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EyePoint Pharmaceuticals Reports First Quarter 2019 Financial Results and Highlights Recent Company Progress - YUTIQ and DEXYCU commercially launched in 1Q2019 - - YUTIQ recommended for specific J-code by Centers for Med

Key Takeaway: EyePoint Pharmaceuticals Reports First Quarter 2019 Financial Results and Highlights Recent Company Progress DEXYCU commercially launched in 1Q2019 - - YUTIQ recommended for specific J-code by Centers for Medicare & Medicaid Services - and equity public offering generated ne

Full Press Release Details

EyePoint Pharmaceuticals Reports First Quarter 2019 Financial Results and Highlights
Recent Company Progress
DEXYCU commercially launched in 1Q2019 -
- YUTIQ recommended for
specific J-code by Centers for Medicare & Medicaid Services -
and equity public offering generated net proceeds of approximately $30.0 million -
- Company optimistic that current cash balance
and cash inflows from product sales to provide sufficient capital to fund operations through to positive cash flow in 2020 -
Management to host a conference call and webcast today at 8:30 AM ET -
WATERTOWN, Mass., May 8, 2019 - EyePoint Pharmaceuticals,
Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, today reported financial results for the first quarter ended March 31, 2019, and highlighted recent
corporate developments.
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.
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
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.
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 http://www.eyepointpharma.com. A replay of the
webcast will also be available on the corporate website.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (formerly pSivida Corp.) (www.eyepointpharma.com), headquartered in Watertown, MA, is a specialty biopharmaceutical company
committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. With the approval by the FDA on October 12, 2018 of the
YUTIQ three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, the Company has developed five of the six FDA-approved sustained-release treatments for eye diseases. The most common adverse reactions reported for YUTIQ were cataract development and increases in intraocular pressure. DEXYCU was approved by the FDA on February 9, 2018. DEXYCU, administered as a single intraocular dose at the end of ocular surgery for the treatment of postoperative inflammation, is the first and
only FDA-approved intraocular product with this indication. The most common adverse reactions reported by 5-15% of patients were increased intraocular pressure, corneal
edema and iritis. DEXYCU employs the Verisome extended-release drug delivery technology, which encompasses a broad number of related, but distinct drug delivery systems with the potential of
incorporating an extensive range of active agents, including small molecules, proteins and monoclonal antibodies. ILUVIEN (fluocinolone acetonide intravitreal implant), a micro-insert for
diabetic macular edema, licensed to Alimera Sciences, Inc. ( Alimera ), is currently sold directly in the U.S. and several EU countries. Retisert (fluocinolone acetonide
intravitreal implant), for non-infectious posterior segment uveitis, is licensed to and sold by Bausch & Lomb, Inc. The Company s pre-clinical development
program is focused on using its core Durasert and the Verisome platform technologies to deliver drugs to treat wet age-related macular degeneration,
glaucoma, and other diseases. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter, LinkedIn, Facebook and Google+.
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 optimism that our existing cash and cash
equivalents at April 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund our operations through to the generation of positive cash flow in 2020, 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 are risks and uncertainties inherent in our business
including, without limitation: our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient
commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and
DEXYCU; the regulatory approval and successful release of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; potential off-label sales of ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye; consequences of fluocinolone acetonide side effects for YUTIQ; consequences
of dexamethasone side effects for DEXYCU; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema, or DME; Alimera s ability to obtain additional marketing approvals and the effect of pricing and
reimbursement decisions on sales of ILUVIEN for DME; Alimera s ability to commercialize ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye in the territories in which Alimera is
licensed to do so; potential declines in Retisert royalties; our ability to market and sell products; the success of current and future license agreements; termination or breach of current license agreements; our dependence on contract research
organizations, contract sales organizations, vendors and investigators; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of
intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business
operations; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed,
anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations
expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated,
estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any
obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except per share amounts)
Three Months Ended March 31,
2019 2018
Revenues:
Product sales, net $ 1,227 $
Collaborative research and development 65 524
Royalty income 720 404
Total revenues 2,012 928
Operating expenses:
Cost of sales, excluding amortization of acquired intangible assets 330
Research and development 3,797 3,325
Sales and marketing 7,311
General and administrative 4,610 2,281
Amortization of acquired intangible assets 615
Total operating expenses 16,663 5,606
Loss from operations (14,651 ) (4,678 )
Other income (expense), net
Interest and other income 243 25
Interest expense (1,020 )
Loss on extinguishment of debt (3,810 )
Change in fair value of derivative liability (2,325 )
Total other expense, net (4,587 ) (2,300 )
Net loss $ (19,238 ) $ (6,978 )
Net loss per common share:
Basic and diluted $ (0.20 ) $ (0.15 )
Weighted average common shares outstanding:
Basic and diluted 95,452 45,644
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2019 December 31, 2018
Assets
Current assets:
Cash and cash equivalents $ 43,379 $ 45,261
Accounts receivable 2,258 627
Other current assets 2,735 1,713
Total current assets 48,372 47,601
Operating lease right-of-use assets 3,393
Intangible assets, net 29,514 30,129
Other assets 575 438
Total assets $ 81,854 $ 78,168
Liabilities and stockholders equity
Current liabilities:
Accounts payable and accrued expenses $ 9,242 $ 6,429
Accrued development milestone 15,000 15,000
Operating lease liabilities - current 417
Deferred revenue 30
Total current liabilities 24,659 21,459
Long-term debt 31,952 17,621
Operating lease liabilities - noncurrent 3,266
Other long-term liabilities 2,100 1,455
Total liabilities 61,977 40,535
Stockholders equity:
Capital 446,769 445,287
Accumulated deficit (427,731 ) (408,493 )
Accumulated other comprehensive income 839 839
Total stockholders equity 19,877 37,633
Total liabilities and stockholders equity $ 81,854 $ 78,168
Last updated: May 8, 2019