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Pharming Group N.V. Reports Half year Results 2000, Revenues up 75% — Pharming strengthened partnership with Genzyme

Business Wire, August 1, 2000

    Business Editors

      LEIDEN, The Netherlands--(BUSINESS WIRE)--Aug. 1, 2000--Pharming
Group N.V. (EASDAQ: PHAR / AEX: PHAR) announced financial interim
results for its first half-year ended June 30, 2000.

Financial Highlights

--       Total revenues increased 75% to EUR 7.8 million
--       Total expenses increased 22% to EUR 15.5 million
--       Operating loss decreased 7% to EUR 7.6 million
--       Dutch government assigned a grant of EUR 1.0 million for the
         development of hLF and hCol
--       Partner revenue of EUR 6.2 million.

Operational Highlights

--       Pharming and Genzyme obtain the rights of Pompase(R) enzyme
         replacement therapy from Synpac
--       Announcement of final results of phase II clinical trial of
         human alpha-Glucosidase for Pompe's disease, which are
         recently published in the medical journal The Lancet
--       Agreement with Baxter Healthcare Corporation on co-
         development of human C1 Inhibitor for Hereditary Angioedema
--       Phase I clinical study on intravenous use of human
         Lactoferrin finalized
--       Third US patent on transgenic cattle issued to Pharming
--       New patent issued in New Zealand and Australia


Financial Review

Statement of operations

      Pharming reported total revenues this half-year increased 75% to
EUR 7.8 million compared to the first half-year in 1999. This number
includes revenues from the Pharming/Genzyme Joint Venture and from
Baxter for a combined amount of EUR 6.2 million. An amount of EUR 1.0
million has been accounted for stemming from a Dutch government grant.
Revenue from patents amounted to EUR 0.2 million

      Total expenses amounted EUR 15.5 million an increase of 22%
compared to first half-year of 1999 as a result of an increase in
research and development costs and operational costs of the company.
Because of the strong growth of the companys revenues, the operating
loss was reduced by 7% to EUR 7.6 million Pharmings share in the
result of the Pharming/Genzyme joint venture amounted to EUR 2.9
million. This amount represents 50% of the result of the joint
venture, which is Pharmings share after reaching the US$ 14 million
development cost fully paid by Genzyme. The financial income amounted
EUR 0.8 million mainly related to interest received on deposits. The
net loss for the company increased 38% to EUR 9.8 million compared to
first half-year 1999.

Cash position

      The cash position this half-year decreased by EUR 4.1 million. The
most important increases in the cash position result from the receipt
of revenues from partners, receipt of the government grant as well as
an increase of the lending and lease facility from Fortis Lease
Belgium. The cash out has been mainly related to the capital
investments. The resulting cash position is EUR 48.6 million,
primarily invested in term deposits in Netherlands guilders, US
dollars en Euros.

Balance sheet

      The total fixed assets increased by EUR 22.0 million compared to
December 31, 1999. The most significant increases are related to
Pharmings share in the acquisition of the exclusive rights to
Pompase[registered] (EUR 10.9 million), which rights have been capitalized as
intangible fixed asset, and the investments in tangible fixed assets
(EUR 10.9 million). These investments are mainly related to the
production facility in Geel, Belgium and the Company's new
headquarters in Leiden, The Netherlands. The total current assets
decreased this half-year by EUR 3.7 million to EUR 57.6 million. This
change is mainly related to the reduction of the cash position of the
company by EUR 4.1 million.
      Group equity decreased to EUR 62.9 million. An increase of EUR 2.9
million stems from the issue of new shares, a decrease of EUR 9.8
million relates to this half-years result. Long-term liabilities
increased by EUR 14.6 million. The largest increase (EUR 10.7 million)
is caused by the convertible loan Pharming issued to Genzyme related
to the acquisition of Pompase[registered]. Other increases are related to loans
received from ABN Amro bank and the State of Wisconsin for the
investment in Vienna Pharms, Wisconsin USA. Current liabilities
increased by EUR 10.6 million this half year. The lending and leasing
facility from Fortis Lease (formerly FMN Finance) for the plant in
Geel, Belgium is currently being utilized for the maximum amount of
EUR 11.2 million.
      The number of fully diluted shares increased by 703,439 shares
compared to June 30, 1999 of which 623,615 potential shares are
related to the convertible note issued to Genzyme.

Product Development

Human alpha-Glucosidase: Pompe's disease

      In April, Pharming and Genzyme announced their intention to
co-develop and commercialize Pompase(R) enzyme replacement therapy for
Pompe's disease; a therapy based on human alpha-Glucosidase (hAG)
produced in CHO-cells. Genzyme had acquired the exclusive rights to
Pompase(R) from Synpac, Inc., and had offered these rights to the
Pharming/Genzyme joint venture. Pharming has issued a convertible note
of USD 10 million to Genzyme as part of this acquisition. By focusing
on CHO-cells for the production of hAG, Pharming and Genzyme have
ensured that in the end, a therapy for Pompe's disease will come
available in the shortest possible time. Final agreement was reached
June 30, 2000. All patients currently in clinical trials in both
Rotterdam, the Netherlands and Essen, Germany are doing relatively
well and will continue to receive transgenically produced hAG until a
transition to CHO-material is deemed feasible and acceptable. At
present, clinical data for both the transgenic product and the
CHO-product are being compared . The prospective clinical trial in
severe infantile Pompe patients will start in the second half of 2000.
These infantile patients will be treated with CHO derived hAG in the
US and Europe, and will be compared to a historical control group. The
trial is expected to last for 12 months, with market launch expected
in 2002. A prospective juvenile trial will start in 2001, and will be
expected to complete in 2003. The construction of the multi-purpose
plant in Geel, Belgium will be completed as planned. With the shift to
CHO-cells for the production of hAG, the extra available capacity will
benefit the other development programs.

Human C1 Inhibitor: Hereditary Angioedema

      The pre-clinical development of human C1 Inhibitor (hC1) is
progressing according to plan. High quality hC1 has been purified from
transgenic rabbit milk and this material is used in a pre-clinical
safety program. Pharming and Baxter, our co-development partner, have
decided to start the clinical phase of the development program before
the end of 2000.

Human Lactoferrin: pharmaceutical applications

      Recent data generated in animal models show a significant
potential of human Lactoferrin (hLF) in treating very serious
infections that are otherwise difficult to treat due to the
continuously increasing resistance to more traditional antibiotics.
These new insights, combined with the excellent safety profile of
human Lactoferrin as was recently demonstrated in our Phase I clinical
trial with intravenously administered hLF, open the way for developing
this product as a therapy for the rapidly growing market of resistant
systemic infections, such as Methicilline Resistant Staphylococcus
Aureus (MRSA) infections .

Patents

      In January Pharming was issued a third US patent on transgenic
cattle, which broadly covers the production of recombinant proteins in
the milk of transgenic cattle. Also in January a patent on nuclear
transfer technology was issued to Pharming's partner Infigen, Inc.,
with claims covering both the use of primordial germ line derived
cells (PGCs), as well as the use of somatic cells in Infigens
specific NT and cell culture procedures. Furthermore a new patent was
issued to Pharming in New Zealand, which patent is relating to the
purification of human Lactoferrin from milk. In addition, an
Australian patent was issued to the Women and Children's Hospital in
Adelaide, to which Pharming is exclusively licensed. This patent
broadly covers methods for the diagnosis of lysosomal storage
diseases. Pharming's patent portfolio now comprises 31 issued patents
worldwide.

Corporate Affairs

      Pharming N.V., the Belgian subsidiary, was awarded a grant of EUR
1.0 million by the Flemish Institute for Industrial Science &
Technology for a feasibility study in 2000, to test recombinant human
C1 Inhibitor (hC1) as a therapeutic for acute Hereditary Angioedema.
This project covers the development of an efficient and reproducible
large scale purification process, the pre-clinical safety evaluation
of the hC1 material and the development of extensive biochemical
characterization methods for the subsequent clinical evaluation of the
product.
      As of May 1, Pharming has appointed Karin Lutz - van der Kley as
Corporate counsel and Company Secretary. Mrs. Lutz - van der Kley
mainly gained her experience at Royal Gist-Brocades, where she worked
for 10 years. At this company she held various legal positions, among
which Company Secretary and Legal counsel to the Research &
Development department and the Industrial Pharmaceutical Products
division.
      Pharming Group N.V. focuses on the development, production and
commercialization of human therapeutic proteins from the milk of
transgenic animals that have been created using the company's
proprietary technology. Pharming's portfolio comprises products for
(rare) genetic disorders, surgical and traumatic bleeding, infectious
and inflammatory diseases, tissue and bone repair and blood-related
disorders. The company has operations in Belgium, Finland, the
Netherlands and the USA.

      This press release contains forward-looking statements about
potential therapeutic uses and effects of human alpha-Glucosidase,
human C1 Inhibitor, human Lactoferrin and the expected timing of
clinical trials of human alpha-Glucosidase. Actual results may differ
materially depending on the actual therapeutic effect of human
alpha-Glucosidase, human C1 Inhibitor, human Lactoferrin, the actual
timing and results of clinical trials, the actual timing and content
of regulatory submissions and decisions of the US Food and Drug
Administration and the European Medicine Evaluation Agency, or any
other regulatory authority.

-0-
*T


Consolidated Balance Sheet
(unaudited)
                              June 30, 2000         Dec., 31 1999
                                 EUR,000               EUR,000
Assets

fixed assets
Intangible fixed assets          13,772                 2,687
Tangible fixed assets            29,977                19,013
Financial fixed assets               22                    22
Total fixed assets               43,771                21,722

current assets
Livestock                           121                    15
Receivables and accrued income    8,844                 8,558
Cash                             48,614                52,700
Total current assets             57,579                61,273

Total assets                    101,350                82,995

Group equity and liabilities

Group equity                     62,955                69,817
Long-term liabilities            16,924                 2,301
Current liabilities              21,471                10,877

Total group equity and
 liabilities                    101,350                82,995

shareholders equity

Share capital                    32,939                31,725
Additional paid-in capital       79,976                78,285
Accumulated deficit             (49,960)              (40,193)
Total shareholders equity       62,955                69,817


Consolidated statement of operations
(unaudited)
                              Jan  Jun, 2000      Jan  Jun, 1999
                                  EUR,000             EUR,000

Revenues                          7,841               4,475
Expenses                         15,497              12,701
Operating income (loss)         (7,656)              (8,226)
Result Joint Venture            (2,928)                   0
Financial income (net)             817                1,143
Net income (loss)               (9,767)              (7,083)

Number of shares              13,724,618           13,207,785
Number of shares fully
 diluted                      16,186,752           15,483,313

Net income (loss) per share       (0.71)               (0.54)
Net income (loss) per share
 fully diluted                    (0.60)               (0.46)


Consolidated cash flow statement
(unaudited)
                              Jan - Jun, 2000      Jan - Jun, 1999
                                  EUR,000              EUR,000

Cash flow from operational
 activities                       1,370                (1,929)
Cash flow from investing
 activities                     (22,985)               (5,663)
Cash flow from financing
 activities                      17,529                  (220)
Increase (Decrease) of cash      (4,086)                (7,812)

Note

      The unaudited quarterly financial information has been prepared on
the basis of the accounting policies set out in the 1999 annual report
and has been approved by the Board of Management and the Board of
Supervisory Directors of Pharming Group N.V.

-0-

    --30--eb/ny*

    CONTACT: Europe:
             Rob Meines (Media)
             +31 71 5247 429
                      OR
             Eva Lindner (Investors)
             +31 20 575 4023
                      OR
             USA:
             Tonua Fedusenko
             +1 302 328 3347

    KEYWORD: INTERNATIONAL EUROPE afxuk
    INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL BIOTECHNOLOGY EARNINGS
COPYRIGHT 2000 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning
 

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