Business model and strategy

Saniona commercializes its research efforts through the following three business models:

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By internal development of selected programs through the early phases of drug development before out-licensing to pharmaceutical companies, who will take over the further development of Saniona’s programs and typical pay upfront, milestone and royalty payments on product sales to Saniona.

 

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Through early stage research and development collaboration with pharmaceutical companies, who will fund the research and development activities and pay upfront, milestones and royalty payments on product sales to Saniona.

 

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Through joint ventures or spin-outs, where Saniona’s financial partner will obtain a share of the upside by financing the development of one of Saniona’s programs, alternatively through a spin-out which is financed through an independent public listing. 

 

Saniona’s research strategy is consequently based on the establishment of partnerships with pharmaceutical companies and joint ventures/spin-outs, which are financed by partners or through independent public listings. 

This strategy ensures a high intensity of Saniona’s research efforts with moderate capital requirements. Saniona achieves critical mass and can effectively utilize its key competences in focused research areas while simultaneously utilizing its partners’ expertise in clinical development and marketing of medicines in a wide range of disease areas. This strategy also enables Saniona to spread the risks on a relatively large number of pharmaceutical programs. 

Saniona’s research activities in early stage collaborations will usually be fully funded by Saniona’s partners. It is Saniona’s objective that the majority of its internal operational costs shall be financed through revenues from collaboration agreements. Therefore, the income from Saniona’s research collaborations represents an important contribution to the Saniona’s operation in the short term. However, the majority of Saniona’s income from research collaborations with pharmaceutical companies (for example Boehringer Ingelheim and Proximagen) is expected to be clinical milestone payments and royalties on product sales when the product candidates are commercialized. 

In addition to early stage research collaborations, Saniona also intends to develop selected drug candidates internally with the aim of adding more value into these programs before out-licensing to third parties. In the short term, it is Saniona’s objective to develop at least one drug candidate internally, in order to achieve proof-of-concept in clinical Phase 2 study, and then to out-license the program to a major pharmaceutical company for further development. Recently, a Phase 2a clinical trial for Tesomet in patients with type 2 diabetes was successfully completed. Currently, two Phase 2 studies are ongoing including NS2359 for treatment of cocaine addiction and Tesomet where we are planning to initiate a Phase 2a proof of concept study with the aim of demonstrating a clinically relevant weight loss in patients with Prader Willi syndrome.

Saniona expects to receive upfront payments upon out-licensing of its internal developed programs to partners, hereunder in particular for programs which are out-licensed following completion of Phase 2 clinical studies. In addition to this, Saniona expects to receive clinical milestone payments and royalties on product sales when the product candidates are commercialized. 

In general, Saniona expects to out-license its research and the internal developed programs on world-wide basis. However, Saniona may also out-license a particular program for a limited territory and thereby retain the commercial rights to other territories. In 2016, Saniona signed a collaboration with Medix for development of tesofensine and Tesomet in Mexico and Argentina. Medix received in April 2017 approval to initiate a Phase 3 study for tesofensine in obese Mexican patients. Medix will later on initiate Phase 2 and Phase 3 studies with Tesomet for the markets in Mexico and Argentina. Saniona retains the rights in the rest of world. This structure enables Saniona to finance late stage clinical trials through third parties while maintaining significant commercial rights.

In the event that a program is developed through spin-outs (for example, Ataxion "Luc Therapeutics", Initiator Pharma, and Scandion Oncology) or joint ventures, the majority of Saniona’s income will be payable upon exits, e.g. the sale of the spin-out or program to a third party. 

The proceeds from significant exits and income from milestones and royalty payments will be used to the continued development of Saniona or be payable as dividends to Saniona’s shareholders.