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Dec 31, 2019
Kala Bio Q4 2019 Earnings Report
Reported financial results for the fourth quarter and full year ended December 31, 2019.
Key Takeaways
Kala Pharmaceuticals reported Q4 2019 financial results, with net product revenue of $1.2 million from INVELTYS sales. The company completed the last patient visit for the STRIDE 3 trial and anticipates topline results in Q1 2020.
Completed the last patient last visit in STRIDE 3 Phase 3 trial for EYSUVIS.
Targeting topline results from STRIDE 3 in Q1 2020 and NDA resubmission in H1 2020.
Reported approximately 47,000 INVELTYS prescriptions in Q4 2019, a 17% increase compared to Q3 2019.
Kala had $85.4 million in cash as of December 31, 2019, expected to fund operations into Q2 2021.
Kala Bio
Kala Bio
Forward Guidance
Kala anticipates existing cash resources and projected INVELTYS revenue will fund operations into the second quarter of 2021. The company is on track to report topline data in Q1 2020 and resubmit the NDA for EYSUVIS in Q2 2020.
Positive Outlook
- On track to report topline data from STRIDE 3 in the first quarter of 2020.
- Targeting NDA resubmission to the FDA in the second quarter of 2020.
- Existing cash resources and projected INVELTYS revenue will fund operations into the second quarter of 2021.
- Completed the last patient last visit in STRIDE 3 Phase 3 trial for EYSUVIS.
- If approved, EYSUVIS could become the preferred prescription therapy for dry eye flares.
Challenges Ahead
- Uncertainties inherent in the availability and timing of data from ongoing clinical trials, including STRIDE 3.
- Risk of additional clinical trials being required for EYSUVIS prior to approval of the NDA.
- Potential inability to execute on the commercial launch of EYSUVIS, if and when approved, on the timeline expected.
- Risk that the Company will be unable to generate its projected net product revenue on the timeline expected.
- Risk that the Company's cash resources will be insufficient to fund operating expenses and capital expenditure requirements for the Company's expected timeline.