On May 8, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the first quarter ended March 31, 2019, and highlighted recent corporate developments (Press release, pSivida, MAY 8, 2019, View Source [SID1234535925]).
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"The initial launches of our two commercial ocular products, DEXYCUTM and YUTIQTM, have generated a strong initial reception by treating physicians and patients, which we will look to leverage to drive sales growth in the coming quarters," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We are now a fully-integrated, commercial-stage specialty ophthalmology company and are very pleased with the early momentum we are seeing for our two new innovative ocular products, each of which have significant market potential. We are also optimistic that we are well-positioned financially to execute on our goals following the addition of a new credit facility in February with CRG and the recent equity offering that we completed in April to support our operations through to positive cash flow in 2020."
Recent Highlights
YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye was made commercially available on February 4, 2019. YUTIQ received a preliminary recommendation from the Centers for Medicare & Medicaid Services (CMS) for a specific J-code through the Healthcare Common Procedure Coding System (HCPCS).
Ten 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 10 KAMs.
Since launch, over 100 YUTIQ orders have been shipped for use in patients.
Over 300 benefit investigations have been received.
YUTIQ has been included in 9 academic formularies and is pending inclusion for an additional 11.
As of April 30, our market access initiatives have resulted in over 93% of commercial lives covered, over 75% of Medicare Advantage lives covered and 95% of Medicare Fee-For-Service lives covered.
DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following cataract surgery was made commercially available on March 12, 2019.
34 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, nearly 200 surgeons in more than 150 ambulatory surgical centers (ASCs) have completed the training/certification program and are now able to purchase DEXYCU.
Since launch, over 1,200 patients have been injected with DEXYCU via the Company’s sampling program.
Since launch, over 2,000 medical professionals and office staff have been called on to discuss DEXYCU.
As of April 30, our market access initiatives have resulted in over 90% of commercial lives covered, over 75% of Medicare Advantage lives covered and 100% of Medicare Fee-For-Service lives covered.
At the 2019 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Vancouver, British Columbia, 36-month efficacy and safety data supporting YUTIQ was presented in an oral session entitled, "Treatment of Non-infectious Uveitis that Affects the Posterior Segment with a Single Intravitreal Fluocinolone Acetonide Insert (FAi) – 3-year Results." The 36-month follow up data of the Phase 3 clinical trial of YUTIQ showed a 56.3% recurrence rate of uveitis eye flares, significantly lower than eyes treated with sham (92.9%). The p-value was <0.001. 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. 34.5% of YUTIQ treated eyes needed the assistance of an adjunctive systemic steroid or immunosuppressant compared to 50.0% for sham treated eyes. Intraocular pressure (IOP) lowering drops were used in 42% of YUTIQ treated eyes and 33% of sham treated eyes with IOP lowering surgeries performed in 6% of YUTIQ treated eyes and 12% of sham treated eyes. Safety and side effects were consistent with those reported for previous analyses of earlier timepoints. These durable 36-month results continue to reinforce the potential of YUTIQ as a long-acting treatment option for patients suffering from this chronic disease.
At the 2019 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting in San Diego, California, data supporting DEXYCU was presented in a paper session entitled, "Effect of Dexamethasone Intraocular Suspension 9% on IOP after Cataract Surgery: Results of Two Phase 3 Studies." An analysis of the IOP data from two Phase 3 studies of DEXYCU showed that the IOP effect of DEXYCU was comparable to short-term topically administered prednisolone acetate or placebo in cataract surgery patients. Mean IOP was only slightly elevated, to approximately 19 and 18 mmHg at postoperative Day 1 in the DEXYCU and prednisolone acetate arms, respectively, and it returned to baseline in both arms by Day 3. The proportion of patients at each measured IOP category in both studies were similar between the DEXYCU and control group cohorts. These data further support DEXYCU’s safety profile for the treatment of post-operative inflammation.
On April 1, 2019, the Company completed a public offering of 10,526,500 shares of its common stock at a public offering price of $1.90 per share. The net proceeds of the offering to the Company were approximately $18.6 million.
During April 2019, the Company exercised its option to draw an additional $15.0 million under the CRG Loan Agreement and paid a $15.0 million development milestone that was due to the former Icon security holders following the first commercial sale of DEXYCU. At April 30, 2019, the Company had $56.9 million of cash and cash equivalents.
Review of First Quarter Results Ended March 31, 2019
For the three months ended March 31, 2019, total net revenue was $2.0 million compared to $928,000 for the three months ended March 31, 2018. Net revenue from DEXYCU was $684,000, and for YUTIQ net revenue was $543,000. Neither of these products had net revenue in the corresponding quarter in 2018. Net revenue from royalties and collaborations for the three months ended March 31, 2019 totaled $785,000 compared to $928,000 in the corresponding quarter in 2018.
Operating expenses for the three months ended March 31, 2019 increased to $16.7 million from $5.6 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation and amortization of the DEXYCU intangible asset. Non-operating expense, net, for the three months ended March 31, 2019 totaled $4.6 million and consisted of $777,000 of net interest expense and $3.8M from the loss on extinguishment of debt related to the pay off of the SWK term loan. Net loss for the three months ended March 31, 2019 was $19.2 million, or $0.20 per share, compared to a net loss of $7.0 million, or $0.15 per share, for the prior year quarter.
Cash and cash equivalents at March 31, 2019 totaled $43.4 million compared to $45.3 million at December 31, 2018. At April 30, 2019, the total amount outstanding under the CRG debt facility was $50 million and cash and cash equivalents as of that date were $56.9 million.
Financial Outlook
Early sales of YUTIQ and DEXYCU have been encouraging, and the Company is optimistic that existing cash and cash equivalents at April 30, 2019, and cash inflows from anticipated YUTIQ and DEXYCU product sales, will be sufficient to fund the Company’s current and planned operations through to the generation of positive cash flow in 2020.
Conference Call Information
EyePoint will host a conference call today, Wednesday, May 8, 2019, at 8:30 AM ET to discuss the results for the first quarter ended March 31 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 1192368. 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.