Glaukos(GKOS)

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Glaukos' (GKOS) iDose TR Receives Permanent J- Code From CMS
Zacks Investment Research· 2024-04-04 17:05
Glaukos Corporation (GKOS) recently announced that its prostaglandin analog iDose TR (travoprost intracameral implant) 75 mcg was assigned permanent Healthcare Common Procedure Coding System J-code by the U.S. Centers for Medicare and Medicaid Services (CMS). This prostaglandin analog is indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.The new J-code for iDose TR, J7355, is likely to become effective starting Jul 1, 2024. It is expected to ...
Here's Why You Should Retain Glaukos (GKOS) Stock for Now
Zacks Investment Research· 2024-03-13 13:01
Glaukos Corporation (GKOS) is well-poised for growth on the back of favorable clinical trial results and a robust product pipeline. However, stiff competition is a concern.Shares of this currently Zacks Rank #3 (Hold) company have risen 15.3% in the past six months compared with the industry’s 13.6% growth. The S&P 500 Index has also increased 12.7% in the same time frame.Glaukos, with a market capitalization of $4.3 billion, is a leading ophthalmic medical technology and pharmaceutical company. It projects ...
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 ...