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SEC Filings

10-Q
OREXIGEN THERAPEUTICS, INC. filed this Form 10-Q on 05/12/2017
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*If Contrave does not achieve broad market acceptance, the revenues that we generate from its sales will be limited.

The commercial success of Contrave or any other product candidates for which we obtain marketing approval from the FDA or other regulatory authorities will depend upon the acceptance of these products by both the medical community and patient population. Coverage and reimbursement of our product by third-party payors, including government payors, generally is also necessary for optimal commercial success. The degree of market acceptance of any of our approved products will depend on a number of factors, including:

 

our ability to provide acceptable evidence of safety and efficacy;

 

the timing of market introduction of our products as well as competitive products;

 

the relative convenience and ease of administration;

 

the prevalence and severity of any adverse side effects;

 

limitations or warnings contained in a product’s FDA-approved labeling, including, the “boxed” warning(s) and pregnancy precautions associated with the active pharmaceutical ingredients, or APIs, in Contrave and included in Contrave’s product label;

 

availability of alternative treatments and the potential or perceived advantages or disadvantages of such treatments, including, in the case of Contrave, a number of competitive products approved for the treatment of weight loss or expected to be commercially launched in the near future;

 

pricing, discounts and cost effectiveness;

 

our Risk Evaluation and Mitigation Strategy, or REMS, if any are imposed;

 

the effectiveness of our, our contract sales organization’s, and our collaborators’ sales and marketing strategies, including our telemedicine pilot program;

 

the effectiveness of our ability to distribute our products to our customers, including our ability to negotiate the terms of our agreements with third party distributors that are consistent with, or as favorable as, terms that were negotiated when we had a large pharmaceutical partner; 

 

our and our partners’ ability to obtain sufficient third-party coverage or reimbursement; and

 

the willingness of patients to pay out of pocket in the absence of third-party coverage.

If Contrave does not achieve an adequate level of acceptance by physicians, health care payors and patients, we may not generate sufficient revenue from our product, and we may not become or remain profitable. In addition, our efforts to educate prospective patients, the medical community and third-party payors on the benefits of our product may require significant resources and may never be successful.

*We have limited sales and marketing experience and resources.

To date, the marketing of Contrave has been focused on large markets traditionally served by general and family practitioners and internists. General physicians number in the several hundred thousand in the United States and hundreds of thousands outside the United States. Traditional pharmaceutical companies employ groups of sales representatives numbering in the thousands to call on this large generalist physician population. In August 2016, we assumed full responsibility for the continued development and commercialization of Contrave in the United States from our former collaboration partner, Takeda. We have never, as an organization, commercialized a product and there is no guarantee that we will be able to do so successfully.  Included in our strategy in the United States is the establishment of a specialty sales force to continue the commercialization of Contrave.  While we have established our commercial team and have hired our U.S. sales force, we will need to continue to further develop the team and our marketing strategy in order to successfully market and sell Contrave in the United States which will require significant time and resources and our ability to market and sell our product and generate revenues from Contrave may be delayed or limited. Our sales organization is currently contracted through a contract sales force. Although the new contract sales force consists of sales professionals with experience in the pharmaceutical industry, including many with experience selling weight management products, we cannot assure you that their sales efforts will be effective or produce the results we expect.  We will be competing with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.  Further, we may face difficulties or delays in obtaining and maintaining the required licenses and permits to sell Contrave in individual states and jurisdictions.

Also included in our strategy in the United States is the use of telemedicine which is advertised on the brand website for Contrave.  Telemedicine is relatively new and unproven and it is uncertain whether it will achieve and sustain high levels of demand,

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