EyePoint Pharmaceuticals Reports Third Quarter 2019 Financial Results and Highlights Recent Corporate Progress
– U.S. commercial launch trajectory for DEXYCU® and YUTIQ® gains momentum with strong customer order growth over Q2 –
– DEXYCU customer orders increased 207% over Q2 with repeat customers representing 74% of order volume –
– YUTIQ customer orders up 17% over Q2 with repeat customers representing 85% of order volume and prior to effective date of permanent J-Code –
– Announced access to large integrated payor networks including
– Management to host a conference call and webcast today at 8:30 AM ET –
“We are pleased with the strong growth in customer orders during the quarter as our sales team is making significant progress in penetrating targeted accounts for both DEXYCU® and YUTIQ®,” said Nancy Lurker, President and Chief Executive Officer of
Commercial Performance in Third Quarter 2019
DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery
- Customer orders up 207% over Q2 with September representing the highest volume month to date, and with repeat customers representing 74% of Q3 order volume.
- The average time for an account to re-order dropped from 4.8 weeks during Q2 to 2.5 weeks during Q3, as customers incorporate DEXYCU as part of their surgical protocol.
Medicarefee for service claims continue to be paid consistently, and Medicare Advantageand Commercial insurance claims increased quarter over quarter.
- The average time to payment in all payor sectors continues to improve post launch. We expect the time to payment to decrease as payor systems incorporate DEXYCU’s J-Code.
- Since launch, over 5,400 patients have been injected with DEXYCU. In that time, over 500 physicians have been trained to use the product.
YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for chronic non-infectious uveitis affecting the posterior segment of the eye
- Customer orders up 17% over Q2, prior to effective date of a permanent J-Code.
- Repeat customers represented 85% of order volume, and importantly, 40% of the target account list has ordered, representing solid adoption with continued growth opportunity.
Medicarefee for service claims paid consistently and Medicare Advantageand Commercial payors beginning to cover YUTIQ.
- The permanent and specific J-Code, J7314, was issued by the
Centers for Medicare and Medicaid Services(CMS) one quarter earlier than under prior CMS policy and is in effect as of October 1, 2019.
November 2019, EyePoint announced two new agreements to expand the reach of DEXYCU and YUTIQ within large integrated healthcare networks. An interim agreement with the U.S. Department of Veterans Affairs(VA) became effective on November 2, 2019, adding DEXYCU and YUTIQ to the Federal Supply Schedule. The VA serves approximately nine million beneficiaries. A final VA contract is anticipated within several months and is expected to have a five-year term. In addition, a three-year contract was signed with Vizient Inc., effective November 1, 2019, offering DEXYCU to its diverse membership network. Vizientprovides solutions and services to over 50% of the nation’s acute care providers, including 95% of the nation’s academic medical centers, and more than 20% of ambulatory care providers.
August 2019, EyePoint received a $1 millionmilestone payment from Ocumension Therapeutics triggered by the approval of its Investigational New Drug (IND) in Chinafor Eyepoint’s three-year intravitreal micro-insert containing 0.18mg of fluocinolone acetonide using the Durasert™ technology (known as YUTIQ in the United States). The IND allows the importation of finished product into Chinafor use in its initiated clinical trial to support regulatory approval for the treatment of chronic uveitis affecting the posterior segment of the eye. Ocumension has also received a special approval by the Hainan Province People's Government to market this product for chronic, non-infectious posterior segment uveitis in the Hainan Bo Ao Lecheng International Medical Tourism Pilot Zone.
- Two oral presentations highlighting 36-month data supporting YUTIQ for the treatment of non-infectious uveitis affecting the posterior segment of the eye occurred at the annual
Retina Societymeeting held in London, United Kingdom, on September 11-15, 2019. The first presentation “Minimizing Uveitic Recurrences: Results from a 36M Study of Fluocinolone Acetonide Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment” concluded that treatment with YUTIQ not only resulted in a reduction in the 3-year rate of uveitic recurrences but that YUTIQ also reduced the cumulative number of inflammatory episodes in eyes that did relapse. The second presentation, “The Use of Adjunctive Anti-inflammatory Medications: Results from a 36M Study of a Fluocinolone Acetonide Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis (NIPU) Affecting the Posterior Segment” highlighted that the treatment with a single intravitreal injection of YUTIQ significantly reduced the need for adjunctive therapies in this group of patients.
- YUTIQ was highlighted in separate events at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting held October 12 – 15, 2019 in San Francisco, CA. First, an oral presentation entitled, “Effect of Fluocinolone Acetonide Insert on the Presence of Uveitic Macular Edema: Outcomes at 36 Months” was presented at a well-attended session at the Retina Subspecialty Day and demonstrated the long-term durability of YUTIQ for this difficult to treat ocular disease. Additionally, a poster entitled, “Fluocinolone Acetonide Intravitreal Insert for Noninfectious Posterior Uveitis: Analysis of Significant IOP Elevation” provided further evidence of the favorable safety and tolerability profile of YUTIQ.
Review of Results for Third Quarter Ended September 30, 2019
For the three months ended September 30, 2019, total revenue was $2.5 million. Net product revenue was $1.0 million, primarily generated from sales of DEXYCU.
DEXYCU and YUTIQ are sold through a distributor under a title model and, accordingly, product revenue is recognized as inventory is shipped to the distributor and title transfers. Due to this title model, quarterly reported revenue and underlying customer sales will likely track separately for an extended period of time beyond initial launch, as customer demand patterns may not align with the distributor’s inventory restocking procedures.
Net revenue from licenses, royalties and collaborations for the three months ended September 30, 2019 totaled $1.5 million compared to $486,000 in the corresponding quarter in 2018.
Operating expenses for the three months ended September 30, 2019 increased to $16.6 million from $14.0 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, and cost of sales related to product revenue, partially offset by a decrease in research and development expense. Non-operating expense, net, for the three months ended September 30, 2019 totaled $1.6 million of net interest expense. Net loss for the three months ended September 30, 2019 was $15.6 million, or $0.15 per share, compared to a net loss of $33.1 million, or $0.44 per share, for the prior year quarter.
Review of Nine Months Results Ended
For the nine months ended
Operating expenses for the nine months ended
Cash and cash equivalents at September 30, 2019 totaled $31.8 million compared to $44.2 million at June 30, 2019.
We expect that the Company’s existing cash and cash equivalents at September 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund the Company’s operating plan into 2020.
Conference Call Information
EyePoint will host a conference call today, Thursday, November 7, 2019 at 8:30 AM ET to discuss the results for the third quarter ended September 30 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 3149087. A live webcast will be available on the Investor Relations section of the corporate website at http://www.eyepointpharma.com. A replay of the webcast will also be available on the corporate website.
About EyePoint Pharmaceuticals
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about our commercialization of YUTIQ and DEXYCU, the potential for our products to alter the treatment landscape for ocular diseases; our expectations regarding the regulatory review of our sNDA filing for our YUTIQ line extension shorter-acting treatment for non-infectious uveitis affecting the posterior segment of the eye; the expected use of proceeds from our debt refinancing and equity offering and our expectation that the Company’s existing cash and cash equivalents at
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands except per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Product sales, net||$||1,009||$||—||$||8,941||$||—|
|License and collaboration agreement||1,054||56||1,125||798|
|Cost of sales, excluding amortization of acquired intangible assets||327||—||1,363||—|
|Research and development||3,484||6,233||11,237||14,323|
|Sales and marketing||7,778||3,646||22,373||5,158|
|General and administrative||4,365||4,161||13,790||10,662|
|Amortization of acquired intangible assets||615||—||1,845||—|
|Total operating expenses||16,569||14,040||50,608||30,143|
|Loss from operations||(14,060||)||(13,554||)||(38,876||)||(28,014||)|
|Other income (expense):|
|Interest and other income, net||183||129||692||181|
|Loss on extinguishment of debt||—||—||(3,810||)||—|
|Change in fair value of derivative liability||—||(18,886||)||—||(45,164||)|
|Total other expense, net||(1,587||)||(19,572||)||(7,507||)||(46,518||)|
|Net loss per share - basic and diluted||$||(0.15||)||$||(0.44||)||$||(0.45||)||$||(1.27||)|
|Weighted average shares outstanding - basic and diluted||106,938||75,170||102,900||58,840|
|EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash and cash equivalents||$||31,760||$||45,261|
|Accounts and other receivables, net||8,855||627|
|Other current assets||6,446||1,713|
|Total current assets||47,061||47,601|
|Operating lease right-of-use assets||3,186||—|
|Intangible assets, net||28,284||30,129|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||9,907||$||6,429|
|Accrued development milestone||—||15,000|
|Operating lease liabilities - current portion||461||—|
|Total current liabilities||10,368||21,459|
|Operating lease liabilities - noncurrent||3,028||—|
|Other long-term liabilities||3,000||1,455|
|Accumulated other comprehensive income||840||839|
|Total stockholders' equity||15,938||37,633|
|Total liabilities and stockholders' equity||$||79,067||$||78,168|
Source: EyePoint Pharmaceuticals, Inc.