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)
Impressions: 54768
As
compared to the previous months, September was a slower month for dealmaking.
The Wall Street Journal recently attributed the drought in big biotech deals to the riskiness of the business. In a note to clients, a Jefferies health care trader wrote: “What appears to be a best-in-class drug on a Monday can often be deemed obsolete headed into the weekend, given the pace of development”.
Last
month, Novartis continued its strategic revamp by selling selected portions of its Sandoz US generics portfolio and Alexion diversified its rare disease pipeline. In addition, a lot of companies announced large investments into manufacturing.
Novartis unloads troubled US generics to India’s Aurobindo Pharma
Novartis finally got rid of some troubled US generic assets when it sold 300 products and several development projects in
its Sandoz US generic oral solids and dermatology business to
Indian drug maker Aurobindo Pharma for US$ 1
billion. Aurobindo agreed to pay US$ 900 million upfront and up to
US$ 100 million in performance payments.
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The deal
relieves Novartis of a troubled franchise, while catapulting Aurobindo to the position of the
second-largest generics player by prescriptions in the US.
The deal with Aurobindo is part of Novartis’ effort to focus Sandoz’s US operations on higher-margin assets like biosimilars and complex generics, which would include injectables, respiratory drugs and eye therapies.
As part of the deal, Aurobindo also gets Sandoz’s dermatology development center, as well as manufacturing facilities in Wilson, North Carolina, and Hicksville and Melville, New York, which Aurobindo said are “highly complementary” to its existing production footprint.
When the deal was announced, investors in two other drug companies — Mylan and Teva — weren’t so happy. The reason? The US$ 900 million upfront payment reached by Novartis and Aurobindo was less than the 2017 annual revenue the portfolio sold, Wells Fargo analyst David Maris said.
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“Although clearly Teva and Mylan have very different businesses than the largely commodity and dermatology portfolio Sandoz is selling, we believe some investors are looking at this as a proxy for what the commodity portions of Teva’s US and Mylan’s US businesses might be worth,” said Maris.
According
to Aurobindo, the acquired portfolio brought in sales of about US$ 1.2 billion
in 2017, higher than the US$ 1 billion the deal could eventually be worth if
performance-related payments are added.
Novartis’ US Sandoz business has been suffering due to the
increased pricing pressure that has wreaked havoc across the entire US generics
industry. Mylan and Teva face the same pricing pressures in the US as
Novartis.
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Meanwhile,
Mylan finally revealed what it had bought during the last quarter for US$ 463 million. The company had purchased Novartis’ Tobi Podhaler and Tobi liquid, two cystic
fibrosis products. The company expects to pay US$ 240 million of that sum this
year.
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Last month, Olon S.p.A., a leading
active pharmaceutical ingredients (API) contract development and manufacturing
organization (CDMO) and generics supplier, announced the acquisition of a local
generics chemical operations API manufacturing facility in Mahad, India,
as part of a continuing expansion of its global footprint.
Olon is a division of Italy’s P&R Group, which had acquired the Infa Group in 2016. P&R rolled Infa’s manufacturing sites in Labochim and Sifavitor in Italy and Derivados Químicos in Spain into the Olon operations. Last year, Olon bought the chemical division of Ricerca Biosciences, a CRO and CDMO based in Concord, Ohio.
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Alexion, Roche, Amicus lead deal making for new developments
Massachusetts-based Alexion announced
its plans to acquire Syntimmune, a
clinical-stage biotechnology company developing antibody therapeutics targeting
the neonatal Fc receptor (FcRn), a protein that is encoded by the FCGRT gene in
the human body.
Alexion would pay US$ 400 million upfront for Syntimmune, and follow it up with US$ 800 million in
milestone payments.
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Syntimmune’s lead candidate, SYNT001 – a humanized monoclonal antibody — is currently being evaluated in Phase 1b/2a studies in patients with warm autoimmune hemolytic anemia (WAIHA) and in patients with pemphigus vulgaris (PV) or pemphigus foliaceus (PF) and has demonstrated proof of mechanism showing rapid IgG reduction.
Alexion sees “potential for broad application across a number of indications” for SYNT001. A related company presentation listed potential indications in neurology, hematology,
nephrology, rheumatology and dermatology.
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Roche acquires Tusk Therapeutics: Tusk Therapeutics Ltd announced it
would be acquired by Roche. Under the
terms of the agreement, Tusk’s shareholders will receive an upfront cash payment of Euro 70 million (US$ 79.79 million), plus additional contingent payments of up to Euro 585 million (US$ 666.8 million) based on achievements of certain predetermined milestones.
Tusk has developed an antibody with a novel mode of action aimed at
depleting regulatory T-cells (Tregs). Tregs suppress immune responses,
including those against cancer cells.
Preclinical data has shown that depleting Tregs from the tumor microenvironment can enhance and/or restore anti-tumor immunity. Tusk’s antibody has been designed to deplete these harmful Tregs, while not interfering with other immune cells acting against the tumor.
In other deals, Amicus Therapeutics paid
US$ 100 million upfront to obtain worldwide development and commercial rights
for 10 gene therapy programs developed at The Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital and The Ohio State
University.
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The 10 programs are licensed to Amicus from Nationwide Children’s Hospital through the acquisition of Celenex, a private, clinical stage gene therapy company. The lead programs in CLN6, CLN3, and CLN8 Batten disease are potential first-to-market curative therapies for these rare diseases.
Celenex shareholders are also eligible for up to US$ 15 million in
development milestones and US$ 262 million in BLA/MAA submission and approval
milestones across multiple programs.
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As demand for drugs surge, so do manufacturing investments
Regeneron plans
to invest approximately US$ 800 million over seven years to expand its
laboratory space, manufacturing capacity and warehouse facilities at its
Rensselaer, New York campus. The expansion will create 1,500 new full-time jobs
in the area.
Alvotech of Iceland, an independent sister company of US pharmaceutical firm Alvogen Group Inc, joined hands with China’s Changchun High & New Technology Industries group to develop, manufacture and commercialize its biosimilar portfolio in China. The
collaboration will see a new joint venture with manufacturing capabilities in
China's Jilin province, which will be equally funded by both the companies.
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This collaboration aligns the interests and strengths of Alvotech and
Changchun, A new state-of-the-art biologics drugs manufacturing facility will
be built in Changchun, China. Under the terms of the agreement, Changchun will
fund the joint venture with US$ 100 million while Alvotech will contribute
additional capital and six drug market authorizations for its monoclonal
antibodies, used in advanced therapy of cancer and autoimmune diseases, valued
at US$ 100 million. The construction of a jointly owned facility is expected to
start as early as in the first half of 2019.
BioMarin, a
pharmaceutical company focused on developing drugs for rare diseases, said
it will invest US$ 43 million to further
expand its manufacturing plant in Cork, Ireland, adding drug product filling
capabilities to help meet the growing demand for its rare disease medicines.
BioMarin produces the APIs for Vimizim (a drug for the treatment of Morquio syndrome) and its second-newest drug Brineura (enzyme replacement treatment for Batten disease) at the Cork facility.
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As the
need for contract development and manufacturing grows, Lonza announced a CHF 400 million (US$ 400.87
million) investment at its biopark in Visp, Switzerland, to expand its drug
substance development and drug substance and drug product manufacturing
offerings.
With the
objective to allow customers to manage the complete product lifecycle in one
site and shorten time to clinic and to market by 2020, Lonza will offer a
fixed-price gene-to-vial package with terms under which Lonza will deliver drug
product based on at least 1 kg drug substance within 12 months.
Lonza will also be offering services that
enable biologics license applications (BLAs) to be submitted within 22 months
from the start of process characterization.
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Our view
Given the pace of deal making we have seen during much of 2018, September was a bit of an outlier as there weren’t too many multi-billion dollar deals.
However, the month saw a stock market launch. Since
Pfizer listed Zoetis Inc, the largest animal health company, five years ago, the firm’s value has nearly tripled. In September, Eli Lilly followed Pfizer’s footsteps. Elanco Animal Health
Incorporated, a subsidiary of Eli Lilly held its initial public offering (IPO) of
62.9 million shares of its common stock at a price to the public of US$ 24.00
per share.
Following the IPO, Lilly holds over 80 percent of
Elanco and a month after the IPO, the share is up over 30 percent and trading
at US$ 32, indicating the opportunities which reside within pharmaceutical
companies to generate value for their shareholders.
Keep track of dealmaking in the world of pharmaceuticals with PharmaCompass’ compilation of Top Pharma & Biotech Deals — PharmaFlow.
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Impressions: 2696