Glaukos(GKOS)

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Glaukos(GKOS) - 2023 Q4 - Annual Report
2024-02-22 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 No. 001-37463 GLAUKOS CORPORATION (Exact name of registrant as specified in its charter) Delaware 33-0945406 (State or other ...
Glaukos (GKOS) Conference Transcript
2023-12-14 14:30
Summary of Glaukos (GKOS) Conference Call - December 14, 2023 Company Overview - **Company**: Glaukos Corporation - **Product**: iDose TR, a micro-invasive injectable therapy for glaucoma Key Industry Insights - **FDA Approval**: iDose TR received FDA approval, marking a significant milestone for glaucoma treatment and Glaukos [6][10] - **Market Need**: High non-compliance rates (up to 90%) with traditional glaucoma medications create a strong demand for effective alternatives [12][16] Core Points and Arguments 1. **Product Description**: iDose TR is designed to lower intraocular pressure (IOP) for up to three years, addressing patient non-compliance and chronic side effects associated with topical medications [6][7] 2. **Clinical Efficacy**: - Phase 3 trials showed IOP reductions of 6.6 to 8.4 mmHg for iDose TR compared to 6.5 to 7.7 mmHg for topical Timolol [9] - 81% of iDose TR subjects were free of IOP-lowering topical medications at 12 months [13] - 93% of subjects remained well-controlled on the same or fewer medications after a single administration [14] 3. **Safety Profile**: iDose TR demonstrated excellent tolerability with no serious adverse events related to corneal endothelial cell loss or periorbital fat atrophy [10][15] 4. **Regulatory Pathway**: The FDA's conservative approach led to restrictions on repeat administration, which Glaukos plans to address in future discussions [11][36] 5. **Commercial Strategy**: - A controlled launch is planned for the first half of 2024, focusing on surgeon training and market access initiatives [20][22] - A temporary C code will be used until a permanent J code is established, expected in the second half of 2024 [22][50] 6. **Pricing**: The wholesale acquisition cost for iDose TR is set at $13,950 per dose, which is considered competitive given its long-duration therapy [25][72] Additional Important Information - **Manufacturing Capabilities**: Glaukos has developed a state-of-the-art nanotechnology manufacturing facility in California, which passed FDA inspection with no observations [18] - **Patient Access Initiatives**: Glaukos is committed to ensuring access for all eligible patients, including a philanthropic initiative to donate units for qualifying requests [26][27] - **Revenue Guidance**: The company reaffirmed 2023 revenue guidance of $307 to $310 million and introduced preliminary 2024 guidance of $350 to $360 million, factoring in iDose TR's launch [28][29] Conclusion - The approval of iDose TR represents a transformative opportunity for glaucoma management, with a strong focus on addressing patient non-compliance and improving treatment outcomes. Glaukos is well-positioned to capitalize on this market need through strategic commercialization efforts and robust clinical data supporting the product's efficacy and safety.
Glaukos(GKOS) - 2023 Q3 - Quarterly Report
2023-10-31 16:00
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-37463 GLAUKOS CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organizat ...
Glaukos(GKOS) - 2023 Q2 - Earnings Call Transcript
2023-08-03 01:30
Glaukos Corporation (NYSE:GKOS) Q2 2023 Earnings Conference Call August 2, 2023 4:30 PM ET Company Participants Christopher Lewis - VP, IR & Corporate Affairs Thomas Burns - Chairman & CEO Joseph Gilliam - President & COO Alex Thurman - SVP & CFO Conference Call Participants Thomas Stephan - Stifel, Nicolaus & Company Ryan Zimmerman - BTIG Charles Ellson - Wells Fargo Securities Joseph Conway - Needham & Company Joanne Wuensch - Citigroup George Sellers - Stephens Inc. Phillip Dantoin - Piper Sandler & Co. ...
Glaukos(GKOS) - 2023 Q2 - Quarterly Report
2023-08-01 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-37463 GLAUKOS CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of Delaware 33-0945406 (I.R.S. Emp ...
Glaukos(GKOS) - 2023 Q1 - Earnings Call Transcript
2023-05-04 02:53
Glaukos Corporation (NYSE:GKOS) Q1 2023 Earnings Conference Call May 3, 2023 4:30 PM ET Company Participants Chris Lewis – Vice President-Investor Relations and Corporate Affairs Tom Burns – Chairman and Chief Executive Officer Joe Gilliam – President and Chief Operating Officer Alex Thurman – Chief Financial Officer Conference Call Participants Tom Stephan – Stifel Ryan Zimmerman – BTIG George Sellers – Stephens Allen Gong – JP Morgan Anthony Petrone – Mizuho Group Operator Welcome to Glaukos Corporation’s ...
Glaukos(GKOS) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-37463 GLAUKOS CORPORATION (Exact name of registrant as specified in its charter) Delaware 33-0945406 (I.R.S. Employer Identification No.) Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 (Stat ...
Glaukos(GKOS) - 2022 Q4 - Annual Report
2023-02-23 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 No. 001-37463 GLAUKOS CORPORATION (Exact name of registrant as specified in its charter) Delaware 33-0945406 (State or other ...
Glaukos(GKOS) - 2022 Q4 - Earnings Call Transcript
2023-02-23 02:02
Glaukos Corporation (NYSE:GKOS) Q4 2022 Earnings Conference Call February 22, 2023 4:30 PM ET Company Participants Chris Lewis – Vice President-Investor Relations and Corporate Affairs Tom Burns – Chief Executive Officer Alex Thurman – Chief Financial Officer Joe Gilliam – President and Chief Operating Officer Conference Call Participants Ryan Zimmerman – BTIG Tom Stephan – Stifel Larry Biegelsen – Wells Fargo George Sellers – Stephens, Inc. Margaret Kaczor – William Blair Phil Dantoin – Piper Sandler David ...
Glaukos(GKOS) - 2022 Q3 - Earnings Call Transcript
2022-11-05 02:26
Glaukos Corporation (NYSE:GKOS) Q3 2022 Earnings Conference Call November 2, 2022 4:30 PM ET Company Participants Chris Lewis - Vice President-Investor Relations & Corporate Affairs Tom Burns - Chairman & Chief Executive Officer Joe Gilliam - President & Chief Operating Officer Alex Thurman - Chief Financial Officer Conference Call Participants David Saxon - Needham & Company Tom Stephan - Stifel George Sellers - Stephens Inc Allen Gong - JPMorgan Operator Welcome to the Glaukos Corporation Third Quarter 20 ...