Jan 30, 2019
Quarterly Cashflow Report
Melbourne, Australia; 30 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2018.
Starpharma’s cash balance as at 31 December 2018 was $44.4 million, with net operating and investing cash outflows for the quarter of $5.3 million. The cash outflows include expenditure related to the commercialisation and upcoming launch of VivaGel® BV and costs related to Starpharma’s DEP® clinical programs. As in prior years, the December quarter also includes a number of one-off annual payments.
The cash balance does not include the anticipated $4.0 million R&D tax incentive which is expected to be received during the March quarter.
Starpharma’s strong cash balance enables the Company to support international approvals and launch of VivaGel® BV in multiple markets in parallel with continuing to build its high-value DEP® portfolio.
Key events during the quarter:
- Starpharma signed a US licence for VivaGel® BV with ITF Pharma, Inc, a specialty pharmaceutical company focused on Women’s Health. The deal includes milestones of up to US$101M in addition to escalating, double-digit royalties on sales.
- Starpharma and its partners, Mundipharma and Aspen, undertook advanced pre-launch activities for VivaGel® BV including extensive sales training, promotional activities and product manufacture, in readiness for launch in multiple territories in 1H 2019. In parallel, registration activities for several Mundipharma territories continued to advance to support further international launches.
- US FDA completed its review of the VivaGel® BV NDA and advised that it requires confirmatory clinical data prior to approval. Starpharma is in the process of securing a meeting with the FDA to clarify what clinical data will be required and is working with expert FDA consultants to expedite the path to approval.
- VivaGel® condom received final regulatory approval in Japan. Starpharma’s partner in Japan, market-leader Okamoto, has already commenced launch preparations and expects to launch the VivaGel® condom in the first half of 2019.
- DEP® docetaxel and DEP® cabazitaxel trials continue to progress well with encouraging efficacy signals in both trials in a range of tumour types, including prostate and lung cancer. Both products continue to exhibit a notable lack of bone marrow toxicity and other common side effects.
- The final stages of preclinical work for the DEP® irinotecan phase 1 / 2 trial are now complete and trial preparations are well advanced for trial commencement in FY19.
- DEP® docetaxel and DEP® cabazitaxel showed significant efficacy and safety benefits over gemcitabine alone, Abraxane® alone and in combination, in a human pancreatic cancer model.
- Other partnered and preclinical programs continue to progress, including AstraZeneca’s AZD0466, which is due to enter the clinic this year.
- Starpharma’s internal DEP® programs included initial testing of a number of DEP® radiopharmaceutical candidates which demonstrated significant tumour accumulation in both prostate and brain cancer models.
- The US Patent and Trademark Office granted Starpharma a patent for SPL7013 ophthalmic drops for viral conjunctivitis. This follows the independent US market research which confirmed a high degree of interest from both ophthalmologists and primary care physicians.
Dr Jackie Fairley, Starpharma CEO, commented: “In December, we were pleased to execute a US licence for VivaGel® BV with ITF Pharma. While we are clearly disappointed with the US FDA's request for confirmatory data, we are looking forward to the upcoming launch of VivaGel® BV in multiple non-US territories which are planned for the first half of 2019. In parallel, we continue to generate impressive data across multiple DEP® programs, internal and partnered, which continue to demonstrate the DEP® platform’s ability to significantly enhance the performance of drugs alone and in combination.”
- Launch of VivaGel® BV in Australia, Europe and other international markets
- Meeting with FDA to discuss its request for confirmatory clinical data for VivaGel® BV
- Further regulatory approvals for VivaGel® BV
- Revenue from VivaGel® BV milestones and sales
- Launch of VivaGel® condom in Japan and approvals in additional regions, such as Europe and China
- Progress with DEP® docetaxel and DEP® cabazitaxel clinical trials
- DEP® irinotecan trial commencement
- Other internal DEP® candidates entering development
- AstraZeneca program developments, AZD0466 advanced to the clinic and revenue from milestones; further DEP® compounds advanced/nominated/licensed
- New partnered DEP® deals and program developments, including for Targeted DEP®
Download ASX Announcement: Quarterly Cashflow Report (PDF, 310kb)