Glaukos(US:GKOS)2025-10-30 22:53Financial Performance - Net sales for the three months ended September 30, 2025, were $133.5 million, a 38.1% increase from $96.7 million in the same period of 2024[123] - Gross margin for the three months ended September 30, 2025, was 78%, compared to 77% for the same period in 2024[123] - The company incurred net losses of $16.2 million and $54.0 million for the three and nine months ended September 30, 2025, respectively, compared to net losses of $21.4 million and $112.8 million for the same periods in 2024[123] - Net sales for the nine months ended September 30, 2025, were $364.3 million, a 31% increase from $278.0 million in the same period of 2024[182] - U.S. net sales of glaucoma products increased by 48% to $212.2 million, driven by higher volumes of iDose TR[183] - International sales of glaucoma products rose by 18% to $89.7 million, with significant growth in key markets like France, Japan, and the UK[184] - Gross profit for the nine months ended September 30, 2025, was $284.3 million, reflecting a gross margin of 78%, up from 76% in 2024[186] Expenses - SG&A expenses increased by 30% to $83.0 million for the three months ended September 30, 2025, up from $64.0 million in 2024[173] - R&D expenses rose by 10% to $38.1 million for the three months ended September 30, 2025, compared to $34.7 million in 2024[177] - Selling, general and administrative (SG&A) expenses increased by 23% to $237.0 million, with $17.1 million attributed to increased compensation and related employee costs[189] - Research and development (R&D) expenses totaled $107.0 million, with $75.6 million in core R&D and $31.4 million in clinical expenses[191] Cash Flow and Investments - Cash and cash equivalents as of September 30, 2025, totaled approximately $98.2 million, with short-term investments at $175.5 million[198] - Operating activities used $21.6 million in net cash for the nine months ended September 30, 2025, a significant improvement from $61.8 million used in the same period of 2024[207] - The company plans to invest over $80.0 million in a new 200,000 square foot R&D and manufacturing facility in Huntsville, Alabama, with construction expected to begin in 2026[204] - For the nine months ended September 30, 2025, the company received $18.2 million from stock options and employee stock purchases[216] - For the nine months ended September 30, 2024, the company received $36.9 million from stock options and employee stock purchases[217] Market Developments - The company received FDA approval for Epioxa on October 20, 2025, which is the first incision-free topical drug therapy for keratoconus, with plans to commercialize in Q1 2026[125] - The approval of Epioxa is anticipated to disrupt the U.S. Corneal Health franchise as the market transitions from Photrexa to Epioxa[145] - The establishment of reimbursement for the iDose TR procedure is expected to increase utilization as it becomes more consistent across all MACs[142] - The international glaucoma business saw a positive impact of approximately 330 basis points on net sales growth for the three months ended September 30, 2025, primarily due to currency fluctuations[133] Challenges - The company experienced higher costs for certain components and raw materials due to ongoing supply chain challenges and inflationary pressures[129] - Non-operating income decreased to $0.4 million for the three months ended September 30, 2025, from $3.4 million in 2024, primarily due to changes in unrealized foreign currency amounts[179] - There have been no significant changes to material cash requirements as of September 30, 2025, compared to the previous disclosures[219] - There have been no material changes in exposure to market risk since December 31, 2024[225]