NEOSTEM, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
With our acquisition of a controlling interest in Erye and expansion into China, we have transitioned from being a one-dimensional U.S. service provider with nominal revenues to being a multi-dimensional international biopharmaceutical company with current revenues and operations in three distinct segments: (i) Cell Therapy — United States; (ii) Regenerative Medicine — China; and (iii) Pharmaceutical Manufacturing — China.
Erye is constructing a new pharmaceutical manufacturing facility and began transferring its operations in January 2010. The relocation is continuing as the new production lines are completed and receive cGMP. certification through 2011. In January 2010, Eyre received notification that the SFDA approved Erye’s application for cGMP certification to manufacture solvent crystallization sterile penicillin and freeze dried raw sterile penicillin at the new facility, which provides for 50% to 100% greater manufacturing capacity, than its existing facility. Historically these lines accounted for 20% of Erye’s sales. In June 2010, Erye passed the government inspection by the SFDA to manufacture penicillin and cephalosporin powder at the new facility. The facility is fully operational with respect to these lines. Erye has now relocated 90% of its 2010 sales capacity to the new facility. The new facility is estimated to cost approximately $38 million, of which approximately $34 million has been incurred through December 31, 2010. Construction has been and will continue to be self-funded by Erye and EET, the holder of the minority joint venture interest in Erye. We have agreed for a period of another two years to reinvest in Erye approximately 90% of the net earnings we would be entitled to receive under the Joint Venture Agreement by reason of our 51% interest in Erye.
We are also engaged in other initiatives to expand our operations into China including with respect to technology licensing, establishment of stem cell processing and storage capabilities and research and clinical development. In June 2009 we established NeoStem (China) as our wholly foreign-owned subsidiary or WFOE. To comply with PRC’s foreign investment regulations regarding stem cell research and development, clinical trials and related activities, we conduct our current stem cell business in the PRC through two domestic variable interest entities (“VIEs”). We have incurred and expect to continue to incur substantial expenses in connection with our China activities.
In early 2010, Erye began relocating its operations to its new state-of-the-art manufacturing facility. While the facility is not yet operating at peak efficiency, it has already begun to see increased production from the two cGMP approved lines for the manufacturing of penicillin and cephalosporin powder for injection that have historically accounted for over 70% of Erye's revenues. At its peak, the new facility is expected to provide an increase in production capacity of more than 50% over the old facility.
Additionally, the Company has begun to generate revenues from its pipeline of licensed stem cell-based regenerative medicine therapies; a key element of NeoStem's growth strategy in both the United States and China. Recently, the local authority in charge of pricing for public medical services in China approved pricing and eligibility for patients to receive reimbursement for up to 80% of the cost of an orthopedic procedure under the new technology category being administered at a leading specialist orthopedic hospital in China. This approval is a significant milestone that the Company believes will fuel its revenues from such activities and facilitate the execution of similar arrangements with other specialist hospitals in China in the near future. see release
Stem Cell
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