Market Place
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: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
Share
PharmaCompass has assessed the second quarter US Drug Master
File (DMFs) filings. In our view, with five potential first-to-file (FTF)
applications along with another five DMFs challenging markets that have been
monopolized for decades, the pharmaceutical industry in the United States
should brace itself for some serious shakeups. Unlike the first
quarter of 2015 where 241 new DMF filings were listed on the USFDA site,
this quarter saw a reduction of almost 35 percent in the DMFs filed. As DMFs
form a critical part of the regulatory submissions made by generics to
challenge innovator companies, a reduction in filings, in the recent quarter,
seems to bear no correlation with the disruption the market will potentially
witness in times to come. The ‘first-to-file’ disruptors Profits in the generic pharmaceutical business are highly dependent on how quickly a drug is introduced in the market. The ‘first-to-file’ generic is a coveted position, since the company is legally granted
a 180-day period of market exclusivity, where no other generic can be in the
market. This six month exclusivity invariably leads to windfall gains for the
company.This quarter DMFs were received by the FDA, which could potentially drive the first-to-file challenges against J&J’s blockbuster Inovkana (canagliflozin), Eisai’s Belviq (lorcaserin
hydrochloride), Incyte’s Jakavi (ruxolitinib
phosphate), Celgene’s Pomalyst (pomalidomide) and Akorn’s Zioptan (tafluprost).However, given the complexities involved in bringing a
generic product to market, the first DMF filing does not always result in the
first generic challenge to the brand drug. The second DMFs filed for a product
are also strong contenders which must not be ignored. For example, Glenmark
recently filed their DMF for tofacitinib,
almost 18 months after serial-DMF filing by MSN
Pharmaceuticals. But Glenmark
has moved ahead by already getting their DMF reviewed by the FDA. Similarly, while Alp Pharma Beijing’s dapagliflozin, Perrigo’s ferric citrate and Amino Chemicals’ miglustat
are the second DMFs to be received by the FDA, the innovator should start
counting the days before they are plagued by generic challengers. Exclusively
not-patentedFor several years, Indian companies have been leading many
first-to-file generic challenges in the United States. However, as they have
scaled up in size, the same companies have also obtained rights to some
exclusive markets in the United States; either through acquisitions or
alliances. Sun Pharmaceutical’s US
$ 230 million acquisition of dermatology specialist Dusa was triggered by the successful sales of Dusa’s photo-chemotherapy treatment, Levulan. German Midas Pharma GmbH’s filing will not only subject Sun’s market domination to generic competition, the fact that there are six other DMFs filed for this product (of which none of the filings have come from Indian or Chinese companies) indicates a change in the way the industry is beginning to operate. Like Sun Pharmaceutical’s monopoly of Levulan, Dr. Reddy’s has enjoyed no competition for their topical treatment, Cloderm (clocortolone
pivalate) since 2011 when they purchased the rights for the product by
making an
upfront payment of US $ 36 million to Canadian, Valeant Pharmaceuticals. Dr. Reddy’s needs to start monitoring the progress of Italian Trifarma’s filing since this is the fifth time a DMF for this product has been received by the FDA.Indian companies aside, Aspen’s Leukeran, Bausch & Lomb’s Zirgan, Mission Pharmaceuticals’ Thiola and GSK’s topical treatment Abreva have
all marketed their products without any competition. The DMF filings of this
quarter indicate that generics have narrowed in on the profits being made and
the market dynamics for these products will change in the future. Down, but not outIntriguingly, companies like Apotex
Pharmachem, Emcure
Pharmaceuticals and Global Calcium
are currently on the FDA Import Alert list and banned from exporting products
to the United States since they did not operate in
conformity with the current good manufacturing practices (GMP's). However, these companies are definitely optimistic about
their future since they have all filed new DMFs this quarter. It remains to be
seen if the bans will get lifted in the near future.This quarter also saw Dr. Reddy’s get creative in their challenge to Japanese Astellas Pharma’s leaky bladder treatment, Myrbetriq (mirabegron).
After having filed a DMF last year, they re-filed again recently, with a
different polymorphic form, to potentially circumvent the patents around this
product. Our supportGeneric pharmaceutical companies are continuously looking
for opportunities where they can get the maximum possible market share in the
fastest way possible. While the number of manufacturers of active pharmaceutical
ingredients (APIs) keep increasing, we are also witnessing an increase in the cost
of regulatory support required to sustain the production of these APIs. The industry is becoming more challenging – identifying target markets is becoming a science which requires high-level management focus. In order to help you, PharmaCompass will share its compilation of this quarter’s DMF filing list. Just send
us an email by clicking here and we’re happy to support you in every possible way.Last week, the FDA also announced the fee dues (as on
October 1, 2015), as per the Generic Drug User Fee Act (GDUFA). We are sharing
the amounts due, in case you have not been able to access this information.
FISCAL YEAR AND FEE TYPE
2014 (Rate)
2015 (Rate)
$ & %
Difference from previous year
Abbreviated New Drug Application
$63,860
$58,730
-$5,130 (-8.0%)
Prior Approval Supplement
$31,930
$29,370
-$2,560 (-8.0%)
Drug Master File
$31,460
$26,720
-$4,740 (-15.1%)
Finished Dosage Form Facility
$220,152 (Domestic)
$247,717 (Domestic)
$27,565 (12.5%)
$235,152 (Foreign)
$262,717 (Foreign)
Active Pharmaceutical Ingredient
Facility
$34,515 (Domestic)
$41,926 (Domestic)
$7,411 (21.5%)
$49,515 (Foreign)
$56,926 (Foreign)
Impressions: 5140
https://www.pharmacompass.com/radio-compass-blog/generic-challenges-the-next-first-to-files-gdufa-dues-fy-2016-and-more
#PharmaFlow by PHARMACOMPASS
13 Aug 2015
We always knew math was fuzzy, but never imagined addition could get so
complicated.
A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best
selling products along with the top therapy areas.
The list, based on data published by IMS Health,
caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical
companies.
As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics.
Which pharmaceutical company is the largest?
Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company.
Should divisions like diagnostics, animal health, vaccines, consumer
health be counted when determining the size of a pharmaceutical company?
FiercePharma, in their analysis, used the total
revenue of all divisions of the organizations to determine the largest
organization; in their case it is Johnson & Johnson.
IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest
company.
As currency exchange rate fluctuations have their own, big role, in
determining the size of organizations, we believed it would be best to share
the revenues, as presented, so that you can draw your own conclusions.
Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports)
Big Pharma
IMS Rank
IMS Sales
(US $Mn)
Fierce Pharma Rank
Fierce Pharma Sales (US $Mn)
Group Sales based on the Annual Report
(Currency as reported, Mn)
Novartis
1
51,307
2
57,996
USD
57,996
Pfizer
2
44,929
4
49,605
USD
49,605
Sanofi
3
40,037
5
43,070
Euro
33,770
Roche
4
37,607
3
49,866
CHF 49,866
Merck & Co
5
36,550
6
42,237
USD
42,237
Johnson &
Johnson
6
36,422
1
74,331
USD
74,331
AstraZeneca
7
33,313
8
26,095
USD
26,095
Glaxo SmithKline
8
31,470
7
37,960
GBP
23,006
Teva
9
26,001
11
20,272
USD
20,272
Gilead Sciences
10
23,673
10
24,474
USD
24,890
Amgen
11
20,473
12
20,063
USD
20,063
Lilly
12
19,909
14
19,615
USD 19,615
AbbVie
13
19,049
13
19,960
USD
19,960
Bayer
14
18,347
9
25,470
Euro
42,239
Bristol-Myers
Squibb
Not
in Top 20
15
15,879
USD
15,879
NB: Mn is million
Click here to access and download all
the 2014 data (Excel version available) for FREE!
Since each group has multiple divisions, we further split the sales for
you to brainstorm:
Table 2/ Sales comparison of the different divisions of top
pharmaceutical companies in 2014 (Annual Reports in Mn)
Big Pharma
Pharma Division
Vaccine Division
Generics
Consumer Health
Other Divisions
Medical Devices/ Diagnostics Division
Animal Health Division
Divestures/ Other adjustments
Novartis
USD 31,791
Sandoz USD 9,562
Alcon USD 10,827
USD 5,816
Pfizer
USD 45,708
USD 3,446
USD 451
Sanofi
Euro 22,578
Euro 3,974
Euro 1,805
Euro 3,337
Euro 2,076
Roche
CHF 38,969
CHF 10,897
Merck & Co
USD 30,740
USD 5,302
USD 6,195
Johnson &
Johnson
USD 32,313
USD 14,496
USD 27,522
AstraZeneca
USD 26,095
Glaxo SmithKline
GBP 18,670
GBP 4,336
Teva
USD 10,458
USD 9,814
Gilead Sciences
USD 24,474
USD 416
Amgen
USD
19,327
USD 736
Lilly
USD 16,481
USD 788
USD 2,346
AbbVie
USD 19,960
Bayer
Euro 12,052
Euro 7,923
Euro 22,264
Bristol-Myers
Squibb
USD 15,879
Click here to access and download all
the 2014 data (Excel version available) for FREE!
Not sure that it adds any extra clarity on what should define a global pharmaceutical company…
Since the various divisions make
companies complicated to assess, what about product sales?
The good news is that we have a winner!
Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason.
Unfortunately, things stopped making sense the moment we reached the
number-two product on the IMS list. Lantus®,
Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%.
So unless the Euro/Dollar exchange rate moves back towards the 1.5
range, there seems to be a serious difference in the way the product sales are
calculated by companies and by IMS.
Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications!
Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports)
Products
IMS Rank
IMS Sales (US $Mn)
Annual Reports Sales (US $Mn)
Pharma
Compass Rank
Big Pharma
Currency
Annual Reports Sales in Mn
Marketing Partner
Marketing Partner Annual Report Sales
(US $Mn)
Humira®
1
11,844
12,543
1
Abbvie
USD
12,543
Lantus®
2
10,331
7,676
5
Sanofi
Euro
6,344
Sovaldi®
3
9,375
10,283
2
Gilead Sciences
USD
10,283
Abilify®
4
9,285
7,556
6
Bristol
Myers-Squibb
USD
2,020
Otsuka
5,536
Enbrel®
5
8,707
8,538
4
Amgen
USD
4,688
Pfizer
3,850
Seretide®
6
8,652
6,589
8
GSK
GBP
4,229
Crestor®
7
8,473
5,512
11
AstraZeneca
USD
5,512
Remicade®
8
8,097
9,880
3
Johnson &
Johnson
USD
6,868
Merck & Co.
2,372
Mitsubishi
Tanabe
640
Nexium®
9
7,681
3,655
19
AstraZeneca
USD
3,655
Mabthera®
10
6,552
6,936
7
Roche
CHF
5,603
Roche
1,305
Avastin®
11
6,070
6,449
9
Roche
CHF
6,417
Lyrica®
12
6,002
5,168
12
Pfizer
USD
5,168
Herceptin®
13
5,564
6,306
10
Roche
CHF
6,275
Spiriva®
14
5,483
3,917
17
Boehringer
Euro
3,237
Januvia®
15
4,991
3,931
16
Merck & Co.
USD
3,931
Copaxone®
16
4,788
4,237
14
Teva
USD
4,237
Novorapid®
17
4,718
2,835
20
Novo Nordisk
DKK
17,449
Neulasta®
18
4,627
4,596
13
Amgen
USD
4,596
Symbicort®
19
4,535
3,801
18
AstraZeneca
USD
3,801
Lucentis®
20
4,437
4,152
15
Novartis
USD
2,441
Roche
1,711
Click here to access and download all
the 2014 data (Excel version available) for FREE!
It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view.
Our take:
With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing
upon and others, which may not be worthwhile to pursue.
While the assessment of pharmaceutical sales is far more complicated
than what we had originally imaged, the focus of Big Pharma on small molecules
is on Hepatitis C drugs (Sofosbuvir, Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments.
Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports)
Products
Big Pharma
Sales (US $Mn) 2013
Sales (US $Mn) 2014
Growth (%)
Ibrutinib
Pharmacyclics,
Inc
(now
AbbVie)
14
492
3414%
Dasatinib
Bristol-Myers
Squibb
1280
1493
17%
Trametinib
GSK
10
68
580%
Nilotinib
Novartis
1266
1529
21%
Ruxolitinib
Novartis
163
279
71%
Ceritinib
Novartis
Not
launched
31
Sunitinib
Maleate
Pfizer
1204
1174
-2%
Crizotinib
Pfizer
282
438
55%
Axitinib
Pfizer
319
410
29%
Tofacitinib
Citrate
Pfizer
114
308
170%
Click here to access and download all
the 2014 data (Excel version available) for FREE!
However, Big Pharma is now all about biologics.
IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”.
The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis).
Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!
Impressions: 12778
https://www.pharmacompass.com/radio-compass-blog/who-has-the-biggest-one-sales-of-the-top-pharma-products-by-revenue
#PharmaFlow by PHARMACOMPASS
23 Apr 2015
