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PHARMD BIOLOGICS TRAINING PROGRAM At Regeneron, everything starts with science

At Regeneron, everything starts with science

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Page 1: At Regeneron, everything starts with science

PHARMDBIOLOGICSTRAINING PROGRAM

At Regeneron, everything starts with science

Page 2: At Regeneron, everything starts with science

CONTENTSAbout Regeneron

PharmD Biologics Training Program

PharmD Associates

PharmD Alumni

Want To Be Part of The BTP?

Program Leadership

Q&A

Clinical Product Candidates

Regeneron By The Numbers

Technology and Marketed Products

Leonard Schleifer, MD, PhD and George Yancopoulos, MD, PhD

Awards

About Our Location20

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Page 3: At Regeneron, everything starts with science

The passion for science, coupled with innovative ideas, and a support system with mentors who want to see you succeed makes Regeneron a great place to begin your career.

Nitin Kumar, PharmD, MBAFairleigh Dickinson University

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At Regeneron we make it our business every day to bring innovative thinking to the challenge of discovering and developing new medicines. Our pursuit has one singular intent – to improve therapeutic outcomes for patients.

ABOUT THE COMPANYRegeneron (NASDAQ: REGN) is a leading biotechnology company

that invents life-transforming medicines for people with serious

diseases. Founded and led for 30 years by physician-scientists,

our unique ability to repeatedly and consistently translate science

into medicine has led to seven FDA-approved treatments

and numerous product candidates in development,

all of which were homegrown in our laboratories. Our

medicines and pipeline are designed to help patients

with eye diseases, allergic and inflammatory diseases,

cancer, cardiovascular and metabolic diseases,

infectious diseases, pain and rare diseases.

THE REGENERON WAYScience drives our business and passion drives our science. Whether you’re doing science, supporting science or delivering science. It’s what we do.

We take the long view and tackle the big ideas, the unsolvable problems, and the bottlenecks that get in the way. We pursue ideas with passion and courage, to make a real difference.

It may not always be easy, but we figure it out and get it done. We have little appetite for unnecessary bureaucracy that can get in the way of innovation or quality.

While others talk about teamwork, we actually do it. When you work with smart, fun people, you bring out the best in each other and can do the extraordinary.

We do well by doing good. We act with integrity and pride ourselves on doing the right thing – by each other, our communities, our patients and the world around us.

Lead With Science

Take On Big Ideas

Be Great Together

Do What'sRight

Make It Happen

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PHARMDBIOLOGICSTRAINING PROGRAM

The PharmD Biologics Training Program (BTP) is an intensive, rotational, interdisciplinary program for graduating PharmD candidates. The objective for the BTP is to provide training by Regeneron subject matter experts and hands-on experience in a variety of global development roles. The BTP is for highly motivated individuals seeking to build a career in the biopharmaceutical industry with a foundation in Clinical Sciences, Clinical Operations, and Regulatory Affairs.

OBJECTIVESPharmD Associates will:

» Gain knowledge of biopharmaceutical development in a variety of clinical development related roles

» Develop a balanced foundation of skills through hands-on experience in industry areas such as clinical development and regulatory affairs

» Cultivate technical and non-technical skills through diverse cross functional experiences, ongoing mentorship, and targeted training

» Engage in interdisciplinary professional development sessions to maximize the learning and overall experience at Regeneron

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WHO IS THE PERFECT BTP CANDIDATE?The ideal applicant is flexible, intellectually curious, hard-working, and passionate about science and continuous learning.

The candidate graduated from an accredited pharmacy program. These individuals have a high academic standing preferably with some research experience. They have strong analytical, communication, and organizational skills, and are adept at leadership and team roles.

This unique program provides participants with the foundations for multiple potential roles within Global Development.Throughout the program, participants will cultivate technical and non-technical skills through diverse cross functional experiences, ongoing mentorship, and targeted training. Each assignment in this 2-year development program will expose candidates to critical issues and decision-making processes to gain broad experience across several clinical/scientific research areas. The selected program participants will acquire high level knowledge of the business and department operations, as well as gain hands-on work experience in a variety of areas.

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PROGRAM STRUCTUREThe two-year program consists of core and elective rotations.

» Regulatory Strategy

In Regulatory Affairs, the Associate will support and provide management for the operations governing pharmaceutical drug development to all aspects of Regeneron’s quality, preclinical and clinical drug development programs, policies, and procedures meeting the necessary state of compliance relative to all regulatory commitments. The Associate will

• Assist in managing the preparation, compilation, and organization of regulatory submissions including INDs, BLAs, IND amendments, and BLA supplements in accordance with title 21 CFR and all FDA and ICH guidelines

• Support the drafting of regulatory documents, including briefing materials and labeling documents

• Participate in cross-functional departmental team projects and product development activities/meetings

• Produce regulatory intelligence reports or deliverables as it relates to project strategies

During this rotation, the Associate will be able to learn about other roles within Regulatory, including Regulatory Intelligence, Advertising/Promotion, and Labeling.

CORE ROTATIONS » Clinical Development (Clinical Sciences and

Operations)

In Clinical Development, the Associate will support and own key activities across clinical trials in the Clinical Development Portfolio

In Clinical Operations, the Associate will

• Support key activities during the clinical trial start-up, maintenance, and close out

• Participate in site initiation visits (including presentations), site monitoring visits, patient enrollment planning and oversight

• Review clinical study budget and timelines, CRO and vendor management and interact cross functionally with various internal team members and external clinical sites and vendors

In Clinical Sciences, the Associate will

• Learn about clinical trial design and protocol writing

• Monitor the occurrence of adverse events, participate in clinical data review and in database locks

• Support the elaboration of clinical study reports and related documents

ELECTIVE ROTATIONSCan include but are not limited to:

» Medical Affairs• Headquarters and Field-based

Activities

• Medical Information

• Health Economics and Outcomes Research

• Medical Education

» Pharmacovigilance and Risk Management

» Clinical Pharmacology• Pharmacokinetics• Pharmacodynamics• Modeling

» Development Program Management

» Therapeutic Area Project Management

» Data Management

» Regulatory Affairs• Labeling

• CMC (Chemistry, Manufacturing and Controls)

• Advertising and Promotion

• Submission Project Management

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The Regeneron Way is evident in all aspects of the company, including the experienced leadership mentors, fast-paced clinical studies, and inspiring work culture. This program’s structure enables associates to not only contribute to meaningful work, but also gain critical exposure to the biopharmaceutical industry in its entirety.

Regeneron is a company who embraces science and whose number one goal is to help patients. Biologics are the future of modern medicine and the PharmD Biologics Program offers a unique rotational experience that allows the associate to experience all parts of the biologics drug development process.

CURRENT FIRST YEAR PHARMD ASSOCIATES

Shivani is currently supporting global Clinical Development in a number of immuno-oncology programs. Her role provides her clinical trial exposure spanning from phase 1 to phase 3.

SHIVANI GUPTA, PHARMDRutgers University

Brian is completing a rotation in Clinical Development supporting rare diseases and immunology that are primarily in early phases of development.

BRIAN SNOW, PHARMDVirginia Commonwealth University

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The program here at Regeneron is rooted in its mission of developing professionals who have a strong understanding of how core functional areas in the biopharmaceutical industry work together to support drug development. Regeneron’s commitment to patients is something that is apparent in every day.

The individuals at Regeneron have a real passion for science and it becomes clear when you join the Biologics Training Program and see first hand how driven Regeneron is to help their medicines reach their patients. The passion for science, coupled with innovative ideas, and a support system with mentors who want to see you succeed makes Regeneron a great place to begin your career.

CURRENT SECOND YEAR PHARMD ASSOCIATES

Having completed his rotation in Clinical Development, Nitin is currently rotating in Regulatory Affairs Strategy. He is supporting various programs, including the antibody cocktail for COVID-19 and the cardiovascular and metabolism programs.

NITIN KUMAR, PHARMD, MBAFairleigh Dickinson University

Ryan completed an 8 month rotation in Clinical Development and is in the second year of the PharmD Biologics Program. He is currently completing an 8 month rotation in Regulatory Affairs focused in Regulatory Strategy for treatment of inflammatory diseases

RYAN PENNINGTON, PHARMDUniversity of Connecticut

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Working across several functions and therapeutic areas as an Associate has not only supported my professional development through well-rounded hands-on experiences, it has also enabled me to build relationships with and learn from talented team members and mentors.

JENNIFER LIANG, PHARMDManager, Medical Affairs

The most effective industry professionals are those who understand how their contributions fit in to the bigger picture. The rotational nature of the PharmD Biologics Training Program provides every Associate with immersive experience in several distinct functional areas within Global Development. The combination of technical training and diverse exposure prepared me to become a Global Regulatory Liaison directly out of the program.

ELIZABETH BRADLEY, PHARMDManager, Regulatory Affairs

The ability to train within different functional areas during the PharmD Biologics Training Program prepared me as a Clinical Scientist to think and plan using parallel viewpoints and thought processes for the strategy, design and, implementation of early clinical development programs.

ANDREW KORDAHI, PHARMDAssociate Manager, Early Clinical Development

HOW HAS YOUR EXPERIENCE IN THE PHARMD PROGRAMPREPARED YOU FOR YOUR ROLES?

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APPLY AT CAREERS.REGENERON.COM AND SEARCH PHARMD BIOLOGICS TRAINING PROGRAM » Application must include CV and cover letter

» Interviews will be conducted virtually

IF YOU HAVE QUESTIONS, PLEASE CONTACT: » Carolyn Myers

([email protected]) – HR Contact

» Shivani Gupta ([email protected]) – First Year Associate

Application Opens at careers.regeneron.com

WANT TO BE PART OF THE BTP?

Online Application Portal Opens

Webinar Online Application Portal Closes

Virtual Interviews

OCTOBER 9TH OCTOBER 14TH NOVEMBER 1ST NOVEMBER - EARLY DECEMBER

WebinarMake sure to register

Application Closes Virtual Interviews

HERE

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PROGRAM LEADERSHIP

EXECUTIVE PROGRAM SPONSORS

PROGRAM ADVISORS AND MENTORS

I’m excited to be a program mentor where numerous opportunities exist for PharmD graduates to explore several departments through our core and elective rotations. Our ‘science first’ culture at Regeneron, which fosters curiosity, collaboration, and exploration, is embedded into the program, giving us opportunities to continually learn and grow at the company.

MIRIAM KORE, PHARMDSenior Director, Therapeutic Area Operations Leader

BARI KOWALVice President, Global Clinical Operations

MARY ALICE RAUDENBUSHExecutive Director, Regulatory Affairs

The Biologics Training Program at Regeneron is a two-way avenue, wherePharmD graduates have a unique opportunity to learn and contribute to thecutting-edge science and drug development that is performed acrossseveral departments, and at the same time it allows Regeneron Associatesto advance their people managing and mentoring skills.

EDUARDO FORLEO NETO, MDExecutive Director, Clinical Sciences

Since the inception of the program in 2015, we designed a program thatprovides a unique opportunity to obtain skills in various functions of the drugdevelopment process and gain scientific knowledge by working with leadersin the industry committed to science and innovation. We encourage ourBiologics Training Program Associates to be curious and discover their owncareer paths while working in clinical development, regulatory affairs, and anelective of their choice. Specifically, in regulatory affairs, the BTP associateswill understand the regulatory foundation in drug development while exploringother aspects of regulatory including labeling and advertising and promotion.

YUNJI KIM, PHARMDDirector, Regulatory Affairs

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PROGRAM ADVISORS AND MENTORS

I’m very excited to be a board member and a mentor for this program to share my passion for drug development and mentoring highly engaged and committed individuals like yourself to achieve your goals to be the next generation leaders. This program will offer you an opportunity to explore and find your passion for the area of your interest and to continually learn and grow in The Regeneron Way where we Lead With Science, Take On Big Ideas, Make It Happen, Be Great Together, and Do What’s Right. At Regeneron, it’s all about the PATIENT!

YAMINI PATEL, PHDSenior Director, Strategic Program Direction

The program advisors are available to help navigate your experience, help you connect with resources within the company, and

provide feedback to support your continued growth at

Regeneron.

Regeneron is a dynamic company and we have created a unique opportunity for highly motivated and scientifically curious individuals to train and work with some of the best in the industry. Although the demands are significant, the program provides a solid foundation of biopharmaceutical principles in a supportive “learn while doing” environment to encourage growth and exploration.

ROBERT LEWIS, PHARMDSenior Director, Medical Information

The Biologics Training Program at Regeneron provides PharmD Associates the opportunity to gain a broad experience across multiple development functions, providing a foundation to those beginning their biopharmaceutical careers. We strive to provide fellows with the opportunity to learn and explore and value them as integral members of our project teams.

STEPHANIE BIEDERMANNDirector, Development Program Management

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Q&A

1. What is the difference between a fellowship and our PharmD program?Some differences include that our program has no university affiliation. Additionally, the expectation from associates is that they are fully active members of the team.

2. What is the timeline of the program? How is the program broken down?The program is structured so that the associate first rotates in clinical development for 8 months, next rotates in regulatory affairs for 8 months, and finally has 8 months to pursue electives of their choosing.

3. In the Clinical Development program, are Clinical Operations/Clinical Sciences program 4 months each or combined?The Clinical Development program is a combination of Clinical Operations and Sciences for 8 months.

4. Do you choose your therapeutic area or is it assigned to you?Designation of therapeutic area is decided based on a combination of personal choice, which area has meaningful ongoing activity, the business needs, and availability of team members to mentor new associates.

5. When will we hear back after we submit our application?This is a rolling submission. Applicants are strongly encouraged to submit application materials as soon as possible to request an interview. The final day to submit an application is November 1st.

6. Will Regeneron host an informational webinar before applications are due? The informational webinar will be held on October 14th 2020 at 7:00 PM EST. Registration link can be found here

7. To whom should the cover letter and other application requirements be addressed?Please address your letter of intent to:PharmD Biologics Training ProgramRegeneron Pharmaceuticals777 Old Saw Mill River RdTarrytown, NY 10591

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CLINICAL PRODUCT CANDIDATES

Not for use in promotion.For approved corporate use only.

CEMIPLIMAB*PD-1 Antibody Non-small cell lung cancer (NSCLC), cervical cancer; adjuvant cutaneous squamous cell carcinoma (CSCC)

FASINUMAB†NGF Antibody Osteoarthritis pain of the knee or hip

REGN-EB3Ebola Multi-Antibody TherapyEbola virus infection

SARILUMAB* IL-6R Antibody Ex-U.S. study in hospitalized “critical” COVID-19 patients

EVINACUMABANGPTL-3 Antibody Homozygous familial hypercholesterolemia (HoFH)

REGN5093MET X MET AntibodyMET-altered advanced non-small cell lung cancer (NSCLC)

ALIROCUMAB PCSK9 Antibody Homozygous familial hypercholesterolemia (HoFH) in adults and pediatrics, heterozygous familial hypercholesterolemia (HeFH) in pediatrics

DUPILUMAB* IL-4R Antibody Atopic dermatitis in pediatric patients 6 mo.–11 y.o., asthma in pediatric patients 6-11 y.o., eosinophilic esophagitis in patients 6 and older, chronic obstructive pulmonary disease (COPD), bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, allergic bronchopulmonary aspergillosis

CEMIPLIMAB* PD-1 Antibody Basal cell carcinoma (BCC), metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), neoadjuvant CSCC

DUPILUMAB* IL-4R AntibodyPeanut allergy

EVINACUMABANGPTL-3 AntibodyRefractory hypercholesterolemia (both HeFH and non-FH), severe hypertriglyceridemia

GARETOSMABActivin-A Antibody Fibrodysplasia Ossificans Progressiva (FOP)

REGN3500* IL-33 Antibody Asthma, chronic obstructive pulmonary disease (COPD)

CEMIPLIMAB*PD-1 Antibody Cancer

REGN1979CD20 X CD3 Antibody B-cell non-Hodgkin lymphoma

REGN3767 LAG-3 Antibody Solid tumors, advanced hematologic malignancies

REGN4018*MUC16 X CD3 Antibody Platinum-resistant ovarian cancer

REGN1908-1909Fel d 1 Multi-Antibody Therapy Cat allergy

POZELIMABC5 Antibody Paroxysmal nocturnal hemoglobinuria, CD-55 deficient protein-losing enteropathy

REGN4461LEPR Agonist Antibody Generalized lipodystrophy

REGN5069GFRα3 Antibody Osteoarthritis pain of the knee

REGN5458*BCMA X CD3 AntibodyMultiple myeloma

AFLIBERCEPT VEGF-TrapRetinopathy of prematurity (ROP), high-dose formulation (8mg) for wet age-related macular degeneration (AMD) and diabetic macular edema (DME)

REGN5713-5714-5715Bet v 1 Antibodies Birch allergy

REGN1979CD20 X CD3 Antibody B-cell malignancies

REGN5459*BCMA X CD3 AntibodyMultiple myeloma

REGN5678PSMA X CD28 AntibodyProstate cancer

AFLIBERCEPT VEGF-TrapHigh-dose (8mg) for wet age-related macular degeneration (AMD)

SARILUMAB* IL-6R AntibodyPolyarticular-course juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis

REGN-COV2SARS-CoV-2 Virus Multi-Antibody TherapyMulti-dose Phase 1 safety study in healthy volunteers

REGN-COV2SARS-CoV-2 Virus Multi-Antibody TherapyTreatment for hospitalized and non-hospitalized patients with COVID-19

REGN-COV2SARS-CoV-2 Virus Multi-Antibody TherapyPrevention of COVID-19 in household contacts of diagnosed patients

I M M U N O L O G Y & I N F L A M M AT O R Y D I S E A S E S

C A R D I O V A S C U L A R / M E TA B O L I C D I S E A S E S

O N C O L O G Y I N F E C T I O U SD I S E A S E S

O P H T H A L M O L O G Y P A I N R A R E D I S E A S E S

* IN COLLABORATION WITH SANOFI † IN COLLABORATION WITH TEVA AND MITSUBISHI TANABEThis graphic displays pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been fully evaluated by any regulatory authorities for the indications described in this section.

PHASE 1 PHASE 2 PHASE 3

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REGENERON BY THE NUMBERS

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TECHNOLOGYOur core capabilities for target discovery and validation are enabled by a series of Regeneron-invented technologies that accelerate, improve and disrupt the traditional drug discovery and development process. Collectively, these technologies represent some of the most valuable biotechnologies ever created, and aid our efforts to continuously accelerate the average timeline from discovery to drug approval — ultimately allowing us to help more patients around the world, faster. We will continue to raise the bar for R&D excellence and productivity in the biotech industry.

MARKETED PRODUCTS

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Regeneron has become one of the great science-driven companies of our generation, with seven approved treatments, an entirely homegrown pipeline and the best technologies in the business. We got here by following the science and trusting our people. But at Regeneron, we’re never done. Our goal is to continue pushing the boundaries of science, to the extent that we aren’t even able to imagine the breakthroughs and cures we will be known for in ten or twenty years. It’s an incredible time to be at Regeneron, as we stand on the edge of an unprecedented future.

GEORGE D. YANCOPOULOS, MD, PHDFounding Scientist, President & Chief Scientific Officer

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AWARDS

Fortune: Change the World, 2020

Fortune: Best Companies to Work for, 2020

Newsweek, America’s Most Responsible Companies, 2020

Civic 50: Most Community-Minded Companies in the Nation, 2020

Fast Company: Best Workplaces for Innovators, 2020

Great Places to Work: Best Workplace in Ireland, 2020

IDEA Pharma, Pharmaceutical Invention Index, 2019

RobecoSAM and S&P Dow Jones Indices: Dow Jones Sustainability World Index, 2019

Science: Top Employer, 2019

Harvard Business Review: Best Performing CEOs, 2019

Shingo Institute: The Shingo Prize, 2019

Forbes: Top 10 Most Innovative Companies, 2018

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ABOUT OUR LOCATION

The PharmD Biologics Training Program is located in Tarrytown, NY. Tarrytown is located along the eastern bank of the Hudson River, about 25 miles north of midtown Manhattan.

In 2012, Forbes named Tarrytown as one of the prettiest towns in America and was ranked second in the top 10 places to live in New York State for 2014 according to the national online real estate brokerage, Movoto.

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