0001564590-19-040377.txt : 20191105 0001564590-19-040377.hdr.sgml : 20191105 20191105161042 ACCESSION NUMBER: 0001564590-19-040377 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20191104 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Amendments to the Registrant's Code of Ethics, or Waiver of a Provision of the Code of Ethics ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20191105 DATE AS OF CHANGE: 20191105 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Principia Biopharma Inc. CENTRAL INDEX KEY: 0001510487 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 263487603 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38653 FILM NUMBER: 191193391 BUSINESS ADDRESS: STREET 1: 400 EAST JAMIE COURT, SUITE 302 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: (650) 416-7700 MAIL ADDRESS: STREET 1: 400 EAST JAMIE COURT, SUITE 302 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 prnb-8k_20191104.htm 8-K prnb-8k_20191104.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 4, 2019

 

Principia Biopharma Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38653

26-3487603

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

 

 

 

220 East Grand Avenue

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 416-7700

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading Symbol(s)

 

 

 

Name of each exchange

on which registered

Common Stock, Par Value $0.0001 Per Share

 

PRNB

 

 

 

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2019, Principia Biopharma Inc. (the “Company”) issued a press release announcing our financial results for the third quarter ended September 30, 2019. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Exhibit 99.1 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 5.05 Amendment to Registrant's Code of Ethics, or Waiver of a Provision of the Code of Ethics

On November 4, 2019, the Board amended and restated the Company’s Code of Business Conduct and Ethics (“Code of Ethics”), effective as of such date, to reflect modified procedures adopted by the Company and to simplify and make the language of the Code of Ethics more accessible to all employees.

The foregoing description of the Code of Ethics is subject to, and qualified in its entirety by, the full text of the amended Code of Ethics, which is incorporated herein by reference as Exhibit 14.1 to this Current Report on Form 8-K and is available on the Company’s investor relations website at ir.principiabio.com/investors. The contents on the Company’s website are not otherwise incorporated by reference in, or a part of, this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

PRINCIPIA BIOPHARMA INC.

 

 

 

Date:  November 5, 2019

By:

/s/ Christopher Y. Chai

 

 

Christopher Y. Chai

 

 

Chief Financial Officer

 

 

EX-14.1 2 prnb-ex141_7.htm EX-14.1 prnb-ex141_7.htm

Exhibit 14.1

 

CODE OF BUSINESS CONDUCT AND ETHICS

 

Message from the CEO

At Principia, we are dedicated to bringing important novel therapies forward that improve patients’ lives, the hallmark of success for our business in the biopharmaceutical industry. With that focus on people and patients, how we achieve our success is as important as what we achieve!  

 

We are committed to maintaining the highest standards of business and professional conduct and integrity. Our colleagues, external partners, regulators, customers, and the patients we hope to serve, expect us to operate with these high standards. This Code of Business Conduct and Ethics (the “Code”) outlines our values and expectations and should be used as a tool by everyone in the company, regardless of role, to help us guide the decisions we make every day.

 

We pledge to foster an open-door environment, and we need you to speak up if you ever have questions about the right thing to do or feel that this Code is being violated.  Talk with your manager or with anyone in my leadership team. You may also share concerns anonymously through our hotline, the COMET-line.

 

At a minimum, we will:

 

Maintain and adhere to the highest ethical standards

 

Comply with all federal, state and local laws and regulations, as well as all company policies and procedures, including this Code

 

Foster a diverse and inclusive work environment that ensures everyone is treated with respect and dignity

 

Avoid any and all conflicts of interest, and the appearance of such

 

Keep property, resources and information secure, including non-public customer, shareholder, company and employee information

 

Promptly report any ethical concerns to the appropriate persons, as specified in this Code

 

When in doubt, ask!

 

Thank you for your commitment to Principia and to our mission, and especially for conducting yourself with the highest standards of ethics and integrity.

 

Martin Babler

President and CEO

 

 

 

COMET-line: (877) 221-5401 and http://www.openboard.info/PRNB/


210301092 v2


 

CODE OF BUSINESS CONDUCT AND ETHICS

 

Compliance with Laws and High Ethical Business Standards

Principia (or the “Company”) expects all of its directors, officers and employees, wherever located and regardless of function, to conduct all activities in accordance with our high standards of honesty and ethics and in compliance with the laws, regulations, and written directives everywhere we do business. This expectation also extends to third party contractors who conduct certain activities on our behalf. When used in this Code, “employees” includes all individuals covered by the Code as described above.

 

Employees are expected to be familiar with the basic legal requirements that apply to their respective functions or services. This Code is supported by Principia policies, SOPs, and Work Instructions which have been designed to provide specific guidance in particular areas. Every employee must be familiar with and follow these guidelines. Compliance is everyone’s responsibility.

COMET:  Our Compliance and Ethics Program

Principia has an established compliance program designed and implemented to ensure adherence to all relevant laws and regulations as well as ethics provisions of this Code. Our COMpliance and EThics program is named COMET and is overseen by the Executive Committee, the Chief Compliance Officer, and the Governance Committee of the Board of Directors. These individuals and groups are responsible for developing and enforcing COMET and our Code of Business Conduct and Ethics, including:

 

 

Ensuring an effective Compliance Program

 

Directing management focus to areas of our business that by their nature may present compliance risks

 

Ensuring that all Principia employees are appropriately trained on this Code and the policies of the Company that support it

 

Assessing whether the goals and principles of our Code of Business Conduct and Ethics are being upheld

 

Fostering an “open-door” environment where questions or concerns related to conduct and ethics can be appropriately addressed

 

Ensuring that Principia’s undertakings to governments and regulators are followed

 

Directing investigations of any alleged violation of this Code

 

Ensuring that appropriate actions are taken if there is a substantiated violation

 

Defining and driving whatever compliance initiatives may be necessary, and

 

Championing a culture of compliance throughout the Principia organization.

 

Functional and department leaders are responsible for fostering a culture of compliance, leading by example, and ensuring the spirit and letter of this Code are followed.

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Understanding and Complying with Laws and Regulatory Requirements

We expect employees to understand the requirements applicable to their functions and areas of responsibility. While we do not expect all of our employees to know the details of the underlying laws and regulations, we do expect you to understand, know and comply with the relevant policies, SOPs and Work Instructions which are based on those laws and regulations.  We provide initial and periodic training in a variety of ways, including live and online sessions. We also expect our employees to use the resources we make available to them and to ask when in doubt.

Honesty with Regulators and Other Government Officials

Principia is subject to many domestic and international laws, regulations, and guidelines. Particular care must be taken to ensure that no inaccurate, incomplete, or misleading reports, certifications, claims, or statements are made to any government agency or official. When dealing with government officials and employees, Principia employees should avoid even the appearance of impropriety. Any activity, anywhere in the world, that could be perceived as an attempt to improperly influence or mislead government officials to obtain favorable treatment or for any other purpose is strictly prohibited. Local custom or common practices are not a basis for permissible activity.

Maintenance of Corporate Books, Records, Documents and Accounts

All Principia records must be prepared accurately, truthfully, and in a timely manner. The making of false or misleading entries in any Principia record is strictly prohibited.

 

Financial activities are to be recorded in compliance with all applicable laws and accounting practices. All employees must cooperate fully with the Finance Department, as well as our independent public accountants, and provide complete and accurate information to them to help ensure that all of Principia’s financial books, records and reports are accurate.

 

Similarly, our research and development records form the basis of government and non-government decisions regarding the development and approval of our products.  Accordingly, they must be complete, accurate, and recorded in accordance with all applicable laws and regulations.

Public Disclosure and Communications

We are committed to full, fair, accurate, timely, and understandable disclosure in reports and documents we file with the U.S. Securities and Exchange Commission (SEC) and in other public communications. Only authorized officers of the Company may make public disclosures.

 

In support of this commitment, each officer and employee must (a) follow Principia’s various policies dealing with external communications, (b) maintain complete and accurate records, and (c) not knowingly misrepresent, or cause others to misrepresent, facts about Principia to anyone.

Science, Clinical Program and Approved Product Communications

It is Company policy to communicate about our science, clinical programs and approved products in a factual and informative manner. All such communications must be consistent with applicable regulations.

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Medical information and promotional materials disseminated by Principia or by others on Principia’s behalf must accurately and fairly describe the Company’s science, clinical programs and/or approved products and not be false, misleading or deceptive. It is also Company policy to use only medical, sales and marketing programs and materials that have been approved in accordance with Company procedures.

Confidential, Private, and Proprietary Information

The protection of confidential business information and trade secrets is vital to the interests and success of Principia. Such information should not be shared, unless it is necessary to do so in the performance of a job or activity, and such sharing is covered by a confidentiality agreement.

 

As an employee, officer or director of Principia, you may learn of information about Principia, or about third parties that have shared information with Principia under confidentiality agreements, that is confidential and proprietary. You also may learn of information before that information is released to the general public. Employees who have received or have access to confidential information should take care to keep this information confidential. Confidential information includes non-public information that might be of use to competitors or harmful to Principia or its customers if disclosed, such as business plans, scientific and technical strategies, financial information, information related to the Principia’s research platform, data and results, inventions, works of authorship, trade secrets, processes, conceptions, formulas, patents, patent applications, licenses, suppliers, manufacturers, customers, market data, personnel data, personally identifiable information pertaining to our employees, trial participants, customers or other individuals (including, for example, names, addresses, telephone numbers and social security numbers), and similar types of information provided to us by our customers, suppliers and partners. This information may be protected by patent, trademark, copyright and trade secret laws.

 

Acquiring proprietary information from others through improper means, possessing trade secret information that was improperly obtained, or inducing improper disclosure of confidential information from past or present employees of other companies is prohibited, even if motivated by an intention to advance our interests.

 

All employees are required to sign an Employee Proprietary Information and Inventions Agreement promising they will not divulge Principia’s proprietary information or material outside of Principia and that the ideas, inventions, products, and processes developed while working for Principia are the property of Principia.

Protection of Personal Information

Principia is committed to the lawful stewardship of personal information that is collected, stored and used by the company. We respect personal privacy. In addition to confidentiality requirements, Principia employees are also obligated to respect privacy-related state and federal laws and regulations in the U.S. and, as applicable to Principia, outside the U.S. Principia is committed to ensuring these protections are extended to any third-parties providing services to our Company or conducting business on Principia’s behalf; the Company may terminate any services that violate our policies.

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CODE OF BUSINESS CONDUCT AND ETHICS

 

Insider Trading

Employees who have access to confidential (or “inside”) information are not permitted to use or share that information for stock trading purposes or for any other purpose except to conduct our business. All material, nonpublic information about Principia or about companies with which we do business is considered confidential information. To use material, nonpublic information in connection with buying or selling securities, including “tipping” others who might make an investment decision on the basis of this information, is both unethical and illegal. Employees must exercise the utmost care when handling material inside information and must keep such information confidential unless and until that information is released to the public through approved channels (usually through a press release, an SEC filing or a formal communication from a member of senior management). Please refer to the Principia’s Insider Trading Policy for more detailed information.

Antitrust, Competitive Practices and Interactions with Competitors

Antitrust laws are designed to protect the competitive process. These laws are based on the premise that the public interest is best served by competition and will suffer from illegal agreements or collusion among competitors. Principia will, at all times, uphold the principles of free and open competition.  We will not enter any agreement that improperly restrains competition. We will not share with any competitor information relating to Principia prices or pricing policies or any other competitive information. We will not conduct competitive intelligence practices that are unlawful or unethical.

 

Certain kinds of information, such as pricing, production and inventory, should not be exchanged with competitors, regardless of how innocent or casual the exchange may be and regardless of the setting, whether business or social, direct or incidental.

Giving and Receiving of Business Gifts and Entertainment

The giving and receiving of business gifts and entertainment is meant to create goodwill and sound working relationships and not to gain improper advantage with customers, facilitate approvals from government officials or allow Principia employees to take advantage of the Company’s business relationships for their own personal gain.  Every employee is expected to exercise good judgment.

 

An employee with questions regarding the appropriateness of giving or receiving a gift or entertainment should seek guidance from their manager, the Legal Department, or one of our Compliance Officers.

These principles apply to our transactions everywhere in the world, even where the practice is widely considered “a way of doing business.”  Employees should not accept gifts or entertainment that may reasonably be deemed to affect their judgment or actions in the performance of their duties.  Our customers, suppliers and the public at large should know that our employees’ judgment is not for sale.

 

Under some statutes, such as the U.S. Foreign Corrupt Practices Act, giving anything of value to a government official to obtain or retain business or favorable treatment is a criminal act subject to prosecution and conviction.  Discuss with your supervisor or one of our Compliance Officers any proposed entertainment or gifts if you are uncertain about their appropriateness.

 

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CODE OF BUSINESS CONDUCT AND ETHICS

 

In addition, Principia strictly prohibits providing any gifts or entertainment as inducements to any health care provider and any other person or entity in a position to influence the design or conduct of research studies, prescribe, purchase, recommend, refer or arrange for the purchase, sale, or formulary placement of Principia approved products, or to develop clinical practice guidelines relevant to Principia approved products. 

Meals and Entertainment

Excluding interactions with health care providers or anyone who can recommend the prescription of one of our products, the exchange, as a normal business courtesy, of meals or entertainment (such as dinner, tickets to a game or the theatre or a round of golf) is a common and acceptable practice as long as it is not extravagant. Meals and business entertainment cannot be offered, provided, sought or accepted by any employee unless they are within reasonable and customary limits and not (i) susceptible of being construed as a bribe or kickback, (ii) made or received on a regular or frequent basis, or (iii) in violation of any laws.  The appropriateness of an invitation for a meal or entertainment that is more than modest should be directed to one of the Compliance Officers for an evaluation.  For clarity, a single meal or a single entertainment that can reasonably be expected to cost more than $100 per person is considered to be more than modest for purposes of this Code.

Gifts, Services and Favors

Principia follows procedures to ensure that employees exercise appropriate judgment and diligence in the choice of business partners. All Principia purchases and awards of subcontract in every country where Principia operates must be made strictly on the basis of quality, suitability, service, price and efficiency.  Failure to follow these principles may be a violation of laws, including, but not limited to, the Foreign Corrupt Practices Act.

 

Each Principia employee is expected to deal fairly with our customers, suppliers, employees and anyone else with whom we have contact in the course of business. Be aware that the Federal Trade Commission Act provides that “unfair methods of competition in commerce, and unfair or deceptive acts or practices in commerce, are declared unlawful.” It is a violation of the Federal Trade Commission Act to engage in deceptive, unfair or unethical practices and to make misrepresentations in connection with sales activities.

 

Employees may not offer, provide, seek or accept, directly or indirectly, any service, favor, or gift from any outside person or entity that does business with, seeks to do business with, or is a competitor of, the Company, unless (a) it is not susceptible of being construed as a bribe or kickback, (b) it is not in violation of any laws, (c) acceptance could not reasonably influence or reasonably appear to influence the employee’s business judgment and (d) the service, favor, or gift has a value of less than $100 (and never cash). Exceptions  must be approved by both the employee’s manager and one of our Compliance Officers.  Gifts from vendors should be shared with other Principia employees to the extent possible.

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CODE OF BUSINESS CONDUCT AND ETHICS

 

Conflicts of Interest

Avoiding Conflicts of Interest

Employees must avoid any relationship or activity that might affect, or even appear to affect, their ability to make objective and fair decisions when performing their duties for Principia, and must at all times be free from any influence that might conflict with the interests of Principia.  

 

A conflict of interest may arise when:

 

You allow a personal or outside interest to interfere with or influence the performance of your duties;

 

You make a decision or engage in conduct that is not in the best interest of Principia;

 

Your responsibilities at Principia involve you in a matter that creates or may create a personal or financial interest or opportunity for you, or your family or friends;

 

You are asked to be on the Board of, or to perform services for or assist, any entity that is a competitor or vendor of Principia.

Determinations regarding Potential Conflicts

Determining whether a conflict of interest exists is not always easy to do.    Before engaging in any activity, transaction or relationship that may give rise to a conflict, or if you are unsure whether a conflict may exist, you must seek review from your manager as well as one of our Compliance Officers.  The Compliance Officers are responsible for determining whether there is in fact a conflict of interest and will recommend appropriate actions. Determinations by the Compliance Officers related to potential conflicts related to Section 16 officers are to be reported to the next meeting of the Governance Committee of the Board.  Any waiver is to be handled in accordance with the waiver provisions below.

Corporate Opportunities

You may not take personal advantage of opportunities for the Company that are presented to you or discovered by you as a result of your position with us or through your use of corporate property or information, unless authorized by your supervisor, the Compliance Officer or the Governance Committee. Even opportunities that are acquired privately by you may be questionable if they are related to our existing or proposed lines of business. Significant participation in an investment or outside business opportunity that is directly related to our lines of business must be pre-approved. You may not use your position with us or corporate property or information for improper personal gain, nor should you compete with us in any way.

Investments

Employees are not prohibited from investing in entities that are potential or current competitors or suppliers to Principia; however, such investments may constitute only a small fraction of the employee’s overall investment portfolio, and may never represent an interest that is greater than 5% of such company. Further, such investments may require the investing employee to recuse himself or herself from any future business dealings between Principia and the company in which the employee is invested.

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Trading in such companies based on confidential information obtained in the course of Principia business activities, such as advisory boards, is prohibited. As noted above, any significant participation in an investment or outside business opportunity must be pre-approved.

Board Memberships

Employees are not prohibited from serving as a civic or charitable board member, or trustee, provided that the time commitment does not interfere with your job duties. However, if the group focuses on a disease area for which a Principia product is being developed, you need to obtain prior approval.

 

Serving on the Board of a for-profit entity requires the pre-approval of our CEO and one of our Compliance Officers, and employees may not serve on the board of a competitor or vendor of Principia or any entity that has an adverse relationship to Principia.

 

If Principia’s President and Chief Executive Officer or the Board of Directors, in their sole discretion, determine that an employee’s service as a director or trustee adversely affects the performance of his/her duties for Principia, he/she may be asked to resign from such service.

 

All Principia employees, except the Company’s President and Chief Executive Officer, may seek conflict of interest determinations from one of the Compliance Officers. If the employee is a Section 16 officer of Principia, approval to sit on the board of a for-profit healthcare company must be obtained from the Board of Directors.  If the Compliance Officer reasonably believes that the position presents a potential conflict and requires a waiver from this Code, the Compliance Officer must submit the matter to the Company’s Board of Directors as provided below in the “Approvals and Waivers” section. The President and Chief Executive Officer of the Company must seek conflicts determinations and, if necessary, approvals and waivers directly from the Principia Board of Directors.

Outside Consulting and Employment

Employees who are not Section 16 officers may, with the permission of the officer in charge of your department, provide limited services as a consultant or otherwise to another entity, if such activity does not conflict with the interests of Principia. Section 16 officers, except the President and Chief Executive Officer, must discuss all such outside employment and consulting opportunities with a Compliance Officer for determination. The President and Chief Executive Officer must present all such opportunities directly to the Board of Directors for determination and, if necessary, waiver. Employees may not solicit business on Principia premises or while working on Principia time. Employees are not permitted to use Principia materials or proprietary information for any outside work, and may make only nominal and minimal use of Principia’s facilities and equipment for such purposes. In general, such outside work should not interfere with the employee’s regular work duties during Principia’s normal business hours.

 

If an employee serves as a consultant or as a corporate, civic or charitable director or trustee (with prior approval, when such approval is required), the employee has the duty and obligation to take any and all reasonable steps to avoid creating the appearance of a conflict, as would be judged by a reasonable person who is experienced in our business.

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CODE OF BUSINESS CONDUCT AND ETHICS

 

Employing Multiple Family Members

It is not against our policies for more than one family member to work for Principia. However, no family member should be employed in a position that reports to another family member (anywhere in the same management line) or works within another family member’s line of authority. Also, an employee should never make or be involved in any promotion decision or any other significant decision or action involving the employment of a member of his or her family.

Company Assets

Principia’s assets should be used for Principia business only.

 

Upon termination of employment with Principia, each employee shall return to and not take from Principia any Principia property, including, but not limited to: (a) any inventory, material, supply, communication, correspondence, document or product; (b) any idea, invention, and/or process that was developed while working for Principia; (c) any form of reproduction or copy of any of (a) or (b) above, including without limitation any electronic (e.g., email) versions; and/or (d) any proprietary or confidential property or information of Principia as defined in Principia's Proprietary Information and Inventions Agreement.

Media and Publicity

It is our policy to disclose material information concerning the Company to the public only through specific limited channels to avoid inappropriate publicity and to ensure that all those with an interest in the company will have equal access to information. All inquiries or calls from the press and financial analysts should be referred to the CEO, CFO, CMO or VP Communications. We have designated our CEO, CFO, CMO and VP Communications as our official spokespersons for financial, scientific, clinical, technical and other related information. Unless the CEO and the CFO have specifically designated other Company employees to speak on behalf of the Company, these designees are the only people who may communicate with the press on behalf of the Company. No employee may provide any information to the media about the Company off the record, for background, confidentially or secretly.

Political Contributions

In countries where corporations are prohibited from making any direct or indirect contributions or expenditures in connection with elections or political activities, contributions, if any, may only be made on a personal basis, not on behalf of the Company, and reimbursement must not to be sought from the Company, directly or indirectly.

International Business

All employees are expected to comply with the laws in all countries in which they operate permanently, temporarily, or incidentally. In some countries certain laws prohibiting particular conduct may not be enforced in practice, but this will not excuse non-compliance. All employees also must comply strictly with U.S. laws and regulations applicable to the conduct of business outside the United States.

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Environment, Safety and Sustainability

Principia is committed to a safe environment and to taking sound environmental actions. Principia strives to comply fully with all environmental and safety laws and regulations.

 

It is our policy to conduct our business in an environmentally responsible and sustainable way that minimizes environmental impacts and promotes the sustainable use of resources. We are committed to bringing our novel chemistry to patients. We are equally committed to minimizing the use of any substance or material that may cause environmental damage, reducing waste generation and disposing of all waste through safe and responsible methods, minimizing environmental risks by employing safe technologies and operating procedures, and being prepared to respond appropriately to accidents and emergencies.

Approvals and Waivers

Except as otherwise provided in this Code, the Board of Directors or the Governance Committee must review and approve any matters requiring special permission under this Code for a Section 16 officer or a member of the Board of Directors.  Except as otherwise provided in this Code, the Chief or Deputy Compliance Officer must review and approve any matters requiring special permission under this Code for any other employee, consultant, contractor or other agent.

 

A “waiver” of this Code is defined by the SEC as the approval by the Company of a material departure from a provision of its code of ethics.

 

Principia's CEO, on behalf of Principia, and with advice of Legal, the Compliance Officer and/or the Board, may waive the requirements of this Code in writing on a case-by-case basis. Each such waiver shall be promptly disclosed if required by law or regulation, along with the reasons for the waiver.

 

Any waiver of this Code for Section 16 officers or a member of the Board of Directors may be authorized only by the Principia Board of Directors or, to the extent permitted by the rules of The Nasdaq Stock Market and Principia’s Corporate Governance Guidelines, a committee of the Board of Directors, and will be disclosed as required by applicable laws, rules and regulations.

Reporting Concerns and Potential Violations

Every employee has a responsibility to report any potential misconduct, including, but not limited to: discrimination, harassment, and violations of Principia’s policies concerning: (a) accounting, (b) internal accounting controls, (c) disclosure controls or auditing matters, (d) illegal activities in any and all countries in which Principia operates, (e) fraud, (f) abuse of Principia’s assets, (g) violations of the standards in this Code of Business Conduct and Ethics, and (h) violations of Principia’s compliance program.

 

If you believe but are not certain that misconduct or an improper activity may have occurred, you are encouraged to discuss your concern with one of our Compliance Officers, with Legal or any member of the Executive Committee. This discussion will be kept confidential, consistent with conducting a thorough investigation.

 

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CODE OF BUSINESS CONDUCT AND ETHICS

 

The Anonymous Tip Line has been set up so that all anonymous reports route directly to our Compliance Officers, Legal, and our Chief Financial Officer, who will inform the appropriate members of senior management and, if appropriate, members of the Board of Directors.

 

Anonymous reports that concern accounting and auditing matters, e.g., embezzlement; falsification of contracts, reports, or records; securities violations; and violations of other financial-related policies, will be routed to the Chief Financial Officer and the Chair of the Audit Committee of the Principia Board of Directors.

 

If you choose to identify yourself, your identity will be kept strictly confidential to the extent possible, consistent with conducting an effective investigation.

 

 

International: The Anonymous Tip Line is accessible from all countries.

 

COMET Line

Ethics and Compliance Hotline

 

Reports may be made anonymously in writing, or via Principia’s Anonymous Ethics and Compliance Hotline, which is operated by an outside vendor.

 

Via telephone:  The Anonymous Tip Line is available 24 hours a day, seven days a week, by phone 1(877) 221-5301; or

 

Via the Principia intranet:  http://www.openboard.info/PRNB/

 

 

 

 

 

 

 

 

 

 

Investigative Procedures: Upon learning of an allegation of misconduct, the Chief Compliance Officer or Legal Department will conduct a timely, full, and fair fact-finding to determine whether a violation has indeed occurred. Based on findings, the Chief Compliance Officer will seek advice and assistance from Legal, the Chief Financial Officer, the Board of Directors (or appropriate Board Committees), and/or outside counsel, as necessary.

 

Addressing reports: Principia will treat any report of misconduct with respect and urgency in order to determine the appropriate course of action, including possible disclosure of any misconduct to stockholders or regulators. Circumventing these internal reporting procedures may cause serious damage to an individual and the Company.

 

 

No retaliatory action will be taken against employees making good faith reports. Principia prohibits retaliation against any employee, officer or director who, in good faith, seeks help or reports known or suspected violations. Any reprisal or retaliation against an employee, officer or director because he or she, in good faith, sought help or filed a report will be subject to disciplinary action, including potential termination of employment.

 

 

11

 

 


 

CODE OF BUSINESS CONDUCT AND ETHICS

 

ACKNOWLEDGEMENT

 

I have read Principia’s Code of Business Conduct and Ethics, and I understand its contents.

 

I agree to comply fully with the standards, policies, and procedures contained in the Code and with Principia’s related policies and procedures. I commit to research, develop, market, sell, promote, and advertise our products in compliance with the written directives or requirements of all applicable federal, state and international laws. Furthermore, I understand that failure to uphold this commitment will negatively affect my performance evaluation and could result in disciplinary action, up to, and including, termination of my employment, as well as in legal sanctions against me and the Company.

 

I understand that the Company has a culture based upon our core values and expects all employees, officers and directors to behave according to those values, and to observe them, both internally and externally, in performing their daily tasks.

 

I acknowledge that the Code is a statement of policies for business conduct and does not, in any way, constitute an employment contract or an assurance of continued employment.

 

 

 

 

Printed Name

 

Date

 

 

 

Signature

 

 

 

12

 

 

EX-99.1 3 prnb-ex991_8.htm EX-99.1 prnb-ex991_8.htm

 

Exhibit 99.1

 

Principia Biopharma Reports Third Quarter Financial Results

 

SOUTH SAN FRANCISCO, Calif., November 5, 2019 – Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing novel therapies for immune mediated diseases, today announced financial results for the third quarter ended September 30, 2019.

“With our focus on execution, we made significant progress on our clinical programs during the third quarter. We also recently reported preliminary positive data from our ongoing Phase 2 pemphigus and Phase 1/2 immune thrombocytopenia (ITP) clinical trials with PRN1008. Following these announcements, we were able to execute a successful follow-on offering of common stock with gross proceeds of $241.5 million,” said Martin Babler, president and chief executive officer of Principia Biopharma. “We are also pleased industry veteran Shawn Tomasello joined our Board of Directors as she brings an extensive track record in commercializing novel pharmaceutical products.”

Third Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $161.2 million as of September 30, 2019, compared to $180.6 million as of December 31, 2018. In addition, in October 2019, we completed a follow-on public offering which resulted in net proceeds of $226.5 million after deducting underwriting discounts and commissions and estimated offering expenses.

Revenues: We did not recognize any collaboration revenue for the three months ended September 30, 2019, compared to $18.6 million for the same period in 2018. The $18.6 million recognized for the three months ended September 30, 2018 consisted of a portion of upfront fees and milestone payments from our Sanofi and AbbVie collaborations.

R&D Expenses: Total research and development expenses were $18.4 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.8 million, compared to $9.2 million for the same period in 2018, including stock-based compensation expense of $0.3 million. The increase in total research and development expenses was mainly driven by an increase in personnel-related expenses as we build out our R&D team, and an increase in PRN1008 program costs, due to the initiation of a global Phase 3 trial in patients with pemphigus in November 2018 and certain manufacturing campaigns to supply drug products for our PRN1008 clinical trials.

 


 

G&A Expenses: General and administrative expenses were $5.0 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.5 million, compared to $2.9 million for the same period in 2018, including stock-based compensation expense of $0.4 million. The increase in total general and administrative expenses was primarily driven by increased personnel-related expenses and headcount costs related to operating as a public company.

Net Income (Loss): For the three months ended September 30, 2019, net loss was $22.3 million compared to a net income of $6.7 million for the same period in 2018, as we did not recognize any collaboration revenue for the three months ended September 30, 2019.

About Principia Biopharma

Principia is a late-stage biopharmaceutical company focused on developing novel therapies for immune mediated diseases. Principia’s proprietary Tailored Covalency® platform differentiates the company’s investigational therapies from traditional small molecules and provides the potential to deliver the potency, selectivity and safety of injectable drugs while maintaining the convenience of a pill. This highly reproducible approach enables the company to pursue multiple programs efficiently. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 1/2 clinical trial in patients with ITP. PRN2246/SAR442168, a covalent BTK inhibitor that crosses the blood-brain barrier, is being evaluated in a Phase 2 clinical trial in patients with multiple sclerosis, and has been partnered with Sanofi. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor (FGFR) is being evaluated in a Phase 1 trial in patients with bladder cancer. 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 timing, scope and success of additional clinical results (including, without limitation, the final results from Part B of the Phase 2 trial of PRN1008 in patients with pemphigus, and the Phase 1/2 clinical trial of PRN1008 in patients with immune thrombocytopenia). 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
September 30,

 

Nine Months Ended
September 30,

 

 

2019

 

2018

 

2019

 

2018

Revenue

 

$             —

 

$      18,564

 

$      35,160

 

$      43,000

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

         18,368

 

           9,200

 

         52,609

 

         26,855

General and administrative

 

           4,965

 

           2,887

 

           14,705

 

           7,265

Total operating expenses

 

         23,333

 

         12,087

 

         67,314

 

         34,120

Income (loss) from operations

 

          (23,333)

 

           6,477

 

         (32,154)

 

           8,880

Other income (expense), net

 

              3

 

            (133)

 

              (38)

 

            (655)

Interest income

 

           1,034

 

              339

 

           3,324

 

              565

Net income (loss)

 

$    (22,296)

 

$        6,683

 

$       (28,868)

 

$        8,790

Net income (loss) attributable to common stockholders

 

$    (22,296)

 

$             —

 

$       (28,868)

 

$             —

Net income (loss) per share attributable to common stockholders

 

 

 

 

 

 

 

 

Basic

 

$          (0.93)

 

$             —

 

$        (1.21)

 

$             —

Diluted

 

$          (0.93)

 

$             —

 

$        (1.21)

 

$             —

Weighted-average shares used to calculate net income (loss) per share attributable to common stockholders

 

 

 

 

 

 

 

 

Basic

 

   24,018,192

 

       5,087,792

 

   23,937,701

 

       2,149,583

Diluted

 

   24,018,192

 

     6,144,492

 

   23,937,701

 

     3,096,952

 


 


 

Principia Biopharma Inc.

Summary Consolidated Balance Sheet Data

(Unaudited)

(In thousands)

 

 

 

September 30,
2019

 

December 31,
2018

Cash, cash equivalents and marketable securities

 

$    161,217

 

$    180,637

Total assets

 

       174,087

 

       195,521

Stockholders’ equity

 

       152,675

 

       169,860

 

 

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