On August 7, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the second quarter ended June 30, 2019 and highlighted recent commercial and corporate developments (Press release, pSivida, AUG 7, 2019, View Source [SID1234538309]).
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"The physician feedback to date from our two commercial product launches, YUTIQ and DEXYCU, has been very positive, and we have seen a solid uptake in treatment volume along with tremendous progress in market access," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "Our field force has received similar reception and eagerness to meet from physicians in the office setting for YUTIQ and at ambulatory surgery centers (ASCs) for DEXYCU. Our efforts on training and certifying physicians during our phased launch of DEXYCU are generating sales momentum with a solid start in July, as evidenced by the number of ASCs purchasing product for the first time, as well as repeat purchases. YUTIQ continues to address a large unmet need for patients afflicted with chronic non-infectious posterior segment uveitis and July sales remain on a solid upward trajectory with the number of ordering physicians increasing month over month. With the recently accelerated October 1, 2019 effective date of a permanent and specific J code for YUTIQ, J7413, payor approval and reimbursement will soon become even easier and more streamlined."
Ms. Lurker continued, "Physicians are now actively seeing the clinical results of both YUTIQ and DEXYCU with their patients and to date have experienced positive efficacy and safety results as seen in the pivotal clinical studies. We are very proud to have launched our two exciting ophthalmic products, YUTIQ and DEXYCU, and to bring these innovative products to patients in need."
"In an effort to support our commercial activities we have enhanced our leadership team with the appointments of Scott Jones as Chief Commercial Officer and Said Saim, Ph.D., as Chief Technology Officer. We look forward to making further progress in growing the reach of our commercially available products and advancing the balance of our pipeline to deliver much-needed innovation to ophthalmic patients," concluded Ms. Lurker.
Commercial Performance in Second Quarter 2019
YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for chronic non-infectious uveitis affecting the posterior segment of the eye
10 Key Account Managers (KAMs) are dedicated to calling predominantly uveitis specialists across the U.S.
Since the February launch, approximately 95% of the top decile uveitis specialists have been visited by the 10 KAMs.
YUTIQ has been included in more than 20 Academic Formularies and is pending inclusion for an additional 8.
As of July 31, market access has been well established with 100% of Medicare patients being covered and benefit investigations being approved for over 95% of Medicare advantage and commercial plan patients.
DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following cataract surgery
33 KAMs dedicated to the promotion of DEXYCU have focused on a phased launch program to ensure proper physician training for the preparation, application and administration of DEXYCU
Since launch, over 400 surgeons in more than 275 ambulatory surgical centers (ASCs) have completed the training/certification program and are now able to purchase DEXYCU.
Since launch, over 4,200 patients have been injected with DEXYCU via the Company’s sampling program.
Since launch, over 3,000 medical professionals and office staff have been called on to discuss DEXYCU.
As of July 31, our market access initiatives have resulted in 100% of Medicare Fee-For-Service lives being covered and benefit investigations being approved for over 90% of Medicare Advantage and commercial plan patients.
R&D Highlights
At the 37th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) that took place July 26-30, 2019 in Chicago, three podium presentations highlighted data supporting YUTIQ for the treatment of non-infectious posterior segment uveitis. Highlights from each of the presentations include
Results at the 36-month follow up of the Phase 3 trial of YUTIQ demonstrated that visual acuity gains of 3-lines were more common with YUTIQ (33% vs 15%) and losses were more common with sham (9% vs 1%).
At 36-months, the recurrence rate in YUTIQ randomized eyes was significantly lower than in sham treated eyes (56.3% vs. 92.9%, respectively; p<0.001). The number of eyes with at least 1 recurrence was 49 for YUTIQ and 39 for sham treated eyes, with total recurrences of 103 for YUTIQ and 166 for sham treated eyes. The median time to the first recurrence was 1,051 days for YUTIQ (95% CI 686, 1,125) and 95 days for sham-treated eyes (95% CI 71, 117).
Safety data showed 19.5% of YUTIQ treated eyes needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 69.0% for sham treated eyes.
Corporate Updates
Scott Jones was appointed Chief Commercial Officer in June 2019 and will lead the Company’s sales and marketing efforts for the Company’s two ophthalmic commercial products. Mr. Jones brings significant experience commercializing drugs and devices globally to EyePoint. Most recently, he served as Chief Commercial Officer and Vice President, Business Development at Notal Vision, where he developed the commercial and growth strategy for the organization.
Also in June 2019, Said Saim, Ph.D., was appointed Chief Technology Officer, a newly created position at the Company, where he will be responsible for advancing EyePoint’s pipeline products and technology for ocular treatments from formulation, preclinical research up to clinical development, as well as pharmaceutical sciences, manufacturing and operations. Dr. Saim has more than 25 years of product development experience. He most recently served as Vice President, Pharmaceutical Development at Collegium Pharmaceutical, where his responsibilities included managing formulation development, clinical trial manufacturing, and commercial manufacturing for immediate, delayed and controlled release dosage forms.
In July 2019, Wendy DiCicco, CPA, was appointed to the Company’s Board of Directors and Audit Committee, where she serves as Chair of the Committee. Ms. DiCicco most recently was Chief Operating and Financial Officer of Centinel Spine, a privately-held designer, developer and worldwide distributor of spinal implants, where she established the Company’s international operations, and was instrumental in both the recapitalization of the Company’s financial structure as well as active in corporate development initiatives.
Review of Second Quarter Results Ended June 30, 2019
For the three months ended June 30, 2019, total revenue was $7.2 million. Net product revenue was $6.7 million generated from sales of YUTIQ. Due to adequate inventory stocking by the Company’s distributor, Cardinal Health, ahead of the mid-March launch prior to the end of the first quarter, DEXYCU did not generate product revenue during the second quarter of 2019. Neither of these products had net revenue in the corresponding quarter in 2018.
Net revenue from royalties and collaborations for the three months ended June 30, 2019 totaled $505,000 compared to $715,000 in the corresponding quarter in 2018.
Operating expenses for the three months ended June 30, 2019 increased to $17.4 million from $10.5 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation and cost of sales related to product revenue. Non-operating expense, net, for the three months ended June 30, 2019 totaled $1.3 million of net interest expense. Net loss for the three months ended June 30, 2019 was $11.5 million, or $0.11 per share, compared to a net loss of $34.4 million, or $0.62 per share, for the prior year quarter.
Review of Six Months Results Ended June 30, 2019
For the six months ended June 30, 2019, total net product revenue was $7.9 million. Neither product had net revenue in the corresponding period in 2018. Net revenue from royalties and collaborations for the six months ended June 30, 2019 totaled $1.3 million compared to $1.6 million in the corresponding period in 2018.
Operating expenses for the six months ended June 30, 2019 increased to $34.0 million from $16.1 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation, cost of sales related to product revenue and amortization of the DEXYCU intangible asset. Non-operating expense, net, for the six months ended June 30, 2019 totaled $5.9 million and consisted of $2.1 million of net interest expense and $3.8 million from the loss on extinguishment of debt related to the payoff of the SWK term loan. Net loss for the six months ended June 30, 2019 was $30.7 million, or $0.30 per share, compared to a net loss of $41.4 million, or $0.82 per share, for the prior year period.
Cash and cash equivalents at June 30, 2019 totaled $44.2 million compared to $45.3 million at December 31, 2018.
Financial Outlook
Given that the Company’s two commercial products, YUTIQ and DEXYCU, have not yet established a consistent sales trajectory, guidance regarding the timing of positive cash flow is not being provided at this time. We expect that the Company’s existing cash and cash equivalents at June 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund our operating plan into 2020.
Conference Call Information
EyePoint will host a conference call today, Wednesday, August 7, 2019 at 8:30 AM ET to discuss the results for the second quarter ended June 30 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 5175125. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.