Kiadis Pharma announces annual results for the year ended December 31, 2018
30 Avril 2019 - 5:45PM
Amsterdam, The Netherlands, 30 April 2019 - Kiadis
Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext
Amsterdam and Brussels: KDS), a clinical-stage
biopharmaceutical company, today announces its audited 2018 Annual
Results for the year ended December 31, 2018, which have been
prepared in accordance with International Financial Reporting
Standards (IFRS) as adopted by the European Union.
Arthur Lahr, CEO
of Kiadis Pharma, commented: "Kiadis made
significant progress in 2018 as we continue on our journey to bring
innovative cell therapies to patients. In 2018, we added commercial
and medical affairs capabilities to support the potential launch of
ATIR101 in the EU. Additionally, we have expanded our manufacturing
and quality teams to ensure that we have adequate capacity to serve
patients in the EU as well as patients enrolling in our global
phase 3 study for ATIR101.
"As our company
grows, we are all working to re-imagine medicine - leveraging the
natural strengths of humanity and our collective immune system to
source the best cells for life. Our uncompromising approach to
serve patients, their families and caregivers aims to minimize harm
and maximize help - delivering personalized treatments for every
single patient to offer hope, reduce suffering and provide new
life. We look forward to continuing this journey together to
achieve our vision to improve the lives of patients suffering from
life-threatening diseases."
Operating
highlights (including post reporting period)
-
Kiadis' marketing authorization application for
ATIR101 is currently under review. Kiadis plans to respond to day
180 outstanding issues by the end of May 2019. The Company aims to
receive CHMP opinion in 2019, which, if positive, would enable a
conditional marketing approval from the European Commission,
followed by commercial launch of ATIR101 in a European country by
the end of 2019.
-
The global phase 3 trial for ATIR101,
CR-AIR-009, is ongoing. The study, which will enroll approximately
250 patients, is comparing ATIR101 to the post-transplant
cyclophosphamide (PTCy) or 'Baltimore' protocol.
-
Additionally, over the past year the
organization has been strengthened across all functions, with the
addition of more than 60 staff, including key management team
members.
-
On April 17, 2019, Kiadis announced that it had
entered a definitive agreement to acquire US-based CytoSen
Therapeutics, Inc., subject to shareholder approval and customary
closing conditions. The combination of Kiadis and CytoSen will
create a leader in cell-based cancer immunotherapy, with
complementary T-Cell and NK-cell platforms.
Financial highlights
(including post reporting period)
(Amounts in EUR million, except per share
data) |
2018 |
2017 |
Change |
Total revenue and other
income |
-- |
-- |
-- |
Total operating expenses |
(25.2) |
(16.1) |
(9.1) |
Research and development |
(17.5) |
(11.2) |
(6.3) |
General and administrative |
(7.7) |
(4.9) |
(2.8) |
Operating result |
(25.2) |
(16.1) |
(9.1) |
Net financial result |
(4.6) |
(0.9) |
(3.7) |
Net result |
(29.8) |
(17.0) |
(12.8) |
Net operating cash flow |
(24.2) |
(15.9) |
(8.3) |
Cash position at end of
year |
60.3 |
29.9 |
30.4 |
Equity |
44.1 |
15.9 |
28.2 |
Earnings per share before dilution
(EUR) |
(1.46) |
(1.14) |
(0.32) |
Operating
expenses
-
Operating expenses increased to EUR 25.2 million
in 2018 from EUR 16.1 million in 2017, an increase of EUR 9.1
million.
-
Research and Development expenses increased to
EUR 17.5 million in 2018 from EUR 11.2 million in 2017. Without the
expenses for share-based compensation, Research and Development
expenses increased to EUR 16.6 million in 2018 from EUR 10.9
million in 2017, an increase of EUR 5.7 million. This increase was
primarily caused by a further expansion of the workforce in all
areas of the organization, clinical expenses related to the
CR-AIR-009 study, the move to a larger building which includes a
commercial manufacturing facility, laboratories and office
space.
-
General and Administrative expenses increased to
EUR 7.7 million in 2018 from EUR 4.9 million in 2017. Without the
expenses for share-based compensation, General and Administrative
expenses were EUR 3.0 million higher at EUR 7.0 million in 2018
compared to EUR 4.0 million in 2017. The increase was due to
the expansion of the workforce, higher consultancy expenses related
to market access preparations and financing rounds.
Operating
results
Net financial
result
-
Net finance expenses for 2018 increased to EUR
4.6 million from EUR 0.9 million in 2017. The increase of EUR 3.7
million is mainly due to interest on outstanding debt for the
amount of
EUR 1.6 million, interest on leases of our new Amsterdam office for
the amount of EUR 0.5 million in 2018, unfavorable results of net
foreign exchange and fair value adjustment of derivatives in 2018
versus 2017 for an amount of EUR 1.7 million and EUR 0.6 million
respectively.
Net
result
Cash position
-
The Company significantly strengthened cash
position in 2018 with private placements of 6.5 million ordinary
shares raising EUR 54.6 million and a debt financing facility from
Kreos Capital of up to EUR 20 million.
-
The cash position increased by EUR 30.4 million
to EUR 60.3 million at year-end 2018 compared to EUR 29.9 million
at the end of 2017. This increase mainly results from the net
proceeds of two share offerings for a total amount of EUR 50.6
million and net proceeds drawn on a new debt facility agreement
(EUR 20 million total) of EUR 4.8 million and the cash proceeds
from the exercise of warrants for the amount of EUR 2.9 million. In
2018, the net operating cash outflow amounted to EUR 24.2 million
and further included the acquisition of PP&E, repayments of
loans and lease liabilities for a total amount of EUR 4.0
million.
-
The Company's cash position as of March 31, 2019
was EUR 49.0 million.
Equity
-
The Company's equity position amounted to EUR
44.1 million at year-end 2018 versus
EUR 15.9 million at the end of 2017, an increase of EUR 28.2
million. The main drivers of this increase are net proceeds of two
share offerings of EUR 50.6 million in total, shares issued upon
the exercise of warrants for EUR 5.0 million, partly offset by the
loss for the year of EUR 29.8 million.
Earnings per
share
Annual
Report
The Annual Report 2018 is
available on Kiadis Pharma's website April 30, 2019.
For more information, please contact:
Kiadis Pharma:
Amy Sullivan, SVP, Corporate Affairs
Tel. +1 508 479 3480
a.sullivan@kiadis.com |
Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 950 9144
David Brilleslijper (Amsterdam)
Tel: +31 610 942 514
kiadis@optimumcomms.com |
About Kiadis
Pharma
Kiadis Pharma is developing its lead product candidate, ATIR101,
for use in conjunction with haploidentical HSCT for adult blood
cancers to address key limitations of haploidentical HSCT, without
prophylactic immunosuppression and its associated morbidity and
mortality. Based on the positive results from the single dose Phase
II CR-AIR-007 study, the Company submitted a marketing
authorization application to the European Medicines Agency in April
2017 for approval of ATIR101 as an adjunctive treatment in
haploidentical HSCT for high risk adult hematological malignancies.
If the product is conditionally approved, Kiadis Pharma intends to
launch ATIR101 in selected countries in Europe through its own
commercial organization starting in the second half of 2019.
In December 2017, Kiadis Pharma
commenced an international, multicenter, randomized and controlled
Phase III clinical trial of ATIR101 against the Post-Transplant
Cyclophosphamide, or PTCy protocol, the main protocol used to
perform a haploidentical HSCT. The trial will be performed in 250
patients with acute leukemia and myelodysplastic syndrome at
approximately 50 sites in the United States, Canada, Europe and
certain additional countries. ATIR101 received regenerative
medicine advanced therapy designation from the FDA in September
2017, which provides benefits that are materially equivalent to a
breakthrough designation from the FDA. In addition, ATIR101 has
been granted multiple orphan Drug designations both in the European
Union and the United States.
The Company's shares are listed on
Euronext Amsterdam and Brussels under the ticker KDS.
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 directors' current expectations
and projections about future events. By their nature,
forward-looking statements involve a number of risks, uncertainties
and assumptions that could cause actual results or events to differ
materially from those expressed 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, competition and technology, can
cause actual events, performance or results to differ significantly
from any anticipated 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, Kiadis Pharma
expressly disclaims any obligation or undertaking to release any
update or revisions to any forward-looking statements in this press
release as a result of any change in expectations or any change in
events, conditions, assumptions or circumstances on which these
forward-looking statements are based. Neither Kiadis Pharma nor its
advisers or representatives nor any of its subsidiary undertakings
or any such person's officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in this
press release or the actual occurrence of the forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Kiadis Pharma N. V. via Globenewswire