Pharming Group N.V. Reports Fiscal 1999 Year-End Results.Business Editors LEIDEN, The Netherlands--(BUSINESS WIRE)--March 27, 2000 Pharming pharming (fär`mĭng), the use of genetically altered livestock, such as cows, goats, pigs, and chickens, to produce medically useful products. Group N.V. (AEX AEX See: Amsterdam Exchange : PHAR /Easdaq: PHAR) today announced financial results for its fiscal year ended December 31, 1999. The Company reported that revenues for the fiscal year 1999 increased 54% to EUR EUR In currencies, this is the abbreviation for the Euro. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 12.5 million from EUR 8.1 million for the comparable period 1998. The revenues comprised payments of EUR 9.8 million from corporate partners, EUR 2.5 million from government grants, and EUR 0.2 million from patent licensing fees. Expenses increased 45% in 1999 to EUR 26.5 million from EUR 18.3 million in 1998, reflecting, amongst other factors, the continued development of human alpha-Glucosidase, human Lactoferrin lactoferrin (lak´tōfer´in), n an iron-binding protein found in the specific granules of neutrophils where it apparently exerts an antimicrobial activity by withholding iron from ingested bacteria and fungi. , human C1 Inhibitor, and other products. The net loss from ordinary activities for 1999 was EUR 12.6 million, compared with EUR 9.1 million reported for the year ended December 31, 1998. The net loss before and after tax for 1999 amounted to EUR 12.6 million, a marked decrease from the EUR 17.4 million net loss in 1998. As of December 31, 1999, Pharming had cash and cash equivalents of EUR 52.7 million primarily invested in term deposits. Pharmings cash position was reduced by EUR 18.6 million due to the net loss and the investments in fixed assets fixed assets npl → activo sg fijo fixed assets npl → immobilisations fpl fixed assets fix npl → , most notably the investments in the manufacturing plant for rabbit milk based biopharmaceuticals in Geel, Belgium and the state-of-the-art pharmaceutical farm in DeForest de·for·est tr.v. de·for·est·ed, de·for·est·ing, de·for·ests To cut down and clear away the trees or forests from. de·for , Wisconsin, USA. The Company believes that its current cash position will allow it to reach the next phase of development, and the market launch of the lead biopharmaceutical product human alpha-Glucosidase for Pompes disease, and will also suffice to execute other development programs. Highlights 1999 1. Co-listing on Amsterdam Exchanges Amsterdam Exchange (AEX) Exchange that comprises the AEX-Effectenbeurs, the AEX-Optiebeurs (formerly the European Options Exchange or EOE) and the AEX-Agrarische Termijnmarkt. (AEX) 2. Continued strong financial government support 3. Collaboration with DSM 1. DSM - Data Structure Manager. An object-oriented language by J.E. Rumbaugh and M.E. Loomis of GE, similar to C++. It is used in implementation of CAD/CAE software. DSM is written in DSM and C and produces C as output. 4. Further strengthening of patent portfolio 5. Pharming competition takes license on Pharming patents 6. Opening of worlds first pharmaceutical cattle farm in Wisconsin, USA 7. Birth of worlds first female transgenic trans·ge·nic adj. 1. Of, relating to, or being an organism whose genome has been altered by the transfer of a gene or genes from another species or breed: transgenic mice. 2. calves, generated through nuclear transfer 8. Orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designations for human C1 Inhibitor targeted at hereditary angioedema Hereditary angioedema A complement deficiency characterized by lymphatic vessel blockages that cause temporary swelling (edema) of areas of the skin, mucous membranes, and, sometimes, internal organs. Mentioned in: Complement Deficiencies 9. Phase II trial human alpha-Glucosidase for Pompe's disease Pom·pe's disease n. See type 2 glycogenosis. Pompe's disease see bovine generalized glycogenosis, glycogenosis type I. concluded with positive results Pompe disease Pompe disease Glycogen storage disease, type II, see there - human alpha-Glucosidase In the fourth quarter 1999, the first-ever clinical study of human alpha-Glucosidase with Pompes disease patients at the Sophia Childrens Hospital in Rotterdam, the Netherlands, was concluded. The positive results of the Phase II trial showed survival, skeletal muscle regeneration, and overall improvement of heart and lung functions. After 36 weeks in the study the four included infantile infantile /in·fan·tile/ (in´fin-til) pertaining to an infant or to infancy. in·fan·tile adj. 1. Of or relating to infants or infancy. 2. patients reached the age range of 12 to 17 months, which is well beyond the mean age of survival in untreated infantile Pompe patients. Repeated muscle biopsies In medicine, a muscle biopsy is a procedure in which a piece of muscle tissue is removed from an organism and examined microscopically. A biopsy needle is usually inserted into a muscle, wherein a small amount of tissue remains. demonstrated that the transgenic recombinant enzyme is taken up by the main target tissue, skeletal muscle, reaching normal levels of alpha- Glucosidase activities, which are comparable to healthy individuals. In the skeletal muscle tissue, the enzyme shows to be active, since on histological his·tol·o·gy n. pl. his·tol·o·gies 1. The anatomical study of the microscopic structure of animal and plant tissues. 2. The microscopic structure of tissue. evaluation lysosomal lysosomal pertaining to or emanating from lysosomes. lysosomal enzymes enzymes located in the lysosomes. lysosomal phospholipidosis glycogen glycogen (glī`kəjən), starchlike polysaccharide (see carbohydrate) that is found in the liver and muscles of humans and the higher animals and in the cells of the lower animals. storage decreased and muscle regeneration was observed. The most prominent effect was seen on the heart. In untreated patients, the left ventricular posterior wall thickness increases over time as the disease progresses. After start of treatment, the slope of left ventricular posterior wall thickness versus time changed significantly for all four patients. This was in-line with a concomitant significant decrease of left ventricular mass index (a measure for the dimension of the left ventricle left ventricle n. The chamber on the left side of the heart that receives the arterial blood from the left atrium and contracts to force it into the aorta. ) over time, with the largest improvement to less than 30% of the original baseline value at the beginning of the study. In addition, symptoms of cardiac instability diminished in all patients. The treatment also has an effect on respiratory function. The two patients included prior to 3 months of age never became dependent on artificial ventilation artificial ventilation n. See artificial respiration. and are treated as outpatients, receiving their weekly infusions on a day care basis . The development of human alpha-Glucosidase is the focus of a joint venture between Pharming and Genzyme General of Cambridge, MA, USA, to develop and commercialize worldwide the enzyme human alpha-Glucosidase as a treatment for Pompes disease, a hereditary, lethal lysosomal storage disorder. Hereditary angioedema human C1 Inhibitor Other important product development milestones in 1999 are the two orphan drug designations granted by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. for Pharmings human C1 Inhibitor for the treatment of hereditary angioedema, a grave and sometimes lethal disorder. Pharming expects to initiate a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in the course of 2000 and has recently signed an agreement with Baxter Healthcare Corporation on the co-development and marketing of human C1 Inhibitor for hereditary angioedema. Heparin heparin (hĕp`ərĭn), anticoagulant produced by cells in many animals. A polysaccharide, heparin is found in the human body and occurs in greatest concentration in the tissues surrounding the capillaries of the lungs and the liver. neutralization neutralization, chemical reaction, according to the Arrhenius theory of acids and bases, in which a water solution of acid is mixed with a water solution of base to form a salt and water; this reaction is complete only if the resulting solution has neither acidic nor human Lactoferrin Pharmings Phase I trial in human volunteers with human Lactoferrin was concluded with positive results. Considering the commercial potential of human Lactoferrin for heparin neutralization after open-heart surgery open-heart surgery Any surgical procedure opening the heart and exposing one or more of its chambers, most often to repair valve disease or correct congenital heart malformations (see congenital heart disease). , and the size of the market, Pharming is currently discussing the further development human Lactoferrin for this indication with potential partners. As a first step Pharming closed an agreement with DSM Biologics for large-scale purification of human Lactoferrin to guarantee sufficient supply for Phase II and Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the . Female transgenic calves through nuclear transfer 1st pharmaceutical farm Together with its strategic partner Infigen of DeForest, Wisconsin, Pharming achieved substantial success in its nuclear transfer program. The collaboration is well beyond the stage of proof-of-principle, and has already resulted in the generation of some 25 transgenic female calves. By mid-2000, this number will double to 50 transgenic female calves on the ground. The fact that Infigen and Pharming have the capability to routinely generate female transgenic calves, enables Pharming to shorten time-to-market by two years, since the male founder stage is no longer required. As a result of the progress in Wisconsin, Pharming has built a state-of-the-art pharmaceutical farm in DeForest, the worlds first dedicated to cattle, where the young animals YOUNG ANIMALS. It is a rule that the young of domestic or tame animals belong to the owner of the dam or mother, according to the maxim Partus sequitur ventrem. Dig. 6, 1, 5, 2; Inst. 2, 1, 9. are born and reared. Patent portfolio Pharming continued to aggressively expand its patent portfolio. In 1999, nine new patents were obtained in the principal markets where the company is active. A clear sign of Pharming's strong intellectual property position was the licensing agreement with Genzyme Transgenics trans·gen·ics n. (used with a sing. or pl. verb) The study of or methodology used to create transgenic animals or plants. that allows the latter the freedom to continue its development program of human Serum albumin serum albumin n. See seralbumin. . Pharming currently has a portfolio of 30 patents granted and pending. Other financial highlights To further improve access to its shares, Pharming obtained a co-listing on the Amsterdam Exchanges on 16 June, 1999. As expected the reaction of retail investors Retail Investor Individual investors who buy and sell securities for their personal account, and not for another company or organization. Notes: Retail investors buy in much smaller quantities than larger institutional investors. was enthusiastic, and the trading activity in Pharmings stock has increased substantially since. The 1999 annual report is available as of March 31, 2000. Pharming is very pleased to have achieved several important milestones during 1999, said George J M Hersbach, President and Chief Executive Officer of Pharming Group N.V. After the positive completion of our Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II with human alpha-Glucosidase for Pompe's disease in Rotterdam at the end of 1999, Pharming has proceeded to expand the trial into Phase II/III. We are dedicated to the success of this potentially life-saving therapy, and expect to launch the product in 2001. At the same time Pharming achieved excellent results with its Phase I study with human Lactoferrin for heparin neutralization, and it concluded its preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development of human C1 Inhibitor for hereditary angioedema, which the company will take into a Phase I clinical trial in 2000, in collaboration with our partner, Baxter. In 1999, Pharming has continued to show the solid foundation and commercial potential of its broad product portfolio. Pharming focuses on the development, production and worldwide commercialisation of human therapeutic proteins, produced at high levels in the milk of transgenic animals Transgenic animal Animals that have had genes from other species inserted into their genetic code. Mentioned in: Glycogen Storage Diseases that have been created using the companys proprietary technology. Statements included in this press release which are not historical in nature are intended to be, and are hereby identified as, "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " for purposes of the safe harbour provided by Section 21E of the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Forward-looking statements may be identified by words including "anticipates", "believes", "intends", "estimates", "expects" and similar expressions. The company cautions readers that forward-looking statements, including without limitation those relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the company's future operations and business prospects, are subject to certain risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Factors that could cause actual results and future operations and business prospects to materially differ from those anticipated in these forward looking statements include, but are not limited to, clinical and scientific results and developments concerning corporate collaborations and the company's proprietary rights and other known and unknown risks including risk factors described in the prospectus relating to the company's recent initial public offering. Pharming Group N.V. cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Pharming expressly disclaims any obligation or undertaking to release publicly any updates or revisions of such statements to reflect any changes in Pharmings expectations or any change in events, conditions or circumstances on which any risk statement is based.
CONSOLIDATED STATEMENT OF OPERATIONS 1999 1998
Year ended December 31, 1999 EUR,000 EUR,000
REVENUES
Research and development contracts 9,795 3,771
Government grants 2,510 4,220
Patent revenues 200 85
Total Revenues 12,505 8,076
EXPENSES
Research and development 11,122 7,952
Operations 6,530 3,564
Sales, general and administrative 7,538 5,799
Depreciation and amortisation 1,325 975
Total Expenses 26,515 18,290
Operating income / (loss) (14,010) (10,214)
Result joint venture (347) (40)
Financial income 1,734 1,200
NET RESULT from ordinary activities
before exceptional items (12,623) (9,054)
Exceptional items - (7,103)
NET RESULT from ordinary activities
before and after income (12,623) (16,157)
taxes
Extra-ordinary income /(loss) - (1,263)
NET RESULT before and after income taxes (12,623) (17,420)
============= =============
PROFIT AND LOSS FROM OPERATIONAL ACTIVITIES PER SHARE
(excluding exceptional items)*
1999 1998
Result from ordinary activities (12,622,689) (9,054,276)
Number of ordinary shares ** 13,218,622 13,163,601
Earnings (loss) per share (0.95) (0.69)
Number of ordinary share fully diluted ** 15,502,962 15,418,046
Earnings (loss) per share fully diluted (0.81) (0.59)
PROFIT AND LOSS FROM CONTINUING
OPERATIONS PER SHARE
(including exceptional items),
after taxes: 1999 1998
Net income (loss) from continuing
operations before and after taxes (12,622,689) (16,157,298)
Net income (loss) per share (0.95) (1.23)
Net income (loss) per share fully diluted (0.81) (1.05)
* The calculation of earnings per share excluding exceptional items
give the most appropriate measure of the underlying performance of
the company
** The earnings (loss) per share, respectively net income (loss) per
share have been calculated using the number of shares per
year-end.
CONSOLIDATED BALANCE SHEET
Year ended December 31, 1999
1999 1998
EUR,000 EUR,000
ASSETS
Fixed assets Intangible fixed assets 2,687 2,631
Tangible fixed assets 19,013 8,706
Financial fixed assets 22 131
Total fixed assets 21,722 11,468
========== =========
Current assets
Livestock 15 141
Receivables and accrued
income 8,558 6,271
Cash 52,700 71,335
Total current assets 61,273 77,747
========== =========
TOTAL ASSETS 82,995 89,215
========== =========
GROUP EQUITY AND LIABILITIES
Group Equity 69,817 82,614
Long Term liabilities 2,301 1,567
Current liabilities 10,877 5,034
TOTAL GROUP EQUITY AND LIABILITIES 82,995 89,215
========== =========
CONSOLIDATED CASH FLOW STATEMENT
Year ended December 31, 1999
1999 1998
EUR,000 EUR,000
Cash Flow from operational activities
Net loss for the year (14,010) (10,214)
Depreciation and amortisation 1,325 975
Result joint venture (347) (40)
Exceptional items - (7,103)
Changes in working capital:
* Decrease (Increase) of livestock 127 92
* Decrease (Increase) of receivables (2,287) (3,746)
* Increase of current liabilities 5,843 1,282
3,683 (2,372)
(9,349) (18,754)
Interest received 2,027 1,448
Interest paid (110) (76)
1,917 1,372
Cash Flow from operational activities (7,432) (17,382)
Cash Flow from extraordinary income / - (1,263)
(losses)
Cash Flow from investing activities
Investments in intangible fixed assets (292) (731)
Investments in tangible fixed assets (11,612) (5,384)
Investments in financial fixed assets 109 5
Cash Flow from investing activities (11,795) (6,110)
Cash Flow from financing activities
Proceeds from share issue 40 84,238
Increase/ (decrease) Long term debt 734 (645)
Cash Flow from financing activities 774 83,593
Net cash flow (18,453) 58,838
Foreign currency gains (losses) (182) (274)
Increase/decrease of cash (18,635) 58,564
============= ==========
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