Pharmaceutical Innovation and Invention Index 2021 W H I T E PA P E R Celebrating the Most Innovative and Inventive Companies in Pharma 2 Introduction The tenth annual Pharmaceutical Innovation Index is a Here’s to the next 10 years - celebrating the time to reflect on why it exists at all. We (still) have an successes of one of the great industries. When the industry that behaves as if the molecule does all the world asked, in 2020, a few companies delivered - work, and that simply getting it into the pipeline is 99% not just in discovery, but in painstaking development, of what matters… However, 2020, more than ever, manufacture, distribution and more. Those are the revealed how much difference a company, and its real lessons of innovation - that it is hard and decisions, can make. worthwhile, and that it is still down to people and their decisions. The Index focuses on value creation, on the differential ability to launch pipeline successfully. That no two Mike Rea, companies are alike in this fundamental ability is as CEO evident in this year’s index as it has ever been. We still can put hand to heart and say that a molecule given to two different companies will have a different outcome - when and how it fails, or when and how it succeeds - and that there are a lot of companies who have no choice but to trade on past glories (revenues from products launched 15, 20 or more years ago). MORE 2021 Pharmaceutical Innovation Index INNOVATIVE 1 BMS Incyte Pfizer Eli Lilly BeiGene 6 Johnson & Johnson AstraZeneca INVENTIVE Regeneron MORE Novartis 11 Takeda Merck & Co Gilead Moderna Roche 2021 Pharmaceutical Invention Index GSK 16 AbbVie Amgen Boehringer Ingelheim Biogen 21 Bayer Vertex Daiichi Sankyo Seagen Sanofi Merck KGaA 26 Eisai Alexion Astellas Otsuka H. Lundbeck 31 Novo Nordisk 31 26 21 16 11 6 1 2 ©2021 IDEA Pharma | ideapharma.com Invention vs. Innovation 3 Meaningful Development Launch Novelty Asymmetric Performance P HA RM A CE UT I CA L P HA RM A CE UT I CA L INVENTION INDEX INNOVATION INDEX Invention: Bringing ideas or Innovation: Return on technologies together in a novel invention; creation of way to create something that did meaningful value from not exist before. invention. 2 ©2021 IDEA Pharma | ideapharma.com 4 Pharmaceutical Innovation Index 2021 Top 10 The Pharmaceutical Innovation Index seeks to This tenth annual index provides a systematic answer the provocative question, ‘If two pharma and objective assessment of how well the top companies were given the same molecule in early 30 companies perform in bringing new phase, which of the two would be better in medicines to market and commercializing them developing and launching it?”. The Innovation successfully. index ranks companies utilizing a range of clinical, regulatory, and commercial metrics, ranging from the corporate level down to individual product decisions and outcomes. 2021 C O M PA N IES CHANGE 2020 1 Eli Lilly +4 5 2 Roche -1 1 3 Regeneron +7 10 4 Seagen - NR 5 Incyte - NR 6 GlaxoSmithKline +5 11 7 Sanofi +10 17 8 AstraZeneca +1 9 8 Pfizer +7 15 10 Gilead Sciences +5 15 10 Novartis -7 3 Companies included in the Innovation index for the first time in 2021: Incyte, Moderna, BeiGene and Seagen ©2021 IDEA Pharma | ideapharma.com 5 Pharmaceutical Invention Index 2021 Top 10 Released for the first time in 2019, and now in its 3rd year, the Pharmaceutical Invention Index examines pipeline invention and novelty by taking a focused look at the breadth and depth of novel agents currently being developed within the Top 30 Pharma pipelines. The Invention Index provides a more forward-looking view of who is developing medicines that matter, embracing science and innovations in R&D. 2021 C O M PA N IES CHANGE 2020 1 Bristol-Myers Squibb +1 2 2 Incyte - NR 3 Pfizer +8 11 4 Eli Lilly -1 3 5 BeiGene - NR 6 AstraZeneca -5 1 6 Regeneron 0 6 8 Johnson & Johnson +5 13 9 Novartis -5 4 10 Merck & Co -2 8 Companies included in the Invention index for the first time in 2021: Incyte, Moderna, BeiGene and Seagen ©2021 IDEA Pharma | ideapharma.com 6 Top Performers Across Both Innovation and Invention Rankings: ELI LILLY 1: Innovation 4: Invention One year after regressing to 5th place on the innovation scale, The newly approved Tauvid along with Amyvid which was Eli Lilly has claimed the top spot for 2021. The four-spot rise is launched back in 2012, provide physicians new and due mainly to a plethora of positive clinical results, notable meaningful tools for the evaluation of patients suspected of regulatory wins, accompanied by a solid financial performance. having AD (highlighting beta-amyloid neuritic plaques and tau NFTs in the brain). This is a significant step forward in Lilly brought in nearly $24.6 billion in revenue in 2020, an AD as determining the anatomic distribution and density of impressive 10% increase from the prior year, with the biggest tau NFTs in the brain was previously only possible at revenue growth being driven by its Diabetes portfolio- primarily autopsy. Jardiance and Trulicity. Lilly’s total R&D investment was up 9% from last year, although its R&D spend as a proportion of In Oncology Lilly scored an FDA approval for Cyramza in revenue was down from 25.1% in 2019, to 24.8% combination with Roche’s Tarceva as a first-line treatment in 2020. for EGFR-mutated NSCLC. Additionally, the company marked its contribution to the industry-wide response to Perhaps the biggest win of the year for Lilly came from its COVID-19 by scoring an emergency use authorization for migraine drug Emgality, as it rolled out key differentiated data, Omulant to be used in combination with remdesivir for making it the first drug in its class to demonstrate a reduction in COVID-19 hospitalized patients in need of non-high-flow total pain burden for patients with episodic and chronic oxygen without mechanical ventilation. This came shortly migraines. The data was collected using electronic patient after it gained an EUA for bamlanivimab, beating diaries, where patients reported their pain burden by tracking Regeneron as the first antibody therapy for COVID-19 the length (i.e., time) and intensity of pain. This exceptional infection. The approval of not one, but two therapies for example of innovation gave Emgality a significant competitive COVID-19 patients is yet another example of Lilly’s edge over its competitors Aimovig (Amgen) and Ajovy (Teva). commitment to innovation which ultimately contributed to its ability to secure the top spot in the 2021 Innovation Index. Lilly also scored two novel drug approvals in 2020. In oncology, Retevmo (selpercatinib) was approved by the FDA for treatment Furthermore, Lilly continues to boast a healthy pipeline. Late of patients with certain RET positive cancers including NSCLC, in 2020, the company announced topline phase III results medullary thyroid cancer (MTC), and other advanced thyroid from its promising novel diabetes treatment trizepatide, cancers. Retevmo’s approval marks the first of its kind to treat which significantly reduced A1C and body weight in people cancer patients with RET gene mutations. with type II diabetes. Lilly’s new anti-IL-23p19 Mirikizumab met all primary and secondary endpoints in its phase III trial Later in the year, Lilly’s Tauvid (flortaucipir F 18 injection) was for moderate to severe plaque psoriasis. These, along with approved as an Alzheimer’s disease (AD) diagnostic agent for the promising results of lebrikizumab in atopic dermatitis positron emission tomography (PET) brain imaging. The and Pirtobrutinibin in oncology demonstrate that Lilly may approval was achieved by Lilly’s fully owned subsidiary, Avid continue to hold a top 10 position on the Pharmaceutical Radiopharmaceuticals, and comes after 2 successful clinical Innovation and Invention Index for years to come. studies demonstrated the diagnostic tool was effective in estimating the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adults with cognitive impairment. Tauvid marks the first and only approved diagnostic agent to image tau NFTs in the brain. ©2021 IDEA Pharma | ideapharma.com 7 ROCHE 2: Innovation 13: Invention Roche falls below the top 10 on the Invention scale , but the As mentioned above, Roche scored the highest number company ranks 2nd on the Innovation ranking, driven largely of novel FDA approvals in 2020. Its new drug Evrysdi, by having the highest number of novel FDA drug approvals was approved for the treatment of spinal muscular in 2020. atrophy where it is expected to challenge Biogen’s blockbuster Spinraza by stealing considerable market Roche had a bit of a mixed financial year across the board, share due to its competitive pricing and convenient oral with total revenue down 5% in 2020, while R&D spend and dosing. Enspryng was another novel therapy the FDA net income was up 4% and 7%, respectively. Its approved in 2020 for the treatment of neuromyelitis pharmaceutical sales declined by 2%, while its diagnostics optica spectrum disorder- a serious neurological disease sales were driven up 14% by sales of its COVID-19 related with high unmet need that can lead to blindness, tests. Roche’s blockbuster MS drug Ocrevus brought in paralysis, nerve pain, and respiratory failure. over $4 billion in sales in 2020, up 24% from 2019 while at the same time, its Oncology portfolio experienced a 10% Its third novel approval, Gavreto, which Roche shares decline in sales, with Avastin bringing in shy of $5 billion, a rights to with partner Blueprint Medicines, was approved 25% drop from 2019. for the treatment of RET positive NSCLC becoming the second drug approved for this indication. Roche also encountered some setbacks with Tecentriq and Venclexta failing key phase III trials; in the case of Venclexta, it was significant enough to place its AML FDA approval (attained back in 2018 with partner AbbVie) in jeopardy. ©2021 IDEA Pharma | ideapharma.com 8 REGENERON 3: Innovation 6: Invention Regeneron has climbed 7 positions, from 10th on last year’s Regeneron’s COVID-19 response hit a setback when its index, to 3rd. The climb represents the company’s strong drug Kevzara failed to demonstrate a shortening of commitment to growing Dupixent across indications, a hospital visits in a 420-patient study. However, the myriad of positive clinical data readouts, multiple regulatory company triumphed with a COVID-19 antibody cocktail, approvals, and a strong financial performance in 2020. which marked the second antibody treatment to secure FDA EUA status. Regeneron’s antibody treatment cut the Regeneron’s revenue grew by 30% in 2020, bringing in risk of ventilator requirement, or death by approximately approximately $8.5 billion, while its net revenue grew by half in hospitalized patients with low-flow oxygen. 66%, and R&D spend increased by 36% last year. In Oncology, Regeneron’s bispecific antibody The biggest growth came from Dupixent, bringing in a little REGN5458, demonstrated deep and durable responses over $4 billion in 2020, an impressive increase of 75% from in patients with heavily pre-treated multiple myeloma. 2019. Last year, Sanofi and Regeneron’s Dupixent picked This promising new therapy will deliver hope for patients up a Breakthrough therapy designation in Eosinophilic who have few treatment options remaining. Additionally, Esophagitis (EoE) paving the way to an FDA approval to the company received an FDA priority review for Libtayo mark the first therapy approved for EoE. The companies for the treatment of first-line non-small cell lung cancer are awaiting other key data for Dupixent in COPD, prurigo (NSCLC) after the I-O therapy cut the risk of death by nodularis- a condition that causes hard, itchy lumps on the 43% in patients with PD-L1 levels of 50% or more. In skin and has no FDA-approved therapies- and chronic addition to NSCLC, the drug is the first and only spontaneous urticaria-aka hives. treatment indicated for patients with locally advanced basal cell carcinoma (laBCC) who have previously been treated with a hedgehog pathway inhibitor (or for whom an HHI is not appropriate), and advanced CSCC- where it’s sure to face steep competition from IO rival Keytruda. SEAGEN 4: Innovation 22: Invention Seagen – formerly Seattle Genetics – has not only Tukysa, was approved this past year in combination with appeared for the first time on the Pharmaceutical Roche’s Herceptin and chemo for treatment of patients Innovation and Invention Index, but it has also captured the with metastatic, HER2-positive breast cancer who have 4th position on the innovation scale. failed on a first-line treatment. The company has already filed a BLA for what is expected to be its fourth approval Seagen delivered a strong financial performance in 2020, of its novel treatment tisotumab vedotin (TV) for patients with a total revenue growth of 137%, reporting nearly $2.2 with recurrent or metastatic cervical cancer, and it is billion. The specialty oncology company has 3 marketed currently investigating this agent in combination with oncology products: antibody drug conjugates Adcetris and Keytruda in metastatic cervical cancer. Padcev, and newly approved best-in-class TYK inhibitor Tukysa. Additionally, Seagen has 9 pipeline program Despite its size, Seagen’s innovative approach to candidates, two of which are in late-stage development. oncology drug development by leveraging its capabilities, while maximising value through partnerships, drove its success on the innovation scale this year. ©2021 IDEA Pharma | ideapharma.com 9 INCYTE 5: Innovation 2: Invention Appearing for the first time on the Pharmaceutical Jakafi, which brought in just shy of $ 2 billion dollars in Innovation and Invention Index, Incyte has ranked among revenue in 2020 and is forecasted to make $3 billion the top five companies for 2021. Incyte’s total revenue grew dollars in peak year sales, now holds a new indication by an impressive 24% in 2020, and that success is partially under its belt as it marked a historic approval by attributed to blockbuster JAK inhibitor Jakafi which grew by becoming the first FDA-approved drug for patients with 15% in net product revenue in 2020. acute graft-versus-host disease who do not respond to steroids. The company scored two novel oncology approvals in 2020. Monjuvi received its first approval to treat adults with Jakafi narrowly missed the mark in achieving a diffuse large B-cell lymphoma (DLBCL) whose disease has statistically significant mortality improvement in severe come back or has not improved after previous treatments, COVID-19 patients on mechanical ventilation. However, and who are not eligible to receive stem cell transplant, and the U.S. trial population data, that made up 90% of the Pemazyre which received approval for patients with study, did achieve statistically significant improvement in cholangiocarcinoma, a rare form of cancer that forms in bile mortality. The company is committed to working with the ducts. FDA to make the drug available in this patient population with high unmet medical need. Incyte and Lilly’s other JAK inhibitor Olumiant yielded positive phase III results in patients with atopic dermatitis, as it marches closer towards an approval in a highly competitive market where it will face competition from Sanofi and Regeneron’s Dupixent. ©2021 IDEA Pharma | ideapharma.com 10 ASTRA ZENECA 8: Innovation 6: Invention AstraZeneca (AZ) is up one position, coming in at number 8 In chronic lung disease, AZ gained traction with its three- on the 2021 innovation scale, and a drop to 6th on the 2021 in-one inhaler Breztri, which demonstrated significantly invention scale after holding the 1st place in last year’s reduced exacerbations in patients with moderate to Invention ranking. One of the drivers of this year’s severe COPD. Furthering the effort, Fasenra scored innovation ranking is attributed to Tagrisso’s major positive phase III data by demonstrating that it expansion by achieving an FDA approval in early-stage significantly reduced the size of nasal polyps and the EGFR-mutated NSCLC patients. This follows their previous seriousness of nasal blockage among patients suffering success in creating a new standard for treating metastatic from chronic rhinosinusitis with nasal polyps. In another EGFR-mutated NSCLC. Tagrisso’s early-stage approval phase 3b trial it spared the use of corticosteroids use in was granted based on the phase III Adaura trial, which was 62% of severe asthma patients. stopped two years early due to early positive efficacy signal. Data from the Adaura trial also demonstrated that On the flip side, AZ’s invention score was heavily Tagrisso when used as an adjuvant post-surgery, cut the impacted by tezepelumab’s phase III trial failure, as the risk of CNS recurrence by an impressive 82%. drug missed the mark on achieving statistical significance. compared to placebo, in reducing the daily Also in oncology, AZ and Merck’s Lynparza received an oral corticosteroid dose without the loss of asthma FDA nod for use in ovarian cancer patients regardless of control. BRCA mutation status as a maintenance therapy in combination with Roche’s Avastin. Later in the year, AZ Overall, the outlook for 2020 was very positive for AZ. secured another FDA approval in prostate cancer with data The company advanced therapies across multiple that demonstrated the drug cut the risk of death by 31% therapy areas, as well as developed a lifesaving COVID- over J&J’s Zytiga and Pfizer and Astellas’s Xtandi. 19 vaccine that is currently being administered Lynparza now holds the lead among the PARP inhibitors by worldwide. having the highest number of indications under its belt across tumor types, including ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. ©2021 IDEA Pharma | ideapharma.com 11 PFIZER 8: Innovation 3: Invention Pfizer jumped up significantly on both the Invention and Beyond its response to COVID-19, Pfizer demonstrated Innovation scale this year, landing 8th on the Innovation its continued commitment to advancing life-saving and 3rd on the Invention rankings. The company made treatments to its patients. In Oncology, Pfizer achieved nearly $42 billion in revenue in 2020, only a 2% change FDA approvals for two of its treatments. Braftovi plus from 2019, with the highest revenue generated from its top- cetuximab was approved for adults with metastatic selling vaccine Prevnar 13/Prevenar 13, which made $5.8 colorectal cancer, and Bavencio plus chemotherapy was billion in revenue. While Prevnar 13 has held the crown as approved for adults with advanced urothelial carcinoma the world’s top-selling vaccine for many years, Pfizer based on data where it demonstrated that patients on the estimates that its new COVID-19 vaccine BNT162b2 is drug lived for a median 21.4 months vs. 14.3-month forecasted to generate approximately $15 billion in median for patients on the control arm. In addition, Pfizer revenues in 2021, setting a new record in vaccine revenues announced positive phase III data for Lorbrena, the drug for Pfizer. it has developed as a follow-up to Xalkori. The drug significantly improved progression-free survival in first- One of Pfizer's biggest developments in 2020 was the line ALK-positive NSCLC vs its predecessor Xalkori. unprecedented development of its groundbreaking mRNA COVID-19 vaccine in less than 8 months, marking the Earlier in 2020, Pfizer announced top-line results from a historic first COVID-19 vaccine to be authorized for use in third phase III trial of its pipeline agent abrocitinib in the United States. moderate to severe atopic dermatitis, solidifying its commitment to further strengthening its JAK portfolio. ©2021 IDEA Pharma | ideapharma.com 12 NOVARTIS 10: Innovation 9: Invention Retaining its place among the top 10 yet dropping several Novartis made significant progress in breast cancer spots on the Pharmaceutical Innovation and Invention treatment last year. The company reported positive data Index, Novartis settles into the 10th and 9th positions on the from Kisqali, a CDK inhibitor for menopausal women with innovation and invention rankings, respectively, for 2021. HR+ or HER2- metastatic breast cancer, by showing that Despite the challenges of the global pandemic, Novartis Kisqali in combination with different endocrine therapies delivered on its commitment to bringing meaningful reduced the risk of death by 24%. Additionally, its kinase treatments to its patients in 2020. inhibitor Piqray, demonstrated that in combination with chemo the treatment almost doubled the time to disease Novartis’ global revenue grew 3% to $ 48.7 billion in 2020. progression or death in comparison to chemo alone. Novartis’ products that grew in sales included immunology blockbuster Cosentyx, which grew by 13%, bringing in Novartis also reported several positive clinical data from nearly $ 4 billion in 2020, and Entresto, a treatment for its novel pipeline assets. Most noteworthy were the heart failure, which grew by 44%, reporting nearly $2.5 superior phase III data from its investigational STAMP billion in sales. inhibitor asciminib (ABL001) which beat Pfizer’s Bosulif with superior MMR rate in chronic myeloid leukemia. Novartis successfully got two novel treatments approved in 2020. Isturisa was approved for patients with Cushing’s Novartis has had a consistent track record of holding a disease- a rare disease in which the adrenal glands make position among the top 10 most innovative companies in too much of the cortisol hormone because of stimulation Pharma, and this year is no different despite the global from a pituitary tumor. The second, Tabrecta-was approved challenges of the COVID-19 pandemic. under an accelerated approval pathway based on the overall response rate and duration of response, is indicated for treatment of adult patients with metastatic NSCLC whose tumors have a mutation that leads to mesenchymal- epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. ©2021 IDEA Pharma | ideapharma.com 13 GILEAD 10: Innovation 11: Invention This year, Gilead landed 10th on the Innovation and 11th on Gilead’s pipeline assets span three key focus areas: viral the Invention rankings. diseases, inflammatory diseases, and oncology, with 51 active clinical stage programs. Last year Gilead reported Gilead’s year-end revenues were up 10% to $24.4 billion, top-line data from its promising new investigational LAI primarily due to Veklury (remdesivir), which grew by 30% in HIV treatment lenacapavir, which reduced viral load in 2020. Whereas Yescarta, the cell therapy Gilead inherited 88% of participants in the highly treatment experienced from Kite and spent nearly $12 billion to acquire, brought in setting. Lenacapavir, which has received an FDA only $607 million, and its slowing growth has Gilead Breakthrough designation, is a promising new HIV-1 rethinking its decision. Despite its underperformance, capsid inhibitor that will provide a new option for patients Gilead is committed to expanding Yescarta into additional with limited treatment options. indications. Their cell therapy is the first CAR T-cell therapy to demonstrate impressive response rates and durable clinical benefit in a pivotal Indolent Non-Hodgkin Lymphoma study. The company reported that 92% of patients with relapsed or refractory iNHL achieved a response to Yescarta, including 76% with a complete response. BRISTOL M YERS SQUIBB 17: Innovation 1: Invention This year Bristol Myers Squibb has claimed the top spot in Earlier in 2020, BMS reported its decision to withdraw its our Invention ranking. This is largely attributed to BMS EMA application for authorization for the use of Opdivo having substantially expanded its pipeline through its and Yervoy in the treatment of first-line metastatic acquisition of Celgene. Through that acquisition, BMS NSCLC on the basis on its CheckMate-227 data. This inherited the new blockbuster hopeful MS drug ozanimod, came as an EMA committee concluded that a full for which it received FDA approval last year. assessment of the application was not possible given the multiple changes made in the trial protocol by BMS. Later The company delivered an impressive financial in the year, positive news did follow Opdivo and Yervoy performance in 2020, as it reported $42.5 billion in as BMS expanded the duo into a number of indications revenues in 2020, an increase of 63% from the previous including hepatocellular carcinoma (HCC), NSCLC year. Its highest selling drug in 2020, Revlimid-a legacy (recurrent or metastatic), advanced esophageal Celgene drug launched back in 2005, brought in $12 billion squamous cell carcinoma (ESCC), malignant pleural in sales, its runner up Eliquis and Opdivo brought in $9 mesothelioma, and advanced renal cell carcinoma. billion and nearly $7 billion, respectively. As BMS transforms its high potential inventions into With a new boosted pipeline, BMS reported numerous successful innovations, we expect to see it continue to clinical “wins” in 2020. Its highly promising TYK2 oral rise up the Innovation rankings in the coming years. treatment which is in development for multiple immune- mediated diseases, has delivered exemptional “biologic- level” results in patients with moderate-to-severe plaque psoriasis. Additionally, the drug is currently in phase II being investigated in patients with psoriatic arthritis, where it has also delivered promising results. ©2021 IDEA Pharma | ideapharma.com 14 PII Innovation Methodology HYPOTHESIS: If two companies each had the same NCE at the same stage of development (end of Phase 1), which company would do the best job of commercializing the product? CONSTRAINTS: This hypothesis cannot be measured directly, therefore, a surrogate measures is required. Each measure of the index must be measured universally across ALL pharmaceutical companies under consideration in a comparable manner and be publicly accessible. The Pharmaceutical Innovation Index consists of the following key metrics: 1. ‘Freshness Index’ - percentage of company sales generated by products launched in the last three and five years (a measure of a company’s ability to “refresh” its portfolio in the face of patent loss, providing a comprehensive portfolio) 2. Regulatory designations & approvals 3. Financial performance related to (but not limited to): a) Revenue growth (1-year, as well as 5-year change) b) R&D spend (1-year, as well as 5-year change) 4. In addition, IDEA Pharma monitors company websites, annual reports and industry sites to identify key events related to (but not limited to): a) Label expansions of currently approved branded products b) Progression of assets to next phase c) Study successes/ failures d) Return vs investment e) Contracts with major payor organizations, expanded access to different markets f) Changes in R&D strategy, research collaborations, etc. g) Company restructuring to capitalize on areas of strength, optimization of portfolios/ franchises h) Innovative commercialization or sales strategies i) Mergers and acquisitions which would increase a company’s ability to generate commercial success Each of the above are collated by IDEA Pharma and scored. The combination of these scores is subsequently used to calculate an overall company score and provide an ordinal ranking. ©2021 IDEA Pharma | ideapharma.com 15 PII Invention Methodology HYPOTHESIS: An index designed to objectively examine pipeline invention and measure pipeline novelty CONSTRAINTS: Third party pharma company data inputs (source: GlobalData) are used to feed each of the key metrics. Our best assumption is the data is comprehensive, and up to date. The Pharmaceutical Invention Index consists of five key metrics: 1. The proportion of pipeline to marketed drugs 2. The number of trials investigating novel agents 3. The proportion of ‘novel’ regulatory designations 4. An assessment of the companies’ R&D investments 5. The number and scale of key events related to novel pipeline agents Data from GlobalData are used to objectively evaluate each company and produce an independent category score for each of the top 30 companies. Additionally, key company events are monitored, and stories related to novel pipeline agents are carefully reviewed for each PII company. Companies are scored on the basis of the number of events as well as the potential scale of pipeline impact. The combination of these scores is subsequently used to calculate an overall company score and provide an ordinal ranking. ©2021 IDEA Pharma | ideapharma.com 16 Drug approvals vs R&D expenditure Top 30 Pharma 2015-2020 40 9,000 35 8,000 7,000 30 6,000 25 5,000 20 4,000 15 3,000 10 2,000 5 1,000 0 - 2015 2016 2017 2018 2019 2020 Total Novel Approvals Total BLAs Total Approvals Average R&D spend per Approval ©2021 IDEA Pharma | ideapharma.com Al H. ex Lu io - n nd 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 Re Ph be ge Ot ar c ne su ma S k A 2015-2020 ro ka ce ea S Ve n P Ho u t g e rte ha ld ica n x rm in g ls I Ph a s nc ar ce Co m uti L ac ca td eu ls tic In al c s ©2021 IDEA Pharma | ideapharma.com I M No v nc od a er rtis n In a In Ei cyte c sa I i C nc Da E o i c li ei Lt d B hi Lil G Sa ly en nk and e As yo C te C o lla o s Lt Ph Sa d ar o n m f Am a i 5yr Average R&D spend per approval g e In c Top 30 average $m = 4,815 Pf n In i As A zer c Jo tra bbV I nc hn Ze ie so n e In n ca c & Ta Jo Plc ke G o N hn R&D cost per approval 5yr average $m so da la vo x n Ph o No Ba R&D cost per approval 5yr ALL average $m ar Sm rd yer m ith is ac K k A eu lin S tic e P G a ile M l C lc ad e o Br Sc rck L td is ie & F. to nc C Ho l-M es o ffm ye In an rs S io c B n - q ge La uib n Ro b C M ch o er e ck Lt KG d aA 17 18 Top 30 vs Non-top 30 approvals 2015-2019 90 80% 80 70% 70 60% 60 50% 50 40% 40 30% 30 20% 20 10 10% 0 0% 2015 2016 2017 2018 2019 2020 Non Top 30 BLAs 9 14 19 18 18 20 Non Top 30 Novel Approvals 13 9 22 36 25 33 Top 30 BLAs 4 1 3 3 4 3 Top 30 Novel Approvals 32 13 24 23 23 20 Total Approvals 58 37 68 80 70 76 Top 30 Novel Approvals % 71% 59% 52% 39% 48% 38% Top 30 BLAs % 31% 7% 14% 14% 18% 13% ©2021 IDEA Pharma | ideapharma.com 19 Did you know? FOR THE TOP 30 PHARMACEUTICAL COMPANIES IN 2020… ~$715bn 20 Novel GLOBAL REVENUE & 3 BIOLOGIC DRUGS TOTALED APPROVED TO MARKET ~$150bn ~$4.8 BILLION GLOBAL R&D 21% AVERAGE COST OF EXPENDITURE LAUNCHING A NEW DRUG TOTALED, REPRESENTING 11 0 9 897 218 25 PHI Trials PHII Trials PHIII Trials Pre-Registrational Trials ~1,200 DRUGS ARE IN DEVELOPMENT IN OVER 2,200 CLINICAL STUDIES 1 , 3 6 0 R E G U L AT O R Y D E S I G N AT I O N S : 940 189 47 Orphan Drugs Fast Tracks Priority Reviews 12 104 68 Accelerated Breakthrough Other (i.e., Sakigake Assessments Therapies Designation, PRIME) ©2021 IDEA Pharma | ideapharma.com Index Company Rank Change from 2020 2021 Eli Lilly 1 4 Roche 2 -1 Regeneron 3 7 Pharmaceutical Seagen 4 NEW Incyte 5 NEW GlaxoSmithKline 6 5 Innovation Sanofi 7 10 AstraZeneca 8 1 Pfizer 8 7 Gilead Sciences 10 5 Novartis 10 -7 Vertex Pharmaceuticals 12 -9 Merck & Co 13 -6 #1 Novo Nordisk 13 -1 Eli Lilly AbbVie 15 -13 First in Innovation Johnson & Johnson 15 -1 Bristol-Myers Squibb 17 6 Amgen 18 1 Eisai 19 3 +10 Astellas Pharma 20 -2 Biogen 20 1 Sanofi Most Improved Moderna 20 NEW Alexion Pharmaceuticals 23 -17 Daiichi Sankyo 24 -5 Lundbeck 25 1 Innovation: Return on Merck KGaA 26 2 invention; creation of BeiGene 27 NEW meaningful value from Takeda 28 -4 invention. Boehringer Ingelheim 29 -4 Bayer 30 -3 Otsuka 31 -2 ©2021 IDEA Pharma | ideapharma.com Index Company Rank Change from 2020 2021 Bristol-Myers Squibb 1 1 Incyte 2 NEW Pfizer 3 8 Pharmaceutical Eli Lilly 4 -1 BeiGene 5 NEW AstraZeneca 6 -5 6 0 Invention Regeneron Johnson & Johnson 8 5 Novartis 9 -5 Merck & Co 10 -2 Gilead Sciences 11 -6 Takeda 12 2 Roche 13 -3 #1 Moderna 13 NEW Bristol-Myers Squibb AbbVie 15 -8 First in Invention GlaxoSmithKline 16 -4 Amgen 17 0 Biogen 18 6 Boehringer Ingelheim 19 -1 +8 Bayer 20 7 Vertex Pharmaceuticals 21 -12 Pfizer Most Improved Daiichi Sankyo 22 -7 Seagen 22 NEW Sanofi 24 -2 Merck KGaA 25 -4 Invention: bringing ideas Eisai 26 -3 or technologies together Alexion Pharmaceuticals 27 -2 in a novel way to create Astellas Pharma 28 -10 something that did not exist before. Otsuka 29 -1 Lundbeck 30 0 Novo Nordisk 31 -2 ©2021 IDEA Pharma | ideapharma.com Pharmaceutical Innovation and Invention Index 2021 W H I T E PA P E R Celebrating the Most Innovative and Inventive Companies in Pharma www.protodigm.co Protodigm. Our new IDEA. Be BOLD. Think BIG. We want to develop a new way of doing drug development. We believe that technology can provide data and insights earlier, enabling a more efficient, more effective, and more precise evidence-driven process in matching the right [platform] with the right patient [to build a clear path to market]. Protodigm is the partner for alternative development and commercial solutions for the Biopharma industry, helping our clients to more effectively deliver innovative treatments to patients. Born out of the experience at sister company IDEA Pharma, which specialises in developing positioning and path to market strategies for the Biopharma industry, Protodigm is being formed to address an upstream roadblock in the innovation funnel – evidence generation. Too often in [drug] development, early decision- making is driven by preconceived assumptions of what an asset should be, rather than the evidence itself, which can result in rising opportunity costs and inefficient allocation of limited R&D resource. 1 - Options 2 - Evidence We bring a learning mindset to the process We believe that by providing the relevant of asset prioritisation and development. evidence in response to an individualised suite of development options / questions, 3 - Decisions which have been generated in the context We want to empower more efficient, of the client and the asset, we can combat effective decision-making in drug the progression-seeking biases and development. We seek to enable evidence- rational optimism in drug R&D. driven decisions in asset development, not just avoiding the unknowns but addressing the unknowns to help illuminate the right options for an asset. Our process is driven by our client and the asset. We believe there is no one-size-fits all methodology for drug development and successful positioning of a pharmaceutical product. Each biopharma company is unique, with its own set of strategic objectives. Each asset is novel, with its own universe of characteristics. Our solution is tailored to deliver an actionable plan, backed by the relevant evidence. We are not a CRO. We are not a consultancy. We are a closely-knit network/team of [cross-functional] experts that will work together with our partners and clients to bring transparency to the decision-making process through a targeted, evidence-led development process.
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