On March 15, EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a pure-play biosimilar company focused on the global development and commercialization of biosimilar monoclonal antibodies (mAbs), reported financial results for the fourth quarter and fiscal year of 2015, and provided a business update (Press release, Epirus Biopharmaceuticals, MAR 15, 2016, View Source [SID:1234509549]).

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"During 2015, we made significant progress on our strategy of efficiently developing high quality biosimilars that will allow more people globally to benefit from biologic innovation," stated Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. "We added new product candidates to our pipeline, acquired the Bioceros technical platform, completed several early launch market regulatory submissions and, through partnerships, expanded our global commercial network which now enables us to access over 70 markets. EPIRUS is well positioned in the market as physicians, patients and payers look for innovative market-based solutions to address the problem of high drug costs."

"We are off to a strong start in 2016 with the initiation of UNIFORMi, the pivotal Phase 3 global registration study for BOW015 (infliximab, reference biologic Remicade) designed to support our filings anticipated in 2017 for marketing approval in Europe and North America. In 2016, we plan to continue to increase the number of patients treated with BOW015, which we expect will help support regulatory filings and provide valuable in-market experience as we continue to make BOW015 available globally. We will also focus on completing BOW050 (adalimumab, reference biologic Humira) process lock and initiating the global registration program, identifying our U.S. commercialization strategy and planning for management of cost of goods sold through efficient manufacturing and supply chain strategies."

Key Accomplishments

Initiated UNIFORM, a 58-week, double-blind, one-to-one randomized, comparator-controlled multi-center global study, to compare efficacy, safety and immunogenicity and demonstrate clinical equivalence of BOW015 with Remicade in active Rheumatoid Arthritis (RA) patients

Submitted regulatory applications for marketing authorization of BOW015 in multiple Southeast Asian and Latin American countries
Advanced programs for six product candidates, including preparing for pivotal Phase 3 global clinical study of BOW050 (adalimumab, reference biologic Humira)

Established distribution access to over 70 global markets through partnerships with Polpharma Group, mAbxience, Sun Pharma and Livzon

Expanded biosimilar pipeline, product development capabilities and experienced management team and staff through the acquisition of privately-held Bioceros Holdings B.V.

Summary Financial Results

Cash and cash equivalents and marketable securities, collectively "cash," totaled $31.5 million at December 31, 2015. The Company is in the process of evaluating various financing alternatives for operations, by raising additional capital through equity or debt financings or entering into collaboration agreements.

Fourth Quarter 2015 Financial Highlights

Revenue totaled approximately $285,000 for the fourth quarter of 2015, compared to $4,000 for the fourth quarter of 2014. The revenue in 2015 related to collaboration revenue under the Polpharma agreement of $185,000, royalties and milestones under the Sun Pharmaceutical agreement of $44,000, and $56,000 related to development service revenues from the recently acquired Bioceros subsidiary in the Netherlands.

Research and development (R&D) expenses totaled $10.6 million for the fourth quarter of 2015, compared to $4.8 million for the fourth quarter of 2014, an increase of $5.8 million. The increase was driven by increased development expenses, including headcount, related to BOW015 and BOW050.

General and administrative (G&A) expenses totaled $5.8 million for the fourth quarter of 2015, compared to $5.4 million for the fourth quarter of 2014, an increase of $0.4 million. The increase was primarily driven by increased headcount and related costs, offset in part by a gain of $0.6 million related to a change in the contingent consideration related to the Bioceros acquisition.

Other income and tax (expense), net totaled $0.7 million for the fourth quarter of 2015, compared to $(0.2) million for the fourth quarter of 2014, an increase of $0.9 million. The increase was driven by a gain of $1.0 million related to the sale of our Canadian subsidiary, offset in part by increased interest expense of $0.1 million.

Net loss was $15.4 million for the fourth quarter of 2015, compared to $10.4 million for the fourth quarter of 2014.

Fiscal 2015 Financial Highlights

Revenue totaled $576,000 in 2015, compared to $4,000 in 2014. The revenue in 2015 related to collaboration revenue under the Polpharma agreement of $235,000, royalties and milestones under the Sun Pharmaceutical agreement of $155,000 and $186,000 related to development service revenues from the recently acquired Bioceros subsidiary in the Netherlands.

Research and development (R&D) expenses totaled $31.0 million in 2015, compared to $16.3 million in 2014, an increase of $14.7 million. The increase was driven by increased development expenses, including headcount, related to BOW015 and BOW050, as well as an impairment charge related to the Z944 intangible asset of $1.7 million and a one-time $1.8 million commitment charge for commercial batches of BOW015.

General and administrative (G&A) expenses totaled $21.9 million in 2015, compared to $23.0 million in 2014, a decrease of $1.1 million. The decrease was primarily due to costs incurred in the third quarter of 2014 related to severance of former Zalicus employees of $1.8 million, professional fees related to becoming a public company of $2.1 million and a gain of $0.6 million related to a change in the contingent consideration related to the Bioceros acquisition, offset in part by increased headcount and related costs and a one-time settlement fee of $2.2 million related to the RLS Settlement Agreement recorded in the second quarter of 2015.

Other income and tax (expense), net totaled $0.1 million in 2015, compared to $(2.6) million in 2014, an increase of $2.7 million. The increase was primarily driven by reduced interest expense as a result of the conversion of convertible notes in March and April 2014 of $2.4 million, a gain of $1.0 million related to the sale of the Company’s Canadian subsidiary and an income tax benefit of $0.5 million resulting from the asset impairment and amortization of deferred taxes partially offset in part by interest on debt entered into in the third quarter of 2014 of $1.3 million.

Net loss was $52.2 million in 2015, compared to $41.8 million in 2014.

Pipeline Status Update

BOW015 (infliximab, reference biologic Remicade) — Global Phase 3 registration study initiated in February 2016 for BOW015 in active RA patients; harmonized global filing anticipated in 2017.

BOW050 (adalimumab, reference biologic Humira) — Harmonized global filing anticipated in 2018.

BOW070 (tocilizumab, reference biologic Actemra) — Harmonized global filing anticipated in 2019.

BOW080 (eculizumab, reference biologic Soliris) – Harmonized global filing anticipated in 2020.

BOW090 (ustekinumab, reference biologic STELARA) – Harmonized global filing anticipated in 2021.

BOW100 (golimumab, reference biologic SIMPONI) – Harmonized global filing anticipated in 2022.