Lifestyle OTCs still the best hope for OTC switch revival

otcinaction

2019 has been a slow year for Rx-to-OTC switch news, with activity dropping off markedly in the key US market in recent years, and Asia-Pacific (especially China, Japan and Indonesia) and Europe (Poland especially) the main source of developments. In this context, it was welcome news last week that Norway will become the second European market for OTC Viagra, after the Norwegian Medicines Agency approved the OTC sale of Viagra Reseptfri (Pfizer, sildenafil 50mg) erectile dysfunction treatment to men aged 18+ years, with this to be accompanied by pharmacist advice.

Pfizer plans to launch Viagra Reseptfri in pharmacies in early 2020, while Rx Viagra will remain available. The medicines agency recommends that men have a check-up with their doctor within six months of purchase so that any potential underlying conditions can be investigated. Viagra Reseptfri will be the first medicine available in Norway under the country’s new category of non-prescription medicine with guidance, and the Rx-to-OTC switch follows similar measures elsewhere in Europe. In Poland, sildenafil 25mg is available OTC from a number of domestic players, with initial launch from Adamed in May 2016, while Viagra Connect was launched in the UK in March 2018.

Of the 20 key markets covered by OTC New Products Tracker every month since the start of 2013, Poland has been the most active in terms of Rx-to-OTC switch activity, with 54 products reclassified to non-prescription status. A liberal switch environment has helped bring about a raft of Rx-to-OTC switches since 2014, including Europe’s first OTC erectile dysfunction brand and Poland’s first OTC systemic cold sore treatment.

Viagra Norway

Despite some notable failures (such as urinary product Flomax Relief), so-called “lifestyle” drugs remain the primary source of switch activity, helping to extend the reach of the OTC market into new categories such as contraception, erectile dysfunction and cardiovascular disease. A key switch development in 2019 was the downscheduling in Japan of Taisho’s hyperlipidaemia treatment Epadel T (ethyl eicosapentaenoate) to Class I OTC, where sales are permitted in pharmacies (and online) after professional consultation. Downscheduling may have come just in the nick of time – sales data suggest Epadel T had failed to make any noticeable impact on the OTC market in its almost six years as an Instruction-Required Drug.

There also remains hope that Sanofi may one day market Eli Lilly’s erectile dysfunction treatment Cialis as an OTC medicine (it owns the rights to market Cialis OTC in the USA, UK, Canada and Australia), but is switch application has been stuck at the FDA a full five years since its submission. In July 2019, Sanofi also signed a deal with Roche for the exclusive OTC rights to Tamiflu (oseltamivir 75mg capsules, Genentech / Roche Group) for flu prevention and treatment in the USA. Under the terms of the agreement, Sanofi will be responsible for leading negotiations with the US FDA for the OTC switch and subsequent exclusive marketing, scientific engagement and distribution of Tamiflu OTC in the USA. Let’s hope for the sake of OTC growth that its negotiations go smoothly.

Clear your diary for Nicholas Hall’s 31st European Conference, which will be held in Athens on 28-30 April 2020, on the theme of Advancing in CHC: The Must-Dos and  Reasons Behind Them. To register your interest in this event, or for more information on sponsorship opportunities, please contact jennifer.odonnell@NicholasHall.com.

Advertisements

Pfizer-GSK j-v approved, Pfizer-Mylan to close mid-2020

otcinaction

At the end of last week, it was announced that GSK and Pfizer have closed their j-v, combining the groups’ respective consumer healthcare businesses to create the world’s largest CHC company. According to the latest MAT Q1 2019 data (see table below), this new entity – which will operate globally as GSK Consumer Healthcare – will become the standout No.1, increasing its global share from around 4% to roughly 7%, though of course divestitures will be necessary. Those already identified include ThermaCare (by the EU authorities) and Pfizer’s antacid tablet business (by the Brazil authorities), while some OTC brands (like Viagra Connect) will stay with Pfizer.

As previously announced, under the deal Pfizer owns a 32% equity stake in the j-v and GSK owns 68%. The combined company, which will be led by CEO Brian McNamara, will take leadership positions in pain relief, respiratory, VMS and therapeutic oral health. The new business will also hold the No.1 CHC spot in the USA and the No.2 position in China. As part of the agreement, Pfizer has appointed three of the nine members of the j-v’s board. GSK intends to separate the j-v as an independent company via a demerger of its equity interest to its shareholders and will list it on the UK equity market.

Screen Shot 2019-08-04 at 17.51.02.png

 

 

Screen Shot 2019-08-04 at 17.51.37.png

In the same week, Pfizer announced plans to enter into a definitive agreement to combine Upjohn, its off-patented branded and generics business, with Mylan. The new company, which will be renamed and rebranded when the transaction closes (expected mid-2020), will expand the capabilities of both Mylan and Pfizer across 165+ markets. Mylan brings a diverse portfolio across many geographies and key therapeutic areas, while Upjohn brings iconic brands such as Lipitor, Celebrex and Viagra and leadership positions in China and other emerging markets.

The combination will drive a diverse portfolio of Rx medicines, complex generics, OTCs and biosimilars. It will be based in the USA and led by Mylan’s current Chairman Robert Coury, who will serve as Executive Chairman. Pfizer shareholders will own 57% of the new company and Mylan shareholders will own 43%. The new company is expected to have pro forma 2020 revenues of US$19bn-20bn.  

Commenting on the deal, Nicholas Hall said: “The new company will be a top CHC player, owing to Mylan’s 17th ranking, plus the Viagra Connect business and sundry other Pfizer CHC brands that didn’t go into the GSK j-v. That could well move NewCo into the Top 10. The questions in my mind are: will NewCo keep these assets or sell them on; and (more importantly) will it license out the rights to what is one of the best switch portfolios in the industry or manage the switches themselves.”

The evolving OTC market will be under the spotlight in our forthcoming report, Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, written by Nicholas himself! Other chapters will include Healthcare Trends, Regulation, Digital engagement amongst many others. Nicholas will also unveil the 15 “Infinity Zones” he has identified as being crucial to the future growth of the industry. You can upgrade your purchase to include a customised in-house presentation or webinar with Nicholas for an additional GB£10,000. To find out more or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Uncertain economic outlook in 2019

OTCINACTION

As well as the ongoing uncertainty over Brexit, another cloud on the economic horizon for 2019 is the health of the US retail sector. According to a report over the weekend by the FT, shares in US retailers are set for their biggest quarterly sell-off since the financial crisis. This follows weak economic data in Asia-Pacific, especially China where retail sales hit a 15-year low in November 2018, and Europe, prompting concerns about a global economic slowdown.

Tariffs, and the threat of tariffs, have been one factor. Some US retailers are reportedly now having to offload surplus stock at a heavy discount, after accelerating imports in recent months to avoid planned higher tariffs (which are now on hold), while the fall in industrial output in China is partly linked to US tariffs that have been imposed. Also, concerns have resurfaced among investors about the ability of bricks & mortar retailers to navigate the e-commerce revolution. As a result, shares in various US retailers have fallen sharply, from high-end to mass market chains, like Target (down 23%).

2349-amazon-header-2-780x300.png

Amazon shares have also declined this quarter, though the e-commerce giant still looks on course to disrupt pharmaceutical distribution and reimbursement in 2019, a fact that hasn’t eluded many top pharma executives. J&J CEO, Alex Gorsky, in an interview with Fortune, said: “We have conversations at all levels going on with Amazon. I think Jeff (Bezos) and as importantly Amazon is a very innovative organisation, and they see this as an opportunity to make a difference. Just as we are partnering with them today in areas of our consumer products, we’ll look forward to partnering with them in the future in some of these other areas as well.”

Pfizer Chairman & CEO Ian Read also said late last year: “Any system of distribution that can cut costs and get a wide availability of products to patients is something that the whole industry would be interested in.” This disruption to pharma distribution, allied with the current economic uncertainty, looks set to make for a volatile year in 2019. According to Nicholas Hall, the “Big Beasts of Big Pharma are right. Amazon and Alibaba are today the most powerful disruptors of the healthcare industry. Some brand marketers will embrace this change, most will not … until it’s too late.” 

Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, our upcoming new Signature Report written by Nicholas, focuses on a range of important issues surrounding the CHC Market, including Innovation, Success Factors, Digital Engagement, Competition and much more. It is an essential read for all players striving to compete in this rapidly evolving marketplace. To find out more or to place your order, please contact melissa.lee@NicholasHall.com

GSK, RB pull out of running for Pfizer OTC

Last week was a dramatic one for M&A news in the OTC industry. In the days running up to the deadline for binding offers for Pfizer Consumer Healthcare, both RB and GSK announced they had withdrawn from the process. 

RB’s CEO, Rakesh Kapoor, said: “Our priority remains organic growth, including the completion of the integration of Mead Johnson Nutrition and creating further value from re-organising into two new business units — Health and Hygiene Home … An acquisition for the whole Pfizer consumer health business did not fit our acquisition criteria and an acquisition of part of the business was not possible.”

GSK’s CEO, Emma Walmsley, later commented: “While we will continue to review opportunities that may accelerate our strategy, they must meet our criteria for returns and not compromise our priorities for capital allocation.”

All three companies are in the Top 6 globally, and a tie-up between No.6 RB and No.5 Pfizer would have created a new No.1 globally. Meanwhile, if the current No.1 GSK had acquired Pfizer, its lead would have been significantly enhanced – see the chart below for a sense of what might have been (assuming both GSK and Pfizer would not have had to make divestments).

Pfizer and GSK.png

Investors have reacted positively to the news of no M&A deal, sending shares in both RB and GSK higher. In the latter case, some had been concerned that the potential US$20bn deal could have distracted from GSK’s focus on pharma, and jeopardise its dividend.

After RB’s withdrawal, Pfizer stated that it “continues to evaluate potential strategic alternatives for the CH business, which include a spin off, sale or other transaction, and Pfizer ultimately retaining the business. We have not yet made a decision, but continue to expect to make one in 2018.”

Nicholas Hall, in Friday’s OTC.Newsflash, commented: “I recently addressed a group of private equity and hedge fund investors about the future of CHC, and all they wanted to talk about was RB, GSK and the disruption of the industry by private label and Big Tech. The investment community is very concerned about the growth prospects of the CHC industry, and that is one of the reasons strong signals were sent to RB not to overpay for Pfizer Consumer Health; as we now know RB subsequently pulled out of the bidding. Briefly, that left “the last woman standing”, GSK’s Emma Walmsley, but GSK like RB was unprepared to pay the $20bn that seems the generally-accepted valuation for PCH. As readers of this column know, my thinking had tilted towards “no sale” in the past few weeks, and unless there is a last-minute change of heart, the likelihood is that Pfizer will keep its CHC division and look at other options: retain and grow; spin off; make a j-v.”

NHC’s 40th Anniversary in 2018

New Year’s message from our Chairman & CEO Nicholas Hall:nh

The start of a new year, and already there is a big ripple of activity in the global CHC market. MM&M NewsBrief ran a story on Tuesday headlined: “CPG companies Nestle and Kellogg court OTC”. It is an interesting notion that Kellogg could buy into the mainstream CHC market as their previous forays have focused on functional foods. But it seems a stretch to me, although there would be a certain neatness if Steve Cahillane, the new CEO of Kellogg and formerly Nature’s Bounty President & CEO would bid for Pfizer Consumer, where Paul Sturman was President. And where is Paul now? — Steve’s replacement at Natures Bounty.

So, it’s possible but unlikely that Steve will become a New Friend (or more properly a Friend Reunited), but our New Friend at FDA, Scott Gottlieb, is making interesting noises that could potentially liberalise the rather static US market. Could this include a new 3rd Class, about which I have been a lone voice in the wilderness for almost all of my time in the CHC industry (more on that later)? CHPA and other stakeholders (apart from retail pharmacy) say “No” as this is illiberal. Mmm, I think the other way. Switching more Rx products under the personal supervision of a pharmacist is very liberal, and will certainly lower costs, which is empowering for consumers — a key test of liberalism. And rounding up the last of our New Friends in this New Year issue, let’s welcome Amazon as a CHC brand marketer, not just an online platform. Some would say, who needs friends like Amazon? Well, I would rather have Amazon as a Friend than an Enemy!

Two prominent association leaders are leaving the industry, the Departing Doctors Gerald Dziekan and Hubertus Cranz. They have done amazing work, as my Good Friend Birgit Schuhbauer relates below, and will be very much missed. I hope the NHC Group will have good or possibly even better relations with their successors. Another Departing Friend who will be particularly missed is Senator Orrin Hatch, who did so much to override FDA when we had no friends there at all. Former presidential candidate Mitt Romney will probably succeed to the Utah seat of Senator Hatch. I hope that the man who made millions at Bain will be as — or even more — sympathetic to CHC.

What about Remaining Friends? Well, that’s us. I almost can’t believe it, but we set up NHC in January 1978. Indeed, a few minutes ago one of my Very Best Friends sent congratulations on our 30th Anniversary. Obviously we were having too much fun to count! I still have clients and colleagues from that era, including the redoubtable Gilbert (Sans Frontieres) Mertens, who still comes to our conferences and last year was our guest in Singapore. 40 years is an amazing length of time, but we at NHC are all about the Future.

So after many years of some change and a lot that’s still the same, good or bad, it is with very great pleasure that all of us at NHC Group wish our contacts a Happy New Year for the 40th time. May it be one of good health, great happiness, peace, success and prosperity. We will be here for another 40 years (at least corporately) and we hope you will be too!!

MAT Q3 2017: Trends to look out for in 2018

OTCINACTION

Intense work is underway to complete the Q3 2017 update early next week, which will provide OTC DASHBOARD subscribers with the latest trend info and analysis on the performance of the global OTC market. In the meantime, taking a closer look at the latest news and data does reveal a few trends that are likely to characterise the OTC space in 2018, not least:

The growing power of the Emerging Markets

A coming shake-up of the global Top 10 OTC marketers

As this week’s infographic demonstrates, Turkey was one of the leading contributors to OTC growth in the MAT Q3 2017 period. Over recent years, both Turkey and South Africa have emerged as global Top 20 OTC markets, powered by high growth (though the trend in South Africa did show signs of slowing in Q3 2017). In No.21 spot, Algeria looks poised to enter the Top 20 in the very near future, thanks to continued high growth (+10% MAT Q3 2017). To keep up with the latest trends in the Middle East & Africa, OTC DASHBOARD remains your best port of call.

MEA Q2 2017.png

Top 3 Middle East & Africa markets, according to MAT Q2 2017 data

As for the leading OTC marketers, the big news in 2017 was Pfizer’s October announcement that it would be starting a bidding war for its consumer healthcare division, with RB, J&J and GSK all widely cited as possible suitors. However, there were at least two other major developments in 2017 that could cause a shake-up of the global Top 10 in the coming years – in October 2017, Novartis announced that plans to spin off its Alcon eye care business, following a strategic review, would be delayed until H1 2019 at the earliest, while in the same month the FT reported that Merck KGaA was pressing ahead with the sale of its consumer healthcare unit.

Nestle has been cited as a potential suitor for Merck KGaA’s OTC business and will be one of the companies to watch next year. Last week, Nestle agreed to acquire Canadian-based Atrium Innovations from investors led by Permira Funds for US$2.3bn cash. Atrium will become part of Nestle Health Science upon closing, which is expected in Q1 2018. Atrium’s largest brands are Florida-based Garden of Life, which manufactures certified organic, non-GMO supplements sold in health food stores and online in the US, and the Pure Encapsulations line of hypoallergenic, research-based dietary supplements sold in the US via healthcare practitioners, online and in pharmacies in several European markets. The portfolio also includes specialty brands such as Wobenzym, an oral enzyme combination containing proteolytic enzymes + bioflavonoid for osteoarthritis pain. 

If Nestle were to also acquire the Merck KGaA OTC business next year, and continue on its path of strong M&A growth, it could soon break into the global OTC Top 10. In addition, Merck KGaA would not only be a good fit with Nestle’s strategy of expanding in the field of high-quality vitamins, minerals & supplements, but would also give the company a strong foothold in the Emerging Markets, where Merck KGaA currently generates around half of its global Consumer turnover.

Pfizer OTC up for sale: How the OTC industry could be transformed

Near the end of last week, a Reuters news story broke indicating that Pfizer would be opening an auction process for its OTC business as early as this November, and that preliminary discussions had already taken place. GSK and RB have been tipped as frontrunners in securing a deal, though P&G, Sanofi, J&J and Nestlé have also been cited as possible bidders.

In Friday’s OTC.Newsflash bulletin, Nicholas Hall stated that there could possibly be 3-4 strategic buyers in the final bidding, and that the eventual selling price of Pfizer’s OTC unit could rise above US$20bn.

During GSK’s Q3 2017 results presentation, CEO Emma Walmsley confirmed that the company is interested in bidding for Pfizer’s OTC division and “building up our Consumer business”. However, there was a note of caution when the GSK CEO stated that “our first focus in capital allocation was clearly around our biggest business in Pharma, and R&D within that”. 

Using the latest DB6 figures for the MAT Q2 2017 period, now available on the OTC DASHBOARD website, we have created a graph below showing how the global Top 5 in the OTC industry would be transformed if GSK was to snap us Pfizer’s OTC business (assuming, of course, that there wouldn’t be any divestments):

GSK+Pfizer.jpg

As you can see, the deal would put GSK far ahead of its rivals, and make it the standout OTC marketer in what it is currently a very tight and competitive Top 4. Likewise, we also analysed the data to see the impact of RB acquiring Pfizer’s OTC unit on the global Top 5 and again the result would likely be a clear new global No.1:

RB+Pfizer.jpg

As ever, it’s hard to be sure how the situation will unfold, and it’s possible that Pfizer may even decide to hold on to its OTC business, but whatever happens we’ll be sure to keep you updated with the latest news and analysis here at OTC DASHBOARD.