Aerie Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Business Update
05/06/2020
Conference Call and Webcast Today,
Aerie First Quarter Highlights
-
The Aerie glaucoma franchise, including Rhopressa® (netarsudil ophthalmic solution) 0.02% and Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, generated first quarter 2020 net revenues of
$20.3 million , equivalent to an average of$88 per bottle. Wholesaler shipments totaled 232,000 bottles during the first quarter of 2020 compared to 206,000 bottles shipped during the fourth quarter of 2019. The net revenue per bottle is lower than prior quarters reflecting higher penetration of Medicare Part D and other government-funded programs. -
Market access for Medicare Part D plans increased considerably effective
May 1, 2020 . Rhopressa® now has market access for 88 percent of lives covered under Medicare Part D plans, up from 75 percent previously. Rocklatan® currently has market access for 55 percent of Medicare Part D lives, up from 38 percent previously, and currently has an additional 15 percent of remaining Medicare Part D lives, which, while not yet covered on formulary, have affordable access throughU.S. government funded Low Income Subsidy programs through which co-pays are less than$10 per month. Commercial coverage for Rhopressa® and Rocklatan® remain at 90 percent and 88 percent of covered lives, respectively. -
Aerie remains focused on its dry eye product candidate now named AR-15512 obtained through the
December 2019 acquisition ofAvizorex Pharma S.L . (Avizorex). Toxicology studies are underway as part of the evaluation of different concentrations of the product candidate, and Aerie plans to initiate a large Phase 2b study in late 2020. -
Aerie’s retina program continues to advance. The AR-1105 (dexamethasone steroid implant) Phase 2 clinical trial, which commenced in
March 2019 for macular edema due to RVO (retinal vein occlusion), was fully enrolled ahead of schedule inOctober 2019 with a readout expected in the second half of 2020. The first-in-human clinical trial for AR-13503 (Rho kinase and Protein kinase C inhibitor implant) commenced in the third quarter of 2019 for neovascular age-related macular degeneration and DME (diabetic macular edema). Aerie currently expects to commence enrollment of the Phase 2 clinical trial in the second half of 2020, with a readout expected in 2021. -
Aerie held a meeting with the
Japanese Pharmaceuticals andMedical Devices Agency (PMDA) inApril 2020 to discuss Phase 3 trial designs for Rhopressa®, while continuing to prepare for the trials. Aerie expects to initiate a Rhopressa® Phase 3 clinical trial inJapan , potentially commencing in the second half of 2020, along with exploring a collaboration with a potential partner inJapan to advance Aerie’s clinical development and ultimately commercialize Rhopressa® and Rocklatan® inJapan . -
Aerie received approval from the
U.S. Food and Drug Administration (FDA) inJanuary 2020 to produce Rocklatan® in Aerie’s Athlone,Ireland , manufacturing facility for commercial distribution in the U.S. market. The manufacturing plant began production of commercial supplies of Rocklatan® during the first quarter of 2020. Aerie also plans to file a Prior Approval Supplement with the FDA in second-quarter 2020 to obtain FDA approval to manufacture Rhopressa® in Athlone for commercial distribution in the U.S. market. -
The European Commission granted a centralised marketing authorisation for Rhokiinsa® (netarsudil ophthalmic solution) 0.02% inNovember 2019 . TheEuropean Medicines Agency (EMA) accepted for review the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% (marketed as Rocklatan® in theU.S. ) inDecember 2019 . An opinion from the EMA’s Committee for Medicinal Products for Human Use on the MAA for Roclanda® is expected in the fourth quarter of 2020. Topline data from the Rocklatan® Mercury 3 Phase 3 clinical trial inEurope is expected potentially in late 2020, the results of which will help determine commercial prospects in the region. -
Net cash used in operating activities for the quarter ended
March 31, 2020 on aU.S. GAAP basis totaled approximately$41.8 million , resulting in$264.7 million in cash and cash equivalents and investments as ofMarch 31, 2020 .
Impact of the COVID-19 Pandemic
-
In
December 2019 , there was an outbreak of a new strain of coronavirus (COVID-19) and onMarch 11, 2020 , theWorld Health Organization declared COVID-19 a pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and workforce participation due to “shelter-in-place” restrictions by various governments worldwide and created significant volatility and disruption of financial markets. -
While Aerie sales volumes increased in the first quarter of 2020 compared to the fourth quarter of 2019 for both Rhopressa® and Rocklatan®, total prescription volumes, as seen within the entire pharmaceutical market according to IQVIA data, has declined as the COVID-19 impact grew commencing in late
March 2020 . There has been a partial volume offset for Aerie due to an increasing proportion of prescriptions for 90-days’ supply, however, with many eye care professionals’ offices closed or operating with limited capacity, new prescription growth has slowed. Our sales force remains engaged with eye care professionals primarily through virtual means, and we are diligently managing our expenses including reducing travel and meeting expenses. - Aerie does not yet know whether or how the progress of the COVID-19 pandemic will affect clinical operations or the timing of the approval by the EMA of the MAA for Roclanda®.
- Aerie has observed no disruptions to date in its supply chain for production of Rhopressa® and Rocklatan®. Aerie believes it has approximately three years of starting materials and active pharmaceutical ingredient in inventory, and adequate supply of finished product on hand to support its commercial efforts for at least the next six months. Production of Rhopressa® and Rocklatan® is continuing.
2020 Guidance
-
Considering the rapidly evolving status of the unprecedented COVID-19 situation and the uncertainty around its ultimate impact, Aerie announced on
April 9, 2020 the withdrawal of its 2020 guidance for net revenues and net cash used in operations. Guidance will be updated when there is clarity going forward.
“First and foremost, we are focused on the health and safety of our employees and their families, along with our patients and eye care professionals as we endure the COVID-19 pandemic. I am personally very grateful to our employees for their diligence in executing their responsibilities in a largely virtual environment. 2020 was off to a strong start for Aerie, but the momentum was unfortunately cut short by the COVID-19 impact late in the first quarter and continuing to the second quarter of this year. While we have seen a reduction in total prescriptions and particularly in new prescriptions, our average weekly sales-out to pharmacies was approximately 17,000 bottles in April, consistent with volumes experienced during the fourth quarter of 2019. It is difficult to project if this trend will continue but we appear to be experiencing a lower level of weekly decreases in the last few weeks than in early April. Further, we are delighted to have gained significant additional Medicare Part D coverage effective
“Our clinical programs and plans, both in
First Quarter 2020 Financial 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 Aerie’s website at http://investors.aeriepharma.com. Please connect to Aerie’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 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, dry eye, retinal diseases and potentially other diseases of the eye. Aerie’s first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by 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 in this release include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the duration and severity of the recent coronavirus disease (COVID-19) outbreak, including the impact on our clinical and commercial operations, demand for our products and financial results and condition of our global supply chains; our expectations regarding the commercialization and manufacturing of Rhopressa®, Rocklatan®, Rhokiinsa® and Roclanda® or any current or future product candidates, including the timing, cost or other aspects of their commercial launch; our commercialization, marketing, manufacturing and supply management capabilities and strategies in and 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 cost of goods sold, adjusted selling, general and administrative expenses, adjusted pre-approval commercial manufacturing expenses, adjusted research and development expenses, adjusted total operating 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.
|
||||||||
|
|
|
|
|
||||
Assets |
|
|
|
|
||||
Current assets |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
134,179 |
|
|
$ |
143,940 |
|
Short-term investments |
|
130,552 |
|
|
165,250 |
|
||
Accounts receivable, net |
|
42,941 |
|
|
38,354 |
|
||
Inventory |
|
20,225 |
|
|
21,054 |
|
||
Prepaid expenses and other current assets |
|
10,540 |
|
|
7,744 |
|
||
Total current assets |
|
338,437 |
|
|
376,342 |
|
||
Property, plant and equipment, net |
|
57,223 |
|
|
58,147 |
|
||
Operating lease right-of-use assets |
|
15,465 |
|
|
16,523 |
|
||
Other assets |
|
1,152 |
|
|
1,596 |
|
||
Total assets |
|
$ |
412,277 |
|
|
$ |
452,608 |
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity |
|
|
|
|
||||
Current liabilities |
|
|
|
|
||||
Accounts payable |
|
$ |
9,208 |
|
|
$ |
12,770 |
|
Accrued expenses and other current liabilities |
|
64,323 |
|
|
65,376 |
|
||
Operating lease liabilities |
|
5,614 |
|
|
5,502 |
|
||
Total current liabilities |
|
79,145 |
|
|
83,648 |
|
||
Convertible notes, net |
|
193,833 |
|
|
188,651 |
|
||
Long-term operating lease liabilities |
|
10,829 |
|
|
12,102 |
|
||
Other non-current liabilities |
|
1,261 |
|
|
1,257 |
|
||
Total liabilities |
|
285,068 |
|
|
285,658 |
|
||
Stockholders’ equity |
|
|
|
|
||||
Common stock |
|
46 |
|
|
46 |
|
||
Additional paid-in capital |
|
1,072,412 |
|
|
1,062,996 |
|
||
Accumulated other comprehensive loss |
|
(120) |
|
|
(92) |
|
||
Accumulated deficit |
|
(945,129) |
|
|
(896,000) |
|
||
Total stockholders’ equity |
|
127,209 |
|
|
166,950 |
|
||
Total liabilities and stockholders’ equity |
|
$ |
412,277 |
|
|
$ |
452,608 |
|
|
||||||||
|
THREE MONTHS ENDED |
|||||||
|
2020 |
|
2019 |
|||||
Product revenues, net |
$ |
20,341 |
|
|
$ |
10,852 |
|
|
Total revenues, net |
20,341 |
|
|
10,852 |
|
|||
Costs and expenses: |
|
|
|
|||||
Cost of goods sold |
6,092 |
|
|
381 |
|
|||
Selling, general and administrative |
36,902 |
|
|
36,282 |
|
|||
Pre-approval commercial manufacturing |
2,114 |
|
|
4,457 |
|
|||
Research and development |
19,173 |
|
|
17,884 |
|
|||
Total costs and expenses |
64,281 |
|
|
59,004 |
|
|||
Loss from operations |
(43,940) |
|
|
(48,152) |
|
|||
Other (expense) income, net |
(5,222) |
|
|
111 |
|
|||
Loss before income taxes |
(49,162) |
|
|
(48,041) |
|
|||
Income tax (benefit) expense |
(33) |
|
|
(90) |
|
|||
Net loss |
$ |
(49,129) |
|
|
$ |
(47,951) |
|
|
Net loss per common share—basic and diluted |
$ |
(1.07) |
|
|
$ |
(1.06) |
|
|
Weighted average number of common shares outstanding—basic and diluted |
45,792,504 |
|
|
45,270,660 |
|
|
||||||||
|
|
THREE MONTHS ENDED |
||||||
|
|
2020 |
|
2019 |
||||
Net loss (GAAP) |
|
$ |
(49,129) |
|
|
$ |
(47,951) |
|
Add-back: stock-based compensation expense |
|
10,529 |
|
|
12,620 |
|
||
Adjusted Net loss |
|
$ |
(38,600) |
|
|
$ |
(35,331) |
|
|
|
|
|
|
||||
Cost of goods sold (GAAP) |
|
$ |
6,092 |
|
|
$ |
381 |
|
Less: stock-based compensation expense |
|
(497) |
|
|
— |
|
||
Adjusted cost of goods sold |
|
$ |
5,595 |
|
|
$ |
381 |
|
|
|
|
|
|
||||
Selling, general and administrative expenses (GAAP) |
|
$ |
36,902 |
|
|
$ |
36,282 |
|
Less: stock-based compensation expense |
|
(6,908) |
|
|
(9,121) |
|
||
Adjusted selling, general and administrative expenses |
|
$ |
29,994 |
|
|
$ |
27,161 |
|
|
|
|
|
|
||||
Pre-approval commercial manufacturing expenses (GAAP) |
|
$ |
2,114 |
|
|
$ |
4,457 |
|
Less: stock-based compensation expense |
|
(294) |
|
|
(849) |
|
||
Adjusted pre-approval commercial manufacturing expenses |
|
$ |
1,820 |
|
|
$ |
3,608 |
|
|
|
|
|
|
||||
Research and development expenses (GAAP) |
|
$ |
19,173 |
|
|
$ |
17,884 |
|
Less: stock-based compensation expense |
|
(2,830) |
|
|
(2,650) |
|
||
Adjusted research and development expenses |
|
$ |
16,343 |
|
|
$ |
15,234 |
|
|
|
|
|
|
||||
Total operating expenses (GAAP) |
|
$ |
58,189 |
|
|
$ |
58,623 |
|
Less: stock-based compensation expense |
|
(10,032) |
|
|
(12,620) |
|
||
Adjusted total operating expenses |
|
$ |
48,157 |
|
|
$ |
46,003 |
|
|
||||||||
|
|
THREE MONTHS ENDED |
||||||
|
|
2020 |
|
2019 |
||||
Net loss per common share—basic and diluted (GAAP) |
|
$ |
(1.07) |
|
|
$ |
(1.06) |
|
Add-back: stock-based compensation expense |
|
0.23 |
|
|
0.28 |
|
||
Adjusted Net loss per share—basic and diluted |
|
$ |
(0.84) |
|
|
$ |
(0.78) |
|
Weighted average number of common shares outstanding—basic and diluted |
|
45,792,504 |
|
|
45,270,660 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200506005835/en/
Media:
Investors:
Source: