Aerie Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Business Update
08/01/2017
Conference Call and Webcast Today,
Aerie Highlights
-
Phase 3 clinical trials required for approval in the
U.S. for both RhopressaTM (netarsudil ophthalmic solution) 0.02%, and RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, are now successfully completed. -
All programs remain on track, with the goal date of
February 28, 2018 set for the RhopressaTMFDA (U.S. Food and Drug Administration ) PDUFA (Prescription Drug User Fee Act), and the Company's submission of the RoclatanTM New Drug Application (NDA) anticipated in the first half of 2018. -
Initial scientific introductory meetings on RhopressaTM have
been held with many major
U.S. payors. -
Mercury 3, the RoclatanTM Phase 3 clinical trial to be
conducted in
Europe for European markets, is set to commence in the third quarter of 2017. - Recently announced collaboration with DSM is focused on the potential of sustained delivery of Aerie compounds to treat retinal diseases, unlocking a new pipeline opportunity.
-
As of
June 30, 2017 , Aerie had$307.9 million in cash, cash equivalents and investments. Cash burn for the first half of 2017 totaled$48.4 million . Cash burn for the year endingDecember 31, 2017 is expected to be in the range of$100 million to$110 million .
"This has been a highly productive period for Aerie, and we are actively
engaged in all facets of commercialization preparation as we look to
make our RhopressaTM launch as successful as possible, upon
approval. For our RoclatanTM program, we also recently
completed the Mercury 1 12-month study, and we look forward to the
upcoming commencement of the Mercury 3 trial in
Second Quarter 2017 Financial Results
As of
The
The
The higher operating expenses in the second quarter of 2017 as compared to the second 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 commercialization efforts, including commercial manufacturing for RhopressaTM.
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 (
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.
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| Consolidated Balance Sheets | ||||||||||
| (Unaudited) | ||||||||||
| (in thousands) | ||||||||||
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| 2017 | 2016 | |||||||||
| Assets | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | $ | 242,650 | $ | 197,945 | ||||||
| Short-term investments | 65,269 | 35,717 | ||||||||
| Prepaid expenses and other current assets | 2,057 | 4,028 | ||||||||
| Total current assets | 309,976 | 237,690 | ||||||||
| Property, plant and equipment, net | 14,391 | 7,857 | ||||||||
| Other assets | 2,617 | 2,707 | ||||||||
| Total assets | $ | 326,984 | $ | 248,254 | ||||||
| Liabilities and Stockholders' Equity | ||||||||||
| Current liabilities | ||||||||||
| Accounts payable and other current liabilities | $ | 13,265 | $ | 18,820 | ||||||
| Interest payable | 545 | 551 | ||||||||
| Total current liabilities | 13,810 | 19,371 | ||||||||
| Convertible notes, net | 123,692 | 123,539 | ||||||||
| Other non-current liabilities | 4,440 | — | ||||||||
| Total liabilities | 141,942 | 142,910 | ||||||||
| Stockholders' equity | ||||||||||
| Common stock | 36 | 33 | ||||||||
| Additional paid-in capital | 555,930 | 422,002 | ||||||||
| Accumulated other comprehensive loss | (81 | ) | (68 | ) | ||||||
| Accumulated deficit | (370,843 | ) | (316,623 | ) | ||||||
| Total stockholders' equity | 185,042 | 105,344 | ||||||||
| Total liabilities and stockholders' equity | $ | 326,984 | $ | 248,254 | ||||||
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| Consolidated Statements of Operations | ||||||||||||||||||
| (Unaudited) | ||||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||||
| THREE MONTHS ENDED | SIX MONTHS ENDED | |||||||||||||||||
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Selling, general and administrative | $ | 17,153 | $ | 9,386 | $ | 31,628 | $ | 19,187 | ||||||||||
| Research and development | 10,615 | 13,304 | 21,569 | 25,613 | ||||||||||||||
| Total operating expenses | 27,768 |
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22,690 |
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53,197 |
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44,800 | |||||||||||
| Loss from operations | (27,768 | ) | (22,690 | ) | (53,197 | ) | (44,800 | ) | ||||||||||
| Other income (expense), net | (618 | ) | (482 | ) | (930 | ) | (1,030 | ) | ||||||||||
| Net loss before income taxes | (28,386 | ) | (23,172 | ) | (54,127 | ) | (45,830 | ) | ||||||||||
| Income tax expense | 47 | 47 | 93 | 93 | ||||||||||||||
| Net loss | $ | (28,433 | ) | $ | (23,219 | ) | $ | (54,220 | ) | $ | (45,923 | ) | ||||||
| Net loss per common share—basic and diluted | $ | (0.82 | ) | $ | (0.87 | ) |
$ |
(1.58 | ) | $ | (1.72 | ) | ||||||
| Weighted average number of common shares outstanding—basic and diluted | 34,783,195 | 26,773,337 | 34,283,073 | 26,748,301 | ||||||||||||||
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| Reconciliation of GAAP to Non-GAAP Financial Measures | ||||||||||||||||||
| (Unaudited) | ||||||||||||||||||
| (in thousands) | ||||||||||||||||||
| THREE MONTHS ENDED | SIX MONTHS ENDED | |||||||||||||||||
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||||
| GAAP Net loss | $ | (28,433 | ) | $ | (23,219 | ) | $ | (54,220 | ) | $ | (45,923 | ) | ||||||
| Non-cash stock-based compensation | 6,665 | 3,881 | 11,515 | 7,415 | ||||||||||||||
| Adjusted Net loss | $ | (21,768 | ) | $ | (19,338 | ) | $ | (42,705 | ) | $ | (38,508 | ) | ||||||
| Selling, general and administrative expense (GAAP) | $ | 17,153 | $ | 9,386 | $ | 31,628 | $ | 19,187 | ||||||||||
| Non-cash stock-based compensation | 5,251 | 3,067 | 9,037 | 5,889 | ||||||||||||||
| Adjusted selling, general and administrative expense | $ | 11,902 | $ | 6,319 | $ | 22,591 | $ | 13,298 | ||||||||||
| Research and development expense (GAAP) | $ | 10,615 | $ | 13,304 | $ | 21,569 | $ | 25,613 | ||||||||||
| Non-cash stock-based compensation | 1,414 | 814 | 2,478 | 1,526 | ||||||||||||||
| Adjusted research and development expense | $ | 9,201 | $ | 12,490 | $ | 19,091 | $ | 24,087 | ||||||||||
| Total operating expenses (GAAP) | $ | 27,768 | $ | 22,690 | $ | 53,197 | $ | 44,800 | ||||||||||
| Non-cash stock-based compensation | 6,665 | 3,881 | 11,515 | 7,415 | ||||||||||||||
| Adjusted total operating expenses | $ | 21,103 | $ | 18,809 | $ | 41,682 | $ | 37,385 | ||||||||||
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| Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share | ||||||||||||||||||
| (Unaudited) | ||||||||||||||||||
| THREE MONTHS ENDED | SIX MONTHS ENDED | |||||||||||||||||
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||||
| Net loss per common share - basic and diluted (GAAP) | $ | (0.82 | ) | $ | (0.87 | ) | $ | (1.58 | ) | $ | (1.72 | ) | ||||||
| Non-cash stock-based compensation | 0.19 | 0.15 | 0.34 | 0.28 | ||||||||||||||
| Adjusted Net loss per share - basic and diluted | $ | (0.63 | ) | $ | (0.72 | ) | $ | (1.24 | ) | $ | (1.44 | ) | ||||||
| Weighted average number of common shares outstanding - basic and diluted | 34,783,195 | 26,773,337 | 34,283,073 | 26,748,301 | ||||||||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170801006378/en/
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
Source:
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