On August 5, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported financial results for the second quarter ended June 30, 2020 (Press release, Arena Pharmaceuticals, AUG 5, 2020, View Source [SID1234563218]).
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"Over the quarter, we delivered positive Phase 1 data from the etrasimod controlled-release program, fully enrolled the Phase 2b ADVISE trial in atopic dermatitis – meeting the high-end of our enrollment range and allowing for the availability of data in 2020 as guided, and completed a capital raise to further strengthen our balance sheet," said Amit D. Munshi, President and CEO of Arena. "I am extremely proud of the resiliency and tenacity that our team has demonstrated during the past several months as they overcame challenges that our industry is facing as a result of the global COVID-19 pandemic. Our team has adapted quickly and focused on execution in order to achieve key milestones for the company, and I want to acknowledge the hard work that went on across the organization. As a leadership team, we are consistently evaluating the impact of the pandemic and assessing the appropriate level of action needed as circumstances evolve."
Program Update
Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial enrollment completed; topline data expected Q4 2020
Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to initiate in H2 2020; topline data for both trials expected by year end 2021
Etrasimod CULTIVATE Phase 2b dose-ranging trial in Crohn’s disease (CD) initiated and ongoing; confirming plans to help facilitate availability of topline data in 2021; continue to suspend overall program guidance based on expected COVID-19 impact
Etrasimod eosinophilic esophagitis (EoE) Phase 2b and alopecia areata (AA) Phase 2 planning ongoing; initiation in 2020 dependent on COVID-19 situation in Q3/4
Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome (IBS-C, IBS-D) ongoing; experiencing some COVID-19 related impact on trial enrollment; topline data expected Q1 2021
APD418 in acute heart failure (AHF) with Fast Track designation; Phase 1 trial has resumed; topline data expected Q4 2020
Financial Update
Second Quarter 2020 Financial Results
Revenues for the second quarter were zero compared to $1.0 million in the second quarter of 2019
Research and development (R&D) expenses for the second quarter totaled $64.9 million compared to $51.2 million in the same period 2019. This increase was primarily driven by our advancing clinical studies, including the etrasimod Phase 3 program, as well as an increase in personnel expenses as we staff to support our clinical programs. The R&D non-cash share-based compensation was $6.3 million in the second quarter as compared to $7.0 million in the same period 2019
General and administrative (G&A) expenses for the second quarter totaled $22.9 million, compared to $18.4 million in the second quarter of 2019. This increase is primarily attributed to personnel expenses. The G&A non-cash share-based compensation was $6.0 million in the second quarter as compared to $6.4 million in the same period 2019
Net loss for the second quarter was $84.9 million compared to net loss of $61.4 million for the same period in 2019
Basic and diluted net loss per share for the second quarter was $1.61 compared to basic and diluted net loss per share of $1.24 for the same period in 2019
Cash, cash equivalents and marketable securities were $1.3 billion at June 30, 2020, including $301.8 million in net proceeds received from the sale of approximately 6.3 million shares of common stock under an equity financing, as compared to $1.0 billion at March 31, 2020
Financial Outlook for 2020
Arena’s 2020 financial guidance range:
No change from the previous guidance, cash used in operating activities for the full-year 2020 is expected to be $400 million to $430 million
Conference Call & Webcast Information
Arena will host a live and webcast question and answer session via conference call with the investment community today, Wednesday, August 5, 2020, at 4:30 PM ET, to discuss the financial results and corporate update.
When: Wednesday, August 5, 2020, at 4:30 PM ET
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 5343486
Please join the conference call at least 20 minutes early to register. You can access the live webcast under the investor relations section of Arena’s website at: www.arenapharm.com. A replay of the event will be archived under the investor relations section of Arena’s website for 30 days shortly after the call.