REGULATED INFORMATION
A
year of many momentous moments
GHENT, Belgium,
22 February 2018 - Ablynx [Euronext Brussels and Nasdaq: ABLX]
today announced its financial results for the year ended
31st December
2017, which have been prepared in accordance with IFRS as issued by
the IASB and adopted by the European Union, business highlights
year-to-date and the outlook for the remainder of the year.
2017 Highlights
-
Compelling Phase III data for caplacizumab
(wholly-owned, anti-vWF Nanobody®) for the treatment of acquired
thrombotic thrombocytopenic purpura (aTTP), a potential €1.2
billion per annum market, which will support
both the ongoing regulatory review process in Europe and the
planned Biologics License Application (BLA) in the USA
-
Successful US initial public offering (IPO)
raising $230 million
-
Completed the dose escalation part of the Phase
IIb RESPIRE study in 36 infants with the wholly-owned anti-RSV
(respiratory syncytial virus) Nanobody, ALX-0171, and initiated the
parallel dose part in 144 infants, with topline results expected in
Q4 2018
-
Research collaboration with Sanofi on up to
eight new programmes, focussed on immune-mediated inflammatory
diseases, with €23 million in upfront payments and up to €2.4
billion in potential milestones plus tiered royalties
-
Received €15 million milestone payment from
Merck KGaA for the completion of a pre-clinical package for
ALX-1141, targeting ADAMTS-5 in osteoarthritis, which has since
entered Phase I trials
-
Total revenues of €55.5 million and net cash
burn[1] of
€60.4 million resulting in a cash position, including cash, other
financial assets, restricted cash and deposits of €354.3
million
On 29th January
2018, Ablynx announced an offer by Sanofi to acquire all its
outstanding ordinary shares (including shares represented by
American Depository Shares (ADSs), warrants and convertible bonds)
at a price of €45 per share, which represents an aggregate equity
value of approximately €3.9 billion. This proposed transaction was
unanimously approved by both the Sanofi and Ablynx Board of
Directors. The tender offer is expected to be launched in the
beginning of the second quarter of 2018. Sanofi will publish an
offer document in which it will set out the full details of its
tender offer, and the Board of Directors of Ablynx will publish a
response memorandum ('memorie van antwoord'),
in which it will set out its position on the tender offer.
Dr Edwin Moses, CEO of Ablynx
said:
"We experienced many momentous moments this year including the
compelling Phase III results for our lead product caplacizumab and
our successful US initial public offering. Caplacizumab has the
potential to change the lives of patients affected by aTTP, a
devastating disease for which there is currently no approved drug
available. We are proud to be pioneers in the treatment of aTTP and
are working with the regulatory authorities to obtain marketing
approval and make caplacizumab rapidly available to patients."
"We are also pleased with the progress made with
our anti-RSV Nanobody, ALX-0171, that is delivered via
nebulisation, a technique with potential in other pulmonary
diseases, and we look forward to the results from our Phase IIb
RESPIRE study which should be available before the end of this
year."
"The offer made by Sanofi on 29th
January 2018 to acquire Ablynx for €3.9 billion represents
compelling value for shareholders and builds on a successful
existing partnership. We strongly believe that Sanofi's global
infrastructure, commitment to innovation and commercial
capabilities will accelerate Ablynx's therapeutic programmes and
maximise the potential of our pipeline and unique Nanobody
technology platform to the benefit of all stakeholders."
Operational review
R&D
update
In January, Ablynx's partner,
Merck KGaA, reported encouraging results from their Phase Ib study
of the bi-specific anti-IL-17A/F Nanobody, in patients with
moderate to severe psoriasis.
In February, Ablynx submitted a
marketing authorisation application (MAA) to the European Medicines
Agency (EMA) for caplacizumab, its wholly-owned anti-vWF-Nanobody,
caplacizumab, for the treatment of aTTP, including data from the
Phase II TITAN study. In November, the MAA was further updated with
the positive results of the Phase III HERCULES study that were
announced in October.
In May, Ablynx received a €15
million milestone payment from Merck KGaA for the completion of a
pre-clinical package for a novel Nanobody (ALX-1141) targeting
ADAMTS-5 in osteoarthritis, with Merck KGaA subsequently starting a
Phase I study.
In June, Ablynx achieved a second
milestone in the immuno-oncology collaboration with Merck &
Co., Inc., (known as MSD outside the USA and Canada) triggering a
€2.5 million payment to Ablynx.
In July, Ablynx received Fast
Track designation from the FDA for caplacizumab for the treatment
of aTTP.
In August, Ablynx announced the
completion of the sequential dose escalation part of the Phase IIb
RESPIRE study in 36 infants hospitalised as a result of a RSV
infection and the initiation of the parallel dose part in 144
infants with ALX-0171, the Company's inhaled anti-RSV Nanobody.
Results from this Phase IIb study are expected in Q4 2018.
In October, Ablynx announced
positive topline results from the Phase III HERCULES study of
caplacizumab, in 145 patients with aTTP. The study met its primary
and two key secondary endpoints and reported a favourable safety
profile.
In December, Ablynx reported
additional clinically important benefits of caplacizumab from its
Phase III HERCULES study in aTTP at the 59th Annual
Meeting of the American Society of Hematology (ASH) as part of the
late-breaking abstracts session.
Also in December, Ablynx announced
positive data from a single and multiple dose Phase I study of
caplacizumab, demonstrating comparable pharmacokinetics in 60
healthy Japanese and Caucasian subjects.
Corporate
developments
In June, Ablynx appointed Dr Markus Ewert as Chief Business Officer
to lead Ablynx's business development activities and become a
member of the Executive Committee.
In July, Ablynx announced a
research collaboration and global exclusive licensing agreement
with Sanofi to develop up to eight Nanobody product candidates
initially focused on immune-mediated inflammatory diseases. Ablynx
received an upfront payment of €23 million plus research funding
for the initially selected targets and is eligible to receive
further option exercise fees from additional targets and up to €2.4
billion in potential future milestone payments and royalties on the
net sales of any products originating from the
collaboration.
In October, following the positive
Phase III data of caplacizumab, Ablynx completed its initial US
public offering, raising $230 million in gross proceeds from the
sale of 13,144,500 ordinary shares in the form of ADSs, including
the full exercise of the underwriters' option, at a price of $17.50
per ADS. The US public offering was nearly three times
oversubscribed and was upsized from the $175 million initially
targeted.
Also in October, Ablynx
established Ablynx, Inc., its subsidiary in the USA and appointed
Mr Daniel Schneider as the General Manager to lead the
commercialisation of caplacizumab in North America.
Post-period
highlights
In January 2018, Ablynx announced
the appointment of Robert Friesen, PhD, as Chief Scientific
Officer, effective 1st March 2018.
Dr Friesen will lead the Company's scientific, research and
technology activities and become a member of the Executive
Committee.
In January and February 2018,
Ablynx announced changes to its Board of Directors with the
departures of Dr Peter Fellner and Dr Bo Jesper Hansen
respectively. Dr Russell G. Greig, who has been a non-executive
Director of Ablynx since 2012, is now the new Chairman of the
Board.
On 16th February
2018, Ablynx announced that as part of the research collaboration
signed in July 2017, Sanofi has exercised its options for two
additional multi-specific Nanobody product candidates, triggering
the payment to Ablynx of €13 million in exercise fees.
On 1st March 2018,
Piet Houwen will join Ablynx as Chief Operating Officer. Mr Houwen
will be responsible for the support of Ablynx's business and
R&D processes and become a member of the Executive
Committee.
Outlook for the
remainder of 2018
During H1 2018, a BLA will be
submitted for caplacizumab in the USA. In Europe, the Company has
the potential to receive marketing authorisation for caplacizumab
in aTTP in Q3 2018 followed by potential first commercial sales in
Germany.
For ALX-0171, a Phase II study in
Japanese infants, hospitalised as a result of a RSV infection, and
a global Phase II study in hematopoietic stem cell transplant
patients who become infected with RSV, are expected to be initiated
in H1 2018. Results from the ongoing Phase IIb study in
RSV-infected hospitalised infants are expected in Q4 2018.
The Phase II study results for
vobarilizumab (anti-IL6R Nanobody) in 312 systemic lupus
erythematosus (SLE) patients are expected in H1 2018 followed by
AbbVie's decision on whether to opt-in and license the
compound.
The Company expects up to three
Nanobodies to enter Phase I studies from our collaborative
programmes during the year.
Detailed financial review
(€ million) |
FY 2017 |
FY 2016 |
Variance |
Total revenue and grant income |
55.5 |
85.2 |
(35%) |
|
R&D income |
55.5 |
84.8 |
(35%) |
|
Grants |
- |
0.4 |
|
Operating expenses |
(109.7) |
(113.8) |
(4%) |
|
R&D |
(90.9) |
(100.3) |
(9%) |
|
G&A |
(18.8) |
(13.5) |
39% |
Operating loss |
(54.2) |
(28.6) |
(90%) |
Net financial result |
(54.3) |
27.5 |
< (100%) |
Net loss |
(108.5) |
(1.1) |
< (100%) |
Net cash burn* |
(60.4) (1) |
(72.2) (3) |
16% |
Cash position** at 31 December |
354.3 (2) |
235.4 (4) |
51% |
(1) excluding
€179.3 million net proceeds from Nasdaq IPO
(2) including
€1.6 million in restricted cash
(3) excluding
€71.4 million net proceeds from the private placement announced on
1 June 2016
(4) including
€1.6 million in restricted cash
* Net cash burn is the difference between the cash
position of the current year and the previous year minus the
proceeds (net of issue costs) from the issue of ordinary
shares
** Cash position includes cash, other financial assets, restricted
cash and deposits
Income
statement
Total revenues and grant income decreased by 35%
to €55.5 million (2016: €85.2 million), mainly driven by lower
recognition of upfront payments from the ongoing collaborations
with AbbVie and Merck & Co., Inc.
Total research and development costs decreased to
€90.9 million (2016: €100.3 million) in line with the decrease in
external development costs, largely related to lower clinical
trials expenditure for vobarilizumab.
General and administrative costs increased to
€18.8 million (2016: €13.5 million), related to expenditure for
consultancies and staff, including pre-commercialisation costs for
caplacizumab and costs related to the IPO on Nasdaq completed in
October 2017.
As a result of the above, the operating loss was
€54.2 million (2016: €28.6 million).
The net financial loss of €54.3 million comprises
finance expenses of €46.6 million resulting from an increase in the
fair value of the derivative associated with the convertible bond
(following an increase in the Ablynx share price at year-end
compared to that at the end of 2016), and finance costs of €7.4
million (mainly related to the amortisation of the debt component
of the convertible bond).
As a result, the net loss for 2017
increased to €108.5 million (2016: net loss of €1.1 million).
Balance
sheet
The Company's non-current assets of €78.5 million
are €53.9 million higher than at 31 December 2016, mainly driven by
the purchase of Interest Structured Notes with a maturity of two
years and higher receivables for research and development
incentives.
Ablynx's current assets of €311.3 million consist
mainly of cash and cash equivalents and other financial assets.
Cash and cash equivalents consist of cash and deposits held on call
with several banks. The Company also places cash in term accounts
with maturities limited to a maximum of one year.
Shareholders' equity increased from €103.1 million
at the end of 2016 to €179.9 million at the end of 2017, mainly as
a result of the €179.3 million net proceeds from the IPO on Nasdaq
and the incorporation of the €108.5 million loss for the
period.
Non-current liabilities relate to the senior
unsecured bonds due on 27 May 2020 with a principal value of €100
million.
Current liabilities consist mainly of trade
payables and deferred income related to the upfront payments
received from partners.
Cash flow statement
Net cash outflow from operating activities was
€57.8 million as compared to a net outflow of €66.6million in 2016.
The difference primarily relates to lower operating expenses for
the current period.
Cash flow from investing activities resulted in a
net outflow of €160.0 million as compared to a net inflow of €45.9
million in 2016. The net cash outflow primarily relates to the
movements from deposits with a term of less than 1 month to
deposits with a term greater than 1 month.
Cash flow from financing activities represented a
net inflow of €179.5 million compared to a net inflow of €70.4
million in 2016. The difference primarily relates to higher net
proceeds from the issue of new shares on Nasdaq in 2017 compared to
the net proceeds raised via an accelerated book building procedure
in 2016.
The Company ended the period with a total
liquidity position of €354.3 million (2016: €235.4 million) which
consists of cash and cash equivalents of €14.9 million, other
financial assets of €337.8 million and restricted cash of €1.6
million.
Investor
Conference Call and Webcast
In light of the pending transaction with Sanofi,
Ablynx will not be hosting a conference call to discuss its 2017
full year results.
Next financial
events
27 March 2018 - online publication Annual Report
2017
26 April 2018 - Annual General Meeting 2018
Glossary of
terms
ADS American Depositary Shares
ASH American Society of Hematology
aTTP acquired thrombotic thrombocytopenic
purpura
BLA biologics license application
EMA European Medicines Agency
IPO Initial Public Offering
MAA marketing authorisation application
RA rheumatoid
arthritis
RSV respiratory syncytial virus
SLE systemic lupus erythematosus
About
Ablynx
Ablynx is a biopharmaceutical
company engaged in the development of Nanobodies, proprietary
therapeutic proteins based on single-domain antibody fragments,
which combine the advantages of conventional antibody drugs with
some of the features of small-molecule drugs. Ablynx is dedicated
to creating new medicines which will make a real difference to
society. Today, the Company has more than 45 proprietary and
partnered programmes in development in various therapeutic areas
including inflammation, haematology, immuno-oncology, oncology and
respiratory disease. The Company has collaborations with multiple
pharmaceutical companies including AbbVie; Boehringer Ingelheim;
Eddingpharm; Merck & Co., Inc., Kenilworth, New Jersey, USA;
Merck KGaA; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The
Company is headquartered in Ghent, Belgium. More information can be
found on www.ablynx.com.
For more
information, please contact
Ablynx:
Dr Edwin Moses
CEO
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
e: edwin.moses@ablynx.com
Lies Vanneste
Director Investor Relations
t: +32 (0)9 262 01 37
m: +32 (0)498 05 35 79
e: lies.vanneste@ablynx.com
Follow us on Twitter @AblynxABLX
Ablynx media
relations:
Consilium Strategic Communications
Mary-Jane Elliott, Philippa Gardner, Sukaina Virji
t: +44 (0)20 3709 5700
e: ablynx@consilium-comms.com
Joele Frank,
Wilkinson Brimmer Katcher
Dan Katcher or Joseph Sala
t: +1 212-355-4449
Disclaimer
Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect the Company or, as appropriate, the
Company 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, the Company 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 the Company nor its advisers or
representatives nor any of its parent or 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.
Additional
Information for US Investors
The tender offer for the outstanding ordinary shares ("Shares"),
American Depositary Shares issued by J.P. Morgan Chase Bank, N.A.,
acting as depositary ("ADSs"), warrants ("Warrants") and
convertible bonds of Ablynx ("Bonds" and, together with the Shares,
ADSs and Warrants, the "Securities") has not yet commenced. This
communication is for informational purposes only and is neither a
recommendation, an offer to purchase nor a solicitation of an offer
to sell any Securities of Ablynx.
At the time the tender offer is
commenced, Sanofi will file, or cause to be filed, a tender offer
statement on Schedule TO with the SEC and thereafter, Ablynx will
file a solicitation/recommendation statement on Schedule 14D-9.
Holders of Securities are urged to carefully review the documents
that will be filed by Sanofi and Ablynx with the SEC because these
documents will contain important information, including the terms
and conditions of the tender offer.
The offer to purchase, the related
letter of transmittal and certain other tender offer documents, as
well as the solicitation/recommendation statement, are available to
all holders of Securities of Ablynx at no expense to them. These
documents are available for free at the SEC's website at
www.sec.gov. Additional copies may be obtained for free by
contacting Sanofi at ir@Sanofi.com or on Sanofi's website at
https://en.Sanofi.com/investors. You should read the filings made
by Sanofi and Ablynx with the SEC carefully before making a
decision concerning the U.S. Offer.
[1] Net cash
burn is the difference between the cash position of the current
year and the previous year minus the proceeds (net of issue costs)
from the issue of ordinary shares
pdf version of the press
release
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Ablynx via Globenewswire
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