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Kala Pharmaceuticals(KALA) - 2019 Q4 - Annual Report
2020-02-12 22:24
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, 2019 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) - 2019 Q4 - Earnings Call Transcript
2020-02-12 16:38
Financial Data and Key Metrics Changes - As of December 31, 2019, the company's cash position was $85.4 million, down from $170.9 million as of December 31, 2018 [32] - For Q4 2019, INVELTYS net revenue was reported at $1.2 million, while the full-year 2019 net revenue was $6.1 million [33] - The net loss for Q4 2019 was $22 million, or $0.63 per share, compared to a net loss of $25.2 million, or $0.76 per share for the same period in 2018 [37] Business Line Data and Key Metrics Changes - INVELTYS prescriptions grew to over 144,000 since its launch, with approximately 47,000 prescriptions reported in Q4 2019, representing a 17% increase over Q3 2019 [11][23] - The company achieved an 11.2% NRx share in the branded steroid market and an 18.8% NRx branded market share among eye care professionals [24] - EYSUVIS is expected to target a market of approximately 33 million patients with dry eye disease in the U.S., with an estimated total addressable market potential exceeding $8 billion annually [19][20] Market Data and Key Metrics Changes - The branded steroid market and prescriptions were down by 16.5% between Thanksgiving and Christmas holidays, yet INVELTYS showed positive growth [23] - The company has achieved unrestricted access for approximately 80% of all commercial lives and about 23% of Medicare Part D lives [26] Company Strategy and Development Direction - The company aims to position EYSUVIS as the preferred first-line prescription therapy for dry eye flares, with launch preparations already underway [28] - The sales force is expected to grow from 57 to between 75 and 100 representatives to effectively cover 75% to 85% of all dry eye prescriptions if EYSUVIS is approved [27][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming top-line results from the STRIDE 3 trial and the potential for EYSUVIS to meet a significant unmet need in the dry eye market [54] - The company anticipates a stable operating expense situation in 2020, with a reduction in R&D expenses expected following the completion of the STRIDE 3 trial [56][73] Other Important Information - The company plans to resubmit its NDA for EYSUVIS in Q2 2020, expecting a Class II designation which would entail a six-month review period [10][48] - The company reported that the weighted average number of shares outstanding at the end of 2019 was 35.5 million [74] Q&A Session Summary Question: Differences in patient characteristics in STRIDE trials - Management explained that changes in STRIDE 3 aimed to exclude patients with unstable symptom profiles during the run-in phase, which could improve statistical outcomes [42][43] Question: Update on INVELTYS prescriber growth - The company reported that over 3,300 physicians have prescribed INVELTYS, achieving about 50% penetration of the target universe of 6,000 to 7,000 physicians [47] Question: Confidence in EYSUVIS filing timeline - Management reiterated confidence in the six-month filing timeline for EYSUVIS based on previous experiences with similar resubmissions [48] Question: 2020 priorities in light of EYSUVIS results - Management expressed excitement about the STRIDE 3 trial results and the potential market need for EYSUVIS, indicating readiness to launch if results are positive [52][54] Question: R&D expense expectations post-STRIDE 3 - Management confirmed expectations for reduced R&D expenses in 2020, particularly related to clinical trial work [73] Question: Shares outstanding and 10-K filing - The company confirmed 35.5 million shares outstanding at the end of 2019 and indicated that the 10-K would be filed within the week [74]
Kala Pharmaceuticals (KALA) Investor Presentation - Slideshow
2020-01-16 19:01
Corporate Highlights & Financial Status - As of December 31, 2019, Kala had $85.4 million in cash [2] - Kala expects existing cash resources, along with projected INVELTYS revenue, to fund operations at least through 1Q2021 [2] INVELTYS Performance & Market - INVELTYS was approved by the FDA in August 2018 and launched in the US in January 2019 [3] - In 2019, INVELTYS generated over 127,000 total prescriptions (TRxs) and achieved an 8.6% branded new prescription (NRx) market share [3] - INVELTYS has approximately 75% commercial coverage and 23% Medicare Part D coverage [3, 24] - The US ocular surgery market is estimated at approximately 8.6 million procedures in 2019 and is projected to grow at a CAGR of 3.5% [16, 17] EYSUVIS Development & Market Potential - STRIDE 3 Phase 3 trial for EYSUVIS is expected to be fully enrolled with topline data expected in 1Q2020 [2, 50, 52] - Approximately 80-90% of dry eye disease (DED) patients experience flares [29, 39] - The addressable US market opportunity for DED flares is estimated to be over $8 billion [39] - Approximately 3% of steroid prescriptions are for dry eye, representing approximately 255,000 prescriptions [38] AMPPLIFY Technology - AMPPLIFY technology increases Loteprednol Etabonate (LE) penetration to corneal and aqueous humor by more than 3x [5, 7]
Kala Pharmaceuticals (KALA) Investor Presentations - Slideshow
2019-11-15 17:53
Corporate Highlights - Kala is well capitalized with cash of $976 million as of September 30, 2019[2] - The company expects existing cash resources, together with projected INVELTYS revenue, to fund operations through the next 18 months[2] INVELTYS (for post-surgical inflammation and pain) - INVELTYS was launched in the U S in January 2019[2,9] - The Wholesale Acquisition Cost (WAC) price of INVELTYS is $245 per prescription[9] - Eye care professionals report prescribing steroids in greater than 90% of cataract, glaucoma and refractive surgeries[17] - In 2018, there were approximately 82 million ocular surgery procedures in the U S, with a projected Compound Annual Growth Rate (CAGR) of 41%[20,59] - Branded products account for approximately 25% of prescriptions and approximately 60% of gross sales in the ocular surgery market, which is estimated to be valued at approximately $17 billion[20] EYSUVIS (for Dry Eye Disease) - Approximately 80-90% of all Dry Eye Disease (DED) patients suffer from flares[29] - Approximately 82% of patients on artificial tears suffer from flares[29] - Approximately 17 million people in the U S are diagnosed with DED[37] - Only 3% of steroid prescriptions are for Dry Eye, representing approximately 255,000 prescriptions[40,41] - The addressable U S market for DED flares is estimated to be greater than $8 billion[42]
Kala Pharmaceuticals(KALA) - 2019 Q3 - Earnings Call Transcript
2019-11-10 05:06
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q3 2019 Earnings Conference Call November 7, 2019 8:00 AM ET Company Participants Niranjan Kameswaran - Vice President, Strategy Mary Reumuth - Chief Financial Officer Mark Iwicki - Chairman, President & Chief Executive Officer Kim Brazzell - Chief Medical Officer Todd Bazemore - Chief Operating Officer Conference Call Participants Chris Neyor - JPMorgan Kambiz Yazdi - Wedbush Securities Faizzan Ahmad - H.C. Wainwright Operator Good morning and welcome to Kala Pharma ...
Kala Pharmaceuticals(KALA) - 2019 Q3 - Quarterly Report
2019-11-07 21:06
Table of Contents 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, 2019 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 ...
Kala Pharmaceuticals(KALA) - 2019 Q2 - Quarterly Report
2019-08-06 20:28
☐ 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. Table of Contents 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 June 30, 2019 OR (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or othe ...
Kala Pharmaceuticals(KALA) - 2019 Q2 - Earnings Call Transcript
2019-08-06 14:12
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q2 2019 Earnings Conference Call August 6, 2019 8:00 AM ET Company Participants Mary Reumuth - CFO Mark Iwicki - Chairman, President & CEO Kim Brazzell - CMO Todd Bazemore - COO Conference Call Participants Biren Amin - Jefferies Esther Rajavelu - Oppenheimer Yi Chen - H.C. Wainwright Operator Good morning, and welcome to Kala Pharmaceuticals Second Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following management's ...
Kala Pharmaceuticals(KALA) - 2019 Q1 - Quarterly Report
2019-05-09 20:36
Table of Contents 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 March 31, 2019 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) Large accelerated filer ☐ Acceler ...
Kala Pharmaceuticals(KALA) - 2019 Q1 - Earnings Call Transcript
2019-05-09 19:48
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q1 2019 Earnings Conference Call May 9, 2019 8:00 AM ET Company Participants Mary Reumuth – Chief Financial Officer Mark Iwicki – Chairman, President and Chief Executive Officer Todd Bazemore – Chief Operating Officer Kim Brazzell – Chief Medical Officer Hongming Chen – Chief Scientific Officer Conference Call Participants Shveta Vilas – Wedbush Esther Rajavelu – Oppenheimer Yi Chen – H.C. Wainwright Operator Good morning, and welcome to Kala Pharmaceuticals First Qu ...