Biofrontera Inc. Financial Performance Update for 2024

Biofrontera Inc. Reports Financial Outcomes for 2024

WOBURN, Mass. -- Biofrontera Inc. (NASDAQ: BFRI), a dedicated biopharmaceutical company focused on photodynamic therapy (PDT), has shared its financial results for the ongoing year. The report highlights both quarterly performance and year-to-date achievements, with insights into various business performance metrics.

Quarterly and Year-to-Date Financial Highlights

For the third quarter of 2024, Biofrontera Inc. reported total revenues of $9.0 million, reflecting a modest increase of 1.5% compared to the same quarter in 2023. It is important to note that this growth could have reached 19%, if not for shipment delays attributed to Hurricane Milton.

The cumulative revenue for the first nine months positioned at $24.8 million shows a growth of $1.3 million or 5.6% compared to the prior year. This includes an expected increase of 12% were it not for Hurricane Milton's impact on shipments.

Product Achievements and Financial Management

September 2024 marked a notable month for the company, with Ameluz® achieving record volume sales. Additionally, the company maintained a disciplined approach to managing selling, general and administrative (SG&A) costs, achieving a remarkable 14% reduction during the first nine months compared to 2023.

Cash Position and Device Launches

As of September 30, 2024, Biofrontera reported cash and cash equivalents totaling $2.9 million, a significant increase from $1.3 million reported at the end of 2023. The company’s ongoing success with the launch of the RhodoLED XL has also been noteworthy, with 39 units installed since its release in late June 2024.

FDA Approval and Clinical Trials

On October 4, 2024, Biofrontera received FDA approval for a supplemental New Drug Application (sNDA), which increased the permitted dosage of Ameluz® from one to three tubes per treatment. This significant approval allows for broader treatment areas of mild to moderate actinic keratosis using Ameluz®-PDT and the BF-RhodoLED® or the RhodoLED® XL lamp. This strategic move is expected to enhance growth potential significantly.

In terms of clinical developments, preliminary results from a Phase 3 study on superficial basal cell carcinoma (sBCC) have shown highly significant metrics, achieving a 75.9% histological clearance rate versus just 19% for the placebo.

Looking Ahead: Strategic Direction

Chief Executive Officer Hermann Luebbert expressed confidence in the company’s trajectory. "Despite external challenges, our recent results underscore the positive reception of our product offerings across the market. As we prepare for our FDA filing for Ameluz® to treat sBCC, we anticipate submitting this in the first half of 2025, with potential approval expected in early 2026. This forms a critical part of our strategy to position Biofrontera for significant sales growth in the years to come," he stated.

Frequently Asked Questions

What were Biofrontera's revenue figures for the third quarter of 2024?

Biofrontera's revenues for Q3 2024 were reported at $9.0 million.

How did Hurricane Milton affect Biofrontera's financial results?

The hurricane caused delays in shipments that impacted revenues, specifically reducing expected quarterly growth from 19% to 1.5%.

What notable product achievement occurred in September 2024?

Ameluz® reached a record volume of sales during September 2024.

What is the current cash position of Biofrontera as of September 30, 2024?

As of that date, Biofrontera reported its cash and cash equivalents at $2.9 million.

What milestone was achieved regarding Ameluz® on October 4, 2024?

The FDA approved an increase in the maximum allowed dosage of Ameluz® from one tube to three tubes per treatment.

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