Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2021 vs FY2020

For purposes of this section (as well as this report in general), references to our products encompass products marketed or otherwise commercialized by us and/or our collaborators [added: or licensees] and references to our product candidates encompass product candidates in development by us and/or our collaborators [added: or licensees] (in the case of collaborated [added: or licensed] products or product candidates under the terms of the applicable collaboration [added: or license] agreements), unless otherwise stated or required by the context.

Please carefully consider all of the information in this Form 10-K, including the full set of risks set forth in this "Risk Factors" section, and in our other filings with the [removed: U.S. Securities and Exchange Commission] [added: SEC] before making an investment decision regarding Regeneron.

- We face risks related to the development, manufacturing, and [removed: potential] commercialization of [removed: REGEN-COV.][added: REGEN-COV and "next generation" monoclonal antibodies targeting SARS-CoV-2.]

- Sales of our products are dependent on the availability and extent of reimbursement from third-party payors, including private payors and government programs such as Medicare and Medicaid, which could change due to various factors such as [removed: the recently announced "most-favored-nation"] drug price control [removed: measures.][added: measures that have been or may be introduced in the United States by various federal and state authorities.]

- We face risks from the improper conduct of our employees, agents, contractors, or collaborators, including those relating to potential non-compliance with relevant laws and regulations such as the Foreign Corrupt Practices [added: Act and the U.K. Bribery] Act.

It has since spread around the [removed: world, including the United States; and, in March 2020, the World Health Organization declared the COVID-19 outbreak] [added: world and caused] a [added: global] pandemic.

This pandemic has adversely affected or has the potential to adversely affect, among other things, the economic and financial markets and labor resources of the countries in which we operate; our manufacturing and supply chain operations, research and development efforts, commercial operations and sales force, [added: administrative personnel, third-party service providers, and business partners and customers; and the demand for our marketed products.]

The COVID-19 pandemic has resulted in [removed: travel and other] [added: the imposition of various] restrictions [added: and mandates around the world] to reduce the spread of the disease, including governmental orders [removed: across the globe, which, among other things,] [added: that] direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, maintain social distancing, [removed: and] order cessation of non-essential [removed: travel.][added: travel, and require proof of vaccination and/or negative COVID-19 test results.]

In addition, our sales and marketing efforts [removed: have been] [added: were previously] negatively impacted and may be further negatively impacted by postponement or cancellation of face-to-face meetings and restrictions on access by non-essential personnel to hospitals or clinics to the extent such measures slow down adoption or further commercialization of our marketed products.

[removed: Demand for some or all of our marketed products may continue to be reduced while the shelter-in-place or social distancing] [added: similar] orders [removed: are] [added: remain] in effect [added: or are re-implemented] and, as a result, some of our inventory may become obsolete and may need to be written off, impacting our operating results.

[removed: Quarantines, shelter-in-place, social distancing, and similar government orders] [added: Various government-imposed or private-sector measures relating to the COVID-19 pandemic] (or the perception that such [removed: orders, shutdowns, or other] restrictions [added: or limitations] on the conduct of business operations could occur) [removed: related to COVID-19 or other infectious diseases are impacting] [added: previously impacted, and may impact in the future,] personnel at our research and manufacturing facilities, our suppliers, and other third parties on which we rely, [removed: and are also impacting] [added: as well as] the availability or cost of materials produced by or purchased from such parties, resulting in supply chain strains or disruptions that may become material.

While some materials and services may be obtained from more than one supplier or provider, port closures and other [removed: restrictions] [added: restrictions, whether] resulting from the COVID-19 pandemic [added: or otherwise] (including any government restrictions or limitations, such as those that may be imposed under the Defense Production [removed: Act)] [added: Act),] could materially disrupt our supply chain or limit our ability to obtain sufficient materials or services (including fill/finish services) required for the development and manufacturing of our products and product candidates as well as our research efforts.

In addition, [removed: infections] [added: infections, hospitalizations,] and deaths related to COVID-19 [removed: have] [added: previously] disrupted and may [removed: continue to] [added: in the future] disrupt the United States' healthcare and healthcare regulatory systems.

In addition, some of our clinical trials [removed: have been] [added: were previously] and may [removed: continue to] [added: in the future] be affected by the COVID-19 pandemic.

This impact [removed: includes] [added: could result in further] delays in site initiation and patient enrollment due to prioritization of hospital resources toward the COVID-19 pandemic, patients' inability to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, and restrictions on trial initiations imposed by hospitals and other trial sites as a result of the COVID-19 pandemic.

Similarly, our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, [removed: has been] [added: was previously] and may [removed: continue to] [added: in the future] be delayed or disrupted.

We [removed: will] continue to evaluate the adverse impact of the COVID-19 pandemic on an individual trial basis.

[removed: The] [added: Any such] disruptions [removed: caused by the COVID-19 pandemic] may further negatively impact the progress of our clinical trials, including the readouts of trial results, the timing of regulatory review, and any anticipated program milestones.

While the potential economic impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, it [removed: recently] [added: previously] caused significant disruption of global financial markets and could cause more economic disruption in the [removed: future.][added: future, making it more difficult for us to access capital if needed.]

[removed: We] [added: As the pandemic continues to rapidly evolve, its ultimate impact is highly uncertain and subject to change and we] do not yet know the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems, or the global economy as a whole.

We face risks related to the development, manufacturing, and commercialization of [removed: REGEN-COV.][added: REGEN-COV and "next generation" monoclonal antibodies targeting SARS-CoV-2.]

In response to the [removed: recent global outbreak of COVID-19,] [added: COVID-19 pandemic,] we [removed: are pursuing] [added: developed REGEN-COV (known as Ronapreve in other countries outside] the [removed: development, manufacturing, and commercialization of REGEN-COV,] [added: United States),] a novel investigational antibody cocktail treatment designed to prevent and treat infection from the SARS-CoV-2 [removed: virus that received an EUA from the FDA in November 2020.][added: virus.]

[removed: There] [added: In addition, there] can be no assurance with respect to how long the EUA will remain in effect [removed: and] [added: or] whether the EUA [removed: is] [added: will be further revised or] revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons.

It is [added: also] possible that the FDA and [added: certain] other regulatory authorities may not grant [removed: the antibody cocktail] [added: REGEN-COV] full marketing approval for the treatment [added: or prevention] of COVID-19, or that any [added: such] marketing approvals, if granted, may have [added: similar or other] significant limitations on its use.

[removed: Further, other parties] [added: superior] may be [removed: successful in developing a more effective treatment for COVID-19;] [added: successfully developed;] and utilization of REGEN-COV [added: previously was, and any future utilization] may [removed: also be] [added: be,] adversely impacted by other factors, such as the rollout of vaccines providing acquired immunity against [removed: COVID-19.][added: COVID-19, other products for treatment or prevention of COVID-19, or the distribution model for REGEN-COV.]

The intense public interest, including speculation by the media, in the development and commercialization of [removed: REGEN-COV] [added: monoclonal antibodies and other products for treatment or prevention of COVID-19] has caused [added: or contributed to] significant volatility in our stock price, which [removed: we expect to] [added: may] continue as data and other information from [removed: the ongoing and] any [removed: future clinical trials] [added: studies] evaluating REGEN-COV [added: (whether conducted by us or others), our "next generation" monoclonal antibodies targeting SARS-CoV-2 discussed below,] and third-party product candidates for the treatment or prevention of COVID-19 as well as any other regulatory actions become public.

We also face risks related to our significant investment in the development, supply, allocation, distribution, pricing, and commercialization of [removed: REGEN-COV.][added: REGEN-COV and our "next generation" monoclonal antibodies (together with REGEN-COV referred to below as "our COVID-19 monoclonal antibodies").]

Given the severity and urgency of the COVID-19 pandemic, we have committed [added: and expect to continue to commit] significant capital and resources to fund and supply clinical trials and to accelerate and scale up the production of [removed: REGEN-COV,] [added: our COVID-19 monoclonal antibodies,] which involves a complex manufacturing process that is both resource- and time-sensitive.

We expect our investment in the development and manufacture of [removed: REGEN-COV] [added: our COVID-19 monoclonal antibodies] to continue through [removed: 2021] [added: 2022] and potentially beyond, although the magnitude of our investment will be subject to clinical data results, the duration of the COVID-19 pandemic, and other factors, including regulatory outcomes.

If we are unable to [removed: maintain the] [added: obtain a new] EUA [added: for any of our "next generation" monoclonal antibodies,] or obtain regulatory [removed: approvals,] [added: approvals for any of the foregoing,] or if we make a strategic decision to discontinue development of [removed: REGEN-COV] [added: our COVID-19 monoclonal antibodies] or are otherwise not successful in [removed: the commercialization of REGEN-COV,] [added: their commercialization,] we [removed: will] [added: may] be unable to recoup our significant expenses incurred to date [removed: and] [added: and/or] in the future related to the development and production of [removed: REGEN-COV.][added: our COVID-19 monoclonal antibodies.]

In addition, our internal [added: and contracted] manufacturing capacity may not be sufficient to cover [removed: the] [added: any potential future] demand for [removed: REGEN-COV.][added: our COVID-19 monoclonal antibodies.]

While we have entered into a collaboration agreement with Roche to develop, manufacture, and distribute [added: outside the United States] REGEN-COV, we cannot be certain that [removed: the technology transfer process required to allow Roche to manufacture REGEN-COV will be completed in the expected time frame or at all nor can we be certain that this collaboration will result in the anticipated increase in the] [added: our] current manufacturing and distribution capacity for REGEN-COV [removed: or that any] [added: and the] increased manufacturing and distribution capacity [added: through our collaboration with Roche] will be [removed: sufficient.][added: sufficient if there is significant future demand for REGEN-COV.]

In addition, we rely entirely on third parties for filling and finishing services for [removed: REGEN-COV.][added: REGEN-COV and, in the future, may rely entirely on such providers for filling and finishing services for our other COVID-19 monoclonal antibodies.]

Our third-party fill/finish providers may not have sufficient capacity or may otherwise not be able to provide such services on a timely basis in the quantities requested (such as because they devote their capacity to other drugs or vaccines against COVID-19), which we [removed: have recently] [added: previously] experienced.

If we are unable to timely enter into alternative arrangements, or if such alternative arrangements are not available on satisfactory terms or at all, we may experience delays in the development, manufacturing, and distribution of [removed: REGEN-COV, which could, among other things, prevent us from meeting] our [removed: supply targets under our agreements with the U.S. government.][added: COVID-19 monoclonal antibodies.]

We and Roche [removed: also] [added: have faced and may in the future] face [added: additional] challenges related to the allocation of [removed: existing and future] supply of [removed: REGEN-COV,] [added: REGEN-COV and other COVID-19 monoclonal antibodies (as applicable),] particularly with respect to geographic distribution.

[removed: As] [added: For example, if] supplies of REGEN-COV are [removed: expected] [added: constrained in response] to [removed: remain constrained,] [added: future demand,] it is possible that the U.S. government may limit or restrict our [added: and/or Roche's] ability to distribute and commercialize REGEN-COV outside [removed: of] the United States.

In addition, as a result of the emergency situations in many countries, there is a heightened risk that [removed: REGEN-COV] [added: products for treatment or prevention of COVID-19] may be subject to [added: adverse governmental actions in certain countries.]

This right may be triggered if we, for example, do not manufacture or supply sufficient product to address such [removed: needs.]

If the U.S. government exercises or asserts any such rights or imposes these or similar measures with respect to our products, product candidates, or related inventions (including [removed: REGEN-COV),] [added: our COVID-19 monoclonal antibodies),] it may adversely impact our business and results of operations.

- We face risks related to the personal data we collect, process, and share.

The COVID-19 pandemic has continued to ebb and flow, with different jurisdictions having higher levels of infections than others and new variants of the SARS-CoV-2 virus (such as the Omicron variant) emerging and spreading more easily and quickly than other variants.

By way of example, continuation or re-imposition of various government-imposed or private-sector measures relating to the COVID-19 pandemic (including those we previously implemented, such as work-from-home policies for some employees) may further negatively impact productivity, disrupt our business, and delay our clinical programs and development timelines beyond the delays we have already experienced and disclosed.

We and our employees may also be subject to government vaccine mandates, such as President Biden's recent Executive Order entitled "Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors" applicable to certain federal contractors.

While enforcement of this mandate is currently enjoined and a similar mandate was recently struck down by the United States Supreme Court, if this mandate or any similar mandate becomes applicable to us, it may have a negative impact on our ability to retain employees or hire new employees and could adversely impact our business.

Demand for some or all of our marketed products may be further reduced if shelter-in-place, social distancing, or

However, based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

In January 2022, the FDA revised the EUA to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron that is not susceptible to the treatment.

With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories, or jurisdictions, since Omicron is currently the dominant variant across the United States.

In light of these developments, we cannot predict whether (if at all) or to what extent REGEN-COV may be reauthorized for use by the FDA in any such jurisdictions in the future.

Similar limitations on the use of REGEN-COV may also be imposed by foreign regulatory authorities in jurisdictions where REGEN-COV is currently authorized for use.

Further, besides currently available therapeutic and prevention options for COVID-19, additional products for treatment or prevention of COVID-19 that are more efficacious, more easily administered, more cost-effective, or otherwise

Any of these factors may further negatively impact any potential future uptake or commercialization of REGEN-COV, and such impact may be material.

We are also subject to similar risks in connection with the development and potential commercialization of any such "next generation" monoclonal antibodies.

In addition to our REGEN-COV program, we are progressing "next generation" monoclonal antibodies targeting SARS-CoV-2 that are active against Omicron, Delta, and other variants of concern.

Although, pending regulatory discussions, new therapeutic candidates could enter clinical development in the coming months, there can be no assurance of the timing of commencement or completion of any such future studies or favorable results from any of them.

While we previously recognized significant revenues in connection with sales of REGEN-COV, the degree to which future sales of our COVID-19 monoclonal antibodies will continue to impact our results of operations is highly uncertain.

needs.

For the years ended December 31, 2021 and 2020, EYLEA net sales in the United States represented 36% and 58% of our total revenues, respectively, with EYLEA net sales as a percentage of our total revenues for the year ended December 31, 2021 being significantly lower due to the net product sales of REGEN-COV we recorded in that period in connection with deliveries of drug product under our agreements with the U.S. government.

Given cost sensitivities in many health care systems (which will likely be exacerbated as a result of the COVID-19

The main proposal aimed at drug pricing introduced at the federal level as part of the "Build Back Better Act" includes measures that would allow the government to negotiate prices of certain prescription drugs under Medicare (including those covered under Medicare Part B, such as EYLEA) and would redesign the Medicare Part D benefit to limit patient out-of-pocket drug costs and shift liabilities among stakeholders, including manufacturers.

In addition, Genentech/Roche recently announced the approval of Vabysmo™ (faricimab-svoa), a bispecific antibody targeting both VEGF and Ang2, for the treatment of wet AMD and DME in the United States.

In addition, the first product to reach the market in

While we exercised our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States and have commenced this co-commercialization, we will continue to rely in part on Sanofi's sales and marketing organization in such jurisdictions and there can be no assurance that we will be able to successfully conduct such co-commercialization in the expected time frame or at all.

Parallel-

We expect significant customer concentration to continue for the foreseeable future, although the degree to which future sales of REGEN-COV will continue to impact our results of operations is highly uncertain.

For example, following the exercise of our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, we have begun establishing commercial capabilities for Dupixent in such jurisdictions.

commercialization of a product in one or more markets outside the United States.

The FDA has

For example, REGEN-COV has been authorized for use in certain individuals in the United States based on an EUA from the FDA.

An EUA terminates when the emergency determination underlying the EUA terminates.

The FDA may also revoke, revise, or restrict an EUA for a variety of reasons, including where it is determined that the underlying health emergency no longer exists or warrants such authorization or the medical product is no longer effective in diagnosing, treating, or preventing the underlying health emergency.

For example, in January 2022, the FDA revised the EUA for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron that is not susceptible to the treatment.

With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories, or jurisdictions, since Omicron is currently the dominant variant across the United States.

Any such termination, revocation, or revision of an EUA could adversely impact our business in a variety of

For example, during the fourth quarter of 2021, we recorded a charge of $231.7 million to write down REGEN-COV inventory, as described in Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations."

In addition such authorities often have the authority to require post-approval studies, such as a PASS and/or PAES, which involve various risks similar to those described above.

Certain of our research and development activities are conducted at our existing facilities primarily located in Tarrytown, New York.

As we continue to expand, we may lease, operate, purchase, or construct additional facilities to expand our research and development capabilities in the future.

- We face potential liability related to the personal information we collect from individuals, data brokers, or research institutions or obtain from clinical trials sponsored by us or our collaborators.

administrative personnel, third-party service providers, and business partners and customers; and the demand for our marketed products.

As a result of these developments, we have implemented work-from-home policies for a significant portion of our employees (except those deemed critical, including those working in our laboratories and manufacturing facilities).

The effects of shelter-in-place and social distancing orders, government-imposed quarantines, and work-from-home policies may further negatively impact productivity, disrupt our business, and delay our clinical programs and development timelines beyond the delays we have already experienced and disclosed, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

It is unknown how long these disruptions could continue.

For example, as noted above in Part I, Item 1.

"Business - Programs in Clinical Development," the ongoing COVID-19 pandemic continues to impact clinical trial execution in many regions across the world for us and our collaborators.

Further, while we continue to focus on developing REGEN-COV to address the COVID-19 pandemic, our research programs and the development of our other product candidates may need to be further de-prioritized.

Any elongation or de-prioritization of our research and development programs and clinical trials or delay in

regulatory review resulting from such disruptions could materially affect the development and study of our product candidates, which would increase our operating expenses and may have a material adverse effect on our operating results.

This disruption, if sustained or recurrent, could make it more difficult for us to access capital if needed.

The global COVID-19 pandemic continues to rapidly evolve.

The ultimate impact of this pandemic is highly uncertain and subject to change.

In addition, while the EUA was granted following our announcement of positive results from the ongoing Phase 2/3 seamless trial in non-hospitalized patients with COVID-19, there are multiple ongoing clinical trials to evaluate the safety and efficacy of the antibody cocktail and there is no assurance of favorable results from any ongoing or future clinical trials or the timing of their completion.

As a result, we may never be successful in fully commercializing REGEN-COV.

adverse governmental actions in certain countries.

For the years ended December 31, 2020 and 2019, EYLEA net sales in the United States represented 58% and 71% of our total revenues, respectively.

covering a particular drug, particularly with respect to higher-priced drugs.

At the federal level, some of the prior budget proposals contained drug price control measures that may be included in future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B (such as EYLEA); to allow some states to negotiate drug prices under Medicaid; and to eliminate cost sharing for generic drugs for low-income patients.

Additionally, the HHS and CMS have been soliciting feedback on some of these measures and may implement others impacting our business under their existing authority.

CMS has also sought public comment on how best to leverage its authority provided under the Competitive Acquisition Program and introduce competition into Medicare Part B by allowing CMS to bring on vendors to negotiate payment amounts for Medicare Part B drugs.

In addition, since January 1, 2019, CMS has allowed Medicare Advantage ("MA") plans to use step therapy for Part B drugs (such as EYLEA).

In addition, in September 2020, the Executive Order of the President entitled "Lowering Drug Prices by Putting America First" (the "MFN Executive Order") was issued.

The MFN Executive Order provides that it is "the policy of the United States that the Medicare program should not pay more for costly Part B or Part D prescription drugs or biological products than the most-favored-nation price" within the member countries of the Organization for Economic Co-operation and Development (the "MFN Price"); and directs the Secretary of the HHS to implement rulemaking to test a payment model (the "MFN Model") pursuant to which Medicare would pay no more than the MFN Price for certain drugs covered by Medicare Parts B and D.

On November 20, 2020, HHS, acting through CMS, issued an interim final rule with comment period to implement the MFN Model (the "MFN Interim Final Rule"), which was intended to commence on January 1, 2021.

The MFN Interim Final Rule has been challenged in court by various groups and individual companies, including Regeneron.

See Note 15 to our Consolidated Financial Statements for further details regarding the lawsuit relating to the MFN Interim Final Rule filed by Regeneron.

While preliminary injunctive relief preventing the MFN Interim Final Rule from becoming effective on January 1, 2021 has been granted and such relief has not been appealed, if the MFN Interim Final Rule is not permanently enjoined or repealed or the MFN Model is otherwise implemented, this would have a material adverse impact on the extent of Medicare reimbursements for EYLEA and our results of operations.

For example, there are several companies that are

Effective April 1, 2020, we and Sanofi amended the Antibody Collaboration to remove Praluent from the LCA such that, among other things, the LCA no longer governs the development, manufacture, or commercialization of Praluent.

Effective as of the same date, we and Sanofi entered into the Praluent Cross License & Commercialization Agreement whereby we, at our sole cost, are solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States; and Sanofi pays us a 5% royalty on Sanofi's net product sales of Praluent outside the United States until March 31, 2032.

We sell EYLEA, Libtayo, Praluent, and ARCALYST in the United States to several distributors and specialty pharmacies, as applicable.

We expect this significant customer concentration to continue for the foreseeable future.

The

However, the FDA may revoke this EUA (or any other EUA we may be granted in the future) if it is determined that the underlying health emergency no longer exists or warrants such authorization; therefore, we cannot predict how long this EUA (or any other EUA we may be granted in the future) will remain in effect.

For example, in August 2017, we reported that the Phase 3 study evaluating suptavumab, an antibody to RSV, did not meet its primary endpoint of preventing medically-attended RSV infections in infants; as a result, we have discontinued further clinical development of this antibody.

or after marketing approval when large numbers of patients were treated.

For example, in February 2018, we issued a letter to healthcare professionals providing updated guidance relating to reports of IOI following EYLEA injections.

In this letter, we noted that while our review did not identify any association of IOI rates with the EYLEA drug itself, an association was seen with certain batches of the syringe that were included in specific lots of final packaged EYLEA kits.

In any such case, we may be dependent on the sustained

Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2019] [added: 2020] (filed with the SEC on February [removed: 7, 2020)] [added: 8, 2021)] for additional discussion of our financial condition and results of operations for the year ended December 31, [removed: 2018,] [added: 2019,] as well as our financial condition and results of operations for the year ended December 31, [removed: 2019] [added: 2020] compared to the year ended December 31, [removed: 2018.*][added: 2019.*]

[removed: We are] [added: Regeneron Pharmaceuticals, Inc. is] a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for [removed: the treatment of] serious diseases.

Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, [added: hematologic conditions,] infectious diseases, and rare diseases.

[removed: As described in] [added: Refer to] Part I, Item 1.

[removed: "Business," we] [added: We] currently have [removed: eight] [added: nine FDA-approved] products that have received marketing approval and [removed: approximately] [added: over] 30 product candidates in clinical development, almost all of which were homegrown in our laboratories.

"Business - Products" and "Business - Programs in Clinical Development" for additional [removed: information.][added: information related to marketed products and product candidates.]

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our [removed: marketed] products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits or losses from sales of [removed: commercialized] products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate.

We recognize revenue from product sales at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt [added: or acceptance] by our customer.

In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration [removed: that] [added: to which] we will be [removed: entitled to.][added: entitled.]

This estimate is based upon contracts with [removed: customers] [added: customers, healthcare providers, payors] and government agencies, statutorily-defined discounts applicable to [added: government-funded programs, historical experience, estimated payor mix, and other relevant factors.]

We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize [added: products and/or] product [removed: candidates and utilize our technology platforms.][added: candidates.]

In agreements involving multiple goods or services promised to be transferred to our collaborator, we must assess, at the inception of the contract, whether each promise represents a separate obligation [removed: (*i.e.*,] [added: (i.e.,] is "distinct"), or whether such promises should be combined as a single unit of account.

When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period [removed: (*i.e.*,] [added: (i.e.,] over time).

Due to the variability in the scope of activities and length of time necessary to develop a drug product, potential delays in development programs, changes to development plans and budgets as programs progress, including if we and our collaborators decide to expand or contract our clinical plans for a drug candidate in various disease indications, and uncertainty in the ultimate requirements to obtain governmental approval for commercialization, revisions to our estimates are likely to occur [removed: periodically and could result] [added: periodically, potentially resulting] in material changes to amounts [removed: recognized each year in the future.][added: recognized.]

When we are entitled to reimbursement of all or a portion of the expenses [removed: (*e.g.*,] [added: (e.g.,] research and development expenses) that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

If [removed: both we and] our collaborator [removed: perform] [added: performs research and] development work or commercialization-related activities and share costs, we also recognize, as expense [removed: (*i.e.*,] [added: (e.g.,] research and development expense or selling, general and administrative expense, as applicable) in the period when our collaborator incurs such expenses, the portion of the collaborator's expenses that we are obligated to reimburse.

- [removed: are obligated to use commercially reasonable efforts to] supply commercial product to our collaborator, we may be reimbursed for our manufacturing costs as commercial product is shipped to the collaborator; however, recognition of such cost reimbursements [removed: is] [added: may be] deferred until the product is sold by our collaborator to third-party customers;

Our collaborators provide us with estimates of product sales and our share of profits or losses, as applicable, for [removed: such] [added: each] quarter.

[removed: Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of our Common Stock price, (ii) the periods of time over] which employees and members of our board of directors are expected to hold their options prior to exercise (expected lives), (iii) expected dividend yield on our Common Stock, and (iv) risk-free interest rates, which are based on quoted U.S. Treasury rates for securities with maturities approximating the options' expected lives.

Expected lives are principally based on our historical exercise experience with previously issued employee and board of [removed: directors] [added: director] option grants.

[added: The] expected dividend yield is zero as we have never paid dividends and do not currently anticipate paying any in the foreseeable future.

We adjust the [removed: level] [added: amount] of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions.

We periodically analyze our inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and [removed: write-down] [added: write down] such inventories as appropriate.

If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, we record a charge to write down such [removed: unmarketable] inventory to its estimated realizable value.

| [removed: (In] [added: *(In] millions, except per share [removed: data)] [added: data)*] | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| Revenues | | | $ | [removed: 8,497.1] [added: 16,071.7] | | | | | $ | [removed: 6,557.6] [added: 8,497.1] | | | | | $ | [removed: 5,145.6] [added: 6,557.6] | |

| Operating expenses | | | [removed: 4,920.5] [added: 7,124.9] | | | | | | [removed: 4,347.8] [added: 4,920.5] | | | | | | [removed: 2,611.2] [added: 4,347.8] | | |

| Income from operations | | | [removed: 3,576.6] [added: 8,946.8] | | | | | | [removed: 2,209.8] [added: 3,576.6] | | | | | | [removed: 2,534.4] [added: 2,209.8] | | |

| Other income [removed: (expense), net] [added: (expense)] | | | [removed: 233.8] [added: 379.0] | | | | | | [removed: 219.3] [added: 233.8] | | | | | | [removed: 19.1] [added: 219.3] | | |

| Income before income taxes | | | [removed: 3,810.4] [added: 9,325.8] | | | | | | [removed: 2,429.1] [added: 3,810.4] | | | | | | [removed: 2,553.5] [added: 2,429.1] | | |

| Income tax expense | | | [removed: 297.2] [added: 1,250.5] | | | | | | [removed: 313.3] [added: 297.2] | | | | | | [removed: 109.1] [added: 313.3] | | |

| Net income | | | $ | [removed: 3,513.2] [added: 8,075.3] | | | | | $ | [removed: 2,115.8] [added: 3,513.2] | | | | | $ | [removed: 2,444.4] [added: 2,115.8] | |

| Net income per share - diluted | | | $ | [removed: 30.52] [added: 71.97] | | | | | $ | [removed: 18.46] [added: 30.52] | | | | | $ | [removed: 21.29] [added: 18.46] | |

| [removed: (In millions)] [added: *(In millions)*] | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2020] [added: 2021] vs. [removed: 2019] [added: 2020] | | | | | | [removed: 2019] [added: 2020] vs. [removed: 2018] [added: 2019] | | |

| EYLEA | | | $ | [removed: 4,947.2] [added: 5,792.3] | | | | | $ | [removed: 4,644.2] [added: 4,947.2] | | | | | $ | [removed: 4,076.7] [added: 4,644.2] | | | | | $ | [removed: 303.0] [added: 845.1] | | | | | $ | [removed: 567.5] [added: 303.0] | |

| Libtayo | | | [removed: 270.7] [added: 306.3] | | | | | | [removed: 175.7] [added: 270.7] | | | | | | [removed: 14.8] [added: 175.7] | | | | | | [removed: 95.0] [added: 35.6] | | | | | | [removed: 160.9] [added: 95.0] | | |

| Praluent | | | [removed: 150.9] [added: 170.0] | | | | | | [removed: *] [added: 150.9] | | [added: *] | | | | * | | | | | | * | | | | | | * | | |

| REGEN-COV | | | [removed: 185.7] [added: 5,828.0] | | | | | | [removed: —] [added: 185.7] | | | | | | — | | | | | | [removed: 185.7] [added: 5,642.3] | | | | | | [removed: —] [added: 185.7] | | |

| ARCALYST | | | [removed: 13.1] [added: 2.2] | | | | | | [removed: 14.5] [added: 13.1] | | | | | | [removed: 14.7] [added: 14.5] | | | | | | [removed: (1.4)] | | | | | | [removed: (0.2)] [added: (1.4)] | | |

| [removed: Sanofi and Bayer collaboration] [added: Collaboration] revenue: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

In addition, REGEN-COV has not been approved by the FDA, but has been authorized under an EUA for COVID-19 (see Part I, Item 1.

"Business - REGEN-COV - Emergency and Temporary Use Authorizations" for a description of recent revisions to the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment).

The estimates are revised, if necessary, in subsequent periods if actual expenses differ from those estimates.

The estimates are revised, if necessary, in subsequent periods if our share of actual profits or losses differ from those estimates.

Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of our Common Stock price, (ii) the periods of time over

See Note 6 to our Consolidated Financial Statements for information related to our inventory write-offs and reserves.

| Evkeeza | | | 18.4 | | | | | | — | | | | | | — | | | | | | 18.4 | | | | | | — | | |

| Roche | | | 361.8 | | | | | | — | | | | | | — | | | | | | 361.8 | | | | | | — | | |

| Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

As of December 31, 2021, the Company had completed its final deliveries of drug product under its agreements with the U.S. government.

The degree to which future sales of our COVID-19 monoclonal antibodies will continue is highly uncertain and will depend on, among other factors, the number of new COVID-19 cases and effectiveness of our product against variants of concern.

"Business - Products - REGEN-COV - Emergency and Temporary Use Authorizations" for additional information.

| Provisions | | | 1,047.1 | | | | | | 363.6 | | | | | | 150.4 | | | | | | 1,561.1 | | |

| Credits/payments | | | (1,034.7) | | | | | | (360.8) | | | | | | (127.6) | | | | | | (1,523.1) | | |

| Balance as of December 31, 2021 | | | $ | 214.6 | | | | | $ | 80.0 | | | | | $ | 67.6 | | | | | $ | 362.2 | |

| Regeneron's share of profits in connection with commercialization of antibodies | | | | | | $ | 1,363.0 | | | | | $ | 785.2 | | | | | $ | 209.3 | |

| *(In millions)* | | | | | | 2021 | | | | | | 2020 | | | | | | 2019 | | |

| *(In millions)* | | | | | | 2021 | | | | | | 2020 | | | | | | 2019 | | |

| Regeneron's net profit in connection with commercialization of EYLEA outside the United States | | | | | | $ | 1,349.2 | | | | | $ | 1,107.9 | | | | | $ | 1,091.4 | |

*Roche Collaboration Revenue*

"Business - Agreements Related to COVID-19 - Roche", Roche distributes and records net product sales of the casirivimab and imdevimab antibody cocktail outside the United States, and the parties share gross profits from worldwide sales, depending on the amount of manufactured product supplied by each party to the market.

Each quarter, a single payment is due from one party to the other to true-up the global gross profits between the parties.

If Regeneron is to receive a true-up payment from Roche, such amount will be recorded to Other collaboration revenue.

If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.

During the year ended December 31, 2021, the Company recorded $361.8 million of true-up payments, within Other collaboration revenue, from Roche in connection with this agreement.

Reimbursement of research and development expenses by collaborators included reimbursements from Roche related to REGEN-COV of $128.1 million and $78.5 million for the years ended December 31, 2021 and 2020, respectively.

Selling, general, and administrative expenses increased in 2021, compared to 2020, primarily due to an increase in commercialization-related expenses for (i) EYLEA, including direct-to-consumer advertising, (ii) REGEN-COV, including costs associated with educational campaigns related to COVID-19, and (iii) Libtayo; and higher headcount-related costs.

During 2021, the Company also recorded a $259.6 million true-up payment owed in connection with global gross profits under our Roche collaboration agreement described above.

Additionally, during the fourth quarter of 2021, the Company recorded a $231.7 million charge to write down its REGEN-COV inventory as a result of data that showed REGEN-COV was highly unlikely to be active against the Omicron variant and the FDA revision of the EUA for REGEN-COV, pursuant to which REGEN-COV was no longer authorized for use in any U.S. states, territories, or jurisdictions.

"Business - Products - REGEN-COV - Emergency and Temporary Use Authorizations" for additional information.

Other income (expense), net, was $379.0 million in 2021, compared to $233.8 million in 2020.

This change was primarily driven by an increase in unrealized gains on equity securities of $190.1 million.

| *(In millions)* | | | 2021 | | | | | | 2020 | | | | | | $ Change | | |

| | | | $ | 12,532.7 | | | | | $ | 6,722.6 | | | | | $ | 5,810.1 | |

| | | | $ | 10,082.4 | | | | | $ | 7,081.7 | | | | | $ | 3,000.7 | |

2021

As of December 31, 2021, Accounts receivable had increased by $1.927 billion, compared to December 31, 2020, primarily due to REGEN-COV sales in connection with our September 2021 agreement to supply drug product to the U.S. government.

Other non-cash items, net, in 2021 included inventory write-offs and reserves totaling $457.1 million, primarily related to REGEN-COV.

Accounts payable, accrued expenses, and other liabilities as of December 31, 2021 included a $259.6 million fourth quarter 2021 true-up payment owed in connection with global gross profits under our Roche collaboration agreement.

We also expect continued significant capital expenditures over the next several years in connection with the planned expansion of our Tarrytown, New York campus.

In addition, REGEN-COV received Emergency Use Authorization from the FDA for the treatment of mild to moderate COVID-19 in certain patients at high-risk for progressing to severe COVID-19 and/or hospitalization.

government-funded programs, historical experience, estimated payor mix, and other relevant factors.

Our collaborators' estimates are reconciled to their actual expenses for such quarter in the subsequent fiscal quarter, and our portion of our collaborators' expenses that we are obligated to reimburse is adjusted on a prospective basis accordingly, as necessary.

These estimates are reconciled to actual results in the subsequent fiscal quarter, and collaboration revenue is adjusted accordingly, as necessary.

The

Certain revisions have been made to the previously reported December 31, 2019 and 2018 amounts below in connection with changing the presentation of certain amounts earned from collaborators; see Note 1 to our Consolidated Financial Statements for further details.

Net product sales of EYLEA in the United States were lower in the second quarter of 2020, compared to the second quarter of 2019, due to lower sales volume attributable to the impact of the COVID-19 pandemic.

While we observed an increase in U.S. EYLEA demand during the remainder of 2020 relative to the second quarter of 2020, we are unable to predict whether there will be additional adverse impacts on net product sales from shelter-in-place, social distancing, and other similar measures due to the COVID-19 pandemic (refer to Part I, Item 1A.

"Risk Factors - *Our business may be further adversely affected by the effects of the COVID-19 pandemic*).

"Risk Factors - *Sales of our marketed products are dependent on the availability and extent of reimbursement from third-party payors, and changes to such reimbursement may materially harm our business, prospects, operating results, and financial condition*" for information and potential future risks concerning the MFN Interim Final Rule issued by the HHS on Medicare reimbursements for EYLEA.

Refer to Part I, Item.

1.

"Collaboration, License, and Other Agreements - *Sanofi* - *Antibody*" for further details.

In January 2021, the Company announced an agreement to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S. government.

| Balance as of December 31, 2017 | | | $ | 29.9 | | | | | $ | 34.1 | | | | | $ | 21.3 | | | | | $ | 85.3 | |

| Provisions | | | 223.4 | | | | | | 211.0 | | | | | | 44.5 | | | | | | 478.9 | | |

| Credits/payments | | | (212.2) | | | | | | (203.1) | | | | | | (57.5) | | | | | | (472.8) | | |

| Percentage not meaningful | | | | | | | | | | | | | | | | | | | | |

"Collaboration, License, and Other Agreements - Sanofi - Antibody", effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States.

In addition, other revenue increased, to a lesser extent, due to the following:

- recognition of revenue in connection with our agreement with BARDA related to funding of certain development activities for Inmazeb for the treatment of Ebola;

- effective April 1, 2020, Sanofi's reimbursement for our manufacturing of Praluent commercial supplies and royalties of 5% on Sanofi’s net product sales of Praluent outside the United States; and

- royalties in connection with a June 2009 agreement with Novartis, under which we receive royalties on worldwide sales of Novartis' Ilaris® (canakinumab).

The royalty rates in the agreement start at 4% and reach 15% when annual sales exceed $1.5 billion.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Kevzara (sarilumab) | | | | | | 73.4 | | | | | | 13.7 | | | | | | 7.1 | | | | | | 59.7 | | | | | | 6.6 | | |

| Evkeeza (evinacumab) | | | | | | 33.8 | | | | | | 36.1 | | | | | | 21.9 | | | | | | (2.3) | | | | | | 14.2 | | |

Research and development expenses in 2019 included a $400.0 million up-front payment to Alnylam.

See Part I, Item 1.

"Collaboration, License, and Other Agreements" for further information.

Research and development expenses in 2020 also included costs in connection with investigating the use of REGEN-COV and Kevzara for COVID-19.

Selling, general, and administrative expenses increased in 2020, compared to 2019, primarily due to higher headcount-related costs, an increase in commercialization-related expenses for EYLEA and Libtayo, higher contributions to independent not-for-profit patient assistance organizations, and, effective April 1, 2020, no longer receiving Praluent-related cost reimbursements from Sanofi for Regeneron-incurred expenses.

In addition, in 2019, we recorded a $35.2 million charge related to employee separation costs, as the Company eliminated certain commercialization activities and related headcount in connection with the restructuring of the antibody agreement with Sanofi (as described in Part I, Item 1.

"Business - Collaboration, License, and Other Agreements - *Sanofi* - *Antibody*").

These increases were partly offset by lower period costs for our Limerick commercial manufacturing facility.

In addition, Cost of goods sold for the years ended December 31, 2020 and 2019 included inventory write-downs and reserves totaling $39.2 million and $73.8 million, respectively.

In addition, Cost of collaboration and contract manufacturing increased in 2020, compared to 2019, due to process validation costs in connection with manufacturing Inmazeb under our BARDA agreement.

Other income (expense), net, in 2020, compared to 2019, was positively impacted by the recognition of unrealized and realized gains on marketable securities.

Other income (expense), net, in 2020, compared to 2019, was negatively impacted by a decrease in interest income earned on available-for-sale debt securities primarily due to lower interest rates.

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a [removed: $48.1] [added: $120.0] million and [removed: $48.6] [added: $48.1] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.

We have exposure to market risk for changes in interest rates, including the interest rate risk relating to our [removed: March 2017] variable rate Tarrytown, New York lease (as described in Part II, Item 7.

In [added: 2021,] 2020, [removed: 2019,] and [removed: 2018,] [added: 2019,] we did not record any charges for credit-related impairments of our available-for-sale debt securities.

We are subject to credit risk associated with the receivables due from our collaborators, including [removed: Bayer, Sanofi,] [added: Bayer] and [removed: Teva.][added: Sanofi.]

In [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018,] [added: 2019,] we did not recognize any charges for write-offs and allowances of accounts receivable related to credit risk for our collaborators or customers.

As of December 31, [removed: 2020 and 2019,] [added: 2021,] three customers accounted on a combined basis for [removed: 93% and 97%, respectively,] [added: 91% (including 29% related to the U.S. government)] of our net trade accounts receivables.

As discussed further above, [removed: Bayer and Sanofi] [added: our collaborators] market certain products outside the United States, and we share in profits and losses with these collaborators from commercialization of [removed: products (including the receipt of a percentage of EYLEA sales in Japan).][added: products.]

Therefore, significant changes in foreign exchange rates of the countries outside the United States where our [removed: product is] [added: products are] sold, where development expenses are incurred by us or our collaborators, or where we incur operating expenses can impact our operating results and financial condition.

We recorded [removed: $196.0] [added: $386.1] million [removed: of net unrealized gains] and [removed: $118.3] [added: $196.0] million of net unrealized gains on equity securities in Other income (expense), net for the years ended December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.

[removed: These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, "Regeneron’s Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA®* *(aflibercept) Injection, Dupixent*® *(dupilumab) Injection, Libtayo*® *(cemiplimab) Injection, Praluent*® *(alirocumab) Injection, Kevzara*® *(sarilumab) Injection, Inmazeb*TM *(atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV™ (casirivimab and imdevimab), fasinumab, Evkeeza*TM *(evinacumab), garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-5715, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of our anticipated development milestones referenced in this report; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation EYLEA, Dupixent, Libtayo, Praluent, Kevzara, REGEN-COV, fasinumab, Evkeeza, garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, and REGN5713-5714-5715; the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; 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 our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; uncertainty of market acceptance and commercial success of Regeneron's Products and Regeneron's 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 Regeneron's Product Candidates; our ability to manufacture and manage supply chains for multiple products and product candidates; the ability of our 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 Regeneron's Product Candidates; the availability and extent of reimbursement of Regeneron’s Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid (including the impact of the recently issued "most-favored-nation" interim final rule); coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors; unanticipated expenses; the costs of developing, producing, and selling products; our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including our agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to REGEN-COV, to be cancelled or terminated; 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 EYLEA, Dupixent, Praluent, and REGEN-COV described further in Note 15 to our Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 15 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.][added: These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron’s Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA®* *(aflibercept) Injection, Dupixent*® *(dupilumab) Injection, Libtayo*® *(cemiplimab) Injection, Praluent*® *(alirocumab) Injection, Kevzara*® *(sarilumab) Injection, Evkeeza®* *(evinacumab), Inmazeb*® *(atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV*® *(casirivimab and imdevimab), aflibercept 8 mg, fasinumab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-5715, REGN1908-1909, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of our anticipated development milestones referenced in this report; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation those listed above; the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates; our ability to manufacture and manage supply chains for multiple products and product candidates; the ability of our 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 Regeneron's Product Candidates; the availability and extent of reimbursement of Regeneron’s Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors; unanticipated expenses; the costs of developing, producing, and selling products; our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including our agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve*™ *in other countries), to be cancelled or terminated; 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 EYLEA, Dupixent, Praluent, and REGEN-COV described further in Note 15 to our Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 15 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.]

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for [removed: the treatment of] serious diseases.

Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, [added: hematologic conditions,] infectious diseases, and rare diseases.

| [removed: (In] [added: *(In] millions, except per share [removed: data)] [added: data)*] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019*] [added: 2020] | | | | | | [removed: 2018*] [added: 2019] | | |

| Revenues | | | | | | $ | [removed: 8,497.1] [added: 16,071.7] | | | | | $ | [removed: 6,557.6] [added: 8,497.1] | | | | | $ | [removed: 5,145.6] [added: 6,557.6] | |

| Net income | | | | | | $ | [removed: 3,513.2] [added: 8,075.3] | | | | | $ | [removed: 2,115.8] [added: 3,513.2] | | | | | $ | [removed: 2,444.4] [added: 2,115.8] | |

| Net income per share - diluted | | | | | | $ | [removed: 30.52] [added: 71.97] | | | | | $ | [removed: 18.46] [added: 30.52] | | | | | $ | [removed: 21.29] [added: 18.46] | |

For purposes of this report, references to our products encompass products marketed or otherwise commercialized by us and/or our collaborators [added: or licensees] and references to our product candidates encompass product candidates in development by us and/or our collaborators [added: or licensees] (in the case of collaborated [added: or licensed] products or product candidates under the terms of the applicable collaboration [added: or license] agreements), unless otherwise stated or required by the context.

| Product | | | | | | [removed: Disease Area] [added: Disease] | | | | | | Territory | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Dupixent (dupilumab) Injection(2) | | | \- | | | Atopic dermatitis (in adults and [removed: adolescents)(5)] [added: adolescents)] | | | | | | a | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| [removed: Libtayo (cemiplimab) Injection(2)] | | | \- | | | Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") | | | | | | a | | | | | | a | | | | | | | | | | | | a | | | | | | | | |

| Product (continued) | | | | | | [removed: Disease Area] [added: Disease] | | | | | | Territory | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Praluent (alirocumab) Injection(3) | | | \- | | | LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") [removed: (in adults)] | | | | | | a | | | | | | a | | | | | | [removed: (7)] | | | | | | a | | | | | | | | |

| Kevzara (sarilumab) Solution for Subcutaneous Injection(2) | | | \- | | | Rheumatoid arthritis ("RA") [removed: (in adults)] | | | | | | a | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| ARCALYST® (rilonacept) Injection for Subcutaneous [removed: Use(8)] [added: Use(7)] | | | \- | | | [removed: Cryopyrin-Associated Periodic Syndromes] [added: Cryopyrin-associated periodic syndromes] ("CAPS"), including [removed: Familial Cold Auto-inflammatory Syndrome] [added: familial cold auto-inflammatory syndrome] ("FCAS") and Muckle-Wells [removed: Syndrome] [added: syndrome] ("MWS") [added: (in adults and adolescents)] | | | | | | a | | | | | | | | | | | | | | | | | | | | | | | | | | |

| ZALTRAP® (ziv-aflibercept) Injection for Intravenous [removed: Infusion(6)] [added: Infusion(8)] | | | \- | | | Metastatic colorectal cancer ("mCRC") | | | | | | a | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| [removed: Note 1:] [added: Note:] Refer to "Net Product Sales of Regeneron-Discovered Products" section below for information regarding whether net product sales for a particular product are recorded by [removed: us, Bayer,] [added: us] or [removed: Sanofi] [added: others. In addition, unless otherwise noted, products in the table above are approved for use in adults in the above-referenced diseases.] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (1) In collaboration with Bayer [removed: (outside] [added: outside] the United [removed: States)] [added: States] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (3) [removed: In collaboration with Sanofi prior] [added: Pursuant] to [removed: April 2020. Effective April 2020,] [added: a 2020 agreement,] the Company is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United [removed: States. Pursuant to the April 2020 agreement,] [added: States (and] Sanofi pays us a royalty on net product sales of Praluent outside the United [removed: States. Refer to "Collaboration, License, and Other Agreements - Sanofi" section below for further details.] [added: States).] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (4) Rest of [removed: world. Checkmark] [added: world ("ROW"). A checkmark] in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union ("EU"), or Japan. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (6) Pursuant to a 2015 amended and restated ZALTRAP agreement,] [added: (8)] Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net product sales of [removed: ZALTRAP] [added: ZALTRAP.] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (8)] [added: (7)] Pursuant to a 2017 license agreement with [removed: Kiniksa Pharmaceuticals, Ltd.,] [added: Kiniksa,] we granted Kiniksa the right to develop and commercialize certain new indications for ARCALYST. [removed: We currently maintain exclusive rights to ARCALYST in the United States for existing indications. Commencing with the receipt of] [added: In March 2021, Kiniksa received] marketing approval [removed: by Kiniksa] for [removed: the] [added: its] first new indication of ARCALYST in the United [removed: States,] [added: States; consequently] we [removed: will grant] [added: granted] U.S. commercial rights to ARCALYST for all [added: previously] approved indications and Kiniksa [removed: will pay] [added: pays] us a share of ARCALYST profits. [removed: Refer to "Collaboration, License, and Other Agreements - Kiniksa" section below for further details.] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

[removed: REGEN-COV - Emergency] [added: Emergency] Use [removed: Authorization][added: Authorization]

In November 2020, [removed: REGEN-COV (antibody] [added: the antibody] cocktail casirivimab and imdevimab administered [removed: together)] [added: together, known as REGEN-COV in the United States,] received Emergency Use Authorization ("EUA") from the [removed: FDA] [added: U.S. Food and Drug Administration ("FDA")] for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are [added: at high risk for progressing to severe COVID-19 and/or hospitalization.]

| | | | | | | [removed: | | | 2020 | | |] [added: 2021] | | | | | | | | | | | | | | | [removed: 2019] | | | [added: 2020] | | | | | | | | | | | | | | | [removed: 2018] | | | [added: 2019] | | | | | | | | | | | | | | |

| [removed: (In millions) | | |] [added: *(In millions)*] | | | | | | U.S. | | | | | | ROW | | | | | | Total | | | | | | U.S. | | | | | | ROW | | | | | | Total | | | | | | U.S. | | | | | | ROW | | | | | | Total | | | [removed: | | |]

| EYLEA(a) | | | | | | [removed: U.S. | | | | | |] $ | [removed: 4,947.2] [added: 5,792.3] | | | | | $ | [removed: 2,961.5] [added: 3,592.4] | | | | | $ | [removed: 7,908.7] [added: 9,384.7] | | | | | $ | [removed: 4,644.2] [added: 4,947.2] | | | | | $ | [removed: 2,897.4] [added: 2,961.5] | | | | | $ | [removed: 7,541.6] [added: 7,908.7] | | | | | $ | [removed: 4,076.7] [added: 4,644.2] | | | | | $ | [removed: 2,668.9] [added: 2,897.4] | | | | | $ | [removed: 6,745.6] [added: 7,541.6] | |

| [removed: Dupixent | | | | | | (b)] [added: Dupixent(b)] | | | | | | $ | [removed: 3,226.2] [added: 4,713.0] | | | | | $ | [removed: 818.6] [added: 1,485.3] | | | | | $ | [removed: 4,044.8] [added: 6,198.3] | | | | | $ | [removed: 1,871.2] [added: 3,226.2] | | | | | $ | [removed: 444.4] [added: 818.6] | | | | | $ | [removed: 2,315.6] [added: 4,044.8] | | | | | $ | [removed: 776.3] [added: 1,871.2] | | | | | $ | [removed: 145.7] [added: 444.4] | | | | | $ | [removed: 922.0] [added: 2,315.6] | |

| [removed: Libtayo(b) | | | | | | U.S.] [added: Libtayo(c)] | | | | | | $ | [removed: 270.7] [added: 306.3] | | | | | $ | [removed: 77.5] [added: 151.9] | | | | | $ | [removed: 348.2] [added: 458.2] | | | | | $ | [removed: 175.7] [added: 270.7] | | | | | $ | [removed: 18.1] [added: 77.5] | | | | | $ | [removed: 193.8] [added: 348.2] | | | | | $ | [removed: 14.8] [added: 175.7] | | | | | [removed: —] [added: $] | [added: 18.1] | | | | | $ | [removed: 14.8] [added: 193.8] | |

| [removed: Praluent(c) | | | | | | U.S.] [added: Praluent(d)] | | | | | | $ | [removed: 186.0] [added: 170.0] | | | | | $ | [removed: 172.8] [added: 251.1] | | | | | $ | [removed: 358.8] [added: 421.1] | | | | | $ | [removed: 126.0] [added: 186.0] | | | | | $ | [removed: 162.7] [added: 172.8] | | | | | $ | [removed: 288.7] [added: 358.8] | | | | | $ | [removed: 181.3] [added: 126.0] | | | | | $ | [removed: 125.5] [added: 162.7] | | | | | $ | [removed: 306.8] [added: 288.7] | |

| [removed: Kevzara | | | | | | (b)] [added: Kevzara(b)] | | | | | | $ | [removed: 141.6] [added: 161.9] | | | | | $ | [removed: 128.3] [added: 176.1] | | | | | $ | [removed: 269.9] [added: 338.0] | | | | | $ | [removed: 129.0] [added: 141.6] | | | | | $ | [removed: 77.7] [added: 128.3] | | | | | $ | [removed: 206.7] [added: 269.9] | | | | | $ | [removed: 74.7] [added: 129.0] | | | | | $ | [removed: 21.9] [added: 77.7] | | | | | $ | [removed: 96.6] [added: 206.7] | |

| [removed: REGEN-COV(d)] [added: REGEN-COV(e)] | | | | | | [removed: U.S.] [added: $] | [added: 5,828.0] | | | | | $ | [removed: 185.7] [added: 1,745.9] | | | | | [removed: —] [added: $] | [added: 7,573.9] | | | | | $ | 185.7 | | | | | — | | | | | | [removed: — | | | | | | —] [added: $] | [added: 185.7] | | | | | — | | | | | | — | | | | | | — | | |

| [removed: ZALTRAP | | | | | | (b)] [added: ZALTRAP(b)] | | | | | | $ | [removed: 5.8] [added: 5.3] | | | | | $ | [removed: 97.9] [added: 86.4] | | | | | $ | [removed: 103.7] [added: 91.7] | | | | | $ | [removed: 7.3] [added: 5.8] | | | | | $ | [removed: 101.1] [added: 97.9] | | | | | $ | [removed: 108.4] [added: 103.7] | | | | | $ | [removed: 9.0] [added: 7.3] | | | | | $ | [removed: 98.8] [added: 101.1] | | | | | $ | [removed: 107.8] [added: 108.4] | |

| [removed: ARCALYST | | | | | | U.S.] [added: ARCALYST(g)] | | | | | | $ | [removed: 13.1] [added: 2.2] | | | | | — | | | | | | $ | [removed: 13.1] [added: 2.2] | | | | | $ | [removed: 14.5] [added: 13.1] | | | | | — | | | | | | $ | [removed: 14.5] [added: 13.1] | | | | | $ | [removed: 14.7] [added: 14.5] | | | | | — | | | | | | $ | [removed: 14.7] [added: 14.5] | |

| (a) Regeneron records net product sales of EYLEA in the United States. Bayer records net product sales of EYLEA outside the United States. The Company records its share of profits/losses in connection with sales of EYLEA outside the United [removed: States within Bayer collaboration revenue. | | | | | |] [added: States.] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (b) [removed: Regeneron records net product sales of Libtayo in the United States.] Sanofi records [removed: net product sales of Libtayo outside the United States and] global net product sales of Dupixent, Kevzara, and ZALTRAP. The Company records its share of profits/losses [removed: within Sanofi collaboration revenue] in connection with [removed: (i) sales of Libtayo outside the United States, and (ii)] global sales of Dupixent and [removed: Kevzara.] [added: Kevzara, and] Sanofi pays the Company a percentage of net sales of ZALTRAP. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [removed: | | | | | |]

| [removed: (c)] [added: (d)] Effective April 1, 2020, Regeneron records net product sales of Praluent in the United States. Also effective April 1, 2020, Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales. Previously, Sanofi recorded global net product sales of Praluent and the Company recorded its share of profits/losses in connection with such [removed: sales within Sanofi collaboration revenue.] [added: sales.] Refer to [removed: "Products" section above and] "Collaboration, License, and Other Agreements - Sanofi" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [removed: | | | | | |]

| [removed: (d)] [added: (e)] Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S. government. [added: Roche records net product sales of the antibody cocktail outside the United States and the parties share gross profits from global sales based on a pre-specified formula.] Refer to "Agreements Related to [removed: COVID-19 - U.S. Government"] [added: COVID-19"] below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [removed: | | | | | |]

The COVID-19 pandemic and the restrictions adopted around the globe to reduce the spread of the disease have impacted and [removed: will] [added: may] continue to impact our clinical development programs.

| Clinical Program | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory [removed: Review(i)] [added: Review(h)] | | | | | | [removed: 2020] [added: 2021] and [removed: 2021] [added: 2022] Events to Date | | | | | | Select Upcoming [removed: Milestones(k)] [added: Milestones(i)] | | |

| | | | \- | | | Asthma (in pediatrics 6–11 years of age) | | | | | | a | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Libtayo (cemiplimab) Injection(2) | | | \- | | | Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC") | | | | | | a | | | | | | a | | | | | | | | | | | | a | | | | | | | | |

| | | | \- | | | Metastatic or locally advanced basal cell carcinoma ("BCC") | | | | | | a | | | | | | a | | | | | | | | | | | | a | | | | | | | | |

| | | | \- | | | Homozygous familial hypercholesterolemia ("HoFH") | | | | | | a | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGEN-COV(5) | | | \- | | | COVID-19 | | | | | | | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| Evkeeza (evinacumab) Injection(6) | | | \- | | | HoFH (in adults and adolescents) | | | | | | a | | | | | | a | | | | | | | | | | | | | | | | | | | | |

| | | | \- | | | Recurrent pericarditis (in adults and adolescents) | | | | | | a | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (5) Known as REGEN-COV in the United States and Ronapreve in other countries | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (6) In January 2022, the Company entered into a license and collaboration agreement for Ultragenyx to develop and commercialize Evkeeza outside of the United States. Ultragenyx pays us a percentage of net product sales of Evkeeza outside the United States and the Company is also eligible to receive regulatory and sales milestone payments. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

*REGEN-COV - Emergency and Temporary Use Authorizations*

In June 2021, the FDA updated the EUA for REGEN-COV, lowering the dose to 1,200 mg (which is half the dose originally authorized) and allowing for subcutaneous injections as an alternative when intravenous ("IV") infusion is not feasible and would lead to a delay in treatment.

In July 2021, the FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and who have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).

Based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

In January 2022, the FDA revised the EUA for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment.

With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories, or jurisdictions, since Omicron is currently the dominant variant across the United States.

If, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas.

Emergency or temporary pandemic use authorizations are also currently in place in numerous other countries outside the United States.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| | | | | | | Year Ended December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Evkeeza(f) | | | | | | $ | 18.4 | | | | | — | | | | | | $ | 18.4 | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (c) Regeneron records net product sales of Libtayo in the United States and Sanofi records net product sales of Libtayo outside the United States. The parties equally share profits/losses in connection with global sales of Libtayo. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (f) Regeneron records net product sales of Evkeeza in the United States. Pursuant to the January 2022 agreement, Ultragenyx will record net product sales of Evkeeza outside of the United States and will pay the Company a percentage of such sales. Refer to "Products" section above and "Collaboration, License, and Other Agreements - Ultragenyx" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (g) Amounts reflected in the table above represent net product sales recorded by Regeneron. Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States and pays us a share of ARCALYST profits, if any. Refer to "Products" section above and "Collaboration, License, and Other Agreements - Kiniksa" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| EYLEA (aflibercept)(b) | | | | | | | | | | | | | | | | | | –Retinopathy of prematurity ("ROP")(c) | | | | | | –ROP (EU and Japan) | | | | | | –Initial results from National Institutes of Health ("NIH")-sponsored Protocol W trial in non-proliferative diabetic retinopathy ("NPDR") were announced; data confirmed results from Company-sponsored PANORAMA trial and demonstrated reduced risk of developing vision-threatening complications with every-16-weeks dosing regimen –Completed enrollment in Phase 3 study for ROP | | | | | | –Submit supplemental BLA ("sBLA") for every-16-weeks dosing regimen in patients with NPDR (first half 2022) –Report results from Phase 3 study in ROP (second half 2022) | | |

| Aflibercept 8 mg(b) | | | | | | | | | | | | –Wet AMD | | | | | | –Wet AMD –DME | | | | | | | | | | | | –Completed enrollment in Phase 3 studies in wet AMD and DME –Reported initial data from Phase 2 trial in wet AMD and that trial met its primary safety and efficacy endpoints | | | | | | –Report detailed results from Phase 2 trial in wet AMD (first quarter 2022) –Report results from Phase 3 studies in wet AMD and DME (second half 2022) | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2021 and 2022 Events to Date | | | | | | Select Upcoming Milestones(i) | | |

| Kevzara (sarilumab)(a) *Antibody to IL-6R* | | | | | | | | | | | | –Polyarticular-course juvenile idiopathic arthritis ("pcJIA") –Systemic juvenile idiopathic arthritis ("sJIA") | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Itepekimab(a) (REGN3500) *Antibody to IL-33* | | | | | | | | | | | | | | | | | | –COPD | | | | | | | | | | | | | | | | | | | | |

| REGN1908-1909(f) *Multi-antibody therapy to Fel d 1* | | | | | | | | | | | | | | | | | | –Cat allergy | | | | | | | | | | | | –Reported that Phase 2 study in cat allergic patients with mild asthma met its primary and key secondary endpoints | | | | | | | | |

| REGN5713-5714-5715 *Multi-antibody therapy to Bet v 1* | | | | | | | | | | | | | | | | | | –Birch allergy | | | | | | | | | | | | –Initial Phase 3 study in birch allergic patients with allergic rhinoconjunctivitis met its primary endpoint | | | | | | | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2021 and 2022 Events to Date | | | | | | Select Upcoming Milestones(i) | | |

| Libtayo (cemiplimab)(a)(g) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Reported positive results from Phase 3 trial in cervical cancer, demonstrating an overall survival benefit; trial stopped early based on IDMC recommendation –Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies | | | | | | | | |

| REGN4336 *Bispecific antibody targeting PSMA and CD3* | | | | | | –Prostate cancer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN5093-M114 *Bispecific antibody-drug conjugate targeting two distinct MET epitopes* | | | | | | –MET overexpressing advanced cancer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Fianlimab(f) (REGN3767) *Antibody to LAG-3* | | | | | | –Solid tumors and advanced hematologic malignancies | | | | | | | | | | | | | | | | | | | | | | | | –Presented positive data from Phase 1 trial in combination with Libtayo in advanced melanoma at American Society of Clinical Oncology Annual Meeting | | | | | | –Initiate Phase 3 study in first-line metastatic melanoma (first half 2022) | | |

| REGN6569 *Antibody to GITR* | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2021 and 2022 Events to Date | | | | | | Select Upcoming Milestones(i) | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2021 and 2022 Events to Date | | | | | | Select Upcoming Milestones(i) | | |

| | | | | | | | | | | | | | | | | | | | | |

| * Certain revisions have been made to the previously reported revenues for the years ended December 31, 2019 and 2018. See Note 1 to our Consolidated Financial Statements for further details. | | | | | | | | | | | | | | | | | | | | |

| Note 2: Refer to product label in each territory for specific information | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (5) Approval in Japan is for adults and adolescents 15 years of age and older | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (7) No longer marketed by Sanofi in Japan due to injunction (see Note 15 to our Consolidated Financial Statements for further details) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

*Additional Information - Product Updates*

Inmazeb

Inmazeb is a cocktail of three fully-human monoclonal antibodies that each bind to the Ebola virus at different points, which may serve to increase efficacy, reduce the development of viral sequences that lead to resistance, and potentially enable utility in future outbreaks as viruses continue to evolve.

In October 2020, the U.S. Food and Drug Administration ("FDA") approved Inmazeb for the treatment of infection caused by *Zaire ebolavirus* in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

In connection with this approval, we were also granted a material threat medical countermeasure priority review voucher by the FDA.

at high risk for progressing to severe COVID-19 and/or hospitalization.

See information regarding ongoing clinical trials of REGEN-COV below.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | Net Product Sales Recorded by Regeneron | | | | | | Year Ended December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

We believe that our ability to develop product candidates is enhanced by the application of our *VelociSuite*® technology platforms (refer to "Research and Development Technologies - *VelociSuite*" section below).

We continue to invest in the development of enabling technologies to assist in our efforts to identify, develop, manufacture, and commercialize new product candidates.

At this time, we expect fully enrolled clinical studies to remain generally on track.

However, the ongoing pandemic continues to impact clinical trial execution in many regions across the world for us and our collaborators.

| EYLEA(b) | | | | | | | | | | | | –High-dose formulation in wet AMD | | | | | | –Retinopathy of prematurity ("ROP")(c) –High-dose formulation in wet AMD –High-dose formulation in DME | | | | | | | | | | | | –Approved by Ministry of Health, Labour and Welfare ("MHLW") for NVG in Japan –Pre-filled syringe approved by European Commission ("EC") | | | | | | –Report results from Phase 2 study for high-dose formulation in wet AMD (second half 2021) | | |

| Kevzara (sarilumab)(a) *Antibody to IL-6R* | | | | | | | | | | | | –Polyarticular-course juvenile idiopathic arthritis ("pcJIA") –Systemic juvenile idiopathic arthritis ("sJIA") | | | | | | | | | | | | | | | | | | –Reported that Phase 3 studies in COVID-19 patients did not meet primary and key secondary endpoints –Discontinued clinical development in polymyalgia rheumatica and giant cell arteritis | | | | | | | | |

| Itepekimab(a) (REGN3500) *Antibody to IL-33* | | | | | | | | | | | | | | | | | | –COPD | | | | | | | | | | | | –Discontinued further clinical development in atopic dermatitis due to lack of efficacy | | | | | | | | |

| REGN1908-1909(f) *Multi-antibody therapy to Feld1* | | | | | | | | | | | | –Cat allergy | | | | | | | | | | | | | | | | | | | | | | | | –Report results from Phase 2 study in cat allergic asthmatics (first half 2021) | | |

| REGN5713-5714-5715 *Multi-antibody therapy to Betv1* | | | | | | | | | | | | | | | | | | –Birch allergy | | | | | | | | | | | | | | | | | | | | |

| REGN3767(f) *Antibody to LAG-3* | | | | | | –Solid tumors and advanced hematologic malignancies | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN6569 *Antibody to GITR* | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | | | | | | | –Dosing and enrollment in Phase 1 trial temporarily suspended due to a serious adverse event | | | | | | | | |

| REGEN-COV (casirivimab and imdevimab)(g)(n) *Multi-antibody therapy to SARS-CoV-2 virus* | | | | | | –COVID-19 multi-dose safety study | | | | | | –COVID-19 dose-ranging virology study in non-hospitalized patients | | | | | | –COVID-19 treatment in non-hospitalized patients –COVID-19 treatment in hospitalized patients –COVID-19 treatment in hospitalized patients (UK-based RECOVERY trial) –COVID-19 prevention(m) | | | | | | –European Medicines Agency ("EMA") Rolling Review of casirivimab and imdevimab data | | | | | | –Reported results from first 799 non-hospitalized COVID-19 patients in Phase 2/3 trial showing that trial met primary and key secondary endpoints –Received EUA from FDA for mild to moderate COVID-19 in high risk non-hospitalized patients –Reported data from Phase 1/2/3 trial in hospitalized COVID-19 patients requiring low-flow oxygen and that Phase 3 program will continue based on passing futility analysis –IDMC recommended further enrollment of hospitalized patients requiring high-flow oxygen or mechanical ventilation be placed on hold | | | | | | –Report additional data from Phase 3 portion of COVID-19 study in non-hospitalized patients (first half 2021) –Report results for lower 1,200 mg dose from Phase 3 portion of COVID-19 study in non-hospitalized patients (first half 2021) –Report additional data from Phase 3 portion of COVID-19 prevention study (second quarter 2021) –Data to be reported from Phase 3 RECOVERY trial in hospitalized patients (first half 2021) | | |

| REGEN-COV (casirivimab and imdevimab)(g)(n) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Reported positive initial results from Phase 3 portion of COVID-19 prevention study –Papers published in *Science* and *New England Journal of Medicine* ("NEJM") describing REGEN-COV and initial trial results | | | | | | –Report data from Phase 2 dose-ranging virology study in non-hospitalized patients (first half 2021) –Submit BLA and MAA for COVID-19 (mid-2021) | | |

| Praluent (alirocumab)(j) *Antibody to PCSK9* | | | | | | | | | | | | | | | | | | –Homozygous familial hypercholesterolemia ("HoFH")(c) in pediatrics –HeFH in pediatrics | | | | | | –HoFH in adults (U.S.) | | | | | | –Reported results from Phase 3 study in adult patients with HoFH | | | | | | –FDA decision on sBLA for HoFH in adults (target action date of April 4, 2021) –Report interim results from Phase 3 study for HeFH in pediatrics (first half 2021) | | |

| Evkeeza (evinacumab)(f) *Antibody to ANGPTL3* | | | | | | | | | | | | –Severe hypertriglyceridemia | | | | | | | | | | | | –HoFH (U.S. and EU)(c)(d) | | | | | | –*NEJM* published positive results from Phase 3 trial in HoFH | | | | | | –FDA decision on BLA (target action date of February 11, 2021) and EC decision on MAA for HoFH (first half 2021) | | |

| Garetosmab(f) (REGN2477) *Antibody to Activin A* | | | | | | | | | | | | –Fibrodysplasia ossificans progressiva ("FOP")(c)(d)(e) (potentially pivotal study) | | | | | | | | | | | | | | | | | | –Reported results from Phase 2 study in FOP –Paused dosing in the open-label portion of the Phase 2 study in FOP based on reports of serious adverse events | | | | | | –Further review trial data and determine next steps for the program (first half 2021) | | |

| Note 2: We have discontinued further clinical development of REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee | | | | | | | | | | | | | | |

| (g) We and the Biomedical Advanced Research Development Authority ("BARDA") of the U.S. Department of Health and Human Services ("HHS") are parties to agreements whereby HHS provides certain funding to support research and development of this product candidate | | | | | | | | | | | | | | |

| (p) In collaboration with Alnylam | | | | | | | | | | | | | | |

*Clinical Development Program Updates*

In April 2020, the Company moved its leading neutralizing antibodies into preclinical and clinical-scale cell production lines, and in June 2020, initiated its first clinical trial of REGEN-COV.

Following a positive review from the IDMC of the REGEN-COV Phase 1 safety results in an initial cohort, the program advanced to late-stage clinical trials (see table above for further details).

The REGEN-COV clinical program consists of the following separate study populations: non-hospitalized symptomatic and asymptomatic COVID-19 patients, hospitalized COVID-19 patients, uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate), and healthy volunteers.

In October 2020, we announced positive results from the first 799 patients in the ongoing Phase 2/3 seamless trial in non-hospitalized patients with COVID-19, showing that REGEN-COV significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits, and/or physician office/telemedicine visits).

The trial met the primary and key secondary endpoints.

| | | | For the fiscal year [removed: ended] [added: ended December 31, 2021] | | | [removed: December 31, 2020] | | | | | |

| | | | Commission File [removed: Number:] [added: Number: 0-19034] | | | [removed: 0-19034] | | | | | |

| The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was approximately [removed: $63,344,000,000,] [added: $57,065,000,000,] computed by reference to the closing sales price of the stock on NASDAQ on June 30, [removed: 2020,] [added: 2021,] the last trading day of the registrant's most recently completed second fiscal quarter. For purposes of this calculation only, the registrant has assumed that all of its directors and executive officers, and no other persons, are its affiliates. This determination of affiliate status is not necessarily a determination for other purposes. | | | | | | | | | | | | | | |

| The number of shares outstanding of each of the registrant's classes of common stock as of January [removed: 29, 2021:] [added: 27, 2022:] | | | | | | | | | | | | | | |

| Class A Stock, $.001 par value | | | | | | [removed: 1,848,970] [added: 1,823,283] | | |

| Common Stock, $.001 par value | | | | | | [removed: 105,282,929] [added: 106,715,999] | | |

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2021] [added: 2022] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 92] [added: 95] to [removed: 97] [added: 101] of this filing. | | |

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| "ARCALYST®," [removed: "Evkeeza™,"] [added: "Evkeeza®,"] "EYLEA®," [removed: "Inmazeb™,"] [added: "Inmazeb®,"] "Libtayo®" (in the United States), "Praluent®" (in the United States), [removed: "REGEN-COV™," Regeneron®,"] [added: "REGEN-COV®," "Regeneron®,"] "Regeneron Genetics Center®," [removed: "*Veloci-Bi*®," "*VelociGene*®," "*VelociHum*®," "*VelociMab*®," "*VelocImmune*®," "*VelociMouse*®," "*VelociSuite*®," "*VelociT*™,"] [added: "RGC™," "Veloci-Bi®," "VelociGene®," "VelociHum®," "VelociMab®," "VelocImmune®," "VelociMouse®," "VelociSuite®," "VelociT®,"] and "ZALTRAP®" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. [added: This report refers to products of Regeneron Pharmaceuticals, Inc., its collaborators, and other parties. Consult the product label in each territory for specific information about such products.] | | |

| [PART I](#i58977c8e94dd4577b7dd02b6fd4ef00f_10) | | | | | | | | | | | | | | |

| [PART II](#i58977c8e94dd4577b7dd02b6fd4ef00f_37) | | | | | | | | | | | | | | |

| [Item 6.](#i58977c8e94dd4577b7dd02b6fd4ef00f_43) | | | | | | [\[RESERVED\]](#i58977c8e94dd4577b7dd02b6fd4ef00f_43) | | | | | | [78](#i58977c8e94dd4577b7dd02b6fd4ef00f_43) | | |

| [Item 9C.](#i58977c8e94dd4577b7dd02b6fd4ef00f_1615) | | | | | | [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#i58977c8e94dd4577b7dd02b6fd4ef00f_1615) | | | | | | [93](#i58977c8e94dd4577b7dd02b6fd4ef00f_1615) | | |

| [PART IV](#i58977c8e94dd4577b7dd02b6fd4ef00f_85) | | | | | | | | | | | | | | |

| [PART I](#i3994c168200943f68ab4a775a46b7f13_10) | | | | | | | | | | | | | | |

| [PART II](#i3994c168200943f68ab4a775a46b7f13_37) | | | | | | | | | | | | | | |

| [Item 6.](#i3994c168200943f68ab4a775a46b7f13_43) | | | | | | [Selected Financial Data](#i3994c168200943f68ab4a775a46b7f13_43) | | | | | | [74](#i3994c168200943f68ab4a775a46b7f13_43) | | |

| [PART IV](#i3994c168200943f68ab4a775a46b7f13_85) | | | | | | | | | | | | | | |

We also own an approximate 100-acre parcel of undeveloped land adjacent to our Tarrytown, New York [removed: location.][added: location, which we plan to start developing in 2022, primarily in connection with expanding our research and support facilities to accommodate our growth.]

We are in the process of further developing this property to support our growth and expand our manufacturing capacity.

This includes approximately 110,000 square feet of recently constructed space to support our growth and increased manufacturing capacity.

As of January [removed: 29, 2021,] [added: 27, 2022,] there were [removed: 162] [added: 166] shareholders of record of our Common Stock and [removed: 16] [added: 15] shareholders of record of our Class A Stock.

Set forth below is a line graph comparing the cumulative total shareholder return on Regeneron's Common Stock with the cumulative total return of (i) the NASDAQ US Benchmark Pharmaceuticals Total Return Index ("NQ US Pharma TR Index"), and (ii) Standard & Poor's 500 Stock Index ("S&P 500") for the period from December 31, [removed: 2015] [added: 2016] through December 31, [removed: 2020.][added: 2021.]

The comparison assumes that $100 was invested on December 31, [removed: 2015] [added: 2016] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | | | [removed: 12/31/2015] [added: 12/31/2016] | | | | | | [removed: 12/31/2016] [added: 12/31/2017] | | | | | | [removed: 12/31/2017] [added: 12/31/2018] | | | | | | [removed: 12/31/2018] [added: 12/31/2019] | | | | | | [removed: 12/31/2019] [added: 12/31/2020] | | | | | | [removed: 12/31/2020] [added: 12/31/2021] | | |

The table below reflects shares of Common Stock we repurchased under [removed: the] [added: our] share repurchase [removed: program approved in November 2019,] [added: programs,] as well as Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans, during the three months ended December 31, [removed: 2020.][added: 2021.]

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital [removed: Resources - *Share Repurchase Program*"] [added: Resources"] for further details of [removed: the] [added: our] share repurchase [removed: program.][added: programs.]

| Period | | | | | | Total Number of Shares Purchased | | | | | | Average Price Paid per Share | | | | | | Total Number of Shares Purchased as Part of [removed: a] Publicly Announced [removed: Program] [added: Programs] | | | | | | Approximate Dollar Value of Shares that May Yet [removed: Be Purchased] [added: Be Purchased] Under the [removed: Program(b)] [added: Programs *(in millions)*] | | | [added: | | |]

| (a) The difference between the total number of shares purchased and the total number of shares purchased as part of [removed: a] publicly announced [removed: program] [added: programs] relates to Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans. | | | | | | | | | | | | | | | | | | | | | | | | | | | [added: | | |]

| (b) In [removed: January] [added: November] 2021, our board of directors authorized [removed: a new] [added: an additional] share repurchase program to repurchase up to [removed: $1.5] [added: $3.0] billion of our Common Stock. [removed: See Item 7. "Liquidity and Capital Resources - Share Repurchase Program" for further details.] | | | | | | | | | | | | | | | | | | | | | | | | | | | [added: | | |]

| Regeneron | | | $ | 100.00 | | | | | $ | 102.42 | | | | | $ | 101.75 | | | | | $ | 102.29 | | | | | $ | 131.61 | | | | | $ | 172.03 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 119.42 | | | | | $ | 111.97 | | | | | $ | 144.31 | | | | | $ | 167.77 | | | | | $ | 212.89 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 120.40 | | | | | $ | 128.60 | | | | | $ | 147.25 | | | | | $ | 162.74 | | | | | $ | 202.43 | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| 10/1/2021–10/31/2021 | | | | | | 1,195,053 | | | | | | $ | 560.51 | | | | | 1,195,053 | | | | | | $ | 27.5 | | | | |

| 11/1/2021–11/30/2021 | | | | | | 110,500 | | | | | | $ | 645.90 | | | | | 110,500 | | | | | | $ | 2,956.1 | | (b) | | |

| 12/1/2021–12/31/2021 | | | | | | 271,289 | | | | | | $ | 643.03 | | | | | 176,000 | | | | | | $ | 2,845.0 | | | | |

| Total | | | | | | 1,576,842 | | | (a) | | | | | | | | | 1,481,553 | | | (a) | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Regeneron | | | $ | 100.00 | | | | | $ | 67.62 | | | | | $ | 69.25 | | | | | $ | 68.80 | | | | | $ | 69.17 | | | | | $ | 88.99 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 109.54 | | | | | $ | 130.81 | | | | | $ | 122.65 | | | | | $ | 158.07 | | | | | $ | 183.77 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 98.91 | | | | | $ | 119.09 | | | | | $ | 127.20 | | | | | $ | 145.65 | | | | | $ | 160.97 | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| 10/1/2020–10/31/2020 | | | | | | 72,870 | | | | | | $ | 556.23 | | | | | 72,870 | | | | | | $ | 332,144,883 | |

| 11/1/2020–11/30/2020 | | | | | | 596,867 | | | | | | $ | 524.36 | | | | | 596,867 | | | | | | $ | 19,172,999 | |

| 12/1/2020–12/31/2020 | | | | | | 41,636 | | | | | | $ | 516.76 | | | | | 36,854 | | | | | | — | | |

| Total | | | | | | 711,373 | | | (a) | | | | | | | | | 706,591 | | | (a) | | | | | |

The selected financial data set forth below for the years ended December 31, 2020, 2019, and 2018 and as of December 31, 2020 and 2019 are derived from and should be read in conjunction with our audited financial statements, including the notes thereto, included elsewhere in this report.

Certain prior year amounts have been reclassified to conform to the current year's presentation, including revisions related to the change in presentation for certain amounts received from collaborators who are not deemed to be our customers; see Note 1 to our Consolidated Financial Statements for further details.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | Year Ended December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | |

| *(In millions, except per share data)* | | | | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |

| Statement of Operations Data: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Revenues: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Net product sales | | | | | | $ | 5,567.6 | | | | | $ | 4,834.4 | | | | | $ | 4,106.2 | | | | | $ | 3,718.5 | | | | | $ | 3,338.4 | |

| Sanofi and Bayer collaboration revenue | | | | | | 2,372.5 | | | | | | 1,549.2 | | | | | | 910.4 | | | | | | 456.3 | | | | | | 223.9 | | |

| Other revenue | | | | | | 557.0 | | | | | | 174.0 | | | | | | 129.0 | | | | | | 82.7 | | | | | | 68.3 | | |

| | | | | | | 8,497.1 | | | | | | 6,557.6 | | | | | | 5,145.6 | | | | | | 4,257.5 | | | | | | 3,630.6 | | |

| Expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Research and development(1) | | | | | | 2,735.0 | | | | | | 2,450.0 | | | | | | 1,468.8 | | | | | | 1,180.5 | | | | | | 1,297.4 | | |

| Selling, general, and administrative | | | | | | 1,346.0 | | | | | | 1,341.9 | | | | | | 1,127.2 | | | | | | 940.0 | | | | | | 860.9 | | |

| Cost of goods sold | | | | | | 491.9 | | | | | | 362.3 | | | | | | 180.0 | | | | | | 202.5 | | | | | | 194.6 | | |

| Cost of collaboration and contract manufacturing | | | | | | 628.0 | | | | | | 402.8 | | | | | | 237.5 | | | | | | 169.4 | | | | | | 82.6 | | |

| Other operating (income) expense, net | | | | | | (280.4) | | | | | | (209.2) | | | | | | (402.3) | | | | | | (314.5) | | | | | | (135.6) | | |

| | | | | | | 4,920.5 | | | | | | 4,347.8 | | | | | | 2,611.2 | | | | | | 2,177.9 | | | | | | 2,299.9 | | |

| Income from operations | | | | | | 3,576.6 | | | | | | 2,209.8 | | | | | | 2,534.4 | | | | | | 2,079.6 | | | | | | 1,330.7 | | |

| Other income (expense), net | | | | | | 233.8 | | | | | | 219.3 | | | | | | 19.1 | | | | | | (1.1) | | | | | | (0.9) | | |

| Income before income taxes | | | | | | 3,810.4 | | | | | | 2,429.1 | | | | | | 2,553.5 | | | | | | 2,078.5 | | | | | | 1,329.8 | | |

| Income tax expense(2) | | | | | | 297.2 | | | | | | 313.3 | | | | | | 109.1 | | | | | | 880.0 | | | | | | 434.3 | | |

| Net income | | | | | | $ | 3,513.2 | | | | | $ | 2,115.8 | | | | | $ | 2,444.4 | | | | | $ | 1,198.5 | | | | | $ | 895.5 | |

| Net income per share - basic | | | | | | $ | 32.65 | | | | | $ | 19.38 | | | | | $ | 22.65 | | | | | $ | 11.27 | | | | | $ | 8.55 | |

| Net income per share - diluted | | | | | | $ | 30.52 | | | | | $ | 18.46 | | | | | $ | 21.29 | | | | | $ | 10.34 | | | | | $ | 7.70 | |

| | | | | | | As of December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | |

| *(In millions)* | | | | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |

| Balance Sheet Data: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Cash, cash equivalents, and marketable securities (current and non-current) | | | | | | $ | 6,722.6 | | | | | $ | 6,471.1 | | | | | $ | 4,564.9 | | | | | $ | 2,896.0 | | | | | $ | 1,902.9 | |

| Total assets | | | | | | $ | 17,163.3 | | | | | $ | 14,805.2 | | | | | $ | 11,734.5 | | | | | $ | 8,764.3 | | | | | $ | 6,973.5 | |

| Long-term debt(3) | | | | | | $ | 1,978.5 | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| Finance lease liabilities | | | | | | $ | 717.2 | | | | | $ | 713.9 | | | | | $ | 708.5 | | | | | $ | 703.5 | | | | | $ | 481.1 | |

| Stockholders' equity | | | | | | $ | 11,025.3 | | | | | $ | 11,089.7 | | | | | $ | 8,757.3 | | | | | $ | 6,144.1 | | | | | $ | 4,449.2 | |

| (1) Research and development expenses for the year ended December 31, 2019 includes a $400.0 million up-front payment to Alnylam in connection with our collaboration agreement. See Part I, Item 1. "Collaboration, License, and Other Agreements - Alnylam") for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (2) As a result of the Tax Cuts and Jobs Act being signed into law in December 2017, income taxes for the year ended December 31, 2017 included a charge of $326.2 million related to the re-measurement of our U.S. net deferred tax assets at the lower enacted corporate tax rate. See Note 14 to our Consolidated Financial Statements for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (3) In 2020, the Company issued and sold senior unsecured notes. See Item 7. "Liquidity and Capital Resources - Issuance of Senior Notes" for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

The [removed: financial statements] [added: information] required by this Item [removed: are] [added: is] included on pages F-1 through [removed: F-47] [added: F-42] of this [removed: report.][added: report and is incorporated herein by reference.]

The supplementary financial information required by this Item is included at page F-47 of this report.

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2020] [added: 2021] using the framework in *Internal Control - Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Based on that evaluation, our management has concluded that our internal control over financial reporting was effective as of December 31, [removed: 2020.][added: 2021.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2020] [added: 2021] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears under Part IV, Item 15.

There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, [removed: 2020] [added: 2021] that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

PART III

Not applicable.

PART III

The information required by this item (other than the information set forth in the next paragraph in this Item 10) will be included in our definitive proxy statement with respect to our [removed: 2021] [added: 2022] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2021] [added: 2022] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2021] [added: 2022] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2021] [added: 2022] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2021] [added: 2022] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

| 4.1 | | | [Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex41xdescriptiono.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex41xdescriptiono.htm)[(Incorporated] [added: 1934. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex41xdescriptiono.htm) | | |

| 10.2.17 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[(Incorporated] [added: 2019). (Incorporated] by reference from [removed: the](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm) [F](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[orm] [added: the Form] 10-K for the Registrant, for the year ended December 31, [removed: 201](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[9](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[,] [added: 2019,] filed February 7, [removed: 20](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[20](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] | | |

| 10.2.18 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P. Roy Vagelos, M.D. under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)[(Incorporated] [added: 2019). (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 201](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)[9](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)[,] [added: 2019,] filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm) | | |

| 10.2.19 + | | | [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm) [(Incorporated] [added: 2019). (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm) | | |

| 10.2.20 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)[(Incorporated] [added: 2019). (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm) | | |

| 10.2.21 + | | | [Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)[(Incorporated] [added: 2019). (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm) | | |

| 10.2.22 + | | | [Form of performance restricted stock unit award agreement and related notice of grant for use in connection with the grant of performance restricted stock units to Leonard S. Schleifer, M.D., Ph.D., George D. Yancopoulos, M.D., Ph.D., and P. Roy Vagelos, M.D. under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10222ar2014ltip.htm) [(Incorporated] [added: Plan. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10222ar2014ltip.htm) | | |

| 10.3 + | | | [removed: [Second](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm) [Amended] [added: [Second Amended] and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)[(Incorporated] [added: Plan. (Incorporated] by reference from the Registration Statement on Form S-8 for the Registrant, filed [removed: June](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm) [16](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)[, 20](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)[20](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)[.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)] [added: June 16, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)] | | |

| 10.3.1 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)] [added: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8,](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm) [2021](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)[.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)] | | |

| 10.3.2 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P. Roy Vagelos, M.D. under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)] [added: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)] | | |

| 10.3.3 + | | | [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] [added: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] | | |

| 10.3.4 + | | | [Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to P. Roy Vagelos, M.D. under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm)] [added: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm)] | | |

| 10.3.5 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)] [added: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)] | | |

| 10.3.6 + | | | [Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)] [added: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)] | | |

| 10.3.7 + | | | [Form of performance restricted stock unit award agreement and related notice of grant for use in connection with the grant of performance restricted stock units to Leonard S. Schleifer, M.D., Ph.D. and George D. Yancopoulos, M.D., Ph.D. under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)] [added: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)] | | |

| 10.11.2 | | | [Second Amendment Agreement, dated December 19, 2019, by and between Bayer HealthCare LLC and the [removed: Registrant.](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10102secondamen.htm) [(Incorporated] [added: Registrant. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10102secondamen.htm) | | |

| 10.29 | | | [Master Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2019, filed August 6, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex104.htm)] [added: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex104.htm)] | | |

| 10.29.1 | | | [Form of Co-Co Collaboration Agreement (Exhibit B to Master Agreement contained in Exhibit [removed: 10.2](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)[9](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)[).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)] [added: 10.29).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)] | | |

| 10.29.2 | | | [Form of License Agreement (Exhibit C to Master Agreement contained in Exhibit [removed: 10.2](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)[9](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)[).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)] [added: 10.29).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)] | | |

| 10.34 | | | [Project Agreement, dated as of July 6, 2020, by and between the Registrant and Advanced Technology [removed: International.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn_exx1034-12312020x10k.htm)] [added: International.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn_exx1034-12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn_exx1034-12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn_exx1034-12312020x10k.htm)] | | |

| 10.34.1 | | | [removed: [Modification](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm) [](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm)[No. 01](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm) [to Project](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm) [Agreement,] [added: [Modification No. 01 to Project Agreement,] dated as of October 13, 2020, by and between the Registrant and Advanced Technology [removed: International.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm)] [added: International.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm)] | | |

| 10.34.2 | | | [Modification No. 02 to Project Agreement, dated as of November 17, 2020, by and between the Registrant and Advanced Technology [removed: International.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10342x12312020x10k.htm)] [added: International.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10342x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10342x12312020x10k.htm)[(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10342x12312020x10k.htm)] | | |

| 21.1 | | | [Subsidiaries of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_211x12312020x10k.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_211x12312021x10k.htm)] | | |

| 23.1 | | | [Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_231x12312020x10k.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_231x12312021x10k.htm)] | | |

| 24.1 | | | [Power of Attorney (included on the signature page of this Annual Report on Form [removed: 10-K).](#i3994c168200943f68ab4a775a46b7f13_91)] [added: 10-K).](#i58977c8e94dd4577b7dd02b6fd4ef00f_91)] | | |

| 31.1 | | | [Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_311x12312020x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_311x12312021x10k.htm)] | | |

| 31.2 | | | [Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_312x12312020x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_312x12312021x10k.htm)] | | |

| 32 | | | [Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section [removed: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_32x12312020x10k.htm)] [added: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_32x12312021x10k.htm)] | | |

| 101 | | | Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Consolidated Balance Sheets as of December 31, [removed: 2020] [added: 2021] and [removed: 2019;] [added: 2020;] (ii) the Registrant's Consolidated Statements of Operations and Comprehensive Income for the years ended December 31, [added: 2021,] 2020, [removed: 2019,] and [removed: 2018;] [added: 2019;] (iii) the Registrant's Consolidated Statements of Stockholders’ Equity for the years ended December 31, [added: 2021,] 2020, [removed: 2019,] and [removed: 2018;] [added: 2019;] (iv) the Registrant's Consolidated Statements of Cash Flows for the years ended December 31, [added: 2021,] 2020, [removed: 2019,] and [removed: 2018;] [added: 2019;] and (v) the notes to the Registrant's Consolidated Financial Statements. | | |

| * | | | [removed: | | |] Portions of this document have been omitted and filed separately with the Commission pursuant to requests for confidential treatment pursuant to Rule 24b-2 | | |

| | | | [removed: | | |] Certain confidential portions of this exhibit were omitted in accordance with Item 601(b)(10) of Regulation S-K | | |

| + | | | [removed: | | |] Indicates a management contract or compensatory plan or arrangement | | |

| 10.14.4 | | | [Fourth Amendment to Amended and Restated License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regen-ex_10144x12312021x10k.htm) | | |

| 10.18.1 | | | [Amendment No. 1 to Credit Agreement, dated as of November 11, 2021, by and among the Registrant, as a borrower and guarantor; certain direct subsidiaries of the Registrant, as subsidiary borrowers; JPMorgan Chase Bank, N.A., as administrative agent; and the lenders party thereto.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_10181x12312021x10k.htm) | | |

| 10.20.1 | | | [First Amendment to Immuno-oncology License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant and Sanofi Biotechnology SAS.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_10201x12312021x10k.htm) | | |

| 10.25.1 | | | [First Amendment to Amended and Restated Participation Agreement, dated as of October 6, 2021, by and among Old Saw Mill Holdings LLC, as lessee; the Registrant, as parent guarantor; certain subsidiaries of the Registrant, as subsidiary guarantors; BA Leasing BSC, LLC, as lessor; Bank of America, N.A., as administrative agent; and the lenders party thereto.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_10251x12312021x10k.htm) | | |

| | | | | | |

| --- | --- | --- | --- | --- | --- |

| 10.36 | | | [Supply Agreement, dated as of January 12, 2021, by and between the Registrant and the U.S. Army Contracting Command, New Jersey. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2021, filed May 6, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000017/regn-ex_101x3312021x10q.htm) | | |

| 10.36.1 | | | [Modification P00004 to Supply Agreement, dated as of July 26, 2021, by and between the Registrant and the U.S. Army Contracting Command, New Jersey. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000033/regen-ex_101x9302021x10q.htm) | | |

| 10.36.2 | | | [Modification P00005 to Supply Agreement, dated as of September 14, 2021, by and between the Registrant and the U.S. Army Contracting Command, New Jersey. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000033/regen-ex_102x9302021x10q.htm) | | |

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| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Date: | | | February [removed: 8, 2021] [added: 7, 2022] | | | | | | By: | | | /s/ LEONARD S. SCHLEIFER | | | | | |

| /s/ LEONARD S. SCHLEIFER | | | | | | *President, Chief Executive Officer, and Director (Principal Executive Officer)* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ ROBERT E. LANDRY | | | | | | *Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ CHRISTOPHER R. FENIMORE | | | | | | *Senior Vice President, Controller (Principal Accounting Officer)* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ GEORGE D. YANCOPOULOS | | | | | | *President, Chief Scientific Officer, and Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ P. ROY VAGELOS | | | | | | [removed: *Chairman] [added: *Chair] of the [removed: Board*] [added: Board of Directors*] | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ BONNIE L. BASSLER | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ MICHAEL S. BROWN | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ N. ANTHONY COLES | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ JOSEPH L. GOLDSTEIN | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ CHRISTINE A. POON | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ ARTHUR F. RYAN | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ GEORGE L. SING | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ MARC TESSIER-LAVIGNE | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| /s/ HUDA Y. ZOGHBI | | | | | | *Director* | | | | | | February [removed: 8, 2021] [added: 7, 2022] | | |

| [Report of Independent Registered Public Accounting [removed: Firm](#i3994c168200943f68ab4a775a46b7f13_97)] [added: Firm (PCAOB ID](#i58977c8e94dd4577b7dd02b6fd4ef00f_97) 238[)](#i58977c8e94dd4577b7dd02b6fd4ef00f_97)] | | | | | | [removed: [F-](#i3994c168200943f68ab4a775a46b7f13_97)[2](#i3994c168200943f68ab4a775a46b7f13_97)] [added: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_97)[2](#i58977c8e94dd4577b7dd02b6fd4ef00f_97)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 20](#i3994c168200943f68ab4a775a46b7f13_100)[20](#i3994c168200943f68ab4a775a46b7f13_100) [and 2](#i3994c168200943f68ab4a775a46b7f13_100)[019](#i3994c168200943f68ab4a775a46b7f13_100)] [added: 2021 and 2020](#i58977c8e94dd4577b7dd02b6fd4ef00f_100)] | | | | | | [removed: [F-](#i3994c168200943f68ab4a775a46b7f13_100)[4](#i3994c168200943f68ab4a775a46b7f13_100)] [added: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_100)[4](#i58977c8e94dd4577b7dd02b6fd4ef00f_100)] | | |

| [Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, [removed: 20](#i3994c168200943f68ab4a775a46b7f13_106)[20](#i3994c168200943f68ab4a775a46b7f13_106)[, 201](#i3994c168200943f68ab4a775a46b7f13_106)[9](#i3994c168200943f68ab4a775a46b7f13_106)[,] [added: 2021, 2020,] and [removed: 2](#i3994c168200943f68ab4a775a46b7f13_106)[018](#i3994c168200943f68ab4a775a46b7f13_106)] [added: 2019](#i58977c8e94dd4577b7dd02b6fd4ef00f_103)] | | | | | | [removed: [F-](#i3994c168200943f68ab4a775a46b7f13_106)[5](#i3994c168200943f68ab4a775a46b7f13_106)] [added: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_103)[5](#i58977c8e94dd4577b7dd02b6fd4ef00f_103)] | | |

| [Consolidated Statements of Stockholders' Equity for the Years Ended December 31, [removed: 20](#i3994c168200943f68ab4a775a46b7f13_109)[20](#i3994c168200943f68ab4a775a46b7f13_109)[, 201](#i3994c168200943f68ab4a775a46b7f13_109)[9](#i3994c168200943f68ab4a775a46b7f13_109)[,] [added: 2021, 2020,] and [removed: 2](#i3994c168200943f68ab4a775a46b7f13_109)[018](#i3994c168200943f68ab4a775a46b7f13_109)] [added: 2019](#i58977c8e94dd4577b7dd02b6fd4ef00f_106)] | | | | | | [removed: [F-](#i3994c168200943f68ab4a775a46b7f13_109)[6](#i3994c168200943f68ab4a775a46b7f13_109)] [added: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_106)[6](#i58977c8e94dd4577b7dd02b6fd4ef00f_106)] | | |

| [Consolidated Statements of Cash Flows for the Years Ended December 31, [removed: 20](#i3994c168200943f68ab4a775a46b7f13_112)[20](#i3994c168200943f68ab4a775a46b7f13_112)[, 201](#i3994c168200943f68ab4a775a46b7f13_112)[9](#i3994c168200943f68ab4a775a46b7f13_112)[,] [added: 2021, 2020,] and [removed: 2](#i3994c168200943f68ab4a775a46b7f13_112)[018](#i3994c168200943f68ab4a775a46b7f13_112)] [added: 2019](#i58977c8e94dd4577b7dd02b6fd4ef00f_109)] | | | | | | [removed: [F-](#i3994c168200943f68ab4a775a46b7f13_112)[8](#i3994c168200943f68ab4a775a46b7f13_112)] [added: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_109)[8](#i58977c8e94dd4577b7dd02b6fd4ef00f_109)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i3994c168200943f68ab4a775a46b7f13_115)] [added: Statements](#i58977c8e94dd4577b7dd02b6fd4ef00f_112)] | | | | | | [removed: [F-](#i3994c168200943f68ab4a775a46b7f13_115)[9](#i3994c168200943f68ab4a775a46b7f13_115)] [added: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_112)[9](#i58977c8e94dd4577b7dd02b6fd4ef00f_112)] to [removed: [F-](#i3994c168200943f68ab4a775a46b7f13_190)[48](#i3994c168200943f68ab4a775a46b7f13_190)] [added: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_166)[42](#i58977c8e94dd4577b7dd02b6fd4ef00f_166)] | | |

We have audited the accompanying consolidated balance sheets of Regeneron Pharmaceuticals, Inc. and its subsidiaries (the "Company") as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the related consolidated statements of operations and comprehensive income, of stockholders' equity and of cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] including the related notes (collectively referred to as the "consolidated financial statements").

We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

A company's internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of [added: financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.]

[removed: *Recognition of] [added: *Accounting for] Other Operating Income related to Research and Development Up-front and Milestone Payments*

Other operating income for non-refundable up-front payments and development milestones for which management used an input method, was [removed: $276.7] [added: $42.5] million for the year ended December 31, [removed: 2020.][added: 2021.]

The principal considerations for our determination that performing procedures relating to [removed: recognition of] [added: the accounting for] other operating income related to research and development up-front and milestone payments is a critical audit matter are the significant judgment by management when determining the estimate of total expected research and development costs to complete the obligation, which in turn led to [removed: significant audit] [added: a high degree of auditor judgment, subjectivity and] effort in performing procedures and evaluating evidence to assess the reasonableness of the estimates of the costs to complete.

These procedures included testing the effectiveness of controls relating to the [added: accounting for] other operating income [removed: recognition process,] [added: related to research and development up-front and milestone payments,] including controls over the determination of the estimate of total expected research and development costs to complete the obligation.

| | | | [added: | | | 2021 | | | | | |] 2020 | | | | | | 2019 | | |

| Cash and cash equivalents | | | [added: | | |] $ | [added: 2,885.6 | | | | | $ |] 2,193.7 | | | | | $ | 1,617.8 | |

| Marketable securities | | | [removed: 1,393.3] [added: 2,809.1] | | | | | | [removed: 1,596.5] [added: 1,393.3] | | |

| Accounts [removed: receivable - trade,] [added: receivable,] net | | | [removed: 3,111.5] | | | [added: —] | | | [removed: 2,100.0] | | | [added: $ | 77.1 | |]

| Inventories | | | [removed: 1,916.6] [added: 1,951.3] | | | | | | [removed: 1,415.5] [added: 1,916.6] | | |

| Prepaid expenses and other current assets | | | [removed: 160.8] [added: 332.4] | | | | | | [removed: 273.7] [added: 160.8] | | |

| Total current assets | | | [removed: 9,779.1] [added: 14,014.9] | | | | | | [removed: 7,689.1] [added: 9,779.1] | | |

| Marketable securities | | | [removed: 3,135.6] [added: 6,838.0] | | | | | | [removed: 3,256.8] [added: 3,135.6] | | |

| Property, plant, and equipment, net | | | [removed: 3,221.6] [added: 3,482.2] | | | | | | [removed: 2,890.4] [added: 3,221.6] | | |

| Deferred tax assets | | | [removed: 858.9] [added: 876.9] | | | | | | [removed: 824.2] [added: 858.9] | | |

As of December 31, 2021, $322.5 million was included in other liabilities representing the amount of previously deferred non-refundable up-front and development milestones expected to be recognized in other operating income over time.

February 7, 2022

| | | | 2021 | | | | | | 2020 | | |

| Accounts receivable, net | | | 6,036.5 | | | | | | 4,114.7 | | |

| Finance lease liabilities | | | 719.7 | | | | | | — | | |

| Deferred revenue | | | 442.0 | | | | | | 577.7 | | |

| Deferred revenue | | | 73.3 | | | | | | 57.8 | | |

| Net income | | | | | | $ | 8,075.3 | | | | | $ | 3,513.2 | | | | | $ | 2,115.8 | |

| Balance, December 31, 2021 | | | | | | 1.8 | | | | | | — | | | | | | 126.2 | | | | | | $ | 0.1 | | | | | $ | 8,087.5 | | | | | $ | 18,968.3 | | | | | $ | (26.2) | | | | | (19.4) | | | | | | $ | (8,260.9) | | | | | $ | 18,768.8 | |

| Net income | | | | | | $ | 8,075.3 | | | | | $ | 3,513.2 | | | | | $ | 2,115.8 | |

| Gains on marketable and other securities, net | | | | | | (387.0) | | | | | | (221.8) | | | | | | (131.5) | | |

We currently have nine products that have received marketing approval by the U.S. Food and Drug Administration ("FDA").

In addition, REGEN-COV® has not been approved by the FDA, but has been authorized under an Emergency Use Authorization ("EUA") (see Note 3 and Note 6 for additional information).

As of December 31, 2021, three individual customers accounted for 91% (including 29% related to the U.S. government) of the Company's net trade accounts receivable balances.

- *Rebates:* The Company’s rebates include amounts paid to managed care organizations, group purchasing organizations, state Medicaid programs, and other rebate programs.

The Company estimates reductions to product sales for each type of rebate and records an allowance for rebates in the same period in which the related product sales are recognized.

The Company estimates reductions to product sales for each type of chargeback and records an allowance for chargebacks in the same period that the related product sales are recognized.

As of December 31, 2021, $322.5 million was included in other liabilities representing the amount of previously deferred non-refundable up-front and development milestones expected to be recognized in other operating income over time.

The estimates are revised, if necessary, in subsequent periods if actual expenses differ from those estimates.

The estimates are revised, if necessary, in subsequent periods if our actual share of profits or losses differ from those estimates.

| Evkeeza® | | | | | | 18.4 | | | | | | — | | | | | | — | | |

| Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States. Previously, the Company recorded net product sales of ARCALYST in the United States. | | | | | | | | | | | | | | | | | | | | |

| * Net product sales of REGEN-COV in the United States relate to product sold in connection with our agreements with the U.S. government. See Note 3 for further details. | | | | | | | | | | | | | | | | | | | | |

As of December 31, 2021 and 2020, the Company had $5.059 billion and $3.112 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

| U.S. government | | | 43 | | % | | | | * | | | | | | — | | |

| * Sales to the U.S. government represented less than 10% of total gross product revenue during the period | | | | | | | | | | | | | | | | | |

| Provisions | | | 1,047.1 | | | | | | 363.6 | | | | | | 150.4 | | | | | | 1,561.1 | | |

| Credits/payments | | | (1,034.7) | | | | | | (360.8) | | | | | | (127.6) | | | | | | (1,523.1) | | |

| Balance as of December 31, 2021 | | | $ | 214.6 | | | | | $ | 80.0 | | | | | $ | 67.6 | | | | | $ | 362.2 | |

| Regeneron's obligation for its share of Sanofi commercial expenses | | | | | | Selling, general, and administrative expense | | | | | | $ | (36.3) | | | | | $ | (22.4) | | | | | $ | (15.4) | |

| *(In millions)* | | | | | | 2021 | | | | | | 2020 | | |

In addition, the Company has no further obligations to develop drug product candidates under the Amended IO Discovery Agreement.

of 2.5% from January 1, 2024 through December 31, 2026.

| *(In millions)* | | | | | | 2021 | | | | | | 2020 | | |

| *(In millions)* | | | | | | | | | 2021 | | | | | | 2020 | | | | | | 2019 | | | | | |

| *(In millions)* | | | | | | 2021 | | | | | | 2020 | | |

As of December 31, 2021, the Company had received an aggregate $120.0 million of development milestones from Teva.

| *(In millions)* | | | | | | | | | 2021 | | | | | | 2020 | | | | | | 2019 | | | | | |

| *(In millions)* | | | | | | 2021 | | | | | | 2020 | | |

Pursuant to the agreement, the U.S. government was obligated to purchase 1.25 million doses of drug product, which we delivered by June 30, 2021, resulting in payments to the Company of $2.625 billion.

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

REGENERON PHARMACEUTICALS, INC.

*Changes in Accounting Principles*

As discussed in Note 1 to the consolidated financial statements, the Company changed the manner in which it accounts for amounts received from collaborative partners who are not deemed to be the Company's customers in 2020 and the manner in which it accounts for revenues from contracts with customers in 2018.

financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

February 8, 2021

| Accounts receivable - Sanofi, net | | | 404.7 | | | | | | 260.6 | | |

| Accounts receivable - other, net | | | 598.5 | | | | | | 425.0 | | |

| Deferred revenue - Sanofi | | | 341.7 | | | | | | 310.5 | | |

| Deferred revenue - other | | | 236.0 | | | | | | 71.6 | | |

| Other liabilities - Sanofi | | | 122.4 | | | | | | 85.0 | | |

| Deferred revenue - Sanofi | | | 16.7 | | | | | | 27.7 | | |

| Deferred revenue - other | | | 41.1 | | | | | | 77.6 | | |

| Other liabilities - Sanofi | | | 189.3 | | | | | | 482.0 | | |

| | | | | | | | | | | | | | | | | | | | | |

| Balance, December 31, 2017 | | | | | | 1.9 | | | | | | — | | | | | | 109.5 | | | | | | $ | 0.1 | | | | | $ | 3,512.9 | | | | | $ | 2,946.7 | | | | | $ | 0.6 | | | | | (3.8) | | | | | | $ | (316.2) | | | | | $ | 6,144.1 | |

| Cumulative-effect adjustment upon adoption of new accounting standards | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (136.8) | | | | | | (6.6) | | | | | | — | | | | | | — | | | | | | (143.4) | | |

| Other | | | | | | — | | | | | | — | | | | | | (10.0) | | |

The Company's products that have received marketing approval consist of EYLEA® (aflibercept), Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn), ARCALYST® (rilonacept), and ZALTRAP® (ziv-aflibercept)*.* In addition, REGEN-COV™ (casirivimab and imdevimab) received Emergency Use Authorization from the U.S. Food and Drug Administration ("FDA") for the treatment of mild to moderate COVID-19 in certain patients at high risk for progressing to severe COVID-19 and/or hospitalization.

Effective January 1, 2020, we changed the presentation of cost reimbursements from collaborators who are not deemed to be our customers from collaboration revenue to a reduction of the corresponding operating expense (*i.e.*, either Research and development or Selling, general, and administrative) incurred by us.

We made these changes in presentation because we believe the new presentation is preferable, as it better reflects the nature of the Company’s costs incurred and revenues earned pursuant to arrangements with collaborators and enhances the comparability of our financial statements with industry peers.

The change in presentation has been applied retrospectively.

The tables below present the impact of the change on the Company’s previously-filed Consolidated Balance Sheet as of December 31, 2019, the Consolidated Statement of Operations for the years ended December 31, 2019, and 2018, and the Consolidated Statement of Cash Flows for the years ended December 31, 2019, and 2018.

The Company’s previously-filed balance sheet has been updated to reflect the addition of the caption Other liabilities for the presentation of up-front and development milestones paid by collaborators that are deferred.

There was no impact on the Company’s previously-filed Consolidated Statements of Stockholders’ Equity.

| | | | | | | December 31, 2019 | | | | | | | | | | | | | | |

| Balance Sheet Data: | | | | | | As Previously Reported | | | | | | Adjustments | | | | | | As Revised | | |

| Deferred revenue - Sanofi (current) | | | | | | $ | 395.5 | | | | | $ | (85.0) | | | | | $ | 310.5 | |

| Deferred revenue - other (current) | | | | | | $ | 196.2 | | | | | $ | (124.6) | | | | | $ | 71.6 | |

| Other liabilities - Sanofi (current) | | | | | | — | | | | | | $ | 85.0 | | | | | $ | 85.0 | |

| Deferred revenue - Sanofi (noncurrent) | | | | | | $ | 509.7 | | | | | $ | (482.0) | | | | | $ | 27.7 | |

| Deferred revenue - other (noncurrent) | | | | | | $ | 109.3 | | | | | $ | (31.7) | | | | | $ | 77.6 | |

| Other liabilities - Sanofi (noncurrent) | | | | | | — | | | | | | $ | 482.0 | | | | | $ | 482.0 | |

| Other noncurrent liabilities | | | | | | $ | 286.0 | | | | | $ | 31.7 | | | | | $ | 317.7 | |

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Statement of Operations Data: | | | | | | As Previously Reported | | | | | | Adjustments | | | | | | As Revised | | | | | | As Previously Reported | | | | | | Adjustments | | | | | | As Revised | | |

| Sanofi collaboration revenue | | | | | | $ | 1,426.8 | | | | | $ | (1,023.2) | | | | | $ | 403.6 | | | | | $ | 1,111.1 | | | | | $ | (1,236.8) | | | | | $ | (125.7) | |

| Bayer collaboration revenue | | | | | | $ | 1,188.8 | | | | | $ | (43.2) | | | | | $ | 1,145.6 | | | | | $ | 1,076.7 | | | | | $ | (40.6) | | | | | $ | 1,036.1 | |