Aerie Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update
05/07/2019
Conference Call and Webcast Today,
Aerie Highlights
- The Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% U.S. commercial launch is underway with the sales force actively calling on 14,000 eye care professionals. Upon launch, Rocklatan® had 60% of commercial lives covered in non-preferred brand Tier 3.
-
Rhopressa® (netarsudil ophthalmic solution) 0.02% generated
first quarter net revenues on a U.S. GAAP (generally accepted
accounting principles) basis of
$10.9 million , equivalent to an average of$100 per bottle, lower than prior quarters as the result of a higher share ofMedicare Part D business. First-quarter 2019 net revenues reflect a higher proportion ofMedicare Part D rebates which are steeper than commercial rebates, along with the increased level of government-mandated donut hole funding in 2019 forMedicare Part D programs. -
Rhopressa® now has preferred brand Tier 2 market access for
approximately 75% of lives covered under
Medicare Part D plans. Rhopressa® also has approximately 90% of lives covered under commercial plans, including 55% in preferred brand Tier 2 and 35% in Tier 3. -
Rhopressa® shipments to wholesalers, and from wholesalers
to pharmacies, have been achieving record levels in April and into
May 2019 . Rhopressa® sales out to pharmacies totaled over 10,500 bottles for the week endedMay 3 rd, compared to less than 9,600 bottles for the week endedMarch 29 th. -
International expansion activities are progressing. The Rhopressa®
Phase 2 clinical trial in
Japan commenced inMarch 2019 in preparation for subsequent Phase 3 registration trials inJapan . The Rocklatan® Mercury 3 Phase 3 clinical trial continues to progress inEurope . -
Aerie’s retina program continues to advance with the IND
(Investigational New Drug application) for AR-13503 (Rho kinase and
Protein kinase C inhibitor implant) accepted by the
FDA (theU.S. Food and Drug Administration ) inApril 2019 . Clinical trials for this product candidate are expected to commence in the second quarter of 2019 for wet age-related macular degeneration and DME (diabetic macular edema). The AR-1105 (dexamethasone steroid implant) Phase 2 clinical trial commenced inMarch 2019 for macular edema due to RVO (retinal vein occlusion). Safety and efficacy data for AR-1105 will be evaluated at six months after dosing. -
Net cash burn for the three months ended
March 31, 2019 was approximately$54 million , and cash and cash equivalents were$148.9 million as ofMarch 31, 2019 . In addition, with the$200 million in undrawn credit facility capacity available, total liquidity was approximately$350 million atMarch 31, 2019. Shares outstanding atMarch 31, 2019 totaled 45.9 million. -
Aerie reiterated that it expects full-year 2019 net revenues in the
range of
$110 million to $120 million on a U.S. GAAP basis for the combined net revenues for Rhopressa® and Rocklatan®. -
Aerie also reiterated its net cash burn guidance for full-year 2019 in
the range of
$130 million to $140 million . This range includes the gross cash burn guidance of$210 million to $220 million , partially offset by estimated full-year 2019 revenue-related net cash inflows of$80 million , which includes accounts receivable collections and rebate payments.
“We are now uniquely positioned with two very exciting glaucoma products
in the market. With the recent significant gains in Rhopressa®
market access for the
Dr. Anido continued, “We currently have the highest level of financial
liquidity in Aerie history, at approximately
First Quarter 2019Financial Results
As of
The
The
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 6786103.
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 6786103. The
telephone replay will be available until
About
Aerie is an ophthalmic pharmaceutical company focused on the discovery,
development and commercialization of first-in-class therapies for the
treatment of patients with open-angle glaucoma, retinal diseases and
other diseases of the eye. Aerie’s first product, Rhopressa® (netarsudil
ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S.
Food and Drug Administration (
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: our
expectations regarding the commercialization and manufacturing of
Rhopressa® and Rocklatan® or any future product
candidates, including the timing, cost or other aspects of the
commercial launch of Rhopressa® and Rocklatan® or
any future product candidates; our commercialization, marketing,
manufacturing and supply management capabilities and strategies; the
success, timing and cost of our ongoing and anticipated preclinical
studies and clinical trials for Rhopressa® and Rocklatan®,
with respect to regulatory approval outside of
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 expenses, adjusted selling, general and administrative expenses, and adjusted net loss per share. For reconciliations of non-GAAP measures to the most directly comparable 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 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) |
||||||||
MARCH 31, 2019 | DECEMBER 31, 2018 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 148,868 | $ | 202,818 | ||||
Accounts receivable, net | 14,758 | 2,715 | ||||||
Inventory | 10,192 | 10,112 | ||||||
Prepaid expenses and other current assets | 6,499 | 4,530 | ||||||
Total current assets | 180,317 | 220,175 | ||||||
Property, plant and equipment, net | 62,982 | 60,525 | ||||||
Operating lease right-of-use assets | 16,394 | — | ||||||
Other assets | 3,357 | 4,344 | ||||||
Total assets | $ | 263,050 | $ | 285,044 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 11,121 | $ | 12,403 | ||||
Accrued expenses and other current liabilities | 35,810 | 38,381 | ||||||
Operating lease liabilities | 5,032 | — | ||||||
Total current liabilities | 51,963 | 50,784 | ||||||
Long-term operating lease liabilities | 12,044 | — | ||||||
Other non-current liabilities | 6,893 | 6,454 | ||||||
Total liabilities | 70,900 | 57,238 | ||||||
Stockholders' equity | ||||||||
Common stock | 46 | 45 | ||||||
Additional paid-in capital | 936,474 | 924,180 | ||||||
Accumulated deficit | (744,370 | ) | (696,419 | ) | ||||
Total stockholders’ equity | 192,150 | 227,806 | ||||||
Total liabilities and stockholders’ equity | $ | 263,050 | $ | 285,044 | ||||
AERIE PHARMACEUTICALS, INC. Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share data) |
||||||||
THREE MONTHS ENDED |
||||||||
2019 | 2018 | |||||||
Product revenues, net | $ | 10,852 | $ | — | ||||
Total revenues, net | 10,852 | — | ||||||
Costs and expenses: | ||||||||
Cost of goods sold | 381 | — | ||||||
Selling, general and administrative | 36,282 | 22,930 | ||||||
Pre-approval commercial manufacturing | 4,457 | 4,893 | ||||||
Research and development | 17,884 | 12,972 | ||||||
Total costs and expenses | 59,004 | 40,795 | ||||||
Loss from operations | (48,152 | ) | (40,795 | ) | ||||
Other income (expense), net | 111 | 96 | ||||||
Loss before income taxes | (48,041 | ) | (40,699 | ) | ||||
Income tax benefit | (90 | ) | — | |||||
Net loss | $ | (47,951 | ) | $ | (40,699 | ) | ||
Net loss per common share—basic and diluted | $ | (1.06 | ) | $ | (1.05 | ) | ||
Weighted average number of common shares outstanding—basic and diluted | 45,270,660 | 38,598,827 | ||||||
AERIE PHARMACEUTICALS, INC. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (in thousands) |
||||||||
THREE MONTHS ENDED |
||||||||
2019 | 2018 | |||||||
Net loss (GAAP) | $ | (47,951 | ) | $ | (40,699 | ) | ||
Add-back: stock-based compensation expense | 12,620 | 8,719 | ||||||
Adjusted Net loss | $ | (35,331 | ) | $ | (31,980 | ) | ||
Selling, general and administrative expenses (GAAP) | $ | 36,282 | $ | 22,930 | ||||
Less: stock-based compensation expense | (9,121 | ) | (6,214 | ) | ||||
Adjusted selling, general and administrative expenses | $ | 27,161 | $ | 16,716 | ||||
Pre-approval commercial manufacturing expenses (GAAP) | $ | 4,457 | $ | 4,893 | ||||
Less: stock-based compensation expense | (849 | ) | (470 | ) | ||||
Adjusted pre-approval commercial manufacturing expenses | $ | 3,608 | $ | 4,423 | ||||
Research and development expenses (GAAP) | $ | 17,884 | $ | 12,972 | ||||
Less: stock-based compensation expense | (2,650 | ) | (2,035 | ) | ||||
Adjusted research and development expenses | $ | 15,234 | $ | 10,937 | ||||
Total operating expenses (GAAP) | $ | 58,623 | $ | 40,795 | ||||
Less: stock-based compensation expense | (12,620 | ) | (8,719 | ) | ||||
Adjusted total operating expenses | $ | 46,003 | $ | 32,076 | ||||
AERIE PHARMACEUTICALS, INC. Reconciliation of GAAP Net Loss Per Share to Adjusted Net Loss Per Share (Unaudited) |
||||||||
THREE MONTHS ENDED |
||||||||
2019 | 2018 | |||||||
Net loss per common share—basic and diluted (GAAP) | $ | (1.06 | ) | $ | (1.05 | ) | ||
Add-back: stock-based compensation expense | 0.28 | 0.22 | ||||||
Adjusted Net loss per share—basic and diluted | $ | (0.78 | ) | $ | (0.83 | ) | ||
Weighted average number of common shares outstanding—basic and diluted | 45,270,660 | 38,598,827 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190507005617/en/
Source:
Aerie Pharmaceuticals
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors:
Ami Bavishi 908-947-3949; abavishi@aeriepharma.com