Biofrontera Conference: Ameluz Growth Plan, 80%+ Margin Outlook, and FDA Catalysts in Focus

Executives from Biofrontera (NASDAQ:BFRI) and LSL Pharma Group (TSXV:LSL) outlined their commercial strategies, pipeline priorities, and recent corporate developments during presentations and fireside chats at the Lytham Partners 2026 Investor Healthcare Summit.

Biofrontera highlights Ameluz growth strategy and improving gross margin profile

Biofrontera CEO Dr. Hermann Lübbert said the company’s marketed product, Ameluz, is used in photodynamic therapy (PDT) for dermatologic and oncologic indications and is currently FDA-approved for actinic keratosis (AK) on the face and scalp. The therapy is administered in a physician’s office and requires use of a dedicated light source, which Biofrontera also sells; the company reported about 800 devices in the field.

Lübbert said reimbursement is “well established,” describing a buy-and-bill model in which Biofrontera sells Ameluz directly to the physician. He cited a list price of $381 per unit and said payers broadly reimburse the product, including all Medicare payers and 95% of private payers, using a specific J-code (J7345). Physicians also bill for the PDT procedure using CPT codes; Biofrontera said Ameluz qualifies for the highest code due to a debridement step in the label, which management said pays $262, compared with a cited $162 reimbursement level for cryotherapy when more than 14 lesions are treated.

Biofrontera reported $37.3 million in 2024 revenue and said it experienced “considerable growth” in 2025. Management also discussed the impact of COVID-19 on prior results, emphasizing that PDT is an in-office procedure and that office closures reduced treatment volumes.

New U.S. ownership structure for Ameluz and expected margin expansion

A key corporate change discussed was Biofrontera’s revised arrangement with its former parent, Biofrontera AG. Lübbert said Biofrontera previously had an exclusive U.S. license to sell Ameluz, but in mid-2025 ownership of Ameluz was transferred to Biofrontera Inc. along with responsibility for manufacturing. Under the updated structure, the former parent receives a royalty of 12% of net sales up to $65 million and 15% above.

CFO Fred Leffler said the new structure is expected to materially lift gross margins. He contrasted historical gross margins in the “high 40s, 50%” range under the prior transfer pricing arrangement with an expected 80%–85% gross margin profile going forward. Leffler said gross margin was about 46% through Q3 2024 and 70% through Q3 2025, and he said the company expects to be in the 80%–85% range this year.

In the Q&A, management also said full ownership provides more control over the product and enables the company to use the product as collateral in financing arrangements.

Biofrontera outlines label expansion plans and near-term regulatory milestones

Lübbert described AK as an attractive market, citing about 13 million treatments annually in the U.S. and estimating the current PDT segment at about 2% of treatments, which he said already represents $120 million split between two products. He characterized Biofrontera’s “immediate market opportunity” for AK at $500 million, including cases where patients with many lesions would be better served by field therapy rather than cryotherapy.

The company emphasized a pipeline strategy focused on expanding Ameluz’s label toward broader European Union usage. Management said a key competitive limitation in the U.S. is that the other marketed PDT drug is approved for AK on upper extremities, while Ameluz is not. Lübbert said Biofrontera has completed a phase three trial to support approval beyond the face and scalp and that the company “just last week” closed the database and is awaiting results for an FDA submission.

Biofrontera also described additional programs:

• Basal cell carcinoma: Lübbert said this indication has been submitted to the FDA, with an expected approval decision “by the end of September.”
• Moderate to severe acne: the company completed a phase 2 study and said it is waiting for data.

Leffler added that management expects low- to mid-double-digit revenue growth over the next several years, citing growth initiatives including increased PDT adoption, sales force productivity, refinement of go-to-market strategy, and reimbursement support. He also referenced timing expectations for future drivers, including sBCC in fall 2026 and a mid-2027 PDUFA expectation for trunk and extremities.

Biofrontera discusses liquidity and breakeven expectations

Leffler said the company had $3.4 million on the balance sheet as of September 30 (end of Q3), adding that it is “stronger today,” though updated figures had not yet been released. He also discussed Biofrontera’s share count on an as-converted basis, stating the company expects 47.5 million common shares when preferred shares convert, and said that at a price of about $0.82, market capitalization “as converted” would be about $39–$40 million.

On capital needs, Leffler said that, following the 2025 deal, the company has financing to support the AK business “through breakeven,” which management expects in 2026.

LSL Pharma outlines three business segments and acquisition-led scaling

In a separate fireside chat, LSL Pharma Group CEO François Roberge described LSL as a specialty pharmaceutical company focused on manufacturing and commercialization rather than developing innovative drugs. He said the company began in 2014 with less than $1 million in revenue and is “looking to be over $60 million top line this year.”

Roberge said LSL operates across three segments:

• Contract manufacturing (CMO): four plants in Quebec producing solid dosage, liquid, and semi-solid products for OTC and prescription customers. He cited a base of roughly 60 to 70 clients and said the CMO division is expected to generate close to CAD 45 million top line next year.
• Eye care (Steri-Med): a Quebec-based plant producing ophthalmic ointments for Canada and developing additional products, including in-licensed eye drops that arrive in Canada ready to sell. Roberge said the company received Health Canada approval on November 6 for a new eye drop product expected to launch in Q2 next year and is working on “maybe another 10, 12” in-licensing opportunities for 2026 and 2027. He also said the company expects to receive U.S. FDA approval very shortly for Steri-Med to manufacture ointments for the U.S. market.
• OTC private label: LSL acquired Juno OTC from Juno Pharmaceuticals in December, describing it as a private label business supplying products across Canada, including ibuprofen gel, acetaminophen formats, denture cleaner, Epsom salt, and nicotine gum. Roberge said the acquisition targets CAD 20–25 million in revenue next year and includes launching up to 10 new products next year, including OTC eye drops.

Roberge also discussed expansion at Steri-Med, noting a new filling line received in April of the prior year that he said would increase annual capacity from about 1.1–1.2 million units to up to 8 million units. He said LSL’s goal is for the ophthalmic business to reach roughly 50% of top line and 70% of EBITDA over three to five years, due to a higher margin profile relative to OTC and CMO operations.

On financial metrics, Roberge said LSL expects 2025 revenue of about CAD 30 million with approximately CAD 4 million of EBITDA, with final numbers expected in April or May. He cited gross margin ranges of roughly 25%–35% for CMO, about 25% for OTC, and said the ophthalmic business could range from 50%–75% as capacity improves.

Looking ahead, Roberge identified integration of the recent Juno OTC and Duvar acquisitions as key challenges for early 2026 and said the company continues to evaluate additional M&A opportunities. He also said LSL aims to reach $100 million in revenue within two years through a combination of organic growth and “one or two” additional acquisitions.

About Biofrontera (NASDAQ:BFRI)

Biofrontera AG is a specialty biopharmaceutical company focused on the research, development and commercialization of products for dermatological applications. The company’s core expertise lies in photodynamic therapy (PDT), a treatment modality that uses a photosensitizing agent activated by a specific light source to target diseased skin cells while sparing surrounding healthy tissue.

The flagship product in Biofrontera’s portfolio is Ameluz (aminolevulinic acid hydrochloride 10 % gel), which has received marketing approval in the European Union for treatment of actinic keratosis and basal cell carcinoma, and in the United States for actinic keratosis.