KALA BIO, Inc. Q4 FY2020 earnings call

2020 Achievements

• Received FDA approval for EYSUVIS in October 2020, launched EYSUVIS in January 2021.
• INVELTYS had 41,000 prescriptions in Q4 2020 (+8% QoQ) and 143,000 prescriptions in 2020 (+11% YoY) despite COVID-19 impact on ocular surgeries.

EYSUVIS Launch

• Early positive response from eye care professionals, with over 2,200 prescriptions filled in the first six weeks and over 550 eye care professionals prescribing. Added to Express Scripts' formularies one month into launch. Positive feedback on rapid onset of action and comfort of the eye drop.

INVELTYS Update

• 41,000 prescriptions in Q4 2020, 143,000 in 2020, strong commercial coverage with over 80% of commercial lives covered.

Pipeline

• Three preclinical programs: SEGRM, Tyrosine Kinase Inhibitor, and ocular surface targeted steroid. SEGRM program aims to identify a development candidate by end of 2021; Tyrosine Kinase Inhibitor program shows promise for retinal diseases like AMD.

For the fourth quarter of 2020, Kala Pharmaceuticals had net product revenues of $2.2 million. EYSUVIS contributed $300,000 (13.6% of total net product revenues), while INVELTYS contributed $1.9 million (86.4% of total net product revenues). As of December 31, 2020, cash position was $153.5 million, up from $85.4 million in 2019.

• Cash resources as of Dec 31, 2020: $153.5 million, expect to fund operations into Q4 2022. Anticipate EYSUVIS revenue to provide additional runway. - INVELTYS prescriptions and revenues expected to grow, but uncertainty remains due to COVID-19 impact on elective procedures.

• Impact of COVID-19 on ocular surgeries affecting INVELTYS prescriptions. - Uncertainty in payer coverage and formulary access for EYSUVIS. - Risks associated with forward-looking statements, actual results may differ from expectations.

Q: On EYSUVIS payer contracting, confidence in additional contracts and product profile attractiveness.

A: Todd Bazemore discussed ongoing negotiations, positive clinical differentiation recognized by payers.

Q: Impact of COVID-19 on EYSUVIS sales force launch.

A: Mark Iwicki said 90% sales interactions are face-to-face, positive receptivity.

Q: Factors in formulary access for EYSUVIS and launch ramp.

A: Mark Iwicki mentioned clinical differentiation and rapid onset of action.

Q: Topical TKI for AMD, confidence in topical route.

A: Kim Brazzell discussed preclinical data and potential for topical treatment.

Q: EYSUVIS prescribers and outreach.

A: Todd Bazemore talked about early adopters, optometrists, and sales force reach.

Q: Reimbursement, Express Scripts coverage, co-pay.

A: Todd Bazemore and Mark Iwicki discussed quick coverage, co-pay range, and co-pay assistance program.

Q: Ocular surgeries trend.

A: Todd Bazemore discussed negative impact of COVID-19 spikes on surgeries.

Q: TKI candidate for AMD, long-acting treatment.

A: Kim Brazzell discussed topical and intravitreal sustained delivery options.

Q: Sampling program and face-to-face meetings.

A: Todd Bazemore talked about sampling, early prescriptions, and positive feedback.

Q: Gross to net expectations for EYSUVIS vs INVELTYS.

A: Todd Bazemore explained different market dynamics affecting gross to net.