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Dragon Reports 2003 Second Quarter Financial Results
Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG) today announced results for the three-month and six-month periods ending June 30 2003. During the quarter, the Company posted revenues of $1,007,686 from the sales of rHu Erythropoietin (EPO), which is currently marketed for use in the treatment of anemia related to chronic renal failure and for surgery patients in China, India, Egypt, Peru and Brazil.
For the 3-month ended June 30, 2003 Revenues of $576,894 were generated from sales in China and $430,792 from sales in other countries compared to $826,659 in China and $199,500 sales outside of China in 2002. The gross profit margin was 68% for the second quarter of 2003 compared to 83% for the same period in 2002 due to the fact that the Company decided to sell some products with short-term expiry dates at a reduced price.
Operating expenses for the quarter in 2003 were $0.93 million, down from $2.69 million from the same period in 2002, which included Research & Development expenses of $1.02 million, reflecting the results of our continued efforts to streamline our operations and tight control of expenses. Net loss for the quarter in 2003 was $236,424, or $0.01 per share, reduced from a loss of $1,824,867, or $0.09 per share, for the second quarter of 2002.
For the six-month ended June 30, 2003 For the six-month period, revenues in 2003 were $1.67 million down from $2.40 million for the same period in 2002. Operating expenses were reduced to $2.1 million for the first six months of 2003 from $4.8 million for the same period in 2002. Net loss for the first six months of 2003 was $0.97 million ($0.05 per share) reduced from a loss of $2.76 million ($0.14 per share) for the six months ended June 30, 2002.
“While the overall Chinese and international markets were affected by the outbreak of SARS (Severe Acute Respiratory Syndrome), our company achieved a 52% sequential growth in revenue from a modest first quarter of 2003 ($0.66 million in 2003 first quarter vs. $1.01 million in 2003 second quarter), with a 23% decrease of the operating expenses from the first quarter of 2003. As a result, our net loss has been reduced to $0.24 million in second quarter of 2003 ($0.01 per share) compared to $0.73 million in first quarter of 2003 ($0.04 per share).” said, Dr. Alexander Wick, President and CEO of Dragon Pharmaceutical Inc. “With the projected increase in revenues from both Chinese and International markets and our continued tight control over both the production costs and other operating expenses, we expect further improvement of our results for the remaining of 2003. We continue to work toward our stated objective of achieving a break-even in 2003.”
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Dragon Announces the Appointment of Board of Directors and Auditor
Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG) announced the completion of the Company’s Annual General Meeting held in Vancouver on June 26, 2003. The shareholders have re-elected the following five members of the Board of Directors.
Dr. Alexander Wick, President and Chief Executive Officer
Dr. Longbin Liu, M.D., Chairman of the Board of Directors
Dr. Ken Z. Cai, Ph.D., Director
Dr. Y.K. Sun, M.B., B.S. (HK), Director
Mr. Philip Yuen, Director
Prior to the Annual General Meeting, Mr. Greg Hall, a member of the Board of Directors since 1998, withdrew his nomination as a Director of the Company due to personal reasons. “On behalf of Dragon’s Board of Directors and the management team, I wish to express our sincere appreciation to Mr. Hall for his contribution to the Company. As a director of the Company, Mr. Hall had shared many responsibilities that led to prompt and sound decisions by the Board.” said Dr. Alexander Wick, President and Chief Executive Officer of Dragon.
The Company also announced that shareholders of the Company have ratified the re-appointment of Moore Stephens Ellis Foster Ltd., Chartered Accountants, to audit Dragon’s financial statements for the year ending December 31, 2003.
About Dragon Pharmaceutical Dragon Pharmaceutical Inc. is an international biopharmaceutical company headquartered in Vancouver, Canada, with cGMP production and research and development facilities in Nanjing, China. The Company develops and commercializes human proteins for therapeutic use. Based on its proven protein expression technology, Dragon believes that it has become a competitive producer of Erythropoietin (EPO), a breakthrough drug that has revolutionized the treatment of anemia. Dragon’s EPO is currently approved to treat anemia due to renal failure and surgery in China, India, Brazil, Egypt and Peru. Additional regulatory submissions are in progress throughout Central and Eastern Europe, Asia, Latin America, the Middle East and Africa.
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Dragon Appoints New President
The Board of Directors of Dragon Pharmaceuticals Inc. (TSX: DDD; OTC BB: DRUG) today announced the appointment of Dr. Alexander E. Wick as President. Dr. Wick will continue to serve as a Director of Dragon, a position he has held since the Company’s inception in 1998.
Dr. Longbin Liu, Dragon’s co-founding President and CEO, has stepped down from his management role and has been appointed Chairman of the Board. He will focus his efforts on providing strategic direction as well as scientific and technical guidance to the Company. Dr. Liu succeeds Dr. Ken Cai, co-founder of Dragon, as Chairman. Dr. Cai remains a Director of the Company and has been appointed to the newly formed Executive Committee of the Board along with fellow Directors Dr. Wick and Mr. Philip Yuen.
“I am delighted that Alex has agreed to lead Dragon through the next phase of the Company’s development,” said Dr. Liu. “With his extensive global experience in the pharmaceutical industry, I am confident that under his leadership Dragon will achieve its full potential and I look forward to working with him to achieve this goal.” Dr. Wick’s extensive career in the pharmaceutical industry includes senior management positions in Europe and the U.S. Dr. Wick most recently served as Chairman, President and CEO of Sylachim S.A., an international fine chemicals and manufacturer serving primarily the pharmaceutical industry, where he led all aspects of the organization including the strategic initiative resulting in the company’s acquisition by the German conglomerate Dynamit-Nobel GmbH in 2001. Prior to Sylachim, Dr. Wick’s positions with notable pharmaceutical companies include 12 years in research with Hoffmann-La Roche in both the US and Switzerland and 15 years as Vice-President of Medicinal Chemical Research and Development at Synthelabo S.A. in France. Dr. Wick continues to serve as a Director of a number of global pharmaceutical companies.
Dr. Wick is an organic chemist with a PhD degree in synthetic organic chemistry from the Swiss Institute of Technology (Zurich) and completed post-doctoral studies at Harvard University (Cambridge, Massachusetts).
“I am honored to have the opportunity to be President of Dragon,” said Dr. Wick. “On behalf of Dragon’s Board of Directors, I wish to express our sincere appreciation to both Dr. Liu and Dr. Cai for their leadership in building a strong foundation and positioning Dragon to become a major supplier of high quality therapeutic proteins. I am very much looking forward to working with the Board and management team towards the Company’s future success.”
About Dragon Pharmaceuticals
Dragon Pharmaceuticals Inc. is a fully integrated, international biopharmaceutical corporation engaged in the discovery, development and commercialization of genetically engineered human proteins for therapeutic use. Based on its proprietary protein expression technology, Dragon believes that it has become one of the world’s lowest cost producers of Erythropoietin (EPO) ?a breakthrough drug that has revolutionized the treatment of severe anemia with estimated worldwide sales of US$6 billion in 2001. Dragon is also applying its platform technology to the development of other branded as well as novel protein drugs.
Cautionary Statement for Purposes of the “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995: All statements, other than historical facts, included in the foregoing press release are forward-looking statements. These statements are based on management’s beliefs and assumptions, and on information currently available to management. Forward-looking statements are not guarantees of future performance. They involve risk, uncertainties and assumptions including risks discussed under “Risks Associated With Dragon Pharmaceuticals” in the Company’s annual report on Form 10-K, SEC File No.: 0-27937, all of which are incorporated herein by reference. The Company does not undertake the obligation to publicly revise these forward-looking statements to reflect subsequent events or circumstances.
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Dragon Reports 70% Increase in Second Quarter Revenues
Dragon Pharmaceuticals Inc. (TSX: DDD; OTC BB: DRUG) today announced results for the three-month and six-month periods ending June 30 2002. For greater detail, please refer to the Company’s 10-QSB, which has been filed with the U.S. Securities and Exchange Commission and the Ontario Securities Commission. The full financial statements will also be available on Dragon’s website at www.dragon-pharma.org. The Company’s financial statements comply with U.S. GAAP (Generally Accepted Accounting Principles) and all dollar amounts are expressed in U.S. currency.
During the quarter, the Company posted revenues of $1.03 million, up more than 70% from revenues of $602,341 in the second quarter of 2001. The Company’s revenues are derived from sales of EPO, which is currently approved and marketed for use in the treatment of anemia related to chronic renal failure in China, India, Egypt and Peru. Revenues of $826,659 were generated from sales in China and $199,500 from sales in other developing countries. Gross profit margin rose to 83% from 74% in the same period last year, due to improved production efficiency.
For the second quarter 2002, operating expenses were $2.69 million, up from $1.54 million from the same period last year, largely due to an increased investment in Research and Development efforts. Research expenses were $1.02 million in the second quarter 2002 compared to just $26,537 for the comparable period a year ago. These expenses included $750,000 to fund preclinical studies for the Company’s insulin project and $250,000 for the development of the G-CSF project. Total contracted development costs for the insulin and G-CSF projects, from cell line development through to preclinical and clinical studies and submission to the SDA for drug licenses, are expected to be $2.5 million and $2.0 million respectively.
Net loss was $1.82 million, or $0.09 per share, compared to a loss of $972,713, or $0.06 per share, for the second quarter of fiscal 2001.
For the six-month period, revenues in 2002 doubled to $2.40 million. Net loss for the first six months of 2002 was $2.76 million ($0.14 per share) compared to a loss of $1.83 million ($0.11 per share) for the six months ended June 30, 2001.
“While we remain confident that revenues for 2002 will increase at least 100% over 2001 revenues of $3.1 million, we anticipate that sales revenues for the year will be lower than previously forecast due to generally weaker market conditions and delayed product approvals resulting from increasing regulatory requirements in several key countries,” said Dr. Longbin Liu, President and CEO. “Dragon is complying with the regulatory changes and fully expects to successfully complete product registrations and subsequently launch EPO in these markets.”
As previously announced, during the quarter Dragon began trading on the Toronto Stock Exchange, under the symbol DDD. Listing on a senior stock exchange should help the Company gain an institutional following and raise its profile in the Canadian investment community.
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Dragon Posts 106% Increase in First Quarter Revenues
D For greater detail, please refer to the Company’s 10-QSB, which has been filed with the U.S. Securities and Exchange Commission. The full financial statements will also be available on Dragon’s website at www.dragon-pharma.org. All dollar amounts are expressed in U.S. currency.
- Generated revenues of $1.37 million, up 106% from Q1 2001
- Submitted SDA application for marketing approval of EPO in surgical patients
- Acquired remaining 25% of GMP-certified manufacturing facility in Nanjing, China
- Obtained a TSX listing under the symbol ‘DDD’ subsequent to quarter-end
“This quarter marks the first time that EPO sales outside of China have surpassed Chinese sales,” said Dr. Longbin Liu, President and CEO. “While maintaining our 30% market share position in China’s EPO market, we have successfully diversified our customer base and expanded our international presence by marketing our lead product in other developing countries. Our current distribution licenses cover over 90 countries and we expect key approvals to come on line throughout the year, leading to continued growth in international sales.”
Dragon’s EPO is currently approved and marketed for use in the treatment of anemia related to chronic renal failure in China, India, Egypt and Peru. During the quarter, the Company submitted its application to the Chinese State Drug Administration (SDA) for the use of EPO in surgical patients and expects to receive a New Drug License in China for this indication shortly.
“Use of EPO for surgical indications is a key step in the development and marketing of our lead product,” said Dr. Liu. “We expect the surgical indication to really expand our potential market in many countries. Additionally, we are working on a chemotherapy-related indication for EPO, for which we expect to complete Phase III clinical trials late in 2002.”
During the quarter, Dragon acquired the remaining 25% equity interest in its GMP-certified production facility located in Nanjing, China. The acquisition will allow Dragon to meet the growing demand for its commercially available therapeutic protein, EPO, and expedite the development of other pipeline products.
Subsequent to quarter-end, Dragon began trading on the Toronto Stock Exchange on May 9, 2002 under the symbol DDD. Listing on a senior stock exchange should help the Company gain an institutional following and raise its profile in the Canadian investment community.
Revenues for the first quarter totalled $1.37 million, an increase of over 106% from $664,000 in the first quarter 2001. Gross profit margin rose to 86% from 78% of the same period last year. The significant increase in gross profit margin is mainly due to the economies of scale the company achieved over the year.
Operating expenses for the first quarter 2002 were $2.15 million, up from $1.54 million from the same period last year, largely due to increased investment in Research and Development efforts.
Net loss for the period was $938,000, or $0.05 per share, compared to $856,000, or $0.05 per share, for the first three months of fiscal 2001.
“With the anticipated growth of our top line revenues, we expect to see significant improvement to our bottom line,” said Dr. Liu. “In addition to obtaining additional international marketing approvals as well as regulatory approvals for new applications of our EPO, our upcoming development efforts will focus on commercializing the additional protein therapeutics in our product pipeline.”
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Dragon Acquires Remaining 25 % of Nanjing Huaxin Biopharmaceutical Co., Ltd.
Dragon Pharmaceuticals Inc. (OTCBB :DRUG.OB) announces that it has acquired the remaining 25% of equity interest in Nanjing Huaxin Bio-pharmaceutical Co., Ltd. (“Huaxin”), an integrated biotech company with a GMP-certified production facility located in Nanjing, China. Combined with the 75% interest acquired in 1999, Dragon now owns 100% of Huaxin. The acquisition reaffirms Dragon’s current commitment to Huaxin and will allow Dragon to meet the growing demand for its commercially available therapeutic protein, Epoetin-Alfa (EPO), and expedite the development of other pipeline products. Dragon acquired the remaining 25% interest in Huaxin for US $1.4 million.
Dragon also reports the progress of other products under development including thrombopoietin (TPO), granulocyte-colony stimulating factor (G-CSF), human insulin, slow-release EPO and Hepatitis B vaccine.
TPO is a protein that is produced mainly by the liver to stimulate the production of platelets by bone marrow. Dragon is optimizing its TPO cell lines and intends to complete all pre-clinical testing in 2002.
G-CSF stimulates the bone marrow to produce white blood cells that help fight infection and disease. Dragon recently completed the G-CSF cell line development. Worldwide annual sales for G-CSF are over US $1 billion.
Insulin is a peptide hormone secreted by the pancreas that allows the body to regulate blood sugar levels. Dragon has developed a Pichia yeast cell line for insulin and is set to begin animal studies and other pre-clinical testing. Annual global sales of recombinant human insulin are over US $3 billion.
Both conventional and slow-release EPO stimulate red blood cell production in patients with anemia related to kidney failure, chemotherapy and surgery. Slow-release EPO has the added advantage of requiring significantly fewer doses than conventional EPO. Dragon is currently working with Renapharm AB of Sweden and Transworld Pharmaceuticals of Portugal to finalize the formulation for the slow-release product and expects to enter human clinical trials in 2003.
Dragon’s acquisition of the remaining 25% in Huaxin reflects the Board of Directors’ current commitment to produce and market EPO as well as to develop the products discussed above. As a result of this commitment, the Board of Directors has decided not to pursue the Hepatitis B vaccine project with Alphatech Bioengineering Limited. Because Dragon has decided not to pursue this project, it will be repaid the US $4 million purchase price with interest.
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Dragon Lists on the TSX Under Symbol ‘DDD’
Dragon Pharmaceuticals Inc. is pleased to announce that it has received final approval from the Toronto Stock Exchange (TSX) for listing the Company’s shares on the TSX. The shares will be traded under the symbol DDD commencing today. Dragon’s shares will continue to trade on the NASDAQ OTC BB under the symbol DRUG. Maison Placements Canada, Inc. acted as the sponsor for the Company’s TSX listing.
“This is a tremendous step for us as we seek to raise our corporate profile in the investment community,” said Longbin Liu, CEO of Dragon. “Our listing on the TSX will significantly support our efforts to increase the institutional following of our company.”
The TSX has listed Dragon as a technology company. Dragon has developed a proprietary DNA vector technology platform that can be used to construct a wide range of recombinant, or genetically engineered, human protein cell lines. The cell lines developed with Dragon’s technology are capable of producing, at commercial volumes, premium quality proteins at exceptionally high yields and low per unit production costs.
Dragon has validated its proprietary technology platform with the commercial production of Epoetin Alfa (EPO) at the Company’s GMP-certified manufacturing facility in Nanjing, China. Dragon is one of the world’s largest producers of EPO, and is marketing the product in China, Egypt, India and Peru for use in anemia related to chronic renal failure. The Company has initiated, through its 11 international licensees, regulatory submissions for marketing approval throughout Central and Eastern Europe, Southeast Asia, Latin America and the Middle East. Dragon has completed clinical trials and submitted its application to the Chinese State Drug Administration for use of EPO in surgery-related anemia and is currently conducting Phase II/III clinical trials in chemotherapy-related anemia.
The Company is applying its technology platform to other drugs in its development pipeline, which include slow-release EPO, thrombopoietin, granulocyte-colony stimulating factor, and insulin, as well as to its novel drug discovery candidates.
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Dragon Releases 2001 Year End Results
Dragon Pharmaceuticals Inc. (OTC BB: DRUG) today announced results for the three-month and twelve-month periods ending December 31, 2001. All dollar amounts are expressed in U.S. currency. For greater detail, please refer to the Company’s 10-K for fiscal 2001, which has been filed with the U.S. Securities and Exchange Commission.
- Generated revenues of $3.1 million
- Produced 3.3 million doses of EPO
- Maintained 30% share of the Chinese EPO market
- Launched EPO internationally in India, Egypt and Peru
- Initiated regulatory approvals for EPO throughout licensed, international territories
- Completed multi-centre Phase II/III clinical trial for use of EPO in surgical patients
- Initiated multi-centre Phase II/III clinical trial for use of EPO in chemotherapy patients
- Acquired rights to a novel, slow-release formulation of EPO
- Completed $7 million private placement financing
“Probably the most significant development for Dragon in fiscal 2001 was the regulatory approval and subsequent sale of our EPO in international markets outside of China. We anticipate strong growth in international sales as we obtain additional product approvals throughout global, non-patent protected territories,” said Dr. Longbin Liu, President and CEO.
In 2001, Dragon further established itself as one of the lowest cost producers of generic EPO. Investment into additional production infrastructure and process improvements in 2001 reduced average direct cost of production by 58% from fiscal 2000.
Dragon maintained its 30% share of the Chinese EPO market. The Company anticipates significant expansion of the EPO market in China with the upcoming finalization of a new health insurance plan, which is expected to include mandatory coverage for dialysis treatments.
The Company has entered into a series of marketing and license agreements with 11 partners, covering non-patent protected countries around the world. The Company’s regional pharmaceutical licensees initiated product registration applications for EPO in key markets in Central and Eastern Europe, Southeast Asia, Latin America and the Middle East. Approvals were received in Egypt, India, and Peru and sales were initiated in all three countries in 2001. Additional approvals are expected in 2002.
In 2001, Dragon completed pivotal Phase II/III clinical trials for EPO for use in anemia related to surgery and expects to receive Chinese governmental approval for this indication in 2002. Additionally, the Company initiated multi-centre Phase II/III clinical trails for the use of EPO in chemotherapy patients and expects to complete these trials in 2002.
During the year, Dragon entered a co-development agreement for a novel, slow-release formulation of EPO with Transworld Pharmaceuticals Corp. of Portugal and Renapharm AB of Sweden. Under the agreement, Dragon has sole worldwide manufacturing rights and exclusive marketing rights to Asia, including Japan. A pilot clinical trial indicated that monthly administration of the slow-release formulation had the same therapeutic effect as four times per week conventional EPO.
Revenues for the fourth quarter totalled $1.0 million, up from $978,000 in the same period in 2000. Net loss for the quarter was $1.2 million, or $0.07 per share, an improvement over the net loss of $2.0 million, or $0.11 per share in the fourth quarter 2000.
Revenues for the year were $3.1 million, down from $3.2 million in fiscal 2000. Although revenues decreased slightly, the number of doses sold increased 53% compared to the previous year. Revenues did not increase proportionately to sales volumes due to competitive EPO price reductions in China over the past year.
Selling, general and administrative expenses increased to $5.3 million from $4.0 million in 2000. Higher expenses in 2001 reflect increased salaries as head office personnel quadrupled. Additionally, the Company incurred significantly higher expenses in the areas of international travel and investor relations.
The loss for the year was $3.7 million or $0.21 per share, compared to $2.7 million or $0.17 per share in fiscal 2000.
On September 14, 2001, Dragon closed a private placement raising $7.0 million through the issuance of 3.5 million common shares at a price of $2.00 per share.
“We expect to post a profit in 2002,” said Dr. Liu. “We are already seeing clear growth in international sales from markets outside China, with international sales orders totaling $937,500 in the first quarter of 2002 alone. In addition to penetrating new international markets, we are expanding our EPO applications to include surgery and chemotherapy, and continue to work towards commercializing the generic biologic drugs in our development pipeline.”
Note: The term “dose” refers to the standard reference dosage of 2,000 IU.
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Dragon Announces Growth in International EPO Sales
Dragon Pharmaceuticals Inc. (NASDAQ OTC: DRUG) today announced the receipt of EPO sales orders from international markets outside of China totaling $937,500 in the first quarter of 2002, representing a 113% increase over total year international sales of $440,125 in 2001. To date, the Company has completed EPO shipments for $847,500 of first quarter orders, and expects to deliver the remaining orders valued at $90,000 next month. All dollar amounts are stated in US dollars.
“In just a few short months, we are seeing clear growth in international sales, which we define as sales from countries other than China,” said Dr. Longbin Liu, President and CEO of Dragon Pharmaceuticals. “To expand our sales base beyond China, where we hold a 30% market share position, we focused in 2001 on establishing distribution partnerships and regulatory product approvals throughout the developing world markets. We have thus far received product approvals in Egypt, India and Peru and expect to see a substantial increase in international sales as additional key approvals come on stream throughout 2002.”
Dragon and its distributors are currently seeking additional regulatory approvals throughout Central and Eastern Europe, Southeast Asia, Latin America and the Middle East.
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Dragon Ships EPO Internationally
Dragon Pharmaceuticals Inc. (NASDAQ OTC: DRUG) today announced that it has filled orders for recombinant erythropoietin (EPO) from Egypt, India and Peru where, in addition to China, the Company’s EPO is approved for use in the treatment of anemia related to chronic renal failure. All dollar amounts are stated in US dollars.
“Penetrating new markets with EPO, our lead product, is key to accelerating revenue growth,” said Longbin Liu, President and CEO of Dragon Pharmaceuticals. “We have secured licensing agreements with 11 distribution partners covering more than 90 countries globally and we expect to receive additional product registration approvals throughout the year. These initial shipments mark the beginning of a strong international presence for Dragon’s EPO.”
On December 31, 2001, Dragon delivered $187,000 of EPO to its licensee for the Middle East, Amoun Pharmaceuticals Ltd, for distribution in Egypt. Total EPO shipments to Egypt for the year amounted to $262,500.
A $60,000 order of EPO was shipped to Emcure Pharmaceuticals Ltd. in India last week. Emcure intends to formally launch EPO in India later this month, after which additional orders are expected to follow.
During 2001, Dragon was awarded two national hospital tenders for EPO in Peru, totalling $195,750. The first of these orders was delivered in November 2001 to Laboratorios AC Farma SA de CV, Dragon’s Peruvian licensee, for receipts of $11,000. The remaining order, valued at $184,750, will be shipped in February.
Dragon and its licensees are currently seeking regulatory approval for the marketing of the Company’s EPO throughout Central and Eastern Europe, Southeast Asia, Latin America and the Middle East.
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