DGAP-News: PAION AG / Key word(s): Half Year Results
PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2016
10.08.2016 / 07:30
The issuer is solely responsible for the content of this announcement.
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PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2016
- Positive remimazolam headline data in pivotal U.S. Phase III study for
procedural sedation during colonoscopy
- License agreement with Cosmo Pharmaceuticals (Cosmo) for development
and commercialization of remimazolam in the U.S.
- Cash and cash equivalents of EUR 32.1 million as of 30 June 2016 and
Cosmo upfront payment of EUR 10 million received in July 2016:
Sufficient to complete ongoing U.S. Phase III development of
remimazolam; if all activities progress as planned, no additional
funding is needed to bring remimazolam to the U.S. market
- Conference call (in English) today at 2:00 pm CEST (1:00 pm BST/8:00 am
EDT)
Aachen (Germany), 10 August 2016 - The specialty pharmaceutical company
PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8)
today reports its consolidated financial results according to International
Financial Reporting Standards (IFRS) for the six months ended 30 June 2016.
In the first half of 2016, revenues were EUR 0.2 million, mainly resulting
from the U.S. license agreement for remimazolam entered into with Cosmo.
Research and development expenses amounted to EUR 12.2 million, a slight
increase compared to the first half of 2015, mainly related to the U.S.
Phase III program for remimazolam. General administrative and selling
expenses increased to EUR 3.3 million compared to the prior-year period
(EUR 2.7 million) mainly due to financing activities. Net loss was EUR 13.2
million for the first half-year 2016 compared to EUR 11.3 million for the
prior-year period.
Cash and cash equivalents were EUR 32.1 million as of 30 June 2016,
compared to EUR 32.7 million as of 31 December 2015. Based on current
planning, PAION believes that cash and cash equivalents together with the
EUR 10 million upfront payment received from Cosmo in July 2016 will enable
PAION to complete the ongoing U.S. Phase III development for remimazolam
including the preparation of filing. Should development, filing and
approval go according to plan, PAION will not need additional funding to
bring remimazolam to the U.S. market including bearing all the costs for
development and preparation of filing.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "We have had significant
achievements in the first half of 2016, highlighted by positive headline
results in our first U.S. Phase III trial with remimazolam and an important
U.S. licensing deal. We are now in a much stronger financial position to
complete Phase III development in the U.S. We expect to be very busy in the
second half of the year as we advance our clinical development work in the
U.S. We also look forward to the presentation of more detailed data from
the first U.S. Phase III trial with remimazolam in procedural sedation in
scientific publications later this year."
Development and Commercialization Activities
In the first half of 2016, PAION focused on advancing its Phase III program
for the development of remimazolam in procedural sedation in the U.S.
U.S.
The patient recruitment in the first U.S. Phase III study was completed in
April 2016, and in June 2016, PAION announced that remimazolam has met its
primary efficacy endpoint in the first study of its pivotal U.S. Phase III
program in patients undergoing procedural sedation. The study enrolled a
total of 461 patients at 13 U.S. sites and was designed to evaluate the
efficacy and safety of remimazolam compared to placebo (with midazolam
rescue) in patients undergoing colonoscopy. Sedation was provided under the
supervision of the endoscopist. The primary outcome measure, success of the
procedure without requirement for rescue sedation, was reached in 91.3% of
the patients in the remimazolam arm and in 5.0% in the placebo (including
midazolam rescue) arm. The safety profile of remimazolam was consistent
with that observed in previous studies. This study also included an open
label arm in which midazolam was dosed according to U.S. label. Evaluation
of the full data set is ongoing and is supposed to be presented in an
appropriate scientific, peer-reviewed format in autumn 2016.
The U.S. Phase III program also includes a second confirmatory,
prospective, double-blind placebo-controlled, randomized, multi-center open
label vs. midazolam trial in 420 patients undergoing bronchoscopies, a
smaller safety trial in 75 high-risk patients (double blind vs. placebo and
open label vs. midazolam) undergoing colonoscopies, and in addition four
ongoing Phase I trials for the purpose of further supporting remimazolam's
safety profile.
In June 2016, PAION entered into an investment and a U.S. license agreement
with Cosmo. In the course of the license agreement, Cosmo received an
exclusive license for the development and commercialization of remimazolam
in the U.S, and bears all future cost for market authorization and sales
and distribution of remimazolam. PAION remains responsible for and bears
the cost associated with the completion of the ongoing U.S. clinical
development program in procedural sedation. PAION received an upfront
payment in the amount of EUR 10 million after the balance sheet date and is
eligible for further payments of up to EUR 42.5 million depending on the
achievement of certain regulatory milestones in the U.S., as well as tiered
royalties upon commercialization ranging from 20% to 25% of the net sales
(which may be adjusted under certain conditions but not to below 15%).
In the course of the investment agreement, Cosmo has committed to invest an
amount of EUR 10 million in PAION shares which are subject to a 12-month
lock-up period upon purchase. In June 2016, Cosmo already invested an
amount of EUR 9.6 million in a private placement; the remaining EUR 0.4
million will be invested at a later date.
EU
In February 2016, PAION decided to discontinue a confirmatory EU Phase III
study with remimazolam in patients undergoing major cardiac surgery. Due to
the complex study design, the trial faced recruitment challenges. Despite
intense efforts to accelerate patient recruitment, the trial proved to be
difficult to implement. PAION is currently evaluating how to resume the
clinical development in the EU.
Japan
In January 2016, PAION held a pre-NDA meeting with the Japanese
Pharmaceuticals and Medical Devices Agency (PMDA). The PMDA stated that
they considered the non-clinical and clinical data package for remimazolam
to be complete for filing for the indication "Induction and maintenance of
general anesthesia". The PMDA previously had confirmed that both the raw
materials produced by PAION in Europe as well as the finished formulation
of remimazolam fulfilled the requirements for filing in Japan.
Outlook
Due to the significant impact of the Cosmo license and investment
agreements on PAION's net assets, financial position and results of
operations, PAION has revised its 2016 financial outlook that was given on
22 March 2016.
Development and Commercialization Activities
PAION's major goals for the remainder of 2016 are the continuation of the
ongoing Phase III development program with remimazolam in the U.S. and the
implementation of the cooperation with Cosmo, including the necessary know-
how transfer. In addition, the focus remains on production development for
remimazolam, in particular the validation of the production at market
scale. PAION expects its other regional partners to continue their
remimazolam development activities.
Subject to completing ongoing U.S. development activities and the
associated know-how transfer to Cosmo, PAION intends to resume development
activities for remimazolam in the EU. The next step is to re-evaluate the
studies already conducted in general anesthesia. Along these lines, in
close collaboration with key opinion leaders in the EU, PAION is analyzing
the design and feasibility of a new development program as a basis for
discussion with the European Medicines Agency (EMA). PAION currently plans
to commercialize remimazolam itself in the EU but is also open to discuss
EU partnerships that are value-creating for its shareholders.
For all regions outside the U.S. and the EU, it is planned to enter into
license or distribution agreements.
Following the positive pre-NDA meeting with the Japanese authority in the
beginning of 2016, in which the details of a market approval for
remimazolam were outlined, PAION is continuing partnering discussions with
potential licensees and is also evaluating the option of filing for market
approval itself alternatively. A Japanese dossier could serve as a
reference dossier for approval in certain other markets.
Patient recruitment for the ongoing U.S. Phase III bronchoscopy trial,
which marks the completion of PAION's U.S. clinical development program in
procedural sedation, has been slower than anticipated and is now expected
to be completed in the second quarter of 2017. PAION is continuously
implementing measures to accelerate patient recruitment of this study. How
soon after completion of the clinical development program filing for
approval is possible, is subject to ongoing discussions with Cosmo, who are
responsible for all approval activities in the U.S.
Financial Outlook
PAION expects revenues of approximately EUR 4 million in 2016, which is the
portion of the EUR 10 million upfront payment received from Cosmo that will
be recognized as revenues in 2016. The remaining approximately EUR 6
million will presumably be recognized as revenues in 2017. This financial
outlook assumes that no further license agreements are entered into during
2016.
Due to the ongoing clinical development of remimazolam, PAION expects R&D
expenses to be between EUR 24 million and EUR 27 million depending on the
progress of the development. Income from tax credits on parts of the
research and development expenses from British tax authorities is expected
to be between EUR 4 million and EUR 4.5 million. General administrative and
selling expenses are expected to amount to approximately EUR 5.5 million.
Net loss is expected to be between EUR 21.5 million and EUR 24 million, a
decrease compared to the previous year (2015: EUR 28.2 million).
This outlook assumes that development activities for remimazolam in the
U.S. will progress as expected. If not, a significant portion of these
costs would instead be expected to occur during 2017. Expense forecasts are
also based on the current status of discussions with the U.S. Food & Drug
Administration (FDA). Although PAION does not currently anticipate that
this will occur, costs could be higher than planned and lead to a delay in
approval should the FDA impose additional requirements for filing for
market approval.
Based on current plans, PAION believes that cash and cash equivalents of
EUR 32.1 million as of 30 June 2016, together with the EUR 10 million
upfront payment received from Cosmo in July, will enable PAION to complete
ongoing Phase III development including the preparation of filing of
remimazolam in the indication procedural sedation in the U.S. Thereafter,
PAION expects to receive milestone payments from Cosmo and, once
remimazolam is approved, royalties on net sales. Should development, filing
and approval go according to plan, PAION will not need additional funding
to bring remimazolam to the U.S. market including bearing all the costs for
development and preparation of filing. Regarding the markets in the EU,
PAION is currently evaluating how to resume the clinical development of
remimazolam. For such a development in the EU, additional funding would be
needed. The amount will only be specified after the currently ongoing
evaluation of a potential new development program has been finalized.
###
Key Consolidated Financial Figures, IFRS
<pre>
(all figures in Q2 2016 Q2 2015 H1 2016 H1 2015
KEUR thousand
unless otherwise
noted)
Revenues 195 6 198 39
Research and -5,653 -6,217 -12,155 -11,980
development
expenses
General -2,070 -1,387 -3,250 -2,724
administrative and
selling expenses
Result for the -6,474 -6,637 -13,203 -11,340
period
Earnings per share -0.13 -0.13 -0.26 -0.22
in EUR for the
period (basic)
Earnings per share -0.13 -0.13 -0.26 -0.22
in EUR for the
period (diluted)
H1 2016 H1 2015
Cash flow from -9,606 -12,033
operating
activities
Cash flow from -138 -5
investing
activities
Cash flow from 9,185 22
financing
activities
Change in cash and -576 -11,951
cash equivalents
Average number of 39 27
employees in the
Group
30 June 2016 31 Dec. 2015
Intangible assets 2,836 3,362
Cash and cash 32,104 32,680
equivalents
Equity 31,360 35,562
Non-current 36 6
liabilities
Current liabilities 7,151 7,900
Balance sheet total 38,547 43,468
</pre>
The full half-year financial report will be available as of 10 August 2016
on PAION's website at http://www.paion.com/media-and-investors/
investorcenter/financial-reports/.
Earnings call and webcast
Conference call and webcast
In addition to the publication of results, the Management Board of PAION AG
will host a conference call (conducted in English) on 10 August 2016 at 2
p.m. CEST (1 p.m. BST, 8 a.m. EDT) to present the financial results of the
first half-year 2016 and provide a pipeline and strategy update and
financial outlook.
To access the call, please dial:
* Germany +49 (0) 69 7104 45598,
* UK +44 (0) 20 3003 2666 and
* U.S. +1 212 999 6659
* Other countries: please use the UK number
When prompted, you will be asked to give the password "PAION". The
conference call will be supplemented by a webcast presentation which can be
accessed during the call under the following link: https://paion-
events.webex.com/paion-events/j.php?MTID=md2ff41fad5ab42f67244b963f5b4b280.
About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing
and aiming to commercialize innovative drugs to be used in out-patient and
hospital-based sedation, anesthesia and critical care services. PAION's
lead compound is remimazolam, an intravenous, ultra-short-acting and
controllable benzodiazepine sedative/anesthetic drug candidate. Currently,
remimazolam is in active Phase III clinical development for use in
procedural sedation in the U.S., where PAION is focusing all its business
and financial resources on successfully completing its ongoing clinical
development program in procedural sedation. Outside the U.S., PAION has so
far focused on the development of remimazolam in the indication general
anesthesia. Development of remimazolam in the indication intensive care
unit (ICU) sedation is also part of the longer term life-cycle plan for
remimazolam.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey,
the MENA region, and South Korea.
PAION is headquartered in Aachen (Germany) with further sites in Cambridge
(United Kingdom) and New Jersey (USA).
PAION's vision is to become an acknowledged "PAIONeer" in sedation and
anesthesia.
Contact
Ralf Penner
Director Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12, 52062 Aachen - Germany
Phone +49 241 4453-152
E-mail r.penner@paion.com
http://www.paion.com
Disclaimer:
This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG's management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such forward-
looking statements. Considering the risks, uncertainties and other factors
involved, recipients should not rely unreasonably upon these forward-
looking statements. PAION AG has no obligation to periodically update any
such forward-looking statements to reflect future events or developments.
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10.08.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart, Tradegate Exchange
End of News DGAP News Service
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490799 10.08.2016
DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2016
| Source: EQS Group AG