Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
News: $LLY Better Buy: Eli Lilly vs. AbbVie
Neither Eli Lilly (NYSE: LLY) nor AbbVie (NYSE: ABBV) has provided much for investors to get excited about so far in 2019. Both big pharma stocks are down by single-digit percentages year to date. But Lilly and AbbVie each hold the potential to deliver more attractive returns down the st...
Find out more LLY - Better Buy: Eli Lilly vs. AbbVie
This Big Pharma Stock $LLY Is Dropping And Should Fall Further, Here's The Trade
Eli Lilly and Co (NYSE:LLY) is a leading pharmaceutical company that has been under pressure over the past couple of months. In fact, the stock topped on March 26, 2019 at $132.13 a share. Since that high pivot, the stock has declined by 14.0 percent and is currently trading at $112.84 a share. Traders and investors should note that LLY is now trading below its 50 and 200-day moving averages. This weak chart formation will usually signal further downside in the near term. The next key support level for LLY will be around the $105.00 area. This important level was defended in October and December 2018. Often, when a stock trades down to a major support area they will be defended again when initially retested.
Nick Santiago
InTheMoneyStocks
I have been diabetic since 1957, taking various forms of animal and human insulins made by LLY. I have been on a Brand and generic form of statins for > 20 years.
https://ih.advfn.com/stock-market/NASDAQ/amarin-AMRN/stock-news/79569055/new-updates-to-the-american-diabetes-association
New data from REDUCE IT on high-dose EPA omega-3 for prevention is added https://t.co/nzFVsvBe9l
— Christopher Cannon, M.D. 🇺🇦 (@cpcannon) March 29, 2019
NSAV news out on contract with LLY
$$$$$$$$$$$$$$
NSAV 8-K officially Eli LillY contract VSRI 12/21/2017
Shanghai based Vital Strategic Research Institute (VSRI), has signed an agreement with Eli Lilly and Company. Under the terms of the agreement, VSRI will provide Eli Lilly with an assessment of Cardio Vascular Disease (CVD) among newly diagnosed diabetes patients at increased risk of CVD in China
*******Copie of Contract*************
http://nsavholdinginc.com/files/VSRI-Eli-Lilly.pdf
Ceo James Tilton wants to be clear with everything
Officieel op Sec EDGAR Search Results
https://www.sec.gov/cgi-bin/browse-edgar?company=Net+Savings+Link%2C+Inc.&owner=exclude&action=getcompany
OTC Reporting
https://www.otcmarkets.com/stock/NSAV/news
ELI LILLY AND COMPANY AND SUBSIDIARIES 2016
Financial Highlights>>>> Revenu 2016 $ 21Billion !!! Netto income 2.7Billion
https://en.wikipedia.org/wiki/Eli_Lilly_and_Company
Eli Lilly builds $23B-plus Sales Forecast for 2017 on diabetes, cancer launches
https://www.fiercepharma.com/pharma/facing-cialis-patent-expiration-and-pricing-strife-diabetes-eli-lilly-eyes-new-launches-for
**China spends $50 billion treating diabetes and related diseases every year,
https://blogs.wsj.com/chinarealtime/2016/11/14/chinas-diabetes-problem-from-1-to-10-in-36-years/
**China, about 230 million people have cardiovascular disease.1
http://www.wpro.who.int/china/mediacentre/factsheets/cvd/en/
ELI LILLY AND CO Share price $ 87.00 Not a bad company to work with!!!
https://www.marketwatch.com/investing/stock/lly
I am going to pick up some NSAV shares before this takes off on this HUUUGE news with LLY.
Yep! This will be a great deal for both companies...
NSAV & LLY will be making $$$$$$$$$$$$$
$LLY ELI LILLY 8K with $NSAV here-in this-post
http://nsavholdinginc.com/files/VSRI-Eli-Lilly.pdf
This is an image, it is not at the link as text.
I am unable, WITH MY MACHINE, to scrape
the text - - and paste it into a post.
I will get the text later. . . . ALL 35 PAGES !
Until
$LLY shares up 1% today after its job cuts announcement.
$LLY Dave Ricks, Lilly's CEO reiterates 5% revenue growth target. But today after their http://alphastreet.com/bb352f5b and http://alphastreet.com/b1849458, the stock is down today. Will the portfolio diversification help the company?
$LLY Dave Ricks, Lilly's CEO reiterates 5% revenue growth target. But today after their http://alphastreet.com/bb352f5b and http://alphastreet.com/b1849458, the stock is down today. Will the portfolio diversification help the company?
Jardiance does have not the amputation side effect of Invokana: #msg-132388586.
If Lilly doesn't sign with Anavex soon, they can kiss Alzheimers goodbye to Biogen/Anavex partnership.
AstraZeneca Cuts Jobs, Signs New Collaboration With Eli Lilly and Co http://marketexclusive.com/astrazeneca-plc-nyseazn-cuts-jobs-signs-new-collaboration-eli-lilly-co-nyselly/44433/?icd1
Will LLY buy AVXL after seeing their Alzheimers results or will it be BIIB?
See AVXL work:
George Perry, PhD, Dean and Professor at the University of Texas at San Antonio and Editor-in Chief of the Journal of Alzheimer's Disease, commented, "Although this is an open label study with 32 patients, I have never seen mild-to-moderate Alzheimer's patients maintain near baseline cognitive and activities of daily living function and positive correlation with all other measures over a 41-week trial period in any prior study with an approved or experimental drug. It is quite plausible that complex CNS diseases like Alzheimer's may require a comprehensive approach, including restoration of cellular homeostasis."
I thought this was an LLY board...lol!
Will LLY buy AVXL or will it be BIIB? BIIB already testing their drug in MS.
Anavex has a drug that does slow the progression of Alzheimer's---check this out----https://globenewswire.com/news-release/2016/11/22/891996/0/en/Anavex-Life-Sciences-Announces-Data-on-41-Week-Treatment-of-ANAVEX-2-73-for-Patients-with-Alzheimer-s-Disease-Investigational-Treatment-suggests-to-curb-Cognitive-and-Functional-De.html
http://www.fiercebiotech.com/story/can-eli-lillys-regulatory-gambit-salvage-its-alzheimers-drug
Imo
Anavex has the most promising science to date in this field by taking a encouraging route
imo
Here’s a Look at the Current CDK Inhibition Landscape
http://marketexclusive.com/heres-a-look-at-the-current-cdk-inhibtion-landscape/2791/
Eli Lilly Reports EPS and Revenues In-Line, Reaffirms FY16 Guidance
http://marketexclusive.com/eli-lilly-and-co-nyselly-reports-eps-and-revs-in-line-reaffirms-fy16-guidance/2021/
Article discusses Eli Lilly: What are the Implications of Eli Lilly’s FDA Black Box?
http://marketexclusive.com/eli-lilly/1109/
Payers push back on LLY’s Jardiance: #msg-117435122.
* * $LLY Video Chart 06-11-15 * *
Link to Video - click here to watch the technical chart video
LLY buys North American rights to Erbitux from BMY: #msg-112837296.
LLY issues 2015 non-GAAP EPS guidance: #msg-109697754.
quick ques,what does everybody think lilly will be trading at between now and 90 days from now price wise and where the company is headed?....
biotech_researcher Tuesday, 10/28/14 05:20:17 PM
Quote:SNY/NVO/LLY—More on the competitive landscape in diabetes:
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CCQQFjAA&url=http%3A%2F%2Fblogs.wsj.com%2Fpharmalot%2F2014%2F10%2F28%2Fsanofi-diabetes-outlook-signals-an-undisciplined-price-war-may-erupt%2F&ei=-cBaVO7iJMyyoQT30YGoDQ&usg=AFQjCNHQD878MVZWf9c-44r6rnplMW862w&bvm=bv.78677474,d.cGU&cad=rjt
"In fact, the U.S. payer market is consolidating. Glaxo, as Moneybeat notes, estimates that the 10 largest commercial plans now control 86% of the marketplace, creating more visibility on contracting strategies and pricing. “I think you have a general shift in power toward the purchaser,” Glaxo chief executive Andrew Witty told analysts last week. Glaxo, for instance, is struggling to successfully launch its new Aroro respiratory treatment."
What is new in Bio Tech and where do the Greatest Opportunities reside:
DewDiligence, Sorry for the delay in answering your question. With a name like DewDiligence, one would think you would know that "FS" means Forward Split.
What does FS mean?
"Looking at the universe of stocks we cover at Dividend Channel, on 11/13/13, xxxxxxx and Eli Lilly & Co. (NYSE: LLY) will all trade ex-dividend for their respective upcoming dividends. xxxxxxxx and Eli Lilly & Co. will pay its quarterly dividend of $0.49 on 12/10/13."
LLY
Eli Lilly Bulls: How Will 2014 Treat You?
Oct 29 2013, 10:08 | about: LLY, includes: BMY, MRK, RHHBY BOOK
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. Fusion Research is a team of equity analysts. This article was written by Satya Prakash, one of our research analysts. We did not receive compensation for this article (other than from Seeking Alpha), and we have no business relationship with any company whose stock is mentioned in this article. (More...)
In our previous article on Eli Lilly (LLY), we discussed the six-month patent extension for "Cymbalta", the blockbuster drug used for treatment of major depressive disorder, or MDD. Cymbalta generated revenue of $5 billion last year and its patent will be expire in December 2013. Evista, another drug of Eli Lilly that is used for preventing and treating osteoporosis in women after menopause, will be losing its patent in March 2014. These two drugs contribute nearly 26% of Lilly's revenue and their patent expiry may hamper its 2014 sales and earnings.
However, we expect Lilly's strong presence in oncology, endocrinology, and cardiovascular markets with drugs including Alimta, Evista, Humalog, Erbitux, and Cialis will drive its earnings in the future. The positive result for its trial Phase drugs will help it expedite the drug approval to further increase its revenue and offset the revenue losses from the patent expiration of Cymbalta and Evista.
On October 23, 2013, the company declared strong third quarter results, mainly driven by high revenue and its ongoing cost cutting plans.
Highlights of third quarter
Lilly reported year-over-year revenue growth of 6% to $5.77 billion.
Gross margin increased 8% to $4.57 billion with net income of $1.2 billion.
EPS non-GAAP increased 41% year over year to $1.11 per share.
Lilly submitted application for "Dulaglutide", a type 2 diabetes drug, for regulatory review in both the U.S. and Europe.
In Phase III trial, as a first-line treatment, its cancer drug, "Necitumumab", met the primary endpoint in treating stage IV metastatic cancer and increasing the overall survival in combination with gemcitabine and cisplatin compared to chemotherapy alone.
The company submitted for approval of "Ramucirumab" as a single-agent for the treatment of gastric cancer in Europe.
Ramucirumab in combination paclitaxel met both the safety and efficacy profile in its Phase III trial.
Opportunity in Gastric Cancer
On September 26, 2013, Eli Lilly declared the results for RAINBOW and ROSE Phase III trials for "ramucirumab." The RAINBOW trial is the global Phase III study of ramucirumab in combination with Bristol-Myers Squibb's (BMY) "paclitaxel", a mitotic inhibitor used in chemotherapy, to treat patients suffering with advance gastric cancer. Ramucirumab was able to meet the primary endpoint in improving the overall survival and secondary endpoint in improving progression-free survival. Under this RAINBOW trial, Ramucirumab with paclitaxel demonstrated the superior efficacy and safety in comparison to the placebo.
Gastric cancer is responsible for worldwide deaths of more than 800,000 patients per year. It is the third leading cause of cancer-related death globally in men and the fifth in women and the second most cause of cancer-related death. It is most prevalent in the countries outside the U.S. and Europe. Gastric cancer cells can travel through the bloodstream and may affect organs like lungs, liver, and bones. We expect the positive Phase III result of ramucirumab provides a great opportunity for the company in the gastric cancer market.
After looking at the superior RAINBOW Phase III trial results, the company is planning to submit an application for ramucirumab in combination with paclitaxel to regulatory authorities for its approval to treat patients with advance gastric cancer. As these cancer cells affect the liver and lungs, it is also testing ramucirumab's efficacy in trial to treat cancer of these organs.
Ramucirumab's superior results in REGARD trial
On October 3, 2013, Eli Lilly announced the Phase III REGARD trial of ramucirumab as a single agent in treating patients with advance gastric cancer compared to placebo. In this trial, around 238 patients were treated with the dose of 8mg/kg of ramucirumab and 117 patients received the placebo intravenously once every two weeks. After the eight week of dosing, patients with the single-agent ramucirumab were able to achieve the overall survival of 5.2 months compared to 3.8 months with the placebo, and it reduced the risk of death by around 22%. The patients treated with ramucirumab achieved the progression-free survival of 2.1 months compared to 1.3 months with placebo.
Currently, there are no drugs specifically approved in the U.S. and Europe for advanced gastric cancer patients. The company submitted ramucirumab as a single-agent for regulatory approval in the U.S. and Europe. Based on its superior results compared to placebo, we expect the company may receive the regulatory approval easily, and ramucirumab will provide a higher growth opportunity for the company.
Growth with other cancer drug
In June 2012, Eli Lilly and Bristol-Myers, with their partner Merck (MRK), received FDA approval for "Erbitux", a colorectal cancer drug, as the first-line treatment in KRAS mutation. Merck has the right to develop and market Erbitux outside North America, while Bristol-Myers and Eli Lilly will market it in North America. Additionally, Eli Lilly, as the owner of Erbitux, is eligible to receive royalties on its sales. Erbitux has generated revenue of $333 million in the second quarter of 2013 for Eli Lilly.
The company has initiated trials for evaluating the efficacy of Erbitux and demonstrated the superior results of Erbitux compared to Roche Holding's (OTC:RHHBY) "Avastin". In a trial it observed that 342 colon cancer patients dosed with Erbitux showed superior efficacy; it has reported the average survival rate of 33.1 months compared to 25.6 months for those treated with Avastin. Erbitux is only approved for treatment of patients suffering with tumors containing the non-mutated version of gene, KRAS, a protein. This protein is responsible for developing many cancers and accounts for 60% of colorectal cancer cases. Eli Lilly is planning to receive regulatory approval in Europe for this drug. It is expected to provide a higher growth opportunity for the company. Erbitux sales are expected to peak at $1.25 billion in 2014 and may slip to $1.1 billion by 2018, as the other drug manufacturers will be free to launch biosimilars in Europe by 2015. This will also help Eli Lilly generate higher revenue and royalties on Erbitux sales through its partners.
On other side, Roche, which is known as the world biggest cancer drug manufacturer, recently posted its third-quarter results. It has reported the year-over-year revenue growth of 6% to $38.2 billion for the first nine months of 2013. This growth was mainly driven by the strong performance of its cancer drugs, which include Avastin, Herceptin, MabThera/Rituxan, Perjeta, and Kadcyla.
The increased uptake of Perjeta and Kadcyla, which have demonstrated superior efficacy in enhancing the survival rates of the women suffering with aggressive breast cancer, and Avastin and Herceptin, its other cancer drugs used for the treatment of advance form of cancer, helped Roche post revenue of $12.67 billion for its third quarter of 2013.
Avastin was approved for treating ovarian cancer in Europe, colorectal cancer in the U.S., and its first approval for newly diagnosed glioblastoma in Japan increased its revenue 13% year over year. With this strong growth, we expect its leading cancer drugs will continue to drive its revenue in the future, and it will be able to maintain its leadership in the cancer drugs market.
Conclusion
We are very optimistic about Eli Lilly's drug pipeline and expect its new drugs to perform significantly in the next few years. The positive response from ramucirumab in treating gastric cancer patients may make it another blockbuster drug for the company, if it reports positive results in treating other forms of cancers also. In its recent guidance, Eli Lilly believes it will generate revenue in the range of $22.6 billion to $23.4 billion in fiscal year 2013. It also expects the EPS growth of 18%-20% in the range of $4.33-$4.38 in 2013. Eli Lilly's stock price witnessed the high of $51 on its result day and generated the return of nearly 4% for its investors.
LLY Chart
(Click to enlarge)
LLY data by YCharts
Further, Eli Lilly, despite patent expiration of its main antidepressant drug, Cymbalta, reaffirmed the revenue guidance of at least $20 billion, net income of $3 billion, and $4 billion in operating cash flow next year. The company also expects to return $5 billion to investors in the form of share buyback and dividends. Recently, it declared the fourth quarter dividend of $0.49 per share payable on December 10, 2013, with the record date of November 15, 2013. Its share buyback plan shows the company's confidence in its future growth and its new drug launches.
We expect the company's initiatives coupled with its strong drug pipeline and the positive response for its new drugs, ramucirumab, Necitumumab, and Dulaglutide, will help the company maintain its future earnings, likely achieve its guidance quite comfortably, and drive the investors' confidence.
______________________________________________
seekingalpha.com/article/1781552-eli-lilly-bulls-how-will-2014-treat-you?source=email_rt_article_readmore
LLY
Eli Lilly: Cymbalta Patent Expiry Quantified
Oct 28 2013, 12:48
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
On December 11th, Eli Lilly (LLY) will lose U.S. patent protection of its antidepressant blockbuster Cymbalta (duloxetine) and the product's U.S. sales are expected to decline significantly. Cymbalta currently accounts for 24% of Lilly's global revenue.
During Q3-2013 earning call, Lilly's management volunteered an estimate of how much sales Cymbalta might lose in the last quarter of this year. We've done the calculations and we tend to agree with Lilly's management that during 2013 the effect of Cymbalta's patent expiry on the company's bottom line will be minimal.
(click to enlarge)
Cymbalta's U.S. sales this year have been $1.1 billion, $1.2 billion and $1.1 billion for the first three quarters, respectively. Lilly anticipates that U.S. Cymbalta sales in Q4 will be closer to $500 million, compared to a street consensus of nearly $800 million for the quarter.
Cymbalta, which generated a total of $29 billion in sales since it was first launched by Lilly in 2004, is expected to generate $5 billion in global sales this year.
Cymbalta is the global leader in the antidepressant therapeutic class with close to 80% of sales realized in the U.S. Several manufacturers have already received approvals to market generic versions of the product and are expected to launch their generics immediately following the loss of patent exclusivity.
Current retail price for Cymbalta can reach over $250 for a month's supply while a generic equivalent would cost less than $20, and there is no major difference in treatment outcome between the two products.
Lilly's management expects minimal wholesaler repurchases after the patent expires on December 11th as well as minimal wholesaler purchases in the three weeks leading up to the patent expiration as wholesalers work down their existing inventories to post-patent expirations levels.
Lilly seems to be prepared to successfully navigate the financial challenge posed by Cymbalta's patent expiration. The company is planning to continue investing in R&D, recapitalize its asset base and return substantial cash to shareholders.
Lilly's board of directors authorized a new $5 billion share repurchase program, which the company intends to complete over a multi-year period, and the company is planning to keep dividend payments at their current levels for the foreseeable future.
During 2013, Lilly completed the regulatory submission of several potential new drugs. The company submitted dulaglutide, designed to be injected weekly for Type II diabetes, in both, the U.S. and Europe and, along with Boehringer Ingelheim, submitted empagliflozin for Type II diabetes.
Lilly also aims to expand its cancer arsenal beyond its Alimta lung-cancer treatment. The company has applied to market a potential gastric-cancer treatment, ramucirumab, which could be launched next year and which analysts say has solid sales potential. It also expects to seek marketing approval before the end of 2014 for a potential lung-cancer drug, necitumumab.
(click to enlarge)
Lilly's Q3 revenue increased 6% driven by growth in key products, including Cymbalta, Alimta, Cialis, Tradjenta, Humalog, Strattera, Humulin and Animal Health. However, its Q3 net income declined 9%. The per share earning decline was slightly less at 6%, reflecting the benefit of its share repurchases late last year and early this year.
Lilly survived generic pressures before. After it lost patent protection for its popular antidepressant Prozac in 2001, a new wave of blockbusters including antidepressant Cymbalta and the erectile-dysfunction pill Cialis helped it recover.
Lilly has restocked its pipeline, in part with modest-size acquisitions and licensing deals, and avoided the type of megamergers pursued by Pfizer (PFE) and Merck (MRK). The pipeline looks robust and could help the company get through Cymbalta's patent loss.
Lilly's share price seems unchanged from its level at the beginning of the year, however it is currently down by 13% from its peak for the year, which was achieved in April. At a P/E of 12 and the prospects of $5 billion in share buybacks, Lilly's shares looks like good value for the time being.
__________________________________________________________
http://seekingalpha.com/article/1778932-eli-lilly-cymbalta-patent-expiry-quantified?source=email_rt_article_readmore
LLY
Earnings Beat from Eli Lilly Again - Analyst Blog
By Zacks.com, October 23, 2013, 12:08:05 PM EDT
Eli Lilly & Company ( LLY ) reported third quarter 2013 adjusted earnings per share of $1.11, well above the Zacks Consensus Estimate of $1.05 and 41% above the year-ago earnings of 79 cents. Year-over-year growth was attributable to the strong performance of several key products, cost control, a lower tax rate as well as a lower share count.
Third quarter revenues increased 6% to $5.77 billion, marginally above the Zacks Consensus Estimate of $5.76 billion. Revenues increased despite the impact of the Zyprexa patent expiry due to the strong performance of key products.
Reported earnings (including special items) declined 6% to $1.11 per share in the third quarter of 2013.
Quarterly Details
Third quarter revenues increased 6% reflecting price increases (5%) and higher volume (3%) that were partially offset by unfavorable currency fluctuation (2%). The higher volume was mainly due to the strong performance of several products like Humalog, Alimta, Trajenta and Forteo and the Animal Health segment. This was partially offset by the loss of exclusivity for Zyprexa, which is facing competition from several generic players as well as volume declines for Cymbalta.
U.S. revenues grew 11% to $3.3 billion mainly due to price increases, especially for Cymbalta. Ex- U.S. revenues remained flat at $2.5 billion mainly due to the unfavorable impact of the depreciation of the Japanese yen.
During the third quarter, Zyprexa recorded a 26% decline in revenues, which came in at $278.7 million. U.S. revenues fell 51% due to lower prices. International revenues decreased 20%, mainly due to the loss of market exclusivity in major markets apart from Japan. Zyprexa sales in Japan were affected by the weakening yen.
Products which performed well in the third quarter included Alimta (up 7% to $690.5 million), Humalog (up 7% to $616 million), Cialis (up 9% to $526.7 million), Forteo (up 6% to $306.7 million) and Strattera (19% growth to $173.2 million) among others.
Cymbalta sales increased 11% to $1.4 billion. However, growth was driven mainly by price increases. With the Cymbalta patent expiry coming up (Dec 11), inventory levels were down both at the wholesale and retail channels. The company expects U.S. sales to drop to about $500 million in the fourth quarter.
Eli Lilly's Animal Health segment contributed $530.3 million (up 11%) to revenues. Sales benefited from the withdrawal of Merck's ( MRK ) food animal product from the U.S. market.
Effient revenues increased 14% to $124.9 million. While U.S. revenues grew 15% to $92.7 million, due to higher prices, ex- U.S. revenues increased 10% to $32.2 million driven by higher volume and favorable currency movement.
Expenses
Eli Lilly's adjusted operating expenses declined 2% to $3 billion. Research and development (R&D) expenses increased 3% to $1.4 billion. Marketing, selling and administrative expenses declined 6% to $1.7 billion reflecting the company's cost control efforts. The company has cut down its sales and marketing activities in the U.S. for Cymbalta and Evista, due to impending generic competition.
EPS Guidance Narrowed
Eli Lilly narrowed its 2013 earnings guidance to $4.10 to $4.15 per share (old guidance: $4.05 - $4.15 per share). Revenue guidance remained unchanged at $22.6 billion - $23.4 billion. The Zacks Consensus Estimate for earnings and revenues is currently $4.12 per share and $22.9 billion, respectively.
Eli Lilly continues to expect marketing, selling and administrative expenses of $7.0 - $7.2 billion and R&D expenses of $5.3 - $5.5 billion.
Eli Lilly will start buying back shares under its new $5 billion share repurchase program shortly.
Our Take
Eli Lilly's third quarter results were once again better-than-expected with products like Cialis, Humalog, Alimta, Forteo and the animal health segment managing to offset the negative impact of the genericization of Zyprexa.
Eli Lilly expects revenues to remain flat or increase by about 3.5% in 2013 despite the expected loss of U.S. exclusivity for Cymbalta later this year.
While revenues will be impacted by the loss of Cymbalta exclusivity and the loss of the 15% royalty on exenatide sales, products like Humalog, Humulin, Cialis, Strattera, Forteo, Alimta, Cymbalta (outside the U.S.), Effient, Tradjenta and Axiron, and the animal health segment should contribute to sales. Emerging markets, especially China, should also drive sales. However, revenue growth in Japan could be adversely affected by the weak yen.
Eli Lilly is also working on controlling costs. Earlier this year, Eli Lilly had announced a restructuring initiative to help lessen the impact of the upcoming loss of patent exclusivity for Cymbalta and Evista, changing consumer needs and the change in the U.S. healthcare environment.
Eli Lilly currently carries a Zacks Rank #3 (Hold).
Read more: http://www.nasdaq.com/article/earnings-beat-from-eli-lilly-again-analyst-blog-cm290621#ixzz2ijlrsl00
_______________________________________________________
LLY
FDA Approves Addition to CIALIS® (tadalafil) Product Label
Study Data Shows Cialis 5 mg Initiated with Finasteride Provides Significantly Greater Improvements in Urinary Symptoms of Benign Prostatic Hyperplasia than Placebo with Finasteride
INDIANAPOLIS, Oct. 25, 2013 /PRNewswire/ --
Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved a product label addition for CIALIS to include data from a 26-week study that showed CIALIS 5 mg for once daily use started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks, compared to placebo with finasteride, in men with BPH and an enlarged prostate. The combination of CIALIS and finasteride initiated for BPH therapy is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown.
CIALIS is approved by the FDA to treat erectile dysfunction (ED), the signs and symptoms of BPH, and both ED and the signs and symptoms of BPH (ED+BPH). Finasteride is a type II 5 alpha-reductase inhibitor (5-ARI) approved by the FDA for the treatment of BPH in men with an enlarged prostate.
"Urinary symptom improvement with 5-ARI therapy can take 6 to 12 months," said Claus Roehrborn, MD, chairman, Department of Urology, The University of Texas Southwestern Medical Center. "These data demonstrate that the combination of CIALIS 5 mg for once daily use with finasteride leads to symptom improvement as early as four weeks in men with BPH and an enlarged prostate. This means that CIALIS 5 mg for once daily use can be an effective option for early symptom relief when started in combination with finasteride."
The primary endpoint of the study - changes in total International Prostate Symptom Score (IPSS) at 12 weeks - demonstrated that symptom improvement in patients starting BPH treatment with CIALIS 5 mg for once daily use and finasteride was greater than those starting with placebo and finasteride (-5.2 vs. -3.8; P = .001). Key secondary endpoints demonstrated that improvements in IPSS occurred at the first scheduled observation at week 4 (-4.0 vs. -2.3; P< .001) and continued through week 26.
It is important to note that CIALIS is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to CIALIS or ADCIRCA® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away.
In a subgroup of patients with BPH who were also sexually active and had ED at baseline, CIALIS initiated with finasteride significantly improved erectile function, as measured by the International Index of Erectile Dysfunction–Erectile Function Domain, compared to placebo with finasteride. These results were evident at 4 weeks (3.7 vs. -1.1; P< .001), 12 weeks (4.7 vs. 0.6; P< .001) and 26 weeks (4.7 vs. 0.0; P< .001).
About the Study
The randomized, double-blind, placebo-controlled, 26-week trial assessed the efficacy and safety of CIALIS 5 mg for once daily use or placebo co-administered with finasteride 5 mg in 696 men aged 45 years and older (mean age 64) with an IPSS of at least 13, a urine flow rate (Qmax) of 4 millimeters per second (mL/sec) to 15 mL/sec and a prostate volume at least 30 mL. The study was conducted at 70 sites in 13 countries.[1]
The primary measure was the IPSS, a questionnaire evaluating lower urinary tract symptoms occurring during the preceding month where lower scores indicate less severe symptoms. The pre-specified secondary measure was the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating erectile function where higher scores indicate better erectile function.
Results from the Phase 3b study – Study H6D-CR-LVIW – have been accepted for publication in The Journal of Urology and are available now online at http://dx.doi.org/10.1016/j.juro.2013.09.059.
About BPH and ED
Benign prostatic hyperplasia (BPH) is a condition where the prostate enlarges, which can cause urinary symptoms like needing to go urgently and frequently.
ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection.
BPH and ED are conditions that may occur in the same patient. Several studies have shown that many men with ED also experience the symptoms of BPH.[2],[3],[4]
About CIALIS
CIALIS is indicated for the treatment of men with erectile dysfunction (ED), men with the signs and symptoms of benign prostatic hyperplasia (BPH), and men with both ED and the signs and symptoms of BPH. CIALIS is not for women or children. If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.
Important Safety Information for CIALIS® (tadalafil) tablets
What Is The Most Important Information I Should Know About CIALIS?
Do not take CIALIS if you:
take medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure
use recreational drugs called "poppers" like amyl nitrite and butyl nitrite
are allergic to CIALIS or Adcirca® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing
After taking a single tablet, some of the active ingredient of CIALIS remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.
Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
What Should I Tell My Healthcare Provider Before Taking CIALIS?
CIALIS is not right for everyone. Only your healthcare provider and you can decide if CIALIS is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. You should not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking CIALIS, tell your healthcare provider about all your medical problems, particularly if you have or ever had:
heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack
high or low blood pressure or have high blood pressure that is not controlled
stroke
liver or kidney problems or require dialysis
retinitis pigmentosa, a rare genetic (runs in families) eye disease
severe vision loss, including a condition called NAION
stomach ulcers or a bleeding problem
a deformed penis shape or Peyronie's disease
an erection that lasted more than 4 hours
blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
Can Other Medicines Affect CIALIS?
Tell your healthcare provider about all the medicines you take especially if you take:
medicines called "nitrates" which are often prescribed for chest pain
alpha-blockers often prescribed for prostate problems
blood pressure medications
medicines for HIV or some types of oral antifungal medications
some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine)
other medicines or treatments for erectile dysfunction (ED)
CIALIS is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. Do not take both CIALIS and Adcirca. Do not take sildenafil citrate (Revatio®)* with CIALIS.
What Should I Avoid While Taking CIALIS?
Do not use other ED medicines or ED treatments while taking CIALIS.
Do not drink too much alcohol when taking CIALIS (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.
What Are The Possible Side Effects Of CIALIS?
The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.
Uncommon but serious side effects include:
An erection that won't go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It's not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS and call a healthcare provider right away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
CIALIS does not:
cure ED
increase a man's sexual desire
protect a man or his partner from sexually transmitted diseases, including HIV
serve as a male form of birth control
CIALIS is available by prescription only. For additional information, talk to your doctor and see full Patient Information at http://pi.lilly.com/us/cialis-ppi.pdf and Prescribing Information at http://pi.lilly.com/us/cialis-pi.pdf, or visit www.cialis.com for more information.
* The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.
TD Con-F ISI 03FEB2012
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.
This press release contains forward-looking statements about the use of Cialis for the treatment of BPH and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue 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.
P-LLY
TD87005
[1] Casabe, A., Roehrborn, C.G., Da Pozzo, L.F., Zepeda, S., Henderson, R.J., Sorsaburu, S., Henneges, C., Wong, D.G., Viktrup, L. Efficacy and safety of the co-administration of tadalafil once daily with finasteride for 6 months: a randomized, double-blind, placebo-controlled study in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. The Journal of Urology. 2013; doi:10.1016/j.juro.2013.09.059.
[2] Rosen R, Altwein J, Boyle P, Roger SK, Lukacs B, Meuleman E, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003;44(6):637-649.
[3] Brookes ST, Link CL, Donovan JL, and McKinlay JB. Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey. J Urol 2008;179:250-255.
[4] Gacci M, et al. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. In press. Eur Urol 2011; doi:10.1016/j.eururo.2011.06.037.
Refer to: Kelly Hoffman, 317-631-6400 (office), 317-459-7826 (mobile),
kelly.hoffman@borshoff.biz
Morry Smulevitz, 317-651-5567 (office), 317-457-3294 (mobile),
smulevitzmb@lilly.com
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
RELATED LINKS
http://www.cialis.com
_____________________________________________________
http://www.prnewswire.com/news-releases/fda-approves-addition-to-cialis-tadalafil-product-label-229234431.html
LLY
Board of Directors authorized a new $5 billion share repurchase program
In the last eight months, Eli Lilly has completed eight U.S., European and Japanese regulatory submission for four potential new medicines; Empagliflozinm, insulin glargine product in collaboration with Boehringer Ingelheim, dulaglutide and ramucirumab.
The company had a number of clinical data readouts, including positive readouts for SQUIRE, a Phase 3 study investigating necitumumab as first-line treatment for squamous non-small cell lung cancer and for RAINBOW, a Phase 3 study of ramucirumab as combination therapy in patients with advanced gastric cancer. In both studies, Eli Lilly saw increased overall survival.
Also for ramucirumab, the Phase 3 RA study in first-line breast cancer failed to meet its primary endpoint of increased progression free survival.
http://stks.co/qY6W
Lilly diabetes drugs, price hikes fuel 6% sales boost
By Carly Helfand Comment | Forward | Twitter | Facebook | LinkedIn
Last quarter, Eli Lilly managed to up its earnings through raising prices and slashing its workforce. This quarter, the Indianapolis pharma giant ($LLY) built on that strategy while adding some higher revenues from diabetes products into the mix. But at least some analysts are skeptical whether Lilly can hang its hat on its diabetes franchise going forward.
Wednesday, Lilly reported third-quarter earnings that fell 9% to $1.11 a share. But that profit topped analyst estimates, and the company can thank a worldwide sales increase of 6% for at least some of that. Diabetes drugs drove the jump, with Humulin sales leaping 22% in the U.S. and Humalog revenues increasing by 6% at home and 8% abroad.
Lilly also managed to reduce costs again for the quarter, shedding 4% of its operating expenses. Crippled by the patent cliff last year as best-seller Zyprexa fell to generic competition, the company has worked to chip away at losses by cutting down on spending. And with new top-seller Cymbalta about to follow suit, Lilly has once again found itself staring down the barrel of a gun. July company-wide salary freezes followed May layoffs totaling 40% of Lilly's sales force. In October, the company announced $5 billion worth of share buybacks to help pull shareholders through the difficulties still to come.
As far as making up for the sales hit from Zyprexa, Lilly is almost in the clear, according to Goldman Sachs analyst Jami Rubin. "Most of the year-over-year impact from the patent cliff will subside this quarter," she wrote in a note seen by Bloomberg. She also noted that large pharma companies aren't getting the credit they deserve for pipeline products. Assuming FDA approval, Lilly has four new diabetes drugs slated to hit the market in 2014 and 2015, Bloomberg reports.
Those could provide a needed boost for Lilly, whose stock has fallen more than 4% within the last year. Still, Rubin, for one, is not convinced Lilly can ride its diabetes franchise into the sunset, especially with rival drugs from fellow heavyweights Merck ($MRK), Pfizer ($PFE) and Johnson & Johnson ($JNJ) in the works. "Lilly has a clinical program heavy in diabetes where differentiation and reimbursement are likely to be challenging," she said.
___________________________________________________________
LLY
FDA Grants Lilly's Ramucirumab Priority Review For Advanced Gastric Cancer
By RTT News, October 23, 2013, 07:00:00 AM EDT
Eli Lilly and Co. ( LLY ) reported that the U.S. Food and Drug Administration or FDA has assigned Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.
According to Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology, "If approved, ramucirumab will be the first FDA-approved therapy for patients in this setting. Overall, stomach cancer is the second leading cause of cancer death globally and remains an area of high unmet need."
The Priority Review status for a biologics license application, or BLA, indicates that the FDA's aim is to take action within 8 months of a completed filing. Hence, Lilly expects agency action on this application in the second quarter of 2014. The priority designation aims at expediting the review of applications for drugs that, if approved, would represent a significant advance in treatment.
Also, Lilly studied ramucirumab in combination with paclitaxel for advanced gastric cancer treatment in its Phase III RAINBOW study. The combination-therapy ramucirumab data from that trial would be the basis for separate regulatory applications. Lilly sees top-line results from three additional Phase III trials of ramucirumab, one each in colorectal, hepatocellular (liver) and lung cancer, in 2014.
For comments and feedback: contact editorial@rttnews.com
http://www.rttnews.com
Read more: http://www.nasdaq.com/article/fda-grants-lillys-ramucirumab-priority-review-for-advanced-gastric-cancer-20131023-00226#ixzz2iXlHwrxr
________________________________________________________
LLY
Eli Lilly beats by $0.08, beats on revenues • 6:32 AM
Eli Lilly (LLY): Q3 EPS of $1.11 beats by $0.08.
Revenue of $5.77B (+6% Y/Y) beats by $0.01B. (PR)
LLY
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
Followers
|
31
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
153
|
Created
|
04/07/08
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |