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FDA approves $LLY's breast cancer drug Verzenio (abemaciclib), which will compete with $PFE's Ibrance and $NVS' Kisqali drugs. Verzenio works by blocking certain molecules involved in promoting the growth of cancer cells. The National Cancer Institute estimated that approximately 252,710 women will be diagnosed with breast cancer this year.
$LLY join hands with diabetes management firm Rimidi to provide personalized solutions for diabetic patients who are using insulin. As per the agreement, Rimidi's diabetes management software platform will be integrated with Lilly's insulin management system which is in development.
For 2017, $LLY cut down its GAAP EPS outlook and confirmed its non-GAAP EPS and revenue targets. New products and volume are estimated to drive the low-single digit revenue growth in 2018. Eli Lilly expects to make regulatory progress in 2018 on its rheumatoid arthritis drug baricitinib and migraine drug galcanezumab.
FDA accepts to review $LLY's Galcanezumab, an injectionable drug for the treatment of migraine. Rivals $NVS and $AMGN already filed their migraine drug with FDA in July 2017, while $TEVA is also expected to join the race. Lilly's pain portfolio also includes Tanezumab, developed in partnership with $PFE, for the treatment of osteoarthritis.
Kimberly Blackwell, a breast cancer researcher, will be joining $LLY's Oncology division as VP of early phase development and immuno-oncology on March 12, 2018. Dr. Blackwell currently serves as professor of medicine and assistant professor of radiation oncology at Duke University Medical Center.
$LLY and $INCY said that rheumatoid arthritis drug Baricitinib gave better outcomes compared to the Humira drug. Lilly plans to resubmit the New Drug Application (NDA) with the FDA for Baricitinib before the end of Jan. 2018. In Sept., Lilly and Incyte reported that Baricitinib showed better outcomes for treating a type of skin inflammation.
$LLY, which announced its plan to layoff 3,500 jobs or 8% of its global workforce in early Sept., had worldwide headcount of 41,225 as of Sept. 30, 2017. This is a decline of 1,175 positions or 2.8% from 42,400 worldwide employees as of Sept. 30, 2016.
For FY17, $LLY hiked its revenue outlook to $22.4-22.7Bil, primarily due to uptake trends for new pharmaceutical products. Lilly's GAAP EPS expectation was lowered to $1.73-1.83 versus prior outlook of $2.51-2.61. However, non-GAAP EPS estimate was increased to $4.15-4.25 from the previous range of $4.10-4.54.
When announcing its 3Q17 results, $LLY said that it is looking for an IPO, sale, merger or spin off its Elanco Animal Health business. Lilly plans to give an update on this regard before the middle of 2018. Animal Health business, which was acquired for $5.4Bil in Jan. 2015 from $NVO, had contributed $740.6MM to Lilly's revenue in 3Q17.
$LLY's GAAP net income fell 29% to $556MM and EPS dropped 27% to $0.53 in 3Q17, hurt by the higher asset impairment and restructuring charges. Revenue rose 9% to $5.67Bil, helped by the volume growth from new pharmaceutical products. Excluding items, Lilly earned $1.05 per share, up 19% from a year ago quarter.
As part of the anticipated $850MM capital investments in US, $LLY plans to invest $72MM in its Indianapolis facility for an insulin manufacturing project. CEO David Ricks said that the current US tax reform proposal would cut the corporate tax rate to 20%, put in place a territorial system, and maintain tax credits for R&D.
$LLY inks a deal with Germany-based CureVac to develop and market up to 5 cancer vaccines. Lilly would pay CureVac $50MM as upfront fee and make an equity investment of EUR45MM. If successful, CureVac would receive more than $1.7Bil as milestone payment. Subject to the closing, Lilly expects to incur a charge of $0.03 per share to its earnings.
FDA grants priority review for $LLY's breast cancer drug Verzenio, which was approved by the agency on Sept. 28. 2017. Now, FDA will speed up the review and will take action within eight months. On Oct. 10, 2017, Lilly announced that Verzenio failed in the Phase 3 study for treating advanced lung cancer.
Biologics, a $MCK Specialty Health oncology pharmacy services company, has been selected by $LLY to be in the limited distribution network for Verzenio (abemaciclib), $LLY's first oral oncolytic indicated for metastatic breast cancer. Verzenio obstructs growth of cancer cells by specifically blocking cyclin-dependent kinases, CDK4 and CDK6.