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INDIANAPOLIS, Nov. 6, 2018 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY) today announced fiscal results for the third quarter of 2018.






$ in millions, except

per share data

3rd Quarter

%


2018


2017

Modify

Revenue

$

6,061.9



$

5,658.0


7%

Net Income – Reported

one,149.5



555.six


NM

EPS – Reported

1.12



0.53


NM






Internet Income – Not-GAAP

ane,424.ii



1,106.7


29%

EPS – Non-GAAP

one.39



i.05


32%

Certain financial information for 2018 and 2017 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.Southward. generally accepted accounting principles (GAAP) and include all acquirement and expenses recognized during the periods. Non-GAAP measures exclude the items described in the reconciliation tables later in the release. The company's 2018 financial guidance is also being provided on both a reported and a not-GAAP basis. The not-GAAP measures are presented to provide additional insights into the underlying trends in the company's business. This press release does not constitute an offer of whatsoever securities for sale.

"Lilly delivered strong financial results in the third quarter. Revenue growth driven by greater use of our newest medicines, coupled with prudent expense management, led to strong EPS growth," said David A. Ricks, Lilly's chairman and CEO. "Our strategy is to focus on discovering and developing breakthrough medicines that can aid doctors and patients who need new handling options for serious diseases. We are pleased with our progress this quarter, achieving key evolution and regulatory milestones in pain and diabetes, while driving continued adoption of our new medicines effectually the world. Consequent with our revised guidance, we expect to finish 2018 by further delivering stiff functioning."

Key Events Over the Terminal Three Months

Regulatory

  • The U.S. Nutrient and Drug Administration (FDA) canonical, and the company launched in the U.Southward., Emgality™ for the preventive handling of migraine in adults. In addition, the European Medicines Agency'due south Committee for Medicinal Products for Human Employ (CHMP) issued a positive opinion for Emgality for the prophylaxis of migraine in adults who accept at least 4 migraine days per month.
  •  Verzenios was canonical in Europe for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally avant-garde or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who take received prior endocrine therapy. Verzenio® was also approved in Japan, where information technology is indicated for 60 minutes+, HER2- unresectable or recurrent breast cancer.

Clinical

  • The company appear that Trulicity® met the primary efficacy objective in the REWIND clinical trial, and significantly reduced major adverse cardiovascular events (MACE), a composite endpoint of cardiovascular (CV) expiry, not-fatal myocardial infarction (centre attack) or non-fatal stroke.
  • The visitor announced that results from a Stage 2b clinical trial of its dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA, LY3298176) showed strong and clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes. Phase 3 studies for type 2 diabetes are expected to begin no afterwards than early 2019 and to be completed in tardily 2021.
  • The company and Boehringer Ingelheim appear that empagliflozin met the primary efficacy endpoint, divers as a change from baseline in A1C versus placebo after 26 weeks of treatment, for all doses investigated in a Phase Iii study in adults with type i diabetes.
  • The visitor announced that readouts from 2 Stage 3 clinical trials demonstrated that Ultra Rapid Lispro (URLi) met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog® and also demonstrated significantly improved postal service-meal glucose control in people with type 1 and blazon 2 diabetes. Based on these results, the visitor is planning to submit URLi to regulatory authorities in 2019.
  • The company and its wholly-endemic subsidiary, Avid Radiopharmaceuticals, Inc., announced that a Stage 3 study of flortaucipir F xviii, a Positron Emission Tomography (PET) imaging agent, met its two primary endpoints, defined equally predicting encephalon tau pathology and predicting Alzheimer'south disease diagnosis.

Business Development/Other Developments

  • Elanco Animal Health Incorporated became a publicly traded visitor via an initial public offering (IPO). As of the closing of the IPO, Lilly owns approximately fourscore.2 percent of Elanco, and is actively working to divest its remaining position through a tax-efficient transaction within i twelvemonth of the IPO. Elanco raised over $4 billion in capital from the IPO and associated debt offering.
  • The company appear a license agreement with Chugai Pharmaceutical Co., Ltd for OWL833, Chugai's oral non-peptidic GLP-1 receptor agonist. OWL833 is being studied for the treatment of type ii diabetes. Nether the terms of the agreement, Lilly will receive worldwide development and commercialization rights to OWL833. Chugai will receive an upfront payment of $50 million and is eligible for milestone payments based on achievement of sure predetermined milestones. If the molecule is successfully commercialized, Chugai would too be eligible for royalty payments.
  • The visitor appear a global licensing and research collaboration with Dicerna Pharmaceuticals focused on the discovery, development and commercialization of potential new medicines in the areas of cardio-metabolic disease, neurodegeneration and hurting, utilizing Dicerna's RNA interference (RNAi) applied science platform.
  • The visitor acquired a Priority Review Voucher (PRV) from SIGA Technologies for $80 one thousand thousand. The company intends to utilise this voucher to fast track a production application for an existing R&D projection, although the specific project has not nonetheless been determined. As a consequence of this transaction, the company will tape an acquired in-process enquiry and development charge of $80 million (pretax), or $0.06 EPS (later on taxation), in the fourth quarter of 2018.
  • The company appear a multi-year collaboration with NextCure, Inc. focused on the discovery and development of immuno-oncology cancer therapies. NextCure will apply its discovery platform to identify novel, functional immune-related targets and Lilly will develop antibodies to these targets.

Tertiary-Quarter Reported Results

In the 3rd quarter of 2018, worldwide acquirement was $6.062 billion, an increment of 7 pct compared with the third quarter of 2017. The increase in acquirement was driven by a 12 percent increase due to volume, partially offset by a 4 percent decrease due to lower realized prices and a 1 percent decrease due to the unfavorable impact of foreign exchange rates.

Revenue in the U.S. increased 11 percentage, to $3.447 billion, driven primarily by increased volume for new pharmaceutical products, including Trulicity, Basaglar®, Taltz®, and Verzenio. The increment in revenue was partially offset past lower realized prices, primarily driven by Basaglar, Humalog and Taltz, every bit well as decreased book for products that have lost exclusivity, including Cialis®, Strattera®and Effient®.

Revenue outside the U.Southward. increased two percentage, to $2.615 billion, driven past increased volume of 8 percentage, which was primarily for new pharmaceutical products, including Trulicity, Olumiant® and Taltz. The increase in revenue was partially offset by lower realized prices for several pharmaceutical products, decreased volume for Cialis due to loss of exclusivity, too as the unfavorable bear upon of foreign exchange rates.

Gross margin increased xi percent, to $4.500 billion, in the third quarter of 2018 compared with the third quarter of 2017. Gross margin as a per centum of revenue was 74.2 percentage, an increase of 2.ii percentage points compared with the third quarter of 2017. The increase in gross margin pct was primarily due to manufacturing efficiencies and, to a bottom extent, the effect of foreign exchange rates on international inventories sold and the favorable impact of product mix, partially beginning by the negative impact of price on revenue.

Operating expenses in the 3rd quarter of 2018, defined every bit the sum of research and development and marketing, selling, and authoritative expenses, increased 1 percent to $2.960 billion. Enquiry and development expenses remained flat at $i.343 billion, or 22.ii percent of revenue, as additional late-stage evolution expenditures were offset past lower development milestone payments compared to the 3rd quarter of 2017. Marketing, selling, and authoritative expenses increased 2 percent, to $one.617 billion, primarily due to increased expenses related to new pharmaceutical product launches, partially starting time by reduced expenses on tardily life-bicycle products. Both research and evolution expenses and marketing, selling, and administrative expenses benefited from previously-announced actions taken to reduce the company'south cost structure.

In the 3rd quarter of 2018, the visitor recognized acquired in-process research and development charges of $30.0 meg related to a collaboration with Anima Biotech for the discovery and evolution of translation inhibitors for several target proteins. In the third quarter of 2017, the company recognized caused in-procedure enquiry and development charges of $205.0 meg associated with strategic collaborations with Nektar Therapeutics to co-develop NKTR-358 and with KeyBioscience focused on the development of Dual Amylin Calcitonin Receptor Agonists (DACRAs).

In the 3rd quarter of 2018, the visitor recognized asset impairment, restructuring, and other special charges of $83.iii meg. The charges are primarily associated with asset impairment and restructuring charges related to the auction of the Posilac® (rbST) make and the October ii, 2018 sale of the Augusta, Georgia manufacturing site. The charges as well include expenses associated with the initial public offering and separation of the Elanco animal health business. In the third quarter of 2017, the company recognized nugget harm, restructuring and other special charges of $406.5 1000000. These charges were partially associated with asset impairments related to lower projected revenue for Posilac. The charges were also associated with severance costs incurred as a result of actions taken to reduce the company's cost structure.

Operating income in the 3rd quarter of 2018 was $1.426 billion, compared to $541.vii meg in the third quarter of 2017.  The increase to operating income was driven by higher gross margin, lower asset damage, restructuring, and other special charges, and, to a bottom extent, lower acquired in-process research and development charges.

Other income (expense) was expense of $15.4 1000000 in the third quarter of 2018, compared with income of $49.9 1000000 in the third quarter of 2017. The reduction in other income (expense) was driven by foreign exchange losses (primarily related to Argentine republic), higher net interest expense and mark-to-market adjustments on investment securities.

The effective tax rate was 18.v percent in the third quarter of 2018, compared with half-dozen.i percentage in the tertiary quarter of 2017. The college constructive tax rate for the 3rd quarter of 2018 is primarily due to a higher income tax benefit in the third quarter of 2017 for acquired in-process enquiry and development charges, nugget harm, restructuring, and other special charges.

In the tertiary quarter of 2018, internet income and earnings per share were $1.149 billion and $1.12, respectively, compared with net income of $555.6 million and earnings per share of $0.53 in the third quarter of 2017. The increases in cyberspace income and earnings per share were primarily driven by higher operating income, partially starting time by higher taxation expense.

Third-Quarter Non-GAAP Measures

On a non-GAAP basis, third-quarter 2018 gross margin increased 10 pct, to $iv.651 billion. Gross margin equally a per centum of revenue was 76.7 percentage, an increment of i.9 percent points compared with the third quarter of 2017. The increase in gross margin per centum was primarily due to manufacturing efficiencies and, to a lesser extent, the outcome of foreign commutation rates on international inventories sold and the favorable impact of product mix, partially showtime past the negative impact of price on revenue.

Reflecting the visitor's previously-appear deportment to reduce its toll construction, operating expenses were 48.8 percent of revenue in the third quarter of 2018, a reduction of 2.7 percentage points compared with the third quarter of 2017.

Operating income increased $377.5 meg, or 29 percentage, to $1.692 billion in the tertiary quarter of 2018, primarily due to higher revenue.

The effective taxation rate was 15.one percent in the third quarter of 2018, compared with 18.9 percent in the third quarter of 2017. The lower constructive tax charge per unit for the third quarter of 2018 was primarily due to U.S. revenue enhancement reform enacted in Dec 2017.

In the third quarter of 2018, net income increased 29 pct, to $i.424 billion, and earnings per share increased 32 percent, to $one.39, compared with $1.107 billion and $one.05, respectively, in the tertiary quarter of 2017. The increases in net income and earnings per share were primarily driven by higher operating income.

For further detail of non-GAAP measures, see the reconciliation below as well equally the Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Data table later in this press release.


Third Quarter


2018


2017

% Change

Earnings per share (reported)

$

1.12



$

0.53


NM

Acquittal of intangible avails

.12



.x



Nugget impairment, restructuring and other special charges

.07



.29



Income taxes(a)

.05





Acquired in-procedure research and development

.02



.xiii



Earnings per share (non-GAAP)

$

1.39



$

1.05


32%






Numbers may not add due to rounding.

(a) Relates to adjustments to the 2017 Price Tax for U.S. tax reform proposed regulations and tax expenses associated with the separation of the Elanco brute wellness business.





Year-to-Date Results

For the first nine months of 2018, worldwide revenue increased 8 percent, to $18.117 billion, compared with $16.711 billion in the same menstruum in 2017. Reported net income and earnings per share were $2.107 billion and $2.03, respectively, for the first nine months of 2018.

Year-to-Date Non-GAAP Measures

For the starting time nine months of 2018, internet income and earnings per share, on a not-GAAP basis, were $4.377 billion and $4.22, respectively.

For further detail of non-GAAP measures, see the reconciliation below also as the Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Data tabular array later in this press release.


Twelvemonth-to-Appointment


2018


2017

% Change

Earnings per share (reported)

$

2.03



$

i.37


48%

Acquired in-process inquiry and evolution

1.57



.94



Acquittal of intangible assets

.36



.33



Asset damage, restructuring and other special charges

.20



.48



Income taxes(a)

.05





Other, net

.01



.02



Earnings per share (non-GAAP)

$

4.22



$

3.14


34%

Numbers may not add due to rounding.

(a) Relates to adjustments to the 2017 Toll Taxation for U.S. tax reform proposed regulations and tax expenses associated with the separation of the Elanco animal health business organization.






Selected Revenue Highlights













(Dollars in millions)

Third Quarter


Year-to-Appointment


Established Pharma
Products

2018


2017


% Change


2018


2017


% Alter


Humalog

$

664.6



$

696.2



(5)%


$

ii,226.1



$

2,083.0



7%


Alimta®

520.5



514.5



one%


1,576.0



one,537.three



3%


Cialis

467.1



564.9



(17)%


1,501.2



i,725.7



(thirteen)%


Forteo®

390.8



441.7



(12)%


1,138.5



1,235.eight



(8)%


Humulin®

322.1



300.5



7%


994.0



972.8



2%


Cymbalta®

172.0



183.ii



(six)%


523.v



564.4



(7)%


Erbitux®

159.v



163.v



(two)%


475.5



477.0



(0)%


Trajenta(a)

135.7



153.3



(12)%


418.5



408.2



three%


Zyprexa®

109.9



140.6



(22)%


360.4



428.9



(xvi)%


Strattera

98.vii



137.1



(28)%


343.5



519.9



(34)%















Select Products
Launched Since 2014













Trulicity

816.2



527.7



55%


two,274.iii



i,380.viii



65%


Taltz

263.9



151.iii



74%


630.4



386.7



63%


Cyramza®

198.4



196.0



i%


600.8



553.5



nine%


Basaglar

201.2



145.7



38%


569.0



278.iii



NM


Jardiance(b)®

166.nine



127.2



31%


465.1



304.3



53%


Lartruvo®

76.9



54.5



41%


221.2



144.0



54%


Verzenio

84.5





NM


171.nine





NM


Olumiant

55.6



16.ii



NM


132.5



22.viii



NM


Subtotal

1,863.vi



i,218.five



53%


five,065.3



3,070.four



65%















Animate being Health

772.7



740.6



4%


2,326.0



2,294.eight



1%















Total Revenue

6,061.9



5,658.0



7%


18,117.1



sixteen,710.vi



eight%















(a) Trajenta includes Jentadueto®

(b) Jardiance includes Glyxambi® and Synjardy®

NM – not meaningful

Numbers may not add due to rounding


Selected Established Pharma Products

Humalog

For the 3rd quarter of 2018, worldwide Humalog revenue decreased v pct compared with the tertiary quarter of 2017, to $664.vi million. Revenue in the U.S. decreased 12 percent, to $365.6 million, driven by lower realized prices primarily due to changes in segment mix and the impact of patient affordability programs, partially offset past increased book. Acquirement outside the U.Southward. increased vi per centum, to $299.0 one thousand thousand, driven past increased volume, partially offset by lower realized prices and the unfavorable impact of foreign exchange rates.

Alimta

For the third quarter of 2018, Alimta generated worldwide revenue of $520.5 million, which increased 1 pct compared with the third quarter of 2017. U.Southward. revenue increased 11 percent, to$288.five 1000000, driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside the U.S. decreased nine percent to $232.0 meg, driven primarily past decreased book due to competitive pressure level and loss of exclusivity in several countries.

Cialis

For the third quarter of 2018, worldwide Cialis revenue decreased 17 pct to $467.i million. U.S. revenue was $295.9 1000000 in the third quarter, a 7 pct decrease compared with the 3rd quarter of 2017, driven by decreased demand due to the entry of generic sildenafil, partially offset by college realized prices. Cialis lost exclusivity, and generic tadalafil entered the U.Due south. market, in tardily September 2018. Revenue exterior the U.South. decreased 30 percent to $171.2 million, primarily driven by the loss of exclusivity in Europe.

Forteo

For the third quarter of 2018, worldwide revenue for Forteo was $390.viii million, a 12 pct decrease compared with the third quarter of 2017. U.South. revenue decreased 22 percentage, to $182.5 million, primarily due to decreased demand and, to a lesser extent, lower realized prices. Revenue outside the U.S. remained apartment at $208.3 million, driven past increased volume, offset by lower realized prices and the unfavorable touch of foreign exchange rates.

Humulin

For the third quarter of 2018, worldwide Humulin revenue increased 7 percent compared with the third quarter of 2017, to $322.1 million. U.Southward. revenue increased seven pct, to $216.9 million, driven past increased book. Revenue outside the U.Southward. increased 8 percent, to $105.1 meg, primarily due to buying patterns in China, partially offset by the unfavorable touch on of foreign exchange rates.

Select Products Launched Since 2014

Trulicity

3rd-quarter 2018 worldwide Trulicity acquirement was $816.2 one thousand thousand, an increase of 55 percentage compared with the tertiary quarter of 2017. U.S. revenue increased 56 percent, to $645.9 million, driven by higher demand. Revenue outside the U.S. was $170.3 million, an increase of 48 percent, primarily driven by increased volume.

Taltz

For the third quarter of 2018, worldwide Taltz acquirement was $263.9 one thousand thousand, an increment of 74 per centum compared with the third quarter of 2017. U.S. revenue was $210.6 one thousand thousand, an increase of sixty percent, driven by college demand, partially starting time by lower realized prices. Revenue outside the U.S. was $53.3 million, an increase of $33.three million, driven by increased book from new launches.

Cyramza

For the third quarter of 2018, worldwide Cyramza revenue was $198.4 million, an increase of one percent compared with the 3rd quarter of 2017. U.Due south. acquirement was $67.0 meg, a decrease of 4 percentage, driven by lower realized prices. Revenue outside the U.S. was $131.4 million, an increase of 4 percent, driven past increased book, partially offset by lower realized prices.

Basaglar

For the third quarter of 2018, Basaglar generated worldwide revenue of $201.two one thousand thousand, an increase of 38 pct compared with the third quarter of 2017. U.S. revenue was $157.3 million, an increment of 37 percent, driven past increased demand, partially offset by lower realized prices due to increased volume in Medicare Part D and, to a lesser extent, changes to estimates for rebates and discounts. Revenue exterior the U.S. was $43.9 million, an increase of 44 percent, primarily driven by increased demand. Basaglar is part of the company's brotherhood with Boehringer Ingelheim, and Lilly reports total sales as revenue, with payments fabricated to Boehringer Ingelheim for its portion of the gross margin reported as toll of sales.

Jardiance

The visitor'southward worldwide Jardiance revenue during the tertiary quarter of 2018 was $166.ix 1000000, an increase of 31 percent compared with the third quarter of 2017. U.Due south. revenue increased 24 per centum, to $104.2 million, driven by increased demand. Revenue exterior the U.S. was $62.7 1000000, an increase of 45 pct, primarily driven by increased volume. Jardiance is part of the company's alliance with Boehringer Ingelheim, and Lilly reports as acquirement a portion of Jardiance'due south gross margin.

Lartruvo

For the third quarter of 2018, Lartruvo generated worldwide revenue of $76.nine meg, an increase of 41 percent compared with third quarter of 2017. U.S. revenue increased 12 percent, to $47.iv million, driven past increased need. Revenue outside the U.S. was $29.v million, an increase of $17.5 million, driven by increased volume from new launches.

Verzenio

For the third quarter of 2018, Verzenio, a treatment for women with 60 minutes+, HER2- advanced breast cancer, generated U.South. acquirement of $84.five meg, an increase of $26.7 meg compared with the 2d quarter of 2018.

Olumiant

For the third quarter of 2018, Olumiant generated worldwide acquirement of $55.6 million.  U.S. revenue was $0.viii million. Revenue outside the U.S. was $54.8 1000000, an increment of $11.nine million compared with the second quarter of 2018, reflecting uptake of new launches in Europe.

Animal Wellness

In the 3rd quarter of 2018, worldwide animal health revenue totaled $772.seven meg, an increment of 4 pct compared with the 3rd quarter of 2017, driven by higher prices and higher book, partially offset by the negative touch on of foreign exchange rates. In terms of animate being health product categories, college sales of companion animal disease prevention, ruminants and swine, and companion fauna therapeutics products were partially offset by lower sales of products that are being exited. For specific beast wellness product performance, refer to today's Elanco Brute Wellness Incorporated press release.

2018 Financial Guidance

The visitor has revised certain elements of its 2018 fiscal guidance on a reported basis and on a non-GAAP footing. On a reported basis, earnings per share for 2018 are now expected to be in the range of $3.04 to $3.09. On a non-GAAP ground, earnings per share are now expected to be in the range of $v.55 to $5.60.


2018

Expectations

% Change from
2017

Earnings per share (reported)

$3.04 to $iii.09

NM

Caused in-process inquiry and development

1.lxxx


Amortization of intangible avails

.43


Nugget impairment, restructuring and other special charges

.22


Income taxes(a)

.05


Other, net

.01


Earnings per share (non-GAAP)

$5.55 to $five.sixty

thirty% to 31%

Numbers may non add due to rounding

(a) Relates to adjustments to the 2017 Toll Tax for U.S. tax reform proposed regulations and tax expenses associated with the separation of the Elanco animal health business.



The company at present anticipates 2018 revenue between $24.3 billion and $24.5 billion. The increase in the low end of the acquirement range from prior guidance is due to strong performance across the pharmaceutical portfolio, especially in diabetes. Revenue growth is however expected to exist driven by new products including Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant and Lartruvo.

Marketing, selling and authoritative expenses are now expected to be in the range of $6.3 billion to $6.5 billion.

The 2018 effective tax charge per unit is nevertheless expected to be approximately 22.five percent on a reported basis and is now expected to be approximately 16 percent on a not-GAAP ground, reflecting recently issued guidance on elements of U.S. tax reform. The 2018 effective tax rate benefits from a lower corporate income revenue enhancement rate, partially offset past the changes to certain concern exclusions, deductions, credits and international revenue enhancement provisions. The 2018 effective taxation charge per unit is subject to change based upon changes in the company'due south interpretations of the revenue enhancement laws, along with subsequent regulations, interpretations, guidance, and accounting policy elections that the company continues to evaluate.

The post-obit tabular array summarizes the company's 2018 financial guidance:


2018 Guidance


Prior


Revised

Revenue

$24.0 to $24.5 billion


$24.3 to $24.5 billion





Gross Margin % of Revenue (reported)

Approx. 73.5%


Unchanged

Gross Margin % of Revenue (non-GAAP)

Approx. 76%


Unchanged





Marketing, Selling & Administrative

$six.2 to $6.5 billion


$6.3 to $6.5 billion





Research & Development

$5.2 to $five.iv billion


Unchanged





Other Income/(Expense)

$75 to $200 million


Unchanged





Tax Rate (reported)

Approx. 22.v%


Unchanged

Revenue enhancement Charge per unit (non-GAAP)

Approx. 17%


Approx. xvi%





Earnings per share (reported)

$iii.19 to $3.29


$iii.04 to $3.09

Earnings per share (non-GAAP)

$5.forty to $5.50


$five.55 to $5.60





Capital Expenditures

Approx. $i.2 billion


Unchanged





Non-GAAP adjustments are consistent with the earnings per share table above.

Webcast of Conference Call

Every bit previously announced, investors and the general public can access a live webcast of the tertiary-quarter 2018 financial results briefing call through a link on Lilly'south website at www.lilly.com. The conference call will exist held today from 9 a.1000. to 10:thirty a.m. Eastern time (ET) and will be available for replay via the website.

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. Nosotros were founded more a century agone by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our piece of work. Across the earth, Lilly employees work to discover and bring life-irresolute medicines to those who need them, better the understanding and direction of affliction, and give dorsum to communities through philanthropy and volunteerism. To learn more nearly Lilly, please visit the states at www.lilly.com and http://newsroom.lilly.com/social-channels.  F-LLY

This press release contains management's current intentions and expectations for the future, all of which are forrard- looking statements within the significant of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "estimate", "projection", "intend", "expect", "believe", "target", "conceptualize" and similar expressions are intended to identify frontward-looking statements. Actual results may differ materially due to various factors. At that place are significant risks and uncertainties in pharmaceutical enquiry and evolution. In that location tin be no guarantees that pipeline products will receive the necessary clinical and manufacturing regulatory approvals or that they volition prove to be commercially successful. The visitor'southward results may likewise be affected by such factors as the timing of predictable regulatory approvals and launches of new products; marketplace uptake of recently launched products; competitive developments affecting current products; the expiration of intellectual property protection for sure of the company'due south products; the visitor's power to protect and enforce patents and other intellectual property; the bear upon of governmental actions regarding pricing, importation, and reimbursement for pharmaceuticals, including U.S. health care reform; regulatory compliance issues or government investigations; regulatory deportment regarding currently marketed products; unexpected condom or efficacy concerns associated with the visitor'southward products; problems with product supply stemming from manufacturing difficulties or disruptions; regulatory changes or other developments; changes in patent law or regulations related to data-packet exclusivity; litigation involving current or hereafter products; the extent to which third-party indemnification obligations relating to product liability litigation and similar matters will be performed; unauthorized disclosure of trade secrets or other confidential data stored in the company'south information systems and networks; changes in tax law and regulations, including the bear upon of tax reform legislation enacted in Dec 2017 and related guidance; changes in inflation, involvement rates, and strange currency exchange rates; asset impairments and restructuring charges; changes in bookkeeping standards promulgated by the Fiscal Accounting Standards Board and the Securities and Commutation Commission (SEC); acquisitions and business organisation development transactions and related integration costs; the impact of exchange rates and global macroeconomic conditions; and uncertainties and risks related to timing and potential value to both Elanco and Lilly of the planned separation of the Elanco animal wellness concern, including business, industry, and market risks, too as risks involving realizing the anticipated taxation-free nature of the separation. For additional information about the factors that could cause actual results to differ materially from forward-looking statements, please see the company'south latest Form ten-K filed with the SEC. You should not place undue reliance on forward-looking statements, which speak only equally of the date of this release. Except equally is required by constabulary, the company expressly disclaims any obligation to publicly release whatsoever revisions to forward-looking statements to reflect events subsequently the engagement of this release.

Alimta® (pemetrexed disodium, Lilly)
Basaglar® (insulin glargine injection, Lilly)
Cialis® (tadalafil, Lilly)
Cymbalta® (duloxetine hydrochloride, Lilly)
Cyramza® (ramucirumab, Lilly)
Effient® (prasugrel, Lilly)
Emgality™ (galcanezumab-gnlm, Lilly)
Erbitux® (cetuximab, Lilly)
Forteo® (teriparatide of recombinant DNA origin injection, Lilly)
Glyxambi® (empagliflozin/linagliptin, Boehringer Ingelheim)
Humalog® (insulin lispro injection of recombinant DNA origin, Lilly)
Humulin® (human being insulin of recombinant Dna origin, Lilly)
Jardiance® (empagliflozin, Boehringer Ingelheim)
Jentadueto® (linagliptin/metformin HCl, Boehringer Ingelheim)
Lartruvo® (olaratumab, Lilly)
Olumiant® (baricitinib, Lilly)
Posilac® (recombinant bovine somatotropin, Lilly)
Strattera® (atomoxetine hydrochloride, Lilly)
Synjardy® (empagliflozin/metformin, Boehringer Ingelheim)
Taltz® (ixekizumab, Lilly)
Trajenta® (linagliptin, Boehringer Ingelheim)
Trulicity® (dulaglutide, Lilly)
Verzenio®, Verzenios™ (abemaciclib, Lilly)
Zyprexa® (olanzapine, Lilly)

Eli Lilly and Company Employment Data



September 30, 2018


Dec 31, 2017

Worldwide Employees

38,585


40,655

Eli Lilly and Company

Operating Results  (Unaudited) – REPORTED

(Dollars in millions, except per share data)




Iii Months Ended



Nine Months Ended



September xxx,



September thirty,



2018

2017

% Chg.



2018

2017

% Chg.













Acquirement

$

half dozen,061.9


$

5,658.0


7

%


$

18,117.1


$

16,710.6


viii













Cost of sales


1,562.3



i,586.3


(2)

%



4,836.iii



4,505.9


7

Inquiry and development


1,343.three



i,340.0


0

%



3,853.3



3,870.4


(0)

Marketing, selling and administrative


ane,616.half-dozen



ane,578.5


two

%



4,770.iii



4,876.six


(2

Acquired in-procedure inquiry
  and development


30.0



205.0


(85)

%



1,654.five



i,062.6


56

Asset impairment, restructuring and
     other special charges


83.3



406.5


(80)

%



236.0



670.4


(65)













Operating income


1,426.4



541.7


NM




2,766.vii



1,724.vii


60













Internet interest income (expense)


(37.three)



(16.8)





(75.1)



(47.5)



Cyberspace other income (expense)


21.9



66.7





165.2



236.i



Other income (expense)


(fifteen.4)



49.9


NM




90.ane



188.6


(52)













Income before income taxes


1,411.0



591.6


NM




2,856.8



1,913.3


49

Income taxes


261.5



36.0


NM




749.8



460.five


63













Internet income

$

one,149.5


$

555.6


NM



$

2,107.0


$

i,452.8


45













Earnings per share - diluted

$

one.12


$

0.53


NM



$

two.03


$

1.37


48













Dividends paid per share

$

0.5625


$

0.52


eight



$

ane.6875


$

1.56


8

Weighted-average shares
     outstanding (thousands) - diluted


1,026,298



ane,056,025





i,037,759



1,056,972




NM – non meaningful

Beginning in 2018, pension and postretirement do good price components other than service costs are presented in other income (expense). As a result, comparable amounts for the 3 and 9 months concluded September xxx, 2017 have been reclassified to adjust with this new presentation.

Eli Lilly and Visitor



Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)



(Dollars in millions, except per share information)







Three Months Ended

September thirty, 2018


Three Months Concluded

September xxx, 2017




GAAP
Reported

Adjustments(c)

Not-GAAP
Adjusted(a)


GAAP
Reported

Adjustments(d)

Non-GAAP
Adjusted(a)










Cost of sales

$

one,562.three


$

(151.3)


$

1,411.0


$

1,586.3


$

(160.0)


$

1,426.three















Operating expenses(b)


2,959.9



(1.i)



ii,958.8



2,918.v



(i.three)



2,917.1


Acquired in-process
     research and evolution


30.0



(30.0)





205.0



(205.0)




Asset damage, restructuring
     and other special charges


83.iii



(83.3)





406.five



(406.5)

















Income taxes


261.5



(9.1)



252.v



36.0



221.9



257.8















Net income


i,149.5



274.seven



one,424.2



555.6



550.9



one,106.seven















Earnings per share - diluted


1.12



0.27



i.39



0.53



0.52



1.05





















Numbers may not add together due to rounding.

The table higher up reflects only line items with non-GAAP adjustments.

Starting time in 2018, pension and postretirement benefit price components other than service costs are presented in other income (expense). As a issue, comparable amounts for the three months ended September 30, 2017 have been reclassified to arrange with this new presentation.


(a)

The visitor uses not-GAAP financial measures that differ from financial statements reported in conformity with U.Southward. more often than not accustomed accounting principles (GAAP). The company's non-GAAP measures conform reported results to exclude amortization of intangibles and items that are typically highly variable, hard to predict, and/or of a size that could take a substantial touch on the company's reported operations for a period. The company believes that these not-GAAP measures provide useful information to investors. Amidst other things, they may help investors evaluate the company's ongoing operations. They can assist in making meaningful period-over-catamenia comparisons and in identifying operating trends that would otherwise be masked or distorted by the items field of study to the adjustments. Direction uses these not-GAAP measures internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive bounty targets. Investors should consider these non-GAAP measures in addition to, not as a substitute for or superior to, measures of financial functioning prepared in accord with GAAP.

(b)

Operating expenses include research and development and marketing, selling and administrative expenses.

(c)

Adjustments to certain GAAP reported measures for the three months ended September thirty, 2018, include the following:



(Dollars in millions, except per
share data)

Amortization(i)

IPR&D(ii)

Other
specified
items(three)

Income
taxes(four)

Full
Adjustments

Toll of sales

$

(152.three)


$


$

1.0


$


$

(151.iii)









Operating expenses

(1.1)





(1.one)


Acquired in-process enquiry and
     evolution


(xxx.0)




(30.0)


Asset harm, restructuring and
     other special charges



(83.three)



(83.three)









Income taxes

29.9


6.3


10.2


(55.5)


(9.1)









Net income

123.5


23.7


72.1


55.5


274.vii









Earnings per share - diluted

0.12


0.02


0.07


0.05


0.27



Numbers may not add due to rounding.

The table higher up reflects only line items with non-GAAP adjustments.




i.

Exclude amortization of intangibles primarily associated with costs of marketed products caused or licensed from tertiary parties.



two.

Exclude costs associated with upfront payments for acquired in-process research and development projects acquired in a transaction other than a concern combination. These costs were related to business concern development activeness for the collaboration with Anima Biotech for the discovery and evolution of translation inhibitors for several target proteins.



iii.

Exclude charges primarily associated with asset impairment and restructuring charges related to the asset impairment and restructuring charges related to the sale of the Posilac (rbST) make and the October two, 2018 auction of the Augusta, Georgia manufacturing site. The charges too include expenses associated with the initial public offer and separation of the Elanco animate being health business organisation.



iv.

Relates to adjustments to the 2017 Price Tax for U.S. tax reform proposed regulations and revenue enhancement expenses associated with the separation of the Elanco animal health business.



(d)

Adjustments to certain GAAP reported measures for the 3 months ended September 30, 2017, include the following:



(Dollars in millions, except per
share data)

Amortization(i)

IPR&D(ii)

Other
specified
items(iii)

Full
Adjustments

Cost of sales

$

(154.5)


$


$

(5.5)


$

(160.0)







Operating expenses

(1.3)




(1.3)


Acquired in-process research and
     development


(205.0)



(205.0)


Asset impairment, restructuring and other
     special charges



(406.five)


(406.5)







Income taxes

46.8


71.8


103.iii


221.9







Net income

109.0


133.three


308.vii


550.9







Earnings per share – diluted

0.10


0.13


0.29


0.52



Numbers may not add due to rounding.

The table above reflects only line items with non-GAAP adjustments.







i.

Exclude amortization of intangibles primarily associated with costs of marketed products caused or licensed from third parties.



ii.

Exclude costs associated with upfront payments for acquired in-process research and development projects acquired in a transaction other than a business combination.  These costs are related to collaborations with Nektar Therapeutics and with KeyBioscience.



iii.

Exclude charges primarily associated with nugget impairments related to lower projected revenue for Posilac (rbST) and severance costs incurred equally a upshot of actions taken to reduce the company's cost construction.

Eli Lilly and Company



Reconciliation of GAAP Reported to Selected Non-GAAP Adapted Information (Unaudited)



(Dollars in millions, except per share data)







Nine Months Concluded

September 30, 2018


9 Months Ended
September xxx, 2017




GAAP
Reported

Adjustments(c)

Non-GAAP
Adjusted(a)


GAAP
Reported

Adjustments(d)

Not-GAAP
Adjusted(a)










Cost of sales

$

four,836.3


$

(487.eight)


$

four,348.5


$

four,505.ix


$

(537.i)


$

iii,968.8















Operating expenses(b)


viii,623.6



(3.seven)



eight,619.9



8,747.0



(iv.ix)



viii,742.1


Acquired in-procedure research and
     evolution


ane,654.v



(1,654.5)





1,062.half-dozen



(1,062.6)




Nugget damage, restructuring and other
     special charges


236.0



(236.0)





670.iv



(670.4)

















Other income (expense)


ninety.1



(25.8)



64.3



188.vi





188.6















Income taxes


749.8



86.2



836.0



460.v



404.2



864.half dozen















Net income


2,107.0



2,270.0



4,377.0



1,452.8



i,870.viii



3,323.7















Earnings per share – diluted


2.03



2.19



4.22



1.37



ane.77



3.14



Numbers may not add due to rounding.

The table above reflects only line items with non-GAAP adjustments.



(a)

The company uses non-GAAP financial measures that differ from financial statements reported in conformity with U.South. generally accustomed accounting principles (GAAP). The company'due south non-GAAP measures conform reported results to exclude amortization of intangibles and items that are typically highly variable, hard to predict, and/or of a size that could have a substantial touch on on the visitor's reported operations for a period. The visitor believes that these non-GAAP measures provide useful information to investors. Among other things, they may assist investors evaluate the company's ongoing operations. They can assist in making meaningful period-over-period comparisons and in identifying operating trends that would otherwise be masked or distorted by the items subject to the adjustments. Direction uses these non-GAAP measures internally to evaluate the performance of the business organisation, including to allocate resources and to evaluate results relative to incentive compensation targets. Investors should consider these not-GAAP measures in addition to, non equally a substitute for or superior to, measures of financial performance prepared in accordance with GAAP.

(b)

Operating expenses include enquiry and development and marketing, selling and authoritative expenses.

(c)

Adjustments to sure GAAP reported measures for the nine months concluded September 30, 2018, include the following:



(Dollars in millions, except per
share data)

Amortization(i)

IPR&D(ii)

Other
specified
items(iii)

Income
taxes(iv)

Total
Adjustments

Toll of sales

$

(455.0)


$


$

(32.8)


$


$

(487.8)








Operating expenses

(3.seven)





(3.7)


Acquired in-process research and evolution


(1,654.5)




(ane,654.5)


Nugget impairment, restructuring and other special charges



(236.0)



(236.0)








Other income (expense)



(25.8)



(25.8)








Income taxes

89.8


20.iii


31.5


(55.5)


86.2








Cyberspace income

368.9


i,634.1


211.4


55.5


two,270.0








Earnings per share – diluted

0.36


1.57


0.21


0.05


2.nineteen



Numbers may non add together due to rounding.

The table in a higher place reflects only line items with non-GAAP adjustments.




i.

Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from 3rd parties.



ii.

Exclude costs associated with upfront payments for acquired in-procedure research and development projects acquired in a transaction other than a business combination. These costs were related to concern development activity, primarily driven past the acquisitions of ARMO BioSciences ($1.476B) and AurKa Pharma ($81.8M), also as collaborations with Sigilon Therapeutics ($66.9M) and Anima Biotech ($30.0M).



3.

Exclude charges primarily associated with asset impairment and restructuring charges related to expenses associated with the sale of the Posilac® (rbST) make and Augusta, Georgia manufacturing site, the review of strategic alternatives for, including expenses associated with the initial public offering and separation of, the Elanco animal health concern, also as charges related to the suspension of commercial activities for Imrestor.



iv.

Relates to adjustments to the 2017 Toll Taxation for U.Due south. tax reform proposed regulations and revenue enhancement expenses associated with the separation of the Elanco animal wellness business.





(d)

Adjustments to certain GAAP reported measures for the nine months concluded September 30, 2017, include the following:






(Dollars in millions, except per
share data)

Amortization(i)

IPR&D(two)

Other
specified
items(three)

Full
Adjustments

Cost of sales

$

(505.1)


$


$

(32.0)


$

(537.1)







Operating expenses

(4.9)




(4.9)


Acquired in-process research and
     development


(1,062.half dozen)



(i,062.6)


Nugget impairment, restructuring and other
     special charges



(670.4)


(670.4)







Income taxes

157.v


71.8


174.9


404.2







Net income

352.vi


990.8


527.four


1,870.8







Earnings per share – diluted

0.33


0.94


0.50


1.77



Numbers may not add due to rounding.

The table above reflects only line items with non-GAAP adjustments.







i.

Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.



ii.

Exclude costs associated with upfront payments for acquired in-procedure research and development projects acquired in a transaction other than a business combination.  These costs are related to the conquering of CoLucid Pharmaceuticals and to collaborations with Nektar Therapeutics and with KeyBioscience.



three.

Exclude charges related to severance costs incurred as a result of actions taken to reduce the company'southward cost structure, asset impairments related to lower projected acquirement for Posilac (rbST), and integration costs, asset impairments related to the acquisition and integration of Novartis Animal Health, likewise every bit inventory step-up costs associated with the acquisition of Boehringer Ingelheim Vetmedica'southward U.S. feline, canine and rabies vaccine portfolio.

Refer to:
Mark Taylor; mark.taylor@lilly.com; (317) 276-5795 (Media)
Kevin Hern; hern_kevin_r@lilly.com; (317) 277-1838 (Investors)

Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-delivers-solid-third-quarter-2018-results-revises-eps-guidance-300744633.html

SOURCE Eli Lilly and Company

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Source: https://investor.lilly.com/news-releases/news-release-details/lilly-delivers-solid-third-quarter-2018-results-revises-eps

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