Novan 2023 first quarter financial results show focus on berdazimer gel launch

Key takeaways:

• Novan reported a total revenue of $3.2 million for the first quarter of 2023.
• The company continues to prepare for its launch of berdazimer gel 10.3%.

Novan released its financial results for the first quarter of 2023, which included continued progress towards its prescription drug user fee act goal date for berdazimer gel 10.3%, according to a company press release.

Novan announced its new drug application submission for berdazimer gel 10.3% for the treatment of molluscum contagiosum in January. The FDA accepted the application for filing and it is currently under review.

“As we get closer to our [prescription drug user fee act goal date] goal date of Jan. 5, 2024, for our lead program, berdazimer gel 10.3% for the treatment of molluscum contagiosum, we are diligently working to prepare for a potential approval and commercial launch of that program,” Paula Brown Stafford, MPH, president and CEO of Novan, said in the release.

“We continue to aggressively pursue a wide variety of potential funding or strategic arrangements and alternatives to address our short-term cash needs, provide the capital necessary to progress development of our lead program, berdazimer gel 10.3%, and support the company’s operations,” Brown Stafford continued, “while at the same time conserving cash by delaying or deferring certain expenditures.”

According to the release, if berdazimer gel is approved, the company believes it will be the first FDA-approved, self-applicating topical indicated for molluscum contagiosum treatment.

Meanwhile, Novan has concluded its first 2023 quarter by entering into a securities purchase agreement with an institutional investor, closing a $6 million registered direct offering.

In December 2022, the company also received a $5 million upfront payment from Sato Pharmaceutical for the exclusive licensing agreement to develop, manufacture and market Rhofade. Novan further reported a decline in the number of Rhofade units sold in the first quarter due to a manufacturing delay with the supplier. However, units have since returned to normal year-to-date sales activity rates as of April.

According to the release, Novan had a total cash and cash equivalents balance of $12.5 million and reported a total revenue of $3.2 million and $1.9 million for the first quarter of 2023 and 2022, respectively.

Compared to the same quarter last year, net product revenues increased from $700,000 to $2.4 million, which represented Rhofade, Wynzora and Minolira sales.

“The first quarter of 2023 represented another strong demonstration of quarterly growth year-over-year across our portfolio of promoted products,” John Donofrio, executive vice president and chief operating officer of Novan, said in the release. “We are encouraged by our continued growth in the market and are focused on executing on our strategic initiatives to bolster our net revenue operating performance moving forward.”