18A.04

In addition to the information set out in Appendix 1A, a Biotech Company must disclose in its listing document:—
 
(1)    its strategic objectives;
 
(2) the details of each Core Product, including:
 
  (a)    a description of the Core Product;
 
  (b) details of any relevant regulatory approval required and/or obtained for each Core Product;
 
  (c) summary of material communications with the relevant Competent Authority in relation to the its Core Product(s) (unless such disclosure is not permitted under applicable laws or regulations, or the directions of the Competent Authority);
 
  (d) the stage of research and development for each Core Product;
 
  (e) development details by key stages and its requirements for each Core Product to reach commercialisation, and a general indication of the likely timeframe, if the development is successful, for the product to reach commercialisation;
 
  (f) all material safety data relating to its Core Product(s), including any serious adverse events;
 
  (g) a description of the immediate market opportunity of each Core Product if it proceeds to commercialisation and any potential increased market opportunity in the future (including a general description of the competition in the potential market);
 
  (h) details of any patent(s) granted and applied for in relation to the Core Product(s) (unless the applicant is able to demonstrate that such disclosure would require the applicant to disclose highly sensitive commercial information), or an appropriate negative statement;
 
  (i) in the case of a Core Product which is biologics, disclosure of planned capacity and production related technology details; and
 
  (j) to the extent that any Core Product is in-licensed, a clear statement of the issuer's material rights and obligations under the applicable licensing agreement;
 
(3) a statement that no material unexpected or adverse changes have occurred since the date of issue of the relevant regulatory approval for a Core Product (if any). Where there are material changes, these must be prominently disclosed;
 
(4) a description of Approved Products (if any) owned by the applicant and the length of unexpired patent protection period and details of current and expected market competitors;
 
(5) details of the Biotech Company's research and development experience, including:
 
  (a) details of its operations in laboratory research and development;
 
  (b) the collective expertise and experience of key management and technical staff; and
 
  (c) its collaborative development and research agreements;
 
(6) details of the relevant experience of the Biotech Company's directors and senior management in the research and development, manufacturing and commercialisation of Biotech Products;
 
(7) the salient terms of any service agreements between the applicant and its key management and technical staff;
 
(8) measures (if any) that the applicant has in place to retain key management or technical staff (for example incentivisation arrangements and/or non-compete clauses), and the safeguards and arrangements that the applicant has in place, in the event of the departure of any of its key management or technical staff;
 
(9) a statement of any legal claims or proceedings that may have an influence on its research and development for any Core Product;
 
(10) disclosure of specific risks, general risks and dependencies, including:
 
  (a) potential risks in clinical trials;
 
  (b) risks associated with the approval process for its Core Product(s); and
 
  (c) the extent to which its business is dependent on key individuals and the impact of the departure of key management or technical staff on the applicant's business and operations;
 
(11) if relevant and material to the Biotech Company's business operations, information on the following:—
 
  (a) project risks arising from environmental, social, and health and safety issues;
 
  (b) compliance with host country laws, regulations and permits, and payments made to host country governments in respect of tax, royalties and other significant payments on a country by country basis;
 
  (c) its historical experience of dealing with host country laws and practices, including management of differences between national and local practice; and
 
  (d) its historical experience of dealing with the concerns of local governments and communities on the sites of its research and trials, and relevant management arrangements;
 
(12) an estimate of cash operating costs, including costs relating to research and development and clinical trials incurred in the development of the Core Product and costs associated with:—
 
  (a) workforce employment;
 
  (b) direct production costs, including materials (if it has commenced production);
 
  (c) research and development;
 
  (d) product marketing (if any);
 
  (e) non-income taxes, royalties and other governmental charges (if any);
 
  (f) contingency allowances; and
 
  (g) any other significant costs; and
 
  Note: A Biotech Company must:
 
    •    set out the components of cash operating costs separately by category;
 
    •    explain the reason for any departure from the list of items to be included under cash operating costs; and
 
    •    discuss any material cost items that should be highlighted to investors.
 
(13)    if the applicant has obtained an expert technical assessment and where relevant and appropriate, include such assessment in its listing document.