·Company to hold conference call for analysts and investors today at
Key Developments (including post reporting period)
- During the first quarter of 2019, Kiadis’ focus was on preparing for approval of the marketing authorization application (MAA) for ATIR101 in the EU; the Company’s regulatory team was engaged in discussions with the
European Medicines Agency (EMA) to respond to day 180 questions and Kiadis’ commercial team was executing a launch plan to be ready to commercially treat the first patient with ATIR in the EU. - During the second quarter of 2019, Kiadis acquired CytoSen Therapeutics and its proprietary Natural Killer (NK) cell therapy platform, a transaction that had the potential to transform Kiadis into a leader in cell-based cancer immunotherapy for the treatment of both liquid and solid tumors.
- During the third quarter of 2019, Kiadis learned that it did not expect a positive response from the EMA and its MAA for ATIR101 would be rejected. As such, Kiadis commenced a strategic review of its current operations and programs to determine the future focus of the company.
- In the fourth quarter of 2019, Kiadis completed the strategic review and decided to terminate the ATIR program and focus solely on the development of K-NK-cell therapies. The Company restructured its organization, reducing staff by approximately 50 percent and shifting its focus and all resources toward the advancement of its K-NK-cell therapy platform and programs.
- In 2020, Kiadis has already made progress advancing its K-NK-cell therapy programs. For the K-NK003 program, the Company is supporting a Phase 1/2 investigator sponsored study with
The Ohio State University for the treatment of R/R AML with off-the-shelf K-NK cells from universal donors. Kiadis also filed the first investigational new drug application with theU.S. Food and Drug Administration (FDA) for its planned NK-REALM Phase 1/2 study, which will evaluate K-NK002 in 63 patients with blood cancer undergoing a haploidentical hematopoietic stem cell transplant (HSCT). Additionally, in April, Kiadis raisedEUR17 million through two private placements with a US biotech investor andLife Sciences Partners to continue to fund the development of the Company’s K-NK-cell therapy programs.
Financial Highlights | |||
(Amounts in EUR million, except per share data) | 2019 | 2018 | Change |
Total revenue and other income | |||
Total operating expenses | |||
Research and development | (43.0) | (17.5) | (25.5) |
General and administrative | (30.2) | (7.7) | (22.5) |
Operating result | (73.2) | (25.2) | (48.0) |
Net financial result | 20.7 | (4.6) | 25.3 |
Net result | (52.6) | (29.8) | (22.8) |
Net operating cash flow | (48.3) | (24.2) | (24.1) |
Cash position at end of year | 29.5 | 60.3 | (30.8) |
Equity | 34.3 | 44.1 | (9.8) |
Earnings per share before dilution (EUR) | (1.92) | (1.46) | (0.46) |
Revenue & Other Income
·The Group did not record revenue and/or other income in 2019 and 2018.
Operating Expenses
- Operating expenses increased to
EUR73.2 million fromEUR25.2 million in 2018, an increase ofEUR48.0 million which includesEUR19.0 million charges related to the termination of the ATIR platform development. - Research and Development expenses increased to
EUR43.0 million fromEUR17.5 million in 2018. Without the expenses for share-based compensation, Research and Development expenses increased toEUR41.4 million fromEUR16.6 million in 2018, an increase ofEUR24.8 million . The increase was primarily caused by the increased clinical trial costs related to the ramp up of the Phase 3 study of ATIR101, and the increase of the work force that the organization experienced prior to the discontinuation of the ATIR activities. Following theJune 2019 acquisition of CytoSen, research and development expenses also include costs associated with the development of K-NK002 and the other NK-programs that we acquired. As a result of the termination of the ATIR platform development, Research and Development expenses include impairment charges of tangible assets for an amount ofEUR0.7 million in addition to restructuring charges ofEUR4.0 million . - General and Administrative expenses increased to
EUR30.2 million fromEUR7.7 million in 2018. Without the expenses for share-based compensation, General and Administrative expenses wereEUR21.6 million higher atEUR28.6 million in 2019 compared toEUR7.0 million in 2018. General and Administrative expenses include impairment charges of intangible assets for an amount ofEUR13.2 million and restructuring charges ofEUR1.1 million . The increase was further due to increased headcount across all departments to support the continued growth of the company and consultancy expenses for business development, market access and the acquisition of CytoSen.
OPERATING RESULTS
As a result of the overall increase in total operating expenses, the Group's operating loss increased from
NET FINANCIAL RESULT
- Net finance income for 2019 increased to
EUR20.7 million from a net finance expenses ofEUR4.6 million in 2018, an increase ofEUR25.3 million . - Finance expenses for our outstanding debt include interest on third party loans for
EUR3.3 million compared toEUR3.7 million in 2018 andEUR0.2 million negative interest on outstanding cash and cash equivalents in 2019 and 2018. Interest expenses on our leases remainedEUR0.5 million in 2019. - In
December 2011 , the Company entered into an agreement withHospira Inc. for which an amount ofUS$24.5 million had been judged as a loan. The payment obligations are linked to sales of our ATIR platform dependent on the commercial sale of ATIR or linked to granting a sublease on the related Theralux technology. For this financial liability, the Company had to make significant judgments and estimates previously about future cash flows towardsHospira Inc. Due to the decision to terminate all ATIR activities, the repayment of the outstanding amount is remote. The Company reduced the outstanding loan balance as ofDecember 31, 2019 to zero resulting in a financial gain ofEUR10.8 million . - The Group recognizes a contingent consideration related to the acquisition of CytoSen. Previous CytoSen’s shareholders and former CytoSen’s option received potential future consideration of additional Kiadis shares upon the achievement of six clinical development and regulatory milestones. The fair value of the contingent acquisition consideration is determined using the assumed probability rates of success (PoS) of the different milestones and the closing price as of each reporting date. As a result of a change in share price from
June 5, 2019 toDecember 31, 2019 the contingent consideration decreased byEUR13.1 million . - The Company recorded favorable results of net foreign exchange 2019 versus 2018 for the amount of
EUR1.8 million . Net foreign exchange gain ofEUR0.8 million in 2019 includes amongst othersEUR0.4 million of realized (non-cash) Canadian dollar/euro exchange rate gain as a result of the impairment of goodwill and in-process R&D which was accounted for in Canadian dollars. The net foreign exchange gain includes unrealized (non-cash) exchange loss ofEUR0.4 million on the loan fromHospira Inc denominated in US dollars and a gain ofEUR0.8 million on an intra-group loans denominated in Canadian dollars.
NET RESULT
·As a result of the above items, the loss for the year increased by
CASH FLOWS
·Total cash and cash equivalents decreased by
EQUITY
·The Company's equity position amounted to
Earnings per share
·The undiluted loss per share for 2019 increased to
Annual Report
The Annual Report 2019 is available on Kiadis Pharma’s website.
Conference Call and Presentation
To participate in the conference call, please call one of the following numbers ten minutes prior to commencement of the call:
US,
US, toll free: 18778709135
Event Plus Passcode: 4968027
A live audio webcast of the call can be accessed from the Events and Presentations section of the Company’s website, https://ir.kiadis.com/events-and-presentations or at https://edge.media-server.com/mmc/p/6ctgdx37.
For more information, please contact:
Tel: +1 (617) 710-7305 m.cimino@kiadis.com | Mary Clark, Tel: +44 203 950 9144 Tel: +31 610 942 514 kiadis@optimumcomms.com |
About Kiadis Pharma’s K-NK-Cell Therapies
Kiadis Pharma’s K-NK platform is designed to deliver potent NK cells to help each patient, without the need for genetic engineering. Kiadis Pharma’s programs consist of off-the-shelf and haploidentical donor NK-cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies.
The Company’s PM21 particle technology enables improved ex vivo expansion and activation of cytotoxic NK cells supporting multiple high-dose infusions. Kiadis Pharma’s proprietary off-the-shelf NK-cell platform is based on NK cells from unique universal donors and can make NK-cell therapy product rapidly and economically available for a broad patient population across a potentially wide range of indications.
About
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Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s officers’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result,
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