Earnings Release • Nov 5, 2015
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Download Source FileCopenhagen, 2015-11-05 09:28 CET (GLOBE NEWSWIRE) --
-- Lyxumia® royalties and milestone revenue of DKK 20.6 million / EUR 2.7
million
-- Net operating expenses of DKK 176.2 million / EUR 23.6 million for the
period
-- Net result of DKK -183.7 million / EUR -24.6 million
-- Financial guidance for 2015 unchanged
-- Significant pipeline progress in Q3 2015:
-- Lixisenatide (Type 2 diabetes) application for regulatory approval in
the US accepted for review by the FDA
-- LixiLan (Type 2 diabetes) showed positive results in two Phase III
trials and Sanofi expects regulatory submission in the US in Q4 2015 and
in the EU in Q1 2016
-- Novel long-acting GLP-2 analogue, ZP1848, advanced into Phase II
development for the treatment of Short Bowel Syndrome
-- Stable glucagon analogue, ZP4207, showed positive results in a
multiple-dose Phase Ib trial for better control of hypoglycemia
Copenhagen, 5 November 2015 – Zealand Pharma A/S (“Zealand”) (CVR no. 20 04 50
78) announces financial results on target for the first nine months of 2015,
from 1 January to September 30, and reports that significant product and
pipeline milestones have been met and announced in Q3 2015.
Financial results for the first nine months of 2015
(Comparative figures for the same period 2014 in brackets)
Lyxumia® royalty revenue: DKK 20.5 million (14.1) / EUR 2.7 million (1.9), up
46% year-on-year
Total revenue: DKK 20.6 million (147.5) / EUR 2.8 million (20.0)
Net result: DKK -183.7 million (-2.0) / EUR -24.6 million (-0.3)
Cash and cash equivalents (as of 30 September 2015): DKK 453.9 million (303.8)
/ EUR 60.8 million (40.8)
Earnings per share: DKK -7.99 (-0.09) / EUR -1.07 (-0.01)
Significant product and pipeline milestones met in Q3 2015 and the period
thereafter
Lixisenatide (Lyxumia®) –Type 2 diabetes (Sanofi): In late September, the US
Food and Drug Administration (FDA) accepted for review Sanofi’s New Drug
Application (NDA) for registration of lixisenatide, an important milestone in
the US regulatory review process for this product.
LixiLan (fixed-ratio combination product of lixisenatide and insulin glargine
(Lantus®) – Type 2 diabetes (Sanofi): In September, Sanofi announced positive
results from LixiLan-L, the second pivotal Phase III trial with LixiLan to meet
the primary endpoint. Positive results from the first pivotal Phase III trial,
LixiLan-O, were reported in July. Based on the results from both trials, Sanofi
is proceeding towards planned submission of LixiLan for regulatory approval in
Q4 2015 in the US and in Q1 2016 in the European Union.
Danegaptide – Cardiac reperfusion injuries: In late August, Zealand completed
the enrolment of 591 patients with an acute myocardial infarction (AMI) into
the Phase II Proof-of-Concept trial. Zealand expects results to be available in
Q1 2016.
ZP1848 – Short Bowel Syndrome: In mid-September, Zealand announced the advance
of its novel, long-acting and stable GLP-2 analogue into clinical Phase
II development. The dosing of the first patients in a Phase II
Proof-of-Concept, dose-finding trial is planned for Q1 2016.
ZP4207 – Stable glucagon for multi-dose use to treat and control mild to
moderate hypoglycemia: In September, Zealand announced positive results from
the clinical Phase Ib trial, supporting good safety and tolerability for ZP4207
after multiple dosing.
In October, as part of Zealand’s collaboration with Boehringer Ingelheim on an
undisclosed target in the cardio-metabolic field, the selection of a lead
candidate for preclinical development led to a DKK 22.4 million (EUR 3.0
million) milestone payment to Zealand. As this event was after the reporting
period, the payment has no impact on the results for the first nine months of
2015.
Commenting on the interim report, Britt Meelby Jensen, President and CEO of
Zealand, said:
“During the last quarter, we have made further important progress across our
portfolio of products, which has provided additional clarity and strength to
Zealand’s business.
We are excited about Sanofi’s filing of lixisenatide for registration in the US
and the positive outcome of two pivotal Phase III studies with LixiLan,
supporting Sanofi’s planned move towards US regulatory filing for this product
before end 2015. In alignment with our strategic focus, we have in parallel
successfully expanded and advanced our proprietary pipeline. We have taken
ZP1848 into Phase II development for SBS, reported positive results from the
Phase Ib multiple-dosing trial with our stable glucagon product, ZP4207, and
completed the enrolment of close to 600 patients into our Phase II trial with
danegaptide. With these significant advances, we continue our progress towards
accelerated value creation for patients and shareholders.”
Financial guidance for 2015 unchanged
Zealand’s financial guidance for 2015 is unchanged as announced in the
company’s interim report for H1 2015.
This includes growing royalty revenue from Sanofi’s global sales of
lixisenatide (Lyxumia®) plus DKK 155 million / EUR 21 million from event driven
milestone payments from partners.
Net operating expenses for the full year are expected to be at the upper end of
the announced range of DKK 225-235 million / EUR 30-32 million.
Expected news flow outlook for the rest of 2015 and H1 2016
Q4 2015 LixiLan: Planned regulatory submission in the US (by Sanofi)
H1 2016 Lixisenatide: Royalty reports for Q4 2015 and Q1 2016 and status
updates
Lixilan: Planned regulatory submission in the European Union
(by Sanofi)
LixiLan: Presentation of results from LixiLan-O and LixiLan-L
at a medical conference
Elsiglutide: Completion of Phase II dose-finding trial
Danegaptide: Topline results from Phase II Proof-of-Concept
trial
ZP1848: Dosing of first patients in Phase II Proof-of-Concept
trial
ZP4207 (rescue pen): Initiate next stage of clinical
development
Boehringer Ingelheim collaboration: Start preclinical
development of new once-weekly GGDA lead
Financial calendar for 2016
16 March Full year announcement and Annual Report 2015
19 April Annual General Meeting
18 May Interim report for first quarter of 2016
25 August Interim report for first half of 2016
9 November Interim report for the first nine months of 2016
Q3 2015 conference call details
Zealand’s management will host a conference call today at 14.00 CET/ 08:00 EDT
to present the interim report for the first nine months of 2015 with focus on
the pipeline progress in Q3 2015. Participating on the call will be Britt
Meelby Jensen, President and Chief Executive Officer, Mats Blom, Chief
Financial Officer, and Hanne Leth Hillman, Senior Vice President for Investor
Relations and Communications. The presentation will be conducted in English and
followed by a Q&A session.
The dial-in numbers are:
DK standard access +45 32 71 16 60
UK and international +44 (0) 20 3364 5381
US (free dial-in) +1 718 354 1158
A live audio cast of the call with an accompanying slide presentation will be
available via the following link, http://edge.media-server.com/m/p/btbiddst,
accessible also from the Investor section of Zealand’s website
(www.zealandpharma.com). Participants in the audio cast are advised to register
approximately 10 minutes before the start of the call.
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For further information, please contact
Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: [email protected]
Hanne Leth Hillman, Senior Vice President for Investor Relations &
Communications
Tel: +45 50 60 36 89, email: [email protected]
About Zealand Pharma
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (“Zealand”) is a biotech company
with leading-edge scientific expertise in turning peptides into medicines.
Zealand has a growing proprietary pipeline of novel specialty drug candidates
and a mature portfolio of products and projects under license collaborations
with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.
Zealand’s first invented medicine, lixisenatide, a once-daily prandial GLP-1
analogue for the treatment of Type 2 diabetes, is marketed globally (ex-US) as
Lyxumia® by Sanofi and under regulatory review in the US. The license agreement
with Sanofi covers also a single-product combination of lixisenatide and
insulin glargine (Lantus®) which is on track for regulatory submission in the
US in Q4 2015 and in the European Union in Q1 2016.
The proprietary pipeline includes; danegaptide for ischemic reperfusion
Injuries in Phase II development; ZP1848 for Short Bowel Syndrome in Phase II
development; and the stable glucagon analogue, ZP4207, in Phase II preparation
both as a single-dose rescue pen for severe hypoglycemia and for multiple-dose
use to treat and control mild to moderate hypoglycemia; as well as several
preclinical peptide therapeutics.
The company is based in Copenhagen (Glostrup), Denmark. For further information
about Zealand’s business and activities, please visit: www,zealandpharma.com or
follow us on Twitter @ZealandPharma
Key figures for the group
DKK thousand 2015 2014 2015 2014 2014
INCOME 1.7 - 30.9 1.7 - 30.9 1.1 - 30.9 1.1 - 30.9 1.1 - 31.12
STATEMENT
AND Note Q3 Q3 Q1-Q3 Q1-Q3 Full year
COMPREHENSIV
E INCOME
Revenue 7,170 58,179 20,570 147,470 153,773
Royalty -952 -809 -2,726 -12,864 -13,776
expenses
Gross profit 6,218 57,370 17,844 134,606 139,997
Research and -44,690 -39,913 -158,967 -121,954 -180,036
development
expenses
Administrativ -8,913 -5,752 -28,000 -20,582 -39,826
e expenses
Other 3,130 2,225 10,787 2,356 6,328
operating
income
Operating -44,255 13,930 -158,336 -5,574 -73,537
result
Net financial -8,427 1,685 -28,896 2,298 1,047
items
Tax on 1,360 1,250 3,555 1,250 7,500
ordinary
activities
Net result -51,322 16,865 -183,677 -2,026 -64,990
for the
period
(after tax)
Comprehensive -51,322 16,865 -183,677 -2,026 -64,990
income for
the period
Earnings per -2.23 0.75 -7.99 -0.09 -2.87
share -
basic (DKK)
Earnings per -2.23 0.74 -7.99 -0.09 -2.87
share -
diluted
(DKK)
2015 2014 2014
STATEMENT OF 30 Sep 30 Sep 31 Dec
FINANCIAL
POSITION
Cash and cash 453,889 303,812 538,273
equivalents
Total assets 534,741 357,773 596,756
Share capital 24,052 23,193 23,193
('000
shares)
Shareholder's 159,425 316,220 252,828
equity
Equity / 0.30 0.88 0.42
assets ratio
Royalty bond 328,233 0 272,170
2015 2014 2015 2014 2014
1.7 - 30.9 1.7 - 30.9 1.1 - 30.9 1.1 - 30.9 1.1 - 31.12
Depreciation 1,539 1,378 4,614 4,330 5,932
Change in -10,881 -11,272 -16,660 -9,013 16,771
working
capital
Investments -1,488 -855 -3,303 -2,891 -4,497
in fixed
assets
Free cash 1 -62,446 4,438 -183,087 -8,424 -46,680
flow
2015 2014 2014
Share price 146.50 69.00 83.00
(DKK)
Market 3,524 1,600 1,925
capitalizati
on (MDKK)
Equity per 2 6.79 13.97 11.17
share (DKK)
Average 112 104 103
number of
employees
Products in 3 7 5 5
clinical
development
(end period)
Medicines on 1 1 1
the market
Notes:
(1) Free cash flow is calculated as cash flow from operating activities less
purchase of property, plant and equipment.
(2) Equity per share is calculated as shareholders equity divided by total
number of shares less treasury shares.
(3) In May 2015, Zealand announced start of clinical development of a
multiple-dose version of its stable glucagon analogue, ZP4207. In September, a
new clinical development program was initiated for ZP1848.
Management review
Products and pipeline
Zealand has a broad and growing portfolio of novel peptide therapeutics, partly
under license collaborations, where all development and commercial costs are
covered outside Zealand, partly proprietary.
Zealand has its first invented medicine, lixisenatide for patients with Type 2
diabetes, marketed globally outside the US as Lyxumia® and filed for
registration in the US, both by Sanofi. The pipeline of novel therapeutics has
one product in preparation for regulatory submissions, three product candidates
in clinical Phase II development, three product candidates in clinical Phase I
development, and several preclinical programs.
Out-licensed products and projects under collaboration – Highlights and outlook
Lixisenatide– GLP-1 analogue for Type 2 diabetes: Marketed globally ex-US as
Lyxumia® and under regulatory review in the US (Sanofi)
-- Lixisenatide (Lyxumia®) is available for patients in more than 40 countries
outside the US. Sanofi plans additional launches in the coming quarters.
-- In late September, the Food and Drug Administration (FDA) accepted Sanofi’s
application (NDA) for regulatory approval of lixisenatide in the US. This
milestone initiated the regulatory evaluation process, and a US regulatory
decision by the FDA is expected in Q3 2016.
LixiLan - Fixed-ratio combination of lixisenatide and insulin glargine
(Lantus®) for Type 2 diabetes: In preparation for regulatory submissions
(Sanofi)
-- In September, Sanofi announced positive results from LixiLan-L, the second
pivotal Phase III trial with LixiLan to meet the primary endpoint. In this
trial, LixiLan showed a statistically superior reduction in HbA1c (average
blood glucose over the previous three months) compared with insulin
glargine (Lantus®) in 736 patients with Type 2 diabetes.
-- In July, a positive outcome from the LixiLan-O pivotal Phase III trial
showed the superiority of LixiLan in the reduction of blood glucose (HbA1c)
in 1,170 patients with Type 2 diabetes insufficiently controlled on
metformin, both compared to lixisenatide and compared to insulin glargine
100 units/mL.
-- Following the positive results from both LixiLan-O and LixiLan-L, Sanofi is
preparing for regulatory submissions of LixiLan, expected in Q4 2015 in the
US and in Q1 2016 in the EU.
Elsiglutide – GLP-2 analogue for chemotherapy-induced diarrhea: In Phase IIb
development (Helsinn Healthcare)
-- The enrolment of patients with colorectal cancer into Helsinn’s ongoing
Phase IIb dose-finding trial is progressing as planned. The trial is
expected to complete in H1 2016.
-- Late June, Helsinn completed the enrolment of 1,700 colorectal and breast
cancer patients into an observational study intended to evaluate the
incidence rates and severity of chemotherapy induced diarrhea across Europe
and the US. Helsinn expects the results from this study to be available in
Q1 2016 and to be important to guide the design of a potential pivotal
Phase III trial program for elsiglutide.
Collaborations with Boehringer Ingelheim
-- Under the license collaboration on novel glucagon/GLP-1 dual agonists for
the treatment of Type 2 diabetes and/or obesity, Boehringer Ingelheim has
changed focus and decided to investigate the development of a new
once-weekly lead peptide candidate. The next development step would be
start of preclinical development, rather than start of clinical development
as previously guided. Preclinical development of the new lead is expected
to start in H1 2016.
-- Under the other collaboration covering an un-disclosed Zealand-invented
therapeutic peptide approach in the cardio-metabolic field, Boehringer
Ingelheim in October selected a lead candidate, which will now be advanced
into preclinical development. As announced, this development milestone was
associated with a payment of DKK 22.4 million (EUR 3.0 million) to Zealand.
Zealand’s proprietary pipeline – Highlights and outlook
Danegaptide – A gap junction modifier to protect against cardiac reperfusion
injuries: In Phase II development
-- In late August, Zealand completed the enrolment of 591 patients with an
acute myocardial infarction (STEMI) into its Phase II Proof-of-Concept
trial. The trial has been running very well and Zealand confirms
expectations for trial completion before the end of 2015 and for top-line
results in Q1 2016.
ZP1848 – Novel long-acting GLP-2 analogue for Short Bowel Syndrome: In Phase II
development
-- In late September, Zealand announced the advance of its proprietary,
long-acting GLP-2 analogue, ZP1848, into clinical Phase II development for
the treatment of Short Bowel Syndrome, a gastro-intestinal specialist care
indication of high, unmet medical needs.
-- The start of Phase II development of ZP1848 for Short Bowel Syndrome is an
important step in line with Zealand’s strategic focus of growing its
proprietary pipeline for accelerated value creation.
-- Enrolment and dosing of the first patients in a Proof-of-Concept,
dose-finding trial is planned for Q1 2016.
ZP4207 - Stable glucagon single-dose, ready-to-use rescue pen for severe
hypoglycemia in diabetes: In preparation for next clinical phase after Phase I
-- Next step is regulatory interactions with the FDA to get feedback on the
planned development path for a single-dose version of ZP4207 for the rescue
treatment of severe hypoglycemia.
-- Pending regulatory feedback, the plan is to initiate the next clinical
study with ZP4207 in H1 2016.
ZP4207 - Stable glucagon for multiple-dose use to control mild/moderate
hypoglycemia in diabetes: Completed Phase Ib development
-- In September, Zealand announced positive results from a Phase Ib trial,
demonstrating that ZP4207 was safe and well tolerated with the ability to
provide a clinically relevant blood glucose response after repeat daily
dosing in healthy volunteers.
-- Based on the Phase Ib results, Zealand is progressing plans for next steps
in the development of ZP4207 for multiple-dose use, including potentially
as a component in an artificial pancreas device, to correct low blood sugar
levels in patients with Type 1 diabetes.
ZP2929 – Glucagon/GLP-1 dual agonist for type 2 diabetes and/or obesity: In
Phase I development
-- Zealand has completed additional supportive preclinical studies with ZP2929
and expects to engage with the FDA in H1 2016, to agree on the clinical
program.
Update on Zealand’s maturing business and strategic outlook: From peptide to
patient
Earlier this week, Zealand released an update on the status of its maturing
business and the strategic direction for the company towards accelerated value
creation for patients and shareholders under the headline “From peptide to
patient”.
Zealand is committed to a diligent growth strategy taking point of departure in
four focus areas:
The update on business and strategy was also presented by president and CEO,
Britt Meelby Jensen at a Capital Markets Day, hosted by Zealand on Tuesday 3
November in New York. Slide presentations from the event are available on the
company’s website and an audio recording will also be accessible.
On Wednesday 18 November, from 1:30 pm (lunch from 1:00 pm) to 4:30 pm, Zealand
will host also a Capital Markets Day for institutional investors and analysts
in Denmark at the company’s offices in Glostrup, Copenhagen. This event will
have a similar agenda to the meeting in New York.
To sign up for participation in the Capital Markets Day at Zealand, please
contact: Executive Assistant Annette Boring Kjær on [email protected].
Financial review
(Comparative figures for the same period 2014 are shown in brackets)
Income statement
The net result for the first nine months of 2015 was a loss of DKK 183.7
million compared to a loss of DKK 2.0 million for the same period of 2014. The
lower net result is a consequence mainly of milestone payments received by
Zealand in the first nine months of 2014 under the license agreements with
Sanofi, Boehringer Ingelheim and Helsinn while no milestone payments have been
received in the same period of 2015. Further, net operating expenses were
higher during the first nine months of 2015 compared to the same period of 2014
due mainly to an increased level of development activities and one-off
severance costs.
Revenue
Zealand received DKK 20.5 million (14.1) in royalty revenue on Sanofi’s sales
of Lyxumia in the first nine months of 2015, representing an increase of 46%
versus the same period last year. There has been a minor license payment from
Helsinn of DKK 0.1 million in the first nine months of 2015. For the same
period in 2014, Zealand received milestone payments of DKK 133.4 million from
Sanofi, Boehringer Ingelheim and Helsinn. Total revenue for the first nine
months of 2015 amounted to DKK 20.6 million (147.5).
Royalty expenses
Royalty expenses for the first nine months of 2015 were DKK 2.7 million (12.9).
Royalty expenses are payments by Zealand to third parties on the bases of
license payments received for Lyxumia®.
Research and development expenses
Research and development expenses for the first nine months of 2015 amounted to
DKK 159.0 million (122.0) which was in line with expectations. The increase of
DKK 37.0 million compared to 2014 is mainly due to increased development costs
of DKK 17.0 million, severance costs of DKK 6.7 million related to management
changes and non-cash effect warrant expenses of DKK 12.1 million.
Administrative expenses
Administrative expenses for the first nine months of 2015 amounted to DKK 28.0
million (20.6). The increase is mainly a consequence of severance costs related
to management changes and non-cash effect warrant expenses and increase in IT
costs.
Other operating income
Other operating income for the first nine months of 2015 amounted to DKK 10.8
million (2.4). Other operating income mainly consists of funding of research
costs under the collaboration with Boehringer Ingelheim.
Operating result
The operating result for the first nine months of 2015 was a loss of DKK -158.3
million (-5.6).
Net financial items
Net financial items consist of interest expenses on the royalty bond,
amortization of costs relating to the royalty bond, interest income, banking
fees and regulations based on changes in exchange rates. Net financial items
for the first nine months of 2015 amounted to DKK -28.9 million (2.3).
Result from ordinary activities before tax
Result from ordinary activities before tax for the first nine months of 2015
came to DKK -187.2 million (-3.3).
Tax on ordinary activities
With a negative result from ordinary activities in the first nine months of
2015 and financial guidance pointing towards a negative result also for the
full year, Zealand expects to be eligible to receive up to DKK 5.9 million in
corporate tax income for 2015 of which DKK 3.6 (1.3) million have been
recognized for the period.
No deferred tax asset has been recognized in the statement of financial
position due to uncertainty whether tax losses carried forward can be utilized.
Net result and comprehensive income
Net result for the first nine months of 2015 amounted to DKK -183.7 million
(-2.0).
Equity
Equity stood at DKK 159.4 million (316.2) at the end of the period,
corresponding to an equity ratio of 30% (88).
Capital expenditure
Investments in new laboratory equipment for the period amounted to DKK 3.3
million (2.9).
Cash flow
Cash flow from operating activities amounted to DKK -179.8 million (-5.5), cash
flow from investing activities to DKK -3.3 million (21.4) of which DKK 0.0
million (24.4) relates to sale of securities, and cash flow from financing
activities to DKK 72.6 million (0.0) relating to exercise of warrants. The
total cash flow for the first nine months of 2015 amounted to DKK -110.4
million (15.9).
Cash and cash equivalents
As of 30 September 2015, Zealand had cash and cash equivalents of DKK 453.9
million (303.8). The increase is mainly explained by the royalty bond issued in
December 2014 adding DKK 272.2 million of cash to the company.
Key financial development in Q3 2015
Revenue in the third quarter amounted to DKK 7.2 million (58.2) of which DKK
7.1 (6.0) million relates to royalty income to Zealand from Sanofi’s commercial
sales of Lyxumia®. This represents an increase of 18% versus the same period
last year.
Total operating expenses amounted to DKK 53.6 million (45.7). The increase of
DKK 7.9 million is mainly explained by increased development costs of DKK 6.2
million.
Net result for the third quarter amounted to DKK –51.3 million (16.9).
Financial guidance for 2015
Zealand’s financial guidance for 2015 is unchanged as announced in the
company’s interim report for H1 2015.
This includes growing royalty revenue from Sanofi’s global sales of
lixisenatide (Lyxumia®) plus DKK 155 million / EUR 21 million from event driven
milestone payments from partners.
Net operating expenses for the full year are expected to be at the upper end of
the announced range of DKK 225-235 million / EUR 30-32 million.
Events after the end of the reporting period
In October 2015, Zealand received a milestone payment of DKK 22.4 million (EUR
3.0 million) relating to the selection of a lead candidate for preclinical
development under our collaboration with Boehringer Ingelheim on an undisclosed
target in the cardio-metabolic field.
Risk factors
This interim report contains forward-looking statements, including forecasts of
future expenses as well as expected business related events. Such statements
are subject to risks and uncertainties as various factors, some of which are
beyond the control of Zealand, may cause actual results and performance to
differ materially from the forecasts made in this interim report. Without being
exhaustive, such factors include e.g. general economic and business conditions,
including legal issues, scientific and clinical results, fluctuations in
currencies etc. A more extensive description of risk factors can be found in
the 2014 Annual Report under the section Risk management and internal control.
Management’s statements on the interim report
The Board of Directors and the Executive Management have today considered and
adopted the interim report of Zealand Pharma A/S for the period 1 January – 30
September 2015. The interim report has not been audited or reviewed by the
company’s auditor.
The report is prepared in accordance with IAS 34 as endorsed by the EU and the
additional Danish disclosure requirements for listed companies. The accounting
principles are unchanged in the first nine months of 2015 and reference is made
to the Annual Report 2014 for a more detailed description of the accounting
policies.
In our opinion, the interim report gives a true and fair view of the Group’s
assets, equity and liabilities and financial position at 30 September 2015 as
well as of the results of the Group’s operations and cash flow for the period 1
January – 30 September 2015.
Moreover, in our opinion, the Management’s Review gives a true and fair view of
the development in the company’s operations and financial conditions, of the
net result for the period and the financial position while also describing the
most significant risks and uncertainty factors that may affect the Group.
Copenhagen, 5 November 2015
Executive Management
Britt Meelby Jensen Mats Blom
President and CEO Senior Vice President and CFO
Board of Directors
Martin Nicklasson Rosemary Crane Catherine Moukheibir
Chairman Vice Chairman
Alain Munoz Peter Benson Michael Owen
Christian Thorkildsen Helle Størum Jens Peter Stenvang
Interim financial statements
CONSOLIDATED 2015 2014 2015 2014 2014
INCOME STATEMENT (DKK Q3 Q3 Q1-Q3 Q1-Q3 Full
'000) Year
Revenue 7,170 58,179 20,570 147,470 153,773
Royalty expenses -952 -809 -2,726 -12,864 -13,776
Gross profit 6,218 57,370 17,844 134,606 139,997
Research and development -44,690 -39,91 -158,967 -121,954 -180,036
expenses 3
Administrative expenses -8,913 -5,752 -28,000 -20,582 -39,826
Other operating income 3,130 2,225 10,787 2,356 6,328
Operating result -44,255 13,930 -158,336 -5,574 -73,537
Financial income 655 1,699 1,036 2,337 3,064
Financial expenses -9,082 -14 -29,932 -39 -2,017
Result from ordinary -52,682 15,615 -187,232 -3,276 -72,490
activities before tax
Tax on ordinary 1,360 1,250 3,555 1,250 7,500
activities
Comprehensive income for -51,322 16,865 -183,677 -2,026 -64,990
the period
Earnings per share - -2.23 0.75 -7.99 -0.09 -2.87
basic (DKK)
Earnings per share - -2.23 0.74 -7.99 -0.09 -2.87
diluted (DKK)
CONSOLIDATED STATEMENT OF 2015 2014 2014
FINANCIAL POSITION (DKK Note 30 Sep 30 Sep 31 Dec
'000)
ASSETS
Plant and machinery 15,276 16,394 15,994
Other fixtures and fittings, 1,286 266 1,573
tools and equipment
Leasehold improvements 754 1,221 1,060
Fixed assets under 0 742 0
construction
Deposits 2,648 2,677 2,693
Non current assets total 19,964 21,300 21,320
Trade receivables 4,518 15,990 25,031
Accrued income and prepaid 1 55,850 6,517 2,209
expenses
Other receivables 1,520 10,154 9,923
Cash and cash equivalents 453,889 303,812 538,273
Current assets total 515,777 336,473 575,436
Note 1: Accrued income and prepaid expenses consists of accrued royalty income
of DKK 7.1 million, accrued corporate tax of DKK 9.8 million and funding from
our collaboration partner Boehringer Ingelheim and the Helmsley Charitable
Trust of DKK 6.4 million, combined with accrued costs related to the royalty
bond of DKK 29.8 million and other prepaid expenses of DKK 2.8 million.
CONSOLIDATED STATEMENT OF 2015 2014 2014
FINANCIAL POSITION (DKK '000) 30 Sep 30 Sep 31 Dec
LIABILITIES AND EQUITY
Share capital 24,052 23,193 23,193
Retained earnings 135,373 293,027 229,635
Equity total 159,425 316,220 252,828
Non-current liability 328,233 0 267,170
Trade payables 15,064 9,335 18,487
Royalty bond 5,000 0 5,000
Prepayment from customers 7,385 6,151 14,383
Other liabilities 20,634 26,067 38,888
Current liabilities 48,083 41,553 76,758
Total liabilities 376,316 41,553 343,928
CONSOLIDATED 2015 2014 2014
STATEMENT OF CASH FLOWS (DKK '000) Q1-Q3 Q1-Q3 Full
Year
Net result for the period -183,677 -2,026 -64,990
Adjustments 19,302 4,137 6,559
Change in working capital -16,660 -9,013 16,771
Cash flow from operating activities before -181,035 -6,902 -41,660
financing items
Financial income received 885 1,408 1,494
Financial expenses paid 366 -39 -2,017
Cash flow from operating activities -179,784 -5,533 -42,183
Change in deposit 45 -107 -123
Purchase of property, plant and equipment -3,303 -2,891 -4,497
Disposal of securities 0 24,383 24,383
Cash flow from investing activities -3,258 21,385 19,763
Proceeds from issuance of royalty bond 0 0 298,675
Payment for debt issue costs 0 0 -26,505
Capital increase 72,594 0 0
Cash flow from financing activities 72,594 0 272,170
Decrease / increase in cash and cash equivalents -110,448 15,852 249,750
Cash and cash equivalents at beginning of period 538,273 286,178 286,178
Exchange rate adjustments 26,064 1,782 2,345
CONSOLIDATED STATEMENT OF Share Retained
CHANGES IN EQUITY (DKK '000) capital earnings Total
Equity at 1 January 2015 23,193 229,635 252,828
Warrants compensation expenses 0 16,748 16,748
Capital increase 859 71,735 72,594
Exchange rate adjustments 0 932 932
Comprehensive income for the period 0 -183,677 -183,677
Equity at 1 January 2014 23,193 292,948 316,141
Warrants compensation expenses 0 2,105 2,105
Comprehensive income for the period 0 -2,026 -2,026
Share capital at 1 January 2015 23,193
Capital increase at 21 March 2015 121
Capital increase at 11 April 2015 106
Capital increase at 2 June 2015 51
Capital increase at 20 June 2015 47
Capital increase at 8 September 2015 383
Capital increase at 26 September 2015 151
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