PureTech Health plc Health PureTech PureTech Health plc Annual reportAnnual accounts and 2017 Annual report and accounts 2017 Building the biopharma company of the future 4336 PureTech ARA Cover 2017_FINAL.indd 3 12/04/2018 14:06 PureTech Health Highlights of the Year – 2017 Building the biopharmaceutical company of the future 2017 PureTech cash and In 2017, PureTech Health made significant progress across its advanced pipeline PureTech Health Built from our unique insights and those • a seasoned management team short-term investments of seven clinical and seven preclinical programmes focused on the crosstalk and of our network of world-renowned of business leaders with proven 3 biological processes associated with the brain-immune-gut (BIG) axis. The Group PureTech Health, plc (HQ: Boston, MA; collaborators, PureTech’s novel successes in developing new $126.7m reported positive clinical results from two pivotal stage affiliates, Akili and LSE: PRTC) (“PureTech Health”, therapeutics harness the brain-immune- medicines and creating significant Gelesis, and other affiliates continued to advance innovative candidates through “PureTech” or the “Company”) is 2016: $192.1m gut (BIG) axis across a range of indications value, an outstanding Board clinical development: developing novel medicines that target 2015: $255.5m where the role of the immune system has of actively-engaged industry pioneers 2014: $53.2m serious diseases resulting from • Akili achieved the primary endpoint in a pivotal trial of its investigational digital medicine not historically been appreciated. PureTech and academic stalwarts, and an dysfunctions in the nervous, immune, for paediatric ADHD and plans to file for US FDA approval in the second quarter of 2018. Health is building the biopharmaceutical extensive network of leading scientific and gastrointestinal systems (brain- 2017 consolidated cash and • Gelesis achieved significant weight loss with an excellent safety profile in its pivotal company of the future with: experts from around the world; immune-gut or the “BIG” axis). short-term investments clinical trial with Gelesis100. The study achieved and exceeded one of two co-primary • an impressive track record of • relationships with leading 3 endpoints and Gelesis plans to file for US FDA approval in the second quarter of 2018 Moving Medicine Forward execution – including two product pharmaceutical companies or their $188.7m and for a European CE Mark in the second half of 2018. Gelesis also initiated a six-month The PureTech Health team is dedicated candidates with positive pivotal data, investments arms, including Pfizer, efficacy proof-of-concept study in people with prediabetes or untreated diabetes for its 2016: $281.5m Overview to tackling some of the most important and several high value catalysts Shire, Janssen Biotech Inc., Eli Lilly, second product candidate, Gelesis200. 2015: $313.7m • resTORbio initiated a Phase 2b clinical study in respiratory tract infections in the elderly, health issues facing society today in order expected over the next 12 to 18 Amgen Ventures, Merck Ventures 2014: $62.7m to positively impact patients’ lives and months – in a capital efficient manner BV2, and Novartis; with results expected in the second half of 2018. In the January 2018 post-period, generate significant value for PureTech’s ($242.1 million in group cash and resTORbio successfully listed on NASDAQ (TORC) with gross proceeds of $97.8 million. • an innovative and entrepreneurial shareholders. PureTech’s entrepreneurial short-term investments as at 31 2017 group cash and short-term • Vedanta Biosciences initiated a Phase 1a/1b clinical trial of VE303, its lead, orally- culture poised to bring ground- investments (APM) and capital-efficient innovation engine is December 20171); augmented by a administered product candidate for recurrent C. difficile infection. breaking new medicines to patients; pioneering new categories of medicine successful raise of $100 million • Karuna developed a single capsule co-formulation of its proprietary product candidate and 3,4 with a potentially superior risk-benefit (approximately £72 million) from new $242.1m (KarXT) for the treatment of schizophrenia and other disorders and is testing the co- profile over existing treatment options. and existing institutional investors in • a strong and growing IP portfolio formulation in a dose-ranging study in healthy volunteers. April 2018; providing long periods of exclusivity 2016: $281.5m • Sonde generated and analysed voice data from over 3,000 subjects as part of the 2015: $313.7m ongoing validation of its vocal biomarker technology for the detection of depression, for our innovative product candidates. 2014: $62.7m suicidality, and Parkinson’s disease. Sonde has also initiated research and development to expand its proprietary technology in Alzheimer’s disease, respiratory disease, Overview Corporate and Social Responsibility 55 Amount of funding secured cardiovascular disease, and other conditions. for affiliates Highlights of the Year 1 Directors’ Report 58 • Follica progressed toward the initiation of the RAIN pivotal clinical study in androgenetic alopecia as well as the identification and testing of next-generation, proprietary compounds. Pipeline 2 Report of the Nomination Committee 64 $102.9m3,5 Letter from the Chairman 4 Report of the Audit Committee 65 PureTech Health has also grown its immunology-focused internally-funded pipeline Directors’ Remuneration Report 67 2016: $98.2m by generating compelling pre-clinical data, forging collaborations with leading Strategic report 2015: $74.6m experts, and securing key intellectual property for: Directors’ Remuneration Policy 69 2014: $8m Letter from the Chief Executive Officer 6 • an approach harnessing the lymphatic system that transports certain immunomodulatory Annual Report on Remuneration 73 Letter from the Chief Scientific Officer 8 drugs directly into the mesenteric lymph nodes where they can directly affect immune cell Cumulative number of patents and priming and proliferation. This approach has the potential to more effectively treat cancer How PureTech Health is building value for investors 10 Financial statements patent applications and inflammatory and auto-immune diseases with an improved safety profile, while also Programme snapshots 14 Independent Auditor’s Report to the Members of PureTech Health plc 80 6 enabling oral administration of medicines that otherwise would not be orally bioavailable; Consolidated Statements of Comprehensive Income/(Loss) 88 521 • a milk exosome-based technology designed to enable the oral administration of Governance Consolidated Statements of Financial Position 89 biologics, nucleic acids (e.g. siRNA, mRNA, antisense oligonucleotides, CRISPR nucleic Risk management 36 2016: 288 acid), and complex small molecules; and Consolidated Statement of Changes in Equity 90 2015: 209 Viability 39 • a novel cell therapy approach involving engineered immune cells recruited and Consolidated Statements of Cash Flows 92 2014: 111 Key performance indicators 40 activated in a tissue selective manner and programmed with disease modifying Notes to the Consolidated Financial Statements 93 activities for the potential treatment of cancer, inflammation, autoimmune disorders, Financial review 41 Number of partnerships entered PureTech Health plc Statement of Financial Position 132 and neuroinflammatory disorders. Chairman’s overview 45 PureTech Health plc Statement of Changes in Equity 133 5 Board of Directors 46 8 The Group continued to build on its leading intellectual property position, with more PureTech Health plc Statement of Cash Flows 134 than 500 owned and licensed patents and patent applications as of 31 December 2017, Management team 49 Notes to the Financial Statements 135 2016: 6 including: The Board 51 2015: 4 Directors, Secretary, and Advisors to PureTech Health plc IBC 2014: 2 • 10 new foundational patents issued in the US and Japan for Vedanta Biosciences’ microbiome platform technology; • additional composition of matter, methods of use, and methods of making allowances in Number of theme-based technologies sourced5 the EU, Japan, Russia, and South Korea for the Gelesis weight loss and gastrointestinal disorders technology; 5 951 • broad coverage for methods of assessing mental and physical conditions from human speech for the Sonde vocal biomarkers technology; and 2016: 918 • broad coverage in the US and Japan for Akili's unique digital mechanism for assessing and 2015: 776 improving cognitive function (post-period). 2014: 521 3 PureTech’s recent placing with gross proceeds of approximately $100.0 million, resTORbio's IPO with $97.8 million in gross proceeds and the Gelesis 1 Group cash and short-term investments includes consolidated cash and fundraising of $30.0 million occurred in the 2018 post-period and are therefore not included in these figures. short-term investments plus the cash and short-term investment position 4 Group Cash is an alternative performance measure (APM) which includes cash reserves held at Independent Affiliates of $53.4 million that are not of Independent Affiliates which are not included in our consolidated included in the consolidated statement of financial position. Group Cash is therefore considered to be more representative of the Group’s cash available statement of financial position to advance product candidates within its independent affiliates, growth stage affiliates and project stage programmes, as the cash held at independent 2 Merck Ventures