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Scientist, deal maker, litigator: Barry Sherman was everything to the Canadian drug giant that turned him into a billionaire. Can the company thrive again now that he's gone?
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By TIM KILADZE, PAUL WALDIE
  
  

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Saturday, April 21, 2018 – Page B1

They arrived in droves, hundreds of mourners wearing bright blue scarves and dresses and T-shirts, coming together to commemorate the man who built an empire.

Six days after Barry Sherman and his wife, Honey, were found dead in their Toronto home, scores of employees from Apotex Inc., the Canadian drug giant that Mr. Sherman founded, gathered at a convention centre on the outskirts of Toronto. There, on a drab December morning, they joined thousands of others at a memorial service for the popular couple.

It was a public spectacle. The Prime Minister attended. Prominent members of Toronto's Jewish community did, too.

Yet away from the limelight, Apotex employees were reeling. Mr. Sherman built their company from the ground up. Its identity, its ethos, was intertwined with his own.

"We are like a family," a solemn employee told reporters. Many of his colleagues wore apparel in the same blue hue as Apotex's signature logo, including T-shirts bearing a powerful message: "We will continue your legacy."

For staffers, life hasn't gotten any easier in the four months since that mournful day. Although the initial shock has dissipated, the upheaval throughout Apotex's far-flung operations hasn't let up.

The company is struggling in the face of challenges that have gripped the generic-drug industry worldwide and led to thousands of layoffs, including hundreds at Apotex - so far.

Not only has the company lost its guiding force, but Mr. Sherman left no ownership succession plan.

Mr. Sherman's stake is likely to be divided among several relatives whose intentions aren't clear. Some employees also hold shares, according to court filings, complicating the company's control even more.

A new management team has been put in place and there are already plans to sell divisions and cut back operations. But there's no guarantee any of that will be successful and the future of one of Canada's premier companies is now in doubt.

Mr. Sherman's death has already set off a round of internal turmoil. Within weeks of the memorial, chief executive officer Jeremy Desai abruptly resigned after 15 years at the company, including nearly four as CEO. Mr. Desai had been enmeshed in a messy lawsuit alleging that he had stolen trade secrets from arch rival Teva Pharmaceutical Industries Ltd., with the help of a U.S.-based Teva executive with whom he'd had an affair.

Without a clear No. 2 to take the reins, the company reached for a familiar hand: Jack Kay, a former Apotex CEO, who agreed to come out of quasi-retirement at age 77.

While Mr. Kay was a familiar face in a fragile time, his steadying influence didn't last long.

A few weeks after his return, Mr. Kay sent an e-mail to Apotex's senior leaders telling them to brace for a significant restructuring. However, it is made clear that someone younger will be charged with implementing the revamp.

The man most likely to do that is Jeff Watson, a Kay protégé and the company's new president and chief operating officer.

Mr. Watson faces a complicated task. Mr. Sherman's legacy looms large at Apotex, even after his death. At the company's office complex in north Toronto, a banner with his portrait hangs over the reception desk.

But Apotex must be re-tooled, which means some of the founder's work will have to be undone. Despite the company's status and its track record of success that made Mr. Sherman a billionaire, it faces serious headwinds.

The generic-drug industry is under siege, and Mr. Sherman and Mr. Desai made key decisions in recent years that have hampered the company's performance.

In a rare interview, the new president is candid about the need for change. Almost everything seems to be on the table. "A year from now, our geographic footprint will look different. A year from now, our supply chain will look different," Mr. Watson said. Apotex's drug portfolio is also likely to shrink.

Altogether, it amounts to a "tighter, more focused approach" - a new strategy that was quietly taking shape last summer and fall. Mr. Sherman's death put things on hold, but the initiative has resumed. Recent changes have included staff cuts at Apotex's hub in Brantford, Ont., about an hour west of Toronto, and putting the company's European division up for sale.

The goal, in Mr. Watson's words, is simply to establish a "sustainable business that can stand on its own two feet."

DISRUPTION FROM ALL ANGLES

Five months before he died, Mr. Sherman finally accepted that the status quo wouldn't suffice. Generic-drug makers used to mint money - with operating profit margins around 30 per cent - but those days were vanishing.

Apotex became a Canadian champion by reverse-engineering the formulations of brand name drugs and then selling them for much lower prices once their patents expired. With his doctorate from the Massachusetts Institute of Technology and brief history in the drug business thanks to an uncle, Mr. Sherman founded the company in 1974 and drove the business hard. He oversaw almost every operation and served as lead scientist, mixing the chemicals that formed the essence of new drugs. By the late 1990s, Apotex had operations around the world and held 40 per cent of Canada's generic market.

In the past few years, most of the institutional drug purchasers in the key market of the United States have either consolidated or formed partnerships. The three largest buyers now make up roughly 90 per cent of drug purchasing in the country, giving them incredible negotiating power over producers.

As well, the U.S. Food and Drug Administration plans to keep increasing the number of generic drugs it approves for sale. The hope is that the greater supply will drive drug costs lower - and new generic drug manufacturers in low-cost countries such as India are desperate to tap the U.S. market.

Generic drug prices had been falling 7 per cent to 8 per cent annually in the United States, and in late 2017 analysts at Credit Suisse projected even more carnage, with prices perhaps soon falling 10 per cent to 12 per cent annually.

"The worst has not yet played out, and returns should decline sharply," they wrote last October.

Similar pressures exist in countries with public health-care systems - including Canada - albeit for different reasons. Chiefly, cash-strapped governments are desperate to save money as their baby boomers age, so they target drug costs. As of 2016, average generic drug prices in Canada had declined to half of what they were a decade ago, according to Canada's Patented Medicine Prices Review Board.

Last year proved to be a turning point. By December, Sandoz, one of the world's largest genericdrug manufacturers, said it was considering exiting its oral dose business in the United States. A week later, Teva announced plans to lay off more than a quarter of its work force and suspended its dividend.

Asked to explain the shake-up on a conference call, Teva CEO Kare Schultz said the generic price wars had gotten ugly. "My guess is that not only Teva but other manufacturers have ended up competing to the bottom, where it's not really sustainable or profitable," he said.

As this global upheaval unfolds, Apotex is particularly vulnerable. The company has developed several business lines, but it is still predominately a producer of oral-dose drugs. In the months before he died, Mr. Sherman had been spending most of his time reworking old concoctions because many weren't robust enough for the current market - they were originally engineered to be stored in the types of pill bottles commonly seen behind Canadian pharmacy counters, but in emerging markets, drugs are typically sold in blister packs that aren't protected by a hard shell. Apotex also needed to make its pills more suitable for what are known as Zone IV climates, which have different temperatures and humidity levels.

"Sandoz, Teva, Mylan - they all lost volumes to the Indians," Ronny Gal, a pharmaceutical equities analyst at Sanford C. Bernstein & Co., said. "It's just that some of these other companies actually had other businesses to fall on, and Apotex did not."

Because the company is privately held, it's not clear how badly Apotex has suffered financially.

But in March, London-based Hikma Pharmaceuticals PLC, whose generics division has a very similar profile to Apotex, announced a $1.1-billion writedown on this unit. Hikma's latest financial reports show the division pulled in one-third of total revenue last year, but generated only 5 per cent of profit.

Complicating things further at Apotex was Mr. Sherman's pride and his combative personality.

Under his leadership, Apotex amassed a huge drug portfolio, but he could be reluctant to cast off poor performers. In his eyes, the drugs were his babies, his inventions. Once, when management signed off on halting some production, Mr. Sherman furiously defended the products and launched into a diatribe about their history and his designs, according to someone who was at the meeting.

Mr. Kay alluded to this trait in a speech at the memorial service.

"Barry would stick to his guns on anything that was important to him, even if the economics would say to let things go," he said. "The concept of letting go was just not anywhere in his DNA."

Mr. Sherman also had pet projects, such as developing a triplecombination drug to treat people who were HIV-positive. "The big pharma companies would say, 'Screw that, why are we going to waste our money on one of those things? Let the universities figure that out,' " said Hank Klakurka, who ran Merck Generics when it was sold to Mylan in 2007. He also worked at Apotex from 1997 to 2001, reporting to Mr. Kay.

Initiatives like these are "the kinds of thing that Barry saw a need for and would finance year after year after year," Mr. Klakurka adds. "Some of us would look around and say, 'Why are we throwing all that money away?' " Mr. Klakurka was not privy to Apotex's finances, but based on his estimates, Merck would have been much more profitable for a simple reason: "Because we were run like a real business."

And then there was Mr. Sherman's penchant for litigation.

Historically, in order to be first to market, generic companies had to push for exclusive rights to launch a generic version just before a patent expired. That has grown more difficult lately because of changes to patent laws that mean generic drug companies typically all start production on the same day.

Mr. Sherman's court contests could also create financial volatility. Apotex was constantly at risk of losing big cases and paying financial penalties, sometimes to the tune of hundreds of millions of dollars. In one famous example, Sanofi and Bristol-Myers Squibb Co. shared a patent on Plavix, a popular blood-thinner. Mr. Sherman thought he'd found a legal window to flood the U.S. market with a generic version of the drug, but the move backfired and after years of litigation, BristolMyers won a $442-million (U.S.) judgment in 2011.

MANUFACTURING WOES

Mr. Sherman was always proud of his Canadian roots. Apotex manufactures roughly 80 per cent of its drugs at plants north of Toronto. The company also employs 6,200 Canadians, a commitment in the face of incessant industry outsourcing that won Mr. Sherman accolades - he was set to receive the Order of Canada before he died - and helped him build relationships with politicians.

So when the U.S. FDA sent inspectors to two Toronto plants in 2009, Mr. Sherman likely felt confident. But FDA inspectors found a host of problems including "yellow powder," "charred material" and other contaminants in certain drugs, according to a warning letter sent to Apotex. Products from the plants were soon banned from entry into the United States, a damaging blow to a company that depended on growing U.S. sales. Apotex later alleged that the ban cost the company hundreds of millions of dollars in lost sales.

Mr. Sherman went to war, ultimately filing a lawsuit against the FDA under the North American free-trade agreement in 2012. Yet the narrative that developed of Mr. Sherman standing up to protect Canadian manufacturing was flawed. In its filings, Apotex acknowledged that its products "did not fully meet specifications," and the company hired someone from a global rival to oversee its quality control.

To make up for the years of legal battles and lost revenues, Apotex had to do something. In 2013, when cash was tight, Mr.

Sherman decided to sell the company's interest in Doc Generici, a profitable Italian generics producer, in a deal alongside its joint venture partners. It was reportedly valued around 300-million (more than $472-million).

It wasn't long before another showdown with the FDA loomed.

Before he'd become CEO in 2014, Mr. Desai had devoted much of his time shepherding Apotex's expansion into India - an initiative designed to fend off lowercost rivals. Yet starting in 2006, the FDA began looking into quality-control issues there, too. And by 2014, the regulator was so concerned that it banned nearly all imports from Apotex's Bangalore plant into the United States.

In a letter, the FDA cited repeated failures to keep proper drugtesting data and alleged Apotex staff had manipulated results. A year later, the regulator raised even more concerns, with inspectors alleging Apotex workers had disregarded adverse test results and conducted unauthorized drug injections.

As the FDA troubles played out, Apotex struggled with a "tech transfer" to India - that is, exporting its Canadian manufacturing prowess abroad. These struggles are common for older companies, yet Apotex's issues were likely rooted in some historical dysfunction, according to Mr. Klakurka. "His [Mr. Sherman's] flaw, I would say, would be that he would put up with technical people and their b.s. for maybe too long, and gave too many people second, and third and fourth chances to get it right - at his expense," he said. "When you have something like India, or China, you've got to have a guy there, sitting on the ground with those people - somebody who you know and trust your life with," he added.

Mr. Sherman trusted Mr. Desai, who led the push into India, but Mr. Desai seemed to lean on local talent. Now, the problems in India are seemingly never-ending.

While the FDA issues were eventually resolved, last December Britain's equivalent to the FDA banned imports from the Indian facility - a ruling that applies to the entire European Union.

"India has been an anchor around Apotex's neck," said a former senior employee.

THE INCREDIBLE SHRINKING COMPANY

After Mr. Desai abruptly left Apotex in January, it fell to Mr. Watson, the new president, to put out all the fires. A Halifax native, he joined the drug maker's sales and marketing team in 1993 after playing a few seasons as an offensive lineman in the Canadian Football League. Save for a brief stint with Shoppers Drug Mart, he has been there ever since. Mr. Watson is a close confidant of Mr. Kay's, and the two men had breakfast every month for years as he rose through the ranks.

The strategy he is now spearheading is multi-faceted. Most notably, although, it emphasizes Apotex's North American roots.

"Over four decades we've been in and out of international markets and learned lots of lessons along the way," Mr. Watson said, sitting in his ground floor office that looks out on a parking lot. As a result, the Apotex of the future won't reflect Mr. Sherman's global ambitions. "I would say a year from now you'll see a very focused footprint geographically," Mr. Watson adds.

As part of the retreat, there is a plan to sell Apotex's European business, which includes an operation in Poland that used to be highly regarded internally. Apotex is also pausing the construction of a massive new manufacturing plant in Florida - an endeavour that Mr. Desai announced in March, 2017, and was set to be the company's largestever investment in the United States, worth US$184-million. In turn, one of the signature components of Mr. Desai's short-lived legacy could get wiped from the books.

The moves do not suggest Apotex is giving up on these markets - especially the United States, which is crucial to the new vision.

It's just that Apotex may source these markets in different ways, perhaps with Canadian production, perhaps through contract manufacturing.

Canada will remain the firm's bread and butter, but Mr. Watson concedes domestic production will need to be even more efficient. Apotex hired McKinsey & Co. in 2015 to consult on its Canadian operations, and despite following some of the recommendations, more work is needed to hold up against lower-cost regions. "We continue to sweat our assets," Mr. Watson said.

In the United States, which is the second linchpin in the new vision, there will be a new strategy.

"In the past, it was really a pursuit to get bigger and better," Mr. Watson explains. Apotex craved market share, and it pursued producing a broad portfolio of drugs.

"We'll continue to launch products, we'll continue to add revenue. ... But we're not really defining ourselves on whether we're going to be able to get close to [the size of] a Mylan or get close to other organizations." Apotex currently has the 11th-largest market share in the country, down from a top-five standing before the FDA bans.

The big question mark is India, especially after Britain's. regulatory ban. There are hints that the latest failed inspection was the final straw for the current leadership team. Mr. Watson acknowledges the country is part of Apotex's review. "Is it delivering to the strategy that we need? It's something that we're taking a close look at," he said. Reading between the lines, it sounds as though Apotex could exit Indian manufacturing, but keep some other operations in the country, such as a business services office in Mumbai and a research and development arm in Bangalore.

Should the Indian plant be shuttered or sold, it would be another blow to the legacy of Mr. Desai, who led the entry in India after being hired as head of research and development in 2003.

The former CEO declined to comment - however, he and Apotex have denied the claims in the Teva lawsuit and the case appears headed for settlement in May, according to recent court filings.

The final leg of the new strategy involves revamping Apotex's drug portfolio, and culling weaker-performing drugs.

"When we had launch calendars that were more robust, many companies would carry what we would call 'the tail' along - products that you weren't really making money on, or they were marginal in nature," Mr. Watson explains. Not anymore. At the same time, Apotex wants to increase its production of complex drugs, such as injectables, which are more difficult for low-cost rivals to replicate. "There's no question that we see a greater involvement in specialty and complex [drugs]," Mr. Watson said.

Apotex isn't starting from a standstill - under Mr. Desai, the drug maker invested heavily in drugs known as biosimilars, and created a division specifically for them, called Apobiologix. Biosimilars are advanced forms of generic drugs, and they are created from living cells.

The task now is to determine how to make them profitable. For all the industry hype around biosimilars, 10 years in, there hasn't been much of a return on investment for anybody. At Apotex, traditional generics still generate 90 per cent of revenues.

"Everybody wanted to look at large molecules and biosimilars as the hope," said Pratap Khedkar, managing principal at pharmaceutical consultancy ZS Associates in Philadelphia. "So many people stampeded in with the gold rush mentality."

Developing biosimilars has proved to be much more intricate than the process for creating traditional generic drugs. With biosimilars, the regulatory bar is much higher, which creates the need for clinical trials. (Read: Higher costs.) At the same time, regulators have been slower to embrace these drugs, because of their complexity.

Marketing biosimilars is also likely to require new skill sets. In their early days, generic drug companies were seen as disruptors, which meant they needed to convince pharmacists to stock their products alongside their branded equivalents. Cash, or heavy rebates, often did the trick, and Apotex was known to offer some of the most aggressive financial rewards.

The biosimilar market is a different ballgame, one that involves educating and marketing to doctors, patients and payers.

"It will be very hard to succeed without taking on some of the trappings of a branded pharma company," Mr. Khedkar said. That means drug makers will need to develop some competencies in sales and marketing, both of which can be expensive endeavours.

THE ODDS OF SUCCESS

The question for Apotex is whether it can restructure fast enough to keep pace with the pharmaceutical market's global giants, which benefit from their scale. As if that isn't enough of a challenge, Apotex must find a way to do so without the guiding vision of the company's founder.

The good news is that Apotex appears to have stability where it needs it most: The backing of the Sherman family. In a deposition last May, Mr. Sherman revealed he had no succession plan, and his death raised questions about future ownership. But the company said family members have endorsed the transformation. "To accomplish what I've been speaking to you about, we certainly have the support and the ability to do that," Mr. Watson said. A request for confirmation through the family's lawyer was not returned.

Given this support, it appears that Apotex will focus on re-tooling as a standalone company.

Some kind of consolidation is common at this stage of the business cycle, but an Apotex spokesperson said that, at this time, there are no plans to sell the company or to take it public.

"There are lots of opportunities for a company like Apotex," Mr. Klakurka argues. Should it seek a partner or even a sale, private equity backers would likely be intrigued.

"As long as there's money coming in, and there are a lot of costs involved," he said, alluding, for one, to Canadian manufacturing, "then there are lots of opportunities for improvement."

What may ultimately determine Apotex's success - or demise - is the commitment of its employees. Even the most exemplary strategies can't be executed if the rank and file don't buy in.

Morale is a powerful thing.

Long before Mr. Sherman died, Apotex suffered on this front.

Some of the company's most respected leaders, including Steve Lydeamore, who used to run the biosimilars division, and Craig Baxter, who was once a close confidante of Mr. Sherman's and one of the few people privy to Apotex's finances, serving as a director on multiple Sherman family holding companies, left the drug maker. Mr. Baxter declined to comment, and Mr. Lydeamore did not respond to requests for comment.

The current leadership team is well aware that business transformations tend to depend on employee support. "There's no question: The people part of this business is where we're really spending our time," Mr. Watson said.

If anything, he adds, this is where Apotex may actually find its strength. This isn't just a company - for many employees, particularly those in Canada, it is a family. And since December, the family has something special to work for. In Mr. Watson's words, "the legacy of Barry has been something people have rallied around."

Associated Graphic

Jeff Watson, president and COO of generic drug company Apotex, is part of the new management team following the death of the company's founder, Barry Sherman.

FRED LUM/THE GLOBE AND MAIL

Apotex employees work at the drug maker's North York, Ont., packaging operations on March 29. Apotex manufactures roughly 80 per cent of its drugs at plants north of Toronto.

FRED LUM /THE GLOBE AND MAIL

Honey and Barry Sherman pose for a photo at a fundraiser. Before he died, Mr. Sherman had been reworking old Apotex drugs that weren't robust enough for modern markets.

JANICE PINTO /THE GLOBE AND MAIL


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