Biofrontera

Biofrontera, Inc. is a biopharmaceutical company, which engages in the commercialization of pharmaceutical products. It specializes in the treatment of dermatological conditions, caused primarily by exposure to sunlight that results in sun damage to the skin. The company is focused on the treatment of actinic keratosis and markets a topical antibiotic for treatment of impetigo. Its products include Ameluz and Xepi, its two prescription drugs, and BF-RhodoLED, a lamp used with Ameluz, for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. The company was founded on March 3, 2015 and is headquartered in Woburn, MA.

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Biofrontera reports Q1 recovery post cyberattack, eyes product expansion

Biofrontera Inc. navigated challenges in Q1 2024, with a cyberattack impacting revenues, but recovery and growth were evident by April 30, 2024.
The company's strategic strengths lie in cost reduction through renegotiations, successful fundraising efforts, and advancements in clinical trials and product development.
Opportunities abound for Biofrontera with upcoming product launches, FDA approvals, and a focus on operational efficiency and financial management to drive future profitability.
Addressing financial challenges and leveraging opportunities will be key for Biofrontera to sustain growth, enhance market position, and deliver value to stakeholders in the coming quarters.

Biofrontera reports robust Q2 sales growth and cost efficiencies

Biofrontera delivered strong sales growth and cost management in Q2 2024, improving financial performance.
While challenges like net losses persist, opportunities exist to leverage momentum for sustained growth.
The company's focus on operational efficiency and revenue expansion sets the stage for future success and value creation.

Biofrontera reports steady Q3 growth amidst operational challenges and opportunities

Biofrontera Inc. showed resilience with revenue growth despite challenges like delayed deliveries.
Strategic strengths include FDA approvals, positive trial results, and focus on operational efficiency.
Challenges in high operating expenses and negative EBITDA highlight areas for improvement.
Opportunities lie in market expansion, clinical trial progress, and strategic financial management.

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Company secures financing of $8.0 million with an additional $8.0 million second tranche tied to milestones for aggregate proceeds of $16 million gross priced at market per Nasdaq rules Funding and recent restructuring of supply agreement allow Biofrontera Inc to assume R&D activities and to support further commercial growth WOBURN, MA / ACCESSWIRE / February 20, 2024 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company") , a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced it has entered into a securities purchase agreement with healthcare-focused institutional investors led by Rosalind Advisors. Pursuant to the securities purchase agreements, the Company will issue to the purchasers (a) an aggregate $8.0 million in shares of the company's Series B-1 Convertible Preferred Stock and (b) warrants to purchase shares of the Company's Series B-3 Convertible Preferred Stock with an aggregate exercise price of $8.0 million exercisable until the earlier of (i) five days after achievement of certain operational and commercial milestones, expected in Q2 of 2024, the approval by the Company's shareholders of an increase in authorized shares and other proposals, and the effectiveness of a registration statement with the U.S. Securities and Exchange Commission covering the resale of the Common Stock underlying all shares of preferred stock that may be issued under the securities purchase agreement or (ii) the five-year anniversary of the issuance of the warrants.

Biofrontera Inc. Announces Private Placement of Up To $16.0 Million Priced at Market per Nasdaq Rules

FDA has set a target action date of October 4, 2024 sNDA supported by two Phase 1 safety studies1 Aims at actinic keratosis (AK) field treatment with up to 3 tubes An estimated 13 million treatments given each year for AK in the US2 WOBURN, MA / ACCESSWIRE / February 5, 2024 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that the U.S. Food and Drug Administration (FDA) has issued a "no filing review issues identified" letter regarding the sNDA (supplementary New Drug Application) submitted by its licensor Biofrontera Bioscience GmbH to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. FDA has completed its filing review and will begin its substantive review of Biofrontera's communication.

Biofrontera Inc. Announces FDA Filing of Supplemental New Drug Application for Ameluz(R) to Permit Up to Three Tubes Per Use

WOBURN, MA / ACCESSWIRE / January 11, 2024 / Biofrontera Inc. (Nasdaq:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced preliminary, unaudited revenues for the three and twelve months ended December 31, 2023. Biofrontera achieved 2023 revenue of approximately $33.8 million to $34.3 million, a record high and up approximately 19% growth compared with 2022.

Biofrontera Inc. Announces Preliminary Revenues for the Fourth Quarter and Full Year 2023

After losing some value lately, a hammer chart pattern has been formed for Biofrontera Inc. (BFRI), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.

Biofrontera Inc. (BFRI) Forms 'Hammer Chart Pattern': Time for Bottom Fishing?

Biofrontera Inc. (NASDAQ:BFRI ) Q3 2023 Earnings Conference Call November 10, 2023 10:00 AM ET Company Participants Tirth Patel - IR Hermann Luebbert - Chairman, CEO and Founder Fred Leffler - CFO Conference Call Participants Jonathan Aschoff - ROTH Bruce Jackson - The Benchmark Company Operator Good day, and welcome to the Biofrontera Inc. Third Quarter 2023 Financial Results and Business Update Conference Call. [Operator Instructions] Please note this event is being recorded.

Biofrontera Inc. (BFRI) Q3 2023 Earnings Call Transcript

Conference call begins at 10:00 a.m. Eastern time on Friday, November 10, 2023 WOBURN, MA / ACCESSWIRE / November 9, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three and nine months ended September 30, 2023 and provided a business update.

Biofrontera Inc. Reports Third Quarter 2023 Financial Results and Provides a Business Update

Biofrontera Inc. (BFRI) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Biofrontera Inc. (BFRI) Upgraded to Buy: Here's What You Should Know

WOBURN, MA / ACCESSWIRE / November 3, 2023 / Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announces it will report financial results for the three and nine months ended September 30, 2023, after the close of the U.S. financial markets on Thursday, November 9, 2023. The Company will hold a conference call on Friday, November 10, 2023 beginning at 10:00 a.m.

Biofrontera Inc. to Report Third Quarter 2023 Financial Results on November 9 and Hold Conference Call on November 10

WOBURN, MA / ACCESSWIRE / October 31, 2023 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, entered into a securities purchase agreement with a certain institutional investor, pursuant to which the Company agreed to issue and sell to the investor an aggregate of 1,205,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase an aggregate of up to 1,807,000 shares of Common Stock, at an exercise price of $3.55 per share of Common Stock. The warrants are exercisable immediately upon issuance and will expire five years following the date of issuance.

Biofrontera Inc. Announces $4.5 Million Registered Direct Offering Priced At-the-market Under NASDAQ Rules

Patent Application Filed with Potential to Extend Ameluz® Protection to 2043 WOBURN, MA / ACCESSWIRE / October 10, 2023 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that its licensor Biofrontera Bioscience GmbH has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Ameluz® (aminolevulinic acid hydrochloride) for the treatment of actinic keratosis (AK). The new formulation is covered by the License and Supply Agreement between the two companies.

Biofrontera Inc. Receives FDA Approval for New Formulation of Ameluz(R)

WOBURN, MA / ACCESSWIRE / October 5, 2023 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced management will deliver a company presentation and hold investor meetings at the Roth MKM 2023 Healthcare Opportunities Conference being held October 12, 2023 in New York. Biofrontera management will also participate in the 43rd Annual Fall Clinical Dermatology Conference being held October 19-22, 2023 in Las Vegas, Nevada, including the exhibition of three posters.

Biofrontera Inc. to Participate in the Roth MKM 2023 Healthcare Opportunities Conference and the 43rd Annual Fall Clinical Dermatology Conference

Revenues Increased 101% to 108% Over the Prior-Year Quarter Affirms Guidance for Full-Year Revenue Growth of at Least 25% over 2022 WOBURN, MA / ACCESSWIRE / October 4, 2023 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced preliminary unaudited revenues for the three months ended September 30, 2023. Revenues for the third quarter of 2023 are anticipated to be in the range of approximately $8.7 million to $9.0 million, an increase of approximately 101% to 108% compared with the third quarter of 2022.

Biofrontera Inc. Announces Preliminary Third Quarter Revenues

All You Need to Know About Biofrontera Inc. (BFRI) Rating Upgrade to Buy

WOBURN, MA / ACCESSWIRE / August 29, 2023 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announced today the appointment of Samantha (Sam) Widdicombe to the newly created position of Senior Director, Strategic Accounts and Communications. Biofrontera created this position in response to the growing demand and opportunity for specialized sales and marketing approaches resulting from an evolving landscape of medical practices consolidating into larger integrated organizations.

Biofrontera Inc. Appoints Samantha Widdicombe to Support Commercial Relationships with Strategic Customer Accounts

WOBURN, MA / ACCESSWIRE / August 28, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces positive topline results from its non-randomized, open-label, multicenter Phase 1 study evaluating the safety and tolerability of 3 entire tubes of BF-200 ALA (Ameluz®) in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy (PDT) using the RhodoLED® XL lamp. Of the 100 patients treated in 9 participating clinical centers, the incidences of Treatment Emergent Adverse Events (TEAEs) were consistent with the TEAEs listed in the US prescribing information (US PI) that are based on studies with 1 tube.

Biofrontera Inc. Announces Positive Results from Phase 1 Safety Study Evaluating Photodynamic Therapy with Three Tubes of Ameluz(R)

Biofrontera Inc. (NASDAQ:BFRI ) Q2 2023 Earnings Conference Call August 11, 2023 8:30 AM ET Company Participants Tirth Patel - Investor Relations Hermann Luebbert - Executive Chairman and Founder Fred Leffler - Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Bruce Jackson - The Benchmark Company Operator Good morning everyone and welcome to the Biofrontera Inc. Second Quarter 2023 Financial Results and Business Update Conference Call. [Operator Instructions] Please also note today's event is being recorded.

Biofrontera Inc. (BFRI) Q2 2023 Earnings Call Transcript

Biofrontera Inc. (BFRI) came out with a quarterly loss of $6.14 per share versus the Zacks Consensus Estimate of a loss of $5.14. This compares to loss of $8.80 per share a year ago.

Biofrontera Inc. (BFRI) Reports Q2 Loss, Lags Revenue Estimates

Conference call begins at 8:30 a.m. Eastern time today WOBURN, MA / ACCESSWIRE / August 11, 2023 / Biofrontera Inc. (Nasdaq:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three and six months ended June 30, 2023 and provided a business update.

Biofrontera Inc. Reports Second Quarter 2023 Financial Results and Provides a Business Update

Trial Results Expected in Mid-2024 WOBURN, MA / ACCESSWIRE / August 10, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces that patient enrollment is now complete in the Phase 3 clinical study evaluating Ameluz®-PDT in combination with the BF-RhodoLED® lamp for the treatment of basal cell carcinoma (BCC). This study is being conducted by Biofrontera Bioscience GmbH.

Biofrontera Inc. Announces Last Patient Enrolled in Phase 3 Clinical Study Evaluating Ameluz(R)-PDT for the Treatment of Basal Cell Carcinoma

WOBURN, MA / ACCESSWIRE / August 4, 2023 / Biofrontera Inc. (Nasdaq:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announces it will report financial results for the three and six months ended June 30, 2023 before the opening of the U.S. financial markets on Friday, August 11, 2023. The Company will hold a conference call that same day beginning at 8:30 a.m.

Biofrontera Inc. to Report Second Quarter Financial Results on August 11, 2023

Management Reaffirms Full-Year 2023 Revenue Growth of at least 25% over Prior Year WOBURN, MA / ACCESSWIRE / July 13, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced preliminary unaudited revenues for the three months ended June 30, 2023. Revenues for the second quarter of 2023 are anticipated to be in the range of approximately $5.7 million to $5.9 million, an increase of approximately 26% to 31% compared with the second quarter of 2022.

Biofrontera Inc. Announces Preliminary Second Quarter Revenues are Up 26% to 31%

WOBURN, MA / ACCESSWIRE / July 12, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces the appointment of Heikki Lanckriet, Ph.D. to its Board of Directors.

Biofrontera Inc. Appoints Dr. Heikki Lanckriet to its Board of Directors

WOBURN, MA / ACCESSWIRE / July 3, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20 that will become effective after the close of trading at 11:59 p.m. today. Biofrontera Inc. common stock will begin trading on Nasdaq on a split-adjusted basis when the market opens on Wednesday, July 5, 2023 under the existing symbol, BFRI, and under a new CUSIP number, 09077D 209.

Biofrontera Inc. Announces 1-for-20 Reverse Stock Split

WOBURN, MA / ACCESSWIRE / June 12, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces its sponsorship of The Sun Bus, a mobile classroom and clinic bringing free skin cancer screenings and public education to communities across the U.S. The 2023 tour kicked off in March in Colorado and continues through November with stops in Texas, Missouri, Iowa, Wyoming and Arizona. The Sun Bus works with local volunteer dermatology providers and educators at each stop - which includes workplaces, community events and festivals - to provide skin cancer screenings, sun safety education and free sunscreen samples.

Biofrontera Inc. Sponsors The Sun Bus, Delivering Free Mobile Skin Cancer Screenings Across the U.S.

WOBURN, MA / ACCESSWIRE / June 1, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces it has engaged a contract manufacturer to develop a new, low-cost portable photodynamic therapy (PDT) lamp for use with Ameluz® (Ameluz®-PDT). Prior to this engagement, Biofrontera acquired one issued U.S. patent and all rights from one of two inventors on another issued U.S. patent related to a portable red-light lamp for use in PDT.

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