Release Date: May 16, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Biofrontera Inc renegotiated its license and supply agreement, significantly reducing costs from 40-50% to 25% for Ameluz during 2024 and 2025, which will step up to 35% by 2032.
- The company successfully raised $8 million in February to support growth and expansion, including covering the costs of clinical trials.
- Biofrontera Inc has taken over all US clinical trials, allowing for more effective cost management and direct oversight, enhancing trial efficacy.
- The introduction of a new formulation of Ameluz without propylene glycol is expected to improve tolerability and potentially extend the product's shelf life.
- The placement of 28 lamps in Q1 2024, a 115% increase compared to the previous year, indicates growing adoption and potential for increased future sales.
Negative Points
- Q1 2024 revenues decreased by 9% compared to Q1 2023, primarily due to a cyber attack on Change Healthcare, impacting healthcare reimbursement and cash flow across the industry.
- The cyber attack led to reduced orders from some customers, shifting expected Q1 revenue to Q2.
- Total operating expenses were $13.4 million in Q1 2024, and despite a decrease from the previous year, the company still operates at a loss.
- Net loss for Q1 2024 increased to $10.4 million, or a loss of $2.88 per share, compared to a net loss of $7.5 million, or a loss of $5.60 per share in Q1 2023.
- Adjusted EBITDA for Q1 2024 was negative $4.6 million, reflecting lower revenues and ongoing financial challenges.
Q & A Highlights
Q: Does the greater than 5% sales growth from January through April underestimate the actual growth, or is it close to 5%?
A (Fred Leffler - CFO, Biofrontera Inc): The greater than 5% growth was based on a milestone that needed to be achieved. Specific numbers weren't issued, but an update for Q2 will be provided in August.
Q: Are you still comfortable with achieving cash flow breakeven around the end of 2025?
A (Fred Leffler - CFO, Biofrontera Inc): Yes, the expectation to reach cash flow breakeven by the end of 2025 remains unchanged. The savings from the LFA amendments and hitting budget numbers should support this goal.
Q: Has the last patient in the basal cell carcinoma study completed their final assessment?
A (Hermann Luebbert - CEO, Biofrontera Inc): Yes, the last patient has completed their assessment. The follow-up data will be available early in Q2, and submission to the FDA is expected thereafter.
Q: Regarding the use of Ameluz, if dermatologists are allowed to use more than one tube, would that increase reimbursement?
A (Hermann Luebbert - CEO, Biofrontera Inc): Doctors are expected to use products according to the label, and payers are monitoring this closely. The ongoing FDA submission for the use of three tubes is very relevant in this context.
Q: Can you provide updates on the enrollment for the acne and actinic keratosis clinical trials?
A (Hermann Luebbert - CEO, Biofrontera Inc): For actinic keratosis, the current enrollment is 57% of the patients. For acne, it's 74% of the subjects.
Q: How do you see sales unfolding for the rest of the year, considering the impact from Change Healthcare?
A (Hermann Luebbert - CEO, Biofrontera Inc): The impact from Change Healthcare was mostly in February and March. Recovery was seen in April, and sales were more than 5% above last year. The same growth expectations from the beginning of the year are maintained.
Q: When is the XL lamp expected to launch?
A (Hermann Luebbert - CEO, Biofrontera Inc): The XL lamp is expected to launch by the end of Q2.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
