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Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)

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29 Apr 2020

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Mylan board survives shareholder meet; Evaluate lowers drug sales growth forecast

This week, Phispers brings you news on the oversubscription of EU’s online pharmacy Zur Rose, and Amazon’s plans of entering the online pharma business. While shareholders voted against Mylan’s executive pay policy, former Turing CEO Martin Shkreli faced trial. In Canada, supply shortages are likely to play spoiler in the country’s plans to rollout legal recreational marijuana. And Evaluate’s latest World Preview report scaled down its forecasts for worldwide drug sales growth. Zur Rose IPO gets over-subscribed; Amazon may launch its online pharmacy soon Swiss online pharmacy Zur Rose Group's initial public offering (IPO) is already well oversubscribed. Zur Rose aims to raise up to 230 million Swiss francs (around US$ 240 million) through the share sale to aid its expansion plans in Germany, open new shops and possibly make acquisitions, the company said last week. The company, which was founded by Swiss doctors back in 1993, has been valued at between 780 to 870 million Swiss francs (US$ 813.5 million to US$ 907.4 million). The IPO is expected to be priced in range of 120 francs to 140 francs (US$ 125 to US$ 146) per share. Demand from long-term investors in Germany, Switzerland, Britain and the United States is being cited as the key reason behind the oversubscription of Zur Rose’s IPO. The stock is due to start trading on the SIX Swiss Exchange on July 6. This news should come as music to Amazon’s ears. Amazon is hiring a business lead to figure how the company can break into the multibillion-dollar online pharmacy market. Amazon is learnt to have begun recruitments from the pharmacy space. According to news reports, over the last few years, the Amazon headquarters in Seattle has been discussing whether it should enter the pharmacy business or not. But this year it is ready to get more serious with its plans. Mylan board survives shareholder meet but receives vote against executive pay policy Last week, we carried news on how rebel investors had upped the ante against Mylan and wanted the drugmaker to remake its board, in wake of the scandal over the high prices of EpiPen. Well, last week, the Mylan shareholders voted against the generic drugmaker's executive pay policy, but re-elected the board at its annual meeting held on June 22. The company did not disclose the vote totals for the directors. In order to vote out the directors, rebel investors needed more than two-thirds of the shares voted, as well as more than half of Mylan’s outstanding shares. New York City Comptroller Scott Stringer, who is one of the chief leaders of this campaign, said failure to disclose the vote totals suggests that the directors of Mylan faced strong opposition. “This company massively hiked prices on life-saving drugs, allegedly overcharged the government for its products, allowed excessive executive pay to go unchecked — all ultimately fundamental failures of board oversight,” Stringer said. BlackRock, Mylan's third-largest shareholder with more than 5 percent of the company's shares, said it had voted against four of the drugmaker’s directors as well as its executive pay. Meanwhile, a Reuters report points that a non-pharmaceutical offering – refined coal – has quietly generated hundreds of millions of dollars in tax credits for Mylan over the last six years, thereby boosting its bottomline. Since 2011, Mylan has bought 99 percent stakes in five companies across the US that own plants which process coal to reduce smog-causing emissions. It then sells the coal at a loss to power plants. This way, it generates credits for itself, that lower Mylan’s tax bill. Supply shortages may delay Canada’s rollout of legal recreational marijuana market Canada plans to legalize the recreational marijuana market over the next one year. This will make it the first economy to do so. However, the biggest challenge for Canada’s prime minister Justin Trudeau’s legalized pot market is, well, shortage of marijuana. This was revealed by Canada’s minister of finance Charles Sousa. The supply crunch was discussed during a meeting with provincial and federal counterparts last week, Sousa said. According to an analyst, the Canadian government may use the supply shortage as an excuse to delay rolling out the program. “Ultimately the biggest problem that appears after today’s discussion is one of supply,” Sousa said. According to his ministry officials, the demand is “quite high” for marijuana. “So we want to make certain that, when we do proceed, there is sufficient supply to accommodate the activity because what we’re trying to do is curb the illicit use and organized crime that now exists around it,” Sousa added. Trudeau had unveiled the framework for legalization of marijuana in April this year. Pricing pressure causes worldwide drug sales forecast to fall for first time in 10 years Across the world, increased scrutiny on the pricing of medicines is beginning to have an impact on drug sales growth. According to Evaluate’s latest World Preview report, consensus forecasts for worldwide drug sales are estimated to hit US$ 1.06 trillion in 2022. However, this is down from the US$ 1.12 trillion that analysts had forecast for the same period last year. It’s the first time in a decade that Evaluate’s forecasts for total drug sales have failed to beat previous year forecasts. However, sales of some of the industry’s top-selling products, such as cancer immunotherapies Keytruda and Opdivo, are expected to help push the sector to its expected trillion dollar sales target. According to this report, despite increasing questions around their pricing, orphan drugs are poised to make up a third of pharma sales by 2022. “The continued political and public scrutiny over pricing of both the industry’s new and old drugs is not going to go away and we are starting to feel the impact now. Market access is becoming harder, as seen by the disappointing sales of the drugs like Repatha, Praluent, and Nucala. And the increasing cost of taking a novel therapy to market, now at US$ 4 billion over the last 10 years puts additional pressure on the productivity of the industry and its longer term sustainability,” Antonio Iervolino, head of forecasting, Evaluate, said. Meanwhile, a Reuters report said the first ever EU antitrust probe into excessive drug pricing is unnerving the European drug industry, with lawyers worried about the reach of market intervention. Last month, the European Commission probed whether Aspen Pharmacare made “unjustified” hikes of up to several hundred percent in the cost of five old cancer drugs. Poster boy of price gouging and America's most hated man Martin Shkreli faces trial Martin Shkreli, who is often referred to as the “most hated man in America” for raising the price of a life-saving drug by 5,000 percent, is undergoing trial this week for a Ponzi-like scheme at his former hedge fund (MSMB Capital Management) and drug company (Retrophin). Shkreli will face charges of securities fraud in federal court in Brooklyn, New York, more than 18 months after he was arrested in December 2015. Back in 2015, as the CEO of Turing Pharmaceuticals, Shkreli had angered patients and US lawmakers by raising the price of anti-parasitic drug Daraprim from US$ 13.50 a pill to US$ 750. Shkreli has been accused of lying to investors in the hedge fund and siphoning off millions of dollars in assets from biopharmaceutical company Retrophin Inc to repay them. He has pleaded not guilty. The trial will be heard by US District Judge Kiyo Matsumoto in Brooklyn, and is expected to last four to six weeks. Nestle may sell L’Oreal stake, which could lead to share sale of Sanofi Dan Loeb, activist investor, recently encouraged Nestle SA to sell its stake in L’Oreal. Loeb has amassed a US$ 3.5 billion stake in Nestle SA. This demand by Loeb could lead to the divestment of yet another long-standing investment: L’Oreal’s US$ 11.6 billion (or Euro 10.4 billion) holding in French drugmaker Sanofi. Paris-based cosmetic maker L’Oreal owns about 9.4 percent of Sanofi. For several years now, speculation has been rife that L’Oreal would sell the stock to finance a repurchase of Nestle’s L’Oreal shares. Nestle had taken the stake in L’Oreal 43 years ago, as the latter had feared nationalization. Back in 1973, L’Oreal had taken control of a French drugmaker named Synthelabo. And in 1999, Synthelabo merged with Sanofi, leaving L’Oreal as a key shareholder. If both these divestments — by Nestle of L’Oreal and by L’Oreal of Sanofi — see the light of the day, they would manifest the growing power of activist investors in Europe. Spokespersons for both L’Oreal and Sanofi declined to comment on a stake sale.

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29 Jun 2017

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India cracks the whip on quality and compliance; Eli Lilly loses patent infringement case in China

This week, Phispers ferrets out global pharma news to bring you the latest on a drug for bipolar disorder, news about two Indian drug makers being put on import alert for refusing an FDA inspection and how GSK’s supply snags in Italy are hurting Denmark Former hedge fund manager who paid an FDA official for tipoffs found deadLast week, a hedge fund manager – Sanjay Valvani (44) – was indicted for allegedly paying a former US FDA official for inside information on product approvals. On June 20, he was reportedly found dead. According to a news report, Valvani was found by his wife at his Brooklyn, New York, home with a neck wound. A suicide note and a knife were also recovered from his home.Valvani had worked at Visium Asset Management. During 2005 to 2011, he had allegedly paid a monthly sum to Gordon Johnston, who once worked as a deputy director of the FDA’s Office of Generic Drugs, for tips. Indian pharma majors among 200 under scrutiny for quality of drugs sold For the first time in India, the Drug Controller General of India (DCGI) has launched inspections against 200 drug makers, including pharmaceutical biggies like Cipla and Pfizer, for allegedly selling poor quality medicines and for not complying with manufacturing norms. An official of the DCGI told a newspaper that the regulator has already inspected 36 drug manufacturing plants over the last three months. In the second phase, the DCGI will inspect 20 more facilities. Notices have also been sent to Cipla and Pfizer informing them of the impending inspection and the violations found in their products. Cipla maintained it has not received any intimation so far, while Pfizer did not comment. Phalanx Labs and Cheryl Labs refuse FDA inspection, put on the Red List The US Food and Drug Administration (FDA) banned two Indian drug manufacturers – Cheryl Laboratories and Phalanx Labs – from shipping products to the US after both the firms refused to allow FDA teams to visit their manufacturing sites for an inspection. Both the firms were put on FDA’s import alert list, also known as the Red List. According to the FDA policy: “The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.” Cheryl Laboratories stopped FDA inspectors from visiting its facility in Navi Mumbai, while Phalanx did not let inspectors visit their site in Visakhapatnam. Cheryl makes creams, ointments, liquid pharmaceutical, antiseptic products and gels from its Navi Mumbai facility. Phalanx’s Vizag facility produces 15 active pharmaceutical ingredients (API) – including erectile dysfunction drugs, ulcer medications and anticoagulants – and chemical intermediaries. Eli Lilly loses patent infringement case in ChinaLast week, China’s apex court rejected the appeal of US pharmaceutical company Eli Lilly against Jiangsu-based Changzhou Watson Pharmaceutical in a long-standing patent infringement case.Eli Lilly and Changzhou Watson have been involved in patent infringement disputes for over a decade over Changzhou Watson’s production of olanzapine, an anti-psychotic drug. The court also overturned a previous ruling on patent infringement in favor of Eli Lilly, that had ordered Changzhou Watson to pay Eli Lilly millions in compensation. The investigators concluded that “the alleged infringement does not fall into the scope of patent protection in the case.”This is the first time that the apex court in China has designated technical investigators in a lawsuit to help clarify the technical details of the case. Using old compounds to create new drug for bipolar disorderBack in 2010, a group at the University of Oxford was looking for ways to treat bipolar disorder by using lithium. Though the drug is known to work well in bipolar disorder, it also has side effects. Therefore, the group – headed by a young physicians called Grant Churchill – asked a physician Justyn Thomas to screen all 450 compounds in the US National Institutes of Health (NIH) Clinical Collection, a library of drugs that had passed safety tests in humans but, for various reasons, had never reached the market. Thomas experimented with these compounds. What took birth was a drug called ebselen, which showed the same benefits as lithium. Churchill’s group did a small trial and found that ebselen could be used safely in healthy volunteers. The University of Oxford has now teamed up with a pharmaceutical company to run clinical trials of ebselen for bipolar disorder. Former CEO of Warner Chilcott acquitted in kickback caseLast week, the US federal court jury acquitted W. Carl Reichel – a former Warner Chilcott executive – of paying bribes to doctors to lure them to boost prescriptions. The decision is being seen as a setback for the US government which has initiated a new effort to hold high-ranking executives at pharma and other companies accountable for such activities. Federal prosecutors charged Reichel with crafting a strategy to give doctors money, free meals, and phony speaking fees in exchange for writing prescriptions of Warner-Chilcott drugs between 2009 and 2012. He was also charged with providing sales representatives with unlimited expense accounts in order to wine and dine with doctors. GSK’s supply snag in Italy creates drug shortage in DenmarkGlaxoSmithKline had temporarily suspended manufacturing at its Parma site in Italy that manufactures sterile products, to investigate environmental monitoring.This has led to shortages of commonly used opioid anesthetic in Denmark. The factory has now recommenced manufacturing. However, a small number of countries have experienced shortages of certain products since April. In Denmark, doctors said they were also running out of the anesthetic Ultiva, which is preferred by patients since they wake up quickly after surgery. The Parma factory also manufactures GSK’s new injectable drug Nucala for severe asthma and Benlysta for lupus. However, these were reportedly not in short supply. Zydus buys two ANDAs from Teva; Cipla heads to RussiaIndia’s Zydus Cadila has strengthened its US portfolio by acquiring two abbreviated new drug applications (ANDAs) from Israel's Teva. The divestiture by Teva is in line with a precondition to its acquisition of Allergan’s generic business. The ANDAs have been acquired by Zydus Cadila’s 100 percent subsidiary Zydus Worldwide DMCC and the transaction will be financed through the group's internal accruals. The estimated market size of the two ANDAs is around US $ 200 million.Meanwhile, another Indian company – Cipla – has entered into an alliance with Russia’s National Immunobiological Company (Nacimbio) for innovative antiviral medical products for HIV and hepatitis C treatment and technology transfer and API manufacturing. As a part of this agreement, Nacimbio, along with Cipla, will set up a manufacturing facility in Russia for antiretroviral drugs.

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23 Jun 2016

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Top drugs and pharmaceutical companies of 2019 by revenues

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India cracks the whip on quality and compliance; Eli Lilly loses patent infringement case in China

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