Below is a look at the company’s 2023/24 highlights, recent acquisitions, best-selling drugs, and more.

Headcount: 37,000
Year Established: 1901
Revenues: $15,846  (+6%)
LOSS: $615  (loss $2.5B FY22)
R&D: $953  (+14%)

Teva is a global pharmaceutical company that operates worldwide, with headquarters in Israel and a significant presence in the U.S. and Europe. It operates its business through three segments: North America, Europe and International Markets. Its product and service portfolio includes generic medicines, biopharmaceuticals, innovative medicines, OTC products, a distribution business, APIs and contract manufacturing.

Revenues in 2023 were $15,846 million, an increase of 6% compared to 2022. This increase was mainly due to an upfront payment received in connection with the collaboration on its anti-TL1A asset, higher revenues from generic products in its International Markets and Europe segments, higher revenues from Austedo and Ajovy, the sale of certain product rights in its Europe segment, as well as higher revenues from Anda, partially offset by lower revenues from Copaxone, API sales to third parties, Bendeka and Treanda, and generic products in its North America segment.

In May 2023, the company introduced its new “Pivot to Growth” strategy, which is based on four key pillars: delivering on its growth engines, mainly Austedo, Ajovy, Uzedy and its late-stage pipeline of biosimilars; stepping up innovation through delivering on its late-stage innovative pipeline assets as well as building up its early-stage pipeline organically and potentially through business development activities; sustaining its generics medicines powerhouse with a global commercial footprint, focused portfolio, pipeline and manufacturing footprint; and focusing its business by optimizing its portfolio and global manufacturing footprint to enable strategic capital deployment to accelerate its near and long-term growth engines and reorganizing certain business units to a more optimal structure while also reorganizing key business unites to enhance operational efficiency.

In July 2023, Teva Pharmaceuticals and Alvotech, a global biotech company, expanded their existing strategic partnership agreement. The companies will continue working closely on matters concerning pending approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab). The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Stelara (ustekinumab), which is currently pending U.S. FDA approval.

In October 2023, Sanofi and Teva Pharmaceuticals entered a collaboration to co-develop and co-commercialize asset TEV’574, currently in Phase 2b trials for the treatment of Ulcerative Colitis and Crohn’s Disease, two types of inflammatory bowel disease.

Most recently, in April, Teva Pharmaceuticals International and mAbxience entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. The licensing agreement covers multiple global markets, including Europe and the U.S.

Headcount: 40,216
Revenues: $16,659  (-1%)
Loss: $3,990  (+>100%)
R&D: $997  (-1%)

TOP SELLING DRUGS

Teva’s revenue fell 1% to $16.7 billion in 2020 mainly due to a decline in revenues from certain oncology products, COPAXONE and certain respiratory products, partially offset by higher revenues from AUSTEDO and AJOVY. The decline in revenues was also affected by reduced demand for certain products resulting from the impact of the Covid-19 pandemic.

In August 2020, the company entered into a partnership agreement with biopharmaceutical company Alvotech for the exclusive commercialization in the U.S. of five biosimilar product candidates. The initial pipeline for this partnership contains biosimilar candidates addressing multiple therapeutic areas. Under this agreement, Alvotech is responsible for the development, registration and supply of the biosimilar product candidates and Teva will exclusively commercialize the products in the United States. Teva and Alvotech will share profit from the commercialization of these biosimilars.

This commercial partnership with Alvotech will enable Teva to lend its technical expertise in working with the FDA to bring products to the U.S. market while broadening its growing biosimilar portfolio and continuing to leverage its unique cross-functional expertise across both specialty and generic medicines.

As a global leader in generics, the past year was marked by several new launches. In October 2020, Teva launched the first Food and Drug Administration (FDA)-approved generic versions of TRUVADA and ATRIPLA tablets in the U.S. for the treatment of HIV-1 infection. In January 2021, the company launched a generic version of NuvaRing (etonogestrel and ethinyl estradiol vaginal ring) in the U.S., an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. This year, the company also launched the first available generic version of AZOPT (brinzolamide ophthalmic suspension) 1%, approved by the U.S. FDAto treat high pressure inside the eye due to ocular hypertension and open-angle glaucoma, and a 1000 mg strength generic version of Casana (mesalamine) suppository medicine used to treat adults with active ulcerative proctitis (ulcerative rectal colitis), in the U.S.

Other recent launches in the U.S. include the first available 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strength generic version of Absorica (isotretinoin) capsules for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older, and the launch of 250 mg and 500 mg strength generic Erythromycin tablets for treatment of a variety of bacterial infections. The most recent rollout was a generic version of THIOLA (tiopronin) tablets, indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine (kidney) stone formation.

In June 2021, Teva filed a new lawsuit against Eli Lilly (#14 on this year’s Top Companies list) in Massachusetts federal court, the same day Teva received two new AJOVY patents from the U.S. Patent and Trademark Office. The company claims that Lilly’s rival migraine prevention drug, Emgality, infringes upon the two newly granted AJOVY patents. Teva is also seeking to block Lilly from making and selling its CGRP inhibitor in the U.S. and is demanding damages. The suit comes after Teva and Lilly previously fought over nine other Teva patents on AJOVY. In early 2020 the U.S. Patent & Trademark office invalidated six patents but upheld the remaining three. Now, both companies are appealing the ruling.

Headcount: 40,039
Revenues: $16,887  (-10%)
Loss: $1,555  (N/M)
R&D: $1,010 (-17%)

TOP SELLING DRUGS

Teva’s revenue fell 10% to $16.9 billion in 2019 mainly due to generic competition to COPAXONE, a decline in revenues from its U.S. generics business, and poor BENDEKA sales. Declines were partially offset by sales from AUSTEDO, AJOVY and QVAR in the U.S.

Teva bolstered its R&D presence in the U.S. with the purchase of three buildings in West Chester, PA, and with three other buildings Teva owns in the same corporate park, established a North America R&D campus. The site is focused primarily on biologics, a core area Teva continues to grow. The R&D campus houses clinical development and manufacturing processes for highly complex biologics. The campus also includes labs where preclinical and clinical testing is conducted to ensure the safety and effectiveness of new drugs.

In addition to infrastructure investment, Teva entered several biopharma research collaborations. Insilico Biotechnology and Teva entered an agreement to apply Insilico’s technology for predictive biomanufacturing to create and implement more efficient production processes of Teva’s biopharmaceuticals.

Insilico’s Digital Twins of biopharmaceutical production processes employ metabolic models of producer organisms in combination with flexible process models and artificial intelligence to create optimized production processes using simulations.

The collaboration runs for three years and will be based at Insilico’s sites in Stuttgart, Germany and at Teva’s West Chester location.

In another deal with Just Biotherapeutics, a design company focused on technologies for the manufacture of biotherapeutics, the companies will work to develop a high productivity biomanufacturing process with the goal of lowering the cost of manufacturing.

Also during the year, Teva teamed up with Genedata Biologics’ to use its workflow platform to streamline the identification, engineering, and characterization of novel biopharmaceuticals drugs.
Teva will use Genedata’s technology as the backbone system across its antibody discovery operations. In addition, the platform will enable a thorough assessment of a drug candidate’s developability profile and facilitate handovers to the Teva development and manufacturing organization.

Lastly, IONTAS, a provider of antibody discovery and optimization of human monoclonal antibody libraries, partnered with Teva to apply its technologies and know-how to the optimization of human antibodies for use as biotherapeutics.

IONTAS will initially apply its technologies to provide Teva with a panel of optimized antibodies against a defined target. Teva will have the option to enter into further optimization programs in the future. The agreement also includes options for the screening of biophysical properties suitable for developable antibodies.

Headcount: 42,535
Revenues: $18,854  (-16%)
Loss: $2,472   (NM)
R&D: $1,213  (-32%)

TOP SELLING DRUGS  

Teva’s revenues in 2018 were $18.8 billion, a decrease of 16% compared to 2017, mainly due to generic competition to multiple sclerosis drug Copaxone, a decline in revenues in the U.S. generics business and loss of revenues following the divestment of products and discontinuation of activities, all of which are part of a global restructuring effort announced by the Israeli generics giant at the end of 2017. In terms of sales, the beginning of 2019 didn’t show signs of hope. Revenues of $4.3 billion in the first quarter of 2019 continued the downward trend, marking a decrease of 15%.

Global restructuring
At the time its plans were unveiled, Teva said it would undergo a major overhaul of its operations, restructuring in an effort to significantly reduce costs and simplify its organization, as it faced $35 billion of acquisition-related debt stemming from the $40.5 billion purchase of Allergan in 2016. The plan called for cutting $3 billion in costs by the end of 2019, including the elimination of 14,000 positions globally, more than 25% of Teva’s total workforce. The majority of cuts occurred in 2018, but have carried over into this year as well.

Teva said it plans to pump up its generics portfolio globally, specifically in the U.S., through price adjustments and/or product discontinuation. It also continues to accelerate the restructuring of its manufacturing and supply network, including the closures or divestments of a significant number of manufacturing plants in the U.S., Europe, Israel and growth markets.

Teva said it will also close or divest a significant number of R&D facilities, headquarters and other office locations across all geographies. The company will also review all R&D programs in generics and specialty, to prioritize core projects and terminate other, non-core assets.

In one instance, Teva and Procter & Gamble agreed to terminate the PGT Healthcare partnership that the two companies established in 2011 to market OTC medicines. PGT Healthcare had grown into a significant presence in over 50 countries, mainly in Europe and Asia, using market-leading brands such as Vick’s and ratiopharm. However after nearly seven years working together, the companies concluded that their priorities and strategies were no longer closely aligned. Each company took back its own brand and product assets to re-establish independent OTC businesses.

As part of the global restructuring process, during the year Teva unveiled plans to consolidate its North America Commercial business into New Jersey. Teva will establish its North America headquarters in Parsippany-Troy Hills, including more than 1,000 jobs and the transfer and creation of more than 800 positions. Teva accepted an offer of a 10-year and $40 million in tax savings incentives from the NJ Economic Development Authority to move forward with the plan. The moved marked yet another step forward and in-line with Teva’s global restructuring effort to drive savings, restore financial security and stabilize its business by reducing the number of sites it operates to unify and simplify the organization, as well as improve productivity and efficiencies.

R&D
In 2018, Teva and Insilico Biotechnology entered an agreement to apply Insilico’s technology for predictive biomanufacturing to create and implement more efficient production processes of Teva’s biopharmaceutical therapeutics. Insilico’s solutions for predictive biomanufacturing are one of the key technologies to convert this value into higher quality therapies and to bring them faster to market. Insilico’s Digital Twins of biopharmaceutical production processes employ metabolic models of producer organisms in combination with flexible process models and artificial intelligence to create optimized production processes by computational simulations. The collaboration will run for three years and will be based at Insilico’s sites in Stuttgart, Germany and at Teva’s West Chester, PA, location.

In another deal to bolster its biomanufacturing operations, Teva teamed up with Genedata, a provider of bioinformatics enterprise software, to use its workflow platform to streamline the identification, engineering, and characterization of novel biopharmaceuticals drugs. Teva will use Genedata Biologics as their backbone system across their antibody discovery operations. In addition, the platform will enable a thorough assessment of a drug candidate’s developability profile and facilitate handovers to the Teva development and manufacturing organization.

In September 2018, Teva received approval from the FDA for its  AJOVY (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. AJOVY, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocksits binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine.

Teva also received approval from the FDA at the end of the year for its ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older. The device contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth Wireless Technology so patients can review their data over time, and if desired, share it with their healthcare professionals.

Headcount: 51,792
Revenues: $22,385  (+2%)
Specialty Pharma Revenues: $7,914  (-9%)
Loss: $16,449  (n/a)
R&D: $1,848  (-12%)

TOP SELLING DRUGS  

It was a rather turbulent year for Teva, fraught with financial losses, a massive cost-cutting restructuring initiative, and executive management tribulations. Among the problems plaguing the company, the $40.5 billion acquisition of Allergan’s generic drug business in 2016 has left Teva in grave debt. Additionally, the softening of global generics market and generic competition to its top selling specialty drug Copaxone for multiple sclerosis, have taken a toll on the generic giant.

The CEO behind the Allergan acquisition, Erez Vigodman, stepped down, along with other executives. In October, Kåre Schultz was appointed president and chief executive officer to help  turn things around and initial cost-cutting efforts included a slew of job cuts. Schultz  says 2018 is off to a solid start and the restructuring program is on track to meet cost-reduction targets of $1.5 billion in 2018 and $3 billion by the end of 2019.

In 2017 results were met with an impairment charge of $17.1 billion, mainly related to the U.S. generics unit; an impairment of assets of $3.8 billion related to revaluation of generic products acquired from Actavis; and amortization of purchased intangible assets totaling $1.4 billion; as well as restructuring expenses of $535 million, just to name a few…

The company made some headway in the first quarter of 2018 but there’s clearly much work to be done. Teva’s revenue was down 10% to $5.1 billion in 1Q18, but earnings were up 77% to $1.1 billion. Sales of Copaxone fell 40% in the U.S., the company’s largest market, and generic medicine sales in the U.S. fell 23%. In Europe, however, Teva’s generic revenues grew 17%, even Copaxone sales were up 1%, and respiratory sales saw 35% growth. Bendeka / Treanda sales were up 16% in 1Q18, and ProAir and QVAR sales were up 7% and 27%, respectively. It’s not clear yet if and for how long these products can sustain Teva.

While these numbers don’t look all that promising, the company said 2018 is shaping up to be a better year than previously expected and raised its outlook for revenues and adjusted earnings. Revenue is now forecast to be between $18.5 billion and $19 billion, up from $18.3 billion to $18.8 billion.

Corporate Restructuring

In October, Teva announced a new organization and leadership structure to drive commercial focus and value creation. The commercial businesses and R&D will no longer have two separate groups for generics and specialty medicines, and will be integrated into one organization.

A newly formed Marketing & Portfolio function will oversee R&D and operations throughout all product lifecycle stages. Also, the commercial structure will rely on one leaner supporting infrastructure. As a result of these changes, Dr. Michael Hayden, Dr. Rob Koremans and Dipankar Bhattacharjee retired from Teva December 31, 2017.

Among the executive changes, in addition to Schultz: Michael McClellan was appointed executive vice president, chief financial officer. McClellan previously served as the U.S. CFO at Sanofi. Dr. Hafrun Fridriksdottir was named executive vice president of Global R&D. Previously, she served as president of Global Generics R&D, and prior to Teva, served as senior vice president and president of Global Generics R&D at Allergan.

Then, in December Teva announced its two-year restructuring plan to reduce its total cost base by $3 billion by the end of 2019, more than half of which is expected to be achieved by the end of 2018. This includes a workforce reduction of more than 25% or 14,000 positions.

In other corporate news, Teva and Procter & Gamble terminated the PGT Healthcare Partnership that the two companies established in 2011 to market OTC medicines. The separation is planned to take effect July 1, 2018. The companies say that their priorities and strategies are no longer closely aligned and each company will take back its own brand and product assets to re-establish independent OTC businesses. The move creates a platform for a strong Teva OTC business, using the assets returning from PGT and the OTC brands acquired primarily through Actavis in 2016. In 2017, the combined sales from Teva’s PGT OTC products and Teva non-PGT OTC products were approximately $1 billion.

To help pay off its considerable debt, Teva sold a portfolio of products within its global women’s health business across contraception, fertility, menopause and osteoporosis, for $703 million in cash. The portfolio, which is marketed and sold outside of the U.S., includes Ovaleap, Zoely, Seasonique, Colpotrophine, Actonel and other products. The business will be known as Theramex. Teva has generated total proceeds of $2.48 billion from these divestitures.

Adding to the revenue stream, Teva signed a global license agreement with Alder BioPharmaceuticals that validates Teva’s IP and resolves Alder’s opposition to Teva’s European Patent for anti-calcitonin gene-related peptide (CGRP) antibodies and methods for their use. Alder received a non-exclusive license to Teva’s anti-CGRP antibodies patent portfolio to develop, manufacture and commercialize eptinezumab, and in exchange Alder agreed to withdraw its Patent appeal.

Teva will receive a one-time payment of $25 million, and another $25 million upon approval of a biologics license application (BLA) for Alder’s eptinezumab with the FDA. Following commercial launch Teva will receive $75 million based on sales-related milestones, and royalties on sales.

R&D

Teva’s specialty medicines segment focuses on treatments for disorders of the central nervous system, including neurological and neurodegenerative diseases, pain, and movement disorders, as well as a portfolio of products in respiratory disease, including asthma, allergic rhinitis, and chronic obstructive pulmonary disease.

In 2018, Teva expects to secure the successful launches of Austedo and fremanezumab. However, Teva’s late stage development program for fremanezumab in chronic cluster headache recently failed. The ENFORCE Phase III program includes a chronic cluster headache study, an episodic cluster headache study, and a long-term safety study.  A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint was unlikely to be met, therefore the company will discontinue the trial for chronic cluster headache.

While the episodic cluster headache study continues as planned, there are several other contenders in the migraine market. If the FDA approves this indication, it will be difficult for fremanezumab to compete with Amgen and Novartis’ Aimovig, which will already have been on the market.

Teva gained FDA-approval for AUSTEDO (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. AUSTEDO was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017. Tardive dyskinesia is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The condition affects about 500,000 people in the U.S. and can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions.

Lastly, following priority review, Teva gained approval of TRISENOX (arsenic trioxide) injection in combination with tretinoin for the treatment of newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

Headcount: 57,000
Revenues: $21,903  (+11%)
Specialty Pharma Revenues: $8,674  (+4%)
Net Income: $311  (-81%)
R&D: $2,111  (+38%)

TOP SELLING DRUGS 

Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis (MS) as well as late-stage development programs for other disorders of the central nervous system (CNS), including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products.

The Generic medicines segment includes chemical and therapeutic equivalents of originator medicines in a variety of dosage forms, such as tablets, capsules, injectables, inhalants, liquids, ointments and creams. Teva is the leading generic drug company in the U.S. and Europe. This segment includes the OTC business, conducted primarily through PGT, a consumer healthcare joint venture with P&G, as well as its active pharmaceutical ingredient (API) manufacturing business.

Specialty medicines includes Teva’s core therapeutic areas of CNS medicines such as Copaxone and Azilect and respiratory medicines such as ProAir and QVAR. The specialty medicines segment also includes products in other therapeutic areas, such as Bendeka/Treanda in oncology and ParaGard in women’s health.

Teva’s revenues in 2016 were $21.9 billion, up from $19.6 the year before. The Generics segment makes up 55% of sales, followed by the Specialty (39%) and Other (6%) segments. In geographic terms, the U.S. accounts for the bulk of sales with a 53% share, followed by Europe (25%) and ROW markets (22%).

Of note during the year, in August, Teva completed its acquisition of Allergan’s worldwide generic pharmaceuticals business, Actavis Generics. At closing, Teva paid Allergan roughly $33.4 billion. The acquisition significantly expanded its generics product portfolio and pipeline, and R&D capabilities.

As part of the Actavis acquisition, Teva divested certain products in the U.S. and Europe, to meet antitrust regulatory requirements. It sold its Actavis Generics assets and operations in the UK and Ireland to Accord Healthcare for approximately $768 million. The sale included a portfolio of generic medicines plus a manufacturing plant in Barnstaple, England.

During the year, Mayne Pharma completed its $652 million transaction with Teva and Allergan, gaining 37 approved and five filed generic pharmaceutical products. This transaction is among the largest generic pharmaceutical divestitures and followed Teva’s purchase of Allergan’s generic drug business.

Also, Impax Laboratories signed definitive agreements with Teva and affiliates of Allergan for the acquisition of a broad portfolio of generic products across solid oral, inhalable, injectable and topical dosage forms for $586 million. The deal also includes the return to Impax of its rights to its pending abbreviated new drug application (ANDA) for the generic equivalent to Concerta (methylphenidate hydrochloride).

In October 2016, Teva completed the acquisition of Anda Inc., the fourth largest distributor of generic pharmaceuticals in the U.S., from Allergan for $500 million.

Other transactions

During the year, Teva entered into a collaborative agreement with Regeneron Pharmaceuticals to develop and commercialize Regeneron’s pain medication product, fasinumab. It paid Regeneron $250 million upfront and will share the global commercial benefits of this product, as well as ongoing associated research and development costs of approximately $1 billion, equally with Regeneron. Following the termination of the Phase II clinical study for chronic low back pain in October 2016, Teva and Regeneron planned to design a Phase III study in chronic low back pain that excludes patients with advanced osteoarthritis.

Teva and Celltrion entered into an exclusive partnership to commercialize two of Celltrion’s mAb biosimilar candidates in the U.S. and Canada. CT-P10 is a proposed mAb biosimilar to Rituxan (rituximab), which is used to treat Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Wegener’s Granulomatosis and Microscopic Polyangiitis (MPA). CT-P6 is a proposed mAb biosimilar to Herceptin (trastuzumab), which is used to treat HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Rituxan and Herceptin have combined annual sales of approximately $6.5 billion in the U.S. and Canada. Teva will be responsible for all commercial activities in the U.S. and Canada, pending regulatory approvals. Celltrion has responsibility for completing all clinical development and regulatory activities. Celltrion receiveed $160 million upfront.

Teva also completed the acquisition of Representaciones e Investigaciones Médicas, S.A. de C.V. (Rimsa), a pharmaceutical manufacturing and distribution company in Mexico, for $2.3 billion. It also established a new business venture with Takeda—Teva Takeda Yakuhin Ltd.—to address the growing importance of generics in Japan.

At the end of the year, Teva entered into an agreement to sell its royalties and other rights in Ninlaro (ixazomib) to a subsidiary of Takeda, for a $150 million upfront payment, with additional consideration of up to $150 million dependent on future sales. Also, it entered into a license agreement for research, development, manufacture and commercializing of Attenukine with a subsidiary of Takeda, for a $30 million upfront payment, with additional milestone payments of up to $280 million and royalties.

Headcount: 42,888
Year Established: 1901
Revenues:  $19,652  (-3%)
Specialty Pharma Revenues:  $8,338  (-3%)
Net Income:  $1,597  (-48%)
R&D:  $1,525  (+2%)

TOP SELLING DRUGS  

Generic drug giant Teva reported sales of $19.7 billion in 2015. The company’s generics business generated 49% of total revenue and includes tablets, capsules, injectables, inhalants, liquids, ointments and creams. Teva is the leading generic drug company in the U.S. and Europe, with 51% of generic revenues in the United States, 28% in Europe and 21% in ROW markets.

Teva’s specialty medicines segment includes several franchises, most significantly in the therapeutic areas of central nervous system (CNS) medicines, such as Copaxone, Azilect, Nuvigil and Zecuity and respiratory medicines such as ProAir HFA and QVAR. The specialty medicines segment was responsible for 42% of total revenue and includes other therapeutic areas, such as oncology and women’s health.

The big news during the year came on the heals of a failed bid to buy Mylan. After the deal fell through Teva got back on the acquisition horse and acquired Allergan Generics for $40.5 billion, bringing together two leading generics businesses and catapulting Teva to the top of the generic leader board.

When combined, with Teva’s strong generics portfolio, Allergan Generics’ generics pipeline, which holds a leading position in first-to-file opportunities in the U.S., further enhances Teva’s stated goals of delivering the highest quality generic medicines at the most competitive prices and cultivating the best development pipeline in the industry. The resulting world-class product portfolio will be complemented by an expanded and more efficient global footprint, including leadership positions and strengthened operations, sales and R&D platforms in markets around the world.

The transaction has also bolstered Teva’s R&D capabilities in the generics industry, directed at fostering innovation, with approximately 320 combined pending ANDAs in the U.S., including exclusive offerings of approximately 110 U.S. FTF pending ANDAs.

During the year Teva also acquired Representacionese Investigaciones Médicas, S.A. de C.V. (Rimsa), a pharmaceutical manufacturing and distribution company in Mexico, along with a portfolio of products, assets, and companies in Latin America and Europe, for $2.3 billion. Rimsa had $227 million in revenues in 2014 with an annual growth of 11%. The company has an extensive portfolio of specialty products, including fixed-dose combination products. The deal makes Teva a leading pharma company in Mexico, the second largest market in Latin America.

Auspex Pharmaceuticals was also bought by Teva in a deal worth approximately $3.2 billion and expands Teva’s CNS franchise. Auspex’s lead investigational product, SD-809 (deutetrabenazine), leverages its deuterium technology platform, and is being developed for the potential treatment of chorea associated with Huntington’s disease, tardive dyskinesia, and Tourette syndrome. The company expects commercial launch for this indication in 2016.

The year also saw Teva divest several assets. ANI Pharmaceuticals acquired 22 previously marketed generic drug products from Teva for $25 million in cash and a percentage of future gross profits from product sales. The acquisition includes 19 solid-oral dosage products, and three oral suspension products. ANI will initially focus to tech transfer four products that qualify as CBE30 filings into ANI’s two manufacturing facilities; these four products have a combined trailing twelve month market value of $210 million, according to IMS Health. The total market value for the 22 products is $650 million on a trailing twelve-month basis, per IMS Health.

In other news, Ignyta, an oncology focused biopharma company, acquired worldwide rights and assets to four of Teva’s targeted oncology development programs for approximately $41.6 million.

Several alliances were formed during the year as well. Notably, Teva and Takeda established a new business venture to meet a range of needs for generics in Japan. Japan is among the fastest growing generics markets in the world, driven by social requirements for stable supply of affordable high quality medicines and the Japanese government’s policy of reduction of healthcare expenditures. Takeda’s strong distribution presence in Japan will combine with Teva’s supply chain, operational network, global commercial infrastructure, and R&D.

The business venture will offer patients and the healthcare system the portfolio of Teva’s generic medicines and Takeda’s products. Teva will have a 51% stake in the new company and Takeda will have 49%. The business venture will operate as an independent company with its own board of directors, chief executive officer, and executive leadership team.

In February 2015, Teva entered into an exclusive license agreement with Eagle Pharmaceuticals for Eagle’s EP-3102, a bendamustine hydrochloride rapid infusion product. In December 2015, the FDA approved the product, Bendeka (bendamustine hydrochloride), an injection for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Teva is responsible for all U.S. commercial activities for the product including promotion and distribution. Bendeka became commercially available in January 2016.

Teva also entered a partnership to explore ways to apply Microchips Biotech’s implantable drug delivery device to Teva’s portfolio of products to enhance clinical outcomes for chronic drug therapies. Microchips Biotech’s electronic device is made up of microchip arrays that can store hundreds of therapeutic doses of drug for periods ranging from months to years and releases each dose at precise times. The device can be programmed to release drug on a pre-determined schedule and will have wireless control features.

The partnership will initially focus on one selected disease area with the option to expand the program into several additional therapeutic areas. As programs advance, Microchips Biotech will receive development and commercial milestone payments and royalties on future product sales. Microchips will also receive funding to develop products for any future additional indications Teva may develop, and Teva will be responsible for Phase II and III development and regulatory filings.

Lastly, Teva entered an agreement to acquire Gecko Health Innovations, a software and product solutions company that aids in compliance and adherence improvement in the management of respiratory diseases. As a result of the deal, Teva gains CareTRx, a cloud-based solution designed to simplify chronic respiratory disease management, connecting patients and caregivers through remote monitoring and real-time adherence tools. Teva will explore ways to apply the CareTRx technology to its pipeline and portfolio of respiratory products with the goal of enhancing clinical outcomes.

TOP SELLING DRUGS  

Teva Pharmaceutical Industries operates two business segments: generic and specialty medicines. It is the world’s largest generics producer, with a portfolio of more than 1,000 molecules producing a wide range of products in nearly every therapeutic area. These include chemical and therapeutic equivalents of originator medicines in a variety of dosage forms, including tablets, capsules, injectables, inhalants, liquids, ointments and creams.

In specialty medicines, Teva has a portfolio of treatments for disorders of the central nervous system (CNS), including pain, as well as a strong portfolio of respiratory products. These include several franchises, most significantly its core therapeutic areas of CNS medicines such as Copaxone, Azilect and Nuvigil and of respiratory medicines such as ProAir HFA and QVAR. The specialty medicines segment also includes other therapeutic areas, such as oncology, women’s health and several other areas.

Teva’s revenues in 2014 amounted to $20.3 billion, which fell flat against last year’s results due to the decline in sales of OTC as well as generic medicines, and offset by higher revenues of specialty medicines. Forty-eight percent of Teva’s revenue was generated from its generics business, including API’s sold to third parties, and amounted to $9.8 billion, a decline of $88 million, or 1%. During the year Teva received 22 final generic drug approvals.

Forty-two percent of revenues came from specialty medicines and amounted to $8.6 billion, an increase of 2%. Copaxone, the leading multiple sclerosis therapy in the U.S. and worldwide, led the charge with $4.2 billion in sales. Teva enhanced its MS franchise through the introduction of a three-times-a-week Copaxone 40 mg/mL product in the U.S., and will launch Copaxone 40 mg/mL in Europe and other countries in 2015.

Geographically, the U.S. market was responsible for 45% of generic sales, Europe 32% while the remaining 23% came from ROW markets, primarily Japan, Canada and Russia.

At the beginning of the year, Erez Vigodman was appointed president and chief executive officer of Teva. Mr. Vigodman, formerly chief executive of Makhteshim Agan Industries (MAI), a global generic agrochemical company, took over for Eyal Desheh, who returned to his position as group executive vice president and chief financial officer. During his tenure with MAI, Mr. Vigodman returned the company to profitability through operations improvements and investing in organic growth, and led the expansion of MAI into emerging markets across Asia and Latin America, and China.

Teva expanded its CNS portfolio with the acquisition of NuPathe Inc. for approximately $144 million. NuPathe shareholders may also receive additional payments if sales milestones are met for NuPathe’s migraine treatment, ZECUITY, the first prescription migraine patch approved by the FDA for the acute treatment of migraine in adults. ZECUITY is a disposable, single-use, iontophoretic transdermal patch that actively delivers sumatriptan, a widely prescribed migraine medication. Teva also gains access to NuPathe’s technology, including its transdermal delivery system.

Also during the year, Teva and Active Biotech decided to continue development of Nerventra (laquinimod) despite the opinion of the Committee for Medicinal Products for Human Use (CHMP), which recommended against approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the EU.

Both companies remain committed to the clinical development program for MS and will evaluate the CHMP feedback to determine potential next steps. To confirm the benefits of the drug on disability progression, Teva is conducting the Phase III CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. Teva is also investigating the potential of Nerventra in progressive forms of MS.

Teva expanded its biotech assets in pain care franchise when it acquired Labrys Biologics, Inc., a privately-held biotechnology company focused on treatments for chronic and episodic migraine, for $200 million and as much as $625 million in potential milestones.

Labrys has a range of investigational, approved and marketed treatments for migraine, cancer pain and chronic pain. Labrys is developing LBR-101, a fully humanized monoclonal antibody in Phase IIb trials for prevention of chronic and episodic migraine.

During the year the company also sold its rights to Andromeda Biotech Ltd. for Andromeda’s drug DiaPep277 for the treatment of type 1 diabetes for $72 million.

Teva made several organizational changes in the middle of the year, aligning all operations under two commercial business units, Global Specialty Medicines (GSM) and the newly-formed Global Generic Medicines group (GGM). GGM will have full global responsibility for all existing generic markets, including portfolio management and selection, product launch, and commercial execution. GGM will also be responsible for Teva’s OTC business, led by its joint venture with The Procter and Gamble Co. Sigurdur Olafsson has been appointed president and chief executive officer of GGM and will be based in the U.S. The GSM group, led by Dr. Rob Koremans, is responsible for Teva’s global specialty medicines business.

Headcount: 46,000
Pharma Revenues: $20,314 (0%)
Net Income: $1,253 (-5%)
R&D Budget: $1,427 (5%)

Top Selling Specialty Drugs

Teva Pharmaceuticals was the first generic drugs manufacturer to be grouped with Big Pharma in IMS’s market research. By launching specialty as well as generics products, the company has broken down the boundaries that have traditionally separated name brand drug companies and generics, and shown that generics companies can also be innovators.

Boundaries have blurred so much since the early days of Hatch-Waxman, that it was amusing to read news from the EU last month, when Reuters reported that Teva and Mylan, together with Servier and other name brand Big Pharma companies, were being fined for “paying to delay” the entry of cheapter generics.

The past year has been a difficult one for the Israeli-based company, whose last CEO, Jeremy Levin, resigned last fall amid rumors of disagreement with the corporate board. Last month, the company’s chairman, Phillip Frost, said that he would leave before the end of 2014.

The company had been criticized at home for a $2-billion cost-cutting and restructuring program that is expected to halve its manufacturing capacity and will reduce the company’s workforce by 10%. The program has been divided into two phases, the first of which is due to be completed by the end of 2014.

CEO Erez Vigodman, who, according to analysts from the Wharton School of Busines, is a top manager and corporate turnaround specialist, has restructured Teva, separating it into global specialties and global generics, and has hired former Actavis Pharma president Sigurdur Olafsson to head up the global generics group. He has been quoted as saying that Teva is “fixing its foundation” for future growth.

The company plans some major product launches this year:
• The Zecurity migraine patch
• Adasuve powder, an inhalation powder for schizophrenic patients, and
• Duo Resp Spromax, an inhaler.

In addition, Teva has 15 products in Phase III clinical testing.

In the specialties area, the company is focusing on expanding its range of new therapeutic entities (NTE’s), particularly in key markets such as CNS/neurological drugs, respiratory therapies, oncology, women’s health.

Its annual report notes that Teva develops 100 NTE ideas per year, but whittles that list down to 10. By the end of 2013, the company had 15 NTEs in its pipeline.

Don’t just copy, innovate
Competitive pressures have led to the need to improve, rather than simply copy products, and driven thinkers to coin new terms such as supergeneric and hybrid generics. Teva was one of the first generics manufacturers to explore this space.

Last Spring, at the preconnect event preceding the CPhI Worldwide meeting in Frankfurt, the audience got some insights into what these changes mean for those working in product and process development. Even if there have been changes since then, the presentation offered a window into processes and a snapshot of 2013 practices.

At that event, Roger Bakale, senior director of Chemical Process R&D, discussed how Teva has been tweaking formulations and processes to enhance active ingredient properties and drug delivery.

Improving ADCs, and Oncology Drug Absorption
Teva is also working to improve antibody drug conjugates and develop oncology drugs with better absorption properties.
In addition to single enantiomers and racemic switch type technologies, Teva is looking at formulation approaches that will allow improvements in metabolic activity to be realized, Bakale said.The company was also working on new cell line technologies for biosimilars that would improve the humanization of the cell lines and increase volumetric productivity. Monocloncal antibodies will be another focus.

Improving glycosylation processes will result in more cost-effective therapies, Bakale said. The question remains: How to bring all these technology developments to bear within generic markets, and particularly within those markets in emerging regions?
dynamic portfolio optimization, based on local needs and preferences.

At that time, the company had set up a Global Specialty Medicines group to optimize the company’s portfolio mix—to allow Teva to assess and respond to differences between various countries and regions within a country in such areas as cost demands and payer structures, whether DTC, physician, or hospital driven, and communicate that to R&D teams.

But specialties are only part of the picture. Roughly half of Teva’s revenues come from generics and about 40% from specialties, with 42% of the generics market based in the U.S., 35% in Europe, and 23% in the rest of the world.

The company bought NuPathe, whose prescription migraine patch enabled development of Zecurity, earlier this year.  It has a respiratory drug delivery venture with Microdine Therapeutx, and a joint venture with Procter and Gamble in consumer healthcare.
In addition, Teva has a venture with Mylan, which can sell its generic version of Nuvigil, a drug developed to treat narcolepsy and sleep apnea. A clinical program evaluating its use in treating depression and bipolar disorder was discontinued.

New Capacity Coming Onstream
Although Teva is restructuring, it has added strategic capacity where needed, for instance, building a new oral solid dosage plant in Russia and an OTC facility in India. Teva has also been aggressively introducing generic versions of branded medicines, launching these in 2013:

•  Carbatrol
•  Maxalt
•  Diprivan
•  Opana
•  Symbytix
•  Xopenox
•  Revato
•  Vepesid
•  Wellcoron IV
•  Soratine
•  Temodar
•  Prevpak
•  Traspec
•  Adlosan
•  Aciphex
•  Cymbalta

That same year, it received tentative approvals to launch generic version of:

•  Diovan
•  Intuniv
•  Baraclude
•  Chantix
•  Zemplar
•  Focalin XR
•  Prezista
•  Oestrin

However, on the specialty drug  side, Teva  has  been vigorously protecting  its patents for the MS drug copaxone, which is due to lose patent protection in two years, as well as other therapies.

Quality Challenges and Recalls
The company has faced some quality problems lately, and, last Spring, it recalled lots of its Cymbalta generic. Ferring Pharmaceutical recalled its Tev Tropin human growth hormone due to concerns about potential contamination, and Teva also was reported in various news sources to have recalled some lots of Qvar, manufactured by a contract partner, due to stability issues.

Headcount: 46,500
Pharma Revenues: $18,535 (11%)
Total Revenues: $20,317 (11%)
Net Income: $1,963 (-29%)
R&D Budget: $1,356 (24%)

Top Selling Drugs

Account for 94% of total pharma sales, down from 96% in 2011

In a year when almost every pharma posted losses or scant gains, Teva managed 11% growth in 2012, moving it up two spots to #10 in our Top Pharma ranks. A full year of Cephalon’s portfolio under its belt helped to juice results, as did another double-digit gain for relapsing multiple sclerosis treatment Copaxone.

Teva got some good news for top-seller Copaxone, which made up 22% of total pharma sales in 2012. In June and July 2012, the company received favorable patent rulings for Copaxone in the U.S. and UK, respectively. As a result, Teva should remain protected from generic exposure through 2015 at least.

In fact, the company is hoping for much longer coverage than that. Unlike the sudden implosion of revenues a typical drug faces when generics enter the field, Teva argues that Copaxone is so complex, with such a poorly understood mechanism of action, that a generic version might require full clinical trials from a regulatory body in order to get on the market. Further, MS is such a difficult disease to treat, and so prone to unpredictable, acute flareups that degrade the patient’s nervous system, that doctors may be inclined to keep using Copaxone and not risk a lesser effect from a generic product. This is a case where we might see extreme reluctance to move a patient from a drug that’s working fine. (The new oral MS treatments that have been making news are meant to be used if Copaxone fails or produces intolerable side effects.)

Teva is also hoping to stay ahead of the generic Copaxone curve by introducing a new dosage form that requires injection three times a week instead of the current daily injection regimen. The company has also moved forward with development of oral laquinimod for MS, with hopes of leapfrogging the oral treatments developed by Novartis, Sanofi/Genzyme and Biogen Idec in recent years.

With Copaxone (relatively) sorted out, chief executive officer Dr. Jeremy Levin can continue his work of trying to bring Teva into its specialty pharma future.

In December 2012, Dr. Levin gave a presentation to investors in which he outlined the shape of the new Teva and its growth plans. He noted that Teva shouldn’t be too reliant on a single product as it currently is, and wants to expand the company’s portfolio through new drugs — many licensed in or co-developed with partners — as well as New Therapeutic Entities (NTEs), Teva’s term for new uses, formulations, or combinations of existing marketed drugs.

The company decided to sell its injectables manufacturing site in Irvine, CA in February 2013. The facility suffered quality issues in 2010 and Teva has poured a lot of money into remediation. Some were surprised at the decision to let the site go, but Dr. Levin noted that five other Teva facilities could take over its production. As with the Mirabel site in Montreal that Teva sold to Halo last year, the company would likely keep a supply agreement in place with the buyer of the Irvine facility.

In April 2013, he announced plans to reduce Teva’s manufacturing footprint further, part of his strategy to lower expenses by $2 billion in the next five years. At that time, he noted that the company’s high-priced acquisitions from the previous decade had left Teva with an inefficient structure that needed streamlining. The company has also shut down some R&D programs and ended collaborations that were outside its comfort zone.

Teva also sold off its animal health business in the U.S. to Bayer HealthCare in September 2012 for $60 million upfront and $85 million in milestones related to manufacturing and sales targets. The facility in St. Joseph, MO and Teva’s Animal Health business, received a consent decree of permanent injunction in 2009, barring the unit from selling veterinary drugs. Some products returned to market in 2011 and Bayer has restored several more, with plans during the next 12 to 18 months to bring more products back after the massive GMP failures from 2007 to 2009.

In April 2013, Teva established a Global Specialty Medicines Group, with the goal of “optimiz[ing] our commercialization,” according to Dr. Levin. The GSM will use the company’s local generics operations to leverage its specialty offerings. In order to make its way into the post-Copaxone era, Teva will need to break into the Chinese market, where it has little presence. Its generic products are much more likely to succeed there than its higher-priced branded meds.

The company is also making strides in building a stable branded portfolio to smooth out the lumps of the generic market. In 1Q12, Teva benefited from first-to-file status for Zyprexa and an “insurance” payout from Ranbaxy for generic Lipitor. Without those boosts in 1Q13, generic revenues dropped $324 million in the U.S. The company will face more pain throughout the year, as Provigil sales fall off a cliff (4Q12 dropped 93%, from $350 million to $25 million; 1Q13 sales fell from $291 million to $24 million).

Teva is a mega-powerhouse in generics, with $10 billion in 2012 revenues, but its branded and biosimilars portfolios will dictate its future. Dr. Levin seems to taken Teva’s foot off the M&A pedal, and now faces the hard work of integrating the company he inherited while advancing its R&D partnerships and finding new uses for its existing portfolio.

Acquisition News
Target: MicroDose Therapeutx
Price: $40 million upfront, $125 million in milestones
Announced: June 2013
What they said: “The MicroDose [respiratory] platform is both simple and attractive, and their addition will help us to address the unmet needs of the youngest and oldest patients, who have a requirement for a better way of taking the medicines they rely upon.”

—Michael Hayden, President, Teva Global R&D, and chief scientific officer

Lowe Down
Deal after deal, acquisition after acquisition: that’s what made Teva the big generics force it is today. But now that it’s the biggest company in that category, management seems to be looking around and wondering why, exactly, they went to all the trouble. The generics business is competitive and cutthroat, with lower margins than those of discovery-based drug companies. It’s supposed to have some stability to make up for that, though, and Teva’s probably waiting for some of that to kick in any time now. Problem is, a good bit of its (high-margin) money is coming from Copaxone, a compound that it has exclusivity on, and the multiple sclerosis space has become hugely competitive over the last two or three years.

Teva’s latest idea is to split the difference between generics and completely new drugs, with something called a New Therapeutic Entity. This would be a reworked version of an existing drug — different enough to sell for more money, but similar enough to have a shorter (and cheaper) path to approval. It all depends on how many opportunities there are in that space, and no one’s quite sure yet. And would a compound that’s different enough to persuade payers to spend more on it really be similar enough to get an easy regulatory path?

—Derek Lowe

Backup Plan
In June 2013, the Obama administration relented and allowed Teva’s Plan B One-Step emergency contraceptive to be sold over the counter without age restrictions. The administration has yielded many disappointments since 2009, but it was quite disheartening to see the Obama White House follow the same anti-science agenda of its predecessor. In 2011, the secretary of Health and Human Services, Kathleen Sebelius, overruled an FDA decision to permit the OTC distribution of Plan B One-Step, earning the ire of a federal judge who ordered the decision reversed. The (male) judge wrote that Sec. Sebelius’ move “was politically motivated, scientifically unjustified, and contrary to agency precedent.”

The FDA had determined that the product was safe and not likely to be abused, but Sec. Sebelius complained that the agency’s studies had not determined whether 11-year-old girls would be capable of reading and understanding the Plan B One-Step’s instructions. This seems like something to take up with the Department of Education and not the FDA.

Teva will have to file a supplemental application for wider OTC distribution of the emergency contraceptive, which the FDA has promised to approve without delay.

Headcount: 39,660

Pharma Revenues: $16,121(16%)

Total Revenues: $16,121 (16%)

Net Income: $3,331 ( 67%)

R&D Budget: $93 (16%)

Top-Selling Drugs in 2010

Account for 99% of total pharma sales, same as in 2009.

PROFILE

The world’s biggest generics company continues to climb in our ranks. In last year’s profile, I noted Teva’s ambitious five-year plan to more than double its revenue to $31 billion. (Teva also plans to increase non-GAAP net income to $6.8 billion by then, but I take non-GAAP results with a grain of salt. After all, there’s a reason they’re called GENERALLY ACCEPTED Accounting Principles.)

During the course of 2010, Teva launched 18 generics that targeted drugs with $12.2 billion in U.S. sales. (Of course, the generic versions will only bring in a fraction of those revenues.) The company reported that it accounts for 21.1% of total U.S. generic prescriptions. Generic introductions in the U.S. slowed to a crawl in 1Q11, but the company plans to launch generics of Zyprex (Lilly) and Nasacort AQ (Sanofi) later in the year.

But what generics giveth, they also taketh away. Teva is battling two generics makers that have filed to market of Teva’s key branded drug, MS treatment Copaxone. The companies are suing to invalidate Teva’s patents, and the years-long case will go to court in September 2011. Teva, meanwhile, is conducting trials for a new, higher dosage of Copaxone.

With Copaxone under siege, Teva makes no bones about the need to grow through acquisition (see our Acquisition News sidebar). Teva added $2.6 billion in revenues with the $5.2 billion acquisition of ratiopharm last year, and will fork over another $6.8 billion to pick up Cephalon, which had revenues of $2.8 billion in 2010. The two moves shore up different areas for Teva: ratiopharm puts it in the top position for generics in Europe, while Cephalon offers a branded and specialty portfolio and pipeline. Teva took the role of the white knight in the Cephalon deal, saving the company from a hostile bid by Valeant Pharmaceuticals, which had planned on selling off Cephalon’s pipeline and eschewing R&D. The move piggybacks Cephalon’s earlier acquisition of Mepha, the top generics company in Switzerland, with presence in emerging markets. Still, the Cephalon move is a risky one for Teva, given Cephalon’s impending patent expirations and the inherent risks in pharma R&D.

But it’s not as though generics are risk-free. In addition to litigation risks, some drugs are just harder to knock off than others. In November 2010, Teva noted that it won’t file for a generic version of GlaxoSmithKline’s Advair franchise until at least 2014 in the U.S., where the “substitutability” hurdles are higher than in the EU. That would shift any U.S. revenues from generic Advair — the branded version brought in $8.0 billion for GSK last year — outside the company’s 2015 timeframe (an EU version may reach the market by 2013 or 2014), although the company still projects that it will get $2.4 billion in annual sales from its respiratory unit by 2015, up from $875 million in 2010. GSK hopes to get its Advair followup approved by 2013, while Teva is now working on an innovator to compete with Advair. Teva executives contend that, in the long term, the respiratory business can hit $5.0 billion in annual sales.

Teva’s respiratory franchise may be gasping a little, but the company is making inroads with its biosimilars strategy. The company posted 2010 sales of $121 million with biosimilars of EPO, HGH and Tevagastim, a biosimilar to Amgen’s Neupogen. The latter was first approved in the EU in September 2008, and Teva is working with the FDA to get it on the U.S. market. Teva is currently working on two biosimilars to Amgen’s more profitable Neulasta and one for Merck Serono’s Gonal-f. Those projects are all in Phase III.

In the other direction, Teva struck a partnership with Procter & Gamble for OTC medicines in March 2011. The companies will form a joint venture to sell OTC meds outside North America. Teva will take over manufacturing for P&G, and control 49% of the JV, which would have had sales of $1 billion in 2010. The move gives P&G and Teva a means to convert prescription drugs to OTC status, capturing revenues and allowing them to sidestep some pharma price controls in Europe.

Teva has a way to go to hit that goal of $31 billion in 2015 sales, but a Copaxone victory, some first-to-file generic wins, and a few more strategic acquisitions (perhaps if Pfizer follows through on its rumored devolution plan) could move it along rather speedily.  —GYR

WARNING!

In January 2011, Teva received a warning letter from the FDA for its oral solid dosage facility in Jerusalem. The letter cited cGMP deficiencies tied to laboratory reporting and systems at the site. Teva said that it’s addressed the FDA’s observations and is trying to resolve the issue. At present, no restrictions have been issued. The facility makes generics of Glucovance and Ambien, amng other drugs.

In December 2009, the company received a warning letter for its parenteral facility in Irvine, CA, after discovery of bacterial endotoxin in a drug, among other observations. The company ceased production at that site in April 2010, but began a product-by-product resumption in February 2011. The shutdown cost Teva approximately $230 million in 2010 revenues.

ACQUISITION NEWS

Target: Theramex

Price: $360 million, plus milestones to Merck KgA

Announced: October 2010

What they said: “Theramex’s diversified product portfolio, its seasoned sales force and promising pipeline will be combined with the strong R&D capabilities and product portfolio of our U.S. women’s health business. Together the global team will accelerate the expansion of our women’s health franchise into key growth markets in Europe and around the world and provide an excellent springboard for future sales.”

—Shlomo Yanai, president, chief executive officer, Teva

Target: Corporacion Infarmasa

Price: not disclosed

Announced: January 2011

What they said: “Infarmasa complements Teva’s activity in Peru and will advance our position as a market leader in this region.”

—Shlomo Yanai

Target: Cephalon

Price: $6.8 billion

Announced: May 2011

What they said: “This is transforming for Teva’s branded business, as it will help us to deliver on our strategic goal of creating a diversified, multi-faceted company.”

—Shlomo Yanai

Target: Taiyo Pharmaceutical

Price: $460 million for 57% of shares, tender extended at enterprise value of $1.3 billiion

Announced: May 2011

What they said: “Taiyo’s strong market reach, cutting-edge production facilities, and impressively large product portfolio, combined with Teva’s scale and capabilities as the world’s largest generics company, will enable us to offer a much wider range of high quality, affordable generics to a much larger segment of the Japanese market.”

—Shlomo Yanai

THE LOWE DOWN

Teva! What on earth am I doing writing about Teva on this list? I was told that it was going to be all Big Pharma companies!

Well, the reason I’m writing about Teva is that it really is a big deal, and the state of the industry is such that its a bigger deal than many of the companies that are trying to discover their own drugs. In fact, if you look at the list of best-selling medicines, you’ll find that the number of generics on it is growing every year. A clearer statement of the trajectory of modern drug discovery I do not know.

But I’m saying that like it’s a bad thing — naturally enough, since I work in research. Take the broader view, though: patients are getting lots of good medications more cheaply as things go off patent. And if that means that companies prosper by waiting for those expirations, and by trying to speed things up in the courtroom whenever remotely feasible, who am I to judge? Now, if the rest of us stop finding so many things to eventually go generic, then the Tevas of the world may have some rethinking to do. But for now, they’re in good shape. —Derek Lowe

Previous Profile: Bristol-Myers Squibb // Next Profile: Takeda

Headcount: 35,809

Pharma Revenues: $13,84(32%)

Total Revenues: $13,899 (25%)

Net Income: $2,000 ( 228%)

R&D Budget: $802 (+2%)

Account for 33% of total pharma sales, up from 31% in 2008.

PROFILE

Teva made its first appearance on our charts last year, and took a big jump up to #13 in this edition. The Israel-based generic/specialty hybrid added $3.3 billion in revenues in 2009, driven largely by its Dec. 2008 acquisition of Barr Pharmaceuticals.

For most companies, you’d think a one-time pop of 33% growth would be a lot to handle, but Teva is thinking bigger. In January 2010, the company announced strategic goals that include more than doubling its revenues in the next five years, to $31 billion. How can they hit 20+% CAGR for five years? By increasing generic penetration in European and international markets, developing more branded specialty products, and marketing biogenerics, of course!

Teva jump-started the growth process by adding $2.6 billion with the $5 billion acquisition of German-based ratiopharm in March 2010 (see Acquisitions). In December 2009, the company expanded its reach in the Japanese generic market, buying a majority stake in Taisho Pharmaceutical Industries. In 2009, nearly 60% of Teva’s revenues came from the U.S. and Canada; the company is clearly trying to broaden its geographic base with moves like these.

In January 2009, Teva and Lonza formed a strategic partnership in biosimilars, and in May 2010, it was revealed that the companies are starting trials on a biosimilar of Rituxan. Lonza was a manufacturer of Rituxan until 2008, which has patent protection outside the U.S. until 2013 (it’s protected until 2018 in the U.S.).

In November 2009, Teva submitted a BLA for a biosimilar version of Neupogen. The FDA accepted the application three months later, setting the stage for an interesting regulatory process. Teva received approval in the EU in September 2008. With tens of billions in biologics losing patent protection in the next decade, Teva has positioned itself very well, especially in its choice of manufacturing partners.

While many of our Top Companies are expanding into generics, Teva is looking to boost the specialty side of its business, recognizing the far greater margins to be had in branded drugs over generics. In December 2009, Teva licensed in a soon-to-be Phase III oncology drug from OncoGenex.

Teva continues to rack up approval after approval for its generics (too many to list in our “Drugs Approved” section), sometimes settling with major companies to drop a challenge in exchange for an authorized generic agreement. But after building most of its business on making generics of major pharma products, Teva is in the position of trying to defend its top moneymaker, MS treatment Copaxone, from patent challenges by Sandoz and Mylan. It’s the Irony of the Year award winner.

Return to Top Pharma Report homepage.