Lilly Announces 2021 Financial Guidance, Updates 2020 Guidance

– Lilly expects to ship robust monetary and operational efficiency in 2021, highlighted by volume-based income development, working margin enlargement, pipeline developments and strong money movement.

– 2021 income is predicted to be between $26.5 billion and $28.0 billion, pushed by quantity development from key development merchandise, together with Trulicity, Taltz, Verzenio, Jardiance, Olumiant, Cyramza, Emgality, Tyvyt, and Retevmo, in addition to an estimated $1 billion to $2 billion of income from COVID-19 therapies.

– Working margin is predicted to be roughly 30 p.c on a reported foundation and roughly 32 p.c on a non-GAAP foundation in 2021.

– Earnings per share (EPS) for 2021 are anticipated to be within the vary of $7.25 to $7.90 on a reported foundation and $7.75 to $8.40 on a non-GAAP foundation.

– Continued pipeline progress in 2021 will embrace a variety of Section 3 knowledge readouts for vital investigational medicines and new indications, the initiation of a number of new Section 3 medical trials, and the potential for a number of regulatory submissions and approvals.

– For 2020, the corporate now expects income to be between $24.2 billion and $24.7 billion, and earnings per share to be within the vary of $6.28 to $6.48 on a reported foundation and $7.45 to $7.65 on a non-GAAP foundation.

INDIANAPOLIS, Dec. 15, 2020 /PRNewswire/ — Eli Lilly and Firm (NYSE: LLY) at present introduced its 2021 monetary steering, highlighted by volume-based income development, elevated funding in analysis and improvement, working margin enlargement and robust earnings efficiency. The corporate additionally revised sure parts of its 2020 monetary steering and reviewed potential key occasions for the upcoming 12 months, together with vital knowledge readouts for a number of investigational medicines in its medical pipeline and the potential for a number of regulatory submissions and approvals.

The corporate’s 2020 and 2021 monetary steering are being offered on each a reported and a non-GAAP foundation. Reported steering is introduced in accordance with U.S. typically accepted accounting rules (GAAP). Non-GAAP measures mirror changes for the gadgets described within the related reconciliation tables. The non-GAAP measures are introduced to offer extra insights into the underlying tendencies within the firm’s enterprise.

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Josh Smiley, Lilly’s chief monetary officer, outlined the corporate’s near-term development prospects and offered 2021 monetary steering. “We’re happy with our efficiency regardless of the unprecedented challenges dealing with the world in 2020. We anticipate 2021 to be one other thrilling 12 months for Lilly, characterised by strong volume-driven income development for our key medicines, whereas we proceed to spend money on and progress our pipeline, broaden working margins and ship spectacular EPS and money movement development. Reflecting this development, we’ve got introduced a 15 p.c enhance in our dividend for 2021. One 12 months after we outlined our high-level outlook by way of 2025, we’re more and more assured in our means to ship top-tier income development and working margin p.c enlargement into the mid-to-high 30s throughout this timeframe.”

Commenting on the corporate’s money movement expectations, Smiley added, “We anticipate to ship robust money movement in 2021, which we are going to proceed to deploy thoughtfully throughout our capital allocation priorities. We stay centered on funding our present marketed merchandise, new launches, lifecycle alternatives and replenishing our pipeline. We are going to proceed to leverage bolt-on acquisitions and licensing alternatives to reinforce our future development prospects with exterior innovation. Lastly, we plan to return money to shareholders by way of an elevated dividend and our ongoing share repurchase program, whereas sustaining robust funding grade rankings.”

“Lilly is within the midst of an thrilling interval of extended development for the corporate, pushed by an increasing portfolio of recent medicines centered on diabetes, oncology, immunology, and neuroscience,” stated David A. Ricks, Lilly’s chairman and chief government officer. “We enter 2021 emboldened by the teachings we’ve got realized in the course of the COVID-19 pandemic, the agility and persistence we’ve got displayed, and the data that we’re supported by one of many quickest rising portfolios within the business. With extra thrilling knowledge readouts and innovation prospects on the best way, we’ve got a exceptional alternative to make life higher for a lot of extra sufferers who can profit from Lilly medicines.”

2020 Monetary Steerage

The corporate has up to date sure parts of its 2020 monetary steering. On a reported foundation, earnings per share for 2020 at the moment are anticipated to be within the vary of $6.28 to $6.48. On a non-GAAP foundation, earnings per share for 2020 at the moment are anticipated to be within the vary of $7.45 to $7.65.

The next reconciliation desk offers additional particulars on non-GAAP measures:

Income for 2020 is now anticipated to be within the vary of $24.2 billion to $24.7 billion, reflecting expectations of elevated bamlanivimab gross sales because of an extra buy settlement with the U.S. authorities.

Gross margin as a p.c of income continues to be anticipated to be roughly 78 p.c on a reported foundation and is now anticipated to be roughly 79 p.c on a non-GAAP foundation, reflecting expectations of elevated bamlanivimab gross sales.

Advertising, promoting and administrative bills are nonetheless anticipated to be within the vary of $6.0 billion to $6.1 billion. Analysis and improvement bills are nonetheless anticipated to be within the vary of $5.8 billion to $5.9 billion.

Working margin, outlined as working earnings as a p.c of income, continues to be anticipated to be roughly 25 p.c on a reported foundation, and is now anticipated to be roughly 30 p.c on a non-GAAP foundation.

Different earnings (expense) is now anticipated to be earnings within the vary of $600 million to $700 million, reflecting extra projected good points on investments in fairness securities. The market valuations for these securities may fluctuate considerably all through the rest of the 12 months, with present valuations inserting different earnings (expense) above the revised 2020 steering vary.

The 2020 efficient tax charge continues to be anticipated to be roughly 14 p.c on each a reported foundation and a non-GAAP foundation.

The next desk summarizes the corporate’s 2020 monetary steering:

Change in Non-GAAP Measures Starting in 2021

Starting in 2021, the corporate will exclude the good points and losses on investments in fairness securities from its non-GAAP measures for different earnings (expense) and earnings per share. Reflecting this modification within the firm’s up to date 2020 monetary steering as detailed above would outcome within the exclusion of roughly $900 million of anticipated different earnings, thereby reducing the corporate’s 2020 expectations for different earnings (expense) on a non-GAAP foundation to be expense within the vary of $200 million to $300 million, and reducing the corporate’s earnings per share expectations on a non-GAAP foundation for 2020 by roughly $0.75 per share to be within the vary of $6.70 to $6.90.

2021 Monetary Steerage

The corporate at present issued its 2021 monetary steering. Earnings per share for 2021 are anticipated to be within the vary of $7.25 to $7.90 on a reported foundation and $7.75 to $8.40 on a non-GAAP foundation. As famous, 2021 monetary outcomes will exclude good points and losses on investments in fairness securities from non-GAAP measures.

The next reconciliation desk offers additional particulars on 2021 non-GAAP measures:

The corporate anticipates 2021 income between $26.5 billion and $28.0 billion, together with an estimated $1 billion to $2 billion of income from COVID-19 therapies. Income development is predicted to be pushed by quantity from key development merchandise together with Trulicity^®, Taltz^®, Verzenio^®, Jardiance^®, Olumiant^®, Cyramza^®, Emgality^®, Tyvyt^®, and Retevmo™, in addition to by COVID-19 therapies. Income development is predicted to be partially offset by decrease income for merchandise which have not too long ago misplaced patent exclusivity. The corporate expects mid-single digit internet worth declines globally in 2021. Within the U.S., the corporate expects low-to-mid-single digit internet worth declines, pushed primarily by elevated rebates to take care of broad business entry and phase combine, partially offset by the profit from the implementation of a restricted distribution program within the firm’s 340B program. Outdoors the U.S., the corporate expects internet worth declines in China, Japan and Europe.

Gross margin as a p.c of income for 2021 is predicted to be roughly 77 p.c on a reported foundation, and roughly 79 p.c on a non-GAAP foundation.

Advertising, promoting and administrative bills for 2021 are anticipated to be within the vary of $6.2 billion to $6.4 billion. Analysis and improvement bills for 2021 are anticipated to be within the vary of $6.5 billion to $6.7 billion, together with roughly $300 million to $400 million of continued funding in COVID-19 therapies.

Working margin for 2021 is predicted to be roughly 30 p.c on a reported foundation and roughly 32 p.c on a non-GAAP foundation.

Different earnings (expense) for 2021 is predicted to be expense within the vary of $200 million to $300 million on each a reported foundation and on a non-GAAP foundation.

The 2021 efficient tax charge is predicted to be roughly 15 p.c on each a reported foundation and on a non-GAAP foundation.

The next desk summarizes the corporate’s 2021 monetary steering.

Webcast of Convention Name

As beforehand introduced, traders and most people can entry a reside webcast of the 2021 monetary steering convention name by way of a hyperlink on Lilly’s web site at www.lilly.com. The convention name will start at 8:30 a.m. Japanese time (ET) at present and can be accessible for replay through the web site.

About Eli Lilly and Firm

Lilly is a world healthcare chief that unites caring with discovery to create medicines that make life higher for folks world wide. We had been based greater than a century in the past by a person dedicated to creating high-quality medicines that meet actual wants, and at present we stay true to that mission in all our work. Throughout the globe, Lilly workers work to find and produce life-changing medicines to those that want them, enhance the understanding and administration of illness, and provides again to communities by way of philanthropy and volunteerism. F-LLY

This press launch comprises administration’s present intentions and expectations for the longer term, all of that are forward- trying statements throughout the that means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Change Act of 1934. The phrases “estimate”, “challenge”, “intend”, “anticipate”, “consider”, “goal”, “anticipate” and comparable expressions are meant to determine forward-looking statements. Precise outcomes might differ materially because of varied components. There are important dangers and uncertainties in pharmaceutical analysis and improvement, in addition to in enterprise improvement actions and capital allocation methods associated to the corporate’s enterprise. There could be no ensures that pipeline merchandise will obtain the required medical and manufacturing regulatory approvals, that they are going to show to be commercially profitable, that the corporate will determine or full any acquisitions or licensing alternatives, or that the corporate’s deployment of capital will favorably influence its monetary place. The corporate’s outcomes might also be affected by such components because the timing of anticipated regulatory approvals and launches of recent merchandise; market uptake of not too long ago launched merchandise; aggressive developments affecting present merchandise and the corporate’s pipeline; the expiration of mental property safety for sure of the corporate’s merchandise; the corporate’s means to guard and implement patents and different mental property; the influence of actions of governmental and personal payers affecting the pricing of, reimbursement for, and entry to prescription drugs; regulatory compliance issues or authorities investigations; regulatory actions relating to presently marketed merchandise; security or efficacy issues related to the corporate’s merchandise; points with product provide stemming from manufacturing difficulties or disruptions; regulatory modifications or different developments; modifications in patent regulation or rules associated to data-package exclusivity; litigation involving previous, present or future merchandise; unauthorized disclosure, misappropriation, or compromise of commerce secrets and techniques or different confidential knowledge saved within the firm’s data methods, networks and amenities, or these of third events with which the corporate shares its knowledge; modifications in tax regulation and rules, together with the influence of U.S. tax reform laws enacted in December 2017 and associated steering; modifications in inflation, rates of interest, and international foreign money alternate charges; asset impairments and restructuring fees; modifications in accounting requirements promulgated by the Monetary Accounting Requirements Board and the Securities and Change Fee (SEC); acquisitions and enterprise improvement transactions and associated integration prices; the corporate’s means to effectuate its potential dividend program and share repurchase exercise; data know-how system inadequacies or working failures; the influence of the evolving COVID-19 pandemic, and the worldwide response thereto; reliance on third-party relationships and outsourcing preparations; and world macroeconomic circumstances. As well as, the corporate might not have the ability to reliably predict the influence of specified gadgets in its 2021 steering past the subsequent 12 months, and the variability of things mentioned in these ahead trying statements may have a big and unpredictable influence on the corporate’s future GAAP outcomes. For added details about the components that might trigger precise outcomes to vary materially from forward-looking statements, please see the corporate’s newest Kind 10-Okay and subsequent Kinds 10-Q and 8-Okay filed with the SEC. You shouldn’t place undue reliance on forward-looking statements, which converse solely as of the date of this launch. Besides as is required by regulation, the corporate expressly disclaims any obligation to publicly launch any revisions to forward-looking statements to mirror occasions after the date of this launch.

Cyramza^® (ramucirumab, Lilly)
Emgality^® (galcanezumab-gnlm, Lilly)
Jardiance^® (empagliflozin, Boehringer Ingelheim)
Olumiant^® (baricitinib, Lilly)
Retevmo™ (selpercatinib, Lilly)
Taltz^® (ixekizumab, Lilly)
Trulicity^® (dulaglutide, Lilly)
Tyvyt^® (sintilimab injection, Lilly)
Verzenio^® (abemaciclib, Lilly)

Confer with: Mark Taylor; mark.taylor@lilly.com; (317) 276-5795 (Media)
Kevin Hern; hern_kevin_r@lilly.com; (317) 277-1838 (Buyers)

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SOURCE Eli Lilly and Firm