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Commercialization Strategy Group Purchasing Organizations Our commercial strategy in the U.S. for ANX-530 and ANX-514 includes seeking to obtain Healthcare Common Procedure Coding System (HCPCS) product codes that are distinct from those for Navelbine and Taxotere, respectively. Additionally, we intend to price ANX-530 at a premium to competitive products. In the U.S. and elsewhere, healthcare providers, including hospitals, nursing homes and physician offices, typically purchase the drugs they administer to patients and then seek reimbursement, primarily from third party payors such as Medicare, Medicaid and private insurance companies. As a result, sales of prescription pharmaceuticals are dependent in large part on the availability and rate of reimbursement to healthcare providers from third party payors. The Healthcare Common Procedure Coding System was established to identify and provide unique codes for healthcare goods and procedures, including codes for injectable oncology drugs such as ANX-530 and ANX-514, should they be approved. Ultimately, CMS is responsible for reviewing and approving applications for new HCPCS codes for injectable oncology drugs. Generic equivalents of drugs are assigned the same HCPCS code as the original drug. Virtually all U.S. payors, including Medicare and private insurance plans, use the HCPCS, including the product codes assigned by CMS. In determining a specific reimbursement rate for a drug, CMS publishes an average sales price for the drug based on manufacturer-reported sales data for all drugs within the same HCPCS product code, including applicable discounts and rebates, as well as a reimbursement rate, expressed as a percentage of the average sales price. Because generic equivalents of drugs are assigned the same HCPCS code as the original drug, generic competition can be expected to decrease the level of reimbursement for all drugs with the same HCPCS product code (both the original drug and its generic equivalents) until price equilibrium is reached. Most private payors use similar methods for determining reimbursement rates, sometimes based on average wholesale prices or CMS' published average sales price. We intend to seek unique HCPCS codes for ANX-530 and ANX-514. If we obtain unique HCPCS codes for our products, they will be reimbursed based on their own sales prices, without including sales prices of the applicable reference product or its generic competition. We believe this will provide us greater freedom to price our products at a premium to competitive products, enhancing their value to us. Group Purchasing Organizations Group purchasing organizations, or GPOs, including distributors and provider networks, are entities that help health care providers, such as hospitals, nursing homes and physician offices, realize savings and efficiencies by aggregating purchasing volume and using that scale to negotiate discounts with manufacturers and other vendors. The U.S. healthcare industry spends more than $200 billion annually in medical and non-medical products, with more than 70% allocated through GPOs. We believe up to 80% of the U.S. markets for ANX-530 and ANX-514 are concentrated within eight to ten GPOs and that a focused, specialized sales force may be able to effectively market and sell our products, once approved, to these organizations. As consolidation within the industry and attempts to further enhance economies of scale and marketing advantages continue, we believe these markets will concentrate further. If our products demonstrate equivalent efficacy and superior tolerability or pharmacoeconomic benefits relative to the reference product, we believe the well-established utility of the reference product should enable GPOs to enact broad and rapid shifts among their constituents from the reference product to our novel emulsion formulations. The concentrated nature of these markets in the U.S. may warrant retaining marketing rights to ANX-530 and ANX-514 in the U.S., which may provide us better value than we could obtain through a partnering relationship. By understanding the organization of our target markets and pursuing directly only those markets we believe are sufficiently concentrated, we seek to avoid the substantial direct and indirect expense associated with large sales and marketing organizations that pursue individual physicians. However, we also remain receptive to partnering these product candidates in the U.S. if presented with terms that are sufficiently attractive. |
