EX-99.1 2 prnb-ex991_31.htm EX-99.1 prnb-ex991_31.htm

Exhibit 99.1

 

Principia Biopharma Reports Second Quarter 2020

Financial Results

 

SOUTH SAN FRANCISCO, Calif., August 6, 2020 – Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune mediated diseases, today announced financial results for the second quarter ended June 30, 2020.

“We are very pleased with the progress the company made on each program in the first half of the year despite the ongoing COVID-19 pandemic challenges. Our investigators were able to present additional positive data for both ITP and pemphigus and Sanofi announced positive Phase 2 data in multiple sclerosis,” said Martin Babler, president and chief executive officer of Principia. “With the initiation of a Phase 3 trial in patients with relapsing multiple sclerosis, we received a $50 million milestone payment from Sanofi which enhances our balance sheet and allows us to continue strong execution on our programs.”

Six-month and year-to date program highlights

Rilzabrutinib for the treatment of pemphigus

 

o

Announced full data set from the Phase 2 Part B pemphigus BELIEVE PV trial during the virtual late-breaker research session of the American Academy of Dermatology

 

o

Results to date demonstrate a positive risk/benefit profile while decreasing daily corticosteroid usage

 

o

Enrollment of the PEGASUS Phase 3 trial continues to be on target

Rilzabrutinib for the treatment of ITP

 

o

Announced updated positive data from an ongoing Phase 1/2 trial in 47 heavily pre-treated patients during the virtual session of the European Hematology Association

 

o

Interim results demonstrate rilzabrutinib reaches primary endpoint in 50 percent of patients treated > 12 weeks with 400 mg twice-daily dose; demonstrated fast onset and durable responses

 

o

Granted orphan drug designation by the European Commission (EC)

 

o

Anticipate initiating a pivotal Phase 3 trial by the end of 2020, assuming no COVID-19 related impact

Rilzabrutinib for the treatment of IgG4-RD

 

o

Announced the expansion of development of rilzabrutinib into IgG4-RD

 

o

Anticipate initiating a Phase 2 trial in the second half of 2020


 

PRN473 Topical for the treatment of immune mediated diseases of the skin

 

o

Announced expansion of its BTK franchise with PRN473 Topical

 

o

Initiated two Phase 1 trials in Australia -- a single ascending dose/multiple dose trial in healthy volunteers and a challenge study

 

o

Anticipate Phase 1 single ascending dose/multiple dose trial results in the second half of 2020

PRN2246/SAR442168 for the treatment of multiple sclerosis

 

o

Demonstrated a significant reduction in disease activity in partner Sanofi’s Phase 2 relapsing multiple sclerosis (MS) trial

 

o

Met primary and secondary objectives with 85 percent or greater relative reduction achieved in the number of new gadolinium-enhancing T1 and new or enlarging T2 hyperintense lesions

 

o

First patient dosed in Sanofi’s Phase 3 trial in relapsing MS, triggering a $50 million milestone payment in the third quarter of 2020

Immunoproteasome Inhibitor

 

o

Selected a candidate molecule to move forward into the preclinical development phase

General Corporate Highlights

 

o

Hosted a virtual Analyst Event highlighting BTK inhibitors’ significant potential beyond B cells, how rilzabrutinib is differentiated from other BTKs due to its reversible covalent binding as well the company’s maturing pipeline and research focus

 

o

The company has hired key employees to meet the expanded development programs and expected organizational growth

Second Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $316.5 million as of June 30, 2020, compared to $367.8 million as of December 31, 2019. In addition, the company received an additional $50.0 million milestone payment from Sanofi in the third quarter of 2020.

Revenues: Collaboration revenues were $50.0 million for the three months ended June 30, 2020, compared to $30.0 million for the same period in 2019, for the achievement of clinical development milestones in our Sanofi collaboration.

R&D Expenses: Total research and development expenses were $30.9 million for the three months ended June 30, 2020, including stock-based compensation expense of $3.9 million, compared to $18.7 million for the same period in 2019, including stock-based compensation expense of $1.8 million. The increase in total research and development expenses was mainly driven by an increase in rilzabrutinib program costs, due to the progression of our global Phase 3 trial in pemphigus, ongoing Phase 2 trial in ITP and certain


 

manufacturing campaigns to supply drug products for our rilzabrutinib clinical trials, the initiation of our Phase 1 trial for PRN473 Topical in March 2020 and an increase in employee-related expenses.

G&A Expenses: General and administrative expenses were $9.2 million for the three months ended June 30, 2020, including stock-based compensation expense of $3.1 million, compared to $5.2 million for the same period in 2019, including stock-based compensation expense of $1.7 million.  The increase in total general and administrative expenses was primarily driven by increased employee-related expenses and costs related to operating as a public company.

Net Income (Loss): For the three months ended June 30, 2020, net income was $10.8 million compared to net income of $7.1 million for the same period in 2019.

About Principia Biopharma

Principia is a late-stage biopharmaceutical company dedicated to bringing transformative therapies to patients with significant unmet medical needs in immune mediated diseases. Through Principia’s proprietary Tailored Covalency® platform, our strategy is to build and advance a pipeline of best-in-class drug candidates with significant therapeutic benefits, limit unintended side effects, improve quality of life and over time modify the course of disease. This highly reproducible approach enables the company to pursue multiple programs efficiently, having discovered three drug candidates. Rilzabrutinib, a reversible covalent BTK inhibitor, is being evaluated in a global Phase 3 clinical trial in participants with pemphigus, a Phase 1/2 clinical trial in participants with immune thrombocytopenia (ITP), and the company plans to initiate a Phase 2 clinical trial in participants with IgG4-Related Diseases and a Phase 3 trial in ITP. PRN2246/SAR442168 is a covalent BTK inhibitor which crosses the blood-brain barrier and is partnered with Sanofi.  Sanofi has announced that SAR442168 will be evaluated in four Phase 3 clinical trials in participants with relapsing and progressive forms of multiple sclerosis. PRN473 Topical, a topical reversible covalent BTK inhibitor designed for immune-mediated diseases that could benefit from localized application to the skin, is being evaluated in Phase 1 trials.  For more information, please visit www.principiabio.com.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Principia’s expectations regarding the Principia pipeline of product candidates, and the initiation, timing, scope and success of additional clinical trials and results. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Principia’s actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. For a description of the risks and


 

uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Principia’s business in general, see the risk factors set forth in Principia’s reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Principia specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

 

Investor Contact
Christopher Chai, CFO
ir@principiabio.com

Media Contact
Paul Laland
415.519.6610
media@principiabio.com



 

 

Principia Biopharma Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share amounts)

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue

 

$

50,000

 

 

$

30,000

 

 

$

50,000

 

 

$

35,160

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

30,888

 

 

 

18,718

 

 

 

57,630

 

 

 

34,241

 

General and administrative

 

 

9,231

 

 

 

5,233

 

 

 

16,600

 

 

 

9,740

 

Total operating expenses

 

 

40,119

 

 

 

23,951

 

 

 

74,230

 

 

 

43,981

 

Income (loss) from operations

 

 

9,881

 

 

 

6,049

 

 

 

(24,230

)

 

 

(8,821

)

Other income (expense), net

 

 

199

 

 

 

(42

)

 

 

199

 

 

 

(41

)

Interest income

 

 

730

 

 

 

1,108

 

 

 

2,342

 

 

 

2,290

 

Net income (loss)

 

$

10,810

 

 

$

7,115

 

 

$

(21,689

)

 

$

(6,572

)

Net income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.33

 

 

$

0.30

 

 

$

(0.66

)

 

$

(0.28

)

Diluted

 

$

0.31

 

 

$

0.28

 

 

$

(0.66

)

 

$

(0.28

)

Weighted-average shares used to calculate net

   income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

33,087,340

 

 

 

23,927,172

 

 

 

33,040,547

 

 

 

23,896,788

 

Diluted

 

 

35,311,938

 

 

 

25,792,101

 

 

 

33,040,547

 

 

 

23,896,788

 

 

 

 

 

 

 

 

 



 

Principia Biopharma Inc.

Summary Consolidated Balance Sheet Data

(Unaudited)

(In thousands)

 

 

 

 

June 30,

2020

 

 

December 31,

2019

 

Cash, cash equivalents and marketable securities

 

$

316,533

 

 

$

367,837

 

Total assets

 

 

385,954

 

 

 

382,736

 

Stockholders' equity

 

 

351,440

 

 

 

358,978