 16.6 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Vraylar | United States | $ | 427 | $ | 346 | 23.4 | % | 23.4 | % | ||||||||||||||||||||||||||||||||||||||||||||
| Duodopa | United States | $ | 24 | $ | 25 | (5.6) | % | (5.6) | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 97 | 104 | (6.9) | % | 0.5 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 121 | $ | 129 | (6.7) | % | (0.8) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Ubrelvy | United States | $ | 138 | $ | 81 | 70.0 | % | 70.0 | % | ||||||||||||||||||||||||||||||||||||||||||||
| Qulipta | United States | $ | 11 | $ | — | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||||||||
| Other Neuroscience | United States | $ | 173 | $ | 156 | 11.0 | % | 11.0 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 4 | 4 | 11.4 | % | 12.2 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 177 | $ | 160 | 11.0 | % | 11.0 | % |
| 2022 Form 10-Q | | 29 |
| Three months ended March 31, | Percent change | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| At actual currency rates | At constant currency rates | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | 2022 | 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Eye Care | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lumigan/Ganfort | United States | $ | 67 | $ | 66 | 1.5 | % | 1.5 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 73 | 77 | (5.7) | % | 0.7 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 140 | $ | 143 | (2.4) | % | 1.0 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Alphagan/Combigan | United States | $ | 70 | $ | 80 | (11.5) | % | (11.5) | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 37 | 38 | (3.9) | % | 5.5 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 107 | $ | 118 | (9.0) | % | (6.0) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Restasis | United States | $ | 235 | $ | 267 | (11.9) | % | (11.9) | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 11 | 13 | (18.1) | % | 1.9 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 246 | $ | 280 | (12.2) | % | (11.3) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Other Eye Care | United States | $ | 124 | $ | 117 | 5.5 | % | 5.5 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 154 | 159 | (2.4) | % | 4.8 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 278 | $ | 276 | 0.9 | % | 5.1 | % | |||||||||||||||||||||||||||||||||||||||||||||
| Other Key Products | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Mavyret | United States | $ | 169 | $ | 170 | (1.0) | % | (1.0) | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 211 | 245 | (13.9) | % | (7.2) | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 380 | $ | 415 | (8.6) | % | (4.6) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Creon | United States | $ | 287 | $ | 274 | 4.7 | % | 4.7 | % | ||||||||||||||||||||||||||||||||||||||||||||
| Linzess/Constella | United States | $ | 233 | $ | 215 | 7.9 | % | 7.9 | % | ||||||||||||||||||||||||||||||||||||||||||||
| International | 7 | 7 | 6.0 | % | 10.2 | % | |||||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 240 | $ | 222 | 7.8 | % | 7.9 | % | |||||||||||||||||||||||||||||||||||||||||||||
| All other | $ | 1,211 | $ | 1,476 | (18.0) | % | (17.1) | % | |||||||||||||||||||||||||||||||||||||||||||||
| Total net revenues | $ | 13,538 | $ | 13,010 | 4.1 | % | 5.4 | % |
n/m – Not meaningful
The following discussion and analysis of AbbVie’s net revenues by product is presented on a constant currency basis.
Global Humira sales decreased by 2% for the three months ended March 31, 2022 primarily driven by direct biosimilar competition in certain international markets, partially offset by market growth across therapeutic categories. In the United States, Humira sales increased by 2% for the three months ended March 31, 2022 primarily driven by market growth across all indications. This increase was partially offset by slightly lower market share following corresponding market share gains of Skyrizi and Rinvoq. Internationally, Humira revenues decreased by 18% for the three months ended March 31, 2022 primarily driven by direct biosimilar competition in certain international markets.
Net revenues for Skyrizi increased by 66% for the three months ended March 31, 2022 primarily driven by continued strong volume and market share uptake since launch as a treatment for plaque psoriasis as well as market growth.
Net revenues for Rinvoq increased by 57% for the three months ended March 31, 2022 primarily driven by continued strong volume and market share uptake since launch for the treatment of moderate to severe rheumatoid arthritis as well as market growth. Net revenues for the three months ended March 31, 2022 were also favorably impacted by recent regulatory approvals and expansion of Rinvoq for the treatment of psoriatic arthritis, atopic dermatitis and ankylosing spondylitis in certain international markets.
Net revenues for Imbruvica represent product revenues in the United States and collaboration revenues outside of the United States related to AbbVie’s 50% share of Imbruvica profit. AbbVie's global Imbruvica revenues decreased by 7% for the three months ended March 31, 2022 as a result of lower new patient starts due to the COVID-19 pandemic and share loss in the United States, partially offset by increased collaboration revenues.
Net revenues for Venclexta increased by 21% for the three months ended March 31, 2022 primarily due to continued expansion of Venclexta for the treatment of patients with first-line chronic lymphocytic leukemia (CLL), relapsed/refractory CLL and first-line acute myeloid leukemia.
Net revenues for Botox Cosmetic used in facial aesthetics increased by 37% for the three months ended March 31, 2022 due to increased consumer demand and penetration rates driven by targeted brand investment.
| 2022 Form 10-Q | | 30 |
Net revenues for Juvederm Collection (including Juvederm Ultra XC, Juvederm Voluma XC and other Juvederm products) used in facial aesthetics increased by 31% for the three months ended March 31, 2022 due to increased consumer demand and penetration rates driven by targeted brand investment.
Net revenues for Botox Therapeutic used primarily in neuroscience and urology therapeutic areas increased by 17% for the three months ended March 31, 2022 due to market growth, higher market share and strong market recovery from the COVID-19 pandemic.
Net revenues for Vraylar for the treatment of schizophrenia, bipolar I disorder and bipolar depression increased by 23% for the three months ended March 31, 2022 due to higher market share and market growth.
Net revenues for Ubrelvy for the acute treatment of migraine with or without aura in adults increased by 70% for the three months ended March 31, 2022 primarily due to increased market share uptake since launch.
Net revenues for Mavyret decreased by 5% for the three months ended March 31, 2022 driven by the continued disruption of global HCV markets due to the COVID-19 pandemic.
Gross Margin
| Three months ended March 31, | ||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | 2022 | 2021 | % change | |||||||||||||||||||||||||||||||||||
| Gross margin | $ | 9,486 | $ | 8,797 | 8 | % | ||||||||||||||||||||||||||||||||
| as a % of net revenues | 70 | % | 68 | % |
Gross margin as a percentage of net revenues increased for the three months ended March 31, 2022 compared to the prior year. Gross margin percentage for the three months ended March 31, 2022 was favorably impacted by changes in product mix and lower amortization of intangible assets associated with the Allergan acquisition.
Selling, General and Administrative
| Three months ended March 31, | ||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | 2022 | 2021 | % change | |||||||||||||||||||||||||||||||||||
| Selling, general and administrative | $ | 3,127 | $ | 2,842 | 10 | % | ||||||||||||||||||||||||||||||||
| as a % of net revenues | 23 | % | 22 | % |
SG&A expenses as a percentage of net revenues increased for the three months ended March 31, 2022 compared to the prior year. SG&A expense percentage for the three months ended March 31, 2022 was unfavorably impacted by litigation reserve charges of $184 million as well as increased brand investment and product launch expenses, partially offset by leverage from revenue growth and increased synergies realized.
Research and Development and Acquired IPR&D and Milestones
| Three months ended March 31, | ||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | 2022 | 2021 | % change | |||||||||||||||||||||||||||||||||||
| Research and development | $ | 1,497 | $ | 1,667 | (10) | % | ||||||||||||||||||||||||||||||||
| as a % of net revenues | 11 | % | 13 | % | ||||||||||||||||||||||||||||||||||
| Acquired IPR&D and milestones | $ | 145 | $ | 185 | (22) | % |
R&D expenses as a percentage of net revenues decreased for the three months ended March 31, 2022 compared to the prior year. R&D expense percentage was favorably impacted by the purchase of a priority review voucher from a third party in the first quarter of 2021, increased scale of the combined company and synergies realized as well as lower integration costs related to the acquisition of Allergan.
Acquired IPR&D and milestones expense represents upfront and subsequent development milestone payments incurred prior to regulatory approval to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Acquired IPR&D and milestones expense in the three months ended March 31, 2022 included a charge of $130 million as a result of acquiring Syndesi Therapeutics SA and its portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118, which is being evaluated to target nerve terminals to enhance synaptic efficiency. There were no individually significant transactions during the three months ended March 31, 2021.
| 2022 Form 10-Q | | 31 |
Other Non-Operating Expenses (Income)
| Three months ended March 31, | ||||||||||||||||||||||||||
| (in millions) | 2022 | 2021 | ||||||||||||||||||||||||
| Interest expense | $ | 548 | $ | 632 | ||||||||||||||||||||||
| Interest income | (9) | (10) | ||||||||||||||||||||||||
| Interest expense, net | $ | 539 | $ | 622 | ||||||||||||||||||||||
| Net foreign exchange loss | $ | 25 | $ | 9 | ||||||||||||||||||||||
| Other income, net | (776) | (395) |
Interest expense, net decreased for the three months ended March 31, 2022 compared to the prior year primarily due to lower average debt balance due to deleveraging.
Other income, net included a benefit related to changes in fair value of contingent consideration liabilities of $748 million for the three months ended March 31, 2022 and $343 million for the three months ended March 31, 2021. The fair value of contingent consideration liabilities is impacted by the passage of time and multiple other inputs, including the probability of success of achieving regulatory/commercial milestones, discount rates, the estimated amount of future sales of the acquired products and other market-based factors. For the three months ended March 31, 2022 and 2021, the change in fair value was driven by higher discount rates partially offset by the passage of time.
Income Tax Expense
The effective tax rate was 9% for the three months ended March 31, 2022 compared to 8% for the three months ended March 31, 2021. The effective tax rate in each period differed from the U.S. statutory tax rate of 21% principally due to the impact of foreign operations which reflects the impact of lower income tax rates in locations outside the United States, tax incentives in Puerto Rico and other foreign tax jurisdictions, business development activities and accretion on contingent consideration. The increase in the effective tax rate for the three months ended March 31, 2022 over the prior year was primarily due to differences in the company’s jurisdictional mix of earnings.
FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES
| Three months ended March 31, | |||||||||||
| (in millions) | 2022 | 2021 | |||||||||
| Cash flows provided by (used in): | |||||||||||
| Operating activities | $ | 4,908 | $ | 4,877 | |||||||
| Investing activities | (1,591) | (342) | |||||||||
| Financing activities | (6,972) | (3,174) |
Operating cash flows for the three months ended March 31, 2022 were flat compared to the prior year primarily due to improved results of operations resulting from revenue growth, offset by the timing of working capital cash flows.
Investing cash flows for the three months ended March 31, 2022 included payments made for net purchases of investment securities totaling $1.4 billion, acquisitions and investments of $185 million and capital expenditures of $162 million. Investing cash flows for the three months ended March 31, 2021 included payments made for acquisitions and investments of $198 million, capital expenditures of $188 million and net purchases of investment securities totaling $5 million.
Financing cash flows for the three months ended March 31, 2022 included an early repayment of $2.9 billion aggregate principal amount of the company’s 3.45% senior notes. Additionally, financing cash flows included repayment of a $2.0 billion floating rate term loan due May 2025 and issuance of a new $2.0 billion floating rate term loan as part of the term loan refinancing in February 2022.
Financing cash flows also included cash dividend payments of $2.5 billion for the three months ended March 31, 2022 and $2.3 billion for the three months ended March 31, 2021. The increase in cash dividend payments was primarily driven by the increase in the quarterly dividend rate.
| 2022 Form 10-Q | | 32 |
On February 17, 2022, the company announced that its board of directors declared a quarterly cash dividend of $1.41 per share for stockholders of record at the close of business on April 15, 2022, payable on May 16, 2022. The timing, declaration, amount of and payment of any dividends by AbbVie in the future is within the discretion of its board of directors and will depend upon many factors, including AbbVie’s financial condition, earnings, capital requirements of its operating subsidiaries, covenants associated with certain of AbbVie’s debt service obligations, legal requirements, regulatory constraints, industry practice, ability to access capital markets and other factors deemed relevant by its board of directors.
The company's stock repurchase authorization permits purchases of AbbVie shares from time to time in open-market or private transactions at management's discretion. The program has no time limit and can be discontinued at any time. AbbVie repurchased 8 million shares for $1.1 billion during the three months ended March 31, 2022 and 5 million shares for $550 million during the three months ended March 31, 2021.
Credit Risk
AbbVie monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. AbbVie regularly communicates with its customers regarding the status of receivable balances, including their payment plans and obtains positive confirmation of the validity of the receivables. AbbVie establishes an allowance for credit losses equal to the estimate of future losses over the contractual life of outstanding accounts receivable. AbbVie may also utilize factoring arrangements to mitigate credit risk, although the receivables included in such arrangements have historically not been a significant amount of total outstanding receivables.
Credit Facility, Access to Capital and Credit Ratings
Credit Facility
AbbVie currently has a $4.0 billion five-year revolving credit facility that matures in August 2024. This credit facility enables the company to borrow funds on an unsecured basis at variable interest rates and contains various covenants. At March 31, 2022, the company was in compliance with all covenants, and commitment fees under the credit facility were insignificant. No amounts were outstanding under the company's credit facility as of March 31, 2022 and December 31, 2021.
Access to Capital
The company intends to fund short-term and long-term financial obligations as they mature through cash on hand, future cash flows from operations or has the ability to issue additional debt. The company’s ability to generate cash flows from operations, issue debt or enter into financing arrangements on acceptable terms could be adversely affected if there is a material decline in the demand for the company’s products or in the solvency of its customers or suppliers, deterioration in the company’s key financial ratios or credit ratings or other material unfavorable changes in business conditions. At the current time, the company believes it has sufficient financial flexibility to issue debt, enter into other financing arrangements and attract long-term capital on acceptable terms to support the company’s growth objectives.
Credit Ratings
In March 2022, Moody’s Investors Service (Moody’s) affirmed its Baa2 senior unsecured long-term rating and the Prime-2 short-term rating. At the same time, Moody’s revised the outlook to positive from stable. Unfavorable changes to the ratings may have an adverse impact on future financing arrangements; however, they would not affect the company’s ability to draw on its credit facility and would not result in an acceleration of scheduled maturities of any of the company’s outstanding debt.
CRITICAL ACCOUNTING POLICIES
A summary of the company’s significant accounting policies is included in Note 2, “Summary of Significant Accounting Policies” in AbbVie's Annual Report on Form 10-K for the year ended December 31, 2021. There have been no significant changes in the company’s application of its critical accounting policies during the three months ended March 31, 2022.
| 2022 Form 10-Q | | 33 |
FORWARD-LOOKING STATEMENTS
Some statements in this quarterly report on Form 10-Q 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, failure to realize the expected benefits from AbbVie's acquisition of Allergan, failure to promptly and effectively integrate Allergan's businesses, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 Annual Report on Form 10-K for the year ended December 31, 2021, which has been filed with the Securities and Exchange Commission. AbbVie notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. 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.
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