Top10 Pharma Companies WP Final_for Clients

7/27/2019 Top10 Pharma Companies WP Final_for Clients

1/12WHITE PAPER| VALUE BASED BUSINESS MODELS

The changing face of thetop 10 pharmaceutical companiesThe beginning of the end for

innovative dominance


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3/12IMS HEALTH| THE CHANGING FACE OF THE TOP 10 PHARMACEUTICAL COMPANIES

WHITE PAPER| VALUE BASED BUSINESS MODELS

market), the amount spent on four "mega mergers" in 2009-2010 alone equated to$200bn and despite this outlay, the Top 10 have only managed to retain share of theprotected market, rather than increase share (figure 1). This thwarted consolidationgoes hand in hand with another key event for the Top 10 in 2012: The arrival of Teva

into the elite Top 10. Replacing Lilly as a Top 10 player, this makes Teva the firstnon-US or European based pharmaco, and the first pharmaco that did not start as atraditional R&D based company, to enter the Top 10 (figure 2). Teva thereforechanges the face of the Top 10 pharmacos forever. Prior to Tevas entry it was a giventhat all Top 10 companies 1) originated in the mature markets of US or Europe and 2) were primarily R&D driven ie most of their sales came from protected products.Teva originates from Israel and has been primarily dependent upon unprotectedproducts, although its protected portfolio is a key driver of profit and now accounts for40% revenue.

FOOTNOTE: As of 1st Jan 2013 Abbotts split iscomplete and neither

AbbVie or Abbott areforecast to be Top 10players. We predictthat Teva will rise to#9 and Lilly re-enterat #10 when salesdata are compiledlater this year. Sales

include selected OTC values.

Source: IMS Health MIDAS September 2012, Market Segmentation, Rx bound.

*2007 Top 10 includes Lilly; 2012top 10 sees Lilly replaced by Teva

350

300

250

200

150

100

50

0

P r o

t e c

t e d M a r k e

t S a

l e s ,

U S $ B n

2007 2012

Top 10 Players

Remaining Market

Top 10 Share of Protected Market 52% 52%

169.5 172.8

326.1 330.5

FIGURE 1: PROTECTED REVENUE OF TOP 10 FIRMS VS PROTECTED PHARMA MARKET*

Source: IMS World Review, IMS Health MIDAS, June 2012. 2002 and 2007 are year end results whereas 2012 is MAT 09 2012.

FIGURE 2: TOP 10 CORPORATIONS RANKINGS BASED ON SALES AT EX-MANF LEVELS, US$

TOP 10 CORPS 2002 TOP 10 CORPS 2007 TOP 10 CORPS 2012

1 Pfizer 1 Pfizer 1 Novartis

2 GlaxoSmithKline 2 GlaxoSmithKline 2 Pfizer

3 Merck & Co 3 Novartis 3 Merck & Co

4 Johnson & Johnson 4 Sanofi-Aventis 4 Sanofi

5 AstraZeneca 5 AstraZeneca 5 Roche

6 Novartis 6 Johnson & Johnson 6 AstraZeneca

7 Aventis 7 Roche 7 GlaxoSmithKline

8 Bristol-Myers Squibb 8 Merck & Co 8 Johnson & Johnson

9 Roche 9 Abbott 9 Abbott

10 Pharmacia 10 Lilly 10 Teva

Disappeared through M&A Entry into Top 10

156.6 157.7




THE RISE OF GENERICS AND INCREASED DIVERSIFICATIONThe last couple of years have seen the peak of small molecule genericisation events with the loss of exclusivity (LoE) of blockbusters such as Lipitor, Diovan, and Plavix.For the period 2011-2016 alone, almost $180bn sales (based on sales in 2011) are at

risk from LoE events, with the biggest losses expected to have occurred in 2012.

This LoE boom has naturally led to an increasing abundance of high-profile generics,at a time when austerity measures in mature markets such as Japan and Europe haveled to an increased push for generics usage over off-patent brands, and even theintroduction of INN prescribing in some countries. Add to this that in the high growthemerging markets where pharma companies are desperately looking for goldenopportunities, typically >50% market value is derived from generic products, it istherefore of little surprise that generics are seen as an increasingly important part of many pharmacos portfolio (figure 3).

Source: IMS MIDAS Sept 2012. *Based on being a Top 5 generics players in multiple regions globally.

FIGURE 3: TOP 10 CORPORATIONS BASED ON SALES AT EX-MANF LEVELS US$

FIGURE 4: BUSINESS AREA MATRIX 2002-2012

TOP 10 CORPS 2012

1 Novartis

2 Pfizer

3 Merck & Co

4 Sanofi

5 Roche

6 AstraZeneca

7 GlaxoSmithKline

8 Johnson & Johnson

9 Abbott

10 Teva

Source: Annual Reports, IMS Company Profiles, Press Releases.

Company active in 2002 and 2012 Company entered since 2002 Company exited since 2002 No presence

Company Pharma(SM) VaccinesAnimalHealth Biologics Bio-similars

Consumer Health Devices Diagnostics Generics Nutrition

Pfizer IPO Jan 2013

Novartis

Sanofi Announced2013

Merck Alliance

AZ

GSK

Roche

J&J

Abbott

Teva

Includes Sandoz sales: The number 2 generics player globally, accountingfor 16% of the Novartis group revenue in 2011. Strong biosimilars play.

Includes generics sales: Generics accounted for 5% overall group salesin 2011. Recently announced plans to develop biosimilar insulins.

Generics play will be emerging markets focussed.

Generics play will be emerging markets focussed.

Entering biosimilars (development phase) in addition to generics play.

Entering biosimilars (development phase).

Includes generics sales: Established Pharmaceuticals will account for25% sales of the new Abbott.

Still strong focus in generics and biosimilars: The most international generics player.*




The generics business continues to remain the core of Tevas model with over 50% of its revenue derived from this despite diversification into innovative pharmaceuticals,and more recently consumer health. With cost containment policies in maturemarkets and the generic dominance of emerging markets, the generics market is

forecast to continue to see strong growth and if Teva can keep pace would certainly seem sufficient to see Teva continue to work its way higher up the Top 10 rankingsand imply that a generics-lead heritage is no barrier to playing at the highest level.

Teva is one of the most international generics players, holding a Top 5 ranking acrossmany countries. However in contrast to the protected, innovative pharmaceuticalmarket, the generics market globally is much more fragmented with very few truly international generics players. But large pharma and large generics corps have theadvantage of being able to travel the value-add route: As the small molecule patent cliff starts to drop off and the focus switches to biologicals LoE, large pharma are at anadvantage across all regions. Development of biosimilars is both exceedingly costly andtime consuming relative to the development of small molecule generics. As a result

players have to be in the biosimilars game for the long haul and many smaller genericscompanies simply cannot afford the investment. Big pharma and the truly internationalgenerics players such as Teva and Sandoz have seized the moment investing heavily inthis space in recent years, with the hope of high returns.

The rise in importance of generics is just one example of an alternative to the smallmolecule protected business that is attractive to pharma. As demonstrated in figure 4there is today a wider range of mainstream business models in the pharmaceuticalindustry than ever before (generics, devices, diagnostics, consumer health). It used to be very clear that the protected small molecule segment of the industry was moreattractive than other business areas, being larger, growing faster, and returning higherprofit margins than anything else. This is no longer the case.

Generics are growing much faster than the protected sector and are a much larger sliceof the pharmaceutical market than ever before; consumer medicine also is growingfaster than protected pharma. Payer pressure on protected medicines, together withsmaller patient populations, larger and longer clinical trial requirements and sloweruptake means that protected medicines are not as profitable as previously, reducingthe gap between the profitability of protected medicines and other areas of pharma(although a gap still exists). A combination of growth moving to other pharmaceuticalsectors, significant increases in the size of other sectors, and a smaller gap between theprofitability of the different sectors means that there is now a greater range of potential business models that big pharma might consider to drive future revenue.

There is today a wider range of mainstream business models in the pharmaceutical industry than ever before, covering generics, biosimilars,devices, diagnostics, consumer health and animal health.




WHAT DOES THIS MEAN FOR INNOVATION?So what does this mean for innovation? Can innovative players still succeed, and inthe cost-constrained environment of today will payers still reward innovation?

Only four products launched globally since 2009 have passed the $1bn thresholdtraditionally used to define the blockbuster. These are Victoza (launched 2009),Gilenya and Prolia (launched 2010), and Incivek (launched 2011). 5 Only one of thesefour blockbuster successes is the product of development of a Top 10 pharmaco(Novartiss Gilenya). Furthermore these products demonstrate the shift towardsspecialty care that is being seen in todays pharmaceutical market. Aside from vaccines,IMS predicts the only remaining fast growing area of primary care is diabetes, wheresignificant unmet need still exists and where payers are willing to reward innovation inthe hope of lessening long-term care costs by failing to act soon enough (figure 5).

The shift towards specialty care has in many ways acted to level the playing field between mid-size pharma and large-pharma, since in so many specialty therapy areaspatients are being segmented into smaller, more targeted, populations. This is mostnotable when looking at the fastest growing players in the innovative space over thelast decade. Restricting the market to non-generics and current Top 50 players, we looked at how many places pharmacos had moved up the rankings over the lastdecade (figure 6 overleaf).

Vertex, who are the makers of Incivek (noted above as one of only four blockbusters tohave launched since 2009), has come from nowhere to enter the pharma Top 50 off the back of just that one product a product that is on track to be one of the most successfullaunches in contemporary history. Incivek is for the treatment of Hepatitis C, a therapy area renowned for its continuing unmet need and market potential. But what makes thesuccess of Incivek even more impressive is that it launched only 10 days apart from

Victrelis, Merck and Cos product for the same disease genotype. Here we see a small biotech with a first launch, taking on the might of big pharma and coming out on top, in what could be described as a David vs Goliath type battle.

FIGURE 5: FORECAST LEADING THERAPY CLASSES IN 2016

Source: IMS Institute for Healthcare Informatics; April 2012.

S p e n

d i n g

C A G R 2 0 0 7 - 2

0 1 1

Antipsychotics

Anti-Ulcerants

Lipid Regs

Anti-Epileptics

Antidiabetics

Cephalosporins Antiviralsexcl HIV

Angiotensin II

Speciality

Traditional

Platelet AggrInhib

-4

-2

0

2

4

6

8

10

12

14

16

1820

-9-10 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Global CAGR2012-2016:3-6%

Narcotic Analgesics Contraceptives

Vaccines

Immunostimulants

Immunostimulants

Autoimmune

Oncologics

HIVAntivirals

MS

Asthma/COPD

Global CAGR2007-2011: 6.0%


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Vertex engaged prescribers and patients in a strong disease awareness campaignthroughout the development cycle and instead of relying on a large conventional salesforce, Vertex focused on MSLs, HCP education, and patient communities. In this way Vertex managed to overcome the inevitably larger promotional budget that Merck hadat their disposal (figure 7). Outside of the US, J&J are marketing the product as Incivo.

In addition to Vertex, within the fastest growing Top 10 we also see companies such as Actelion, Celgene, Gilead, Shire. These are companies which have remained committedto a particular specialist-led therapy area, be it CV, Oncology, HIV, ADHD. Specialty pharma has seen strong growth rates over the last decade and this is true of the areas in

which these companies play. But not only has the therapy area seen strong growth,each of these companies has out-performed its market as a whole. For example theother cardiovasculars market into which PAH is classified, has seen a 32% CAGR

IMS HEALTH| THE CHANGING FACE OF THE TOP 10 PHARMACEUTICAL COMPANIES


FIGURE 6: 2002-2012: TOP 10 FASTEST GROWING CORPS BY NON-GENERIC REVENUE TO BECOME PARGLOBAL TOP 50*

Source: IMS Health MIDAS MAT, Sept 2012. Market Segmentation.*Rx and Non Generics only. Methodology Highest movement in rankings in 10 years to be part of 2012 top 50 companies by revenue.

FASTEST GROWING 2002-2012

1 Vertex2 Actelion3 Reckitt Benckiser4 Celgene5 Gilead6 Endo HS7 Shire8 Otsuka9 Allergan

10 Roche

RANK IN 2002

-322156103596142313910

RANK IN 2012

4250433116372418324

JUMP IN RANKINGS

n/a272113724324181376

FIGURE 7: MID-SIZE VS LARGE PHARMA: VERTEX VS MERCK & CO, US MARKET

Source: IMS Sales & Prescription Data, US data only.NBRx are new to brand prescriptions, TRx are total prescriptions.

$1,600

$1,400

$1,200

$1,100

$800

$600

$400

$200

$0

M i l l i o n s

Cumulative Sales

Incivek

M a y - 1

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J u n - 1

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J u

l - 1 1

A u g - 1

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S e p - 1

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O c t - 1 1

N o v - 1

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D e c - 1

1

J a n - 1

2

F e

b - 1

2

M a r - 1 2

A p r - 1 2

M a y - 1

2

Victrelis

1,4001,2001,000

800600400200

0

NBRx Volume

TRx Volume

M a y - 1

1

J u n - 1

1

J u

l - 1 1

A u g - 1

1

S e p - 1

1

O c t - 1 1

N o v - 1

1

D e c - 1

1

J a n - 1

2

F e

b - 1

2

M a r - 1 2

A p r - 1 2

M a y - 1

2

10,000

8,000

6,000

4,000

2,000

0

Incivek TRx Victrelis TRx




from 2002-2012, yet Actelion has experienced a 60% CAGR. HIV has seen a 12% CAGR, yet Gilead grew at 40% over the last decade. Any diversification has been limited andcomplementary. Gilead has made a play in the HCV space, and indeed is widely forecast to become a dominant player in that field too, but HCV is still an anti-viral treatment so they

are staying within their area of expertise. For those who remain unconvinced that smallercompanies cannot take on the might of big pharma despite the very recent Vertex vsMerck example, remember that when Gilead entered the HIV antivirals market, GSK andBMS between them held a 75% market share a distant cry to Gileads dominance today.

So how can the Top 10 pharma companies fight back in this innovative space? Thereduction in the productivity of R&D, both with respect to the number of NCEs andtheir yield in terms of early sales, peak sales and overall lifetime sales, at the sametime as R&D costs have continued to rise, mean that large pharma need to adapt aradical rather than an incremental approach to innovation (figure 8).

We believe that the imperatives of an innovative model are as follows:

1. FocusThere is an increasing difference of opinion as to what innovation means to key stakeholders. Unmet need still exists, but profitable unmet need is now focused onfewer areas, being much more dependent on what payers will consider as true unmetneed and what they consider to be adequately satisfied with low cost generics. Thispayer unmet need is a subset of all clinical unmet need. What we see from the fastestgrowing innovative companies is a focus on specialty medicine in areas of high unmetneed, strong relationships with both payers and patients, with limited diversificationfrom these core areas of expertise.

2. Nimble and flexibleThe days of being driven for a decade or more by a single blockbuster product areover. As demonstrated above only four products launched in the last three years havereached blockbuster status, and blockbusters will be fewer and further between goingforward. Companies need to adapt to smaller patient populations and be able to movequickly to advance discoveries in a minimal timeframe at lower costs to compensate

for potentially lower overall revenues from individual products. They also need to beable to successfully launch a larger number of products in a shorter time-frame,something that even Top 10 companies have, historically, found challenging.

FIGURE 8: FORMULA FOR SUCCESSFUL INNOVATION

1. Ident ify areas to play

=Diversification from key TAexpert ise is complementar y

& focussed like fastes t growing

+Innovation is focussed in high

return the rapy areas

2. R & D=

R&D process is designedcost-effectively to allow

balanced emerging/ mature NCE sales by enabling volume

play+

R&D process is shared andde-risked through

partnerships and alliances

3. Identifyun-met need

=Identifiable patient

population for whom treatment will work

+Payers agree with targe ted

unmet need+

Appropriate outcomesdata collected and firm

plan for RWE




3. PartnershipsR&D will continue to be hugely expensive and risky, and being more focused andnimble means companies cannot do everything. Partnerships allow companies to bemore flexible. Partnerships are not a new concept in pharma, although they have

typically been most prolific in specialty medicine as we see big pharma partnering with small-mid size pharma to finalise development and commercialization. Goingforward, as fewer companies invest in primary care due to the ongoing small moleculegenericisation, we feel that significant developments in this arena will only comeabout through partnerships to lessen risk. Even in diabetes, the fastest growing area of primary care, partnerships are becoming a dominant force as Lilly/BI and BMS/AZ work together to try and win in the market.

4. Expanding geographic footprint At present although growth in mature markets is essentially flat vs the high growthemerging markets, over 80% of NCE sales come from the mature eight markets. Thetop 20 original brands in emerging markets are all older products, the majority of

which had a first launch 11-20 years ago. Getting the price-volume balance right inthese emerging markets is essential to success for big pharma - they have to be able tomake innovation pay in pharmerging markets because it is under such pressure in thelarge developed markets.

To be able to refocus on innovation and succeed in this new environment, largepharma needs to emulate the focus and entrepreneurial environment of the fastestgrowing companies. By splitting its business into proprietary pharmaceuticals andeverything else Abbott has gone down this path. Pfizers share price hit a high in2012 when Goldman Sachs sparked rumour of a break-up back into core pharma andother pieces, away from the diversified behemoth of present. In addition in the Jan2013 call to investors, Ian Read mentioned again the possibility of a break up. We believe that the innovative requirements of the future means that going forward there will be fewer large pharma companies that are true nuts and bolts R&D firms thantoday, and that as a result there will be fewer truly innovative firms in the Top 10pharma rankings in the future.

There is of course, an additional hurdle for successful pharma players to overcome; its no longer justabout the payer and physician. On a global basis we see health insurance schemes, and governmentschemes, trying to push responsibility for healthcare onto the patient. This is not only in the form of prevention (weight loss, smoking cessation, healthy living) but also in the form of adherence. InGermany for example, there are incentives/bonuses in the private insurance schemes for adhering totreatment plans, participation in special care plans etc. This actually provides pharma with a greatopportunity to increase adherence to medication and improve outcomes measures. Pharma thereforehas opportunities to both educate and engage with the patient. This leads quite naturally into the realmof digital devices and social media. Large pharma has developed a range of tools here including apps foriPhone/iPad which act as diaries or tracking alerts reminding patients to take their medication andtrack their progress. There are also initiatives such as games for younger patients where they arerewarded with points for good adherence. Pharma could undoubtedly go much further with this.Looking at consumer centric companies such as Amazon could teach pharma the principles of a onestop shop offering. Amazon offers an integrated platform to purchase multiple goods/services andcustomized advertising based on the consumers profile and previous purchases. Could pharma emulatethis service-oriented patient centric approach?




THE FUTURE OF THE TOP 10Big pharma unsurprisingly view todays pharmaceutical market environment as highly challenging, which it is. But how much is the perception of an adverse environment aproduct of reliance on a single model of focus on R&D, on protected products, and on

the mature markets? IMS believes that todays prescription medicine environment isthe most diverse ever in terms of geography, stakeholders, product offeringopportunities, pricing/value choices and commercial model options that the industry has ever experienced, giving the big players in the prescription medicines industry more opportunities and options than they have ever had before to become or toremain a Top 10 player.

We believe Teva is just the first of a number of players who will be in the Top 10 with asubstantially different model to the traditional Top 10 player. We believe that goingforward the top of the pharmaceutical industry will see more focussed, nimble,innovation led players, but, unlike today, that will not be the only model. There will also be payer focused (low cost) players and even consumer led players. There will be a

starker choice between size and growth, and profitability, than there has been and many of the current Top 10 pharmacos will be smaller than they were in the 1990s and 2000s.

1. The dominance of the protected product dependent, research based model in the Top10 will be broken over the next 5-10 years.

It will no longer be the case that 100% of the worlds largest prescription medicinescompanies are described as R&D led and mature market dependent. We say this sincenot only has Teva already entered the Top 10 and Sandoz contributes so much toNovartis sales, but also because Andrew Witty has talked about GSK moving away from white pills and western markets 6

2. There will still be innovation focused companies, and they may even be the majority of the Top 10 companies, but these innovation led companies will be very different to thetraditional model.

Instead of being small molecule, primary care focused, addressing large patientpopulations and largely competing with each other, they will become largely specialty driven, with a portfolio which includes biologics, focussing on smaller patientpopulations, and competing on a much more level playing field with the small tomedium sized companies that have been the success story in terms of growth andlaunches over the last few years.

3. The innovation focused companies will still be big, but absolute size in the protectedprescription market will fall.

This will be because more new protected agents will be for smaller patient populations(whether biomarker or payer defined). The logical response of companies wishing to

follow the innovative route and maintain size is to launch a larger number of smallerproducts, and to launch them successfully in a wider group of countries, includingemerging markets. That in itself brings challenges companies have historically not been good at consistently rolling out large numbers of excellent launches in a shortertimeframe, even if their R&D manages to develop large numbers of quality NCEs.Some companies, inevitably, will fail to rise to this challenge. They will see theinnovative portion of their sales reduce considerably and will be reliant on non-protected prescription businesses (even non prescription businesses) going forward.

4. The non-innovation led companies in the Top 10 will undoubtedly include one or morecompanies for whom the unprotected segment is of great importance.

Teva is the first; it may not be the only one. Companies with this model can still have

an innovative sector (Teva does) but it wont be the only driver of the companysgrowth and sales. These companies, to succeed, will be internationalising theunprotected business, which historically has been much more fragmented than the




protected prescription business. They will succeed not only through breadth of geographic expansion but also by their innovativeness in offering a value portfolio including supergenerics, biosimilars and other value adds to protect against thelowest cost generic competition and also to raise margins. The new Abbott will deriveabout 25% of its sales from branded generics, with ~50% of those sales coming fromemerging markets. 7 This is a great example of what was a largely innovative company focussing on growing their back catalogue and acquired generic businesses inemerging markets which is the ideal environment.

5. It is also possible in the next five to ten years that completely new business models startto emerge and are successful enough to maintain or drive companies into the Top 10.

We noted above the rise of the patient as a stakeholder with a voice and an opinion inhealthcare. All prescription medicine players, whether protected or unprotected, haveto take note of this and respond. But just as there is an opportunity for companies whose primary focus is the prescriber (the innovative protected companies) and thepayer (the unprotected prescription companies), perhaps there is also a role for acompany that has as its focus the patient/consumer. Since a primary focus here would be a new entrant it is not yet clear exactly what the core of this model might be it could be from OTC consumer medicines, or potentially from lifestyleprescription products paid for out of pocket. It could even be from the very recent but burgeoning area of medical apps (which can even be prescribable), or a combinationof all these three, so long as the company in question is state of the art in their ability to understand and communicate with the consumer.

What is clear is that the Top 10 of the next 5-10 years will have diversity of businessmodel, primary customer and geography as key features. Completely new approacheshave a better chance of succeeding in this new environment than was ever the case before. We also believe that the Top 10 will hold an even smaller share of thepharmaceutical market going forwards, and become even more fragmented than at

present. One has to hypothesize that if the Top 10 didnt manage to break the 50%market share threshold in the era of $bn blockbusters, they are unlikely to achievethis in the lower revenue era of the future.

The pharmaceutical industry has historically been highly conservative, and that defaultmode is not going to be an asset in the next few years out of the box thinking and a willingness to discard many of the fondly held beliefs of the past will be the crucial asset.

AUTHORS:Carolyn Gauntlett, Senior Consultant, Thought Leadership, [email protected] Rickwood, Director Thought Leadership, [email protected]

[email protected]+44 (0)20 3075 5888www.imshealth.com

REFERENCES:1 IMS Blockbusters White Paper2 Zacks Equity Research Auto Industry Outlook and Review

- October 2012, http://www.zacks.com/stock/news/84881/auto-

industry-outlook-and-review-october-20123 Gartner News Room Aug 2012: Worldwide sales of mobile phones,

http://www.gartner.com/newsroom/id/21200154 IMS MIDAS September 2012, IMS World Review

5 IMS MIDAS September 20126 The Telegraph and other press articles, 2009/2010,

http://www.telegraph.co.uk/finance/newsbysector/pharmaceutical

sandchemicals/7158658/GSK-seeks-to-abandon-white-pill-and- Western-markets-strategy.html

7 Abbott Presentation to JP Morgan Health Conference Jan 2012


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