EyePoint Pharmaceuticals(US:EYPT)2019-05-10 20:07Product Launch and Indications - YUTIQ and DEXYCU were launched directly in the U.S. in February and March 2019, respectively, following FDA approvals in October 2018 and February 2018[131]. - YUTIQ is indicated for chronic non-infectious uveitis affecting the posterior segment of the eye, impacting 55,000 to 120,000 people annually in the U.S., with 30,000 new cases of blindness each year[132]. - DEXYCU is indicated for post-operative ocular inflammation and is the first long-acting intraocular product approved by the FDA for this indication, with approximately 4.8 million cataract surgeries performed in the U.S. in 2018[133]. Market Access and Sales Performance - As of April 30, 2019, YUTIQ has been included in nine academic formularies, with an additional eleven pending inclusion, and over 93% of commercial lives covered[138]. - Since the launch of YUTIQ, over 100 orders have been shipped, and 95% of the top decile of uveitis specialists have been visited by Key Account Managers[138]. - For DEXYCU, over 1,200 patients have been injected, and 34 Key Account Managers have been engaged to promote the product[139]. - Market access initiatives for DEXYCU resulted in 90% of commercial lives covered and 100% of Medicare Fee-For-Service lives covered as of April 30, 2019[139]. Clinical Data and Safety Profile - The 36-month follow-up data for YUTIQ showed a 56.3% recurrence rate of uveitis eye flares, significantly lower than the 92.9% rate for sham-treated eyes[140]. - DEXYCU's mean intraocular pressure (IOP) was only slightly elevated post-surgery, returning to baseline by Day 3, supporting its safety profile[144]. Financial Performance - Total revenues for the three months ended March 31, 2019, increased by 117% to $2,012,000 compared to $928,000 for the same period in 2018[146]. - Product sales, net, totaled $1,227,000 for the quarter, with $543,000 from YUTIQ and $684,000 from DEXYCU, marking a significant increase from zero product revenue in the same quarter of 2018[147]. - Collaborative research and development revenues decreased by 88% to $65,000, primarily due to the absence of $465,000 in revenues from a feasibility study agreement[148]. - Royalty income rose by 78% to $720,000, driven by an increase in the net sales-based royalty rate from 2% to 4%[149]. Operating Expenses and Losses - Total operating expenses surged by 197% to $16,663,000, up from $5,606,000 in the prior year, largely due to increased sales and marketing expenses[146]. - Research and development expenses increased by 14% to $3,797,000, attributed to higher personnel costs and medical affairs program expenses[151]. - Sales and marketing expenses reached $7,311,000, reflecting the build-out of commercial infrastructure for DEXYCU and YUTIQ[152]. - General and administrative expenses rose by 102% to $4,610,000, primarily due to increased personnel and consulting expenses[153]. - The company reported a net loss of $19,238,000 for the quarter, compared to a net loss of $6,978,000 in the same quarter of 2018, representing a 176% increase in losses[146]. Cash Flow and Financial Position - As of March 31, 2019, the company had a total accumulated deficit of $427.7 million, financed primarily through equity sales and debt issuance[160]. - Early sales of YUTIQ and DEXYCU have been encouraging, with optimism that existing cash and cash equivalents of $43.4 million as of April 30, 2019, will fund operations until positive cash flow is generated in 2020[169][179]. - The net loss for the three months ended March 31, 2019, was $19.2 million, an increase of $12.3 million compared to a net loss of $7.0 million for the same period in 2018[172]. - Operating cash outflows for the three months ended March 31, 2019, totaled $13.3 million, primarily due to the net loss[172]. - Net cash provided by financing activities for the three months ended March 31, 2019, was $11.6 million, including $34.1 million from the initial drawdown under the CRG Loan Agreement[175]. - Net cash used in investing activities for the three months ended March 31, 2019, was $182,000, primarily for purchases of property and equipment[174]. Future Outlook and Concerns - The company has no history of direct commercialization of any products, raising substantial doubt about its ability to continue as a going concern for one year from the issuance of the financial statements[170]. - The company is uncertain about the availability of additional capital and the terms under which it may be obtained, which could affect its operations and product development[171]. - The company is focused on the commercialization of DEXYCU and YUTIQ, with success dependent on patient and physician acceptance and reimbursement coverage[168].