2014 Full Year Results and Annual Report

Transcription

2014 Full Year Results and Annual Report
Company Announcement
No. 5/2015
Zealand announces Full Year results in line with guidance and
publication of the Annual Report for 2014

Substantially improved net result of DKK -65 / EUR -9 million (2013: DKK -184 /
EUR -25 million)

Revenue of DKK 154 / EUR 21 million, including DKK 20 / EUR 3 million in
Lyxumia® sales royalties, which grew 214% in 2014

End of year cash position of DKK 538 / EUR 72 million, including proceeds from a
DKK 299 / EUR 40 million royalty bond financing in December 2014, un-locking the
value of Lyxumia® to accelerate development of wholly-owned pipeline products

Important advances in the product pipeline in Q4 2014 and the period thereafter:
- Start of Phase I clinical development of Zealand’s wholly-owned stable glucagon
analogue, ZP4207 to treat severe hypoglycemia events in diabetes
- The first cancer patients were dosed in the Phase IIb trial with elsiglutide, partnered with Helsinn, for the prevention of chemotherapy-induced diarrhea
Copenhagen, 13 March 2015 – Zealand Pharma A/S (“Zealand”) (CVR no. 20 04 50 78) (Nasdaq
Copenhagen: ZEAL) announces financial results in line with guidance and important advances for its
portfolio of therapeutic peptides, for the twelve month period from 1 January to 31 December 2014.
In a comment to this announcement, Britt Meelby Jensen, President and CEO of Zealand, said:
“2014 was an important year in which Zealand put in place the building blocks for accelerated value
growth. We raised USD 50 million, or close to DKK 300 million, in a royalty bond financing, unlocking
the value of Lyxumia® to fund further expansion of our pipeline of wholly-owned peptide medicines - an
essential element in our strategy going forward. In light of this, we are pleased to see both the Phase II
trial with danegaptide for protection against cardiac ischemia injuries and the Phase I trial with our
stable glucagon analogue, ZP4207 for severe hypoglycemia in diabetes, on track for completion later
this year.
“We have also seen substantial progress in our partnered portfolio. Sanofi continues to roll out
Lyxumia® globally, patient enrolment is completed in the LixiLan Phase III trials, and several pivotal
development and regulatory events are in view for both products this year, starting with ELIXA results
expected in Q2. In our partnership with Helsinn, an important milestone was met in February 2015 with
treatment of the first cancer patients in the Phase IIb trial with elsiglutide.
“So, overall we have started 2015 on a strong note, and I look with confidence into the year with several
catalysts in view to take Zealand into its next era.”
Zealand Pharma A/S
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Financial highlights for 2014

Revenue of DKK 153.8 / EUR 20.7 million (2013: DKK 6.6 / EUR 0.9 million).

Royalty expenses of DKK 13.8 / EUR 1.9 million (2013: DKK 0.9 / EUR 0.1 million).

Net operating expenses of DKK 213.5 / EUR 28.7 million (2013: DKK 191.3 / EUR 25.7 million).

Net result of DKK -65.0 / EUR 8.7 million (2012: DKK -183.7 / EUR 24.7 million).

Cash and securities amounted to DKK 538.3 / EUR 72.3 million on 31 December 2014 (2013: DKK
310.6 / EUR 41.7 million).
Financial highlights for Q4 2014 – Royalty bond financing

Revenue of DKK 6.3 / EUR 0.8 million (Q4 2013: DKK 3.2 / EUR 0.4 million).

Net operating expenses of DKK 73.4 / EUR 9.9 million (Q4 2013: DKK 48.2 / EUR 6.5 million).

Net result of DKK - 63.0 / EUR - 8.5 million (Q4 2013: DKK -44.8 / EUR –6.0 million).

In December 2014, Zealand raised DKK 299 / EUR 40 million in a royalty bond financing with net
proceeds of DKK 272 / EUR 37 million. The financing has unlocked the value of Lyxumia® to underpin the company’s capital resources and support the advancement and expansion of the pipeline of
novel wholly-owned peptide medicines. The financing is provided on 86.5% of the future annual royalty revenue received from Sanofi on sales of stand-alone lixisenatide (Lyxumia®), which will be
used to pay interest and principal until the bond is fully repaid. Further sales royalty revenue thereafter will all be retained by Zealand.
Pipeline highlights and update for Q4 2014 and the period thereafter
Lyxumia® for Type 2 diabetes ─ Marketed globally ex-US in license collaboration with Sanofi:

In 2014, Lyxumia® royalty revenue to Zealand amounted to DKK 20.3 / EUR 2.7 million. This represents an increase of 214% over 2013, when Lyxumia® was launched in the first European country in
March. Royalty revenue for Q4 was DKK 6.2 / EUR 0.8 million, an increase of 3% compared to Q3
2014, and an increase of 93% compared to Q4 2013. Of the revenue in Q4 2014, the main contributing countries were the UK, Spain, and Japan.

Lyxumia® is now approved in over 50 countries ex-US. So far, Sanofi has made the product available for patients with Type 2 diabetes in more than 30 of these countries – and further launches
planned in 2015.

In January 2015, Sanofi confirmed its plans to resubmit a regulatory application for Lyxumia® in the
US in Q3 2015 pending results from the ELIXA cardio-vascular safety study, expected in Q2 2015.
Zealand Pharma
Zealand Pharma A/S
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LixiLan (fixed-ratio combination of Lyxumia® and Lantus®) for Type 2 diabetes ─ In Phase III in
license collaboration with Sanofi:

End 2014, Sanofi completed the enrolment of 1,906 patients with Type 2 diabetes into the two
ongoing Phase III trials, LixiLan-O and LixiLan-L, with LixiLan, the fixed-ratio single injection
combination of Lyxumia® and Lantus® (Sanofi’s worldwide most prescribed basal insulin).

Following this, Sanofi earlier this year specified its expectations to report top-line results from both
Phase III trials in Q3 2015 and plans to subsequently submit for regulatory approval of LixiLan in
the US and EU in Q4 2015.
Danegaptide for cardiac reperfusion injuries ─ In Phase II development as a Zealand whollyowned product:

In October 2014, at the Annual Peptide Therapeutics Symposium in the US, Zealand presented
results from studies of danegaptide in large animal models of ischemic reperfusion injuries. The
results demonstrated the ability of this first-in-class therapeutic peptide to protect cardiac tissue
from damage.

Zealand’s ongoing Phase II Proof-of-Concept trial to evaluate the efficacy and safety of
danegaptide as a potential new treatment to prevent cardiac tissue damage in patients after an
acute myocardial infarction is advancing well. As of 9 March 2015, 450 patients were treated in the
trial, representing 75% of the enrolment target. The trial is on track for completion in Q4 2015 with
results expected in early 2016.
Elsiglutide for chemotherapy-induced diarrhea – In Phase IIb development in partnership with
Helsinn:
 In January 2015, Zealand and Helsinn announced that the first patients had been dosed in the
Phase IIb trial of elsiglutide for the prevention of chemotherapy-induced diarrhea in patients with
colorectal cancer. Results from the trial are expected in H1 2016.
ZP4207 (stable glucagon analogue) for severe hypoglycemia in diabetes ─ In Phase I
development as a wholly-owned Zealand product
 Zealand has invented this novel glucagon analogue, ZP4207, which has demonstrated a strong sta-
bility profile, supportive of its use in a liquid formulation as a “ready-to-use” rescue pen for the treatment of severe events of hypoglycemia. Severe hypoglycemia is a life-threatening acute condition
associated with insulin treatment in diabetes.
 In November 2014, Zealand announced it had dosed the first human subjects in the Phase I trial.
The trial is advancing well towards expected completion mid-2015 and results in Q3 2015.
Progress in the collaborations with Boehringer Ingelheim
 Under the first collaboration between Zealand and Boehringer Ingelheim, covering novel glucagon/GLP-1 dual acting agonists for the treatment of Type 2 diabetes and/or obesity, Boehringer
Ingelheim in late 2014 selected a new lead candidate to be advanced for clinical development. The
new candidate has been selected from a portfolio of novel glucagon/GLP-1 dual agonists, invented
Zealand Pharma
Zealand Pharma A/S
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under the collaboration. Under the terms of the collaboration agreement, Zealand is eligible to remaining potential milestone payments of up to a total of EUR 365 million related to the achievement
of pre-specified development, regulatory and commercial milestones.
 In July 2014, a second collaboration was signed between Zealand and Boehringer Ingelheim, covering an un-disclosed specific therapeutic peptide program from Zealand's preclinical portfolio. This
collaboration is also advancing very well. Under the terms of the agreement, Zealand is eligible to
receive up to EUR 295 million / DKK 2.2 billion in total potential milestones for the first product developed and marketed from the collaboration. In 2014, Zealand received payment under this agreement
of DKK 54.1 / EUR 7.3 million.
Advancement towards clinical development of new products and opportunities
 Through 2014 and accelerating towards the end of the year and into 2015, Zealand has identified
and advanced the preparation of new in-house pipeline opportunities for potential entry into clinical
development later in 2015. Furthermore, a number of early stage novel therapeutic peptide projects
have been initiated for expansion of Zealand’s preclinical pipeline.
Appointment of new CEO
 Zealand announced in November 2014 a management transition and as of 15 January 2015, Britt
Meelby Jensen took up the position as new Chief Executive Officer replacing David H. Solomon,
who had been leading the company since 2008.
Financial guidance for 2015
For 2015, Zealand expects revenue in the form of growing royalty payments from Sanofi on global
sales of Lyxumia®. No specific guidance on the level of royalties can be provided for the year, as
Sanofi has given no guidance on 2015 sales of Lyxumia®.
Additional revenue of up to DKK 140 / EUR 19 million may be received from event driven
milestones from partners.
Net operating expenses in 2015 are expected at a range of DKK 225-235 / EUR 30-32 million.
The Annual Report 2014
This full year announcement should be read in conjunction with Zealand’s Annual Report for 2014,
published today and attached to the announcement in a PDF-version. Following publication, an online
version of the Annual Report 2014 will be made accessible via the following link:
http://www.annualreport2014.zealandpharma.com/ and from the front page of Zealand’s website
(www.zealandpharma.com) where the PDF-version can also be accessed and downloaded.
Printed versions of the Annual Report 2014 will be available from the beginning of April and can be
provided by Zealand upon request ([email protected] or [email protected]). The
full report is only available in English, but both pdf and printed versions of the Management Review will
be made available in Danish before the company’s Annual General Meeting on 21 April 2015.
Zealand Pharma
Zealand Pharma A/S
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Conference call
Zealand will host a conference call today, at 2 pm CET/ 9 am EDT to present the Full Year 2014 results
announcement and the Annual Report, which will be followed by a Q&A session. The call will be hosted
by Britt Meelby Jensen, President and Chief Executive Officer, Mats Blom, Chief Financial Officer,
Torsten Hoffmann, Chief Scientific Officer and Hanne Leth Hillman, Vice President, Head of Investor
Relations and Corporate Communications.
The call will be conducted in English and the dial-in details to access the call are as follows:
DK standard access
UK and international
US (free dial-in)
+45 3272 8018
+44 (0) 1452 555131
+1 866 682 8490
A live audio cast of the call including an accompanying slide presentation will be available via the
following link: http://edge.media-server.com/m/p/dds2yh7m, which can also be accessed from the
Investor section of the company’s website (www.zealandpharma.com). Participants are advised to
register for the audio cast approximately 10 minutes before the start.
A replay of the event will be made available from the Investor section of Zealand’s website following the
call.
●●●●●
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, Vice President, Head of Investor Relations & Corporate Communications
Tel: +45 50 60 36 89, email: [email protected]
About Zealand Pharma
Zealand Pharma A/S (“Zealand”) (Nasdaq Copenhagen: ZEAL) is a biotechnology company based in Copenhagen,
Denmark. Zealand has leading expertise in the discovery, design and development of novel peptide medicines and
possesses in-house competences in clinical trial design and management with a therapeutic focus on metabolic diseases
and acute care indications. The company is advancing a proprietary pipeline of novel medicines alongside a partnered
product and development portfolio.
Zealand’s first invented medicine, lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of Type 2 diabetes,
is marketed globally (ex-US) as Lyxumia® and in Phase III development as a single-injection combination with Lantus®
(LixiLan), both under a global license agreement with Sanofi. US regulatory submission of Lyxumia® is planned for Q3
2015 and US/EU regulatory submissions for LixiLan in Q4 2015.
Zealand proprietary pipeline includes danegaptide (prevention of Ischemic Reperfusion Injury) and the stable glucagon
product, ZP4207 (treatment of severe hypoglycemia) as well as several preclinical peptide therapeutics. Partnering
represents an important component of strategy to leverage in-house expertise, share development risk in large clinical
trials, provide funding and commercialize the company’s products. Zealand currently has global license agreements and
partnerships with Sanofi, Helsinn Healthcare, Boehringer Ingelheim and Eli Lilly.
For further information: www.zealandpharma.com
Follow us on Twitter @ZealandPharma
Zealand Pharma
Zealand Pharma A/S
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DKK thousand
INCOME STATEMENT AND
COMPREHENSIVE INCOME
Revenue
Royalty expenses
Gross profit
Research and development expenses
Administrative expenses
Other operating income
Operating result
Net financial items
Tax
Net result for the period (after tax)
Comprehensive income for the period
Note
1
Earnings per share - basic (DKK)
Earnings per share - diluted (DKK)
2014
1.10 - 31.12
Q4
2013
1.10- 31.12
Q4
2014
1.1 - 31.12
Full year
2013
1.1 - 31.12
Full year
6,303
-912
5,391
-58,082
-19,244
3,972
-67,963
-1,251
6,250
-62,964
-62,964
3,176
-417
2,759
-38,281
-10,661
790
-45,393
618
0
-44,775
-44,775
153,773
-13,776
139,997
-180,036
-39,826
6,328
-73,537
1,047
7,500
-64,990
-64,990
6,574
-872
5,702
-164,467
-34,155
7,302
-185,618
1,942
0
-183,676
-183,676
-2.64
-2.64
-1.96
-1.97
-2.87
-2.87
-8.10
-8.10
2014
31 Dec
2013
31 Dec
538,273
0
596,756
23,193
252,828
0.42
272,170
286,178
24,383
346,913
23,193
316,141
0.91
0.00
STATEMENT OF FINANCIAL POSITION
Cash and cash equivalents
Securities
Total assets
Share capital ('000 shares)
Shareholder's equity
Equity / assets ratio
Royalty bond
CASH FLOW
Depreciation
Change in working capital
Purchase of property, plant and equipment
Free cash flow
2
OTHER
Share price (DKK)
Market capitalization (MDKK)
Equity per share (DKK)
Avg. number of employees (full-time equivalents)
Compounds in clinical development (end period)
Products on the market
3
4
2014
1.10 - 31.12
Q4
2013
1.10 - 31.12
Q4
2014
1.1 - 31.12
Full year
2013
1.1 - 31.12
Full year
1,602
25,784
-1,606
-38,256
1,109
464
-2,887
-47,051
5,932
16,771
-4,497
-46,680
5,911
-3,643
-4,569
-174,187
2014
31 dec
2013
31 Dec
83.00
1,925,019
11.17
103
5
1
59.00
1,368,387
13.97
107
6
1
Notes:
(1) According to Danish tax legislation Zealand is eligible to receive DKK 7.5 million in cash relating to the tax losses of 2013 and
2014. DKK 1.2 million is related to the tax loss of 2013, received in November 2014
(2) Free cash flow is calculated as cash flow from operating activities less purchase of property, plant and equipment
(3) Equity per share is calculated as shareholders equity divided by total number of shares less treasury shares
(4) In September 2014, development of ZP1480 (ABT-719) was discontinued by AbbVie
Zealand Pharma
Zealand Pharma A/S
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