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INDIANAPOLIS (Reuters) – Eli Lilly (LLY.N) CEO John Lechleiter has become the adjudicator kid. Clashing his arch rivals, he vows the 134-year-old drugmaker will bang no mega-deals as its top medicines face a appearing Apocalypse of apparent expirations.

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Eli Lilly accumulated address is apparent in this undated advertisement photo. REUTERS/Eli Lilly/Handout

Grappling with a agnate aggression of generics, Pfizer (PFE.N) and Merck (MRK.N) aftermost year purchased Wyeth and Schering-Plough, respectively. By accomplishing so, they acquired new products, the affiance of huge amount accumulation from laying off bombastic staff, and abeyant abiding earnings. They additionally bought themselves acting accord of mind.

The companies had ahead denounced big mergers as a abiding way to abort biologic innovation, but could not abide the abounding concise advantages of accomplishing a deal.

Lechleiter isn’t accepting any of it. He scorns the actual anticipation of a big alliance or aloft accretion to beanbag the apparent blows, alike admitting drugstores will be abounding amid now and 2014 with all-encompassing forms of Lilly’s Gemzar blight drug, Zyprexa schizophrenia treatment, Cymbalta anti-depressant and Evista osteoporosis medicine. Together, the four blockbuster medicines acquire anniversary sales aing $11 billion, accounting for bisected of the company’s revenue.

A 31-year Lilly adept who began as a chemist, Lechleiter says big biologic mergers consistently abort because they annihilate addition and productivity. Lilly credibility to Pfizer Inc, whose laboratories acquire bootless to aftermath any big-selling medicines in the accomplished decade admitting several huge mergers.

Instead, Lechleiter is bent to go it alone. He is counting on Lilly’s own crop of alpha drugs to canyon analytic trials and be accustomed in time to disclose accumulation advance afterwards the aching aeon of apparent lapses, which Lilly has nicknamed “the YZ years.”

“We now acquire about 70 molecules in analytic date development, and others abaft the blind that are not yet in beastly testing,” Lechleiter told Reuters in an account at aggregation headquarters. “While all of those won’t accomplish it, abounding of them will and abounding will be admired articles and ultimately drive actor growth. That is why bodies advance in our industry.”

That said, some bodies who do advance in the industry acquisition his alive optimism a bit baffling. Afterwards all, aback it comes to accepting new articles to market, Lilly and added drugmakers acquire had a continued accident streak.

“It’s a actual aberrant position they’re taking, because what they’re facing,” said Standard and Poor’s analyst Herman Saftlas. “They acquire to do something, or the apparent bluff will annihilate them. How are they activity to abutment their dividend?”

Saftlas believes that Lechleiter’s access may reflect Lilly’s U.S. heartland roots — for bigger or worse. “It seems to be a actual aloof approach, a actual adamant mind-set that is actual altered from what we’ve apparent in New York and New Jersey. There is that blazon of mentality in the Midwest, of afraid to your accoutrements and toughing it out,” he said.

Lilly’s aged allotment amount suggests added investors may accede with him. The accord appearance is that it will be boxy to acclimate the apparent storm afterwards a big accord to augment its artefact calendar and its activity of alpha drugs that has been aching by failures this year.

Industry analysts abhorrence that Indianapolis — home to Lilly and 11,000 of its advisers — could additionally pay dearly for the company’s no-merger strategy. That is, if it doesn’t work, and Lechleiter refuses to acquire it won’t.

The third bigger burghal in the Midwestern United States, with a citizenry of 800,000, Indianapolis fell into adulteration in the 1970s and 1980s. But it has fabricated an absorbing backlash in contempo years, with a new airport terminal, a new home for the Indianapolis Colts football team, Lucas Oil Stadium, and a aloft advancing amplification of its assemblage centermost and hotels.

Its axial breadth and bisect of artery highways — putting the burghal aural a day’s drive of bisected the nation’s citizenry — are a aloft calling card. In acceptable times and bad, Lilly has consistently been a work of stability. But now the drugmaker’s own acceptable health, and survival, are actual abundant at risk.

To adapt for the advancing flood of generics, Lilly a year ago said it would cut 5,500 workers, or about 14 percent of its all-around workforce, by 2011 to save $1 billion annually. Abounding of the cuts are hitting Lilly’s sprawling accumulated headquarters, labs and accomplishment plants in Indiana’s basic city.

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The appointment abstraction amount in burghal Indianapolis has jumped to added than 20 percent, up from 17.8 percent several months earlier, as a aftereffect of Lilly affective out of two abounding barrio a its basic headquarters, according to the Indianapolis Star.

The accepted annular of job cuts is alone bisected over, and some analysts apprehend new circuit to arise as the generics access and demolish its arch brands.

Lechleiter expects anniversary aggregation sales to be aloft $20 billion in 2014, which he calls the “trough year” of the apparent crisis. That would be about in band with 2009 revenue, helped by sales advance of medicines not adverse all-encompassing competition, as able-bodied as an accepted acceleration of sales by afresh in arising markets and of the company’s beastly bloom business.

The angle for profits is far added sobering, if not frightening. Lechleiter expects anniversary net profit, now in the $5 billion range, to retreat to somewhat added than $3 billion in 2014. That agency balance could tumble as abundant as 40 percent, as college taxes and a college allotment of earlier drugs coil accumulation margins.

Yet, with Zen-like composure, Lechleiter says Lilly will booty the balance hit and afresh clean from there. “Whenever the abject is established, that’s activity to be the set point for the advance that hopefully follows, based on the barrage of these articles we now acquire in our portfolio. The key is ablution new medicines.”

Importantly, Lilly expects anniversary banknote breeze of added than $4 billion, which it considers able to agreement that its acceptable allotment — the bonbon that keeps abounding Lilly investors on lath — charcoal complete through the YZ years.

“Our appetence for accomplishing deals is activity to be guided or choleric by the banking constraints we’ve placed on ourselves to advance our allotment at atomic at its accepted rate,” Lechleiter said.

To Sam Isaly, managing accomplice of healthcare advance aing OrbiMed Advisors, Lilly has about a mystical acceptance that its biologic activity will save the day, but afterwards acceptable reason.

“Those guys acquire their alive in the beach — deep, absolute abysmal in the beach — aback you accede their abundance has been aing to zero,” Isaly said.

Although Lilly a decade ago launched the beachcomber of medicines now adverse apparent expirations, it has had an “abysmal” almanac aback Cymbalta was accustomed in 2004, according to Isaly. “They haven’t alien annihilation from their own labs aback then,” he said.

Lilly did in actuality barrage two medicines apparent by added drugmakers during that time. They are Byetta, a diabetes anesthetic awash in affiliation with Amylin Pharmaceuticals Inc, and Effient, a claret array preventer partnered with Daiichi Sankyo. Effient — which Lilly had billed as a abeyant blockbuster aback it was accustomed 16 months ago — has won little apprehension and middling sales.

Although Lilly garners anniversary acquirement of about $400 actor from Byetta, the drug’s sales acquire not lived up to Wall Street expectations. Authoritative affairs worse, the U.S. Food and Biologic Administration aftermost ages alone a long-acting anatomy of Byetta alleged Bydureon — the best important biologic in Lilly’s pipeline. Regulators accepted heart-safety abstracts on the once-weekly product, which could adjournment its barrage for two years, or alike abuse its approval.

Cowen and Co has been counting on Bydureon and Byetta to column accumulated anniversary sales of about $3 billion by 2015, allowance Lilly acclimate its apparent cliff. But the Bydureon adjournment could now acquiesce Novo Nordisk’s afresh accustomed Victoza, a agnate analysis to Byetta, to abduction a greater foothold.

Boxes of cymbalta are apparent on a belt in this undated advertisement photo. REUTERS/Eli Lilly/Handout

A day afterwards the Bydureon rejection, late-stage trials of Lilly’s alpha diabetes biologic teplizumab — which captivated affiance of $500 actor in anniversary sales — were apoplectic aboriginal afterwards it was accounted ineffective.

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Other setbacks acquire accumulated up. In August Lilly scrapped one of its two treatments in late-stage studies for Alzheimer’s disease, alleged semagacestat, afterwards it was accounted ineffective. And federal lath aback backward July acquire attempt bottomward patents on its blight biologic Gemzar and its Strattera analysis for absorption arrears disorder.

Gemzar, with anniversary sales of $1.25 billion, could face U.S. generics aural days. Strattera, accepting sales of added than $500 million, could anon ache the aforementioned fate if Lilly loses its advancing address of the apparent decision.

In animosity of Lilly’s disability to get abounding of its drugs off the ground, Lechleiter has told investors the aggregation affairs to acquire 10 drugs in late-stage studies by the end of aing year. He additionally said the aggregation intends to acquaint two new decree medicines a year, alpha in 2013.

Despite skepticism amid some investors, Jan Lundberg, Lilly’s analysis chief, insists there is far bigger achievement for the aggregation if it charcoal independent. He said all-embracing a big alliance could bandy his scientists and analysis laboratories out of whack.

“Mergers in the pharma apple are added a amount of abbreviation costs, and do not advice productivity,” Lundberg said in an interview. “Scientists become absent about whether they acquire a aing role, so they’d rather do the safe, me-too, affair than the risky, adroit affair because you don’t appetite to booty risks with new bosses. It’s not accessible to innovate beneath the gallows.”

Lundberg said the company’s best able alpha drugs are abeyant treatments for Alzheimer’s disease, cancer, diabetes and autoimmune diseases such as rheumatoid arthritis and assorted sclerosis.

Although semagacestat bootless to advice Alzheimer’s patients, Lundberg said addition biologic in late-stage trials adjoin the degenerative academician disease, alleged solanezumab, holds promise. “If the aggregation succeeds in this breadth it will acquire a huge banking return.”

Lilly’s oncology activity is on par “with the better in the industry,” Lundberg said, with four blight drugs in Phase III trials. They accommodate two biotech medicines acquired in the ImClone deal, ramucirumab (formerly accepted as IMC-1121B) for abdomen and cancers, and necitumumab (formerly IMC-11F8) for lung cancer. Two added compounds are in late-stage trials for melanoma and lymphoma.

A brace of medicines are in late-stage trials for diabetes, including one advised to calm allowed arrangement acknowledgment amid patients with the affiliated Blazon 1 anatomy of the disease. The added medicine, nicknamed GLP-Fc, is agnate to Bydureon. But Lilly owns it absolute and would not acquire to allotment acquirement with a partner.

“The autoimmune breadth is new for Lilly,” Lundberg said, acquainted the aggregation has bets on three drugs in mid-stage trials. One is a high-profile admixture for rheumatoid arthritis that blocks a protein alleged BAFF. “This could be the next-generation treatment” for the debilitating collective disease, he said, and advice the aerial allotment of patients that do not account over time with arch biotech drugs, such as Abbott Laboratories Inc’s (ABT.N) Humira and Johnson & Johnson’s (JNJ.N) Remicade.

Building on the company’s longtime backbone in psychiatry, Lilly is additionally testing new classes of medicines for abasement and schizophrenia.

Several added drugs in earlier-stage trials could be “sleepers,” Lundberg said, with cogent sales abeyant if they bright advancing hurdles. He said they accommodate medicines to acceleration healing of cartilage fractures and to body beef backbone in the elderly. “Hip breach in the aged is a actual astringent action and abounding patients never get mobilized again. It’s a potentially big market.”

In the meantime, Lilly continues to coursing for about baby deals, to authorization or buy new articles to aggrandize its pipeline. The company, which has a bazaar assets of about $41 billion, has focused on affairs in the $1 billion range, although two years ago it paid $6.5 billion for ImClone Systems and its Erbitux blight biologic — its better accord ever. Its additional bigger accord was the $2.3 billion acquirement of biotech ICOS Corp in 2007, giving Lilly abounding affairs of their aggregate Cialis anti-impotence drug.

“Now Lilly has to appraise article a accomplished lot bigger,” Isaly said. “They ability acquire to carapace out $20 billion or added to acquisition the assets to course them over.”

Isaly said biotechs with important products, such as Genzyme Corp GENZ.O — which French drugmaker Sanofi-Aventis (SASY.PA) is advancing to beanbag its own apparent struggles — is the affectionate and admeasurement of accord that ability accomplish faculty for Lilly.

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Other analysts acquire appropriate mid-sized drugmakers such as Gilead Science Inc (GILD.O), Celgene Corp (CELG.O), Biogen Idec (BIIB.O) and Shire Plc (SHP.L). The companies acquire bazaar capitalizations angry from $15 billion to $33 billion, and would acceptable command cogent premiums.

But Derica Rice, Lilly’s arch banking officer, appropriate such cher deals were not in the offing. “Look at the history of Lilly. The bigger accord we’ve anytime done is ImClone, for $6.5 billion, and the aing bigger was $2 billion,” said Rice. “Everything abroad has been smaller. If investors began to see accomplishments from Lilly that are adverse to that, they’d activate to catechism whether administration has afflicted its strategy, and we acquire not.”

Lilly charcoal focused, he said, on affairs baby companies, or licensing their drugs — which are in afterwards stages of beastly trials or advancing approval, and which accompaniment its own agenda of medicines.

For example, he acclaimed that Lilly afresh accountant rights to a statin cholesterol fighter, alleged Livalo, from a captivated Kowa Co Ltd of Japan, and has accountant an underarm testosterone gel alleged Axiron from Australian drugmaker Acrux Ltd (ACR.AX). In addition contempo deal, admired at up to $755 million, Lilly bought all-around rights to Incyte Corp’s (INCY.O) articulate JAK1/JAK2 inhibitor to amusement rheumatoid arthritis.

“It’s bright we’re not advancing all-embracing mergers agnate to our peers,” said Rice. “We’re not block windmills. We acquire a action and that’s our roadmap, our guidepost. And as you go through agitated times area there are a lot of abeyant distractions and noise, conduct and focus will advice us execute.”

The advancing all-encompassing claiming will concealment in accent Lilly’s abrupt accident of apparent aegis in 2001 on Prozac, its flagship drug. The anti-depressant, with anniversary U.S. sales of $2.4 billion, accounted for some 30 percent of the company’s revenue.

Then, as now, Lilly vowed it would not accompany a big alliance to bland out its earnings. And it kept that promise, helped by a bisected dozen alpha medicines that were launched in accelerated assumption and became its better brands — the calendar now adverse apparent expirations.

Rival drugmakers acquire additionally bargain their workforces, and apparent their allotment prices constipate due to their own aing confrontations with generics. Like Lilly, they acquire been clumsy to barrage abounding big-selling new drugs in contempo years due to bootless analytic trials and tougher analysis by the U.S. Food and Biologic Administration. But Wall Street has meted out added abuse to Lilly.

Its shares acquire collapsed 37 percent in the accomplished three years, compared with a 12 percent abatement for the ARCA Biologic Index of abounding U.S. and European drugmakers.

“The amount of the industry has been decimated, and Lilly is conceivably at the basal of the pile,” said Viren Mehta, of Mehta Partners, a pharmaceuticals advising group. “As with the industry, the catechism is how abundant lower Lilly’s appraisal can go.”

Lilly has captivated on to abounding investors with the accomplished allotment amid U.S. rivals, alms an anniversary crop of 5.5 percent. Aggregation shares barter at 7.5 times 2011 per allotment earnings, lower than any of its U.S. rivals, addition absorption of Lilly’s perceived anemic prospects.

But by addition measure, Lilly shares are far from cheap. They are trading at a assorted of 12.5 times projected per allotment balance in 2014, aback the company’s accumulative abrasion from generics will be at its worst, a cogent exceptional to its rivals. That suggests Lilly shares acquire abounding allowance to drop, abnormally if added of its alpha articles abatement by the wayside.

For the moment, Mehta said no beyond rivals arise to be ambit Lilly because best are activity through their own misery. Lilly could become adorable as a takeover target, however, and accountable added of its own workforce to the chopping block if its shares accumulate address value, Mehta said.

Still, he and added critics accede that mega-mergers are no argent bullet. About every one of them in contempo decades acquire failed, acceptation their breeze of important new drugs was balked by cultural clashes or accident of focus as the companies accumulated operations, Mehta said.

“So you can’t badly criticize Lilly’s attitude adjoin mega-mergers because there’s able affirmation they about don’t actualize value. But if addition was accommodating to pay a acceptable premium, afresh Lilly would acquire no advantage but to acquire it.”

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In the meantime, Mehta said best investors acquire already alone Lilly. “Those larboard are acquisitive either for a booty out in the abbreviate term, or, like John Lechleiter, biding their time in hopes article works out.”

Disbelievers predominate, with 20 of 22 analysts polled by Thomson Reuters accepting a “hold,” “underperform” or “sell” appraisement on Lilly. By contrast, bisected of analysts acquire “buy” or “strong buy” ratings for Bristol-Myers Squibb Co (BMY.N), whose apparent expirations through 2013 will be about as astringent as Lilly’s.

But clashing Lilly, its New York battling has a activity beginning with medicines that acquire performed able-bodied in analytic trials, including abeyant blockbuster treatments for melanoma and claret clots that could rejuvenate aggregation sales and balance adequately quickly.

Lilly has its defenders, however. One of them is Avik Roy, a healthcare analyst for New York allowance Monness, Crespi, Hardt & Co. He said the aggregation should be accepted for adamantly afraid Wall Street clamors for a big merger.

“John Lechleiter is assuming bookish adventuresomeness by actuality accommodating to blot up and booty the bite of the aing balance decline, while acquainted the continued appellation amount of the aggregation will be apprenticed by centralized analysis and development productivity,” Roy said.

Like others, he is agnostic of the assets from mega-mergers. “The botheration with big mergers is that the R&D guys from Aggregation A are befuddled calm with those from Aggregation B and the guy with the best cull with chief administration keeps his drugs and his guys on board, while the added guy gets let go,” he said. “It’s not meritocratic; it’s political. It’s rarely a rational action and there’s a five-year aeon of stagnation because of all the backroom in these big mergers.”

By swearing off a aloft deal, Roy said Lechleiter ability be authoritative a claimed banking cede as well. CEOs about win big bonuses, disinterestedness options and added allurement pay already such deals alpha briefly turbocharging earnings.

An acute archetype was above Pfizer CEO Hank McKinnell, who helped spearhead back-to-back mergers with Warner-Lambert and Pharmacia in 2000 and 2003, respectively. Pfizer pushed him out in 2006 afterwards huge amount accumulation from the mergers assuredly evaporated and the aggrandized aggregation languished. Admitting his bootless tenure, McKinnell absolved abroad with added than $200 actor in retirement pay and added compensation.

“When you’re accommodating to say, ‘However I’m paid, I’m added absorbed in the abiding advance of the aggregation than amalgamation with addition else,’ that’s an access bodies should approve,” Roy said.

For that reason, some acquire Lilly’s banal may prove to be a aces gamble. Michael Liss, portfolio administrator of the American Century Amount Fund said Lilly is account captivation for a year or two to see how its activity fares or whether a battling goes gunning for the drugmaker. In either case, he thinks investors angle to profit.

“Lilly’s activity has been actual disappointing, but eventually I anticipate their drugs will be accustomed and become a bartering success,” said Liss.

By his calculations, the company’s accepted allotment amount assumes no amount for any of its alpha medicines. “In actuality there’s about a abrogating amount actuality assigned for their R&D,” Liss said. “People are extrapolating from the aftermost brace of years that none of their new drugs are activity to get passed. But I’m accommodating to bet they will acquire at atomic a few successes.”

If it doesn’t, he additionally predicted Lilly will become a takeover target. “Someone will acquisition them adorable for the drugs they do have, and for amount cuts afterwards affairs them. And Lilly would acquire to do its fiduciary duty, and analyze the achievability of affairs themselves.” He thinks Lilly can authority out “a brace of added years” afore its duke is forced.

The abeyant appulse of a takeover, adverse or otherwise, may not acquire yet absolutely dawned on Indianapolis. If affairs angle in that direction, memories may about-face to 1995 and the burghal of Kalamazoo, Michigan. The Midwestern burghal never recovered from the takeover that year of hometown drugmaker Upjohn by Swedish drugmaker Pharmacia AB and the consistent job cuts.

Upjohn, afflicted by all-encompassing competition, awash itself for $6 billion and the accumulated company, Pharmacia & Upjohn, became headquartered in London. Two years later, Pharmacia & Upjohn relocated to New Jersey and pulled its North American sales and business teams out of Kalamazoo. In 2000, the aggregation alloyed with Monsanto Co, alone to be gobbled up in 2003 by New York-based Pfizer, which alone 20 percent of the actual Pharmacia and Upjohn advisers in Western Michigan.

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Lilly’s paychecks, purchases, borough improvements and cultural alms acquire kept Indiana’s basic burghal bustling for generations, while additionally adorning the Hoosier State. A abstraction by Indiana University calculates the drugmaker contributes added than $8 billion a year to the accompaniment economy.

“Lilly is like a admired uncle in the family,” said Roland Dorson, admiral of the Indianapolis Chamber of Commerce. “They accommodate not alone bags of jobs, but they acquire a heritage, a legacy, of giving back, and they are deeply, acutely complex in the community.”

The drugmaker makes a point of affairs from bounded suppliers and vendors, aloof one archetype of its borough assurance and its accent to the bounded economy.

“Certainly, Lilly has a able ability and conceivably some of that is alive their aesthetics not to accompany big mergers, because that could advance to a ability clash,” said Peter Jankovskis, co-chief advance administrator of Oak Brook Investments. “Being a aggregation town, Lilly has their own way of accomplishing things and there is consistently the crisis a big alliance accomplice will acquire a altered mind-set and way of accomplishing things. That sometimes makes mergers fail.”

The company’s borough alertness goes aback to Colonel Eli Lilly, a chemist and Civil War adept who founded the drugmaker in 1876. He championed the architecture of roads, bridges and parks and lavished the fast-growing burghal with his philanthropy.

Family associates remained alive in the aggregation until contempo decades, but no best are complex in management. The Lilly Endowment, a clandestine ancestors foundation accustomed in 1937 by three of Lilly’s heirs, has awarded added than $7 billion in grants over the years — abundantly to Indiana organizations.

Although the award is the drugmaker’s better stockholder, captivation added than 11 percent of Lilly’s shares, it is not represented on Lilly’s lath of admiral and beneath to animadversion on aggregation strategy.

“More than 90 percent of our assets are in the company, although we are abstracted from the company,” said award backer Gretchen Wolfram. “We vote our shares like any added accepted shareholder.”

The drugmaker, likewise, has its own aggregation of philanthropies, abstracted from the endowment. “Eli Lilly is a huge adherent of the symphony and aggregate in boondocks basically,” Wolfram said.

Just aftermost month, on October 7 from aurora to sunset, added than 8,000 of Lilly’s advisers were freed from their desks and centrifuges to adorn an automated aisle of Artery 70, from the new airport terminal to downtown.

Using shovels, trowels and rakes, they buried 1,600 copse and 72,000 built-in plants and shrubs.

“It will all attending arresting in the spring, aback aggregate blooms,” Dorson said of the aforetime arid amplitude of Interstate.

How adorable Lilly will attending aing year, as its all-encompassing crisis unfolds, is addition question.

(Reporting by Ransdell Pierson; Editing by Jim Impoco)

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