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KALA BIO, Inc.
11/5/2020
in the most recent four weeks versus the four weeks prior compared to the branded market that was up only 4% and the overall market which was up only 3.3% during this time. While we are very encouraged by these trends and believe they bode well for Indultus over the long term, we recognize that the ongoing surge or future surges in COVID cases may result in some states reinstating restrictions on elective procedures. which could again impact indulgent sales. I will now turn the call over to Mary to discuss our third quarter financial results.
Mary Gambaugh- Thanks, Todd. During this discussion of our financial results, I will reference certain non-GAAP financial measures. These non-GAAP financial measures exclude stock-based compensation, depreciation, and non-cash interest expense. For a full reconciliation of our GAAP to non-GAAP financial measures, please refer to today's press release, which is available on our website. As of September 30th, we reported total cash, cash equivalents, and short-term investments of $159.1 million compared to $85.4 million as of December 31st, 2019. This increase reflects proceeds from our underwritten public offering of common stock in March, as well as proceeds from sales of common stock under our ATM program during the first part of this year, partially offset by cash used to fund our operations during the first nine months of 2020. We anticipate that our existing cash, cash equivalents, short-term investments, and anticipated revenue from Inveltis will enable us to fund our operations into at least the third quarter of 2022. We also expect that revenue anticipated to be generated from the sales of ISUVIS will provide additional cash runway. For the third quarter of 2020, we reported In Beltis net revenue of $2.2 million compared to $1.5 million in the third quarter of 2019, or an increase of $0.7 million from the same period last year. Cost of product revenues for the third quarter of 2020 were $0.7 million, which is consistent with the same period in 2019. Non-GAAP cost of product revenues were $0.7 million for the third quarter of 2020, compared to $0.6 million for the same period in 2019. SG&A expenses for the third quarter of 2020 were $23.9 million, compared to $15.3 million for the same period in 2019. The increase was primarily due to an increase in external sales and marketing costs related to preparation for the launch of ISUVIS and increased stock-based compensation costs. Non-GAAP SG&A expenses were $20.5 million for the third quarter of 2020, compared to $13.5 million for the same period in 2019. R&D expenses for the third quarter of 2020 were $3.5 million, compared to $7.1 million for the same period in 2019. The decrease was primarily due to a decrease in external spending on our Stride 3, our Phase 3 clinical trial of ISUVIS. Non-GAAP R&D expenses were $2.4 million for the third quarter of 2020 compared to $6.1 million for the same period in 2019. Loss from operations for the third quarter of 2020 was $25.8 million compared to $21.6 million for the same period in 2019. Non-GAAP operating loss was $21.4 million for the third quarter of 2020 compared to $18.8 million for the same period in 2019. Net loss for the third quarter of 2020 was $27.9 million or 50 cents per share compared to a net loss of $23.2 million or 68 cents per share for the same period in 2019. Non-GAAP net loss was $23.2 million for the third quarter of 2020 compared to $20.1 million for the same period in 2019. Please refer to today's press release for the weighted average number of shares used in the calculation of our net loss per share for each of the quarterly periods discussed. While we've been encouraged with the Invelta's prescription recovery that we've experienced since the end of last quarter, we have continued to see some impact related to COVID during the third quarter as cases surged in different regions throughout the country. As a result, we are still unable to project the specific timing or quantify the specific potential impact on future revenues, given the continued uncertainty around the impact and duration of the restrictions related to COVID-19. However, we expect that net revenues will be negatively impacted for the full year 2020 and could continue to be negatively impacted into 2021. That concludes our prepared remarks for today. I will now pass the call over to the operator for questions.
Thank you. Ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Again, ladies and gentlemen, that's star then 1 to ask a question. Please stand by while we compile the Q&A roster. Our first question will come from Liana Musatos with Wedbush Securities.
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