Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG) announced results for the three-month period ending March 31, 2003. During the quarter, the Company posted revenues of $664,322 from the sales of rHu Erythropoietin (EPO), which is currently approved and marketed for use in the treatment of anemia related to chronic renal failure and surgery patients in China, India, Egypt, Peru and Brazil.
Revenues of $454,347 were generated from sales in China and $209,975 from sales in other countries compared to $525,308 in China and $847,500 sales outside of China, which included one-time revenue of $700,000 bulk EPO for the same period in 2002.
The gross profit margin was 70% for the first quarter of 2003 compared to 86% for the same period in 2002 due to the fact that the Company sold some products with short-term expiry dates at a reduced price.
Operating expenses for the quarter in 2003 were $1.2 million, down from $2.2 million from the same period last year reflecting the results of our continued efforts to streamline our operations.
Net loss for the quarter in 2003 was $734,027, or $0.04 per share, compared to a loss of $937,878, or $0.05 per share, for the first quarter of 2002.
“Subsequent to the quarter end, the Company has received market approval from the Chinese State Drug Administration (SDA) for the use of our EPO in surgical patients in China and a new dosage presentation of 6000 IU. This will expand the market opportunities for our products in the existing approved countries”, said Dr. Alexander Wick, President of Dragon Pharmaceutical Inc. “Given the seasonality nature of the business which is typically slower in the first quarter than the rest of the year, we are confident that the company is still on track to achieve break-even in 2003.”
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Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG) today announced that it has received market approval from the Chinese State Drug Administration (SDA) for the use of rHu Erythropoietin (EPO) in surgical patients in China and a new dosage presentation of 6000 IU which will be used for this new indication. Prior to receiving this additional approval in China, Dragon’s EPO has already been approved and marketed for use in the treatment of anemia related to chronic renal failure in China and for both indications in India, Egypt, Peru and Brazil.
Many patients undergoing surgery are concerned about blood loss. To combat blood loss during surgery, patients can receive a blood transfusion from banked blood supplies, donate their own blood before surgery for transfusion or build up their supply of red blood cells prior to surgery. With greater convenience and no risk of blood-borne contaminants or incompatibility, Dragon’s EPO helps increase the body’s natural supply of erythropoietin, a protein made in the kidneys that is critical to red blood cell production and stimulates bone marrow to produce progenitor cells, which mature into red blood cells.
Like many other advanced regulatory bodies, Chinese SDA has strict requirements for manufacturers of EPO to conduct extensive clinical studies prior to issuance of approval for its use in treating additional indications. This is to ensure the safety and efficacy of the product in the high therapeutic dosages associated with the indication.
The dosage required for surgical patients is usually many times higher than the use in treating anemia associated with chronic renal failure. The approval will expand the market opportunities for Dragon’s EPO in the existing approved countries. “We are confident that Dragon’s competitive cost advantages, its clinically tested EPO at proper dosages for surgery indication and the distribution network in 136 countries built by our licensees will enable Dragon to capture the additional market opportunities as a result of the new approval.” said, Dr. Wick, President of Dragon. “In addition to the approved indications for use in the treatment of anemia related to chronic renal failure and surgical patients, we are also actively pursuing clinical trials for cancer radio and chemotherapy patients in China. Dragon intends to submit a market approval application to the Chinese SDA in 2003 together with the new 10000 IU dosage that will be used in association with this new indication.”
About Dragon Pharmaceutical Inc.
Dragon Pharmaceutical Inc. is an 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 most competitive producers of EPO, a breakthrough drug that has revolutionized the treatment of anemia. Dragon is also applying its platform technology to the development of other generic and novel protein drugs.
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Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG) today announced results for the three-month and twelve-month periods ending December 31, 2002.
- Generated revenues of $7.36 million, representing significant growth from $3.07 million in 2001.
- Enhancement of gross margin in 2002 to 86.7% from 81% in 2001.
- Reported a first ever operating profit of $118,968 in 2002 compared to an operating loss of $4.02 million in 2001 for the Company’s principal Erythropoietin Alfa (“EPO” business.
- Net loss in 2002 was $5.25 million or $0.26 per share, compared to $3.98 million or $0.21 per share in 2001, reflecting the increase in research and development efforts in pipeline products, particularly Insulin and G-CSF and Company’s decision to write down the repayment of the Hepatitis B Vaccine project to a nominal value of $100 from $3.29 million.
- Announced continued realignment and strengthening of the Management team and organization with the appointment of Dr. Alexander Wick as the new President and subsequent to year-end, Mr. James Harris III as the Vice President of Sales and Marketing.
- Obtained a Toronto Stock Exchange (“TSX”) listing under the symbol ‘DDD’
- Added three new Licensees to fourteen Licensees internationally covering 136 countries worldwide.
- Submitted an application for marketing approval of EPO in surgical patients and new dosage of 6000IU for the new indication to the Chinese State Drug Administration (“SDA”)
- Delivered a landmark order for supplying bulk EPO to a major pharmaceutical company for research purposes.
Fourth Quarter of 2002
During the quarter, the Company posted revenues of $1.19 million, a 16% increase from the same period in 2001. We continued to record improvement in gross margin for the quarter in 2002, which was at 87.1%, up from 83.6% recorded for the same period in 2001. Net loss from the quarter was $4.11 million, or $0.20 per share, compared to the net loss of $1.17 million, or $0.07 per share in the fourth quarter in 2001. (See Write off of Hepatitis B Vaccine Project below)
Full Year of 2002
Revenues in 2002 were $7.36 million, representing a very significant increase from the $3.07 million revenues of 2001. Sales in China and outside of China were $3,002,898 and $4,359,350, respectively for 2002 compared to $2,630,182 and $443,703, respectively for 2001. The sales outside of China during 2002 primarily increased due to a breakthrough order worth $3.7 million to a major pharmaceutical company for new drug research and development.
Gross Margin for full year 2002 was 86.7% presenting 570 basis points improvement from 2001, which is mainly due to the efficiency gained from the continued upgrade and improvement invested in the existing cGMP (current Good Manufacturing Practices) production facility in Nanjing, China.
The Company recorded an operating profit of $118,968 in 2002 compared to the operating loss of $4.02 million in 2001 for the Company’s principal business in EPO, reflecting the significant $3.7 million order to the major pharmaceutical company. Net loss of 2002 was $5.25 million or $0.26 per share compared to $3.98 million or $0.21 per share in 2001. The main reasons for the large loss recorded were the Company’s research and development expenses in Insulin and G-CSF and the decision to write-down $3.29 million owed by Dr. Liu, the Chairman of the Company, for the repayment of the Hepatitis B Vaccine project. Pursuant to an agreement dated June 5, 2001, Dr. Liu exercised his right to repurchase the Hepatitis B Vaccine project for the original purchase price of $4.0 million. Dr. Liu paid $0.5 million, with the balance of $3.5 million (which was written down to the book value of $3.29 million), due in September 2003. Although Dr. Liu has reaffirmed his intention to pay the amount owing plus accrued interest, when due, the Company chose to conservatively write down the amount owing due to the significant amount involved and the lack of security.
“I am delighted to announce the remarkable growth of revenue, continued enhancement of gross profit margin and more importantly, the first ever operating profit recorded for our EPO business. Based on the solid foundation we built up over the last four years, we continued to demonstrate strong execution of business opportunities that enhances the growth in revenue and improvement of margin and profitability throughout 2002.” said, Dr. Wick, President of Dragon Pharmaceutical Inc. “In 2003, we will continue to capture existing and future opportunities to achieve our stated goal of turning profitable for the year.”
Following the appointment of Dr. Alexander Wick as the President of Dragon in October, 2002, we announced the appointment of Mr. James Harris III, a 22-year veteran in the biotech and pharmaceuticals industry, as the Vice President of Sales and Marketing in early 2003. “We will continue to strengthen the management team and organization and are determined to realign the Company resources to meet our corporate objectives in 2003.” said, Dr. Wick.
As previously announced, during the second quarter of 2002, Dragon received approval and began trading on the Toronto Stock Exchange, under the symbol “DDD” Listing on a senior stock exchange not only raises our corporate profile in the investment community but also support our efforts to increase the institutional following of our Company.
Sales and Marketing Review
In 2002, Dragon’s EPO was approved and marketed for use in the treatment of anemia related to chronic renal failure in China, India, Egypt and Peru. Subsequent to the year end, we received approval and began our first shipment of order to Brazil. We also added three international Licensees during 2002, which brings the total number of Licensees to fourteen, covering 136 countries worldwide.
During the year, we have submitted an application to the Chinese State Drug Administration for the use of EPO in surgical patients as well as approval for a new dosage of 6000IU, which will be used for this new indication. Furthermore, clinical trials are on-going for cancer radio and chemotherapy patients in China. These data will be submitted to the SDA for approval in 2003 together with the new 10000 IU dosage. “In addition to obtaining additional international market approvals in several key markets in 2003, we anticipate to receive a new drug license in China for the new indication as well as the new dosage shortly.” said Dr. Wick.
Year 2002 marked a remarkable breakthrough for Dragon when the Company successfully entered the bulk EPO market for drug research and development purposes other than in the field of anemia with a $3.7 million order from a well established pharmaceutical company. During 2003, Dragon will continue to actively pursue the market opportunities in the highly prospective bulk EPO and EPO derivatives market.
“2003 is going to be an important milestone year in Dragon’s corporate history. Based on the new business strategies as well as the continued competitive advantages that we enjoy in China, we are confident that the Company will achieve profitability this year.” said Dr. Wick. “In addition to profitable EPO sales, one of the other long term potentials for Dragon relies with the successful outcome of our research partners’ ability to develop new applications for our EPO and to demonstrate the therapeutic validity of these new indications.”
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Dragon Pharmaceuticals Inc. (TSX: DDD; OTC BB: DRUG) is pleased to announce that it has appointed James Harris as VP of Sales and Marketing, replacing Robert Walsh. He will be responsible for increasing the company’s sales and marketing effort in our existing markets outside of China (India, Egypt, Peru and Brazil) and accelerating the introduction of Dragon’s erythropoietin in the other out licensed markets, which cover most of the territories outside Europe, North America and Japan. He will also prepare the company for entry into the European market.
Mr. Harris has over 22 years of experience within the above field in several capacities of increasing responsibility. Prior to Dragon, Mr. Harris has been a consultant in biotech and pharmaceuticals, and he has worked with various firms ranging from large multinationals to small generic companies. Mr. Harris spent eight years with Amgen most recently as a National Accounts Manager and ten years with Bayer in various sales and marketing capacities.
Mr. Harris has been associated with numerous major product launches, including the launches of EPO(Epogen?, GCSF(Neupogen?, and Intravenous Immune Globulin, IVIG (Gamimune?. He has also assisted the field sales organization with training and development efforts.
He also serves as the Assistant Area Chair Department of Graduate Business and Management at the University of Phoenix. Mr. Harris obtained a B.A. in Political Science from Wright State University and an M.B.A., in Finance from Long Island University.
Dr. Wick, President of Dragon Pharmaceuticals said, “James Harris brings to Dragon the extensive sales and marketing experience necessary to further develop our international sales. We are excited to have him as part of the company.”
Robert Walsh has been appointed as Director of Corporate Development, an area in which he has had a keen interest since beginning with Dragon three years ago.
“I am pleased to fill this position with a staff member who is experienced, very knowledgeable in the field of technology and, more specifically, in all aspects of erythropoietin”,said Dr. Wick, “I am determined to realign the company resources to meet our objective of profitability in 2003. This change in management is a clear signal of how we are meeting the identified priorities and the dynamics with which the company is determined to confront the future.”
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Dragon Pharmaceuticals Inc. (OTC BB: DRUG; TSX: DDD) today announced that it has shipped an order of recombinant erythropoietin (“EPO? to Itaca Laboratorios Ltda., (“Itaca” of Brazil.
Itaca, a distribution partner of the company, has won a 3.1 million Brazilian Real tender for Dragon’s EPO in the Brazilian state of Minas, Gerais, which converts to US$ 0.86 million (US$ 0.281057 to 1 Brazilian Real exchange rate on February 4, 2003). The first shipment to Itaca marks the launch of Dragon’s EPO into the Brazilian market.
“This order followed an audit in 2002 by the Brazilian Health Authority (“ANVISA? inspectors of Dragon’s production facility in Nanjing, China. The ANVISA audit has provided valuable feedback to the Nanjing staff as well as the Vancouver management. We have been implementing the necessary steps to elevate our facility to the highest technical and documentary standards expected for today’s biotechnology industry anywhere in the world with the help of international experts” said Dr. Alexander Wick, President of Dragon Pharmaceuticals Inc.
“Our first order in Brazil demonstrates our commitment to expanding sales into new international markets outside of China,” said Dr. Wick, “We have secured licensing agreements with fourteen distribution partners covering more than ninety countries globally and we expect to receive additional product registration approvals throughout the year.”
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Dragon Pharmaceuticals Inc. (OTC BB: DRUG; TSX: DDD) today announced that it has undertaken to reevaluate its corporate strategy following the appointment of Dr. Alexander Wick as President in October 2002. A clear focus on strengthening Dragon’s sales capacity has been decided by the company’s Executive Committee.
“Over the last four years Dragon has established a solid foundation for initiating strong revenue growth. The company has gained extensive expertise in the production of high quality proteins, which has enabled us to capture a significant portion of the Chinese EPO market.” said Dr. Wick. “We now have acquired in depth knowledge and experience in the drug approval procedures with the Chinese State Drug Administration (“SDA? and are able to minimize the cost of operations by conducting product development, clinical trials to support SDA approval, and production in China. As we built our international sales, we have become proficient with the regulatory process in these markets by partnering with established pharmaceutical companies possessing efficient regulatory and marketing expertise.?p> ?003 is going to be an important milestone in Dragon’s corporate history. Based on the new business strategies as well as the continued competitive advantages that we enjoy in China, we are confident that the company will achieve profitability this year” said Dr. Wick. “In addition to profitable EPO sales, one of the other long term blue sky potentials for Dragon relies upon the successful outcome of our research partners?ability to develop new applications for our EPO and to demonstrate the therapeutic validity of these new indications.”
In 2003 Dragon will benefit significantly from its biotechnology experience and regulatory expertise.
1. Expanding Erythropoietin opportunities:
- The company is finalizing product registration and approval of its EPO for surgery and cancer chemotherapy use in China. New dosage strengths will become available following these approvals.
- Dragon will continue to actively pursue the market opportunities in the highly prospective bulk EPO market. Year 2002 marked a remarkable breakthrough for Dragon when the company successfully entered the bulk EPO market for drug research and development purposes. The company recorded a $3.7 million order from a well established pharmaceutical company for research and development last year.
- Successful completion of product registrations and the subsequent launch of EPO in several additional markets are expected. Dragon has partnered with 14 international licensees for the distribution of EPO throughout Central and Eastern Europe, Asia, Latin America, Africa and the Middle East.
- The development of a slow release formulation of our EPO in collaboration with the Swedish firm Bohus BioTech AB is actively being pursued.
2. In-licensing International Products into China:
In 2003, Dragon is undertaking steps to in-license several high-potential third party pharmaceutical products and market through its own sales channels in China. Dragon will capitalize on the efficiencies of the SDA’s clinical trial and regulatory drug approval system by seeking product approvals in China for international pharmaceutical companies.
3. Out-licensing Chinese Products to International Markets:
Dragon will add other Chinese pharmaceutical products to its international distribution network by using its combined regulatory and marketing expertise for approvals.
“To build on our momentum we will further enhance the management team and secure more valuable product lines. Based on the new opportunities, as well as the continued competitive advantages that we enjoy in China, we are confident that the company will achieve our goals this year.” said, Dr. Wick, “Dragon will enjoy a tremendous long-term potential by developing new EPO applications with other research partners.”
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Dragon Pharmaceuticals Inc. (TSX: DDD; OTC BB: DRUG) today announced results for the three-month and nine-month periods ending September 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 $3.8 million, a significant increase from revenues of $787,682 in the third quarter of 2001. The majority of the revenue comes from a single $3 million order for drug development. The balance of 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 $745,000 were generated from sales in China and $3.03 million from sales in other countries.
For the third quarter 2002, operating expenses were $1.7 million, up from $1.5 million from the same period last year, largely due to an increased investment in Research and Development efforts. Research expenses were $350,003 in the third quarter 2002 compared to $9,037 for the comparable period a year ago. These expenses included $100,000 for accelerating the development of the Company’s insulin project and $250,000 for the development of the G-CSF project.
Net profit was $1.6 million, or $0.08 per share, compared to a loss of $737,782, or $0.04 per share, for the third quarter of fiscal 2001.
For the nine-month period, revenues in 2002 more than tripled to $6.2 million. Net loss for the first nine months of 2002 was $1.1 million ($0.06 per share) compared to a loss of $2.6 million ($0.15 per share) for the nine months ended September 30, 2001.
“We are pleased that we have achieved an impressive growth for the quarter” said Dr. Alexander Wick, Dragon’s newly appointed President. “The third quarter revenues include the sale of our recombinant Erythropoietin (EPO) to a well-established pharmaceutical company for drug research and development purposes. The sale marks the break-through of selling our EPO to pharmaceutical companies for research purposes, a new potential business segment that we are actively exploring. This pharmaceutical company conducted extensive due diligence prior to selecting our EPO. Their order represents a strong endorsement of the quality of our product.”
Dragon also announced that it has signed up three new distribution partners, bringing the total number of licensing agreements to fourteen. The new distribution partners are:
- Al-Mak Flower, Inc. covering Macedonia, Kosovo and Albania;
- P.T. Ikapharmindo Putramas Healthcare, Ltd. covering Indonesia; and
- Biogenetech Co., Ltd. covering Thailand, Vietnam, Burma, Laos, Cambodia and the Philippines
“We are pleased to welcome these three new partners on board. We now have licensing agreements in place covering essentially all of the non-patented countries,” said Dr. Wick. “Although our current focus remains on sales in the developing world, we are actively preparing ourselves to enter the European market upon the expiry of the patent.”
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Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG; BBSE: DRP) is pleased to announce the results for the second quarter ended June 30, 2004.
For the three-month ended June 30, 2004 During the second quarter in 2004, the Company posted revenues of $908,145 from the sales of rHu Erythropoietin (EPO) compared to $1,007,686 for the same period of the prior year. Revenues of $657,645 were generated in China and $250,500 from outside of China during the second quarter of 2004 compared to $576,894 in China and $430,792 from outside of China for the same period in 2003. The gross profit margin was 79% for the period in 2004, improved from the gross margin of 68% for the same period in 2003.
Net loss for the second quarter in 2004 was $388,004 or $0.02 per share, compared to a net loss of $236,424, or $0.01 per share, for the same period in 2003. The increase in net loss for the second quarter in 2004 was mainly due to an increase in research and development expenses for the EPO product developed for the European market.
For the six-month ended June 30, 2004 Revenues for the six-month period in 2004 were $1.79 million, up from $1.67 million from the same period in 2003. Sales in and outside of China were $1.36 million and $0.43 million respectively during the period in 2004 compared to $1.03 million in China and $0.64 million outside of China for the same period in 2003. The gross profit margin was 75% for the period of 2004, improved from 68% for the same period in 2003. Net loss for the period of 2004 was $0.64 million or $0.03 per share compared to a loss of $0.97 million or $0.05 per share for the same period in 2003, reflecting the results of effective cost control measures and a leaner corporate structure.
During the second quarter of 2004, Dragon announced entering into a definitive agreement to acquire Oriental Wave Holdings Ltd. The proposed acquisition is subject to a number of conditions including regulatory and shareholders’ approval. If the proposed acquisition is consummated, Oriental Wave will become a wholly owned subsidiary of Dragon and the combined company, headquartered in Vancouver, Canada, will have approximately 1,800 employees worldwide plus over 1,200 sales representatives in China. In addition, the acquisition of Oriental Wave by Dragon will create a competitive and growth oriented pharmaceutical company focusing on major growth sectors of the global pharmaceutical industry, namely, generic drugs (prescription and over-the-counter generic drugs), bulk pharmaceutical chemicals (Clavulanic Acid, 7-ACA and sterilized bulk drugs) and biotech drugs (EPO and in-licensed G-CSF).
“We are pleased with the progress we have accomplished so far in 2004. On one hand, we have achieved operational improvement with an increase in gross profit margin. On the other hand, we have received regulatory approval for the sale of our EPO product in Ecuador in addition to China, India, Egypt, Brazil and Peru. At the same time, we are investing in our future by expanding our research and development efforts for our anticipated EPO product specifically designed for the European market to ensure Dragon a timely entry to this prominent market” said Dr. Alexander Wick, President and CEO of Dragon Pharmaceutical Inc. “However, probably the most important and exciting news for Dragon during the quarter was that Dragon has entered into a definitive agreement to acquire Oriental Wave Holdings Ltd. Now, with a Registration Statement on Form S-4, relating to the acquisition of Oriental Wave filed with the U.S. Securities and Exchanges Commission, we are currently targeting to have the proposed acquisition completed during the fourth quarter of 2004. While we are very pleased with the progress of the proposed acquisition, we look forward to completing the acquisition process as soon as possible so that the combined company will start generating the anticipated benefits as a result of the business combination.”
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Dragon Announces Receiving Common Shares in Escrow from Dr. Liu pursuant to the Settlement Agreement
Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG; BBSE: DRP) today announced that 2.23 million common shares of the Company have been placed in escrow by Dr. Liu, a director of the Company, to secure the debt obligation to the Company pursuant to the Settlement Agreement among Dragon, Dr. Liu and Novagen Holding Inc., Dr. Liu’s associated research company.
With the Settlement Agreement as announced on April 22, 2004, Dragon decided not to pursue the research projects on G-CSF, insulin and a patent project with Dr. Liu and his associated research partners in exchange for Dragon to receive $1.33 million reimbursement of expenses. In addition, the 1 million warrants granted to Dr. Liu for the patent development project are also cancelled. Together with the $3.71 million of principal and interest owing under the Hepatitis B vaccine project, Dr. Liu will pay Dragon a total of $5.04 million, which will be due on December 31, 2004. It was a condition of the Settlement Agreement that 2.2 million common shares of the Company be placed in escrow by June 30, 2004 and such condition has been fulfilled.
“The Settlement Agreement signified a milestone for Dragon to finally move on and disengage itself from any related party transaction and potential conflict of interest in the future. We believe that the settlement will prove to have a positive impact on the Company in the long run especially as we have just announced entering into a definitive agreement to acquire Oriental Wave Holding Ltd. The Company can now concentrate on what is important to create better shareholders value by focusing on growth at both top and bottom lines.” said Dr. Alexander Wick, President and CEO of Dragon.
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Dragon Pharmaceutical Inc. (TSX: DDD, OTC BB: DRUG) announced today that it has learned that Dragon’s stock has been traded on the Berlin-Bremen Stock Exchange without any prior knowledge from the Company. Based on the press releases from many other companies on the Over-the-counter Bulletin Board, we believe that many companies have encountered the same situation and are in the process of addressing it.
“Immediately upon learning of this fact, we have contacted the Berlin-Bremen Stock Exchange in Germany to inquire about the source of the trading of Dragon’s stock on such exchange. Dragon’s shareholders can be assured that the Company will investigate further to determine whether such trading of its stock on the Berlin-Bremen Stock Exchange has any impact on the Company and we will take appropriate action to make sure it is in the best interest of our shareholders.” said Dr. Alexander Wick, Dragon’s President and CEO.
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