EyePoint Pharmaceuticals Reports Second Quarter 2019 Financial Results and Highlights Recent Company Progress
– Company reports total revenue of
– Two commercial product launches in U.S. are underway for DEXYCU®and YUTIQ®with 43 sales reps actively targeting uveitis specialists, cataract surgeons and ambulatory surgical centers –
– YUTIQ receives specific and permanent J Code, effective
– Over 400 physicians have completed a certification program and are now certified to purchase and administer DEXYCU –
– Management to host a conference call and webcast today at 8:30 AM ET –
“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
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
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 Medicarepatients being covered and benefit investigations being approved for over 95% of Medicareadvantage 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 Advantageand commercial plan patients.
- At the 37th Annual Scientific Meeting of the
American Society of Retina Specialists(ASRS) that took place July 26-30, 2019in 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.
Scott Joneswas appointed Chief Commercial Officer in June 2019and 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 Developmentat Collegium Pharmaceutical, where his responsibilities included managing formulation development, clinical trial manufacturing, and commercial manufacturing for immediate, delayed and controlled release dosage forms.
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
Net revenue from royalties and collaborations for the three months ended
Operating expenses for the three months ended
Review of Six Months Results Ended June 30, 2019
For the six months ended
Operating expenses for the six months ended
Cash and cash equivalents at June 30, 2019 totaled $44.2 million compared to $45.3 million at December 31, 2018.
Given that the Company’s two commercial products, YUTIQ and DEXYCU, have not yet established a consistent sales trajectory, guidance regarding the timing of positive cash flow is not being provided at this time. We expect that the Company’s existing cash and cash equivalents at
Conference Call Information
EyePoint will host a conference call today, Wednesday, August 7, 2019 at 8:30 AM ET to discuss the results for the second quarter ended
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about our commercialization of YUTIQ and DEXYCU, the potential for our products to alter the treatment landscape for ocular diseases; the expected use of proceeds from our debt refinancing and equity offering and our expectation that the Company’s existing cash and cash equivalents at
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Product sales, net||$||6,705||$||-||$||7,932||$||-|
|Collaborative research and development||5||218||70||742|
|Cost of sales, excluding amortization of|
|acquired intangible assets||706||-||1,035||-|
|Research and development||3,955||4,765||7,753||8,090|
|Sales and marketing||7,284||1,512||14,595||1,512|
|General and administrative||4,815||4,220||9,425||6,501|
|Amortization of acquired intangible assets||615||-||1,230||-|
|Total operating expenses||17,375||10,497||34,038||16,103|
|Loss from operations||(10,165||)||(9,782||)||(24,816||)||(14,460||)|
|Other income (expense), net|
|Interest and other income||266||27||509||52|
|Loss on extinguishment of debt||-||-||(3,810||)||-|
|Change in fair value of derivative liability||-||(23,953||)||-||(26,278||)|
|Total other expense, net||(1,333||)||(24,646||)||(5,920||)||(26,946||)|
|Net loss per common share:|
|Basic and diluted||$||(0.11||)||$||(0.62||)||$||(0.30||)||$||(0.82||)|
|Weighted average common shares outstanding:|
|Basic and diluted||106,238||55,387||100,847||50,542|
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$||44,161||$||45,261|
|Other current assets||4,814||1,713|
|Total current assets||58,573||47,601|
|Operating lease right-of-use assets||3,291||-|
|Intangible assets, net||28,899||30,129|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||10,280||$||6,429|
|Accrued development milestone||-||15,000|
|Operating lease liabilities - current||441||-|
|Total current liabilities||10,721||21,459|
|Operating lease liabilities - noncurrent||3,149||-|
|Other long-term liabilities||3,000||1,455|
|Accumulated other comprehensive income||840||839|
|Total stockholders' equity||28,210||37,633|
|Total liabilities and stockholders' equity||$||91,330||$||78,168|
Source: EyePoint Pharmaceuticals, Inc.