Showing posts with label COPAXONE. Show all posts
Showing posts with label COPAXONE. Show all posts

Thursday, 28 December 2017

The parlous state of national champions: the sagging fortunes of Teva


One of the darker aspects of hi-tech is the fate of national champions in smaller countries. When we say "fate", we typically mean the rise and fall of such companies in the face of global competitors from the U.S. Nokia in Finland and Nortel in Canada come to mind, both world class competitors, at least for a while, and in Nokia's case, the world leader in an earlier generation of cell phones. To this list the name of the Israeli company Teva Pharmaceutical Industries should be added; in some ways, Teva's story may be the most emotional of all.

For readers who might not be familiar with Teva, the company became the world's largest producer of generic drugs and the undisputed national hi tech champion of Israel. Unlike so many of the vaunted Israeli start-ups that have gone from creation to exit in less than a decade, leaving their founders with millions, if not hundreds of millions of dollars, but adding little to the overall macro-employment situation in Israel, Teva maintained (either organically or by acquisition) multiple plants in Israel, as well as keeping the company an Israeli entity with its headquarters in a suburb of Tel-Aviv. Yet, on December 14th, the company (with a new CEO, Kåre Schultz, formerly of Novo Nordisk) announced that it would eliminate a quarter of its employees world-wide, including 1,700 in Israel.

This number may not seem like the cause for national economic mourning, but in the Israeli context, there is no other way to describe the impact of the cut-backs on the national psyche. The New York Times (" 'Nobody Thought It Would Come to This': Drug Maker Teva Faces a Crisis", December 17, 2017) described Teva as the "corporate version of a national celebrity", the one genuine instance of a home-grown company that became a world leader in its field. Indeed, there are few pension funds in the country that do not hold Teva stock, such that it became, again, in the words of The New York Times, "the people's stock".

It is the company’s long-time roots in the country that strike a particular chord, dating back to the early 20th century, when the predecessor to what is now Teva began to distribute--via camels and donkeys-- drugs and like products in what was then Turkish Palestine. This blogger recalls being told the story of those early days by a third-generation descendant of founders, a source of continuing family pride, but a story also recounted fondly by broader swathes of the Israeli population.

But behind this romanticism is a medium-sized pharmaceutical company, by international standards, which had everything go right for it— for a while. In the 1960's, certain national legislation enabled the company to enter the market for generic drugs and hone the management and execution skills needed to successfully compete in this market. At that time, the company was blessed with a larger-than-life chief executive, Eli Hurvitz, who drove the company's international expansion in the area of generics while continuing to keep the company Israeli-focused to the extent possible throughout his tenure at the company (he retired as CEO in 2002). This included establishing plants in the country's periphery, long a backwater in the country's economy. Further, the company enjoyed oversized success as a patent licensee (from the Weizmann Institute of Science in Israel) of the branded drug—COPAXONE, used to treat multiple sclerosis, the sales of which came to constitute nearly 40% of the company's operating profits in some years.

So what happened? First, starting in about 2010, the economics of the generic drug market significantly changed, especially in the U.S., where large retail pharmacy chains joined with so-called pharmacy-benefit managers to create purchasing giants with the market power to force down prices. With margins narrowing as a result, Teva, at least with respect to the plants in Israel, found itself in an inferior position vis a vis competitors in lower cost countries, both from established generic competitors in India and more recently in China.

Second, the company is facing a patent cliff regarding the COPAXONE product: the brand name is not likely to be of commercial consequence post-patent as competitors enter with lower-cost alternatives. Teva thereby faces the double whammy of not having a proprietary block-buster product to replace COPAXONE plus a declining competitive position in the generic market.

Third, the company's declining fortunes in the generic drug area was exacerbated as a result of its acquisition in 2015 of the Actavis generic products division from Allergen. The purchase price was $40.5 billion. Debate in the Israeli business press has raged over whether Teva overpaid at the time, given the state of the generics market, or whether the wisdom of hindsight rules. Whatever is correct, the company has $35 billion in debt and is facing a cash squeeze. Cutting costs is the only short-term strategy. The announced restructuring is expected to save the company $3 billion by 2019.

This blogger previously discussed ("When a company's future is caught in the generic drug/proprietary drug crosshairs") the particular challenge of a pharmaceutical company of the size of Teva, with 2016 revenues in the amount of $21.9 billion, and a market capitalization that has declined nearly $20 billion during 2017. How to right the ship with respect to its generic products, while also ramping up the necessary R&D to support a viable proprietary drug business, is daunting for even the largest pharmaceutical company. However Teva responds to this challenge, it is difficult to imagine that it will keep its status within Israel as the undisputed national industrial champion. There is no one else to replace it.

By Neil Wilkof

Thursday, 12 January 2017

When a company's future is caught in the generic drug/proprietary drug crosshairs


There is nothing in any other IP regime analogous to the generic/proprietary divide with respect to the exploitation of patent rights in the pharmaceutical industry. The relatively short period of patent protection, 25 years at the most, in light of the multi-generational staying power of some drugs, means that there is potentially big business in commercially exploiting the public domain after a drug has come off patent. Add to this the symbiotic relationship between proprietary and generic products; without the patent protection undergirding the former, the latter would never come to be.

While a first view of the proprietary/ generic landscape might lead one to think that it is a zero-sum game, i.e., a company that is engaged in
proprietary products will not also be involved in the generic market, and vice versa, the commercial reality is much more complex and nuanced. There is no pharmaceutical company that better reflects the challenges of trying to master both these product markets than the Israeli-based company, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) Thus, while it is often said that Teva is the world’s largest generic drug company, its most successful product over recent years has been the proprietary drug for multiple sclerosis, COPAXONE, reportedly amounting to 35% of profits. This reminds us how a basket of generic drug products can be barbelled by a single proprietary blockbuster.

The problem for Teva is that COPAXONE is coming off patent. Add to this a lackluster track record of acquisitions and general pressures from competitors in the generic space, culminating in the failure of its multi-billion dollar acquisition of the Mexican company, Rimsa. This is before President-elect Trump's comments yesterday on drug prices and manufacture abroad, as reported by fellow blogger, Mike Mireles. It is no surprise, perhaps, that Teva’s shares have continued to tumble.

Against this backdrop, the interview given by Teva activist shareholder Benny Landa is an illuminating window through which to view the challenges facing this mid-sized, proprietary cum generic drug company, with a bit more than $20 billion in sales per annum. Landa is an iconic figure within the Israel high-tech scene, best known as the founder of the digital print product company, Indigo, which was acquired by HP in 2002. In an interview that was published by GLOBES, an Israeli business paper, on January 9th, Landa was pointed in his criticism about the management and strategy of the company.

Landa's criticisms derive from the fact that, as he describes--
"[t]he company has lost half of its value. It's worth less than its debt [a drop of nearly 50% in its share price during this period, pushing its market cap down to $35 billion]. “
The problem starts with the inappropriateness of the board of directors as well as the CEO.
"… it's clear to me that they need one of two things: either a CEO with pharma experience or an experienced board of directors to guide him….. I'd like to see at least a third of the directors with substantial experience - at least one third. For that, the board of directors would have to replace itself, and that's not happening."
Landa continues--
"All the directors are excellent people with experience in their fields, but they can't devise a strategy for a company like Teva. It's no wonder that the company made such mistakes. The directors don't even know what questions to ask.”
In addition to the problem of the composition of the board of directors and the expertise of the CEO in the pharma industry, Landa frontally attacks the company's strategy, in the following words--
"In my opinion, the emphasis on generics is a big mistake. It's a misguided return to the comfort zone, based on the idea that what worked so well in the past will go on working. The world has changed, however. Generics is now competition over price - who can produce the most cheaply. Is that Israel's advantage? Cheap production? That's not what we are.

Teva should follow the trail blazed by COPAXONE - Israeli innovation and technology. Teva knows how to be innovative. It's such a pity that all this capital is going to generics. It's just tying the company's hands, and it can't make innovative acquisitions. Teva has to rid itself of its dependence on generics."
He was emphatic—Teva "mustn't be the Walmart of the drug market. It can't operate in the cheap mass sector."

Not surprisingly, Teva has a different view of the situation here.

The criticism leveled by Landa addresses the more general question of the proper business model for the company, given its historical success in the generic market overlaid by several profitable proprietary products. As Landa notes, the generic market puts a premium on operations, while the prerequisite for proprietary market penetration is R&D, either home-grown or acquired. And in this lies the challenge for Teva: can it successfully carry on with its generics business; does it have the savvy to identify winners in the proprietary space; and does it have the wherewithal to do successful R&D (recall that COPAXONE was based on a discovery made at the Weizmann Institute of Science)? To hear Landa, the answers to these questions may be a matter of commercial life or death for the company.

For more on patent exploitation and the public domain, see here.