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.