On May 8, 2018 EyePoint Pharmaceuticals (NASDAQ:EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported operating and financial results for its fiscal 2018 third quarter and nine months ended March 31, 2018 and provided a company update (Press release, pSivida, MAY 8, 2018, View Source [SID1234526250]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The acquisition of Icon Bioscience, Inc. and its FDA approved product, DEXYCU, significantly increases EyePoint Pharmaceuticals’ revenue potential and accelerates our planned transformation to a sustainable growth company," said Nancy Lurker, President and Chief Executive Officer. "The combination of experienced executives leading our commercial team and the additional capital from EW Healthcare and SWK positions EyePoint to successfully execute on the launch of two new products in the first half of 2019, pending favorable regulatory review of YUTIQ. In addition, we anticipate the annual revenue potential for DEXYCU to be $150 – $200 million by the end of the third year on the market."
Key Recent Accomplishments
Acquired privately-held Icon Bioscience, Inc. and its FDA approved product, DEXYCU.
DEXYCU was approved by the FDA on February 9, 2018, for the treatment of postoperative inflammation and is administered as a single intraocular injection at the end of surgery.
EyePoint has expanded the DEXYCU global IP portfolio with Notices of Allowance for two additional patents, including potential claims relating to a method of treating inflammation of an eye following cataract surgery by delivering extremely small (4-6µL) amounts of dexamethasone in acetyl triethyl citrate. These two additional patents, once allowed, will extend to 2032 and 2034.
A New Drug Application (NDA) for YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg three-year treatment for noninfectious posterior segment uveitis was submitted to the Food and Drug Administration (FDA) in January and was accepted for filing in March with a November 5, 2018 PDUFA date.
EyePoint has enhanced the healthcare and capital markets expertise of the Board of Directors with the appointment of Ron Eastman, a Managing Director at EW Healthcare Partners with over 40 years of experience in building healthcare companies.
EyePoint has hired experienced executives to lead the Company’s commercial team and to ensure successful execution of the launches of DEXYCU and YUTIQ
EyePoint presented data on YUTIQ at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting.
EyePoint delisted from the Australian Securities Exchange effective as of May 7, 2018.
Strengthened Balance Sheet
The Company had cash and cash equivalents totaling $16.3 million at March 31, 2018 and, subject to stockholder approval at a special meeting of shareholders scheduled for June 22, 2018, has capital commitments of an additional $30.5 million from EW Healthcare, a third-party investor and SWK. Therefore, the Company is currently projecting a cash balance of approximately $38.0 million at June 30, 2018, the end of its current fiscal year.
The Company expects these proceeds will provide the financial resources to commence the launch of DEXYCU and YUTIQ.
Near-Term Goals and Upcoming Milestones
Gain approval of the second tranche investment by EW Healthcare at the June 22, 2018 special meeting of stockholders.
Implement the Company’s four-pillar commercialization plan:
— Complete the build out of the sales organization;
— Implement the marketing plan;
— Continue to progress market access programs; and
— Initiate medical education initiatives.
Secure pass-through reimbursement for DEXYCU.
Receive FDA approval for YUTIQ based on the PDUFA action date of November 5, 2018.
Present data at leading medical congresses, including for YUTIQ at the American Society of Retina Specialists (ASRS) annual meeting being held in Vancouver from July 20-25.
Launch DEXYCU and YUTIQ (subject to FDA approval) in the first half of calendar 2019.
Fiscal Third Quarter and Nine-Month Results
Revenue for the third fiscal quarter ended March 31, 2018, totaled $928,000 compared to $590,000 for the prior year quarter. Revenues in both periods were derived from feasibility study agreements and royalty income. Operating expenses for the three months ended March 31, 2018 decreased slightly to $5.6 million from $5.8 million a year earlier, due primarily to lower clinical trial costs and stock-based compensation expense, partially offset by higher regulatory and clinical consulting services in support of YUTIQ and higher personnel and related expenses. Net loss for the quarter ended March 31, 2018 was $7.0 million, or $0.15 per share, compared to a net loss of $5.1 million, or $0.15 per share, for the prior year quarter.
Revenue for the nine months ended March 31, 2018 was $2.2 million compared to $6.8 million for the nine months ended March 31, 2017. The prior year period included the recognition of deferred collaborative research and development revenue totaling $5.6 million resulting from the termination of the Pfizer collaboration agreement. Excluding Pfizer, revenues from feasibility study agreements and royalty income increased to $2.2 million for the nine months ended March 31, 2018 compared to $1.2 million in the prior year period. Operating expenses for the first nine months of fiscal 2018 were $18.7 million compared to $19.3 million a year earlier. Net loss for the nine months ended March 31, 2018 was $18.7 million, or $0.43 per share, compared to a net loss of $12.4 million, or $0.36 per share for the corresponding fiscal 2017 year-to-date period. There are currently 54,029,917 common shares outstanding.
In connection with the first tranche EW Healthcare investment, and subject to stockholder approval, the Company agreed to issue units to EW Healthcare and a participating third-party investor, with each unit consisting of the right to purchase (a) one share of Common Stock and (b) one warrant to purchase a share of Common Stock. The purchase price of the common stock and the exercise price of the warrant are both subject to price collars that provide for either a premium or discount to the original price paid in the first tranche investment by EW Healthcare. Because of the collar, the number of units to be issued will be subject to some variability. This second tranche investment will be voted upon at a special meeting of stockholders to be held on June 22, 2018. Accounting guidance required that the future obligation to issue units in the second tranche transaction be recorded as a derivative liability and to be re-measured to fair value at each balance sheet date. As a result of the initial re-measurement, the Company recorded a non-cash charge to non-operating expense of $2.3 million as change in fair value of derivative liability for the three and nine months ended March 31, 2018.
Conference Call Information
The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference ID is 1758647. A live webcast will be available on the Investor Relations section of the corporate website at View Source
A replay of the call will be available beginning May 8, 2018, at approximately 7:30 p.m. ET and ending on May 15, 2018, at 11:59 p.m. ET. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID Number: 1758647. A replay of the webcast will also be available on the corporate website during that time.