Ocular Therapeutix™ Reports Second Quarter 2018 Financial Results and Business Update
DEXTENZA® NDA Resubmission Submitted and Accepted by the
“We are encouraged with our progress through the first half of 2018,”
Key Highlights and Upcoming Events
DEXTENZA® New Drug Application (NDA) resubmission completed and
accepted by the
U.S. Food and Drug Administration( FDA). Ocular resubmitted the NDA to the FDAon June 28th and announced the acceptance of the filing on July 19th. As expected the resubmission will be treated as a Class 2 response with a six-month review period. The target action date under the Prescription Drug User Fee Act, or PDUFA, is December 28, 2018.
- Initiated commercialization planning for DEXTENZA. If DEXTENZA is approved, Ocular intends to launch it with a specialty sales team and has begun executing on the commercial build-out.
- OTX-TP (travoprost insert) Phase 3 topline efficacy data for the treatment of glaucoma expected in the first half of 2019. Enrollment in the 550 patient Phase 3 trial remains steady and the Company continues to anticipate topline data in the first half of 2019. The Company has also dosed the first patient in the third quarter in an open-label, one-year safety extension study that will be included as part of the current pivotal program. This study will provide additional long-term safety data with repeat administration of OTX-TP.
- Dosed first patient in Phase 1 clinical trial of OTX-TIC (travoprost implant). OTX-TIC, Ocular Therapeutix’s second glaucoma product candidate, 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 and ocular hypertension.
- Initiated OTX-TKI (tyrosine kinase inhibitor implant) ex-U.S. Phase 1 clinical trial; the first patient is expected to be dosed in the third quarter. OTX-TKI is a bioresorbable, hydrogel fiber implant with anti-angiogenic properties delivered by intravitreal injection being developed to treat patients with wet Age-related Macular Degeneration (AMD) and other retinal diseases. Preclinical data have demonstrated the ability to deliver an efficacious dose of OTX-TKI to the posterior segment of the eye for the treatment of VEGF-induced retinal leakage for an extended duration of up to twelve months. The Phase 1 trial is a multi-center, open-label, dose escalation study testing the safety, durability, and tolerability of OTX-TKI.
- Regeneron collaboration continues for the development of OTX-IVT (aflibercept implant). The Company, along with Regeneron, continues the pre-clinical development of an extended-delivery formulation of the VEGF trap aflibercept (EYLEA®), delivered by intravitreal injection, for the treatment of retinal diseases such as wet AMD. The Company remains pleased with the state of the collaboration and the teams have been working well together.
Second Quarter 2018 Financial Results
As of the quarter-ended
June 30, 2018, the Company had $56.8 millionin cash and cash equivalents versus $62.9 millionat the end of the first quarter of 2018. The cash balance benefited from $8.4 millionin net proceeds generated from the sale of common stock under the Company’s 2016 Sales Agreement, or ATM, during the second quarter of 2018. Offsetting the ATM inflows during the quarter were a net loss of $13.8 million, principal debt payments of $1.6 million, and capital expenditures of $0.6 million. At the end of Q2 2018, $24.1 millionremained available to be sold under the 2016 Sales Agreement and the Company will continue to monitor the opportunity to sell additional common stock as appropriate under the facility.
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 the second quarter of 2019, exclusive of the potential $10 millionoption payment from our Regeneron partnership.
Research and development expenses for the second quarter were
$8.7 millionversus $8.1 millionfor the second quarter of 2017 and reflect an increase in compensation costs associated with additional hiring primarily in the technical operations and quality departments, as well as an increase in facilities expenses associated with additional lab space at corporate headquarters.
Selling and marketing expenses for the second quarter were
$0.9 millionas compared to $6.8 millionfor the same quarter in 2017. This decrease relates to a significant reduction in pre-commercial activities as a result of the delay in the launch of DEXTENZA.
General and Administrative expenses were
$4.4 millionfor the second quarter versus $3.7 millionin the comparable quarter of 2017. The increase in expenses stemmed primarily from increases in legal costs related to the defense of ongoing legal proceedings.
Revenues for the second quarter of 2018 were driven exclusively by
ReSure Sealant and totaled approximately
$0.6 millioncompared with $0.4 millionin the same period for 2017, reflecting principally an increased number of units sold.
The Company reported a net loss of
$(13.8) million, or a loss of $(0.37)per share for the second quarter of 2018. This compares to a net loss of $(18.7) million, or a loss of $(0.64)per share, for the same period in 2017. The net loss for the second quarter of 2018 included $2.4 millionin non-cash charges for stock-based compensation and depreciation compared to $2.1 millionfor the same quarter in 2017.
The Company had approximately 38.5 million shares issued and
outstanding as of
June 30, 2018compared to 37.3 million shares issued and outstanding as of March 31, 2018.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast today at 4:30 pm Eastern Time to review the
Company's financial results and provide a general business update. The
live webcast can be accessed by visiting the Investors section of the
Company’s website at investors.ocutx.com. Please connect at least 15
minutes prior to the live webcast to ensure adequate time for any
software download that may be needed to access the webcast.
Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620
(International) to listen to the live conference call. The conference ID
number for the live call will be 7875199. An archive of the webcast will
be available until
About Ocular Therapeutix, Inc.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including 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 pain and inflammation, including with
respect to manufacturing deficiencies identified by the
Ocular Therapeutix, Inc.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Costs and operating expenses:|
|Cost of product revenue||153||104||233||219|
|Research and development||8,745||8,117||16,972||14,846|
|Selling and marketing||867||6,832||1,584||12,859|
|General and administrative||4,447||3,724||9,218||7,000|
|Total costs and operating expenses||14,212||18,777||28,007||34,924|
|Loss from operations||(13,564||)||(18,339||)||(27,019||)||(34,011||)|
|Other income (expense):|
|Total other expense, net||(240||)||(355||)||(550||)||(706||)|
|Net loss per share, basic and diluted||$||(0.37||)||$||(0.64||)||$||(0.76||)||$||(1.22||)|
|Weighted average common shares outstanding, basic and diluted||37,524,512||29,026,259||36,160,251||28,352,348|
|Other comprehensive loss:|
|Unrealized gain on marketable securities||—||9||—||5|
|Total other comprehensive income||—||9||—||5|
|Total comprehensive loss||$||(13,804||)||$||(18,685||)||$||(27,569||)||$||(34,712||)|
Ocular Therapeutix, Inc.
(In thousands, except share and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||56,834||$||41,538|
|Prepaid expenses and other current assets||1,222||1,453|
|Total current assets||58,472||43,339|
|Property and equipment, net||10,373||10,478|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||3,680||4,310|
|Notes payable, net of discount, current||6,082||5,545|
|Total current liabilities||11,899||13,426|
|Deferred rent, long-term||3,283||3,387|
|Notes payable, net of discount, long-term||9,548||12,471|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized and 38,476,937 and 29,658,202 shares issued and outstanding at June 30, 2018 and December 31, 2017||4||3|
|Additional paid-in capital||310,559||263,409|
|Total stockholders’ equity||45,729||26,147|
|Total liabilities and stockholders’ equity||$||70,459||$||55,431|
Chief Financial Officer
Senior Vice President, Commercial