Earnings report January – December 2000
EARNINGS REPORT JANUARY – DECEMBER 2000
* A clinical development candidate has been selected in the BMS
collaboration and the collaboration was prolonged for one year to develop
a second-generation compound.
* Extension of the Merck collaboration for two more years in October
2000.
* Initiated a strategic collaboration with Abbott Laboratories on type 2
diabetes in January 2000.
* Novalon Pharmaceuticals was acquired in May 2000 to become Karo Bio
USA.
* New collaborations related to the Karo Bio USA’s BioKey® Technology
signed with Aventis Pharma, GPC Biotech AG, NovImmune S.A., and Boehringer
Ingelheim Pharmaceuticals, Inc.
* Phase II clinical trials in the skin projects started.
* Group net sales increased to SEK 109.2 million (73.0), while loss after
financial items increased to SEK -205.1 million (-35.1) due to goodwill
depreciation following the acquisition of Karo Bio USA and due to progress
and increased investments in the research programs.
* Group cash flow from operations amounts to SEK -48.0 million (-21.3)
and the new share issue completed in May 2000 generated SEK 196.9 million
in cash flow. As a consequence, cash and cash equivalents and short-term
investments amounted to SEK 329.0 million (187.8) at year-end.
COLLABORATIVE PROJECTS
Abbott Laboratories – Type 2 Diabetes
This collaboration started in January 2000. The aim of Karo Bio’s
collaboration with Abbott Laboratories is the discovery and development of
therapeutic compounds based on a novel concept for the treatment of type 2
diabetes. In individuals with type 2 diabetes there is more blood sugar,
glucose, produced than the body needs and the normal mechanisms for
clearing the excess glucose do not work properly. The concept developed at
Karo Bio to treat type 2 diabetes is to safely decrease the amount of
glucose produced and shift a patient’s glucose to a lower, healthier
level. Within this collaboration with Abbott Laboratories, we focus upon
selectively blocking the activity of the glucocorticoid receptor within
the liver, the organ responsible for most glucose production. The organ
selectivity of these therapeutic compounds is important since the
glucocorticoid receptor has critical functions in other systems such as
the immune system.
To date, we have proven that we can discover potent, liver selective
glucocorticoid antagonists and demonstrated that some of these antagonists
are active in animal models of diabetes. During the year selectivity and
potency of several compound classes have been significantly improved. We
intend to continue to optimize these compounds and do more extensive
pharmacological characterizations within the year 2001 and to select
clinical development candidates.
Abbott will pay Karo Bio royalties on future sales of products in addition
to a total of 54 million USD in R & D funding and milestone payments for
two products reaching the market.
Bristol-Myers Squibb – Metabolic Disorders
The collaboration with BMS started in the fall of 1997 with a focus on
metabolic disorders using the thyroid hormone receptor as a target. The
primary therapeutic indication is obesity. During the past two years a
clinical development candidate has been selected. This compound
demonstrated proof of principle in relevant animal models and the pre-IND
testing is ongoing for this compound. Currently, BMS is complementing its
previous IND studies with additional studies. During 2000 this successful
collaboration was prolonged for an additional year with the aim to
discover a second generation of compounds and to explore additional
therapeutic indications.
BMS will pay Karo Bio royalties on future sales of products in addition to
a total of 40 million USD in R & D funding and milestone payments for two
products reaching the market.
Merck & Co – Estrogen Receptor (ER)
The Merck collaboration started in the autumn of 1997 and is directed
toward the development of novel therapies for the treatment of diseases
targeting the human estrogen receptors alpha and beta. Karo Bio was
previously awarded US and European patents for the new estrogen receptor
beta as a drug target and was recently awarded a Japanese patent on that
receptor. The discovery of the new estrogen receptor beta has opened up
the possibility of treating many female disorders in a new way. Classical
diseases such as osteoporosis, postmenopausal symptoms and breast cancer
as well as other diseases may be treated with new receptor-selective
compounds. The collaboration has been successful with the design and
synthesis of selective compounds that in pre-clinical studies have led to
prioritization of clinical indications for further development. Based on
the accomplishments so far, during the year the collaboration was extended
for an additional two-year period. Merck will carry out the clinical
development of the therapeutic products and has global marketing rights.
Karo Bio’s upfront payment, research funding and milestone payments can
amount to USD 80 million if two products for distinct therapies are
developed as a result of the collaboration. Thereafter, royalties shall be
paid upon sales of the products.
BioKey® Collaborations
Karo Bio has several genomics based drug discovery collaborations with
companies such as Aventis, Serono, Bayer AG, GPC Biotech and Millennieum
Pharmaceutical Corporation. In these collaborations, Karo Bio uses its
proprietary BioKey® probes technology to establish high throughput screens
for the discovery of novel chemical compounds. These compounds act through
drug targets discovered from our partner’s genomics programs. In addition
to receiving research support and milestone payments, Karo Bio is eligible
to receive royalty payments upon sales of therapeutic products resulting
from these collaborations.
INTERNAL PROJECTS
Skin Disorders – Thyroid Hormone Receptor (THR)
Skin atrophy (thinning of the skin) is a problematic side effect in for
example patients treated for psoriasis with steroids and often leads to
bruises and impaired wound healing. Karo Bio has in animal studies
previously shown that thyroid hormone effectively can block skin atrophy
induced by steroids. Karo Bio has developed a product for skin atrophy and
Phase II clinical trials are ongoing. In parallel a phase I mechanistic
study regarding effects on human skin composition is under way.
Cardiac Arrhythmia -THR
Karo Bio’s lead compound for cardiac arrhythmia, KB130015, has in previous
pre-clinical studies shown promising properties as a potential new and
safe anti-arrhythmia agent. Karo Bio is now in discussions with several
companies for out-licensing of the compound. In addition a number of new
potent and selective antagonists for the thyroid hormone receptor alpha
has been generated. Since the alpha-receptor appears to play an important
role for cardiac rhythm these compounds will now be evaluated for their
potential to become new anti-arrhythmia pharmaceuticals.
Glaucoma -THR
Recently a new study has been completed where a thyroid hormone analog has
been given as eye drops to normal rabbits. In this study local irritation,
penetration and uptake were monitored. The conclusions are that the
compounds caused no irritations, were well taken up and caused no
significant lowering of pressure. Karo Bio will now seek a partner for the
project.
Exploratory Research Program
Karo Bio has within the exploratory research program started several new
activities during year 2000. This process has been significantly enhanced
by access to the Karo Bio USA’s BioKey® Technology. Classical nuclear
receptors like the androgen receptor (AR), mineralocorticoid receptor (MR)
and the glucocorticoid receptor (GR) are included. For AR Karo Bio
acquired an exclusive European license in August 2000 and important
indications are prostate cancer and male hormone replacement therapy. MR
is an important target for treatment of hypertension and heart failure and
GR for treatment of inflammation. In these projects screening for
compounds has been initiated. Karo Bio has also initiated work on the
orphan receptor LXR. Karo Bio has a strong proprietary position regarding
this receptor which has become a new and exciting target for
atherosclerosis.
Antibacterial Program
Antiinfective drugs constitute a worldwide market of over 26 billion USD
with the majority being anti-bacterials. Resistance to existing drugs is
developing at an alarming rate with resistance to vancomycin, the current
drug-of-last-resort, by Enterococcus species now common. Emerging
resistance to vancomycin by Staphylococcus aureus is of great concern.
Thus, a diverse arsenal of new antibacterial agents is urgently needed to
combat the diminishing efficacy of existing antibiotics.
Technologies for screening these targets now limit drug discovery efforts
because most screening technologies rely on a biochemical assay. The
cornerstone of the antibacterial program is the proprietary BioKey®
technology that enables high throughput screening. BioKey® probes act as
surrogate ligands and bind at essential sites that inhibit the function of
the target protein. More than 10 molecular targets have been screened and
several small-molecule lead compounds have been identified.
RESULTS AND FINANCING
Change in Accounting Policy
Karo Bio has decided to early adopt the revised accounting standard for
consolidations, RR 1:00, issued by the Swedish Financial Accounting
Standards Council in August 2000. It is Karo Bio’s opinion that early
adoption of RR 1:00 in the first annual report including the Karo Bio USA
acquisition leads to a better view of the financial position and result of
Karo Bio. A delayed adoption would result in restatement of financial
statements already issued.
The standard sets new guidelines for establishing the value of shares
issued as consideration in an acquisition by a public company. RR 1:00
requires that the consideration is valued using the share price at the
transaction date. Under the old standard, RR 1:96, the value was based on
the average share price ten days before the acquisition was announced. The
effect for Karo Bio of the revised accounting standard is the valuation of
shares issued in conjunction with the acquisition of Karo Bio USA. For
this acquisition, the transaction date is deemed to be the day when the
transaction was completed and shares exchanged, May 10, 2000. On that day,
the closing share price was SEK 305, compared to the average share price
preliminarily used based on the old accounting standard, SEK 415.
This adjustment to the transaction value leads to the following
adjustments in the financial statements of the Parent Company and the
Group.
SEK million Original Adjusted value
preliminary under RR 1:00
recording
Investment in group 971.5 718.0
companies
Increase in share premium 942.2 688.7
reserve
Goodwill 963.4 709.9
Goodwill depreciation 214.1 157.8
2000
Goodwill depreciation 321.1 236.6
full year
There are no other material effects on the financial statements from
adopting RR 1:00. As the acquisition of Karo Bio USA was made during 2000,
there are no effects from the change in accounting principle on periods
prior to January 1, 2000.
The new accounting standard is effective for financial years beginning on
1 January 2002 or later, but early adoption is encouraged. If early
adopted, it is required by RR 1:00 to early adopt three other new
accounting standards regarding accounting for intangible assets,
provisions and contingencies, and impairments. However, this adoption has
no effect on the financial statements as of December 31, 2000.
The Karo Bio Group
Net sales for the year for the group increased to SEK 109.2 million
(73.0), made up primarily of research funding from the group’s partners.
Group expenses increased according to plan to SEK 324.6 million (115.5),
which is primarily due to increased goodwill depreciation by SEK 157.8
million following the acquisition of Karo Bio USA. The acquisition made
increased activities in the R&D organization possible, leading to higher
expenses for personnel and IT. Pension refund from SPP, included in
operating loss, amounted to SEK 3.5 million, of which SEK 1.4 million
affected cash flows during 2000.
Operating loss for the group increased to SEK -215.5 million (-42.5). Of
the loss increase SEK 173.0 million, SEK 157.8 million is attributable to
increased goodwill depreciation. Financial income increased to SEK 10.4
million (7.4).
Group cash flow from operations amounts to SEK -48.0 million (-21.3)
primarily due to cash acquisition costs and repayment of loans in Karo Bio
USA. Capital investments in equipment amounted to SEK 9.0 million (6.5)
excluding the Karo Bio USA acquisition. Capital investments were mainly
for X-ray crystallography equipment and software purchased for chemistry
operations. As a consequence, cash and cash equivalents and short-term
investments amounted to SEK 329.0 million (187.8) at year-end, including
SEK 196.9 million from the directed new share issue.
Acquisition of Karo Bio USA
The acquisition of Karo Bio USA, Inc. was carried out as a non-cash issue.
The recorded purchase price, including transaction costs, is SEK 718.0
million, (see further Change in Accounting Policy above). The acquisition
brought goodwill of SEK 709.9 million that will be depreciated over a
three-year period beginning at May 1, 2000, from which date the company is
consolidated. Cash and cash equivalents in Karo Bio USA at the time of
acquisition amounted to SEK 38.1 million.
Parent Company
The parent company is reporting a loss for the year of SEK -22.2 million
(-29.8).
Shareholders’ Equity
Shareholder’s equity increased by SEK 699.8 million from the acquisition
of Karo Bio USA, paid by issuance of 2,206,198 new shares and 88,064
warrants in accordance with the resolution of the annual general meeting
April 26, 2000. Warrants were subsequently exercised, leading to 15,731
new shares.
The directed placement performed in May of 600,000 new shares generated an
increase of SEK 196.9 million in equity.
Consequently, the company’s share capital of SEK 59,995,505 is now divided
among 11,999,101 shares at par value of SEK 5. In addition, there are
warrants outstanding representing 157,333 shares.
ORGANIZATION
There were 115 employees by the end of the year, compared to 80 in 1999.
Of these, 33 are based in the United States and 98 are engaged in
research.
In conjunction with the Annual General Meeting of 26 April, 2000, Torben
Jørgensen was installed as President of Karo Bio. He succeeded Per-Olof
Mårtensson who was appointed Chairman of the Board.
ANNUAL GENERAL MEETING AND FINANCIAL REPORTS
The Board of Directors intends to convene the Annual General Meeting on
Thursday 26 April 2001 at 4 p.m. In accordance with the Board’s Policy for
Dividend, the Board will propose that no dividend is paid for the
financial year 2000.
Karo Bio intends to distribute financial reports as follows:
* Annual Report, 2 April.
* Quarterly Reports, 26 April, 12 July, 17 October.
* Earnings Report, 8 February 2002.
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https://www.bit.se/bitonline/2001/02/08/20010208BIT00120/bit0001.doc The full Year-End Report
https://www.bit.se/bitonline/2001/02/08/20010208BIT00120/bit0002.pdf The full Year-End Report