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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
Financial Performance - Net sales for the year ended December 31, 2022, were $282,862,000, a decrease of 3.8% from $294,011,000 in 2021[310]. - Gross profit for 2022 was $213,883,000, down from $227,384,000 in 2021, reflecting a gross margin of approximately 75.7%[310]. - The net loss for 2022 was $99,195,000, compared to a net loss of $49,593,000 in 2021, resulting in a basic and diluted net loss per share of $2.09[310]. - The company reported a total loss before income taxes of $98.4 million for the year ended December 31, 2022, compared to a loss of $49.3 million in 2021[451]. - The company reported a net loss of $31.460 million for the fourth quarter of 2022, compared to a net loss of $27.576 million in the third quarter of 2022[482]. Assets and Liabilities - Total assets decreased to $1.002 billion in 2022 from $1.050 billion in 2021, a decline of 4.5%[309]. - Total liabilities increased to $472.378 million in 2022 from $462.547 million in 2021, a rise of 2%[309]. - The accumulated deficit grew to $464.406 million in 2022 compared to $365.211 million in 2021, reflecting an increase of 27.2%[309]. - The company reported a total stockholders' equity of $530.005 million in 2022, down from $587.151 million in 2021, a decrease of 9.7%[309]. - The fair value of the company's Convertible Senior Notes was $331.9 million as of December 31, 2022, down from $341.8 million in 2021[394]. Cash Flow and Investments - Cash and cash equivalents increased to $119.525 million in 2022 from $100.708 million in 2021, representing a growth of 18.5%[309]. - Cash, cash equivalents, and restricted cash at the end of 2022 totaled $126,603,000, an increase from $110,124,000 at the end of 2021[316]. - The company reported a net cash used in operating activities of $33,083,000 for 2022, compared to net cash provided of $24,708,000 in 2021[316]. - The Company plans to fund its operations and capital needs using existing cash and investments, including net proceeds from convertible notes issued in June 2020 and payments from Ivantis, Inc.[321]. - The Company has a total of $237.724 million in short-term investments as of December 31, 2022, with an estimated fair value of $233.170 million after accounting for unrealized losses[378]. Research and Development - Research and development expenses rose to $123,271,000 in 2022, up from $100,999,000 in 2021, indicating a focus on innovation and product development[310]. - Total operating expenses increased to $296,196,000 in 2022, compared to $260,256,000 in 2021, primarily due to higher research and development costs[310]. - Research and development expenses include personnel costs and clinical trials, with no material adjustments to prior period accrued estimates for clinical trial activities through December 31, 2022[365][366]. Inventory and Receivables - Inventory rose significantly to $37.841 million in 2022, up from $23.011 million in 2021, marking a 64.3% increase[309]. - Accounts receivable increased to $36.073 million in 2022 from $33.438 million in 2021, a growth of 7.9%[309]. - As of December 31, 2022, accounts receivable increased to $37.3 million from $34.8 million in 2021, with an allowance for credit losses of $1.25 million[381]. Foreign Currency and Hedging - The company has not entered into any foreign currency hedging contracts but may consider doing so in the future as international operations grow[295]. - A hypothetical 10% increase or decrease in foreign exchange rates would have had an immaterial impact on the company's net loss as of December 31, 2022[297]. - The company reported a foreign currency translation gain of $985,000 in 2022, compared to a gain of $781,000 in 2021, indicating some positive impact from currency fluctuations[312]. Stock-Based Compensation - The total stock-based compensation expense for the year ended December 31, 2022, was $38.6 million, compared to $30.1 million in 2021[449]. - The weighted average estimated grant date fair value per share of time-based stock options granted in 2022 was $25.43, compared to $43.43 in 2021 and $11.44 in 2020[436]. - The total fair value of time-based stock options that vested in 2022 was $3.6 million, down from $9.7 million in 2021 and $20.3 million in 2020[437]. Tax and Deferred Tax Assets - The company had approximately $449.1 million in federal NOL carryforwards available to offset future taxable income as of December 31, 2022[458]. - The company established a valuation allowance for deferred tax assets, with a net change of $27.9 million in 2022[457]. - The balance of gross unrecognized tax benefits increased to $28.968 million from $25.816 million in 2021, reflecting a net addition of $4.307 million for current year tax positions[462]. Lease and Facility - The Aliso Facility lease commenced on April 1, 2019, for thirteen years, with an option to extend for two additional five-year periods[396]. - Total lease assets decreased from $77,164 thousand in 2021 to $72,427 thousand in 2022, a decline of approximately 6.3%[399]. - Total lease liabilities decreased from $103,359 thousand in 2021 to $101,507 thousand in 2022, a decline of approximately 1.8%[399].
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 ...