Headcount: 17,400
Revenues: $15,775 (0%)
Loss: $5,271 (N/M)
R&D: $1,709 (-25%)

TOP SELLING DRUGS

In the second largest pharma acquisition of 2019, Botox-maker Allergan was bought out by AbbVie for $63 billion. The deal was green lit by the FTC in May 2020 and concluded what had been a rough few years for Allergan beginning with the failed $160 billion mega deal with Pfizer that fell through in 2016 after getting pushback from the Obama administration.

The combined company consists of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care and virology. Projected 2020 revenues for the combined company are expected to come in around $50 billion.

AbbVie had been looking to diversify its portfolio as its blockbuster arthritis treatment Humira faces competition from cheaper versions in Europe and faces expiration of its patents in the U.S. in 2023. Allergan’s aesthetics products, including Botox, and eye care blockbuster Restatis, along with other medicines, could help AbbVie shore up revenue.

As part of the deal, Allergan divested brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to AstraZeneca and Zenpep, a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, to Nestle.

Before the deal closed, in February 2020, Allergan opened a new $180 million state-of-the-art Biologics 2 facility at its Westport Campus in Co. Mayo, Ireland. The new facility, which further cemented Ireland’s position as a global hub for Allergans’ flagship products, including the blockbuster Botox, brings Allergan’s total investment in Ireland since it began operations in the country to roughly $850 million.

The facility features new manufacturing suites to meet growing global product demand. In addition, to support the next generation of biologics innovation, the facility features a new state-of-the-art microbiology and cell-based laboratory with world-class technology and research and development capabilities to support advances in discovery, development and manufacturing.

Coinciding with the opening of the Biologics 2 facility, Allergan marked the shipping of the 100 millionth vial of Botox from the Westport campus as the company celebrated 30 years since the product first received FDA approval. The new facility and famous cosmetic skin injection brand have fallen into AbbVie’s hands with the conclusion of the acquisition deal.

During the year, Allergan R&D continued to advance its pipeline. Most notably, it received approval from the U.S. FDA for the new drug UBRELVY (ubrogepant), a first-in-class oral treatment for migraine. Launch began in January 2020.

Allergan also received two new approvals for BOTOX for pediatric spasticity; approval for VRAYLAR for bipolar depression; and filings for two new eye care drugs—Bimatoprost SR for glaucoma and Abicipar for age-related macular degeneration.

Headcount: 16,900
Revenues: $15,787 (-1%)
Loss: $5,086 (NM)
R&D: $2,266 (+8%)

TOP SELLING DRUGS

Just as this issue was getting ready to fly, AbbVie shook up the pharma world with its $63 billion acquisition of Allergan. The Botox-maker, and biggest name in medical aesthetics, helps AbbVie diversify a portfolio that includes the world’s best-selling drug, Humira, which soon faces generic competition in Europe. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care and virology.

The mega-deal comes after Allergan tried to become more efficient by reducing costs and streamlining operations. At the beginning of 2018 it unveiled a restructuring plan that called for the elimination of 1,000 jobs as part of the effort. It also recently unloaded its generics business to Teva for $40 billion in 2016.

In September 2018 Allergan also divested products in its dermatology unit to Almirall, S.A. for $550 million. The products include Aczone, Tazorac, Azelex and Cordran Tape, as well as sarecycline, a new chemical entity currently under FDA review for the treatment of acne.

Allergan recorded $15.7 billion in revenues in 2018, a drop of 1% from the year before. Its top selling product is Botox, a cosmetic filler with pharmaceutical indications for chronic migraine and overactive bladder, which grew 13% with $3.5 billion in sales. The year wasn’t so good for Allergan’s other top seller, dry eye drug Restasis, which saw its revenue drop 14% to $1.2 billion.

A major highlight during the year saw Allergan and Amgen together win European approval for MVASI (biosimilar bevacizumab). MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers, including in combination with chemotherapy or other therapies for metastatic carcinoma of the colon or rectum, metastatic breast cancer, non-squamous non-small cell lung cancer, renal cell cancer, ovarian, fallopian tube, or primary peritoneal cancer, or metastatic carcinoma of the cervix.

In September 2017, MVASI became the first anti-cancer biosimilar, as well as the first biosimilar bevacizumab, to be approved by the FDA. Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars.

In acquisition news, Allergan bolstered its medical aesthetics portfolio, specifically facial injectables, when it paid $195 million for Bonti, Inc., a clinical-stage biotech focused on novel, neurotoxin programs for aesthetic and therapeutic applications.

Headcount: 17,000
Revenues: $15,941 (+9%)
Loss: $4,404 (n/a)
R&D: $2,100 (-19%)

TOP SELLING DRUGS

While 2016 was the year of acquisitions for Allergan, this year has branded itself as the year of drug approvals from various agencies. The only major acquisition was that of Keller Medical, a privately held medical device company.

Although Allergan posted a solid 9% growth in reveneus in 2017, losses for the year include the impact of taxes paid in connection with the generic businesses sold to Teva Pharmaceuticals, and amortization of approximately $6.5 billion, primarily due to impairment charges recognized in 3Q17 of $3.2 billion related to Restasis and $646 million related to Aczone.

In terms of acceptances, notable highlights include the approval of Ozurdex by the CFDA for the treatment of adult patients with macular edema for retinal vein occlusion. This approval is key, as it is the first approved intravitreal injection for retinal vein occlusion in China, which is one of the most common causes of sudden, unilateral loss of vision. The FDA also accepted the NDA for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids.

In addition, November 2017 brought the FDA’s approval for the sNDA for Vraylar for the maintenance treatment of adults with schizophrenia. Vraylar is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

Also, in February 2018 the FDA approved  Avycaz for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This marks the third therapeutic indication for Avycaz, which was first approved in February 2015 for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and in 2017 for complicated urinary tract infections.

In aesthetics, the FDA approved BOTOX Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas: forehead lines, crow’s feet lines and glabellar lines.

Advancing through the pipeline, Allergan’s oral CGRP receptor antagonist Atogepant recently demonstrated promising efficacy and safety in episodic migraine prevention in a Phase IIb/III trial, meeting the primary endpoint across all doses with a statistically significant reduction in monthly migraine/probable migraine (MPM) headache days in patients with episodic migraine.

Headcount: 16,700
Revenues: $14,571 (+15%)
Net Income: $14,695 (+275%)*
R&D: $2,576 (+9%)

TOP SELLING DRUGS

After selling off its generics business to Teva last year for roughly $40 billion, Allergan was active on the acquisition front in 2016, picking up a handful of biotechs to bolster its pipeline. In April it acquired Topokine Therapeutics, a clinical-stage biotech focused on topical medicines for fat reduction, for $85 million upfront, gaining XAF5, a topical agent in late-stage development for the treatment of steatoblepharon (undereye bags).

In September it inked a deal to buy Vitae Pharmaceutical for $639 million, strengthening its dermatology pipeline with the addition of VTP-43742, a Phase II orally active RORγt (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis and other autoimmune disorders.

In the same month, Allergan bought Tobira Pharmaceuticals, a clinical-stage biopharma company developing therapies for non-alcoholic steatohepatitis (NASH) and other liver disease, for up to $1.7 billion if certain milestones are met. The acquisition adds Cenicriviroc (CVC) and Evogliptin, two development programs for the treatment of the multi-factorial elements of NASH, including inflammation, metabolic syndromes and fibrosis.

In November Allergan paid $125 million for Chase Pharmaceuticals Corp., another clinical-stage biotech developing treatments for neurodegenerative disorders including Alzheimer’s disease (AD). The deal expands Allergans central nervous system (CNS) pipeline with a Phase III-ready AD candidate—Chase’s lead compound, CPC-201, and certain backup compounds.

During the year Allergan entered several licensing agreements. One was with MedImmune, AstraZeneca’s global biologics R&D arm, for the global rights to MEDI2070, an anti-IL-23 monoclonal antibody currently in Phase II development for the treatment of moderate-to-severe Crohn’s disease and ulcerative colitis and other related conditions. Allergan paid $250 million upfront with potential payments of as much as $1.3 billion in milestones.

With Adamis Pharmaceuticals, Allergan entered into a licensing agreement with through its wholly owned subsidiary, Watson Laboratories, to commercialize Adamis’ Epinephrine Pre-filled Syringe (PFS) product candidate for the emergency treatment of anaphylaxis. Watson obtains commercial rights for the U.S. in exchange for an upfront fee and potential regulatory and performance based milestones totaling up to $32.5 million. Additionally, Watson will pay royalties based on future sales of the PFS in the U.S.

In emerging markets, Allergan, again through Watson Labs, inked a $106 million generic oncology deal with China’s CSPC Pharmaceutical Group relating to the product technology licensing and commercialization of an oncology drug in the global market.

Headcount: 31,200
Revenues: $15,071 (+124%)
Net Income: $3,683 (-$1,630 FY14)
R&D: $2,359 (+289%)

TOP SELLING DRUGS

In 2014 after Actavis acquired Allergan in a mega deal worth $66 billion it adopted the Allergan name. The deal was completed in March 2015 and the company’s portfolio was bolstered by the addition of Legacy Allergan’s therapeutic franchises in ophthalmology, neurosciences and medical aesthetics/dermatology/plastic surgery, complementing the its existing central nervous system, gastroenterology, women’s health and urology franchises.

The combined company benefited from Legacy Allergan’s global brand recognition and consumer awareness of key products, including Botox and Restasis. The transaction also expanded the its presence and market and product reach across many international markets, with strengthened commercial positions across Canada, Europe, Southeast Asia and other high-value growth markets, including China, India, the Middle East and Latin America.

The year will be remembered more though for the proposed merger of Pfizer and Allergan in November for a whopping $160 billion, a deal that would have created the largest pharma company in the world. But, the deal didn’t go through. It was called off at the last minute after a change in U.S. tax law and is discussed in more detail in Pfizer’s profile at the beginning of this report.

However, there were several other deals of note that did go through. One was the acquisition of Kythera Biopharmaceuticals for $2.1 billion. Kythera is focused on the discovery, development and commercialization of novel prescription aesthetic products. Its lead product, Kybella injection, is the first and only FDA-approved, non-surgical treatment for moderate to severe submental fullness, commonly referred to as double chin.

In another deal, Allergan acquired Auden Mckenzie, a company specializing in the development, licensing and marketing of niche generic medicines and proprietary brands in the UK and across Europe for approximately $500 million. The acquisition of Auden Mckenzie makes Actavis the number one supplier of generic pharmaceuticals in the UK and gives the company the number three position in the supply of UK pharmaceuticals.

With Ironwood Pharmaceuticals, Allergan struck a deal to acquire rights to Constella (linaclotide) in the EU, Switzerland, Turkey.

Allergan also acquired certain products in early stage development from Naurex, $571 million plus future contingent payments up to $1.1 billion. The deal expands Allergan’s pipeline with Naurex’s two leading product candidates GLYX-13 and NRX-1074, two compounds that utilize NMDA modulation as a potential new approach to the treatment of major depressive disorder (MDD).

Lastly, the company entered into an agreement with Merck to acquire the exclusive worldwide rights to Merck’s early development stage investigational small molecule oral calcitonin gene-related peptide receptor antagonists, which are being developed for the treatment and prevention of migraines for $250 million. Additionally, Merck is owed contingent payments based on commercial and development milestones of up to $965 million as well as royalties.

During the year Allergan entered into an exclusive licensing agreement with Mimetogen Pharmaceuticals, a clinical stage biotechnology company, to develop and commercialize tavilermide (MIM-D3), a topical formulation of a novel small molecule TrkA agonist for the treatment of dry eye disease.

Headcount: 11,100
Bio/Pharma Revenues: $1,7661 (1%)
Total Revenues: $5,806 (7%)
Net Income: $1,0991 (8%)
R&D Budget: $986 (9%)

Top Selling Drugs

Account for 100% of total biopharma sales, same as in 2011

Headcount: 9,200
Pharma Revenues: $1,419 ( 8%)
Total Revenues: $4,919 (9%)
Net Income*: $1 ( -100%)
R&D Budget: $805 (14%)

* $609 million legal settlement in 2010 related to Botox marketing wiped out net earnings

Top-Selling Drugs in 2010

Account for 100% of total biopharma sales, same as in 2009.

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