Aerie Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Business Update
11/08/2017
Conference Call and Webcast Today,
Aerie Highlights
- RhopressaTM (netarsudil ophthalmic solution) 0.02% remains on track after a successful
FDA (U.S. Food and Drug Administration ) Advisory Committee meeting, with a PDUFA (Prescription Drug User Fee Act) goal date ofFebruary 28, 2018 . - Preparation of the RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% NDA (New Drug Application) is progressing on schedule with an expected filing with the
FDA in the second quarter of 2018. - RhopressaTM commercial launch plans for the U.S. are in the advanced stages of development.
- International expansion activities are underway with the commencement in the third quarter of 2017 of the RoclatanTM Phase 3 trial named Mercury 3 to prepare for regulatory filing in
Europe , and the upcoming initiation of the RhopressaTM Phase 2 clinical trial to prepare for regulatory filing inJapan . - Preclinical retina program has expanded to include AR-13154 (Rho kinase inhibitor), as well as AR-1105 (dexamethasone steroid), along with sustained-release delivery technology from DSM and the ophthalmic rights to the PRINT® implant manufacturing technology.
- As of
September 30, 2017 , Aerie had$282.2 million in cash, cash equivalents and investments. Cash burn for the nine months endedSeptember 30, 2017 totaled$74.1 million . Cash burn for the full year endingDecember 31, 2017 is expected to be in the range of$115 million to $120 million , including the cash portion of the asset acquisition announced onOctober 5, 2017 , and acceleration of preparatory commercialization expenses for RhopressaTM.
“The third quarter, and certainly the last few weeks, have proven to be quite successful for Aerie by any measure. We are delighted with the recent positive
Third Quarter 2017 Financial Results
As of
The
The
The higher operating expenses in the third quarter of 2017 as compared to the third quarter 2016 primarily reflect increased activities associated with the expansion of our employee base to support the growth of our operations, and preparatory activities associated with our RhopressaTM commercialization efforts.
Conference Call / Webcast Information
Aerie management will host a live conference call and webcast at
The live webcast and a replay may be accessed by visiting the Company's website at http://investors.aeriepharma.com. Please connect to the Company's website 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 (888) 734-0328 (U.S.) or (678) 894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 5799149. Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 5799149. The telephone replay will be available until
About
Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie's two current product candidates are once-daily intraocular pressure lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA (New Drug Application) for RhopressaTM (netarsudil ophthalmic solution) 0.02% was submitted to the
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current and potential future product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to request, obtain and maintain
Non-GAAP Financial Measures
To supplement our financial statements, which are prepared and presented in accordance with GAAP, we use the following non-GAAP financial measures, some of which are discussed above: adjusted net loss, adjusted total operating expenses, adjusted research and development expense, adjusted selling, general and administrative expense, and adjusted net loss per common share. For a description of the adjusted calculations and reconciliations to the nearest GAAP measures, please see the “Reconciliation of GAAP to Non-GAAP Financial Measures” and “Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share” tables in this press release.
We believe these non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating our business.
The presentation of these financial measures is not intended to be considered in isolation from, or as a substitute for, financial information prepared and presented in accordance with GAAP. Investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool. In particular, the adjustments to our GAAP financial measures reflect the exclusion of non-cash stock-based compensation expense, which is recurring and will be reflected in our financial results for the foreseeable future. In addition, these measures may be different from non-GAAP financial measures used by other companies, limiting their usefulness for comparison purposes. We compensate for these limitations by providing specific information regarding the GAAP amounts excluded from these non-GAAP financial measures.
AERIE PHARMACEUTICALS, INC. | ||||||||||
Consolidated Balance Sheets | ||||||||||
(Unaudited) | ||||||||||
(in thousands) | ||||||||||
SEPTEMBER 30, | DECEMBER 31, | |||||||||
2017 | 2016 | |||||||||
Assets | ||||||||||
Current assets | ||||||||||
Cash and cash equivalents | $ | 194,078 | $ | 197,945 | ||||||
Short-term investments | 87,256 | 35,717 | ||||||||
Prepaid expenses and other current assets | 2,065 | 4,028 | ||||||||
Total current assets | 283,399 | 237,690 | ||||||||
Long-term investments | 901 | — | ||||||||
Property, plant and equipment, net | 19,246 | 7,857 | ||||||||
Other assets | 2,656 | 2,707 | ||||||||
Total assets | $ | 306,202 | $ | 248,254 | ||||||
Liabilities and Stockholders’ Equity | ||||||||||
Current liabilities | ||||||||||
Accounts payable and other current liabilities | $ | 18,045 | $ | 18,820 | ||||||
Interest payable | 551 | 551 | ||||||||
Total current liabilities | 18,596 | 19,371 | ||||||||
Convertible notes, net | 123,769 | 123,539 | ||||||||
Other non-current liabilities | 4,569 | — | ||||||||
Total liabilities | 146,934 | 142,910 | ||||||||
Stockholders' equity | ||||||||||
Common stock | 36 | 33 | ||||||||
Additional paid-in capital | 562,545 | 422,002 | ||||||||
Accumulated other comprehensive loss | (98) | (68) | ||||||||
Accumulated deficit | (403,215) | (316,623) | ||||||||
Total stockholders’ equity | 159,268 | 105,344 | ||||||||
Total liabilities and stockholders’ equity | $ | 306,202 | $ | 248,254 | ||||||
AERIE PHARMACEUTICALS, INC. | ||||||||||||||||
Consolidated Statements of Operations | ||||||||||||||||
(Unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
SEPTEMBER 30, | SEPTEMBER 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Operating expenses: | ||||||||||||||||
Selling, general and administrative | $ | 19,774 | $ | 10,627 | $ | 51,402 | $ | 29,814 | ||||||||
Research and development | 12,408 | 12,688 | 33,977 | 38,301 | ||||||||||||
Total operating expenses | 32,182 | 23,315 | 85,379 | 68,115 | ||||||||||||
Loss from operations | (32,182) | (23,315) | (85,379) | (68,115) | ||||||||||||
Other income (expense), net | (141) | (460) | (1,071) | (1,490) | ||||||||||||
Net loss before income taxes | (32,323) | (23,775) | (86,450) | (69,605) | ||||||||||||
Income tax expense | 49 | 39 | 142 | 132 | ||||||||||||
Net loss | $ | (32,372) | $ | (23,814) | $ | (86,592) | $ | (69,737) | ||||||||
Net loss per common share—basic and diluted | $ | (0.89) | $ | (0.81) | $ | (2.48) | $ | (2.52) | ||||||||
Weighted average number of common shares outstanding—basic and diluted | 36,210,329 | 29,380,453 | 34,932,551 | 27,632,090 | ||||||||||||
AERIE PHARMACEUTICALS, INC. | ||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures | ||||||||||||||||
(Unaudited) | ||||||||||||||||
(in thousands) | ||||||||||||||||
THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
SEPTEMBER 30, | SEPTEMBER 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
GAAP Net loss | $ | (32,372) | $ | (23,814) | $ | (86,592) | $ | (69,737) | ||||||||
Add-back: non-cash stock-based compensation | 6,557 | 4,099 | 18,072 | 11,514 | ||||||||||||
Adjusted Net loss | $ | (25,815) | $ | (19,715) | $ | (68,520) | $ | (58,223) | ||||||||
Selling, general and administrative expense (GAAP) | $ | 19,774 | $ | 10,627 | $ | 51,402 | $ | 29,814 | ||||||||
Less: non-cash stock-based compensation | 4,995 | 3,406 | 14,032 | 9,295 | ||||||||||||
Adjusted selling, general and administrative expense | $ | 14,779 | $ | 7,221 | $ | 37,370 | $ | 20,519 | ||||||||
Research and development expense (GAAP) | $ | 12,408 | $ | 12,688 | $ | 33,977 | $ | 38,301 | ||||||||
Less: non-cash stock-based compensation | 1,562 | 693 | 4,040 | 2,219 | ||||||||||||
Adjusted research and development expense | $ | 10,846 | $ | 11,995 | $ | 29,937 | $ | 36,082 | ||||||||
Total operating expenses (GAAP) | $ | 32,182 | $ | 23,315 | $ | 85,379 | $ | 68,115 | ||||||||
Less: non-cash stock-based compensation |
6,557 |
4,099 | 18,072 | 11,514 | ||||||||||||
Adjusted total operating expenses | $ | 25,625 | $ | 19,216 | $ | 67,307 | $ | 56,601 | ||||||||
AERIE PHARMACEUTICALS, INC. | ||||||||||||||||
Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | ||||||||||||||||
(Unaudited) | ||||||||||||||||
THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
SEPTEMBER 30, | SEPTEMBER 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Net loss per common share – basic and diluted (GAAP) | $ | (0.89) | $ | (0.81) | $ | (2.48) | $ | (2.52) | ||||||||
Non-cash stock-based compensation | 0.18 | 0.14 | 0.52 | 0.42 | ||||||||||||
Adjusted Net loss per share – basic and diluted | $ | (0.71) | $ | (0.67) | $ | (1.96) | $ | (2.10) | ||||||||
Weighted average number of common shares outstanding – basic and diluted | 36,210,329 | 29,380,453 | 34,932,551 | 27,632,090 | ||||||||||||
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Source:
Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Media
Justin Jackson, 212-213-0006
jjackson@burnsmc.com