Revance Reports First Quarter 2021 Financial Results, Provides Corporate Update

Rhea-AI Summary

Revance Therapeutics, Inc. (Nasdaq: RVNC) reported a first quarter 2021 revenue of $13.3 million, a significant increase from $0.1 million in Q1 2020, driven primarily by the RHA® Collection of dermal fillers. However, the company faced a net loss of $71.6 million. SG&A expenses rose to $49.0 million, while R&D expenses decreased to $27.3 million. Cash equivalents stood at $386.8 million, and the company raised $21.7 million from its ATM program. The FDA's review of DaxibotulinumtoxinA for Injection remains pending due to inspection scheduling delays.

Positive

• First quarter 2021 revenue of $13.3 million, up from $0.1 million in Q1 2020
• DaxibotulinumtoxinA for Injection successfully advanced to Phase 3 following positive Phase 2 data
• RHA® Collection revenue totaled $11.6 million in Q1 2021, with strong growth momentum
• Cash reserves of $386.8 million supporting future growth initiatives

Negative

• Net loss of $71.6 million in Q1 2021
• SG&A expenses increased significantly to $49.0 million
• Delayed FDA inspection for DaxibotulinumtoxinA approval

Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

Financial Highlights

• Revenue for the first quarter 2021 totaled $13.3 million compared to $0.1 million for the first quarter 2020. The increase was primarily due to sales resulting from the commercial launch of the RHA® Collection of dermal fillers and increased revenue related to the biosimilar program. Revenue included $11.6 million of product revenue from sales of the RHA® Collection of dermal fillers, $1.5 million of collaboration revenue and $0.1 million of service revenue from the HintMD platform.

• Selling, general and administrative (SG&A) expenses for the first quarter 2021 were $49.0 million compared to $21.2 million for the first quarter 2020. The increase was primarily due to sales and marketing expenses related for the RHA® Collection of dermal fillers, pre-commercial activities for DaxibotulinumtoxinA for Injection and other personnel-related expenses from integrating HintMD. SG&A expenses include depreciation and amortization and stock-based compensation. Excluding these expenses, non-GAAP SG&A expenses were $40.8 million for the first quarter 2021.

• Research and development (R&D) expenses for the first quarter 2021 were $27.3 million compared to $39.8 million for the first quarter 2020. The decrease was primarily due to lower clinical trial costs and regulatory costs as the company completed multiple clinical trials in 2020, offset by costs related to pre-commercial manufacturing and developmental efforts. R&D expenses include depreciation and amortization and non-cash stock-based compensation. Excluding these expenses, non-GAAP R&D expenses were $23.5 million for the first quarter 2021.

• Total operating expenses for the first quarter 2021 were $83.3 million compared to $61.0 million for first quarter 2020. Excluding costs of revenue, depreciation and amortization, stock-based compensation and in-process research and development, non-GAAP operating expenses for the first quarter 2021 were $64.2 million.

• Net loss for the first quarter 2021 was $71.6 million.

• Cash, cash equivalents and short-term investments as of March 31, 2021 were $386.8 million.

• Net proceeds from the issuance of approximately 0.8 million shares of common stock during the first quarter under the company’s At-the-Market (ATM) program totaled $21.7 million. Since the fourth quarter of 2020, a total of $90.1 million in net proceeds have been raised on the ATM program, which has aggregate offering price of up to $125 million.

“We are very pleased with our commercial execution in the first quarter, particularly given the impact of COVID-19 and seasonality, where the first quarter is traditionally a slower time of the year for the aesthetics market. We are also encouraged by the progress we are making in our therapeutics franchise as we begin laying the groundwork for our first anticipated approval in the treatment of muscle movement disorders,” said Mark Foley, President and Chief Executive Officer. “Our FDA approval for DaxibotulinumtoxinA for Injection for glabellar lines remains under review with a deferred action due to COVID-related travel restrictions. We stand ready for the pre-approval inspection of our manufacturing facility and are actively engaging with the FDA to schedule an inspection date as soon as possible. We continue to anticipate an approval this year and, as we have noted before, the FDA did not indicate that there were any other review issues beyond the pending inspection.”

Foley continued, “We remain focused on execution for the balance of the year and believe we are well positioned for continued growth based on our targeted launch strategy, differentiated products and services and anticipated approval of our next-generation neuromodulator. When combined with our efforts in therapeutics and steady progress in our partnerships, we are encouraged by the longer-term growth opportunities that will be available to us.”

First Quarter Highlights and Subsequent Updates

Aesthetics Franchise

• RHA® Collection revenue totaled $11.6 million for the first quarter 2021 and $21.6 million in the first two full quarters of commercial launch. Strong revenue growth was driven by increased account penetration, supported by the ramp up of training programs along with targeted influencer and digital media campaigns. The number of aesthetic accounts across the RHA® Collection and HintMD fintech platform totaled over 1,500 at the end of the first quarter 2021.

• Record quarter for HintMD processing volume run-rate. HintMD’s processing volume run-rate more than doubled to over $400 million from the prior quarter driven by increased account penetration and a streamlined sales and customer acquisition process.

• Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines remains under U.S. Food and Drug Administration (FDA) review. As of the date of this earnings press release, the FDA has not scheduled or conducted a pre-approval inspection of the company's Northern California manufacturing facility. The company previously announced that the FDA did not indicate any further outstanding review issues beyond the pending inspection. The company continues to work closely with the FDA to schedule an inspection as soon as possible and is building inventory of the drug product in preparation for launch. The company will issue a press release when it receives official communication from the FDA on the company’s inspection timing.

Therapeutics Franchise

• Positive topline Phase 2 data from the JUNIPER study on DaxibotulinumtoxinA for Injection for the treatment of adults with upper limb spasticity. In February, the company announced that the JUNIPER study delivered efficacy, safety and dosing data that warranted advancement of the program to Phase 3.

• Strengthened commercial foundation of the therapeutics franchise. Given the company’s progress in its clinical trial programs, including the successful completion of the ASPEN-1 Phase 3 trial of DaxibotulinumtoxinA for Injection in cervical dystonia, the company

FAQ

What were Revance Therapeutics' Q1 2021 financial results?

Revance reported revenue of $13.3 million and a net loss of $71.6 million for Q1 2021.

How much revenue did the RHA® Collection generate in Q1 2021?

The RHA® Collection generated $11.6 million in revenue during the first quarter of 2021.

What is the status of DaxibotulinumtoxinA's FDA approval?

The FDA's review for DaxibotulinumtoxinA for Injection is pending due to a delay in scheduling a pre-approval inspection.

What were the selling, general and administrative expenses in Q1 2021?

SG&A expenses for Q1 2021 were $49.0 million, compared to $21.2 million in the prior year.

What cash reserves does Revance Therapeutics have?

As of March 31, 2021, Revance had cash, cash equivalents, and short-term investments totaling $386.8 million.