Year Established: 1849
Revenues: $48,851 (-2%)
Biopharma Revenues: $45,708 billion (-5%)
Net Income: $6,960 (-24%)
R&D: $7,690 (-8%)
TOP SELLING DRUGS
|Prevnar||family pneumoccal vaccine||$6,245||40%|
Pfizer was at the center of the biggest story to rock the pharma world in 2015 when it was announced in November that it and Allergan would merge in a $160 billion deal, catapulting the combined company past Novartis atop the pharma leader boards.
But, the inversion deal didn’t happen. It was called off at the last minute after a change in U.S. tax law.
If it had gone through Allergan would have acquired Pfizer and the two businesses would be combined under Allergan plc, to later be renamed Pfizer plc. Although on paper Allergan would be buying Pfizer, Pfizer would have retained control of the company with Pfizer stockholders holding 56% of the combined company and Allergan shareholders owning 44%.
In addition, the combined company was expected to maintain Allergan’s headquarters in Ireland creating a huge tax incentive for Pfizer. The U.S. corporate tax rate is 35%, while Ireland’s is just 12.5%. Pfizer’s global operational headquarters would be in New York and its principal executive offices in Ireland.
However, the U.S. Treasury Department introduced rules aimed at reducing the incentives for companies to carry out inversions and taking advantage of another nation’s lower tax rate.
According to Pfizer, the change in rules was impactful enough to reduce the advantages expected from the merger. Pfizer paid Allergan $150 million to cover expenses related to calling off the deal.
If it still has its eyes set on becoming the largest pharma giant in the world, they’re going to have to wait for the time being. That being said, 2015 wasn’t just about the failed Allergan deal.
Pfizer gained a portfolio of biosimilars and sterile injectable products when it bought Hospira for $17 billion. Hospira has built a reputation as a leading provider of injectable drugs and infusion technologies, as well as biosimilars. The global market value for both generic sterile injectables and biosimilars is expected to grow, estimated to be $70 billion and $20 billion in 2020, respectively.
The acquisition expands Pfizer’s portfolio of sterile injectable pharmaceuticals with Hospira’s generic sterile injectables product line, including acute care and oncology injectables, with a number of differentiated presentations. Pfizer’s branded sterile injectables include anti-infectives, anti-inflammatories and cytotoxics. Pfizer also plans to employ its commercial capabilities, global scale, and scientific and development capabilities to significantly expand Hospira’s portfolio of marketed biosimilars, including Retacrit to treat anemia associated with chemotherapy, and Nivestim, a biosimilar version of filgrastim (GCSF), to treat neutropenia.
In another deal, Pfizer acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the company. AM-Pharma is a privately held Dutch biopharma company focused on the development of recombinant human alkaline phosphatase (recAP) for inflammatory diseases.
Pfizer made an upfront payment of $87.5 million for the minority interest and exclusive option, with additional potential payments of up to $512.5 million upon the potential launch of any product from this agreement.
Pfizer may exercise the option upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury (AKI) related to sepsis, for which there are no drugs currently approved. Results from the Phase II trial are expected in 2H16.
During the year Pfizer also acquired a controlling interest in Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharma company, gaining access to a preclinical human cytomegalovirus (CMV) vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine program. CMV is a herpes virus, infecting 50-90% of the adult population, with a majority remaining asymptomatic. A large segment of young adults, especially women of childbearing age, are at high risk of CMV infection during pregnancy and of passing the infection on to the unborn child. One out of every five children born with CMV infection may experience hearing loss and severe neurologic disorders.
In another transaction, Pfizer entered into an agreement with GSK to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130 million. Nimenrix is a single dose meningococcal ACWY-TT (tetanus toxoid) conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. It was launched three years ago and is indicated for all age groups one year and older. Nimenrix is currently approved in 61 countries, with registrations under review in another 18 countries across Africa, Asia, Eastern Europe and the Middle East. Mencevax is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers to countries where the disease is endemic. It’s indicated for use across all age groups from two years of age, and is currently registered and approved in 79 countries across Africa, Asia, Australia, Europe, Latin America, Middle East and New Zealand.
Segment and product performance
Total revenues for Pfizer were $48.9 billion in 2015, driven by the performance of several key products in developed markets, including the continued strong uptake of Prevnar 13, Ibrance, Eliquis, Lyrica and Xeljanz. Direct product sales of more than $1 billion were reported for seven products in 2015.
Pfizer operates through two distinct businesses: an Innovative Products business and an Established Products business. The Innovative Products business is composed of two operating segments—the Global Innovative Pharmaceutical segment (GIP) and the Global Vaccines, Oncology and Consumer Healthcare (VOC). The Established Products business consists of the Global Established Pharmaceutical segment (GEP).
GIP recorded sales of $13.9 billion in 2015. Key therapeutic areas include inflammation/immunology,cardiovascular/metabolic, neuroscience/pain and rare diseases and include leading brands, such as Xeljanz, Eliquis, Lyrica (U.S. and Japan), Enbrel (outside the U.S. and Canada) and Viagra (U.S. and Canada).
VOC netted $12.8 billion in sales and focuses on the development and commercialization of vaccines and products for oncology and consumer healthcare manufacturing and marketing several well known, over-the-counter (OTC) products.
GEP is the largest of Pfizer’s business areas with $21.5 billion in revenue and includes legacy brands that have lost or will soon lose market exclusivity in both developed and emerging markets, branded generics, generic sterile injectable products, biosimilars and infusion systems. Hospira and its commercial operations are now included within GEP.
Geographically, in the U.S., revenues increased $2.6 billion, or 14%, in 2015, compared to 2014, reflecting, among other things the performance of several key products, including Prevnar 13 primarily in adults, up approximately $1.9 billion; Ibrance, which was launched in the U.S. in February 2015, up approximately $720 million; as well as Lyrica (GIP), Eliquis, Xeljanz, Viagra (GIP) and Nexium 24HR, collectively up approximately $1.0 billion in 2015.
Performance was offset by losses of exclusivity and associated multi-source generic competition for Celebrex in the U.S. in December 2014, down approximately $1.6 billion in 2015; the loss of exclusivity for Zyvox and Rapamune, as well as the termination of the Spiriva co-promotion collaboration, collectively, down approximately $620 million in 2015; and the performance of Lipitor and BeneFIX, collectively, down approximately $160 million in 2015.
In Pfizer’s international markets, revenues decreased $3.4 billion, or 11%. Total share of international revenues also dropped in the year from 62% the prior year to 56% in 2015.
Emerging markets represented continued strong operational growth primarily from the Innovative Products business, including Prevenar and Enbrel, among other products, and Lipitor, up approximately $600 million in 2015; higher revenues in developed markets for Eliquis and Lyrica (GIP), as well as from vaccines acquired in December 2014 from Baxter in Europe, collectively, up approximately $590 million in 2015.
Business was offset by lower revenues in developed markets for Lyrica (GEP), Celebrex, Inspra and Viagra (GEP) as a result of the loss of exclusivity, as well as the performance of Lipitor and Norvasc in developed markets, and Zosyn/Tazocin in emerging markets, collectively down approximately $1.0 billion in 2015.
During the year Pfizer and Adaptive Biotechnologies entered into a translational research collaboration to leverage next-gen sequencing of the adaptive immune system to advance Pfizer’s immuno-oncology pipeline. The companies will combine drug development and platform technology biomarker expertise to identify patients who may benefit from immunotherapy.
Adaptive’s immunosequencing platform measures the patient’s immune-cell repertoire, providing a translational tool to accelerate Pfizer’s immuno-oncology biomarker and drug development programs. Adaptive will work with Pfizer to apply its platform technology, bioinformatics capability, and scientific expertise.
Merck KGaA and Pfizer entered into a collaboration Syndax Pharmaceuticals to evaluate avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory T-cells), in patients with heavily pre-treated, recurrent ovarian cancer. Avelumab is currently being investigated across a broad range of tumor types under the alliance between Merck KGaA and Pfizer. This is an exclusive agreement with Syndax to study the combination of these two compounds in ovarian cancer. Syndax will be responsible for conducting the Phase Ib/II trial.
Pfizer and BIND Therapeutics extended the terms of their global collaboration through to create Accurins that optimize two of Pfizer’s targeted oncology drugs. The collaboration was established in April 2013 under which Bind employs its nanomedicine platform to develop targeted and programmable therapeutics known as Accurins.
Pfizer has the exclusive option to pursue development and commercialization of the Accurins selected, at which point Pfizer will have responsibility for development and commercialization of the selected Accurins. Both companies will work together on preclinical research. BIND has the potential to receive as much as $88.5 million based on specified development and regulatory milestones, as well as $110 million for specified commercial events and royalties for each Accurin commercialized.
Will create a single Pfizer Cambridge campus for discovery and development efforts
Pfizer has unveiled plans to expand its lease agreement with a subsidiary of Massachusetts Institute of Technology, creating a unified Pfizer campus in Kendall Square. With this expansion, Pfizer has leased the full 500,000 square feet at 610 Main Street in Kendall Square. This space will continue to house the R&D activities that relocated to 610 Main Street in 2014, and will enable the consolidation of Pfizer’s three other leased spaces in Cambridge into the one campus.
This most recent lease addition secures an added 130,000 square feet of space for potential expansion in the future and will be available for sub-tenancy in 2017. Once the three remote sites are consolidated, 610 Main Street will house approximately 1,000 Pfizer employees.
Pfizer’s R&D efforts in Cambridge will continue to focus on rare diseases, cardiovascular and metabolic disease, inflammation and immunology, neuroscience, and advanced biotherapeutic technologies. The expanded 370,000-plus square foot KSQ research center will help foster a strong laboratory culture, with experimentation and collaboration in the heart of Cambridge’s Kendall Square innovation hub, featuring state-of-the-art labs and an open design to help foster breakthrough productivity and innovation that will potentially advance Pfizer’s pipeline.
The Pfizer Cambridge campus provides more laboratory capabilities in proximity to one another; opportunities for collaborations between Pfizer and smaller start-ups and/or biotechs; the ability to coalesce functions from across Pfizer R&D currently spread across Cambridge; and close proximity to new companies.