FDA Update
On November 25, 2020, Revance Therapeutics, Inc. (the “Company”) announced that the United States Food and Drug Administration (the “Agency”) has deferred a decision on the Biologics License Application (“BLA”) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product, for the treatment of moderate to severe glabellar (frown) lines. In a communication received on November 24, 2020, the Agency reiterated that an inspection of the Company’s manufacturing facility is required as part of the BLA approval process. The Agency was unable to conduct a required inspection of the Company’s manufacturing facility in Newark, California due to the Agency’s travel restrictions associated with the COVID-19 pandemic. The Company confirmed with the Agency that their communication was not a complete response letter.
Though the Company’s application is still under review, the Agency did not indicate there are any other review issues at this time, outside of the on-site inspection. The Agency stated they are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.
Sales Agreement
On November 27, 2020, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Cowen, shares of the Company’s common stock, par value $0.001 per share, having an aggregate offering price of up to $125.0 million (the “ATM Offering”). The shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 to be filed with the United States Securities and Exchange Commission (the “SEC”) on November 27, 2020.
The Company is not obligated to sell any shares under the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, Cowen will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of The Nasdaq Global Market, to sell shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Under the Sales Agreement, Cowen may sell shares by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. The Company will pay Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Cowen with customary indemnification and contribution rights. The Sales Agreement may be terminated by Cowen or the Company at any time upon notice to the other party, or by Cowen at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the shares.
The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 99.1 to this Current Report on Form 8-K.
This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any shares under the Sales Agreement nor shall there be any sale of such shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.