`EX-99.1 2 exhibit991q42019.htm EXHIBIT 99.1
`
`Exhibit
`
`Exhibit 99.1
`
`
`Press Release
`
`
`Regeneron Reports Fourth Quarter and Full Year 2019 Financial and
`Operating Results
`• Fourth quarter 2019 revenues increased 13% to $2.17 billion versus fourth quarter 2018
`• Fourth quarter EYLEA® U.S. net sales increased 13% to $1.22 billion versus fourth quarter 2018
`and full year 2019 EYLEA U.S. net sales increased 14% versus 2018
`• Dupixent® global net sales(2), which are recorded by Sanofi, increased 136% to $752 million versus
`fourth quarter 2018 and increased to $2.32 billion for full year 2019
`• Fourth quarter 2019 GAAP diluted EPS was $6.93 and fourth quarter non-GAAP diluted EPS(1) was
`$7.50
`• The Company and Sanofi announced intent to restructure antibody collaboration for Kevzara® and
`Praluent®
`
`Tarrytown, New York (February 6, 2020) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
`today announced financial results for the fourth quarter and full year 2019 and provided a business
`update.
`
`"Regeneron had a very productive 2019 marked by strong commercial growth for our core franchises,
`significant pipeline and regulatory progress, and positive financial results," said Leonard S. Schleifer,
`M.D., Ph.D., President and Chief Executive Officer of Regeneron. "In 2020, we are focused on driving
`continued growth with EYLEA, Dupixent, and Libtayo and anticipate several new regulatory approvals
`and submissions across our portfolio. Our expanding pipeline of innovative and complementary
`immuno-oncology therapies continues to advance, and we feel confident that we are positioned to
`bring new breakthroughs to cancer patients and be a leader in this rapidly evolving field."
`
`"We continue to work constructively with Sanofi to finalize our modified antibody agreement for
`Praluent and Kevzara, which we expect to be accretive in 2020," said Robert E. Landry, Executive
`Vice President, Finance and Chief Financial Officer of Regeneron. "We will provide financial guidance
`for full year 2020 by no later than the end of the first quarter."
`
`Financial Highlights
`
`
`
`($ in millions, except per share data)
`Total revenues
`GAAP net income
`GAAP net income per
`share - diluted
`Non-GAAP net income(1)
`Non-GAAP net income per
`share - diluted(1)
`
`Three Months Ended
`December 31,
`
`2019
`2018
`
`
`2,170 $
`1,928
`792 $
`820
`
`
`
` $
` $
`
` $
` $
`
` $
`
`6.93 $
`858 $
`
`7.50 $
`
`7.15
`786
`
`6.84
`
`https://www.sec.gov/Archives/edgar/data/872589/000153217620000005/exhibit991q42019.htm
`
`
`% Change
`
`13% $
`(3%) $
`
`Year Ended
`December 31,
`
`2019
`2018
`
`
`7,863 $
`6,711
`2,116 $
`2,444
`
`% Change
`17%
`(13%)
`
`(3%) $
`9% $
`
`18.46 $
`2,827 $
`
`21.29
`2,622
`
`10% $
`
`24.67 $
`
`22.84
`
`(13%)
`8%
`
`8%
`
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`1
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`Business Highlights
`
`Exhibit
`
`Key Pipeline Progress
`Regeneron has 22 product candidates in clinical development, including five of the Company's U.S.
`Food and Drug Administration (FDA) approved products for which it is investigating additional
`indications. Updates from the clinical pipeline include:
`EYLEA® (aflibercept) Injection
`•
`In December 2019, the Company launched the EYLEA pre-filled syringe in the United States.
`
`Dupixent® (dupilumab)
`•
`In October 2019, the European Commission (EC) approved Dupixent in chronic rhinosinusitis with
`nasal polyposis (CRSwNP).
`• The FDA accepted for priority review the supplemental Biologics License Application (sBLA) for
`children aged 6 to 11 years with moderate-to-severe atopic dermatitis, with a target action date of
`May 26, 2020. In addition, a Marketing Authorization Application (MAA) for children aged 6 to 11
`years with moderate-to-severe atopic dermatitis was recently submitted in the European Union.
`• A Phase 2/3 study in bullous pemphigoid and Phase 3 studies in prurigo nodularis and chronic
`spontaneous urticaria were initiated.
`
`Libtayo® (cemiplimab)
`• A Phase 2 neoadjuvant study in cutaneous squamous cell carcinoma (CSCC) was initiated.
`
`REGN1979, a bispecific antibody targeting CD20 and CD3
`•
`In December 2019, the Company reported updated results from the initial clinical trial in patients
`with non-Hodgkin lymphoma.
`• The potentially pivotal Phase 2 study has been expanded to include patients with diffuse large B-
`cell lymphoma (DLBCL) and other non-Hodgkin lymphomas.
`
`REGN5458, a bispecific antibody targeting BCMA and CD3
`•
`In December 2019, the Company announced positive preliminary results from an initial clinical trial
`in patients with relapsed or refractory multiple myeloma.
`
`Pozelimab, an antibody to C5
`•
`In December 2019, the Company announced positive top-line results from a Phase 2 trial in
`paroxysmal nocturnal hemoglobinuria (PNH).
`
`Garetosmab, an antibody to Activin A
`•
`In January 2020, the Company announced encouraging results from a Phase 2 trial in
`fibrodysplasia ossificans progressiva (FOP).
`
`REGN-EB3, a multi-antibody therapy to Ebola virus infection
`• The New England Journal of Medicine published results from the randomized, controlled PALM
`trial showing that Regeneron's REGN-EB3 and another agent provided the highest overall survival
`rates among four investigational treatments for Ebola.
`
`2
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`Business Development Update
`• The Company and Sanofi announced their intent to restructure their antibody collaboration for
`Kevzara and Praluent and enter into a royalty-based arrangement. Under the proposed terms of
`the agreement, Sanofi is expected to gain sole global rights to Kevzara and sole rights to Praluent
`outside of the United States. Regeneron is expected to gain sole U.S. rights to Praluent. Under the
`proposed terms, each party will be solely responsible for funding development and
`commercialization expenses in their respective territories. The proposed agreement, which is
`expected to be finalized in the first quarter of 2020, will not impact the companies' existing
`collaboration relating to Dupixent and REGN3500.
`• The Company entered into a research collaboration and option licensing agreement with Vyriad,
`Inc. to discover and develop new oncolytic (cancer-killing) virus-based treatments for various forms
`of cancer.
`
`Select 2020 Milestones
`Programs
`
`Dupixent
`
`
`
`
`Libtayo
`
`
`REGN1979 (CD20 and CD3
`Antibody)
`
`REGN5458 (BCMA and CD3
`Antibody)
`Evinacumab (ANGPTL3 Antibody)
`
`Pozelimab (C5 Antibody)
`
`Garetosmab (Activin A Antibody)
`
`Fasinumab (NGF Antibody)
`
`REGN-EB3 (Multi-antibody therapy
`to Ebola)
`
`Milestones
`
`- FDA decision (target action date of May 26, 2020) on sBLA and
`EC decision for expanded atopic dermatitis indication in pediatric
`patients (6–11 years of age)
`- Report results from Phase 3 study for asthma in pediatric
`patients (6–11 years of age)
`- Report results from Phase 2 portion of Phase 2/3 study in
`eosinophilic esophagitis (EOE)
`Interim analysis of overall survival in Phase 3 non-small cell lung
`cancer (NSCLC) monotherapy study in patients with high PD-L1
`expression
`- Report results from potentially pivotal Phase 2 study in basal cell
`carcinoma (BCC)
`- Report updated results from initial study in certain B-cell
`malignancies
`- Continue to expand potentially pivotal Phase 2 study
`- Report updated results from initial study in multiple myeloma
`
`-
`
`- Submit BLA and MAA for homozygous familial
`hypercholesterolemia (HoFH)
`Initiate Phase 3 program in PNH
`-
`Initiate combination program with Alnylam's cemdisiran
`-
`- Discuss regulatory submission for FOP with regulatory
`authorities
`- Report results from Phase 3 studies in osteoarthritis pain of the
`knee or hip
`- Complete rolling BLA submission for Ebola
`
`3
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`Exhibit
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`Fourth Quarter and Full Year 2019 Financial Results
`
`Total Revenues: Total revenues increased by 13% to $2.170 billion in the fourth quarter of 2019,
`compared to $1.928 billion in the fourth quarter of 2018. Full year 2019 total revenues increased 17%
`to $7.863 billion, compared to $6.711 billion for the full year 2018.
`
`Net product sales were $1.286 billion in the fourth quarter and $4.834 billion for the full year 2019,
`compared to $1.096 billion in the fourth quarter and $4.106 billion for the full year 2018. EYLEA net
`product sales in the United States were $1.222 billion in the fourth quarter and $4.644 billion for the
`full year 2019, compared to $1.079 billion in the fourth quarter and $4.077 billion for the full year 2018.
`Overall distributor inventory levels for EYLEA in the United States remained within the Company's
`one-to-two-week targeted range.
`
`Total revenues also include Sanofi and Bayer collaboration revenues(2) of $748 million in the fourth
`quarter and $2.616 billion for the full year 2019, compared to $729 million in the fourth quarter and
`$2.188 billion for the full year 2018. Sanofi collaboration revenue in the fourth quarter and full year
`2019 included the Company's share of profits from collaboration antibodies (Dupixent, Praluent, and
`Kevzara) of $104 million and $209 million, respectively, while Sanofi collaboration revenue in the
`fourth quarter and full year 2018 included the Company's share of losses from collaboration antibodies
`of $(44) million and $(227) million, respectively. The increase in the Company's share of profits from
`collaboration antibodies was primarily driven by higher Dupixent profits. Sanofi collaboration revenue
`in the fourth quarter of 2018 also included the recognition of a cumulative catch-up adjustment of $149
`million arising from a change in the estimate of the stage of completion of the collaborations' immuno-
`oncology programs primarily in connection with the Amended IO Discovery Agreement.
`
`Refer to Table 4 for a summary of collaboration and other revenue.
`
`Research and Development (R&D) Expenses: GAAP R&D expenses were $683 million in the fourth
`quarter and $3.037 billion for the full year 2019, compared to $601 million in the fourth quarter and
`$2.186 billion for the full year 2018. The higher R&D expenses in the fourth quarter of 2019 were
`principally due to additional costs incurred in connection with our earlier-stage pipeline and dupilumab,
`and higher headcount and headcount-related costs. The higher R&D expenses for the full year 2019
`were principally due to a $400 million up-front payment to Alnylam, additional costs incurred in
`connection with our earlier-stage pipeline, and higher headcount and headcount-related costs. R&D-
`related non-cash share-based compensation expense was $72 million in the fourth quarter and $250
`million for the full year 2019, compared to $68 million in the fourth quarter and $229 million for the full
`year 2018.
`
`Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were $587 million
`in the fourth quarter and $1.835 billion for the full year 2019, compared to $491 million in the fourth
`quarter and $1.556 billion for the full year 2018. The higher SG&A expenses in the fourth quarter and
`full year 2019 were primarily due to higher headcount and headcount-related costs, an increase in
`commercialization-related expenses for Dupixent and EYLEA, additional accruals for loss
`contingencies associated with ongoing litigation, and higher contributions to independent not-for-profit
`patient assistance organizations. In addition, in the fourth quarter of 2019, the Company recorded a
`charge for restructuring-related costs, primarily related to employee separation costs, as the Company
`has eliminated certain commercialization activities and related headcount in connection with the
`proposed restructuring of the antibody agreement
`
`4
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`with Sanofi (as described above). SG&A-related non-cash share-based compensation expense was
`$45 million in the fourth quarter and $168 million for the full year 2019, compared to $51 million in the
`fourth quarter and $169 million for the full year 2018.
`
`Cost of Goods Sold (COGS): GAAP COGS was $109 million in the fourth quarter and $362 million
`for the full year 2019, compared to $44 million in the fourth quarter and $180 million for the full year
`2018. The increase in COGS was primarily due to our obligation to pay Sanofi its share of Libtayo
`U.S. gross profits, third-party royalties on Libtayo U.S. sales, and higher inventory write-downs and
`reserves.
`
`Cost of Collaboration and Contract Manufacturing (COCM): GAAP COCM was $115 million in the
`fourth quarter and $420 million for the full year 2019, compared to $73 million in the fourth quarter and
`$254 million for the full year 2018. The increase in COCM for the full year 2019 was primarily due to
`the recognition of manufacturing costs associated with higher sales of Dupixent.
`
`Other Income (Expense): GAAP other income (expense), net, includes the recognition of net gains
`on equity securities of $189 million in the fourth quarter and $118 million for the full year 2019,
`compared to net losses of $(63) million in the fourth quarter and $(42) million for the full year 2018.
`
`Income Taxes: GAAP income tax expense was $98 million and the effective tax rate was 11.0% in the
`fourth quarter of 2019, compared to a GAAP income tax benefit of $(144) million and (21.3%) in the
`fourth quarter of 2018. GAAP income tax expense was $313 million and the effective tax rate
`was 12.9% for the full year 2019, compared to $109 million and 4.3% for the full year 2018. The
`effective tax rate for the fourth quarter and full year 2019 was positively impacted, compared to the
`U.S. federal statutory rate, primarily by stock-based compensation, income earned in foreign
`jurisdictions with tax rates lower than the U.S. federal statutory rate, and federal tax credits for
`research activities. The Company's effective tax rate for the fourth quarter and full year 2018 was
`positively impacted, compared to the U.S. federal statutory rate, primarily by the Company's fourth
`quarter sale of non-inventory related assets between foreign subsidiaries, which had a net impact on
`the rate by 24.0% and 6.3% for the fourth quarter and full year 2018, respectively. During the fourth
`quarter and full year 2018, the Company also recorded an income tax benefit of $56 million and $68
`million, respectively, as an adjustment to the provisional amount recorded as of December 31, 2017
`for the U.S. Tax Reform Act.
`
`GAAP and Non-GAAP Net Income(1): GAAP net income was $792 million, or $6.93 per diluted share,
`in the fourth quarter of 2019, compared to GAAP net income of $820 million, or $7.15 per diluted
`share, in the fourth quarter of 2018. GAAP net income was $2.116 billion, or $18.46 per diluted share,
`for the full year 2019, compared to GAAP net income of $2.444 billion, or $21.29 per diluted share, for
`the full year 2018.
`
`Non-GAAP net income was $858 million, or $7.50 per diluted share, in the fourth quarter of 2019,
`compared to non-GAAP net income of $786 million, or $6.84 per diluted share, in the fourth quarter of
`2018. Non-GAAP net income was $2.827 billion, or $24.67 per diluted share, for the full year 2019,
`compared to non-GAAP net income of $2.622 billion, or $22.84 per diluted share, for the full year
`2018.
`
`A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press
`release.
`
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`2020 Financial Guidance
`
`Given the announcement regarding the intent to restructure the antibody collaboration for Kevzara and
`Praluent with Sanofi, Regeneron will provide financial guidance for full year 2020 by the end of the first
`quarter of 2020.
`
`(1) This press release uses non-GAAP net income and non-GAAP net income per share, which are financial
`measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles
`(GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and other items
`from the related GAAP financial measure. Non-GAAP adjustments also include the estimated income tax
`effect of reconciling items.
`
`The Company makes such adjustments for items the Company does not view as useful in evaluating its
`operating performance. For example, adjustments may be made for items that fluctuate from period to
`period based on factors that are not within the Company's control (such as the Company's stock price on
`the dates share-based grants are issued or changes in the fair value of the Company's equity investments)
`or items that are not associated with normal, recurring operations (such as restructuring-related expenses,
`including employee separation costs). Management uses these non-GAAP measures for planning,
`budgeting, forecasting, assessing historical performance, and making financial and operational decisions,
`and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide
`investors with an enhanced understanding of the financial performance of the Company's core business
`operations. However, there are limitations in the use of these and other non-GAAP financial measures as
`they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP
`financial measures may not be comparable with non-GAAP information provided by other companies. Any
`non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a
`substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the
`Company's historical GAAP to non-GAAP results is included in Table 3 of this press release.
`(2) The Company's collaborators provide it with estimates of the collaborators' respective sales and the
`Company's share of the profits or losses from commercialization of products for the most recent fiscal
`quarter. The Company's estimates for such quarter are reconciled to actual results in the subsequent fiscal
`quarter, and the Company's share of the profit or loss is adjusted on a prospective basis accordingly, if
`necessary.
`
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`
`Conference Call Information
`
`Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full
`year 2019 financial and operating results on Thursday, February 6, 2020, at 8:00 AM. To access this
`call, dial (800) 708-4540 (U.S.) or (847) 619-6397 (International). A link to the webcast may be
`accessed from the "Investors and Media" page of Regeneron's website at www.regeneron.com. A
`replay of the conference call and webcast will be archived on the Company's website and will be
`available for at least 30 days.
`
`About Regeneron Pharmaceuticals, Inc.
`
`Regeneron is a leading biotechnology company that invents life-transforming medicines for people
`with serious diseases. Founded and led for over 30 years by physician-scientists, Regeneron's
`unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-
`approved treatments and numerous product candidates in development, all of which were homegrown
`in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with
`eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases,
`pain, infectious diseases, and rare diseases.
`
`Regeneron is accelerating and improving the traditional drug development process through its
`proprietary VelociSuite® technologies, such as VelocImmune® which uses unique genetically-
`humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through
`ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of
`the largest genetics sequencing efforts in the world.
`
`For additional information about the Company, please visit www.regeneron.com or follow
`@Regeneron on Twitter.
`
`Forward-Looking Statements and Use of Digital Media
`
`This press release includes forward-looking statements that involve risks and uncertainties relating to
`future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the
`"Company"), and actual events or results may differ materially from these forward-looking statements.
`Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such
`words, and similar expressions are intended to identify such forward-looking statements, although not
`all forward-looking statements contain these identifying words. These statements concern, and these
`risks and uncertainties include, among others, the nature, timing, and possible success and
`therapeutic applications of products marketed by Regeneron and/or its collaborators (collectively,
`"Regeneron's Products") and Regeneron's product candidates and research and clinical programs
`now underway or planned; the likelihood and timing of achieving any of the anticipated milestones
`described in this press release; unforeseen safety issues resulting from the administration of
`Regeneron's Products and product candidates in patients, including serious complications or side
`effects in connection with the use of Regeneron’s Products and product candidates in clinical trials;
`the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-
`stage product candidates and new indications for Regeneron's Products, including without limitation
`EYLEA® (aflibercept) Injection, Dupixent® (dupilumab) Injection, Libtayo® (cemiplimab) Injection,
`Praluent® (alirocumab) Injection, Kevzara® (sarilumab) Injection, fasinumab, evinacumab, REGN-EB3,
`garetosmab, pozelimab, and REGN1979; the extent to which the results from the
`
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`research and development programs conducted by Regeneron or its collaborators may be replicated
`in other studies and lead to therapeutic applications; ongoing regulatory obligations and oversight
`impacting Regeneron's Products (such as EYLEA, Dupixent, Libtayo, Praluent, and Kevzara),
`research and clinical programs, and business, including those relating to patient privacy;
`determinations by regulatory and administrative governmental authorities which may delay or restrict
`Regeneron's ability to continue to develop or commercialize Regeneron's Products and product
`candidates; competing drugs and product candidates that may be superior to Regeneron's Products
`and product candidates; uncertainty of market acceptance and commercial success of Regeneron's
`Products and product candidates and the impact of studies (whether conducted by Regeneron or
`others and whether mandated or voluntary), on the commercial success of Regeneron's Products and
`product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple
`products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third
`parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and
`other steps related to Regeneron’s Products and product candidates; coverage and reimbursement
`determinations by third-party payors, including Medicare and Medicaid; unanticipated expenses; the
`costs of developing, producing, and selling products; the ability of Regeneron to meet any of its
`financial projections or guidance and changes to the assumptions underlying those projections or
`guidance; the potential for any license or collaboration agreement, including Regeneron's agreements
`with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies,
`as applicable), to be cancelled or terminated without any further product success; and risks associated
`with intellectual property of other parties and pending or future litigation relating thereto (including
`without limitation the patent litigation and other related proceedings relating to Dupixent and Praluent),
`other litigation and other proceedings and government investigations relating to the Company and/or
`its operations, the ultimate outcome of any such proceedings and investigations, and the impact any
`of the foregoing may have on Regeneron’s business, prospects, operating results, and financial
`condition. A more complete description of these and other material risks can be found in Regeneron's
`filings with the U.S. Securities and Exchange Commission. Any forward-looking statements are made
`based on management's current beliefs and judgment, and the reader is cautioned not to rely on any
`forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to
`update publicly any forward-looking statement, including without limitation any financial projection or
`guidance, whether as a result of new information, future events, or otherwise.
`
`Regeneron uses its media and investor relations website and social media outlets to publish important
`information about the Company, including information that may be deemed material to investors.
`Financial and other information about Regeneron is routinely posted and is accessible on
`Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter
`feed (http://twitter.com/regeneron).
`
`Non-GAAP Financial Measures
`
`This press release and/or the financial results attached to this press release include amounts that are
`considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided
`reconciliations of such non-GAAP financial measures.
`
`###
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`Contact Information:
`
`Justin Holko
`Investor Relations
`914-847-7786
`justin.holko@regeneron.com
`
`
`
`
`
`
`
`
`
`
`Hala Mirza
`Corporate Communications
`914-847-3422
`hala.mirza@regeneron.com
`
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`TABLE 1
`
`Exhibit
`
`REGENERON PHARMACEUTICALS, INC.
`CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
`(In millions)
`
`Assets:
`Cash and marketable securities
`Accounts receivable - trade, net
`Accounts receivable from Sanofi and Bayer
`Inventories
`Property, plant, and equipment, net
`Deferred tax assets
`Other assets
`Total assets
`
`Liabilities and stockholders' equity:
`Accounts payable, accrued expenses, and other liabilities
`Deferred revenue
`Finance lease liabilities
`Stockholders' equity
`Total liabilities and stockholders' equity
`
`10
`
`December 31,
`2018
`
`2019
`
`$
`
`$
`
`$
`
`$
`
`6,471.1 $
`2,100.0
`572.2
`1,415.5
`2,890.4
`824.2
`531.8
`14,805.2 $
`
`1,790.9 $
`1,210.7
`713.9
`11,089.7
`14,805.2 $
`
`4,564.9
`1,723.7
`519.5
`1,151.2
`2,575.8
`828.7
`370.7
`11,734.5
`
`1,352.0
`916.7
`708.5
`8,757.3
`11,734.5
`
`https://www.sec.gov/Archives/edgar/data/872589/000153217620000005/exhibit991q42019.htm
`
`11/15
`
`Regeneron Exhibit 2040
`Page 11 of 15
`
`
`
`8/2/2021
`
`TABLE 2
`
`Exhibit
`
`REGENERON PHARMACEUTICALS, INC.
`CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
`(In millions, except per share data)
`
`Three Months Ended
`December 31,
`2019
`2018
`
`Year Ended
`December 31,
`2019
`2018
`
`$
`
`$
`
`$
`$
`
`$
`
`$
`
`$
`$
`
`1,286.4
`427.1
`320.8
`135.2
`2,169.5
`
`683.1
`586.8
`108.5
`115.4
`1,493.8
`
`675.7
`
`214.1
`
`889.8
`
`(97.8)
`
`792.0
`
`7.25
`6.93
`
`109.2
`114.3
`
`$
`
`1,096.4
`427.6
`301.5
`102.3
`1,927.8
`
`601.2
`491.3
`44.0
`73.2
`1,209.7
`
`$
`
`4,834.4
`1,426.8
`1,188.8
`413.4
`7,863.4
`
`3,036.6
`1,834.8
`362.3
`419.9
`5,653.6
`
`4,106.2
`1,111.1
`1,076.7
`416.8
`6,710.8
`
`2,186.1
`1,556.2
`180.0
`254.1
`4,176.4
`
`718.1
`
`2,209.8
`
`2,534.4
`
`(41.9)
`
`219.3
`
`19.1
`
`676.2
`
`2,429.1
`
`2,553.5
`
`144.2
`
`820.4
`
`7.58
`7.15
`
`108.2
`114.8
`
`(313.3)
`
`(109.1)
`
`$
`
`$
`$
`
`$
`
`$
`$
`
`2,115.8
`
`19.38
`18.46
`
`109.2
`114.6
`
`2,444.4
`
`22.65
`21.29
`
`107.9
`114.8
`
`Revenues:
`Net product sales
`Sanofi collaboration revenue
`Bayer collaboration revenue
`Other revenue
`
`Expenses:
`Research and development
`Selling, general, and administrative
`Cost of goods sold
`Cost of collaboration and contract manufacturing
`
`Income from operations
`
`Other income (expense), net
`
`Income before income taxes
`
`Income tax (expense) benefit
`
`Net income
`
`Net income per share - basic
`Net income per share - diluted
`
`Weighted average shares outstanding - basic
`Weighted average shares outstanding - diluted
`
`11
`
`https://www.sec.gov/Archives/edgar/data/872589/000153217620000005/exhibit991q42019.htm
`
`12/15
`
`Regeneron Exhibit 2040
`Page 12 of 15
`
`
`
`8/2/2021
`
`TABLE 3
`
`Exhibit
`
`REGENERON PHARMACEUTICALS, INC.
`RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited)
`(In millions, except per share data)
`
`GAAP net income
`Adjustments:
`R&D: Non-cash share-based compensation expense
`R&D: Up-front payments related to license and
`collaboration agreements
`SG&A: Non-cash share-based compensation expense
`SG&A: Restructuring-related expenses
`SG&A: Litigation contingencies
`COGS and COCM: Non-cash share-based
`compensation expense
`Other income/expense: (Gains) losses on investments
`in equity securities
`Income tax effect of reconciling items above
`Income tax expense: Impact of sale of assets between
`foreign subsidiaries
`Income tax expense: Adjustment to previously
`recorded charge related to enactment of U.S. Tax
`Reform Act
`Non-GAAP net income
`
`Non-GAAP net income per share - basic
`Non-GAAP net income per share - diluted
`
`Shares used in calculating:
`Non-GAAP net income per share - basic
`Non-GAAP net income per share - diluted
`
`Three Months Ended
`December 31,
`2019
`2018
`792.0
`820.4
`
`$
`
`$
`
`$
`
`Year Ended
`December 31,
`2019
`2018
`2,115.8
`2,444.4
`
`$
`
`72.4
`
`30.0
`45.4
`35.2
`60.0
`
`15.7
`
`(189.0)
`(4.1)
`
`68.2
`
`—
`50.8
`—
`30.0
`
`7.8
`
`62.9
`(36.2)
`
`250.4
`
`430.0
`167.7
`35.2
`70.0
`
`46.2
`
`(118.3)
`(169.9)
`
`229.0
`
`—
`169.2
`—
`30.0
`
`29.2
`
`41.9
`(92.1)
`
`—
`
`(162.1)
`
`—
`
`(162.1)
`
`$
`
`$
`$
`
`—
`857.6
`
`7.85
`7.50
`
`109.2
`114.3
`
`$
`
`$
`$
`
`(56.1)
`785.7
`
`7.26
`6.84
`
`108.2
`114.9
`
`$
`
`$
`$
`
`—
`2,827.1
`
`25.89
`24.67
`
`109.2
`114.6
`
`(68.0)
`2,621.5
`
`24.30
`22.84
`
`107.9
`114.8
`
`$
`
`$
`$
`
`12
`
`https://www.sec.gov/Archives/edgar/data/872589/000153217620000005/exhibit991q42019.htm
`
`13/15
`
`Regeneron Exhibit 2040
`Page 13 of 15
`
`
`
`8/2/2021
`
`TABLE 4
`
`Exhibit
`
`REGENERON PHARMACEUTICALS, INC.
`COLLABORATION AND OTHER REVENUE (Unaudited)
`(In millions)
`
`Sanofi collaboration revenue:
`Antibody:
`Reimbursement of research and development expenses
`Reimbursement of commercialization-related expenses
`Reimbursement for manufacturing of commercial supplies
`Regeneron's share of profits (losses) in connection with
`commercialization of antibodies
`Other
`Immuno-oncology:
`Reimbursement of research and development expenses
`Reimbursement of commercialization-related expenses
`Amounts recognized in connection with up-front payments
`received
`Other
`Total Sanofi collaboration revenue
`
`Bayer collaboration revenue:
`Regeneron's net profit in connection with commercialization of
`EYLEA outside the United States
`Reimbursement of development expenses
`Other
`Total Bayer collaboration revenue
`
`Other revenue:
`Reimbursement of research and development expenses - Teva
`Reimbursement of research and development expenses - other
`Other
`Total other revenue
`
`13
`
`Three Months Ended
`December 31,
`2019
`2018
`
`Year Ended
`December 31,
`2019
`2018
`
`$
`
`$
`
`61.2
`130.6
`73.4
`
`104.1
`(0.9)
`
`42.1
`3.3
`
`18.9
`(5.6)
`427.1
`
`298.1
`7.4
`15.3
`320.8
`
`$
`
`64.3
`124.4
`33.2
`
`(44.4)
`(11.8)
`
`86.1
`2.4
`
`178.6
`(5.2)
`427.6
`
`270.8
`2.4
`28.3
`301.5
`
`$
`
`277.7
`479.9
`206.7
`
`209.3
`(1.5)
`
`163.0
`10.3
`
`92.7
`(11.3)
`1,426.8
`
`1,091.4
`23.0
`74.4
`1,188.8
`
`265.3
`417.2
`127.6
`
`(227.0)
`(24.1)
`
`311.8
`8.9
`
`243.8
`(12.4)
`1,111.1
`
`992.3
`10.8
`73.6
`1,076.7
`
`20.0
`57.3
`57.9
`135.2
`
`$
`
`28.4
`4.7
`69.2
`102.3
`
`$
`
`122.9
`94.3
`196.2
`413.4
`
`$
`
`129.5
`17.6
`269.7
`416.8
`
`$
`
`https://www.sec.gov/Archives/edgar/data/872589/000153217620000005/exhibit991q42019.htm
`
`14/15
`
`Regeneron Exhibit 2040
`Page 14 of 15
`
`
`
`8/2/2021
`
`TABLE 5
`
`Exhibit
`
`REGENERON PHARMACEUTICALS, INC.
`NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
`(In millions)
`
`Three Months Ended
`December 31,
`
`EYLEA*
`Libtayo*
`ARCALYST
`Net product sales recorded by
`Regeneron
`
`U.S.
`$ 1,222.1 $
`60