On March 10, 2020 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Principia Biopharma, MAR 10, 2020, View Source [SID1234555370]).
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"Our significant achievements in 2019 lay a strong foundation for us to advance our corporate strategy and the promise of our drug discovery platform. Including our program partnered with Sanofi, we now have proof of concept in three immune-mediated diseases: pemphigus, immune thrombocytopenia and multiple sclerosis. As a result of these clinical milestones, we are now well positioned to progress our clinical programs this year," said Martin Babler, president and chief executive officer of Principia.
Full Year 2019 and Recent Program Highlights
Rilzabrutinib for the treatment of pemphigus (pemphigus vulgaris (PV) and pemphigus foliaceus (PF))
Presented positive data from Phase 2 Part A trial at 2019 American Academy of Dermatology Late-Breaking session
Announced confirmatory preliminary data from Phase 2 Part B trial
Announced accelerated enrollment of Phase 3 pivotal trial– anticipating results in second half of 2021
Anticipated Upcoming Milestones:
1H20 – Presentation of data from Phase 2 Part B trial
Rilzabrutinib for the treatment of Immune Thrombocytopenia (ITP)
Presented positive data from ongoing Phase 1/2 trial in highly treatment-resistant and refractory patients at 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting
Anticipated Upcoming Milestones:
2H20 – Presentation of ITP data from Phase 1/2 trial
Rilzabrutinib for the treatment of IgG4-Related Disease (RD)
Announced expansion into IgG4-RD, an immune-mediated disease of chronic inflammation and fibrosis
Anticipated Upcoming Milestones:
1H20 – Initiation of Phase 2 trial for IgG4-RD
PRN473 Topical for the treatment of immune-mediated diseases
Initiated a third BTK inhibitor clinical program, a Phase 1, randomized, double blind, placebo-controlled, single and multiple dose clinical trial
Anticipated Upcoming Milestones:
2020 – Phase 1 trial results
PRN2246/SAR442168 for the treatment of Multiple Sclerosis (MS)
Presented positive Phase 1 data at Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2019
In February 2020, Sanofi announced PRN2246/SAR442168 met its primary endpoint and was well tolerated in the Phase 2b trial with no new safety findings. Sanofi also announced it expects to initiate four Phase 3 clinical trials in relapsing and progressive forms of MS in the middle of 2020
PRN1371 for the treatment of bladder cancer
Suspended clinical program to focus our portfolio on immune-mediated diseases
General Corporate Updates
Raised $242 million through a public offering of 8,625,000 shares of common stock
Announced generic name for PRN1008 – rilzabrutinib
Fourth Quarter and Full Year 2019 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities were $367.8 million as of December 31, 2019, compared to $180.6 million as of December 31, 2018. The increase in Principia’s cash position is mainly due to net proceeds of $226.5 million from our follow-on offering completed in the fourth quarter of 2019.
Revenues: We did not recognize any collaboration revenue for the three months ended December 31, 2019, compared to $26.1 million for the same period in 2018. Collaboration revenue for the full year of 2019 was $35.2 million, compared to $69.1 million for the full year of 2018. The decrease was due to the revenue recognition for portions of an upfront payment of $40.0 million received in 2017 and milestone payments totaling $25.0 million received in 2018 from Sanofi and an upfront payment of $15.0 million received in June 2017 from AbbVie Biotechnology Limited, which were fully recognized as of year-end 2018. The revenue recognized for the year ended 2019 was primarily for the achievement of a milestone in our Sanofi collaboration.
R&D Expenses: Total research and development expenses were $21.5 million for the three months ended December 31, 2019, including stock-based compensation expense of $1.9 million, compared to $13.7 million for the same period in 2018, including stock-based compensation expense of $0.8 million. For the full year of 2019, total research and development expenses were $74.1 million, including stock-based compensation expense of $6.6 million, compared to $40.5 million for full year of 2019, including stock-based compensation expense of $1.4 million. The increase in total research and development expenses was mainly driven by an increase in rilzabrutinib program costs, attributed to various manufacturing campaigns to supply drug products for our rilzabrutinib clinical trials and the initiation of a global Phase 3 trial in pemphigus in November 2018, as well as an increase in employee-related expenses.
G&A Expenses: General and administrative expenses were $5.1 million for the three months ended December 31, 2019, including stock-based compensation expense of $1.3 million, compared to $4.2 million for the same period in 2018, including stock-based compensation expense of $0.6 million. For the full year of 2019, general and administrative expenses were $19.8 million, including stock-based compensation expense of $5.5 million, compared to $11.5 million for the full year of 2018, including stock-based compensation
expense of $1.4 million. The increase in total general and administrative expenses was primarily driven by increased employee-related expenses and facility costs.
Net Income (Loss): For the three months ended December 31, 2019, net loss was $24.9 million compared to net income of $9.4 million for the same period in 2018. For the full year of 2019, net loss was $53.8 million, compared to net income of $18.2 million for the full year of 2018.
Financial Guidance: The company’s current cash position is anticipated to fund operations beyond the Phase 3 data readout in pemphigus, irrespective of any opt-in decision related to the Sanofi agreement, based on the current operating plan.