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EyePoint Pharmaceuticals Reports Second Quarter 2019 Financial Results and Highlights Recent Company Progress Company reports total revenue of $7.2 million - Two commercial product launches in U.S. are underway for DEXYC

Key Takeaway: EyePoint Pharmaceuticals Reports Second Quarter 2019 Financial Results and Highlights Recent Company Progress Company reports total revenue of $7.2 million - Two commercial product launches in U.S. are underway for DEXYCU and reps actively targeting uveitis specialists, cata

Full Press Release Details

EyePoint Pharmaceuticals Reports Second Quarter 2019 Financial Results and
Highlights Recent Company Progress
Company reports total revenue of $7.2 million
- Two commercial product launches in U.S. are underway for DEXYCU and
reps actively targeting uveitis specialists,
cataract surgeons and ambulatory surgical centers
YUTIQ receives specific and permanent J Code, effective
- Over 400 physicians have completed a certification program and are now certified to purchase
and administer DEXYCU
Management to host a conference call and webcast today at 8:30 AM ET
WATERTOWN, Mass., August 7, 2019 - EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing
and commercializing innovative ophthalmic products, today reported financial results for the second quarter ended June 30, 2019 and highlighted recent commercial and corporate developments.
The physician feedback to date from our two commercial product launches, YUTIQ and DEXYCU , has been very positive, and we have seen a solid uptake in treatment volume along with tremendous progress in market access, said Nancy Lurker, President and Chief Executive Officer
of EyePoint Pharmaceuticals. Our field force has received similar reception and eagerness to meet from physicians in the office setting for YUTIQ and at ambulatory surgery centers (ASCs) for DEXYCU. Our efforts on training and certifying
physicians during our phased launch of DEXYCU are generating sales momentum with a solid start in July, as evidenced by the number of ASCs purchasing product for the first time, as well as repeat purchases. YUTIQ continues to address a large unmet
need for patients afflicted with chronic non-infectious posterior segment uveitis and July sales remain on a solid upward trajectory with the number of ordering physicians increasing month over month. With the
recently accelerated October 1, 2019 effective date of a permanent and specific J code for YUTIQ, J7413, payor approval and reimbursement will soon become even easier and more streamlined.
Ms. Lurker continued, Physicians are now actively seeing the clinical results of both YUTIQ and DEXYCU with their patients and to date have
experienced positive efficacy and safety results as seen in the pivotal clinical studies. We are very proud to have launched our two exciting ophthalmic products, YUTIQ and DEXYCU, and to bring these innovative products to patients in need.
In an effort to support our commercial activities we have enhanced our leadership team with the
appointments of Scott Jones as Chief Commercial Officer and Said Saim, Ph.D., as Chief Technology Officer. We look forward to making further progress in growing the reach of our commercially available products and advancing the balance of our
pipeline to deliver much-needed innovation to ophthalmic patients, concluded Ms. Lurker.
Commercial Performance in Second Quarter 2019
YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for chronic non-infectious uveitis affecting the
posterior segment of the eye
DEXYCU (dexamethasone
intraocular suspension) 9% for the treatment of post-operative inflammation following cataract surgery
Review of Second Quarter Results Ended June 30, 2019
For the three months ended June 30, 2019, total revenue was $7.2 million. Net product revenue was $6.7 million generated from sales of YUTIQ.
Due to adequate inventory stocking by the Company s distributor, Cardinal Health, ahead of the mid-March launch prior to the end of the first quarter, DEXYCU did not generate product revenue during the
second quarter of 2019. Neither of these products had net revenue in the corresponding quarter in 2018.
Net revenue from royalties and collaborations for
the three months ended June 30, 2019 totaled $505,000 compared to $715,000 in the corresponding quarter in 2018.
Operating expenses for the three months ended June 30, 2019 increased to $17.4 million from
$10.5 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation and cost of sales related to product revenue. Non-operating expense, net, for the three months ended June 30, 2019 totaled $1.3 million of net interest expense. Net loss for the three months ended June 30, 2019 was $11.5 million, or $0.11
per share, compared to a net loss of $34.4 million, or $0.62 per share, for the prior year quarter.
Review of Six Months Results Ended June
For the six months ended June 30, 2019, total net product revenue was $7.9 million. Neither product had net revenue in the
corresponding period in 2018. Net revenue from royalties and collaborations for the six months ended June 30, 2019 totaled $1.3 million compared to $1.6 million in the corresponding period in 2018.
Operating expenses for the six months ended June 30, 2019 increased to $34.0 million from $16.1 million in the prior year period, due primarily
to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation, cost of sales related to product revenue and amortization of the DEXYCU intangible asset.
Non-operating expense, net, for the six months ended June 30, 2019 totaled $5.9 million and consisted of $2.1 million of net interest expense and $3.8 million from the loss on
extinguishment of debt related to the payoff of the SWK term loan. Net loss for the six months ended June 30, 2019 was $30.7 million, or $0.30 per share, compared to a net loss of $41.4 million, or $0.82 per share, for the prior year
Cash and cash equivalents at June 30, 2019 totaled $44.2 million compared to $45.3 million at December 31,
Company s two commercial products, YUTIQ and DEXYCU, have not yet established a consistent sales trajectory, guidance regarding the timing of positive cash flow is not being provided at this time. We expect that the Company s existing cash
and cash equivalents at June 30, 2019 and cash inflows from anticipated YUTIQ and DEXYCU product sales will be sufficient to fund our operating plan into 2020.
Conference Call Information
EyePoint will host a
conference call today, Wednesday, August 7, 2019 at 8:30 AM ET to discuss the results for the second quarter ended June 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 5175125. 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. (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 and LinkedIn.
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 expectation that the Company s existing cash and cash equivalents at June 30, 2019 and cash inflows from anticipated YUTIQ
and DEXYCU product sales will be sufficient to fund our operating plan into 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; 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 June 30, Six Months Ended June 30,
2019 2018 2019 2018
Revenues:
Product sales, net $ 6,705 $ $ 7,932 $
Collaborative research and development 5 218 70 742
Royalty income 500 497 1,220 901
Total revenues 7,210 715 9,222 1,643
Operating expenses:
Cost of sales, excluding amortization of acquired intangible assets 706 1,035
Research and development 3,955 4,765 7,753 8,090
Sales and marketing 7,284 1,512 14,595 1,512
General and administrative 4,815 4,220 9,425 6,501
Amortization of acquired intangible assets 615 1,230
Total operating expenses 17,375 10,497 34,038 16,103
Loss from operations (10,165 ) (9,782 ) (24,816 ) (14,460 )
Other income (expense), net
Interest and other income 266 27 509 52
Interest expense (1,599 ) (720 ) (2,619 ) (720 )
Loss on extinguishment of debt (3,810 )
Change in fair value of derivative liability (23,953 ) (26,278 )
Total other expense, net (1,333 ) (24,646 ) (5,920 ) (26,946 )
Net loss $ (11,498 ) $ (34,428 ) $ (30,736 ) $ (41,406 )
Net loss per common share:
Basic and diluted $ (0.11 ) $ (0.62 ) $ (0.30 ) $ (0.82 )
Weighted average common shares outstanding:
Basic and diluted 106,238 55,387 100,847 50,542
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2019 December 31, 2018
Assets
Current assets:
Cash and cash equivalents $ 44,161 $ 45,261
Accounts receivable 9,598 627
Other current assets 4,814 1,713
Total current assets 58,573 47,601
Operating lease right-of-use assets 3,291
Intangible assets, net 28,899 30,129
Other assets 567 438
Total assets $ 91,330 $ 78,168
Liabilities and stockholders equity
Current liabilities:
Accounts payable and accrued expenses $ 10,280 $ 6,429
Accrued development milestone 15,000
Operating lease liabilities current 441
Deferred revenue 30
Total current liabilities 10,721 21,459
Long-term debt 46,250 17,621
Operating lease liabilities noncurrent 3,149
Other long-term liabilities 3,000 1,455
Total liabilities 63,120 40,535
Stockholders equity:
Capital 466,599 445,287
Accumulated deficit (439,229 ) (408,493 )
Accumulated other comprehensive income 840 839
Total stockholders equity 28,210 37,633
Total liabilities and stockholders equity $ 91,330 $ 78,168
Last updated: Aug 7, 2019