Press release
Aug 13, 2019

Sosei Heptares Operational Highlights and Consolidated Results for the First Half of FY2019


Tokyo, Japan and London, UK, 13 August 2019 – Sosei Group Corporation (“the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the first half of FY2019. The full report can be accessed by clicking here.

 

Operational Highlights

· Excellent progress with partnered programs – AstraZeneca (AZD4635), Pfizer (two candidate nominations), Novartis (QVM149), all triggering progress-related milestones to Sosei Heptares

· Positive clinical data readouts of partnered programs – Preclinical and Phase 1a data for AZD4635 presented at AACR 2019 by AstraZeneca, Phase 2 data for QVM149 presented by Novartis at ATS 2019

· Progress with in-house (pre-partnered) pipeline – SSTR5 candidate successfully dosed in subject, new clinical programs initiated and other programs advancing

· Creation of two spin-out companies – Spin out of discovered assets (orexin agonists) into Orexia Ltd and Inexia Ltd with funding of up to €40 million from Medicxi

· Launch of marketed products – ORAVI® Mucoadhesive Tablets 50mg for Oropharyngeal Candidiasis in Japan, Ultibro®Breezhaler® and Seebri®Breezhaler® for COPD in China

 

Post H1 Events

· Two new multi-target collaborations initiated with major global partners – Genentech and Takeda – together bringing more than $50m in upfront and near-term milestone payments, with potential for significant future payments plus royalties

· Milestone payment received from Formosa Pharmaceuticals on advancement of APP13007 – a divested candidate for post-operative inflammation of the eye

· Update on global R&D collaboration with Allergan – work continues to advance programs through development, and multiple compounds with the potential to be new candidates have been generated. Clinical development of HTL0018318 in Alzheimer’s disease remains voluntarily suspended while investigative work is continuing.

· Update on Phase 2 trial of HTL0018318 in DLB patients in Japan – decision made to withdraw study in order to minimize CRO expenditure while clinical trial activities are suspended. The Company remains committed to the DLB program in Japan and plans to file a new clinical trial application with the Japanese PMDA in the future.


 

Financial Highlights for the Six-month Period ending 30 June 2019

· Revenue totalled JPY 5,056 million (US$45.9 million) (an increase of JPY 3,253 million (US$29.5 million) vs. the prior corresponding period), and related primarily to strong growth in milestones, plus royalty payments received.

· Total cash operating expenses[1] were down to JPY 3,101 million (US$28.2 million) (an improvement of JPY 1,911 million (US$17.2 million) vs. the prior corresponding period), primarily due to a decrease in R&D costs.

· Cash profit[2] totalled JPY 1,578 million (US$14.3 million) vs. a cash loss of JPY 3,096 million (US$28.1 million) in the prior corresponding period, as a result of strong revenue growth and tight cost management

· Net profit totalled JPY 395 million (US$3.6 million) vs. a net loss of JPY 3,327 million (US$30.2 million) in the prior corresponding period, on the back of strong business plan execution

· The Company remains well capitalized, with Cash at Hand of JPY 16,915 million (US$157.0 million) as at 30 June 2019

 

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, added: “We have made excellent progress in strengthening our business during the first half of 2019 and are well-positioned to capitalize on a number of strategic opportunities. Our highly productive GPCR-focused drug discovery platform has generated multiple new exciting candidates, and we have actively increased partnered and co-development activities, whilst simultaneously investing to advance our pipeline of emerging in-house candidates to be partnered in the future. The recent collaborations with Genentech and Takeda further exemplify our core strategy in action and reinforce our leadership position in the generation of best- and first-in-class candidates targeting this important class of drug targets.”

 

Abbreviations used: COPD – chronic obstructive pulmonary disease; DLB – dementia with Lewy bodies; GPCR – G protein-coupled receptors

[1] Non-GAAP
[2] Non-GAAP

 

– ENDS –


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