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424B3
BIOTIME INC filed this Form 424B3 on 02/04/2019
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The Projections Used By Raymond James and the Forecasts used by Maxim were prepared for internal use, and were not prepared with a view toward public disclosure, or with a view toward compliance with published guidelines of the SEC regarding projections, the guidelines established by the American Institute of Certified Public Accountants for preparation and presentation of prospective financial information, or GAAP. Neither Asterias’ nor BioTime’s independent registered public accounting firm, nor any other independent accountants, have compiled, examined or performed any procedures with respect to the prospective financial information included below, or expressed any opinion or any other form of assurance with respect thereto or the achievability of the results reflected in such projections, and none of the foregoing assumes any responsibility for such information.

 

For the reasons described above, readers of this joint proxy statement/prospectus are cautioned not to rely on the Projections Used By Raymond James or the Forecasts used by Maxim as predictive of actual future events. Neither Asterias nor BioTime has made, in the Merger Agreement or otherwise, any representation to the other party, or to any other person, concerning any of the Projections Used By Raymond James or the Forecasts used by Maxim.

 

The summaries of the Projections Used By Raymond James and the Forecasts used by Maxim are not included in this joint proxy statement/prospectus in order to induce any BioTime shareholder or Asterias stockholder to vote in favor of the Merger or any of the other proposals to be voted on at either the BioTime Special Meeting or the Asterias Special Meeting.

 

The following tables present, subject to the foregoing, a summary of the Projections Used By Raymond James and the Forecasts used by Maxim:

 

Projections Used By Raymond James With Respect to the Future Operations of Asterias

 

The portion of the Projections Used By Raymond James with respect to the future operations of Asterias was prepared by Asterias management and relies on numerous estimates and assumptions including, among others:

 

  Clinical development – The model assumed clinical development of OPC1 in severe spinal cord injury and of VAC2 in non-small cell lung cancer.  The model assumed OPC1 receives approval to treat AIS-A, AIS-B, or AIS-C patients with C-5 to C-7 spinal cord injuries in the United States in 2026 and in Japan and Europe in 2028.  For VAC2, the model assumed VAC2 receives approval to treat patients with non-small cell lung cancer in the United States in 2027 and China and certain parts of Europe in 2028.  For OPC1, the model assumed an 18.8% cumulative probability success from Phase 2 to commercialization.  For VAC2, the model assumed a 12.5% cumulative probability of success from Phase 1 to commercialization.
     
  Clinical trial and process development costs – For OPC1, the model assumed confirmatory phase 2 clinical trial costs at $25 million and process development costs of approximately $12 million during phase 2 and pivotal trial  costs at $30 million, process development costs of approximately $12 million, and product manufacturing costs of approximately $12 million during phase 3.  For VAC2, the model assumed confirmatory phase 2 clinical trial, process development and product manufacturing costs during phase 2 of approximately $30 million and pivotal trial, process development costs and product manufacturing costs during phase 3 of approximately $48 million.  
     
  Addressable population and penetration – For OPC1, the maximum addressable population of patients (those patients who could possibly benefit from a therapy) was set at 80% due to limited competition in this indication and occurred in the fifth year following commercialization. For VAC2, the maximum addressable population of patients was set at a much lower 15% due to the competitive landscape in non-small cell lung cancer.
     
  Pricing and costs of goods sold (COGS) – For OPC1, a product candidate that has received orphan designation status in the United States, the model assumed a sale price of $250,000 per patient in the United States and Japan and a sale price of $125,000 per patient in Europe, offset by rebates of 10% and royalty payments to certain third parties.  The OPC1 model also assumed a COGS rate of 20%.  For VAC2, the model assumed a sale price of $150,000 per course of therapy in the United States and China and a sale price of $100,000 per course of therapy in Europe, offset by rebates of 10% and royalty payments to certain third parties.  The VAC2 model also assumed a COGS rate of 20%.  
     
  Post-marketing R&D Costs – The model assumed a greater of (i) $10 million per year or (ii) 5% of sales of post-commercial research and development or process development work.  These costs may relate to different OPC1 or VAC2 indications, CMC optimization work, or studies targeting different populations.
     
  Sales and Marketing Costs – Sales and marketing efforts for OPC1 can be targeted due to the limited number of Level 1 Trauma Centers that address these types of injuries (management approximates 30-40 sales persons).  That being said, management assumed sales and marketing costs of the greater of at least $5 million annually or 4% of sales.
     
  General and Administrative (G&A) Costs – The model assumed G&A costs similar to current levels with a 3% annual increase in these costs.  The model also assumed an additional $2 million in G&A costs starting when OPC1 enters the E.U. and Japanese markets.

 

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