OUTLOOK 2016
For the remainder of 2016, the Company expects:
•Investment in the production of RUCONEST® in order to ensure continuity of supply to the growing markets in the US, Europe and the rest of the world.
•Investment in the clinical trial program for RUCONEST® in prophylaxis of HAE and the development of a sub-cutaneous version of RUCONEST®.
•We will also continue to invest carefully in the new pipeline programs in Pompe disease and Fabry’s disease, and other new development opportunities and assets as these occur. To this end, we will be expanding in a modest way at our R&D centre at Evry in France, and in our milk production sites in the Netherlands.
•Increasing selected marketing activity where this can be profitable for Pharming, such as in our current territories of Austria, Germany and the Netherlands.
•We will continue to support all our marketing partners in order to enable the maximization of the sales and distribution potential of RUCONEST® for patients in all territories, as we continue to believe that RUCONEST® represents the fastest, most effective, most reliable and safest therapy option available to HAE patients.
No financial guidance for 2016 is provided.
Although the requirement to produce quarterly reports has been discontinued under the new EU Transparency Directive and the Amended Transparency Directive Implementation Act, Pharming intends to continue to provide quarterly operating and financial reports on a voluntary basis
GOING CONCERN
Pharming’s 2015 financial statements have been drawn up on the basis of a going concern assumption.
The 2015 year-end cash balance of €31.8 million is expected to fund the Company for more than one year from the date of the report. The receipts from commercial supply of product to our partners in the USA,
Europe, the Middle East, Latin America, South Korea and Israel and proceeds from direct sales in Austria, Germany and the Netherlands will further support our financial reserves.
Pharming has a history of operating losses and anticipates that it will continue to incur losses until such quantities of RUCONEST® are being sold (directly or by our partners) that the proceeds to Pharming from such sales become sufficient to meet our operating costs.
Presently, no assurance can be given both on the timing and size of future profits and whether profitability can be achieved on this basis. We remain confident that the development of RUCONEST® will enable this situation to occur, however.
In addition, in the event that the Company needs to raise capital by issuing additional shares,shareholders’ equity interests may be diluted as to voting power, and their interests as to value will depend on the price at which such issues are made.
SUMMARY OF GOALS FOR 2016
• Achievement of (internal) market share/sales targets for RUCONEST®, in the US by Valeant Pharmaceuticals.
• Achievement of (internal) market share/sales targets for RUCONEST® in Europe and otherterritories by our partners SOBI, HyupJin, Cytobioteck and MegaPharm and by direct commercialisation in Austria, Germany and the Netherlands.
• Completion of the Phase II randomised clinical trial of RUCONEST® for the prophylaxis of HAE and continued development on the basis of positive results if these are achieved.
• Prioritisation of new development projects and release in due course of the new products’ clinical strategy and development plans.
• Development of the Company’s visibility amongst institutional investors and other market participants (both buy- and sell-side analysts and financial press and trade press journalists).