Ocular Therapeutix™ Reports Fourth Quarter and Year End 2018 Financial Results and Business Update
DEXTENZA® Commercial Launch Planned for Mid-Year 2019
OTX-TP Phase 3 Data Expected in the First Half of 2019
Strengthened Cash Position with Closing of
“2018 was a transformational year for Ocular highlighted by the U.S.
Food and Drug Administration’s approval of DEXTENZA®, our dexamethasone
intracanalicular insert for the treatment of post-surgical ocular pain,”
Key Highlights and Upcoming Events
DEXTENZA commercial launch planned for mid-year 2019.
Ocular remains on track to begin sampling DEXTENZA in
May 2019with a formal launch planned by July 2019, upon receipt of pass-through payment status, when the Center for Medicare and Medicaid Services(CMS) is expected to issue a C-Code. As of today, applications for both transitional C-Code and permanent J-Code reimbursement are submitted and pending with CMS.
- Preparations for commercial launch of DEXTENZA continue. The Company has completed the hiring of its sales management team and is actively recruiting for the rest of its field organization. Ocular plans to launch with an initial sales force of approximately 20 key account managers plus a field reimbursement team with the goal of being at approximately 40 key account managers by the end of the year. Additionally, the distribution network is in place, a reimbursement services hub is in progress, and the Company expects to schedule meetings with payers in the near term.
- Topline efficacy data for the Phase 3 clinical trial of OTX-TP (travoprost insert) for the treatment of glaucoma expected in the first half of 2019. The Phase 3 clinical trial enrolled 550 subjects with the primary efficacy endpoint being a statistically superior mean reduction of intraocular pressure (IOP) from baseline for OTX-TP treated subjects compared with placebo insert treated subjects at three diurnal time points at each of three measurement dates of 2, 6, and 12 weeks following insertion. In addition, while not a primary endpoint, the Company expects that the IOP reduction will also need to be clinically meaningful for regulatory approval. The Company continues to enroll an open-label, one-year safety extension study with OTX-TP. This study is designed to provide additional long-term safety data with repeat administration of OTX-TP.
- Initial results of the Phase 1 clinical trial of OTX-TIC (travoprost implant) for the treatment of glaucoma are anticipated in first half 2019. OTX-TIC is a bioresorbable, travoprost-containing hydrogel intracameral implant. The U.S. Phase 1 trial is a multi-center, open-label, prospective, dose escalation clinical trial to evaluate the safety, efficacy, durability, and tolerability of OTX-TIC in patients with primary open-angle glaucoma or ocular hypertension. The first subject has been treated for 9 months with a single insert.
Commenced dosing of patients in the Phase 1 clinical trial of
OTX-TKI (intravitreal tyrosine kinase inhibitor implant). OTX-TKI
is a bioresorbable, hydrogel fiber implant with anti-angiogenic
properties delivered by intravitreal injection to the posterior
segment of the eye for the treatment of wet AMD for an extended
duration of up to nine months. The Phase 1 trial is being conducted in
Australiaand is a multi-center, open-label study testing the safety, durability, and tolerability of OTX-TKI.
- Regeneron continues evaluating the final formulation of OTX-IVT (aflibercept implant). OTX-IVT is an extended-delivery formulation of the VEGF trap aflibercept (EYLEA®), delivered by intravitreal injection, for the treatment of retinal diseases such as wet AMD.
Fourth Quarter and Year Ended
The Company augmented cash and cash equivalents of
$54.1 millionat December 31, 2018during the first two months of 2019 with proceeds from $37.5 millionin senior subordinated convertible notes and $5.0 millionof net proceeds raised under the Company’s 2016 Sales Agreement (ATM) during the first two months of 2019. Based on the Company’s current plans and forecasted expenses, Ocular Therapeutixbelieves that existing cash and cash equivalents will fund operating expenses, debt service obligations, and capital expenditures into early 2020.
As of the quarter and year ended
December 31, 2018, the Company had $54.1 millionin cash and cash equivalents versus $56.9 millionat the end of the third quarter of 2018. The year end cash balance benefited from $5.6 millionin net proceeds generated from the sale of common stock under the ATM during the fourth quarter of 2018 as well as $12.0 millionof net proceeds from an expansion and extension of the Company’s existing five-year term loan facility. Offsetting these inflows during the quarter were a net loss of $17.4 millionand principal debt and interest payments of $1.5 million.
Research and development expenses for the fourth quarter were
$10.3 millionversus $7.9 millionfor the fourth quarter of 2017 and reflect increased unallocated other costs, primarily in personnel costs, consulting services, outside testing expenses, and costs associated with additional hiring.
Selling and marketing expenses for the fourth quarter were
$2.3 millionas compared to $0.9 millionfor the same quarter in 2017. This increase relates to initial scale-up in pre-commercial activities as a result of the early approval of DEXTENZA on November 30, 2018.
General and Administrative expenses were
$5.1 millionfor the fourth quarter of 2018 versus $4.3 millionin the comparable quarter of 2017. The increase in expenses stemmed primarily from increases in legal costs related to the defense of the Company in ongoing legal proceedings.
The Company reported a fourth quarter net loss of
$(17.4) million, or a loss of $(0.42)per share. This compares to a net loss of $(13.1) million, or a loss of $(0.44)per share, for the same period in 2017. The net loss for the fourth quarter of 2018 included $2.5 millionin non-cash charges for stock-based compensation and depreciation compared to $2.6 millionfor the same quarter in 2017.
The Company had approximately 42.8 million shares issued and
outstanding as of
March 1, 2019.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast today at
Forward Looking Statements
Any statements in this press release about future expectations, plans,
and prospects for the Company, including the commercialization of
DEXTENZA®, ReSure Sealant, or any of the Company’s product candidates,
including the anticipated commercial launch of, and receipt of
reimbursement codes for, DEXTENZA; the development and regulatory status
of the Company’s product candidates, such as the Company’s regulatory
submissions for and the timing and conduct of, or implications of
results from, clinical trials of DEXTENZA for the treatment of
post-surgical ocular inflammation and the prospects for approvability of
DEXTENZA for post-surgical ocular inflammation or any other indications,
OTX-TP for the treatment of primary open-angle glaucoma and ocular
hypertension, OTX-TIC for the treatment of primary open-angle glaucoma
and ocular hypertension, OTX-TKI for the treatment of retinal diseases
including wet AMD, and OTX-IVT as an extended-delivery formulation of
the VEGF trap aflibercept for the treatment of retinal diseases
including wet AMD; the ongoing development of the Company’s
extended-delivery hydrogel depot technology; the potential utility of
any of the Company’s product candidates; the potential benefits and
future operation of the collaboration with
Ocular Therapeutix, Inc.
Three Months Ended
|Total revenue||504||487||1, 990||1,923|
|Costs and operating expenses:|
|Cost of product revenue||117||113||465||457|
|Research and development||10,258||7,908||36,915||30,880|
|Selling and marketing||2,291||903||4,942||17.000|
|General and administrative||5,121||4,279||18,786||15,509|
|Total costs and operating expenses||17,787||13,203||61,108||63,846|
|Loss from operations||(17,283)||(12,716)||(59,118)||(61,923)|
|Other income (expense):|
|Other income (expense), net||—||—||—||5|
|Total other expense, net||(116)||(386)||(860)||(1,463)|
|Net loss per share, basic and diluted||$||(0.42)||$||(0.44)||$||(1.57)||$||(2.20)|
|Weighted average common shares outstanding, basic and diluted||41,094,230||29,448,993||38,115,142||28,818,196|
|Other comprehensive loss:|
|Unrealized gain on marketable securities||—||—||—||5|
|Total other comprehensive income||—||—||—||5|
|Total comprehensive loss||$||(17,399)||$||(13,102)||$||(59,978)||$||(63,381)|
OCULAR THERAPEUTIX, INC.
|Cash and cash equivalents||$||54,062||$||41,538|
|Prepaid expenses and other current assets||1,713||1,453|
|Total current assets||56,193||43,339|
|Property and equipment, net||10,236||10,478|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||6,194||4,310|
|Notes payable, net of discount, current||—||5,545|
|Total current liabilities||9,159||13,426|
|Deferred rent, long-term||3,221||3,387|
|Notes payable, net of discount, long-term||24,788||12,471|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at December 31, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized and 41,518,091 and 29,658,202 shares issued and outstanding at December 31, 2018 and December 31, 2017||4||3|
|Additional paid-in capital||333,114||263,409|
|Total stockholders’ equity||35,875||26,147|
|Total liabilities and stockholders’ equity||$||73,043||$||55,431|
Chief Financial Officer
Senior Vice President, Commercial