EyePoint Pharmaceuticals Reports Fiscal Third Quarter 2018 Results
Completed Substantive Strategic Initiatives to Accelerate Transformation to a
Conference Call and Webcast Today,
"The acquisition of
Key Recent Accomplishments
- Acquired privately-held
Icon Bioscience, Inc.and its FDAapproved product, DEXYCU™.
- DEXYCU was approved by the
FDAon 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, 2018PDUFA 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 Partnerswith 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 Exchangeeffective as of May 7, 2018.
Strengthened Balance Sheet
- The Company had cash and cash
$16.3 millionat March 31, 2018and, subject to stockholder approval at a special meeting of shareholders scheduled for June 22, 2018, has capital commitments of an additional $30.5 millionfrom EW Healthcare, a third-party investor and SWK. Therefore, the Company is currently projecting a cash balance of approximately $38.0 millionat 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 Healthcareat the June 22, 2018special 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.
FDAapproval 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 Vancouverfrom July 20-25.
- Launch DEXYCU and YUTIQ (subject to
FDAapproval) in the first half of calendar 2019.
Fiscal Third Quarter and Nine-Month Results
Revenue for the third fiscal quarter ended
Revenue for the nine months ended
In connection with the first tranche
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 http://www.eyepointpharma.com.
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.
DEXYCU (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation. WARNINGS AND PRECAUTIONS - Increase in Intraocular Pressure - Steroids should be used with caution in the presence of glaucoma. Delayed Healing - The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Exacerbation of Infection - The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections. Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. Cataract Progression - The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts. ADVERSE REACTIONS - The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis. Please see full Prescribing Information.
EyePoint expects DEXYCU to be granted pass-through status and receive separate payment from Medicare for a period of three years. If after this three-year period, payments for DEXYCU are bundled into the Medicare payment for cataract surgery, the annual revenues generated from DEXYCU would be materially reduced, but if Medicare reimbursement is extended beyond three years then the Company anticipates the revenue potential of DEXYCU could be higher.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM 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 or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to needed capital; our ability to achieve our projected cash balance in future periods; fluctuations in our operating results;
successful commercialization of, and receipt of revenues from, ILUVIEN® for diabetic macular edema ("DME"), which depends on Alimera's ability to continue as a going concern; Alimera's ability to obtain marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN; the number of clinical trials and data required for marketing approval of YUTIQ in the
|FINANCIAL TABLES FOLLOW|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended||Nine Months Ended|
|Collaborative research and development||$||524||$||372||$||1,125||$||6,108|
|Research and development||3,325||3,324||11,413||10,667|
|General and administrative||2,281||2,426||7,325||8,611|
|Total operating expenses||5,606||5,750||18,738||19,278|
|Loss from operations||(4,678||)||(5,160||)||(16,492||)||(12,440||)|
|Interest and other income||25||20||74||71|
|Change in fair value of derivative liability||(2,325||)||-||(2,325||)||-|
|Net loss per common share:|
|Basic and diluted||$||(0.15||)||$||(0.15||)||$||(0.43||)||$||(0.36||)|
|Weighted average common shares outstanding:|
|Basic and diluted||45,644||34,366||43,184||34,238|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||16,346||$||16,898|
|Other current assets||1,329||842|
|Total current assets||17,675||17,740|
|Intangible assets, net||31,973||364|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||5,975||$||5,240|
|Accrued development milestone||15,000||-|
|Total current liabilities||21,215||5,290|
|Other long-term liabilities||938||51|
|Accumulated other comprehensive income||837||833|
|Total stockholders' equity||8,198||13,336|
|Total liabilities and stockholders' equity||$||50,158||$||18,677|
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