2019 Financial Considerations

 

IPM’s cash, cash equivalents and short-term investments as of Dec. 31, 2019, totaled USD 23.6 million. In 2019, IPM advanced five major programs:

 

  • Completing clinical activities for DREAM, an open-label extension study that provided the monthly dapivirine ring to former Ring Study participants for one year. The study ended in January 2019 and reported encouraging increases in adherence and estimated efficacy.
  • Continuing chemistry, manufacturing and control activities to ensure the scale needed for the ring’s launch, pending country approvals, and to support ring research among key groups (adolescent girls and young women, and pregnant and breastfeeding women) and planned regulatory submissions.
  • Conducting regulatory activities to seek approval for the dapivirine ring’s use in African countries where the need is urgent. IPM continued to support the ring’s application to the EMA in 2019 and received a positive scientific opinion in July 2020. IPM also continued preparing applications to African national medical regulatory authorities and the US FDA to be submitted in late 2020.
  • Planning for the dapivirine ring’s potential market introduction. IPM conducted forecasting, mapping and market research to inform access strategies and collaborated with partners to understand policymakers’ questions and end-user needs, and to develop implementation tools.
  • Advancing follow-on products that could further expand women’s options for long-acting HIV prevention methods. Data analysis for safety trials of a three-month dapivirine ring and a three-month dapivirine-contraceptive ring were ongoing in 2019. Given delays due to the COVID-19 pandemic, results for both trials are expected by early 2021.

In 2019, IPM received support from donors including the Ministry of Foreign Affairs of Denmark; the Flanders Department of Foreign Affairs; the German Federal Ministry of Education and Research; Irish Aid; the Ministry of Foreign Affairs of the Netherlands; the UK Foreign, Commonwealth and Development Office (then the Department for International Development); the US President’s Emergency Plan for AIDS Relief through the US Agency for International Development; and the Bill & Melinda Gates Foundation. IPM received approximately USD 29.2 million (cash receipts) in 2019.

 

IPM’s 2019 financial audits continue a history of full compliance with all financial reporting requirements from all US and international government and private donors. In 2019, IPM again received an unmodified, or clean, audit opinion across its South Africa, US and Belgium offices.

 

IPM’s Board of Directors, leadership team and staff remain committed to efficiently and effectively delivering on our mission to develop HIV prevention and other sexual and reproductive health technologies for women, and to make them available and accessible where they are urgently needed. Woman-centered technologies like the long-acting dapivirine ring could help fill an important gap in the existing HIV prevention portfolio, especially in sub-Saharan Africa. With the EMA’s positive opinion for the ring expected to facilitate country approvals in Africa, sustaining financial support for IPM’s work is essential to empowering women with more options they can use to protect their sexual and reproductive health on their own terms. We continue to advocate for increased funds from existing donors and to pursue new funding sources and partnerships.