Workflow
Kala Pharmaceuticals(KALA)
icon
Search documents
Kala Pharmaceuticals (KALA) Investor Presentation - Slideshow
2022-05-07 14:10
Innovation In Ophthalmology CorporateOverview April 2022 NOT FOR PROMOTIONAL USE Disclaimers andNotices 2 This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about our future expectations, plans and prospects, including but not limited to statements about our expectations with respect to and potential advantages of KPI-012, KPI-287 and our SEGRM program, the future development or commercialization of KPI-012, KPI-287 or ...
Kala Pharmaceuticals(KALA) - 2021 Q4 - Annual Report
2022-03-29 20:34
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or other ju ...
Kala Pharmaceuticals(KALA) - 2021 Q4 - Earnings Call Transcript
2022-03-29 16:10
Financial Data and Key Metrics Changes - As of December 31, 2021, the company's cash position was $92.1 million, down from $124.5 million as of September 30, 2021, primarily due to cash used in operations and the $5 million paid for the acquisition of Combangio [31] - For Q4 2021, net product revenues were $1.9 million, a decrease from $3.1 million in Q3 2021, with $1.2 million from EYSUVIS sales and $700,000 from INVELTYS sales [33][34] - SG&A expenses were $24 million for Q4 2021, a decrease of 5% from the previous quarter, while R&D expenses were $2.4 million, also reflecting a decrease [36] Business Line Data and Key Metrics Changes - EYSUVIS prescriptions grew by 21% in Q4 2021 compared to Q3 2021, with a total of approximately 22,460 prescriptions reported [15][34] - INVELTYS prescriptions decreased slightly to approximately 36,700 in Q4 2021 from 37,410 in Q3 2021, with expectations for growth as ocular surgeries return to pre-COVID levels [21] Market Data and Key Metrics Changes - EYSUVIS now has coverage for over 125 million lives, with 70% of all commercial lives in the U.S. and approximately 15% of Medicare lives covered [16] - The company secured coverage with United Healthcare, covering about 13 million lives, and Cigna Medicare, covering about 1.9 million lives, which is expected to enhance prescription fulfillment rates [16][46] Company Strategy and Development Direction - The company aims to reduce expenses by approximately $25 million in 2022 to extend its cash runway beyond Q2 2023 while progressing its development pipeline [13][32] - KPI-012 is being developed for persistent corneal epithelial defect (PCED) and is expected to enter a Phase 2/3 clinical trial in Q4 2022, with potential expansion into other rare ocular diseases [12][27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of EYSUVIS prescriptions and the positive impact of expanding payer coverage on revenue [10][20] - The company anticipates meaningful growth in EYSUVIS revenues to begin in the first half of 2022, driven by recent payer wins and improved market access [74] Other Important Information - The company is actively evaluating other rare disease indications for KPI-012 and plans to provide updates on potential further development later this year [13][28] - The company reported that the initial clinical trial of KPI-012 showed significant improvement in 7 of 8 patients, with complete healing in 6 patients [26] Q&A Session Summary Question: Can you provide insights on how expanded coverage may translate to greater revenues this year? - Management indicated that growing coverage will help increase filled prescriptions and improve gross to nets, as reliance on co-pay assistance programs decreases [40] Question: What is the current percentage of scripts being rejected due to lack of coverage? - Approximately 50% of commercial prescriptions and 70% of Medicare Part D prescriptions are currently not getting filled due to lack of coverage [40] Question: Can you explain the dynamics between EYSUVIS sales and prescription growth? - Management clarified that while prescription volume and shipments were up, the gross to net was impacted by the co-pay assistance program, which is expected to improve with increased coverage [44][50] Question: What is the expected impact of recent payer wins on EYSUVIS? - Management expects that recent wins will significantly improve prescription fulfillment rates and overall revenue growth [46][74] Question: What are the preclinical activities for KPI-012? - The company is optimizing the manufacturing process and preparing for a GLP toxicology study, with plans to submit an IND application later this year [61]
Kala Pharmaceuticals (KALA) Investor Presentation (Slideshow)
2022-01-11 18:06
Innovation In Ophthalmology Corporate Overview January 2022 NOT FOR PROMOTIONAL USE Disclaimers and Notices This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about our future expectations, plans and prospects, including but not limited to statements about our expectations with respect to and potential advantages of KPI-012, KPI-287 and our SEGRM program, the future development or commercialization of KPI-012, KPI-287 o ...
Kala Pharmaceuticals (KALA) Investor Presentation - Slideshow
2021-12-01 07:10
KPI-012 Overview - KPI-012 is a novel clinical-stage secretome therapy in development for Persistent Corneal Epithelial Defect (PCED)[3] - KPI-012 has potential to treat PCEDs of multiple etiologies as well as other severe ocular surface diseases[4] - There are approximately 100,000 PCED patients in the US and 238,000 in the US, EU, and Japan combined[6] - Oxervate, the only approved Rx product, is indicated for neurotrophic keratitis (NK) which is estimated to be the underlying etiology for only ~1/3 of all PCED cases[6] Clinical Trial Results - In a Phase 1b clinical trial, 7 out of 8 PCED patients showed improvement with BID dosing of KPI-012[3,13] - Complete healing of PCED was observed in 6 out of 8 patients, in most cases within 1 to 2 weeks of dosing[3,13] - Of patients reporting pain at baseline (6 of 8), 67% reported 0 pain score at Week 1, and 100% reported 0 pain score at Week 3[18] Market Opportunity and Exclusivity - The industry estimates ~100K PCED patients in the U S and ~ 238K patients in US/EU/Japan combined[19] - If approved as a new biologic product under a BLA, KPI-012 should enjoy 12 years market exclusivity for each indication[22] - A worldwide patent portfolio related to KPI-012 has a 20-year patent term ending in 2040[22]
Kala Pharmaceuticals(KALA) - 2021 Q3 - Quarterly Report
2021-11-15 21:19
Table of Contents ff UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State ...
Kala Pharmaceuticals(KALA) - 2021 Q3 - Earnings Call Presentation
2021-11-15 18:57
Innovation in Ophthalmology KPI – 012 Overview November 15, 2021 Safe Harbor and Disclaimer 2 This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about our future expectations, plans and prospects, including but not limited to statements about our acquisition of Combangio, Inc. (the "Acquisition") and the other transactions contemplated by the Acquisition, and any other statements about future expectations, prospects, es ...
Kala Pharmaceuticals(KALA) - 2021 Q3 - Earnings Call Transcript
2021-11-15 18:20
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q3 2021 Earnings Conference Call November 15, 2021 8:30 AM ET Company Participants Jill Steier – Executive Director, Investor Relations and Corporate Communications Mark Iwicki – Chairman, President and Chief Executive Officer Kim Brazzell – Chief Medical Officer Todd Bazemore – Chief Operating Officer Mary Reumuth – Chief Financial Officer Conference Call Participants Andreas Argyrides – Wedbush Christopher Neyor – JPMorgan François Brisebois – Oppenheimer Chris How ...
Kala Pharmaceuticals (KALA) Investor Presentation - Slideshow
2021-09-16 19:27
Innovation In Ophthalmology Corporate Overview September 2021 NOT FOR PROMOTIONAL USE Disclaimers and Notices 2 This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties, including statements regarding Company's products, EYSUVIS®, for the short term (up to two weeks) relief of the signs and symptoms of dry eye disease, INVELTYS®, the first and only topical twice-daily ocular corticostero ...
Kala Pharmaceuticals (KALA) Corporate Overview - Slideshow
2021-08-23 17:22
Innovation In Ophthalmology Corporate Overview August 2021 NOT FOR PROMOTIONAL USE Disclaimers and Notices This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties, including statements regarding Company's products, EYSUVIS®, for the short term (up to two weeks) relief of the signs and symptoms of dry eye disease, INVELTYS®, the first and only topical twice-daily ocular corticosteroid fo ...