Full Year Report 2001, Quarterly Report October-December 2001
FULL YEAR REPORT 2001
QUARTERLY REPORT OCTOBER-DECEMBER 2001
· American Home Products became strategic partner for
atherosclerosis. The agreement may bring Karo Bio MUSD 100 in revenues
excluding royalty. Down payment received.
· Milestone payment from Karo Bio’s partner Bristol-Myers Squibb
earned after initiation of phase I clinical trials on jointly discovered
compound for treatment of obesity.
· New technology for lead compound characterization and selection
inlicensed from Duke University, North Carolina.
· Karo Bio received US patent for the Liver X receptor beta, the
target for the collaboration with American Home Products.
· Organization strengthened with key management recruitments.
· Group net sales for the full year increased to MSEK 136.9
(100.6) and to MSEK 38.3 (28.5) for the fourth quarter. Cash flows from
operating activities for the full year improved to MSEK -11.9 (-20.8)
and decreased to
MSEK -17.9 (5.6) for the fourth quarter.
· The loss after financial items increased for the full year to
MSEK 320.9 (213.3) and to MSEK 82.9 (75.0) for the fourth quarter.
Operating loss excluding goodwill depreciation amounted to MSEK 92.5
(60.8) for the full year and MSEK 27.8 (17.5) for the fourth quarter.
· Cash and cash equivalents and short-term investments amounted
to MSEK 282.3 (329.0) at the end of the year.
·
OPERATIONS
Karo Bio is a leading drug discovery company in the field of nuclear
receptor biology and medicinal chemistry. The Company develops receptor-
selective and tissue-selective pharmaceuticals for treatment of major
disorders. Karo Bio has operations in Sweden and in USA.
Karo Bio has four strategic partnerships with international
pharmaceutical companies for development of new innovative therapies for
treatment of common diseases. Karo Bio also runs several internal
projects in various clinical areas where the Company has competitive
advantages for discovery of new pharmaceuticals that target nuclear
receptors. Exploratory studies in novel nuclear receptor areas are
conducted in order to maintain a strong pipeline. These studies cover
new indications for classical receptors as well as discovery and
characterization of new receptors.
STRATEGIC PARTNERSHIPS
Atherosclerosis – American Home Products
The liver X receptor is a new and important target for treatment and
prevention of atherosclerosis. Karo Bio has a strong technology and
patent protection around liver X receptor and with this as a basis Karo
Bio has during fall 2001 entered into a strategic partnership with
American Home Products. Both parties will collaborate during the drug
discovery phase. American Home products will be responsible for animal
studies and clinical development as well as sales and marketing. The
initial focus is on atherosclerosis as the first clinical indication.
There are reasons to believe that liver X receptor is an important
target for other metabolic disorders and these are also covered by the
collaboration agreement.
If the partnership results in two distinct globally marketed products,
Karo Bio will receive up to MUSD 100, comprising an up-front payment,
R&D funding, and milestone payments linked to development and global
approvals. Karo Bio will also receive royalties on sales revenue and an
in-market bonus if certain sales goals are met. The collaboration has
progressed very well during the fall of 2001 and proof of concept for
targeting liver X receptor has been obtained in animal models.
Diabetes – Abbott Laboratories
Karo Bio collaborates with Abbott Laboratories for treatment of type 2
diabetes. The aim of the collaboration is to develop liver-selective
antagonists that will normalize the elevated output of glucose from the
liver in type 2 diabetics. During the year, progress has been made
regarding improvements in liver-selectivity and efforts are now focused
onto the most promising compound class. Karo Bio’s clinical rationale is
also supported by the recent discoveries that stress conditions
significantly contribute to risk for development of type 2 diabetes.
Karo Bio and Abbott have during the year jointly determined the three
dimensional structure of the glucocorticoid receptor. This is a
discovery that academia and the pharmaceutical industry have been trying
to pursue for more than ten years. For this reason it represents a major
achievement. Access to the three-dimensional structure gives us
important information for the design and development of potent and
selective compounds. Currently the project is focused on selection of
drug candidates for clinical development.
Obesity – Bristol-Myers Squibb
Karo Bio collaborates with Bristol-Myers Squibb for development of novel
therapies for metabolic disorders by targeting the thyroid hormone
receptor. The collaboration has been very productive, and the parties
have jointly demonstrated proof of concept in animal models. The
collaboration with Bristol-Myers Squibb was extended for an additional
year during fall 2000 and was extended for yet another year in 2001 and
also expanded to include the Molecular Brailletm technology developed at
Karo Bio USA.
In September, the leading compound entered phase I clinical trials for
treatment of obesity that resulted in a milestone payment to Karo Bio,
recorded as revenue in the same month.
In addition to the first generation compound that has entered the
clinical development, Karo Bio and Bristol-Myers Squibb continue to
collaborate on the discovery and development of second-generation
compounds that may expand the possible indications that can be treated
with novel selective thyroid hormone receptor modulators.
Women’s Health Care – Merck & Co.
Existing estrogenic drugs for treatment of various disorders associated
with the menopause in women have suboptimal selectivity at the receptor
level and are associated with certain side effects. The previous
discovery of the estrogen receptor beta by Karo Bio and scientific
collaborators, and the Karo Bio technologies now offer a unique
possibility to develop completely new and safer classes of drugs for
improvement of the classical indications but also for new indications.
The global partner that Karo Bio collaborates with is Merck & Co. The
collaboration was initiated in 1997.
The strategy in the collaboration is to develop a number of different
compound classes and to validate the usefulness of these compounds for
various clinical indications. Apart from complementing Karo Bio in basic
drug discovery Merck is responsible for pre-clinical and clinical
development.
Good progress has been made during the year towards the optimization of
potential pre-clinical development candidates for different clinical
indications.
Technology Outlicensing
In 2001, Karo Bio has actively worked on five BioKey Assay
collaborations, Aventis Pharma, Bayer AG, Boehringer Ingelheim
Pharmaceuticals Inc., GPC Biotech, NovImmune S.A. and Serono
International S.A. The BioKey® technology partners identify target
proteins relevant to their strategic drug discovery efforts for the
development of BioKey Assaystm. These collaborations utilize targets
that are from both prokaryotic and eukaryotic organisms and represent
validated targets with known function, and genomics-derived targets of
unknown function. All collaborations have had success in the
identification of BioKey® probes for the partners’ chosen targets.
The success rate for the BioKey® technology is high. To date, Karo Bio
has identified BioKey® probes with high affinity for approximately 75%
of the targets currently included in the collaborations.
INTERNAL PROJECTS
Skin Disorders
Karo Bio has identified a candidate drug for treatment of skin disorders
where a thyroid hormone agonist is formulated in an ointment. Currently
skin atrophy is the prioritized indication and it results from topical
treatment with anti-inflammatory steroids but also occurs naturally as a
consequence of ageing.
Karo Bio has made an interim report on its phase I and phase II studies.
A positive recovery of healthy skin from steroid treatment was
demonstrated based upon procollagen production. The study on patients
with established skin atrophy does not show increased skin thickness
when measured by sonography. However, morphological evaluation of skin
biopsies is ongoing. During the year Karo Bio received a US patent for
the novel concept of treating skin disorders with thyroid hormone
analogs.
Male Hormone Replacement Therapy and Prostate Cancer
Karo Bio is actively engaged in a drug discovery project aiming at
development of new safe androgens to be used in hormone replacement
therapy and development of new safe antagonists for treatment of
prostate cancer. Karo Bio has exclusive rights to the androgen receptor
in Europe and the technology base at Karo Bio is perfectly suitable for
discovery of new safe pharmaceuticals in this field where there is a
great clinical need and significant commercial opportunities. The
project has made good progress during the year and has therefore been
upgraded regarding resource commitment.
Inflammatory Disorders
There is a great need for development of new pharmaceuticals for
treatment of inflammatory disorders. Although very potent, the side
effects of anti-inflammatory steroids restrict their use. The anti-
inflammatory effects of the steroids is mediated by the glucocorticoid
receptor which is a receptor for which Karo Bio has a world leading drug
discovery technology and unique knowledge. Karo Bio has increased its
drug discovery efforts in this area and significant progress has been
made during the year. In particular the determination of the three-
dimensional structure of the ligand binding domain of the receptor gives
Karo Bio a significant competitive advantage.
EXPLORATORY STUDIES
Cardiac Arrhythmia
Karo Bio has discovered a compound that has promising anti-arrhythmic
properties in animals. During the year Karo Bio discovered new
mechanisms of action for the compound and is evaluating these new
opportunities within the field.
Glaucoma
Karo Bio has data that support the feasibility of treating glaucoma with
thyroid hormone agonists. During the fourth quarter Karo Bio signed an
agreement with SIFI for further evaluation of the concept. SIFI is an
Italian company with an expertise in the field. The agreement gives SIFI
an option to evaluate the project during a one-year period.
TECHNOLOGY DEVELOPMENT
Karo Bio is focused on the discovery and development of novel
therapeutics. For such an endeavor access to leading technology is very
important. In May, Karo Bio reached an Agreement with Duke University,
Durham, North Carolina, granting Karo Bio the exclusive rights to
technologies, including Cellular Brailletm technology, developed at Duke
University Medical Center. The Cellular Braille technology further
expands the capabilities of the Karo Bio Molecular Braille® technology
that was previously developed by Karo Bio USA in collaboration with
scientists at Duke University Medical Center. See below for further
information regarding financial effects and accounting treatment.
ORGANIZATION
Björn Nilsson took office as new President for the Company in July.
Previously, he was Vice President of Research and Development at
Amersham Pharmacia Biotech AB in Uppsala.
Karo Bio’s organization has also been strengthened through several
additional key management recruitments.
Mats Johnson has been recruited as Vice President of Marketing and
Business Development. He comes from a leading position as Vice President
of Proteomics business in Amersham Pharmacia Biotech.
Anders Berkenstam has been recruited as Director of Research for Sweden.
Anders Berkenstam’s previous employment was as President and Head of
Research for Gemini, Sweden. Stefan Nilsson has been appointed Director
of Exploratory Research. This new position is important for generation
of new concepts and projects. Both these positions are reporting
directly to the Chief Scientific Officer Dana Fowlkes.
Berit Edlund fills a newly created position as Director of Human
Resources. Berit Edlund’s previous experience includes leading positions
within Pharmacia Corporation, Skandia and Ericsson.
Bertil Jungmar took the position as Chief Financial Officer effective
February 1, 2001. He has a background in accounting and business
advisory services with PricewaterhouseCoopers.
By the end of the year, Karo Bio had 133 employees (115). Of these, 37
are based in the United States and 109 are engaged in research.
Karo Bio introduced an incentive option program in accordance with the
decision made at the Shareholders’ Meeting April 26, 2001. The Program
is a stock option program and covers all permanent employees of Karo Bio
AB and its subsidiaries. The financial exposure from the stock option
program is hedged by 340 000 warrants issued to a wholly-owned
subsidiary.
RESULT, CASH FLOW AND FINANCING
Group net sales for the full year increased to MSEK 136.9 compared to
last year (100.6 after restatement following the change in accounting
principle regarding revenues, see Accounting and Valuation Principles
below). Corresponding figures for the fourth quarter are MSEK 38.3
(28.5). The increase in revenue for the full year consists of a
milestone payment from Bristol-Myers Squibb that was recorded fully as
revenue in the third quarter. Revenues increased also from research
funding for September – December and the year’s share of the down
payment from the new research collaboration with American Home Products.
Group expenses for the full year increased by MSEK 146.9 to MSEK 471.2
(324.3), which was attributed firstly to the full-year effect of
goodwill depreciation regarding Karo Bio USA compared to eight months in
2000, and secondly due to costs in relation to the new collaboration
agreement and increased activities in other areas. Royalty to the
Swedish Industrial Development Fund and success fees relating to the
milestone payment from Bristol-Myers Squibb is included in other
operating expenses. The increase in the fourth quarter from MSEK 106.4
to 126.5 is primarily due to costs in relation to the new collaboration
agreement.
The operating loss amounted for the full year to MSEK 334.3 (223.7) and
MSEK 88.3 (77.9) for the fourth quarter. Operating loss excluding
goodwill depreciation amounted for the full year to MSEK 92.5 (60.8) and
MSEK 27.8 (17.5) for the fourth quarter. Financial income for the full
year amounted to MSEK 13.4 (10.4).
Cash flows from operating activities improved for the full year to MSEK
-11.9 (-20.8) as a result mainly from the cash receipt of research
funding and down payment from American Home Products. Corresponding
figure for the fourth quarter was MSEK
-17.9 (5.6).
Capital investments in equipment amounted for the full year to MSEK 24.2
(9.0) and to MSEK 6.7 (3.7) for the fourth quarter. Capital investments
were mainly laboratory and IT equipment to enhance capacity and
capabilities and reconstruction of office space.
Cash and cash equivalents and short-term investments amounted to MSEK
282.3 (329.0) at year-end.
Loss per share for the year amounted to SEK 26.70 (19.51), based on the
weighted average number of shares outstanding. The Group’s equity ratio
as of year-end was 81.0% (93.2%) and equity per share at year-end was
SEK 46.37 (73.47).
SHAREHOLDERS’ EQUITY
Shareholders’ equity increased during the year by kSEK 134 from the
exercise of warrants.
At year-end, warrants representing 385 363 shares were outstanding. The
warrants were issued in conjunction with the acquisition of Karo Bio
USA, Inc. in 2000 (45 363 warrants) and the implementation of the
Incentive Program 2001 (340 000 warrants). During the year, 85 000
warrants relating to the Incentive Program 2000 were canceled in
accordance with a decision made at the Shareholders’ Meeting 2001. The
outstanding warrants will lead to no dilution of earnings per share, as
a conversion to shares would lead to an improvement of earnings per
share.
The Company’s share capital amounted to SEK 60 130 355 at the end of the
year representing 12 026 071 shares at a par value of SEK 5. Total
consolidated shareholder’s equity amounted to MSEK 557.7 after taking
into account the effect of the change in accounting principle and the
loss for the year.
PARENT COMPANY
The Parent Company is reporting a loss for the year of MSEK 99.4 (22.2).
ACCOUNTING AND VALUATION PRINCIPLES
This quarterly report and earnings report has been prepared in
accordance with the Swedish Financial Accounting Standards Council’s
(the Council) standard RR 20 for interim reports. The accounting and
valuation principles applied are consistent with provisions of the
Swedish Annual Accounts Act and standards issued by the Council. With
exception from the change in accounting policy described below, the
principles are unchanged compared to what was applied in the Annual
Report for 2000.
Karo Bio has changed the accounting for down payments from collaborative
research projects. Such down payments are received at the initiation of
collaborations and are non-refundable. In previous years, non-refundable
down payments were reported as revenue when received. Beginning January
1, 2001, non-refundable down payments are reported as revenue over the
term of the collaborative research agreement, which is usually three
years. The change is compliant with the new accounting standard
regarding Revenue Recognition RR 11 issued by the Council, which is
effective January 1, 2001.
Beginning in this report, depreciation of goodwill is presented
separately in operating expenses and marketing expenses are included in
administrative expenses as these do not represent a significant portion
of the Company’s total expenses. These changes are made to give a better
view of the Company’s expense structure.
Comparative figures for prior periods have been restated accordingly.
Amounts or figures in parentheses indicate comparative figures for the
corresponding period last year.
INVESTMENT IN TECHNOLOGY
The investment in exclusive rights to technologies from Duke University
as per the Agreement described above was capitalized in May 2001. The
amount capitalized represents the net present value of the determinable
payments according to the Agreement. Payments will be made over a four-
year payment schedule. Additional payments contingent on patents being
received and milestones being achieved are provided for in the
Agreement. These future payments will be substantially less than the
amount capitalized.
Depreciation will be taken over a three-year period, beginning in May
2001. Due to rapid development in the biotech area, a longer
depreciation period is not considered appropriate. The milestone
payments will be expensed as incurred in order to match expected
milestone payments received from partners.
ANNUAL GENERAL MEETING AND SCHEDULED RELEASES OF FINANCIAL INFORMATION
The Board of Directors intends to convene the Annual General Meeting on
Thursday April 25 at 4 p.m. Notice for the meeting will be available on
Karo Bio’s website www.karobio.se from March 26. In accordance with the
Board’s Policy for Dividend, the Board of Directors and the President
will propose that no dividend be paid for the financial year 2001.
Karo Bio intends to distribute financial reports as follows:
· Annual Report 2001 April 2
· Quarterly Reports April 24, July 16, October 16
Printed reports are distributed by mail to shareholders. Electronic
versions of Quarterly Reports and Earnings Report are distributed to
them who have so requested. Financial reports, press releases and other
information is available on Karo Bio’s website www.karobio.se
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