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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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Sales Forecast of FDA’s Novel Drugs Approvals in 2018

The year 2018 was a landmark year for the US Food and Drug Administration (FDA) as the agency approved a record number of novel drugs. FDA approved 62 novel drugs in 2018, out of which 34 were orphan drugs. FDA’s Center for Drug Evaluation & Research (CDER) approved 59 drugs while the other three were approved by the Center for Biologics Evaluation and Research (CBER). In a speech towards the end of the year, FDA Commissioner Scott Gottlieb said: “Far more important than the overall quantity of approvals however is the quality of the new drugs”. He went on to add that some “of [the] previous records were set in years when there were a lot of drugs that critics bemoaned were me-too medicines,” or novel chemical entities that addressed the same common, therapeutic targets. In 2018, FDA reversed three earlier drug rejections, approved the first cannabis-based drug, allowed the first ever RNA interference drug to market and gave the green light to Loxo Oncology/Bayer’s Vitrakvi (larotrectinib) which became the second anti-cancer drug (after Merck’s Keytruda) to bag an approval that treats cancer based on a biomarker across different types of tumors rather than the location in the body where the tumor originated. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Gilead’s Biktarvy tops our list for sales potential PharmaCompass compiled the peak sales estimates of the new drugs approved in 2018 and in our compilation, Gilead’s antiretroviral treatment for HIV — Biktarvy — topped the charts with an estimated sales potential of almost US$ 5.3 billion followed by Vertex’s cystic fibrosis drug Symdeko that is expected to bring in US$ 2.75 billion. Alexion’s Ultomiris, Abbvie’s Orilissa, Novartis’ Lutathera and J&J’s Erleada are all expected to bring in more than US$ 2 billion for their companies at their peaks. Although Loxo’s cancer drug, with an estimated US$ 860 million in peak sales, did not make it to the list of top 15 drugs in 2018 by sales potential, the company got purchased by Eli Lilly earlier this month for US$ 8 billion. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Pfizer won four approvals, Shire won three For 2018, Pfizer led the approvals with four drugs that got the green light, followed by Shire with three drugs. Companies like AstraZeneca, Array Biopharma, Alynlam and Paratek Pharmaceuticals each won two drug approvals. Merck also had two approvals which were in cooperation with other companies. Amgen, Teva and Eli Lilly got their CGRP inhibitors for migraine prevention approved within a few months of each other. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 First cannabis-based drug bagged approval Last year, FDA also approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome. CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. And Epidiolex is the first marijuana-based drug to be approved in the US for epilepsy. It is produced by GW Pharmaceuticals. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 CBD does not cause intoxication. It is one of the hundreds of molecules found in marijuana and has been cited by scientists as a potential treatment for mental health issues. 2018 saw the launch of one-dose flu cure from Shionogi In March 2018, Shionogi & Co Ltd.’s Xofluza — a pathbreaking drug that cures flu with just one dose — was approved in Japan. The drug is a treatment for influenza A and influenza B. In October, the US Food and Drug Administration (FDA) also approved Xofluza (baloxavir marboxil). Xofluza is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 The single dose feature gives Xofluza an edge over other neuraminidase inhibitors like Tamiflu and Relenza. For example, Tamiflu typically requires two doses each day for five days. Therefore, there are nine more doses of Tamiflu required, as compared to the single-dose Xofluza. Shionogi aims to double the global market for flu treatment with Xofluza. “While the global market of flu drug is said to be about US$ 1 billion to US$ 1.5 billion, we want to expand it to around US$ 3 billion,” Shionogi CEO Isao Teshirogi said last year. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Though the FDA approval for Xofluza has been granted to Shionogi, Genentech (a member of the Roche Group which marketed Tamiflu, which is now a generic) will be marketing the medication in the US. Industry gets far lower returns from its drug launches Gottlieb used Twitter to promote the progress of FDA’s review cycle. “In 2018, CDER met its PDUFA goal for 100 percent of the novel drugs approved – 95 percent of which on the first cycle – reflecting our efficiency in getting new therapies to patients quickly,” he tweeted. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 A ‘cycle’ is the time from when CDER accepts an application for a new drug until the agency decides whether to approve it or not. However, the record number of approvals doesn’t present the complete picture for the pharmaceutical industry. A study published in December by Deloitte highlighted that the industry is getting far lower average returns from its drug launches than ever before. While the costs to bring a drug to market have almost doubled in eight years to over US$ 2 billion, peak sales forecasts have halved to a little over US$ 400 million, the study said. Drug discovery reviews in the scientific publication Nature reached a similar conclusion. “Projected peak annual sales for new therapeutic drugs (NTDs) approved in 2018 total US$ 45 billion — lower than 2017’s US$ 58 billion — and the value of the average peak sales per product has continued to trend down to only US$ 720 million per drug in 2018, the lowest figure in almost a decade,” the publication said. “The decline is driven both by fewer blockbusters at the top end, as well as a proliferation of very small products at the bottom end. We believe the underlying driver of both these trends — more approvals but smaller markets per approval — is better understanding of biology fostering precision medicine,” it added. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Our view After suffering brutal losses towards the end of 2018, wherein biotech was among the US stock market’s most oversold sectors and saw a decline of nearly 10 percent, this year the biotech sector has got off to the best start since 2012. Drug companies are continuing to innovate more targeted therapies, and Chinese companies are investing in developing new drugs. While the industry expects to see a lot more mergers and acquisitions in 2019, where smaller biotech companies get acquired by major pharmaceutical corporations, it is unlikely that the general trend of companies bagging more approvals for targeted therapies with a smaller peak sales potential is going to reverse anytime soon. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018

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17 Jan 2019

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