TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
To the OMX Nordic Exchange Copenhagen
Announcement No. 30-07 / Copenhagen 15 August 2007
Interim report
for the six months ended 30 June 2007
• Belinostat has been further strengthened with proof-of-concept data on
peripheral T-cell lymphoma, announced on the 2007 Pan Pacific Lymphoma
conference
• Sales of Savene™ in the Q2 have increased by 24% compared to Q1 and amounted
to DKK 8.3 million for the first six months of 2007
• Operating loss amounted to DKK 93.7 million against a loss of DKK 86.6
million in the year-earlier period
• Loss before tax of DKK 91.2 million, as compared to a loss of DKK 84.4
mil-lion in the same period of last year
• Loss after tax of DKK 91.2 million, as compared to a loss of DKK 82.9
mil-lion in the same period of last year. This corresponds to DKK -1.96 per
share compared to DKK -2.04 last year
• With the DKK 174.1 million acquisition of the Swiss biotech company Apoxis
S.A. TopoTarget has expanded its pipeline with the Phase I compound APO010 and
the Phase II compound APO866
• Following the successful capital raise and the completion of the acquisition
of Apoxis S.A., TopoTarget now expects a pre-tax loss in the range of DKK DKK
275 million and 295 million. The cash burn may be higher than the ex-pected
pre-tax loss due to an increase in sales activities and the resulting change in
working capital
A conference call on the results for the first six months of 2007 will be
hosted today, Wednesday 15 August 2007, at 14.00 (CET). Further information is
contained in this announcement.
Interim report
for the six months ended 30 June 2007
Copenhagen, Denmark - 15 August 2007 - The Board of Directors of TopoTarget A/S
(OMX Nordic Exchange Copenhagen: TOPO) today adopted the company's interim
report for the six months ended 30 June 2007.
During the six months period ended 30 June 2007, operating expenses amounted to
DKK 119.5 million against DKK 100.8 million in the year-earlier period,
primarily due to the establishment of Savene™ sales forces in Europe and the
USA. The operating loss for the period was DKK 93.7 million, compared with DKK
86.6 million in the same period of last year. The company posted a loss before
tax of DKK 91.2 million in the first six months of 2007 against a pre-tax loss
of DKK 84.4 million in the same period of 2006. Cash, cash equivalents and
marketable securities amounted to DKK 519.9 million at 30 June 2007.
Highlights for the first six months of 2007
• In June TopoTarget and CuraGen presented positive updated results on
belinostat at the annual meeting in ASCO and at the 2007 Pan Pacific Lym-phoma
conference. Most importantly we were able to announce proof-of-concept for
belinostat given as single agent to patients with peripheral T-cell lymphoma.
Belinostat also works alone in cutaneous T-cell lymphoma. In December 2006 we
obtained proof-of-concept data in this disease and posi-tive update on these
data were presented at the 2007 Pan Pacific Lym-phoma conference
• On 24 May TopoTarget received an approvable letter from the FDA for Totect™
• On 27 June the acquisition of the Swiss biotech company Apoxis S.A. was
completed. The TopoTarget clinical pipeline has accordingly been expanded with
two promising anti-cancer compounds respectively in phase I and II trials
• On 21 June TopoTarget completed a public offering that brought the com-pany a
gross proceeds of DKK 360 million
Expected key milestones for the remainder of 2007
• Approval of Totect™ and subsequent launch in the USA
• Launch of Savene™ in additional European countries
• Decision regarding regulatory strategy for belinostat
• TopoTarget /CuraGen and the NCI have 15 ongoing studies with belinostat.
Additional results are expected from the oral phase I trial and from three of
the phase II trials
• Results from Baceca® Phase II trial
• Results from a Savicol™ Phase II trial
Savene™/Totect™ status
TopoTarget's first product, Savene™, is for the prevention of severe tissue
damage caused by anthracycline extravasation. Savene™ was launched in Oc-tober
2006.
Launch and commercial activities of Savene™ in Europe are moving forward
according to plan.
In Q2 2007 the Savene™ revenue amounted to DKK 4.6 million compared to DKK 3.7
million in Q1 2007. This is, as expected, an increase of 24 %. Sales of
Savene™ amounted thus to DKK 8.3 million for the first six months of 2007.
The figure below illustrates the quarterly Savene™ sales development, meas-ured
in TDKK since its launch in October 2006.
In the attached pdf page 3 is a figure showing the quarterly development in
sales for Savene since launch in October 2006.
Due to a technical issue at one of our two alternative manufacturing
subcontrac-tors, TopoTarget received in May 2007 an approvable letter for
Totect™ (the US brand for Savene™) from the FDA. TopoTarget expects a FDA
approval soon and to launch Totect™ in the US market in the second half of
2007.
Medical provider groups in the USA have expressed a high degree of desire to
include Totect™ in the treatment protocols for anthracycline extravasation and
TopoTarget has received a large number of requests regarding availability and
education in the use of Totect™.
Status of clinical activities
TopoTarget's clinical pipeline consists of eight product candidates covering a
broad range of cancer and other indications.
The guidance on the development programs is consistent with previously
an-nounced guidance unless otherwise specified below.
Belinostat (PXD101) - an IV and oral pan HDACi for the treatment of multiple
cancer indications
Intravenously and orally administered belinostat is currently evaluated in 15
studies run by CuraGen, TopoTarget and the NCI (National Cancer Institute, US).
Updated results regarding intravenously administered belinostat were presented
at ASCO and the Pan Pacific Lymphoma Conference in June 2007 and the posi-tive
response data further underlined the previously reported proof-of-concept data
demonstrating belinostat to have anti-cancer effect in cutaneous T-cell
lymphoma. In addition, the development of belinostat has been further
strengthened with proof-of-concept data on yet another indication: peripheral
T-cell lymphoma. Furthermore positive safety data was presented: Extensive ECG
monitoring did not demonstrate a risk to heart function (No grade 3 QTc
prolon-gation).
• Thus, in the phase II study evaluating belinostat in cutaneous and
pe-ripheral T-cell lymphoma, four of 14 patients (29%) with advanced cu-taneous
T-cell lymphoma achieved objective response (1 CR (Complete Response) and 3
PR's (Partial Response)). Seventy-seven (77) % of the patients had skin lesion
improvements. Five out of six patients with sig-nificant pruritus (itching) had
a clinically meaningful reduction in pruri-tus
• Among 11 evaluable patients with peripheral T-cell non-Hodgkin's lym-phomas
one patient achieved a CR and one a PR. For both study groups enrolment has
been expanded to enrol total of 34 patients each
• Results from 23 patients with advanced solid tumors indicated that the
combination of intravenous belinostat plus carboplatin and paclitaxel is well
tolerated and confers efficacy in heavily pre-treated patients, in-cluding
RECIST defined responses in pancreatic and rectal cancer, CA-125 response in
ovarian cancer, and multiple long stabilizations of dis-ease (e.g. treatment
duration of ≥ 1 year in bladder cancer, carcinoma of unknown primary, and
melanoma). A Phase II portion of the trial for ovarian cancer has been
initiated with 16 patients treated (13 patients still ongoing). Two of the
ongoing patients had at the investigator meet-ing in June achieved an objective
response resulting in the trial being expanded to enroll up to 32 patients. A
second arm was added to this study and is currently enrolling up to 15 patients
with transitional cell cancer of the bladder
• On 7 August 2007 TopoTarget announced that a Phase I/II clinical trial
evaluating belinostat in combination with idarubicin for the treatment of AML
is being initiated at multiple sites in the EU
• As announced 7 August 2007 the enrollment of further patients, in a Phase II
open-label clinical trial evaluating intravenous belinostat in combination with
Velcade® (bortezomib) for injection in patients with advanced refractory
Multiple Myeloma, has been stopped until we have more knowledge of how to
prevent certain complications in this specific patient population. Our
resources on the development of belinostat will be concentrated on the other
ongoing studies in cancer indications where belinostat has demonstrated a
therapeutic benefit
• Phase Ib results from 25 patients with advanced solid tumors treated with
intravenously administered belinostat in combination with 96-h in-fusion
5-fluorouracil (5-FU) indicated that the combination is generally well
tolerated, including positive safety data from extensive ECG moni-toring in all
patients without any indications for Grade 3 QTc prolonga-tion). A total of
seven patients achieved stabilization of disease (range 2 - 8 cycles); no
RECIST defined responses noted. Enrollment of six addi-tional patients is being
conducted to determine whether there is any ef-fect on the expression of
Thymidylate Synthase (TS) in tissue samples
Baceca® - an HDACi for the treatment of Basal Cell Carcinoma (BCC)
TopoTarget currently conducts two randomised and blinded Phase II
proof-of-concept trials to investigate Baceca® alone, and in combination with
two differ-ent vitamin A like compounds for the treatment of BCC. These trials
will enrol a total of approx. 100 patients.
Savicol™ - an HDACi for the treatment of Familial Adenomatous Poly-posis (FAP)
TopoTarget is currently conducting a Phase II pivotal trial, evaluating the
effect of Savicol™ in the treatment of FAP. This randomised, placebo-controlled
Phase II study takes place in Europe and is expected to enrol a total of 60 FAP
pa-tients.
APO866 - an NAD+ inhibitor for the treatment of cancer
APO866 is a specific inhibitor of the key enzyme involved in the synthesis of
NAD+. A phase I study has been completed, and 3 phase II studies are ongoing in
the following indications: advanced melanoma, cutaneous T-cell lymphoma (CTCL)
and B-cell lymphatic leukaemia (B-CLL).
Zemab® - an antibody-toxin for the treatment of HER2 positive cancers (i.e.
Head & Neck and breast cancer)
One Phase I trial has been completed. Following a new production of Zemab®, new
clinical studies are expected to be initiated in 2008.
APO010 - a human Fas ligand protein for the treatment of cancer
APO010 is a recombinant fusion protein targeting the Fas receptors on the
sur-face of cancer cells. A phase I dose-finding study in patients with solid
tumours is ongoing.
Topotect - a Topoisomerase II inhibitor - a protectant to enable che-motherapy
treatment of brain metastasis
Phase I/II trials with different designs and treatment schedules are ongoing,
exploring the potential of the combination of Topotect and etoposide. As
recruitment of patients has been slower than earlier anticipated the first
results are now expected to be announced in 2008.
Avugane™ - an HDACi for the treatment of Acne Vulgaris
Based on Phase II proof-of-concept results showing comparable efficacy and
advantageous tolerability compared with a standard, marketed retinoid therapy,
TopoTarget now conducts a double-blind, randomised, placebo control Phase II
four-arm clinical trial in mild to moderate acne vulgaris.
Conference call
TopoTarget will host a conference call this afternoon, 15 August, at 14.00
(CET), where management will present and discuss the results for the first six
months of 2007.
A PowerPoint presentation will be available at TopoTarget's website,
www.topotarget.com (under Investor and Media > Presentations and Events),
before the start of the conference call.
To participate in the conference call please dial:
From Denmark: 70 26 50 40
Outside Denmark: +45 70 26 50 40 or +44 208 817 9301
The conference call will be held in English.
A replay will be available two hours after the conference call and until 22
August 2007 at the following number: +353 1 436 4267, security code 971183#.
See page 6 in attached pdf for "highlights and key figures"
TopoTarget A/S
The financial ratios have been calculated in accordance with “Recommendations &
Ratios 2005”, issued by the Danish Society of Financial Analysts.
The interim financial statements are unaudited.
More detailed accounting information is provided in the appendices.
Comments on the interim financial statements for the six months ended 30 June
2007
The company generated revenue of DKK 25.8 million during the period 1 January
to 30 June 2007 compared with DKK 14.2 million in the same period of last year.
Included in revenues are invoicing to CuraGen and Savene™ sales. The higher
revenue in 2007 is mainly due to sales of Savene™ on various Euro-pean markets.
In H1 2007, production costs amounted to DKK 13.0 million as compared with DKK
8.2 million in the same period of 2006. The higher costs were mainly due to
increasing Savene™ sales in Europe.
In H1 2007, research and development costs amounted to DKK 55.4 million as
compared with DKK 62.1 million in the year-earlier period. The company now has
in-house research activities which were outsourced in H1 2006. This has
resulted in savings that allowed the company to perform more research work at
the same cost.
Sales and distribution costs were DKK 26.3 million in H1 2007, up from DKK 8.6
million in the year-earlier period. The increased costs were due to a higher
number of sales representatives in Europe as Savene™ is being launched in more
countries and also due to the sales force which is being established in the US
for the launch of Totect™ in H2 2007. Marketing activities have been initi-ated
in the US.
In H1 2007, administrative expenses amounted to DKK 24.9 million as com-pared
with DKK 22.0 million in the same period of 2006.
Net financial income amounted to DKK 2.5 million in H1 2007, as compared with
DKK 2.2 million in the year-earlier period. The increase is mainly due to
higher interest income on securities.
In H1 2007, tax amounted to DKK nil as compared with DKK 1.5 million in the
same period of 2006. The tax income in H1 2006 was due to a reduction of
de-ferred tax liability relating to the subsidiary TopoTarget Germany AG.
Accordingly, the company recorded a loss after tax of DKK 91.2 million in H1
2007 as compared with a loss after tax of DKK 82.9 million in the year-earlier
period.
At 30 June 2007, total assets amounted to DKK 891.5 million. Of this amount,
cash bank deposits and short-term securities amounted to DKK 519.9 million.
At 30 June 2007, equity amounted to DKK 736.6 million compared with DKK 344.0
million at the same time in 2006. The change consists of a loss of DKK 183.0
million during the period from 1 July 2006 to 30 June 2007, the DKK 121.7
million capital increase in November 2006, additions during the period of
share-based payment totalling DKK 5.4 million, the exercise of warrants
total-ling DKK 7.4 million and fair value adjustment of the bond portfolio
totalling DKK 1.1 million. Also included are net proceeds from the capital
increase in connection with the acquisition of Apoxis S.A. in the amount of DKK
332.0 mil-lion and a non-cash contribution of DKK 107.9 million from the
issuance of con-sideration shares to the former shareholders of Apoxis.
Outlook for 2007
On 27 June 2007, the company completed the acquisition of Apoxis. After the
acquisition of Apoxis, which increased the Group's combined costs for
activities such as clinical trials, the company expects to report a pre-tax
loss in the range of DKK 275 million to DKK 295 million for 2007.
This is a reduction compared to the expected loss for 2007 disclosed in the
pro-spectus dated 4 June 2007. The reason for the reduced expected loss is that
TopoTarget in a period since the publication of the prospectus in coorporation
with the newly acquired Swiss company has assessed that it is possible to
ob-tain further positive synergy effects merging the research development and
administrative activities etc.
The company's cash burn may be higher than the expected pre-tax loss due to an
increase in sales activities and the resulting change in working capital.
See attached pdf page 11-26 for the interim report and notes for the six months
ended 30 June 2007.
Statement by the Board of Directors and Senior Management
The Board of Directors and the Senior Management today discussed and adop-ted
the interim report for the six months ended 30 June 2007.
The interim report, which is unaudited, is presented in accordance with IAS 34
and additional Danish disclosure requirements on the presentation of interim
reports by listed companies.
We consider the accounting policies to be appropriate, the accounting estimates
reasonable and the overall presentation of the interim report to be appropriate
to the effect that the interim report gives a true and fair view of the Group's
assets and liabilities, financial position, results of operations and cash
flows for the six months ended 30 June 2007.
Copenhagen, 15 August 2007
Senior Management
Peter Buhl Jensen
CEO
Board of Directors
Håkan Åström Jesper Zeuthen Jeffrey Buchalter
Chairman
Anders Gersel Pedersen Ingelise Saunders Torbjørn Bjerke
Peter Buhl Jensen
For further information, please contact:
Dr. Peter Buhl Jensen Telephone +45 39 17 83 41
Chief Executive Officer Mobile +45 21 60 89 22
Tim Corcoran Telephone +44 1235 443 713
Chief Operating Officer Mobile +44 787 656 1027
Background information
About TopoTarget
TopoTarget (OMX - The Nordic Exchange: TOPO) is a biotech company,
headquartered in Denmark and with subsidiaries in the UK, Germany, Switzerland
and the US, dedicated to finding ''Answers for Cancer'' and developing improved
cancer therapies. TopoTarget is founded and run by clinical cancer specialists
and combines years of hands-on clinical experience with in-depth understanding
of the molecular mechanisms of cancer. Focus lies on highly predictive cancer
models and key cancer targets (including HDACi, NAD+, mTOR, Fasligand and
topoisomerase II inhibitors) and a strong development foundation has been
built. TopoTarget has a broad portfolio of small molecule pre-clinical drug
candi-dates and eight drugs (both small molecules and protein based) are in
clinical develop-ment, including both novel anti-cancer therapeutics and new
cancer indications for exist-ing drugs. Savene™ is TopoTarget's first product
on the market. The product is expected to be approved and launched in the US in
the second half of 2007. In addition to organic growth, TopoTarget consistently
looks for opportunities to strengthen and expand its activities through
acquisitions and in-licensing. For more information, please refer to
www.topotarget.com.
TopoTarget Safe Harbour Statement
This announcement may contain forward-looking statements, including statements
about our expectations of the progression of our preclinical and clinical
pipeline including the timing for commencement and completion of clinical
trials and with respect to cash burn guidance. Such statements are based on
management's current expectations and are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements. TopoTarget cautions investors
that there can be no assurance that actual results or business conditions will
not differ materially from those projected or suggested in such forward-looking
statements as a result of various factors, including, but not limited to, the
following: the risk that any one or more of the drug development programs of
TopoTarget will not proceed as planned for technical, scientific or commercial
reasons or due to patient enrolment issues or based on new information from
non-clinical or clinical studies or from other sources; the success of
competing products and technologies; technological uncertainty and product
develop-ment risks; uncertainty of additional funding; TopoTarget's history of
incurring losses and the uncertainty of achieving profitability; TopoTarget's
stage of development as a bio-pharmaceutical company; government regulation;
patent infringement claims against TopoTarget's products, processes and
technologies; the ability to protect TopoTarget's patents and proprietary
rights; uncertainties relating to commercialization rights; and product
liability expo-sure; We disclaim any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events, or otherwise, unless required by law.
