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Eli Lilly & Co. : Lilly Declares Fourth-Quarter 2013 Dividend
INDIANAPOLIS, Oct. 21, 2013 /PRNewswire/ --
The board of directors of Eli Lilly and Company (NYSE: LLY) has declared a dividend for the fourth quarter of 2013 of $0.49 per share on outstanding common stock.
The dividend is payable December 10, 2013 to shareholders of record at the close of business on November 15, 2013.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. F-LLY
Refer to: (317) 276-5795 Mark Taylor
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
_____________________________________________________
http://www.4-traders.com/ELI-LILLY--CO-13401/news/Eli-Lilly--Co--Lilly-Declares-Fourth-Quarter-2013-Dividend-17382271/
LLY
10 top drugs in biopharma's late-stage pipeline
October 8, 2013
Let's start with the large print. In the past, when I assembled lists of the biggest blockbusters in the late-stage pipeline, I sometimes just looked for the largest peak sales estimates and went with them, including some extraordinarily high risk/high reward drugs where developers were simply rolling the dice on the outcome.
That explains how drugs like solanezumab and bapineuzumab appeared--even though I had little actual faith that they would turn in positive data. (They didn't.) Some bloggers went so far as to write about it, sagely noting their risks and wondering how many of those drugs would cross the finish line.
That was a mistake. Some analysts would put a peak sales number on fairy dust; or pump up the billions in the sales column to make a client look better. FiercePharma Editor Tracy Staton and I helped underscore that last fall with a roundup of 10 cautionary tales of blockbuster busts. And I find myself repeating that mantra now just about every day.
This year, I'm stepping back and recalibrating. Some drugs are far too speculative to include on any list of prospective game changers. Solanezumab, back in a new Phase III study, is on the lottery list. If Eli Lilly's ($LLY) continued willingness to invest vast sums of money working on a disease that remains a medical mystery eventually pays off, its revenue will outshine that of many if not all of the drugs you'll find below. So far, though, the pharma company has missed time and time again on Alzheimer's. Semagacestat, solanezumab, the decision to buy Amyvid--a diagnostic imaging agent that accomplishes … what?--helps make Lilly look quixotic, at best, which it insists against all appearances is not the case.
Eli Lilly, though, does make the grade here with dulaglutide, a diabetes medication that has some major league potential. I still have plenty of questions about safety and so on that could scuttle the program. Like many Big Pharma developers, Lilly is quite picky about what it will and will not talk about. And when its top execs do talk, reality often flies right out the window. But there's a case to be made here.
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Read more: 10 top drugs in biopharma's late-stage pipeline - FierceBiotech http://www.fiercebiotech.com/special-reports/10-top-drugs-biopharmas-late-stage-pipeline#ixzz2h9DQB6G3
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LLY
Earnings in detail
project revenue to be between $22.6 billion and $23.4 billion
read here
http://www.earningsimpact.com/Transcript/82284/LLY/Q2-2013-Earnings-Call
I posted the CC highlights in #msg-89870017.
Business Update Call Updates
New pivotal trail for solanezumab called EXPEDITION 3
Transcript here
6:20 AM Eli Lilly (LLY) declares $0.49/share quarterly dividend, in line with previous. Forward yield 3.60%. For shareholders of record May 16. Payable June 10. Ex-div date May 14.
The uptrend is continuing since March 2009 and the stock has doubled in the last four years. The real upswing started in the middle of 2011. Even in the last year, the stock has moved up by around 40%. The sales and net income have not shown much growth over the last few years. In fact in 2012, the revenues were $22.60 billion compared with $24.86 billion in 2011 (decline of 9%). The net income has also fallen from $4.34 billion to $4.08 billion (a decline of 5.9%). LLY which is into discovery, development, manufacturing and selling of pharma products, has remained an excellent dividend payer. This is one attribute which makes it a preferred stock for investors (institutional ownership of 73%). All along, the dividends have been flowing at the rate of $1.96 per share per year. So the overall long term returns have been decent. The company is meeting revenue guidance (which has been low) but the drugs under development are not showing great promise. Success of pharma companies is heavily dependent on their ability to develop new drugs in segments which have good potential. One such potential segment on which LLY is concentrating is Oncology. The field is having a huge market and the company has a lot of stakes in it. Other smaller companies e.g. Senesco Technologies (SNTI) which are purely into research, have taken different approaches to treatment of different aspects of myeloma. LLY is one of the top ten cancer research firms in the world but its drugs have not been doing too well. Meanwhile the recent volumes have been low and the momentum is reducing. The fact that patents of some of its major drugs are likely to expire within the next few years will make it very difficult for it to sustain the sales even at current levels.
Good Story mentioning Eli Lilly...
http://emerginggrowth.com/emerging_growth_stock_picks/celldex-nasdaq-cldx-cutting-edge-products/01/16/2013
Many times investors make their stock choices based on how they climb in value on the market. However, savvy investors should also consider the companies that are setting the stage for a series of future significant milestones. Their cutting-edge products will be tapped by thousands of people, and the companies may make for future solid investment.
Let’s look at a company that must be given credit for its contributions to the pharmaceutical industry. Its emerging products will benefit many people affected by breast cancer. One of its treatment studies include CDX-011. The treatment is a conjugate that binds to a specific protein that promotes the migration, invasion, and metastasis of the disease. The company’s results demonstrate overall survival benefits.
CD-011 is the brainchild of Celldex Therapeutics (NASDAQ: CLDX). Since it announced the final results from its study, its stock has risen to $5 a share. While I think its great that Celldex is making progress with CD-011, that’s not the only thing that gets me excited by the stock. The breast cancer treatment is one in a line of studies carried out by the company. What piques my interest are the areas – outside breast cancer – that the company is studying. Another of its ongoing studies is on a vaccine that may act to promote anti-cancer effects in patients who have glioblastoma, a type of brain cancer.
“These events, coupled with ongoing activity in a number of other projects, will set the stage for a series of future milestones,” said Anthony Markucci, the CEO of Celldex while delivering the company’s third quarter report for the nine months ended September 30, 2012.
Celldex reported cash, cash equivalents, and marketing securities of $77.6 million, which the company believes will be sufficient to meet estimated working capital requirements and fund planned for program development into 2014. The decrease of $1.1 million from June 30, 2013 is due primarily to increased operational expenses during the quarter related to the vaccine on brain tumor. However, the cash outflows for these expenses were offset by the issuance of $2.0 million shares that raised net proceeds to Celldex of $10.9 million.
Sure, Celldex reported a net loss of $15 million for the third quarter of 2012 compared with a net loss of $11.8 million for the third quarter of 2011. It reported a net loss of $47.3 million for the nine months ended September 30, 2012, compared to a net loss of $32.1 million for the nine months ended September 30, 2011. But that is primarily due to increased operational expenses related to its studies.
Its competitors in the diagnostic substances industry are Dendreon Corp (NASDAQ: DNDN), Eli Lilly and Company (NYSE: LLY), and Roche Holding AG (NASDAQ: RHHBY). Trading at about $7.30 per share, its market cap is about $470 million. The decision as to whether to trade in Celldex in the first place rests with the individual trader. But if you want to place a pharmaceutical company on your watch list for 2013 and beyond, consider Celldex. Its emerging products may prove to be as strong as those produced by the world’s most valuable pharmaceutical companies.
4:50 PM Eli Lilly & Co. (LLY) declares $0.49/share quarterly dividend, in line with previous. Forward yield 4.05%. For shareholders of record Feb. 15. Payable Mar. 08. Ex-div date Feb. 13. The board approves share repurchase program of $1.5B.
http://seekingalpha.com/article/1000731-5-stocks-that-stand-to-benefit-from-unmet-need-for-alzheimer-s-disease?source=yahoo
Potential upside to LLY and other companies comparable other major pharma companies.
This diseases is a curse and could happen to any one once we hit a certain age.
10:52 AM Leerink Swan ups Eli Lilly (LLY +5.3%) to Outperform and raises sales estimates on the back of positive trial results for its gastric cancer treatment, ramucirumab. The firm thinks the recently released data shows encouraging potential for use on other tumor types, which could boost sales and lower the drug's overall marketing risk outlook.
4:20 PM Eli Lilly (LLY) declares $0.49/share quarterly dividend, in line with previous. Forward yield 3.89%. For shareholders of record Nov 15. Payable Dec 10. Ex-div date Nov 13
Lilly Announces Detailed Results of the Phase 3 Solanezumab EXPEDITION Studies Following a Presentation of the Independent An...
Lilly's analysis, as previously reported, showed primary endpoints, both cognitive and functional, were not met in the two Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's disease
In Lilly's pre-specified secondary analysis of pooled data in patients with mild Alzheimer's disease, a statistically significant slowing of cognitive decline was shown; this finding represented a 34 percent reduction in decline
Independent analyses of EXPEDITION studies conducted by the ADCS were generally similar to Lilly's top-line results reported on August 24, 2012
Next steps for solanezumab will be determined after discussions with regulators
Eli Lilly and Company (NYSE: LLY) today announced its detailed results for the Phase 3, double-blind, placebo-controlled EXPEDITION studies in patients with mild-to-moderate Alzheimer's disease. This announcement follows the presentation of results from independent analyses of the EXPEDITION study data conducted by the Alzheimer's Disease Cooperative Study (ADCS), an academic research consortium, at the annual meeting of the American Neurological Association (ANA) by Rachelle Doody, M.D., Ph.D., professor of Neurology and the Effie Marie Cain Chair in Alzheimer's Disease Research, Baylor College of Medicine. Dr. Doody is a member of the steering committee for the ADCS.
Lilly provided the raw data (the full data set collected from the EXPEDITION studies) to the ADCS. The ADCS statisticians then performed independent analyses of these data. These results were presented at today's meeting.
"Alzheimer's disease research has been extremely challenging," said Dr. Doody. "The data results from the solanezumab Phase 3 trials were encouraging to the ADCS team. These results represent an important step for the medical, academic, and scientific communities in understanding brain amyloid as a target of AD therapies."
Lilly's relationship with the ADCS is longstanding and the decision to have them conduct independent analyses of the Phase 3 solanezumab data was made prior to seeing the top-line results from either of the EXPEDITION studies.
Lilly Results from EXPEDITION1
The EXPEDITION1 study was designed with co-primary cognitive and functional endpoints (the Alzheimer's Disease Assessment Scale- Cognitive subscale [ADAS-Cog11] and the Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL], respectively) in patients with mild-to-moderate Alzeimer's disease.
Lilly's pre-specified secondary analyses showed that results in patients with mild Alzheimer's disease taking solanezumab demonstrated a slowing of cognitive decline compared with placebo (p=.008), as measured by the ADAS- Cog11. This finding represented a 42 percent reduction in decline at the endpoint of the 18-month study. The difference in functional decline (ADCS-ADL) was not statistically significant.
Lilly Results from EXPEDITION2
Based on the results of EXPEDITION1, Lilly modified the statistical analysis plan (SAP) for EXPEDITION2, prior to database lock, to specify a single primary endpoint of cognition in patients with mild Alzheimer's disease as measured by the ADAS-Cog14, a 14-item scale, which includes three additional items considered relevant for patients with mild Alzheimer's disease.1 At the conclusion of EXPEDITION2, there was a 20 percent reduction in cognitive decline in patients with mild Alzheimer's disease taking solanezumab; however, the treatment difference was not statistically significant (p=.120). In the pre-specified secondary endpoint of ADCS-ADL, there was a 19 percent reduction in functional decline in patients with mild Alzheimer's disease treated with solanezumab, as compared with placebo; this difference was not statistically significant (p=.076).
Lilly Results from Pooled Analyses of EXPEDITION1 and EXPEDITION2
A pre-specified secondary analysis of pooled data in patients with mild Alzheimer's disease showed a slowing of cognitive decline (p=.001) compared with placebo, as measured by the ADAS-Cog14; this finding represented a 34 percent reduction in decline. In addition, the secondary analysis of the pooled data in patients with mild Alzheimer's disease showed a 17 percent reduction of functional decline as measured by the ADCS-ADL; however, the treatment difference was not statistically significant compared with placebo (p=.057).
A number of different biomarkers were assessed in the EXPEDITION studies. Some, but not all, of these biomarkers showed an effect of solanezumab. These additional data will be presented by the ADCS at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in Monte Carlo, Monaco, on October 29, 2012, or at subsequent medical meetings and in appropriate scientific venues.
In the EXPEDITION studies, the only adverse event with an incidence of at least 1 percent that occurred statistically significantly more in the solanezumab group than in the placebo group was angina (1.1 percent versus 0.2 percent). The incidence of vasogenic edema (ARIA-E) was approximately 1 percent, occurring in 11 patients treated with solanezumab and 5 patients on placebo, which was not statistically significant.
"This is a complex disease that touches millions of people worldwide," said David Ricks, senior vice president and president, Lilly Bio-Medicines. "Alzheimer's disease causes significant burden on patients, caregivers and our society. While the path forward has not been determined, we believe these data in patients with mild disease may provide a step toward a potential treatment option."
About the Primary Endpoint Scales2
The ADAS-Cog is a standard tool used in pivotal clinical trials to detect therapeutic efficacy in cognition. It consists of subtests related to memory, praxis, and language. Higher scores on the ADAS-Cog indicate more cognitive impairment. The ADCS-ADL measures activities of daily living, such as reading books or magazines, pastime activities, or household chores. Higher scores on the ADCS-ADL indicate less functional impairment.
About the EXPEDITION Trials
The EXPEDITION trials consisted of two Phase 3, double-blind, placebo-controlled solanezumab trials in patients with mild-to-moderate Alzheimer's disease in 16 countries around the world. In both of the EXPEDITION study protocols, mild Alzheimer's disease was defined as a baseline Mini-Mental Status Examination (MMSE) score of 20 to 26 and moderate Alzheimer's disease was defined as a baseline MMSE score of 16 to 19.
The designs of EXPEDITION1 and EXPEDITION2 were the same. Patients aged 55-94 years were eligible to enroll in these studies; EXPEDITION1 enrolled 1,012 patients and EXPEDITION2 enrolled 1,040 patients. Patients received either 400mg of solanezumab infused intravenously (IV) or placebo every four weeks for approximately 18 months. Both EXPEDITION trials allowed patients to remain on stable standard of care (defined as their existing treatment regimen) during these studies. More than 85 percent of the patients in these trials were taking an acetycholinesterase inhibitor and / or memantine.
About Alzheimer's disease
Alzheimer's disease, the most common form of dementia, causes progressive decline in memory and other aspects of cognition.3,4 Researchers do not know exactly what causes Alzheimer's disease and there are currently no approved treatments shown to slow the progression of this devastating disease, only treatment options that reduce certain symptoms of the disease.2,3,5 Alzheimer's Disease International (ADI) estimates that there are currently 35.6 million people with dementia worldwide, with 7.7 million new cases each year (which implies one new case every four seconds).6 The number of people affected is estimated to be over 115 million by 2050.4 Estimates vary, but experts suggest that as many as 5.4 million Americans may have Alzheimer's disease.3
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. P-LLY
This press release contains certain forward-looking statements about solanezumab. This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date, or that solanezumab will be approved as a product or will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
1 Mohs R, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, Thal LJ, and the Alzheimer's Disease Cooperative Study. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broadens its scope. Alzheimer Dis Assoc Disord 1997;11(Suppl 2):S13-S21. 2 Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F. Review of Alzheimer's disease Scales: Is There a Need for a New Multi-domain Scale for Therapy Evaluation in Medical Practice?. Alzheimer's Research & Therapy. 2010; 2(24): 1-13.3 National Institute of Neurological Disorders and Stroke. "Dementia: Hope Through Research." Available at: http://www.ninds.nih.gov/disorders/dementias/detail_dementia.htm#1908919213. Accessed on August 13, 2012. 4 Alzheimer's Association. "2012 Alzheimer's Disease Facts and Figures." Available at: http://www.alz.org/downloads/facts_figures_2012.pdf. Accessed on August 13, 2012. 5 Perrin, R., et al. "Multimodal techniques for diagnosis and prognosis of Alzheimer's disease." Nature 2009 (461); 916-922. 6 Alzheimer's Disease International. "Dementia Statistics." Available at: http://www.alz.co.uk/research/statistics. Accessed on August 13, 2012.
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
7:41 AM On the back of positive results for its Alzheimer's treatment, Eli Lilly (LLY) is upgraded to Neutral with $54 price target from Sell and $42 at Goldman. "Our skepticism was proven wrong." Shares +1% premarket.
1:59 PM Eli Lilly (LLY +2.6%) pops after a new study shows its experimental Alzheimer’s treatment slowed memory loss and cognitive decline in early-stage patients by ~30%, offering the first evidence that a medication may hamper the course of the ailment. The independent analysis supports LLY’s August report that showed the drug, solanezumab, slowed mental decline in those with mild Alzheimer’s
It's a extension into 1st line combined with folfiri. Kras testing is needed.
I would think it has been being used in that indication so I wouldn't expect any sales appreciation per se.
Is this really an expansion? It sounds instead like a refinement of the Erbitux label.
Bristol-Myers Squibb Co. (BMY) and Eli Lilly & Co. (LLY) won U.S. regulatory approval to expand the use of Erbitux as an initial treatment against colorectal cancer that has spread for patients who are first given a genetic screening.
Erbitux should be taken only by patients who have used an agency-approved test to predict whether the drug will work, according to the medicine’s label posted on the Food and Drug Administration’s website. The agency also cleared the threascreen test made by Venlo, Netherlands-based Qiagen NV (QGEN), the first FDA-approved diagnostic that will evaluate each patient’s likelihood of responding to the cancer treatment, Michelle Bolek, a spokeswoman for the agency, said in an e-mail.
Erbitux fails phase-3 trial in stomach cancer; prospects in NSCLC considered dim:
#msg-77240378.
Lilly Declares Third-Quarter 2012 Dividend, Resumes Share Repurchase Program
Lilly Eli (NYSE:LLY)
Today : Tuesday 19 June 2012
Lilly Declares Third-Quarter 2012 Dividend, Resumes Share Repurchase Program
INDIANAPOLIS, June 19, 2012 /PRNewswire/ -- The board of directors of Eli Lilly and Company (NYSE: LLY) has declared a dividend for the third quarter of 2012 of $0.49 a share on outstanding common stock. The dividend is payable September 10, 2012 to shareholders of record at the close of business on August 15, 2012.
The Lilly board of directors has also authorized the resumption of a share repurchase program that was started in 2000, under which the company has thus far purchased $2.58 billion of shares of a total authorization of $3.0 billion. The company expects to complete this program by purchasing the remaining $420 million in shares by the end of 2012. The company also anticipates resuming systematic share repurchases following the completion of the current program. The size and timing of these additional share repurchases will be subject to board approval and will be balanced with other cash flow considerations, including the funding of the company's dividend, capital expenditures, potential business development opportunities and worldwide macroeconomic conditions.
"At Lilly, we're committed to providing a positive return to our shareholders through both a healthy dividend and stock price appreciation. Based on current market valuations and our confidence in Lilly's future, we believe that now is an excellent opportunity to resume buying back Lilly shares even as we maintain the dividend at least at its current level," said John Lechleiter, Ph.D., Lilly chairman, president, and chief executive officer.
All purchases under the share repurchase program will be made on the open market at prevailing prices. Purchases will be made over a period to be determined by management of the company. Shares acquired will be retired. As of March 31, 2012 there were 1,116,982,662 shares of stock outstanding on a diluted basis.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. F-LLY
This press release contains forward-looking statements that are based on management's current expectations, but actual results may differ materially due to various factors. There is no guarantee the company will be able to complete its planned 2012 share repurchases or will continue repurchasing shares in 2013 or beyond. There are significant risks and uncertainties in pharmaceutical research and development. There can be no guarantees with respect to pipeline products that the products will receive the necessary clinical and manufacturing regulatory approvals or that they will prove to be commercially successful. Pharmaceutical products can develop unexpected safety or efficacy concerns. The company's results may also be affected by such factors as competitive developments affecting current products; market uptake of recently launched products; the timing of anticipated regulatory approvals and launches of new products; regulatory actions regarding currently marketed products; issues with product supply; regulatory changes or other developments; regulatory compliance problems or government investigations; patent disputes; changes in patent law or regulations related to data-package exclusivity; other litigation involving current or future products; the impact of governmental actions regarding pricing, importation, and reimbursement for pharmaceuticals, including U.S. health care reform; changes in tax law; asset impairments and restructuring charges; acquisitions and business development transactions; and the impact of exchange rates and global macroeconomic conditions. For additional information about the factors that affect the company's business, please see the company's latest Form 10-Q and Form 10-K filed with the U.S. Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements.
8:29 AM Eli Lilly (LLY +0.6%) declares a Q3 dividend of $0.49 a share and says it will repurchase $420M in stock by the end of 2012 as part of the resumption of a $3B stock buyback program. It's been a long buyback - it started in 2000. The company hopes to begin a new program after it completes the current one.
Lilly Reports Solid Start to the Year With First-Quarter 2012 Results, Raises EPS Guidance
Date : 04/25/2012 @ 6:30AM
Source : PR Newswire
Stock : Lilly Eli (LLY)
~ Wednesday! $LLY ~ Q1 Earnings posted, pending or coming soon! In Charts and Links Below!
~ $LLY ~ Earnings expected on Wednesday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.
http://stockcharts.com/h-sc/ui?s=LLY&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=LLY&p=W&b=3&g=0&id=p54550695994
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<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=LLY >>>>>>
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
<<< $LLY Links! >>> ~ MAC's Quick DD Links without the charts.
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Y! < Company >
Y! Profile ~ http://finance.yahoo.com/q/pr?s=LLY+Profile
Y! Key Stat's ~ http://finance.yahoo.com/q/ks?s=LLY+Key+Statistics
Y! Headlines ~ http://finance.yahoo.com/q/h?s=LLY+Headlines
Y! Summary ~ http://finance.yahoo.com/q?s=LLY
Y! Historical Prices ~ http://finance.yahoo.com/q/hp?s=LLY+Historical+Prices
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Y! < Analyst Coverage >
Y! Analyst Opinion ~ http://finance.yahoo.com/q/ao?s=LLY+Analyst+Opinion
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Y! < Ownership >
Y! Major Holders ~ http://finance.yahoo.com/q/mh?s=LLY+Major+Holders
Y! Insider Transactions ~ http://finance.yahoo.com/q/it?s=LLY+Insider+Transactions
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Y! < Financials >
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Barchart Interactive Chart ~ http://barchart.com/charts/stocks/LLY&style=interactive
Barchart Technical Analysis ~ http://barchart.com/technicals/stocks/LLY
Barchart Trader's Cheat Sheet ~ http://barchart.com/cheatsheet.php?sym=LLY
Barchart Barchart Opinion ~ http://barchart.com/opinions/stocks/LLY
Barchart Snapshot Opinion ~ http://barchart.com/snapopinion/stocks/LLY
Barchart News Headlines ~ http://barchart.com/news/stocks/LLY
Barchart Profile ~ http://barchart.com/profile//LLY
Barchart Key Statistics ~ http://barchart.com/profile.php?sym=LLY&view=key_statistics
OTC: American Bulls ~ http://www.americanbulls.com/StockPage.asp?CompanyTicker=LLY&MarketTicker=OTC&TYP=S
NASDAQ: American Bulls ~ http://www.americanbulls.com/StockPage.asp?CompanyTicker=LLY&MarketTicker=NASD&TYP=S
NYSE: American Bulls ~ http://www.americanbulls.com/StockPage.asp?CompanyTicker=LLY&MarketTicker=NYSE&Typ=S
Marketwatch Profile ~ http://www.marketwatch.com/investing/stock/LLY/profile
Marketwatch Analyst Estimates ~ http://www.marketwatch.com/investing/stock/LLY/analystestimates
Marketwatch Historical Quotes ~ http://www.marketwatch.com/investing/stock/LLY/historical
Marketwatch Financials ~ http://www.marketwatch.com/investing/stock/LLY/financials
Marketwatch Overview ~ http://www.marketwatch.com/investing/stock/LLY
Marketwatch SEC Filings ~ http://www.marketwatch.com/investing/stock/LLY/secfilings
Marketwatch Picks ~ http://www.marketwatch.com/investing/stock/LLY/picks
Marketwatch Hulbert ~ http://www.marketwatch.com/investing/stock/LLY/hulbert
Marketwatch Insider Actions ~ http://www.marketwatch.com/investing/stock/LLY/insideractions
Marketwatch Options ~ http://www.marketwatch.com/investing/stock/LLY/options
Marketwatch Charts ~ http://www.marketwatch.com/investing/stock/LLY/charts
Marketwatch News ~ http://bigcharts.marketwatch.com/news/symbolsearch/symbolnews.asp?news=markadv&symb=LLY&sid=1795093&framed=False
The Lion ~ http://thelion.com/bin/aio_msg.cgi?cmd=search&msg=&si=1&tw=1&tt=1&rb=1&ih=1&fo=1&iv=1&yf=1&sa=1&fb=1&gg=1&symbol=LLY
Search NYSE ~ http://www.nyse.com/about/listed/lcddata.html?ticker=LLY
StockTA ~ http://www.stockta.com/cgi-bin/analysis.pl?symb=LLY&num1=567&cobrand=&mode=stock
StockHouse ~ http://www.stockhouse.com/financialtools/sn_overview.aspx?qm_symbol=LLY
StockHouse Delayed LII ~ http://www.stockhouse.com/financialtools/sn_level2.aspx?qm_page=46140&qm_symbol=LLY
AlphaTrade ~ http://tools.alphatrade.com/index.php?t1=mc_quote_module&t2=mc_quote_module2&t3=historical&template=historical2html&sym=LLY&client_id=2740&a_width=680&a_height=1000&language=english&showVol=1&chtype=8
Reuters ~ http://www.reuters.com/finance/stocks/companyOfficers?symbol=LLY.PK&WTmodLOC=C4-Officers-5
StockWatch ~ http://www.stockwatch.com/Quote/Detail.aspx?symbol=LLY®ion=U
Search NASDAQ ~ http://www.nasdaq.com/symbol/LLY
NASDAQ Divy History ~ http://www.nasdaq.com/symbol/LLY/dividend-history
NASDAQ Short Interest ~ http://www.nasdaq.com/symbol/LLY/short-interest
NASDAQ Institutional Ownership ~ http://www.nasdaq.com/symbol/LLY/institutional-holdings
NASDAQ FlashQuotes ~ http://www.nasdaq.com/aspx/flashquotes.aspx?symbol=LLY&selected=LLY
NASDAQ InfoQuotes ~ http://www.nasdaq.com/aspx/infoquotes.aspx?symbol=LLY&selected=LLY
NASDAQ After Hours Quote ~ http://www.nasdaq.com/symbol/LLY/after-hours
NASDAQ Pre-Market Quote ~ http://www.nasdaq.com/symbol/LLY/premarket
NASDAQ Historical Quote ~ http://www.nasdaq.com/symbol/LLY/historical
NASDAQ Option Chain ~ http://www.nasdaq.com/symbol/LLY/option-chain
NASDAQ Company Headlines ~ http://www.nasdaq.com/symbol/LLY/news-headlines
NASDAQ Press Releases ~ http://www.nasdaq.com/symbol/LLY/news-headlines
NASDAQ Sentiment ~ http://www.nasdaq.com/symbol/LLY/sentiment
NASDAQ Analyst Summary ~ http://www.nasdaq.com/symbol/LLY/analyst-research
NASDAQ Guru Analysis~ http://www.nasdaq.com/symbol/LLY/guru-analysis
NASDAQ Stock Report ~ http://www.nasdaq.com/symbol/LLY/stock-report
NASDAQ Competitors ~ http://www.nasdaq.com/symbol/LLY/competitors
NASDAQ Stock Consultant ~ http://www.nasdaq.com/symbol/LLY/stock-consultant
NASDAQ Stock Comparison ~ http://www.nasdaq.com/symbol/LLY/stock-comparison
NASDAQ Call Transcripts ~ http://www.nasdaq.com/symbol/LLY/call-transcripts
NASDAQ Annual Reports ~ http://www.nasdaq.com/aspx/annualreport.aspx?symbol=LLY&selected=LLY
NASDAQ Financials ~ http://www.nasdaq.com/symbol/LLY/financials
NASDAQ Revenue & Earnings Per Share (EPS) ~ http://www.nasdaq.com/symbol/LLY/revenue-eps
NASDAQ SEC Filings ~ http://www.nasdaq.com/symbol/LLY/sec-filings
NASDAQ Ownership Summary ~ http://www.nasdaq.com/symbol/LLY/ownership-summary
NASDAQ Institutional Ownership ~ http://www.nasdaq.com/symbol/LLY/institutional-holdings
NASDAQ (SEC Form 4) ~
--------- All Trades ~ http://www.nasdaq.com/symbol/LLY/insider-trades
--------- Buys ~ http://www.nasdaq.com/symbol/LLY/insider-trades/buys
--------- Sells ~ http://www.nasdaq.com/symbol/LLY/insider-trades/sells
The Motley Fool ~ http://caps.fool.com/Ticker/LLY.aspx
The Motley Fool Earnings/Growth ~ http://caps.fool.com/Ticker/LLY/EarningsGrowthRates.aspx?source=itxsittst0000001
The Motley Fool Ratios ~ http://caps.fool.com/Ticker/LLY/Ratios.aspx?source=itxsittst0000001
The Motley Fool Stats ~ http://caps.fool.com/Ticker/LLY/Stats.aspx?source=icasittab0000006
The Motley Fool Historical ~ http://caps.fool.com/Ticker/LLY/Historical.aspx?source=icasittab0000004
The Motley Fool Scorecard ~ http://caps.fool.com/Ticker/LLY/Scorecard.aspx?source=icasittab0000003
The Motley Fool Statements ~ http://caps.fool.com/Ticker/LLY/Statements.aspx?source=icasittab0000009
MSN Money ~ http://investing.money.msn.com/investments/stock-ratings?symbol=LLY
YCharts ~ http://ycharts.com/companies/LLY
YCharts Performance ~ http://ycharts.com/companies/LLY/performance
YCharts Dashboard ~ http://ycharts.com/companies/LLY/dashboard
InsideStocks Opinion ~ http://www.insidestocks.com/texpert.asp?sym=LLY&code=XDAILY
InsideStocks Profile ~ http://www.insidestocks.com/profile.asp?sym=LLY&code=XDAILY
InsideStocks Quote ~ http://www.insidestocks.com/quote.asp?sym=LLY&code=XDAILY
InsideStocks Projection ~ http://charts3.barchart.com/procal.asp?sym=LLY
Zacks Quote ~ http://www.zacks.com/stock/quote/LLY
Zacks Estimates ~ http://www.zacks.com/research/report.php?type=estimates&t=LLY
Zacks Company Reports ~ http://www.zacks.com/research/report.php?type=report&t=LLY
Knobias ~ http://knobias.10kwizard.com/files.php?sym=LLY
StockScores ~ http://www.stockscores.com/quickreport.asp?ticker=LLY
Trade-Ideas ~ http://www.trade-ideas.com/StockInfo/LLY/HOT_TOPIC.html
Morningstar ~ http://performance.morningstar.com/stock/performance-return.action?region=USA&t=LLY&culture=en-US
Morningstar Shareholders ~ http://investors.morningstar.com/ownership/shareholders-overview.html?t=LLY®ion=USA&culture=en-us
Morningstar Transcripts~ http://www.morningstar.com/earnings/NoTranscript.aspx?t=LLY®ion=USA
Morningstar Key Ratios ~ http://financials.morningstar.com/ratios/r.html?t=LLY®ion=USA&culture=en-US
Morningstar Executive Compensation ~ http://insiders.morningstar.com/trading/executive-compensation.action?t=LLY®ion=USA&culture=en-us
Morningstar Valuation ~ http://financials.morningstar.com/valuation/price-ratio.html?t=LLY®ion=USA&culture=en-us
CCBN (Thompson Reuters) ~ http://ccbn.aol.com/company.asp?client=aol&ticker=LLY
TradingMarkets ~ http://pr.tradingmarkets.com/?lid=leftPRbox&sym=LLY
OTCBB ~ http://www.otcbb.com/asp/SiteSearch.asp?Criteria=LLY&searcharea=e&image1.x=0&image1.y=0
Insidercow ~ http://www.insidercow.com/history/company.jsp?company=LLY&B1=Search%21
Forbes News ~ http://search.forbes.com/search/find?tab=searchtabgeneraldark&MT=LLY
Forbes Press Releases ~ http://search.forbes.com/search/find?&start=1&tab=searchtabgeneraldark&MT=LLY&pub=businesswire,prnewswire&searchResults=pressRelease&tag=pr&premium=on
Forbes Web ~ http://search.forbes.com/search/web?MT=UNGS&start=1&max=10&searchResults=web&tag=web&sort=null
YouTube Symbol Search ~ http://www.youtube.com/results?search_query=LLY
Buy-Ins ~ http://www.buyins.net/tools/symbol_stats.php?sym=LLY
Quotemedia ~ http://www.quotemedia.com/results.php?qm_page=47556&qm_symbol=LLY
Earnings Whispers ~ http://www.earningswhispers.com/stocks.asp?symbol=LLY
Bloomberg Snapshot ~ http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?ticker=LLY
Bloomberg People ~ http://investing.businessweek.com/research/stocks/people/people.asp?ticker=LLY
Financial Times ~ http://markets.ft.com/Research/Markets/Tearsheets/Summary?s=LLY
Investorpoint ~ http://www.investorpoint.com/ enter "LLY" and click search.
Hotstocked ~ http://www.hotstocked.com/ enter "LLY" and click search.
Raging Bull ~ http://ragingbull.quote.com/mboard/boards.cgi?board=LLY
Hoovers ~ http://www.hoovers.com/search/company-search-results/100003765-1.html?type=company&term=LLY
DD Machine ~ http://www.ddmachine.com/default.asp?m=stocktool_frame.asp?symbol=LLY
SEC Form 4 ~ http://www.secform4.com/insider/showhistory.php?cik=LLY
OTCBB Pulse ~ http://www.otcbbpulse.com/cgi-bin/pulsequote.cgi?symbol=LLY
Failures To Deliver ~ http://failurestodeliver.com/default2.aspx enter "LLY" and click search.
http://www.coordinatedlegal.com/SecretaryOfState.html
http://regsho.finra.org/regsho-Index.html
http://www.shortsqueeze.com/?symbol=LLY&submit=Short+Quote%99
DTCC (PENSON/TDA) Check - (otc and pinks) - Note ~ I did not check for this chart blast. However, I try and help you to do so with the following links.
IHUB DTCC BOARD SEARCH #1 http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18682&srchyr=2011&SearchStr=LLY
IHUB DTCC BOARD SEARCH #2: http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=14482&srchyr=2011&SearchStr=LLY
Check those searches for recent LLY mentions. If LLY is showing up on older posts and not on new posts found in link below, The DTCC issues may have been addressed and fixed. Always call the broker if your security turns up on any DTCC/PENSON list.
http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18682&srchyr=2011&SearchStr=Complete+list
For a complete list see the pinned threads at the top here ---> http://tinyurl.com/TWO-OLD-FARTS
MACDlinks
Lilly Confirms Date and Conference Call for First-Quarter 2012 Financial Results Announcement
Lilly Eli (NYSE:LLY)
Today : Thursday 12 April 2012
Eli Lilly and Company (NYSE: LLY) will announce its financial results for the first quarter of 2012 on Wednesday, April 25, 2012. Lilly will also conduct a conference call on that day with the investment community and media to further detail the company's financial performance.
The conference call will be held from 9:00 a.m. to 10:00 a.m. EDT. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly's website at www.lilly.com. A replay will also be available on the website following the conference call.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. F-LLY
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
1:58 PM Eli Lilly (LLY -0.1%) hopes that a new radioactive dye used to detect Alzheimer's disease will kick up enough revenue to make up for lost income from two patents on high-selling drugs set to expire. CEO Jon Lechleiter tells CNBC (video) the company is working with Medicare and other constituents to get reimbursement coverage for patients undergoing using the brain test with its dye
12:13 PM Eli Lilly (LLY -0.7%) plans to introduce over a dozen different products in China over the next five years in order to achieve a stated goal of being the fastest-growing pharma name in the nation. One area in particular targeted by the company will be the diabetes treatment market - expected to grow to $2.1B by 2019.
~ $LLY ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $LLY ~ Earnings expected on Tuesday *
This Week In Earnings: Earnings are coming or are already posted! This is what the charts look like! If you play the earnings these posts can be very helpful to you!
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.
http://stockcharts.com/h-sc/ui?s=LLY&p=D&b=3&g=0&id=p88783918276&a=237480049
http://stockcharts.com/h-sc/ui?s=LLY&p=W&b=3&g=0&id=p54550695994
~ Barchart: http://barchart.com/quotes/stocks/LLY?
~ OTC Markets: http://www.otcmarkets.com/stock/LLY/company-info
~ Google Finance: http://www.google.com/finance?q=LLY
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=LLY#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=LLY+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=LLY
Finviz: http://finviz.com/quote.ashx?t=LLY
~ BusyStock: http://busystock.com/i.php?s=LLY&v=2
~ CandlestickChart: http://www.candlestickchart.com/cgi/chart.cgi?symbol=LLY&exchange=US
~ Investorshub Trades: http://ih.advfn.com/p.php?pid=trades&symbol=LLY
~ Investorshub Board Search: http://investorshub.advfn.com/boards/getboards.aspx?searchstr=LLY
~ Investorshub PostStream Search: http://investorshub.advfn.com/boards/poststream.aspx?ticker=LLY
~ Investorshub Goodies Search: http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18582&srchyr=2011&SearchStr=LLY
~ Investorshub Message Search: http://investorshub.advfn.com/boards/msgsearch.aspx?SearchStr=LLY
~ MarketWatch: http://www.marketwatch.com/investing/stock/LLY/profile
~ E-Zone Chart: http://www.windchart.com/ezone/signals/?symbol=LLY
~ 5-Min Wind: http://www.windchart.com/stockta/analysis?symbol=LLY
~ 10-Min Wind: http://www.windchart.com/stockta/analysis?symbol=LLY&size=l&frequency=10&color=g
~ 30-Min Wind: http://www.windchart.com/stockta/analysis?symbol=LLY&size=l&frequency=30&color=g
~ 60-Min Wind: http://www.windchart.com/stockta/analysis?symbol=LLY&size=l&frequency=60&color=g
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
LLY’s Evacetrapib boosts good cholesterol: #msg-69029766.
Eli Lilly may partner with Turkish generic maker: report
ReutersBy Soham Chatterjee in Bangalore | Reuters – 8 hrs ago
(Reuters) - U.S. drugmaker Eli Lilly & Co is in talks to form a partnership with, and potentially invest in, Turkish generic-drug company Mustafa Nevzat Ilac Sanayii AS (MN Pharmaceuticals), the Wall Street Journal reported, citing people familiar with the matter.
The talks, which are in an early stage, marks the latest effort by a big Western multinational to tap emerging markets for growth.
The discussions with Indianapolis-based Lilly are currently focused only on a minority interest, the newspaper reported.
A spokesman for Lilly did not immediately comment to the Wall Street Journal, while the paper said a MN representative could not be reached.
Eli Lilly and Mustafa Nevzat were not immediately available for comment to Reuters.
Both Lilly and MN Pharmaceuticals have lined up advisers in advance of a potential deal. Besides a foreign drug company, it is also possible MN could sell a stake to a Middle Eastern sovereign wealth fund, one of the people told the Journal.
A deal with MN Pharmaceuticals would give a foreign drug company access to local distribution, low-cost manufacturing, regulatory expertise and new products. Turkey also could serve as a springboard to fast-growing markets in Asia.
MN Pharmaceuticals, founded in 1923, makes generic drugs such as antibiotics that are injected rather than taken as pills.
(Reporting by Soham Chatterjee in Bangalore; Editing by Matt Driskill)
Is solanezumab licensed from another company or is LLY the sole owner? Does LLY own patents on solanezumab?
CTSO gap getting close to being filled
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=63393976
Cytosorbents Co.(risk) ctso--EU recently approved for sepsis treatment and results due June/July 2011 (already showing a 49.1% IL-6 cytokine reduction along with std of care treatment)
If...approved as broad secondary treatment eu and us this company will definately shine (the holy grail).
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_C/threadview?m=te&bn=55421&tid=35130&mid=35130&tof=6&frt=2#35130
Wow, not a lot of growth here --- was going to look closer, but I think I'll skip it!
UPDATE: DOJ Joins Lawsuit Vs Johnson & Johnson, Scios Unit
Date : 02/19/2009 @ 1:58PM
Source : Dow Jones News
Stock : Eli Lilly & Co. (LLY)
Quote : 34.48 0.08 (0.23%) @ 8:00PM
UPDATE: DOJ Joins Lawsuit Vs Johnson & Johnson, Scios Unit
(Updated with additional information from the Department of Justice.)
By Brent Kendall and Jared A. Favole
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The Department of Justice on Thursday said it has joined two whistleblower lawsuits alleging that Johnson & Johnson (JNJ) and its Scios Inc. unit aggressively and improperly promoted the heart-failure drug Natrecor.
The drug was approved in 2001 by the U.S. Food and Drug Administration to treat patients with severe heart failure, but prosecutors allege that Scios aggressively promoted the drug to patients with less severe heart failure. Such improper promotion of a product is called "off-label" marketing.
Prosecutors allege that the improper marketing caused false and fraudulent claims to be submitted to federal health-care programs, meaning the government ended up footing the bill for the off-label use of Natrecor. It's unclear exactly how much money the government spent covering off-label uses of the drug, but the amount was "substantial," according to a Department of Justice press release.
The FDA approves drugs for specific indications and, while doctors can prescribe a drug for ailments that aren't listed on a drug's label, companies aren't allowed to promote such off-label use. The government has been cracking down on off-label promotion.
Last month, Eli Lilly & Co. (LLY) agreed to pay $1.42 billion in a long-awaited settlement with federal prosecutors regarding allegations of improperly marketing its blockbuster antipsychotic drug Zyprexa.
By intervening in the lawsuits, the Justice Department is joining two lawsuits filed by former Scios managers against the company and Johnson & Johnson. Their lawsuits were filed under a federal provision that allows people to file suits when they think the government is being defrauded. If the government successfully resolves the litigation, the whistleblowers can receive 15% to 25% of the amount recovered from the companies.
Natrecor came under scrutiny a few years ago when two analyses suggested patients taking the drug were at heightened risk of kidney problems and mortality. A panel of cardiologists also told the companies to stop promoting the drug for off-label uses. Scios subsequently told health-care professionals that the company didn't have enough evidence to support the safety and efficacy of the drug in patients with less severe heart failure.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com
Lilly (Eli) & CO. (NYSE:LLY)
Last Price (USD) $ 34.4
Change ▼ -0.18 (-0.52%)
Bid 33.80
Ask 34.77
Volume 5,916,815
Day's Range 34.11 - 34.76
Click for Detailed Quote Page
Last Trade:18:36:04 EST Feb-18-
3rd UPDATE: Lundbeck Buys US-Based Ovation For Up To $900 Million
Date : 02/09/2009 @ 11:24AM
Source : Dow Jones News
Stock : Eli Lilly & Co. (LLY)
Quote : 34.58 -0.85 (-2.40%) @ 8:00PM
3rd UPDATE: Lundbeck Buys US-Based Ovation For Up To $900 Million
(Adds background)
By Gustav Sandstrom
Of DOW JONES NEWSWIRES
Danish pharmaceutical company Lundbeck A/S (LUN.KO) said Monday it has agreed to acquire U.S.-based Ovation Pharmaceuticals Inc. for up to $900 million, giving it a bigger U.S. presence and strengthening its pipeline.
Lundbeck's and Ovation's boards have unanimously approved the deal, which is expected to close in March 2009.
Lundbeck will pay $600 million immediately upon closing of the transaction, and will pay an additional sum of up to $300 million within a year after closing if Ovation achieves certain milestones related to regulatory approval of drug candidate Sabril.
The deal will be financed through a combination of cash and new debt of 2.5 billion Danish kroner ($435 million), underwritten by Nordea and Danske Bank.
The transaction is expected to be accretive to Lundbeck's net profit, after transaction costs and amortization related to the acquisition in 2010.
"Ovation is an excellent match for Lundbeck and will help us realize our strategic goals," Chief Executive Ulf Wiinberg said.
Despite being much smaller in value than other recently-announced deals, Lundbeck's proposed takeover is the latest sign of consolidation in the pharmaceutical industry as drug companies look to bolster thin product pipelines to offset patent expirations for key products and rising competition from generic drugmakers.
Last month, world number one Pfizer Inc. (PFE) announced it will pay $68 billion for smaller rival Wyeth (WYE). Merck & Co. (MRK) and Sanofi-Aventis (SNY) both face similar challenges and are hunting for license deals and acquisitions that can build up their research and commercial portfolios.
But others, like world number two GlaxoSmithKline PLC (GSK), have ruled out any interest in pursuing large merger and acquisition deals, voicing preference instead for small- to mid-sized acquisitions with a focus on emerging markets and consumer healthcare. Glaxo's Anglo-Swedish rival, AstraZeneca PLC (AZN), has said it would consider acquiring branded generic drugs in emerging countries, signaling a shift from its strategy of concentrating on selling high-price patented drugs in the U.S. and European markets.
Privately-held Ovation, which develops drugs mainly for central nervous system disorders, has 283 employees and expected earnings before interest and taxes of $32 million in 2008.
"Ovation will provide a commercial platform in the U.S. with a highly experienced management team and specialty sales force, a late-stage development pipeline and a proven scientific and regulatory expertise in areas of high unmet medical needs," Wiinberg said.
At 1549 GMT, shares in Lundbeck were up DKK7.25, or 5.8%, at DKK132.75, outperforming a 0.5% rise in the broader Copenhagen market. The shares have gained 23% over the past 12 months amid hopes the company may boost its pipeline to compensate for the expected earnings drop after 2012 when the patent for its blockbuster drug Lexapro/Cipralex expires. Sales of the depression treatment made up close to two thirds of Lundbeck's DKK2.8 billion sales in the third quarter 2008.
CEO Wiinberg said at a teleconference after the announcement that the acquisition of Ovation "definitely goes a long way" to replace Lexapro. He said the most valuable asset in the deal is Sabril, a drug candidate for treatment of seizures and spasms which has recently been recommended for approval by an advisory committee to the US Food and Drug Administration.
Analyst Rune Majlund Dahl at Sydbank, who has an overweight rating for Lundbeck, said buying Ovation is an important step towards bolstering Lundbeck's pipeline, and added that it's wise to make up to $300 million of the price conditional upon approval of Sabril.
If Ovation's pipeline proves strong enough, the acquisition price may well be reasonable, he added.
Dahl said Lundbeck will benefit from Ovation's U.S. sales force, which will give access to a vast market for central nervous system treatments and make Lundbeck a more attractive partner if it choses later to in-license drugs from other companies.
Lundbeck retained its financial guidance for 2008 of revenue of DKK11 billion to DKK11.5 billion and earnings before interest and tax of DKK2.8 billion to DKK2.9 billion, excluding one-off items.
The company reports full-year earnings on March 4.
Company Web site: http://www.lundbeck.com
-By Gustav Sandstrom, Dow Jones Newswires; +46-8-5451-3099; gustav.sandstrom@dowjones.com
Eli Lilly & Co. Q1 2008 Earnings Call Transcript
...
John Lechleiter - President and Chief Executive Officer
Thanks Phil, good morning. The overarching purpose of our call this morning is to summarize our financial results for the quarter and their good results. So, let me start by reiterating three of my top priorities as CEO. First, speeding the flow of innovative new products through our development pipeline; second, more effectively engaging our customers, patients, healthcare providers, and payers alike; and third improving quality and productivity across the board. Many successes in the years to come will be based on our ability to execute on these priority, and I intend to see that we do. These mandates are so important that I will begin each of our earnings call this year by giving you an update on our progress. After my update, we'll review financial performance and take your questions.
Let's start with advancing of pipeline. On slide 2, you'll find a summary of our achievements in the first quarter. After advancing a record 16 new molecular entities into the clinic in 2007, Steve Paul and his team set their sites on moving another 15 NMEs into the clinic in 2008. They are on pace to achieve with ambitious goal with three molecules having begun Phase I testing in the first quarter.
In addition to stocking the pipeline with innovative molecules we must move these molecules through clinical testing at a pace that enables us to effectively meet the challenge posed by our patent explorations in the next decade. During the first quarter, we moved two molecules into Phase II clinical trails and we moved one our gamma-secretase inhibitor for Alzheimer's disease into Phase III. We also continue to supplement our own innovation with collaboration, including the recently announced agreements with Transition Therapeutics, for their gastrin-based therapies for type 2 diabetes. In addition, we closed the deal with BioMS Medical giving Lilly exclusive rights to a molecule already in Phase III testing for secondary progressive multiple sclerosis.
Furthermore, we had a number of successes on the regulatory front. The FDA approved Cialis for once daily use. In the first quarter, European regulators gave a positive opinion for Alimta for first-line non-small cell lung cancer, and in early April we received marketing authorization. We also received marketing authorization in Europe for Forsteo for GIOP of steroid induced osteoporosis, and we received an approvable letter Forsteo in the U.S. for the syndication. We launched Cymbalta in Canada and France. Australian regulatory authorities approved Cymbalta, and Cymbalta was submitted in Japan by our partner Shionogi. We launched the Humalog KwikPen in the U.S. We received notice that the FDA granted priority review the prasugrel and we submitted prasugrel in the EU.
Finally along with Amylin, we submitted the application for a monotherapy indication for Byetta. We remain very excited about the prospects for this first-in-class molecule and are working closely with Amylin to maximize its value to patients. In Phase III, development of Arzoxifene continues for the indications of prevention and treatment of osteoporosis, and risk reduction in Invasive breast cancers. While we are still blind to the Phase III data in the ongoing five year generations trial, the overall event rate for invasive breast cancer is lower than expected. Consequently, we will defer the primary analysis for submission to a slightly later date allowing additional events to occur. As a result, we now expect to submit Arzoxifene in the fourth quarter of 2009 rather than earlier in the year.
Running out of pipeline will remind it that there is risk in developing first-in-class, best-in-class medicine they've shown on slide 3. We terminated development of AIR insulin and received a not-approvable letter for Zyprexa long-acting injection. Despite these challenges, our pipeline especially the mid-stage is as strong as ever. As I did this update each quarter, I expect there will be variability in the progress, some quarters will almost certainly be better than others. For example, our plans indicate that movement of molecules into the clinic will be weighted to the back-half of the year. But I can assure you there is clarity throughout Lilly for advancing the pipeline as priority one.
Moving to slide 4, the second priority is more effectively engaging our customers on all fronts: patients, healthcare providers and payers; again there is much to report here. In the quarterly results, you will see continued improvement in Humalog performance. Our solutions based approach integrates Humalog therapy, patient support and tools to improve patient outcome. Some examples: our nutrition in the best lean [ph] series to enable more sensible choices in fast food, the small steps videos outlining the little things that patients with diabetes can do to improve their control and our engagement with efficacy groups to build disease awareness and improve patient outcomes.
In a more traditional example in the first quarter, we announced the partnership with Sanofi-Aventis to expand Cialis promotion to urologists, especially for the new once daily, indication. For Forteo, we've made significant progress in gaining improved access in part D plans with reasonable co-pays and sensible prior authorization requirement. I work in collaboratively with the part D plan; we now have 75% access. In our U.S. operations, we continue to measure effectiveness in engaging our customers using an approach called customer value metrics or CVM.
Through CVM, we systematically collect feedback from our customers to understand Lilly's performance versus the competition in delivering value. Using this approach, we better understand the evolving needs of customers and how we can improve. As a result we have improved several of our sales and marketing practices, and we are seeing results; as one example our CVM scores has significantly increased with psychiatrists showing they now perceive Lilly as a leader in answering product related questions effectively, tailoring our communications to their needs, and providing relevant information to enable them to treat their patients in the most appropriate way.
I'll now turn the call over to Derica, who will recap our strong financial results for the quarter, beginning with a review of progress on a third priority, productivity. Derica?
Derica Rice - Senior Vice President and Chief Financial Officer
Thanks John. Let me begin on slide 5 by focusing on our productivity and flexibility agendas. We continue to make good progress on both fronts. Starting with productivity, let me begin with this chart that shows the trends and sales growth versus operating expense growth and the growth margin percentage. As shown here, operating expenses represents the sum of R&D and SG&A. Furthermore, sales and operating expense growth is on a pro forma basis as if we own ICOS as of January 1st, 2007.
The line represents the gross margin percentage overtime. The bars represent the spread between sales growth and OpEx growth. During the period in which sales are going faster than OpEx, the bars are positive and vice versa. One of the ways we have highlighted the benefits of our productivity initiatives is through the operating leverage on our income statement, growing sales at a faster rate than cost and expenses. For Q1, the 12% growth and pro forma sales is 3 percentage points higher than the growth in pro forma operating expenses.
While this shows substantial leverage on operating expenses, the Q1 growth and cost of sales was 18%, well above the sales growth. Consequently, the gross margin percentage declined slightly from 2007. Now on the surface, these results may appear inconsistent with our productivity objective; however, I like to provide some perspective on the effect of foreign exchange rates in these results. When we consider exchange rate, a different picture emerges as shown on slide 6. This analysis is particularly relevant this quarter given a movement in rate. If we remove the impact of exchange rate, sales grew 7%, almost entirely from volume. Cost of sales grew in a low single digit, and operating expense grew less than sales. Thus as you can see the underlying performance continues to show, operating the leverage and the positive effect of our productivity initiative. In addition, our bottom line is largely hedged against movements in currency exchange rates.
Our productivity efforts continue to drive decreases in our infrastructure and headcount. We have reduced onboard headcount by over 5,500 people or 12% since the peak in mid-2004. Last week, we announced a further stream lining of our manufacturing operations in selected areas of research and development in Indianapolis. We expect the voluntary exit program we are offering will reduce headcount by up to 500 people. This announcement continues to trend a headcount reduction already achieved. Going forward, we will continue to undertake productivity initiatives across the entirety of our business. Along recruiting management of working capital, these productivity improvements are also producing robust cash flow.
In addition, we continue to implement programs to increase our flexibility as shown on slide 7. In the sales force, we are using a number of tools to increase our flexibility. John already summarized our collaboration with the Sanofi-Aventis by the promotion of Cialis. We have discussed our use of contract sales organization supporting Cymbalta and insulin products. We are also expanding the use of a variety of flexible staffing arrangements, including contractors and fixed duration employees. These approaches provide a greater level of flexibility to adjust the sales staff and broader work force to match the needs of the business during a time of significant change.
In R&D, we recently announced expanded collaboration with Nicholas Piramal and Suven Life Sciences, adding molecule...adding additional molecules to these developmental arrangement. As part of our fitness[ph] strategy, these arrangements increase our flexibility and reach enabling us to develop more molecules without expanding Lilly Infrastructure. These are just some of the examples of how we are improving productivity and flexibility throughout Lilly.
Now, let's move to slide 8 and the specific results for the quarter. The Q1 results met our expectation, and we are tracking to our EPS guidance for the year. The solid business fundamental continue. The 12% growth in pro forma sales reflects 6% from volume, 5% from exchange rate and 1% from price. This slide summarize price in volume trends back to the year 2000. The volume growth of 6% in Q1 continues solid volume performance. This volume growth was achieved despite the drag from generic Zyprexa entries in Canada and Germany.
Furthermore, on slide 9, you can see how our major products contribute to their overall volume growth. Led by Cymbalta, all of our growth products are contributing positively to volume growth. You will notice that Zyprexa shows a volume decline, reflecting both the impact of generic entries in Canada and Germany as well as the inventories build in the U.S. during Q4 2007, that depress Zyprexa volume in the first quarter of this year.
Moving to slide 10; before Jim provides the detailed results for each product, let me comment on operating expense trends for the quarter. R&D grew 4% and SG&A grew 13%, though a couple of factors are to consider in these results. For R&D, the growth in Q1 of this year is affected by the conclusion last year of TRITON study of prasugrel, as well as targets in Q1 of 2007, related to Arxxant. These factors there to understate the underlying trends and R&D spend.
For SG&A, the Q1 growth rate was elevated by several factors. First, we continue to make significant investments in Q1 behind our key products including Cymbalta, Cialis, and Humalog. We believe these investments are a key to drive a continued growth of these products. Second, foreign exchange rates added significantly to SG&A growth. Compared to R&D, the geographic distribution of our SG&A costs makes it more acceptably to changes in currency exchange rates. Finally, increased legal costs also contributed to year-on-year growth and SG&A. These costs include the $50 million settlement with the state of Alaska.
Now let me the turn the call to Jim to give a more in-depth review of result. Jim?
Jim Greffet - Manager, Investor Relations
Thanks Derica. Moving on to review financial results for the quarter; worldwide pro forma sales grew 12% to $4.808 billion. We will begin with a review of the sales performance of selected products and then discuss the other lines of the income statement. Slide 11 shows worldwide Zyprexa sales increased 1% to $1.12 billion. Sales in the U.S. decreased 5% to $499 million due primarily to lower demand. International sales increased 6% to $621 million due to the favorable impact of exchange rate. International demand decreased slightly as the impact of generic entries in Germany and Canada more than offset increased demands in other markets.
Moving to slide 12, Cymbalta sales in the first quarter were $605 million, up 37% compared with the first quarter 2007. U.S. sales increased 32% to $511 million due to increased demands. International sales totaled $94 million, an increase of 69% over the prior year. Slide 13 shows worldwide Byetta sales for the quarter for $169 million, a 15% increase driven by demand. Lilly reports half of the gross margin from U.S. sales of Byetta, plus sales of pen to Amylin and 100% of international sales. Total Byetta revenue recognized in Lilly's income statements was $83 or 16% increase. Neither Lilly nor Amylin is satisfied with the performance of Byetta and a number of efforts are being implemented to sustain and improve Byetta performance, particularly in the U.S.
First, sales territories are being aligned to improve accountability and coordination across the Lilly and the Amylin team, and to improve the reach and frequency of customer contact. Second, messaging between the clients is better addressed and is accessible and finalizes their position. Market research indicates their perception of Byetta's efficacy, particularly with binary care position are less than what has been demonstrated. Reinforcing Byetta's efficacy and glycemic control these two [ph]. Third, due to fields domain will help to reinforce glycemic control efficacy.
Both Lilly and Amylin continue to play significant resources behind this first-in-class product to address performance that is inconsistent with what we believe to be is true potential. On slide 14, Humalog sales grew 20% to $407 million. U.S. sales increased 13% to $239 million driven by higher demand and increased prices. Sales outside the U.S. increased 31% to $169 million, driven by increased demand and the favorable impact of foreign exchange rate.
Slide 15 shows growth trends in Humalog new prescriptions and total prescription since 2006. Two trends on this graph are particularly encouraging as we continue the efforts to reaccelerate Humalog performance. First, overall Humalog volume grew for the full year 2007, which was the first time annual Humalog volume grew since 2004. Second, through the first quarter of 2008, we see accelerating growth in both new and total prescription. These trends reflect the sustained efforts behind Humalog, the introduction of several new pen devices and more effective engagement of our customers on all fronts.
On slide 16, Humulin sales for the quarter were up 14% to 258 million. U.S. sales increased 9% to 93 million driven by higher prices. International sales increased 17% due to the favorable impact of foreign exchange rate and increased demand partially offset by lower prices. Slide 17 shows worldwide Cialis sales. The global sales were up 27% in the quarter reaching 337 million. Sales in the U.S. were up 25% to 123 million due to higher prices and increased demand while sales outside the U.S. increased 28% to $214 million driven by increased demand and the favorable impact of foreign exchange rate.
Moving to slide 18, Alimta sales in the first quarter were $247 million, an increase of 32% over Q1 2007. U.S. sales increased 17% to $122 million due primarily to increased demand. Sales outside the U.S. were up 50% to $125 million due to increased demand and the favorable impact of foreign exchange rate, partially offset by lower prices. Slide 19 shows quarterly Forteo sales of $185 million, up 21% over Q1 of last year. U.S. sales were up 10% to $118 million, primarily due to increased volume caused by variations in wholesale or buying pattern and higher prices. International sales of Forteo were up 45% to $67 million due to higher demand and the favorable impact of foreign exchange rate.
Slide 20 shows the revenues from the products Lilly has launched this decade: Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris, and Yentreve. On a pro forma basis, these products grew 26% reaching $1.7 billion or 35% of our sale. On a reported basis, sales of these products grew 33% in the quarter. Before looking at the rest of the income statement, let's look at the impact of price, exchange rates, and volume on the sales result; a summary by geography on a pro forma basis is shown on slide 21.
For the quarter, Lilly sales growth of 12% was driven by a volume impact of 6% and a favorable impact of 5% from exchange rate, and 1% from price. For your information, slide 22 shows the impact of price rate and volume on a reported basis. For the quarter, Lilly's reported sales growth of 14% was driven by a volume impact of 8%, a favorable exchange rate impact of 5% and a favorable price impact of 1%.
Now let's look at the rest of the income statement. Slide 23 shows the pro forma income statements. Gross margin as a percentage of sales in the first quarter was 76.9%, a decrease of 130 basis points compared to Q1 2007. As discussed earlier, this decrease was due to the impact of foreign exchange rate offset impart by manufacturing expenses growing at a slower rate than sale and by price. Operating expenses including marketing, selling and administrative and research and development expenses increased 9% in the quarter or 3% less than sale.
Marketing, selling, and administrative expenses were up 13% to $1.6 billion. This increase was primarily driven by increase marketing expenses in support of key products, including Cymbalta, Cialis and Humulin; the effect of foreign exchange rate and the increased legal cost including the settlement with the state of Alaska. R&D expense grew 4% to $877 million or 18% of sale. The increase was primarily due to increases in discovery, research, and late stage clinical trial cost offset by lower prasugrel clinical trial costs. In the first quarter 2007, write off of Arxxant inventory as a result of the U.S. FDA's approval decision and the withdrawal of the Arxxant application in Europe.
Other significant items decreased from $451 million in Q1 2007 to $233 million in Q1 2008. The 2008 amount includes the $145.7 million charge, primarily related to the decision to terminate the development of their influence and the $87 million charge related to acquired in-process R&D, associated with the BioMS Medical in licensing transaction.
The 2007 amount includes $123 million charge, primarily related to manufacturing site closures and the $328.5 million charge related to acquired in-process R&D, associated with the ICOS acquisition and the OSI in-licensing transaction. The Q1 2008 effective income tax rate reflects a discreet benefit of $210.3 million, resulting from the conclusion of the substantial portion of an IRS audit for the years 2001 through 2004.
For your information, we have provided a reported earnings statement on slide 24. Slide 25 shows fourth quarter... shows first quarter other income and deductions, which contributed $20 million, an increase of $3 million. Slide 26 shows the significant items affecting net income. These items include the $210.3 million after tax benefit or $0.19 per share from the resolution of the companies IRS tax audit for the years 2001 trough 2004.
The $145.7 million pre-tax charge or $0.09 per share for asset impairments and restructuring primarily related to certain wind down costs associated with the termination of the AIR Insulin program, and the $87 million pretax charge or $0.05 per share for acquired in-process research and development for a compound acquired from BioMS Medical. You can see the impact of these items on earnings per share for this quarter in the table. The table also shows the impact of similar items from 2007 for comparison purposes.
Now, let me turn the call back over to Derica to update you on our financial guidance. Derica?
Derica Rice - Senior Vice President and Chief Financial Officer
Thanks, Jim. As shown on slide 27, our 2008 earnings guidance is now $3.90 to $4.05 per share. The change from earlier guidance results from a tax benefit of $0.19 per share resulted from the resolution of the IRS tax audit. A $0.09 per share charge related to the asset impairments and restructuring primarily related to the termination of the AIR Insulin program, and a $0.05 per share charge related to the end licensing transaction with BioMS Medical. After these items, our expected 2008 earnings per share would have remained in the range of $3.85 to $4.00 per share. Note also that this guidance does not reflect potential charges related to the recently announced voluntary exit program.
Slide 28, shows our line item financial guidance. Excluding the effect of the resolution of the IRS tax audit, the estimated effective tax rate has been revised to approximately 22% from the previously stated 23%. This reduction is the result of a more favorable forecast of the mix of income between domestic and international operations, and the alignment of practices with conclusion of the IRS tax audit. No other elements of our previously issued line item guidance have been changed. As discussed on past earnings call, we no longer provide quarterly financial guidance. We realize that financial estimates will be produced by those following our stock. However, we will not comment on the accuracy of these estimates.
This concludes our review for the first quarter, and we will now be happy to take your questions. Operator, first caller please?
Question And Answer
Operator
Our first question will come from the line Jim Kelly from Goldman Sachs. Please go ahead.
James Kelly - Goldman Sachs
Thank you, and good morning. I have a question about the impact in volumes, just taking a look at the comparison from the last quarterly report, where volumes whether it was done in a pro forma or reported basis were slightly higher on a full year basis for 2007. I am really focusing on some markets like Japan, rest of world and animal health. Could you give us some color on those markets, where we don't often see a lot IMS data and other third party sources? Thank you.
Unidentified Company Representative
Perfect way to ask a question, Jim? [ph]
Derica Rice - Senior Vice President and Chief Financial Officer
Good morning, Jim. When you look at our volume growth and especially if you were to look at Q4 2007 or even Q1 '08, there are a number of factors. First of all, overall we still continue to see strong volume growth; the 6% is more than half of our total revenue growth is focused on a pro forma basis and that is a net that 6% is the negative impact of generic Alimta scheme [ph] entrance in Canada and Germany, which we have been able to offset. You also had some wholesaler de-stocking in the U.S. in both the retail channel as well as the wholesale channel. And then you also had some unusual buying patterns in Elanco Animal Health business Q4 '07, but if you were to take those out, you would actually see a fairly solid and pretty much continued sustained effort of volume growth in the business.
John Lechleiter - President and Chief Executive Officer
Jim, this is John Lechleiter. I think in Japan, we also have the impact of the by annual price decrease, which goes into effect April 1. So, it's going to have the impact of depressing volume in the first quarter somewhat there.
Derica Rice - Senior Vice President and Chief Financial Officer
We continue by the way, just to make the point on Japan to move up in the table, where we are now, I think either number 22 or number 23 based on our growth relative to others in that market employees to move into the top 20 by the turn of the decade.
James Kelly - Goldman Sachs
Thank you.
Phil Johnson - Executive Director of Investor Relations
Next caller, please.
Operator
Roopesh Patel from UBS. Your line is open.
Roopesh Patel - UBS
Hi, thanks a lot. Just a couple of questions; first on prasugrel, I was just wondering if you could comment on whether or not based on your discussions with the FDA to date you still expect approval by the June 26th PDUFA date and any light you can shed it on your expectations relative to an advisory committee or panel meeting? And then separately if you could also kindly just comment on the flattishness we've seen in Cymbalta trends and what we should expect going forward? Thanks.
Unidentified Company Representative
Okay, Roopesh, we'll have John handle your first two questions on prasugrel and then Deirdre on Cymbalta.
John Lechleiter - President and Chief Executive Officer
Roopesh we are very much engaged with the FDA as they continue their review of prasugrel toward the June26 action date. It would be impossible for me to speculate on what that action is going to be except to say that there has been considerable amount of back and forth between the FDA and Lilly's. One would expect in a priority review period that shortened down to six months; we still at this point have no indication if there is going to be an advisory committee.
Deirdre Connelly - President, Lilly USA
Good morning, and in terms of Cymbalta; first of all, we continue to see Cymbalta growing faster than any other branded entity present in the marketplace, which makes us obviously very pleased. Those parts of that product that is pen related, as you know, the PNP [ph]. And we've seen a slow down of that part of our business with the recent launch. Now we have every expectation given the many opportunities fibromyalgia offers or pen offers in the future to recapture all part of that business and when we launch our fibromyalgia indication.
Phil Johnson - Executive Director of Investor Relations
Next caller, please.
Operator
David Risinger from Merrill Lynch. Please go ahead.
David Risinger - Merrill Lynch
Yes, thanks very much. I have a couple of questions. First, could you please update us on the Zyprexa Depo formulation, just provide a little bit more detail following your discussions with the FDA in terms of how we should think about that product on a go-forward basis? Second, could you please provide an update on Byetta LAR manufacturing and whether that product is being used in the current clinical trials from the new facility yet? And then finally on Evista; if you could just walk us through the patent challenge situation with Evista, so that we have the appropriate framework for that. Thank you.
Phil Johnson - Executive Director of Investor Relations
Okay. I would ask John to go ahead and handle the Zyprexa Depo and the LAR manufacturing question and Jim handle the second question.
John Lechleiter - President and Chief Executive Officer
Good morning David. When we received the non-approval letter in March, we immediately contacted FDA obviously in effort to really understand the root of their concerns. That has to do with these inadvertent intravascular administration issues that tend to cause or have caused among... about 1% the patients in clinical trials that essentially profound sedation. So, we need to understand that better; we do have a meetings scheduled. It's not yet taken place, and once that meeting is complete and we have a better idea how we might proceed forward, we'll communicate that.
With respect to Byetta LAR, we are just... Amylin is really just bringing up the plant that's going to manufacture the commercial commodities online now. So, our goal is in the intervening March is to really make sure that the material risks that coming out of that plan is in fact equivalent to material that was made using the same process, but on a smaller scale, and that's one of the things we'll need to complete before we file, and the date that we've given remains before the second half... before the first half of 2009.
Jim Greffet - Manager, Investor Relations
And on the specific use in clinical trials, Dave, we've not yet put that commercial scale material from the facility in Ohio into our clinical trials. That may happen this year, but has not happened to-date. On your question for the Evista litigation and challenge from those given bars [ph], we have essentially a couple of dates you want to keep in mind. One is the expiration of a 30 month stay for Teva in November of this year, and then we also have a court date with them in early March here in the southern district of Indiana. The... as you are copying from some of our past comments, the status with bar is frankly on hold; you can say we've not yet provided any actual description of or physical samples of material. I do believe that well it's actually worthy, first filer in this case. So, the status of payments that just recently announced tentative approval for this generic Evista is I think a little bit unclear at this point of time for that reason.
Phil Johnson - Executive Director of Investor Relations
One other thing, just to be absolutely clear on the Byetta once weekly submission timing, it is by the end of the first half of 2009. John, I think you said by the first half of 2009; so, to be clear that timing hasn't changed.
David Risinger - Merrill Lynch
Great; thanks, gentlemen.
Phil Johnson - Executive Director of Investor Relations
Next caller, please.
Operator
Rob Hazlett from BMO Capital market. Your line is open.
Robert Hazlett - BMO Capital Markets
Yes, thanks. Good morning everyone; just a couple of quick ones. Regarding prasugrel, could you discuss any efforts you have made so far to construct the sales effort and the status there? Secondly regarding gross margin, the Zyprexa Canada and Germany generics have an effect in gross margin and maybe you did state that there... but could you just discuss the potential for gross margin effects for the remainder of the year? And third, was there stocking during the quarter of KwikPen... Humalog KwikPen and/or Cialis QD? Thanks.
Phil Johnson - Executive Director of Investor Relations
Okay, I'm going to ask Deirdre to go ahead and take your question on the prasugrel sales effort as well as maybe your last piece on if we can take an initial stocking for Cialis once daily as well as Humalog KwikPen.
Deirdre Connelly - President, Lilly USA
Thank you, Phil. First, thank you very much for the question. Yes, we are absolutely ready for the eventual launch if the FDA... after their review allow us to launch prasugrel, which grows. We all are looking forward to and our preparations consist of and hospital sales division that has been in place now for two quarters, so ready to go when we get the product in our bag. And a primary care division that we have been building in the last few months.
Robert Hazlett - BMO Capital Markets
And in terms of the initial sales as for Cialis once a day as well as the Humalog KwikPen, Deirdre.
Deirdre Connelly - President, Lilly USA
Yes,in terms of KwikPen like John and Jim mentioned previously, the result that we see was our share market with Humalog, we believe reflects the great reception of the marketplace of our KwikPen. So, it has been launched very effectively; in terms of Cialis?
John Lechleiter - President and Chief Executive Officer
Yes, the Cialis daily is 700,000 stocking and then the KwikPen is a little bit of stocking, but with the decline in regular pen.
Deirdre Connelly - President, Lilly USA
Thank you.
Phil Johnson - Executive Director of Investor Relations
Jim, do you want to go forward?
Jim Greffet - Manager, Investor Relations
Sure. On the gross margin, you saw gross margin for the quarter declined 1.3 percentage points, but if you were to exclude the impact of exchange rate, we actually saw gross margin improvement in the quarter and in terms of outlook for the year, I feel while we cannot predict what will happen when exchange rates. In terms of the underlying business fundamentals, we still expect to grow our manufacturing expenses at a slower rate in sales than we should see on a fundamental basis gross margin improvement excluding the impact of exchange rates.
Phil Johnson - Executive Director of Investor Relations
Okay. Next caller, please.
Operator
Tony Butler from Lehman Brothers. Your line is open.
Tony Butler - Lehman Brothers
Just again on the same question on KwikPen; was it also wanted internationally. And then second, Derica could you provide some range for what FX, the FX contribution for SG&A was in the quarter? Thank you.
Phil Johnson - Executive Director of Investor Relations
Well, John will take your question KwikPen and Derica on the SG&A.
John Lechleiter - President and Chief Executive Officer
Totally, we've not yet launched, we had a few... actually a few early pilot countries that we launched in a year or two ago. We have not had a major rollout in another market outside the U.S. We did get approval this quarter in Japan for the pen called MirioPen in Japan, and we have a sequence of rollout that will initiate later this year that outside U.S.
Tony Butler - Lehman Brothers
Okay.
Derica Rice - Senior Vice President and Chief Financial Officer
And Tony regards to the FX impact on SG&A, essentially if you look at the 13% SG&A growth, over half of that was due to the impact of exchange rates and then also a small impact of also the impact of increased litigation costs.
Phil Johnson - Executive Director of Investor Relations
Next caller, please.
Operator
From the line is Steve Scala from Cowen. Please go ahead.
Steve Scala - Cowen And Company
Thank you, I have two questions. What was the first quarter tax rate without the tax benefit and the one time charges? Was it 22%, which would be consistent with the full year guidance? And secondly, given that the 30-month span, GEMZAR expires in July and Teva had extended approval. What are your range of options here? Would you say now that you absolutely will not settle this litigation or would you consider that as one of your options? Thank you.
Unidentified Company Representative
Let me take your first question and I'll have Jim take the second one.
Steve Scala - Cowen And Company
Sure.
Unidentified Company Representative
In regards to the tax rate tax, if you would our reported tax rate if you were to exclude the... or did not have the impact of the tax settlement, we would be in the range of approximately 22% for the quarter.
Jim Greffet - Manager, Investor Relations
Regarding GEMZAR, so we... this has been a frequent topic of conversation. So, we talked with our patent folks and have spent some time with them. And they have really sized up our patent to stay with GEMZAR in comparison to what we've seen in the marketplace with Protonix and others. And at the bottom line, we feel very strong about our protection. We think we will prevail if we did get to the point, where we are looking at an at risk launch, we feel confident in our ability to get a preliminary injunction and the patent folks have looked through the forecast that the court would do for preliminary injunction including the likelihood of wining ultimately a trial. So, their status is we believe that are putting and sound if it... if push came to shall so to speak, we would be successful in getting FDI.
Phil Johnson - Executive Director of Investor Relations
Next caller, please.
Operator
From the line of Catherine Arnold from Credit Suisse. Please go ahead.
Catherine Arnold - Credit Suisse
Hi, thanks. I have a couple of questions; first of all on Byetta. I just want to clarify my understanding was at the timing was the fine by the end of the second... first half '09; however there was an expectation that was it either going to be reaffirm or updated, because there were some strategies in mind that might bring some up side to that. And if I got that wrong, are you really going to hear from you to list that changes? And then on expenses, I wonder if you could just give any color to what you expect in the three quarters of the year, are there unique expense that we should be looking out for in terms of SG&A cost or R&D that would prevent sort of the mistiming of expenses by street estimates?
Phil Johnson - Executive Director of Investor Relations
Thanks Catherine; we'll have Jim handle your first question on the Byetta timing and then Derica the second on the expenses?
Jim Greffet - Manager, Investor Relations
So, you are right Catherine. The affirmative statement we have made on the filing timings for exenatide once weekly as by the end of the first half of 2009, I think in Amylin's analyst meeting late last year, they provided a sort of a continue of options. Remember that one of the key factors influencing the timing is the reconciliation that we will do with the FDA from the lower scale manufacturing that was done in the clinical trial to full commercial scale. The timing that we have given by the end of the first half of '09 really assumes the most robust reconciliation is done. In the event, we are able to get a more streamlined reconciliation agreed to with the FDA that timing could conceivably be sooner. We realized that this is an important question; so for the time being, that's really the state of play as we have more definitive timing to provide based on the developments with GSK [ph], we will give it to you.
Derica Rice - Senior Vice President and Chief Financial Officer
Okay. And Catherine on the expense side, are you not aware of any other unusual expense items now and the next nine months? We... if you recall, when we gave our guidance for the year, I clearly stated that we expect operating leverage both in terms of our gross margins improvements as well as expenses in SG&A and R&D growth in total at a sole rate than revenue growth. As you saw when I took out the FX impact, I think I made it very clear we thought Q1 result that we were able to achieve that leverage and I fully expect that we will continue to drive for the same kind of leverage in the last nine months as well. Once again, knowing where the exchange rates will go. I think that's also consistent with the guidance we gave for the year and when I look at our first quarter results, which I think is very solid in our minds, we are very much on track to achieve the range that we gave for the year as well in the bottom line.
Phil Johnson - Executive Director of Investor Relations
Catherine, it's not in issue for 2008 necessarily. As Derica is mentioning, when you get to the year-on-year compare, Q4 of this year compared to Q4 of '07, you should see a significant step-down what's likely in the FX impact. As well as the fact that in Q4 2007, we had a confluence of quite a number of investment opportunities that raise the SG&A expense in particular in that particular quarter.
Next caller, please.
Operator
Seamus Fernandez from Leerink Swann. Your line is open.
Seamus Fernandez - Leerink Swann LLC
Thanks very much. I have a few questions. First, can you just help me better understand if the mix came in better than your anticipated than your expectations. Can you help me better understand the gross margin percentage printed in the quarter? It seems to have missed my expectations by a substantial amount. And I am just wondering why that would occur, where their accruals booked last year that simply were not booked this quarter that would have come in at 100% gross margin or what really is the impact in the quarter there? Then secondly animal health, three companies or at least two companies have reported so far on the animal health businesses and those are coming in below at least my expectations. Just wondering if there is some buying patterns in the animal health businesses that we should anticipate on a quarter-over-quarter or year-over-year basis or is there something structural in the animal health business that would suggest an economic slowdown would have impact there. And I'll go offline. Thanks.
Phil Johnson - Executive Director of Investor Relations
Thanks very much. I'll have Derica addressable to your question.
Derica Rice - Senior Vice President and Chief Financial Officer
Okay, in regards to the mix impact that was what we saw was driving our gross margin and I think I can cover the mix question as well as if we had booked any charges in this response. Our gross margin declined was entirely driven by the impact of foreign exchange rate. If you were to exclude that the impact of foreign exchange rate, we simply saw substantial gross-margin improvement in the first quarter alone. If you look, there were no special charges in gross margin and so forth; it was all exchange rates. We also... if you look back... by the time you get to the bottom line, we have a natural hedge for the most part in our P&L. For a while, we've had a positive impact on sales; it has a negative effect on gross margin in terms of positives as well as our expense base. So, when you get to the bottom-line, pretty much naturally hedged.
In regards to animal health, we did see some buying patterns in the fourth quarter in U.S. of 2007, but for the most part, our underlying trends have been very solid that we think. And we've also had the continued positive effect of the expansion of our companion animal business most recently with the launch of Comfortis in the U.S.
Phil Johnson - Executive Director of Investor Relations
Seamus,one other comment on the manufacturing expenses and gross margin as a percent of sales, as Derica mentioned, excluding the impact of foreign exchange rates, we actually would have seen an expansion in the gross margin as a percent of sales. That really is not due to mix, it's due to the fact of our manufacturing expenses are growing much slower than sales. We talked in the past year or so about actions we've taken at a plant over in the UK at Basingstoke, also down in Virginia, Prince William County as well as up in Central Indiana at Lafayette, Indiana. We are obviously looking to continue our productivity efforts in this area. We still have a strong gross margin going forward as evidenced by some of the announcements that we talked about just a week ago on restructuring our Indianapolis bulk manufacturing operations.
Next caller, please.
Operator
John Boris from Bear Stearns. Your line is open.
John Boris - Bear Stearns
Okay, thanks for taking the questions. First question on prasugrel; can you just chat about where both manufacturing is coming from and full unfinished and whether the FDA has inspected both of those facilities and whether they have signed off on your CMC section of your NDA? And secondly, have you built large quantities and did launch quantities include five mix, 7.5 and 10 milligram tablets? Second question on Alimta, can you just characterize the EU rollout in first line, non-small cell lung cancer and whether you view that as a material or significant opportunity and when we might be seeing some contribution from that and what the rollout might look like. And then just third on at least a question for John on pricing and rebating at the government level. I think in March there is a bill passed to House Bill 1424, met the whole parody, where they are actually looking for an extra claw back of 5% from the 15.1% to 20.1% price level. I think there was a little executive that was quoted to saying that that looked like price control or form of a price control was looking to be put into effect. Just your thoughts on that going into '09 and where do you see that potentially being more broader... broadly applied to other therapeutic categories going forward? Thanks.
Phil Johnson - Executive Director of Investor Relations
All right, thanks John. I'll handle your first three questions and have John handle your last one on the piping rebating here in the U.S. For prasugrel, the bulk will be coming from Kobe in Japan as the full finish will be done here at our Indianapolis facility. Neither those two facilities yet have been scheduled for the FDA pre-approval inspections are still yet to come. Large qualities, we need to get back to you. We don't have information right now on the status of the actual stocking and inventory build for the product launch. And then for EU for Alimta, it's too early tell right now what kind of uptake that we will see, but clearly this is an important indication for us and the one that we think can get an important advancement particularly if you look to go ahead and have more tailored medicines the physicians have more surety if they are going to get the intended benefit when they prescribe their use, given the fact that they have honed in on [ph] these are the products based of histology. John?
John Lechleiter - President and Chief Executive Officer
John, your question about the mental healthcare and legislation [ph] there is a House version and a Senate version; and the House version includes the pay for provision that wouldn't effect the increase rebates and we are close to that. But certainly within that legislation it's very much that we would support. So, we are really trying to see if there is a way to give the right kind of legislation through that has... that doesn't have this provision in it that you referred to.
Phil Johnson - Executive Director of Investor Relations
We'll take one more call.
Operator
That will come from the line of Ira Dan from Bear Stearns [ph]. Please go ahead.
Unidentified Analyst
Hi, this is... I am speaking for Tim Anderson. I have three questions. First what is the status of Zyprexa Depo internationally, and should we expect similar outcome in terms of safety concerns. The second question is do you have any thoughts on why FDA advisory committee has not been set up for capacity growth? And third the PDUFA Cymbalta and FMA [ph] is approaching and is this could be meaningful what do you expect in terms of regulatory clearance for this product and the syndication? Thank you.
Phil Johnson - Executive Director of Investor Relations
Thanks, Ira. We'll go ahead; I think John is going try both the Cymbalta... I am sorry the Zyprexa Depo question, the FDA outcome on why there may not be accessed to prasugrel and the Cymbalta for fibromyalgia if not we'll have Jim have that as well.
John Lechleiter - President and Chief Executive Officer
Okay Zyprexa Depo is currently under review in Europe; and at this point in time, it has not been the subject of BHMT [ph] decision. That's still in progress and we're still actively prosecuting that filing in Europe. With respect to the FDA advisory committee for prasugrel, we are really not provide the FDA would decide or would not decide to have an advisory committee, but what's very clear at this point is we have no indication from FDA that they will at this point require one.
Jim Greffet - Manager, Investor Relations
Ira, it's Jim. Regarding the fibro PDUFA date upcoming for Cymbalta in the U.S., so you are right, we are looking toward a June timeframe that would put us to the ten month clock from when we had submitted. As Deirdre has mentioned earlier part of the explanation in Cymbalta performance today is the up tick that Lirica [ph] has had from their approval for that indication. So, we are excited about the prospects that this will provide to Cymbalta. Furthermore if you think about the continue of efficacy that we have already shown with Cymbalta with the bonafiding and allergic [ph] effects with ET&T as well as the emotional effects with major depressive indication, we think that's particularly sitting in a space such as fibromyalgia. So, we feel good about the submission package; we provide one dialogue with the agency. We are hopeful for approval on things that will be meaningful benefits for the patients and to the products.
Phil Johnson - Executive Director of Investor Relations
All right. Great, thank you. Let me turn the call now back to John to wrap up the meeting.
John Lechleiter - President and Chief Executive Officer
Thank all of you for your time this morning. And let me summarize a few of our key points. We are delivering on our priorities; we concluded 2007 with accelerating sales growth, solid fundamentals, robust cash flow, and earnings at the top end of our guidance range, bringing positive momentum into 2008. This strong performance is broad based across products and geographies. We have a number of important events in 2008, including U.S. launches now in progress of Cialis for once daily use and Humalog KwikPen plus ongoing all U.S. launches of Cymbalta and Byetta; FDA action on prasugrel, Cymbalta for fibromyalgia and Alimta for first line non-small cell lung cancer; submission for prasugrel in the EU and Byetta monotherapy now completes plus Cialis for pulmonary arterial hypertension and Cymbalta for chronic pain; and the initiation of Phase III studies for our Alzheimer's candidates, plus others to come in 2008 and 2009.
In my new role of CEO, chief among my priorities are increasing the flow of innovative new therapies from our pipeline, engaging our customers in fundamentally new ways by focusing on improved outcomes for individual patients and continuing to reduce our cost base and improve quality and productivity. As already today, we have a sense of urgency to deliver strong results while also reshaping the company to win for the benefit of patients and shareholders alike.
Thank you for joining us this morning, and I look forward to continuing minor actions with our investors.
http://seekingalpha.com/article/73150-eli-lilly-co-q1-2008-earnings-call-transcript?source=yahoo
Eli Lilly looks to cut 500 jobs to streamline manufacturing of insulin products, Forteo drug
The Associated Press
Published: April 16, 2008
INDIANAPOLIS: Drug maker Eli Lilly and Co. plans to cut up to 500 jobs to streamline the manufacturing of some insulin products and the osteoporosis drug Forteo.
The Indianapolis-based company offered a "voluntary exit program" to about 2,000 employees in central Indiana on Wednesday with a goal of trimming its work force by up to 500 people, spokesman Phil Belt said. All the cuts will be made through the voluntary program, he said.
"There's no plan right now to supplement it with a layoff or anything like that," he said.
The voluntary program includes a severance package based on the employees' length of service. Belt declined to offer more details.
The actions come a month after the company ended its development program for inhaled insulin. But Belt said productivity improvements drove the cuts.
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The cuts will affect sites that make ingredients for the insulin products Humalog and Humulin, as well as Forteo. Humalog ranked fourth among Lilly drugs with $1.5 billion (€950 million) in sales last year. Humulin notched $985 million (€622 million), while Forteo took in $709 million (€448 million).
Lilly must align manufacturing with customer demands "over a time period in which some products will lose patent protection while other new products are launched," company CEO John Lechleiter said in a statement.
Humalog is one of several Lilly drugs that will lose patent protection between 2011 and 2014. Others include top seller Zyprexa, an anti-psychotic that had $4.7 billion in sales last year.
Belt said Lilly expects about 430 manufacturing employees to take its offer and about 70 people in research and development. The cuts will be capped at 500. Lilly made its offer Wednesday morning, and employees will have until early next month to decide.
Lilly will record a second-quarter charge for the cuts. The amount will depend on how many employees take the offer.
The drug maker employs 12,600 people in central Indiana. Its worldwide employment stood at 40,300 as of March 31, down nearly 13 percent from 46,100 at the end of 2003.
Lilly shares rose $1 to close at $52.55 in trading Wednesday.
Exubera, the inhaled insulin drug developed by Nektar Therapeutics Inc. and later dumped by Pfizer Inc., may be linked to lung cancer, the companies warn.
Pfizer, which stopped marketing the drug in October because of poor sales, said it updated Exubera's label. Meanwhile, Nektar (NASDAQ: NKTR), which had regained rights to Exubera and was in negotiations with potential inhaled insulin partners, said it has broken off partnership talks as a result of Pfizer's findings.
Six of 4,740 patients using Exubera developed lung cancer, according to a review of clinical trial and data and other reports. That's compared to one of 4,292 patients not using Exubera.
That's too few cases to determine whether the cancer is related to Exubera, the drug's updated label says, and all patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Yet the data is the latest -- and possibly fatal -- blow to inhaled insulin.
Pfizer's (NYSE: PFE) dropping of Exubera was followed by similar moves by Eli Lilly (NYSE: LLY) and Novo Nordisk (NYSE: NVO), which had a inhaled insulin development with Aradigm Corp. of Hayward.
"Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin," said Nektar President and CEO Howard Robin.
Nektar, which agreed to pay past Exubera partners West Pharmaceutical Services Inc. and Consort Medical up to $38.4 million for costs and expenses, will not incur any additional charged related to the lung cancer warning, the company said.
http://sanfrancisco.bizjournals.com/sanfrancisco/stories/2008/04/07/daily21.html?ana=yfcpc
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