CHF 32 Million in Milestone Revenues - Multiple Upcoming Catalysts - Execution Across Clinical and Preclinical Neurodegenerative Development Pipeline

AC Immune SA (NASDAQ: ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, today provided a business and clinical update and reported its consolidated financial results for the third quarter of 2019.

Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: “AC Immune, together with our leading pharmaceutical partners, is advancing one of the industry’s broadest, most diversified development pipelines targeting neurodegenerative diseases. This quarter, we continued to demonstrate strong progress across our pipeline of potentially best-in-class small molecule, antibody, and vaccine therapeutics, as well as our cutting-edge diagnostic agents. This resulted in milestones achieved totaling CHF 32 million which were comprised of CHF 30 million from Eli Lilly and Company and EUR 2 million (CHF 2.2 million) from Life Molecular Imaging.”

Prof. Pfeifer continued, “We anticipate multiple catalysts in 2019 and 2020, highlighted by expected Phase 2 data for semorinemab, our anti-Tau antibody partnered with Genentech/Roche, which we anticipate will be the first Phase 2 data available for a Tau-targeted therapy in Alzheimer’s disease (AD). We also anticipate achieving further progress across our development pipeline with both early and late stage data readouts that we believe will build substantial value for the Company.”

AC Immune’s unique, multi-pronged approach is designed to address the full spectrum of neurodegenerative diseases. By selectively targeting misfolded pathological proteins both intracellularly and extracellularly, and by creating state-of-the-art diagnostic imaging agents that enable early detection of multiple disease pathologies and tracking of disease progression, AC Immune is pioneering a personalized medicine approach to deliver the right therapy to the right patient at the right time.

Research & Development Highlights

  • Earned a EUR 2 million (CHF 2.2 million) milestone following initiation of longitudinal Phase 2 clinical development of next-generation Tau positron emission tomography (PET) tracer PI-2620 by partner Life Molecular Imaging
  • Received first CHF 30 million milestone payment from Lilly based on achievement of preclinical milestones related to the oral small molecule Tau Morphomer program, which is currently advancing in a Phase 1 clinical study. A second CHF 30 million milestone payment is scheduled for Q1 2020, linked to achievement of further development milestones
  • Vaccinated the first patient in a Phase 1b/2a study of anti-phospho-Tau (anti-pTau) vaccine candidate ACI-35.030 in collaboration with Janssen Pharmaceuticals. ACI-35.030 is intended as a disease-modifying treatment for AD and other Tauopathies
  • Recently hosted a key opinion leader event focused on the therapeutic and diagnostic potential of targeting Tau pathology, which highlighted AC Immune’s differentiated Tau pipeline candidates and key  updates  from the ACI-3024 Tau Morphomer™ small molecule  and ACI-35.030 programs
  • Awarded a new grant from The Michael J. Fox Foundation for the Company’s pioneering alpha-synuclein (a-syn) PET tracer program. If successful, AC Immune’s program could deliver the world’s first imaging agent capable of accurately detecting and monitoring progression of Parkinson’s disease

Analysis of Financial Statements for the Three and Nine Months Ended September 30, 2019

  • Cash Position: The Company had a total cash balance of CHF 302.5 million, comprised of CHF 212.5 million in cash and cash equivalents and CHF 90.0 million in short-term financial assets. This compares to a total cash balance of CHF 186.5 million as of December 31, 2018. The increase of CHF 116 million is principally due to the CHF 80 million upfront payment, USD 50 million convertible equity note, and CHF 30 million milestone payment related to the agreement with Lilly. The total shareholders’ equity position increased from December 31, 2018 to CHF 292.4 million from CHF 177.6 million. Further details are available in our corresponding Financial Statements filed on the accompanying Form 6-K
  • Revenues: Revenues for the three and nine months ended September 30, 2019 totaled CHF 33.4 million and CHF 110 million, respectively. This represents an increase of CHF 31.1 million and CHF 104.2 million compared to the respective periods in 2018. The increase for the three-month period relates to the recognition of CHF 30.0 million for the first installment of the first milestone achieved with Lilly and EUR 2 million (CHF 2.2 million) in connection with the initiation of a Phase 2 Trial of Tau PET Tracer with Life Molecular Imaging. The increase for the nine-month period is driven by the recognition of CHF 74.6 million from the right-of-use license and research and development activities linked to the 2018 Lilly agreement and a CHF 30 million payment for the first installment of the first milestone achieved with Lilly
  • R&D Expenditures: R&D expenditures decreased by CHF 0.1 million (-0.6%) and increased CHF 3.6 million (+11%) for the three and nine months ended September 30, 2019 compared to the comparable periods in 2018, respectively. The increase in R&D expenditures in 2019 was largely due to increased investments in non-AD and new discovery programs. For non-AD, the Company increased investment in its Morphomer alpha-synuclein programs and continued to advance the clinical development of its anti-Abeta vaccine ACI-24 in Down Syndrome (DS). In new discovery, the Company continued to focus on its neuroinflammation discovery programs while also increasing investment in its anti-a-synuclein antibody. For AD, the Company’s expenditures for the anti-pTau vaccine program decreased due to the completion of certain toxicology and manufacturing work in the prior year as well as a decrease for ACI-24 related to higher costs for the initiation of the Phase 2 study in the prior period
  • G&A Expenses: For the three and nine months ended September 30, 2019, G&A increased CHF 1.0 million (+35%) and CHF 2.1 million (+24%) to CHF 4.0 million and CHF 10.8 million, respectively. Increases are driven by rental, personnel and IT expenses
  • IFRS Income/(Loss) for the period: The Company recorded net income after taxes of CHF 18.2 million and CHF 64.9 million for the three and nine months ended September 30, 2019, respectively, compared with net losses of CHF 13.5 million and CHF 36.3 million for the comparable periods in 2018