Upgrade to SI Premium - Free Trial

Form 8-K GILEAD SCIENCES INC For: Jul 14

July 18, 2019 11:46 AM

 

 

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): July 14, 2019

 


 

GILEAD SCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware
(State or other jurisdiction
of incorporation)

 

0-19731
(Commission File No.)

 

94-3047598
(IRS Employer
Identification No.)

 

333 LAKESIDE DRIVE, FOSTER CITY, CALIFORNIA

(Address of principal executive offices)

 

94404

(Zip Code)

 

(650) 574-3000

(Registrant’s telephone number, including area code)

 


 

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:

 

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

 

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

 

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

 

o            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, $0.001 per share

 

GILD

 

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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company  o

 

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.  o

 

 

 


 

Item 1.01. Entry into a Material Definitive Agreement.

 

Option, License and Collaboration Agreement

 

On July 14, 2019, Gilead Sciences, Inc. (the “Company”) and Galapagos NV (“Galapagos”) entered into an Option, License and Collaboration Agreement (the “Collaboration Agreement”), pursuant to which the Company and Galapagos entered into a new global collaboration that covers Galapagos’ current and future product portfolio. The parties have been collaborating since 2016 on the development of filgotinib, an investigational, oral, selective JAK1 inhibitor, for inflammatory disease indications.

 

Upon the closing of the Collaboration Agreement with Galapagos, the Company will make an up-front license and option fee payment of $3.95 billion and an equity investment in Galapagos of approximately $1.1 billion. The closing of the Collaboration Agreement is subject to a number of closing conditions, including antitrust clearances required by the U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder and the Company’s and Galapagos’ entrance into the Subscription Agreement (as defined below).

 

Under the Collaboration Agreement, the Company has option rights to acquire an exclusive license to all current and future clinical programs of Galapagos (other than filgotinib, which is already subject to the parties’ existing collaboration) being developed during the 10-year initial option term of the collaboration (subject to extension in certain circumstances) and, for those programs that entered clinical development prior to the end of the initial option term, for up to an additional three years thereafter. The Company may exercise its option to acquire a license to a program after the receipt of a data package from a completed, qualifying Phase 2 study for such program (or, in certain circumstances, the first Phase 3 study).

 

If the Company exercises its option on a clinical program, the Company and Galapagos will collaborate on global development of such program and share development costs equally. Galapagos will retain exclusive rights to commercialize products included in the optioned program in the European Union, Iceland, Norway, Lichtenstein and Switzerland, and the Company will have exclusive commercialization rights for such products for all other countries globally. In addition to the option on all current and future clinical programs, upon the closing of the Collaboration Agreement, the Company and Galapagos will immediately begin collaborating on Galapagos’ autotaxin inhibitor for idiopathic pulmonary fibrosis, GLPG-1690, which is currently in Phase 3 trials, and the Company will receive an exclusive license to the program. If GLPG-1690 receives marketing approval in the United States, the Company will pay Galapagos a $325 million milestone fee as well as the tiered royalties described below.

 

Galapagos also has a compound, GLPG-1972, that inhibits ADAMTS-5, an enzyme that degrades an important structural component of cartilage. If the Company exercises its option to acquire a license to the GLPG-1972 program after the completion of Galapagos’ ongoing ROCCELLA Phase 2 study in osteoarthritis, the Company will pay a $250 million option exercise fee. In addition, following opt-in, Galapagos would be eligible to receive up to $750 million in development, regulatory and commercial milestones on GLPG-1972 as well as the tiered royalties described below.

 

With respect to all other products in Galapagos’ current and future pipeline, if the Company exercises its option to acquire a license to a program, it will pay a $150 million option exercise fee per program. In addition, Galapagos would receive tiered royalties ranging from 20-24% on net sales of all Galapagos products optioned by the Company as part of the Collaboration Agreement (including GLPG-1690 and GLPG-1972), subject to customary royalty terms and adjustments.

 

If the Company exercises its option rights for a program, the Company will share development costs and mutually agreed commercialization costs equally with Galapagos, subject to the ability of either party to conduct certain independent research or development activities and independent commercial activities in their respective territories.

 

For each program the Company opts-in to, the Company is required to use commercially reasonable efforts to obtain marketing approval in the United States and Japan and to market, promote, sell or distribute one product for one indication in the United States and Japan.

 

The Collaboration Agreement also contains customary provisions including representations and warranties of the parties, terms as to governance of the collaboration, commercialization and regulatory responsibilities of the parties, and manufacturing and supply.

 

The Company may terminate the collaboration in its entirety or on a program-by-program and country-by-country basis with advance notice as well as following other customary termination events.

 

2


 

Subscription Agreement

 

Gilead Therapeutics A1 Unlimited Company, an unlimited liability company formed under the laws of Ireland and a wholly owned subsidiary of the Company (“Investor”), and Galapagos entered into a Subscription Agreement, dated July 14, 2019 (the “Subscription Agreement”), pursuant to which Investor agreed to purchase, subject to certain conditions, the number of ordinary shares of Galapagos, no par value (the “Subscription Shares”), sufficient to bring Investor’s aggregate ownership percentage in Galapagos at the closing of the Subscription Agreement to 20.1% on a fully diluted basis (rounded up to the nearest whole share) (provided that if the Investor acquires any existing shares of Galapagos between July 14, 2019 and the closing of the Subscription Agreement, such shares shall not reduce the number of shares to be issued by Galapagos to the Investor at the closing). The price per subscription share is equal to EUR 140.59.

 

The Subscription Agreement contains customary representations and warranties of the parties and is subject to a number of closing conditions, including antitrust clearances required by the U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder and under applicable Austrian law and the Company’s and Galapagos’ entrance into the Collaboration Agreement.

 

The Company and Investor are subject to certain standstill restrictions until the earlier of the date that is 10 years following the date on which the closing of the Subscription Agreement occurs and the termination of the Subscription Agreement (if the closing does not occur). Among other things, during this time, the Company, its affiliates and any parties acting in concert with them may not, without the consent of Galapagos, acquire voting securities of Galapagos exceeding more than 29.9% of the then issued and outstanding voting securities of Galapagos, and the Company and Investor may not propose a business combination with or acquisition of Galapagos. The standstill restrictions are subject to certain exceptions as provided in the Subscription Agreement.

 

Pursuant to the terms of the Subscription Agreement, the Company and Investor agreed that they shall not, and shall cause their affiliates not to, without the prior consent of Galapagos, dispose of any equity securities of Galapagos prior to the earlier of the second anniversary of the closing of the Subscription Agreement and the termination of the Subscription Agreement (if the closing does not occur). During the period running from the date that is two years following the closing of the Subscription Agreement until the date that is five years following the closing of the Subscription Agreement, Company and its affiliates shall not, without the prior consent of Galapagos, dispose of any equity securities of Galapagos if after such disposal they would own less than 20.1% of the then issued and outstanding voting securities of Galapagos. The lock-up restrictions are subject to certain exceptions as provided in the Subscription Agreement and may terminate upon certain events.

 

Subject to the occurrence of the closing of the Subscription Agreement and the approval of Galapagos’ shareholders, until the date that is 10 years following the date on which the closing occurs (or the termination of the Collaboration Agreement, if earlier, other than due to Galapagos’ breach), subject to extension in certain circumstances, Investor will have the right to have two designees appointed to Galapagos’ board of directors (the “Galapagos Board”). From the date that is 10 years following the date on which the closing occurs (or the termination of the Collaboration Agreement, if earlier, other than due to Galapagos’ breach), subject to extension in certain circumstances, until the date that the Company and its affiliates and any party acting in concert with them cease to own, directly or indirectly, at least 20% of the then outstanding shares of Galapagos on a non-diluted basis,

 

3


 

Investor will have the right to have one designee appointed to the Galapagos Board. In the event that either or both of Investor’s designees are not approved by Galapagos’ shareholders, Investor’s designees will be invited to the Galapagos Board as observers.

 

Subject to and upon Galapagos’ shareholder approval, Investor will be issued and will subscribe for a warrant that confers the right to subscribe for a number of new shares to be issued by Galapagos sufficient to bring the number of shares owned by the Company and its affiliates to 25.1% of the issued and outstanding shares. The warrant will expire one year after the issue date and the exercise price per share will be EUR 140.59.

 

Subject to and upon Galapagos’ shareholder approval, Investor will be issued another warrant (the “First 29.9% Warrant”) that confers the right to subscribe for a number of new shares to be issued by Galapagos sufficient to bring the number of shares owned by the Company and its affiliates to 29.9% of the issued and outstanding shares. The warrant will expire on the date that is five years after the date on which the Subscription Shares are issued. The exercise price per share will be the greater of (i) 120% multiplied by the arithmetic mean of the 30-day daily volume weighted average trading price of Galapagos’ shares preceding the date of the exercise notice with respect to such exercise, and (ii) EUR 140.59, being the issue price pursuant to the Subscription Agreement.

 

Between 57 and 59 months after the closing of the Subscription Agreement, subject to and upon Galapagos’ shareholder approval, Investor will be issued a warrant with substantially similar terms, including as to exercise price, to the First 29.9% Warrant. This warrant will expire on the earlier of the date that is five years after the fifth anniversary of the closing and the date that the warrant is issued.

 

Item 9.01.                                        Financial Statements and Exhibits.

 

(d)                                 Exhibits

 

The joint press release issued by the Company and Galapagos is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Exhibit
Number

 

Description

 

 

 

99.1

 

Joint Press Release issued by Gilead Sciences, Inc. and Galapagos NV on July 14, 2019

 

Forward Looking Statements

 

Certain items in this Current Report on Form 8-K may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the transactions described in this Current Report on Form 8-K. These statements are not historical facts. They represent management’s current expectations regarding future events and are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the expected timing and likelihood of completion of the foregoing transactions, including the risk that the transactions may not close due to one or more closing conditions to the transactions not being satisfied or waived. Accordingly, you should not place undue reliance on any forward-looking statements contained herein. For a discussion of these and other risks and important factors that could affect such forward-looking statements, see the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s most recent annual and quarterly reports filed with the Securities and Exchange Commission. New risks and uncertainties emerge from time to time, and it is not possible for the Company to predict or assess the impact of every factor that may cause its actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements contained herein speak only as of the date of this Current Report on Form 8-K, and the Company expressly disclaims any obligation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or change in events, conditions or circumstances on which any statement is based.

 

4


 

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 hereunto duly authorized.

 

 

GILEAD SCIENCES, INC.

 

(Registrant)

 

 

 

/s/ Brett A. Pletcher

 

Brett A. Pletcher

 

EVP, General Counsel and Corporate Secretary

 

Date:  July 18, 2019

 

5


Exhibit 99.1

 

 

CONTACTS:

 

Gilead

Galapagos

Sung Lee, Investors

Elizabeth Goodwin, Investors

(650) 524-7792

(781) 460-1784

 

 

Amy Flood, Media

Carmen Vroonen, Media

(650) 522-5643

+32 473 824 874

 

For Immediate Release

 

GILEAD  AND  GALAPAGOS  ENTER  INTO  TRANSFORMATIVE

RESEARCH  AND  DEVELOPMENT  COLLABORATION

 

Gilead to Make $3.95 Billion Upfront Payment and $1.1 Billion Equity Investment

 

Gilead Gains Access to Galapagos’ Differentiated Drug Discovery Platform and
Current and Future Pipeline Outside of Europe

 

— Investment Enables Galapagos to Expand and Accelerate Research and Clinical Programs

 

Galapagos Gains Broader Commercialization Role for Filgotinib in Europe and Agrees to

Share Equally in Future Development Costs

 

Gilead Agrees to 10-year Standstill

 

Foster City, Calif. and Mechelen, Belgium July 14, 2019 — Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that they have entered into a 10-year global research and development collaboration. Through this agreement, Gilead will gain access to an innovative portfolio of compounds, including six molecules currently in clinical trials, more than 20 preclinical programs and a proven drug discovery platform.

 

Galapagos will receive a $3.95 billion upfront payment and a $1.1 billion equity investment from Gilead. Galapagos will use the proceeds to expand and accelerate its research and development programs. Gilead will receive an exclusive product license and option rights to develop and commercialize all current and future programs in all countries outside Europe. In addition, Gilead and Galapagos have agreed to amend certain terms in the agreement governing filgotinib, the candidate being advanced for rheumatoid arthritis and other inflammatory diseases to provide a broader commercialization role for Galapagos in Europe.

 

The collaboration will allow for closer scientific partnership between the companies. Gilead will have access to Galapagos’ established research base, which includes more than 500 scientists, and to Galapagos’ unique platform, which utilizes disease-related, human primary cell-based assays to discover and verify novel drug targets. Gilead will also nominate two individuals to Galapagos’ Board of Directors following the closing of the transaction.

 

- more -

 


 

July 14, 2019

 

“We are excited to enter into this unique agreement, which will generate both long-term strategic value and mutual, immediate benefits. We chose to partner with Galapagos because of its pioneering target and drug discovery platform, proven scientific capabilities and outstanding team,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “Gilead also gains exclusive access to all current and future compounds in Galapagos’ rich pipeline while Galapagos is able to expand its research activities and build commercial infrastructure. The collaboration reflects Gilead’s intent to grow our innovation network through diverse and creative partnerships.”

 

As part of the collaboration, Gilead gains rights to GLPG1690, Galapagos’ Phase 3 candidate for idiopathic pulmonary fibrosis. Gilead also receives option rights for GLPG1972, a Phase 2b candidate for osteoarthritis, in the United States. Both GLPG1690 and GLPG1972 are first-in-class compounds and could offer important mid- and late-stage pipeline opportunities for Gilead. In addition, Gilead receives option rights on all of Galapagos’ other current and future clinical programs outside of Europe.

 

“What a fantastic moment in our 20th anniversary year to sign this landmark deal with our great partner Gilead,” said Onno van de Stolpe, Chief Executive Officer of Galapagos. “Galapagos has been highly effective at target identification and drug discovery, progressing novel molecules from research into the clinic. We will benefit greatly from Gilead’s expertise and infrastructure and believe this collaboration will provide an accelerated path to advance our pipeline. This agreement is about maximizing innovation based on developing new mode of action medicines. With the capital provided by Gilead, we aim to progress innovation to patients.”

 

Terms of the Collaboration

 

Galapagos will fund and lead all discovery and development autonomously until the end of Phase 2. After the completion of a qualifying Phase 2 study, Gilead will have the option to acquire an expanded license to the compound. If the option is exercised, Gilead and Galapagos will co-develop the compound and share costs equally. Gilead will maintain option rights to Galapagos’ programs through the 10-year term of the collaboration and for up to an additional three years thereafter for those programs that have entered clinical development prior to the end of the collaboration term.

 

If GLPG1690 is approved in the United States, Gilead will pay Galapagos an additional $325 million milestone fee. For GLPG1972, Gilead has the option to pay a $250 million fee to license the compound in the United States after the completion of the ongoing Phase 2b study in osteoarthritis. If certain secondary efficacy endpoints are met, Gilead would pay up to an additional $200 million. Following opt in, Galapagos would be eligible to receive up to $550 million in regulatory and commercial milestones.

 

For all other programs resulting from the collaboration, Gilead will make a $150 million opt-in payment per program and will owe no subsequent milestones. Galapagos will receive tiered royalties ranging from 20-24% on net sales of all Galapagos products licensed by Gilead as part of the agreement.

 

Filgotinib Collaboration

 

Gilead and Galapagos have also agreed to amend certain terms around the development and commercialization of filgotinib, the experimental compound being advanced for rheumatoid arthritis and other inflammatory diseases. The companies have recently completed the comprehensive Phase 3 FINCH

 

2


 

program in rheumatoid arthritis and plan to seek regulatory approval for the medicine in the United States and Europe before the end of the year. Under the amended agreement, Galapagos will have greater involvement in filgotinib’s global strategy and participate more broadly in the commercialization of the product in Europe, providing the opportunity to build a commercial presence on an accelerated timeline.

 

Gilead and Galapagos will co-commercialize filgotinib in France, Germany, Italy, Spain and the United Kingdom and retain the 50/50 profit share in these countries that was part of the original filgotinib license agreement, and under the revised agreement, Galapagos will have an expanded commercial role. Galapagos retains exclusive rights in Belgium, the Netherlands and Luxembourg. The companies will share future global development costs for filgotinib equally, in lieu of the 80/20 cost split provided by the original agreement. Other terms of the original license agreement remain in effect, including the remaining $1.27 billion in total potential milestones and tiered royalties ranging from 20-30% payable in territories outside of Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Spain and the United Kingdom.

 

Terms of the Equity Investment

 

Gilead’s equity investment will consist of a subscription for new Galapagos shares at a price of €140.59 per share, representing a 20% premium to Galapagos’ 30-day, volume-weighted average price. This will increase Gilead’s stake in Galapagos from approximately 12.3% to 22% of the issued and outstanding shares in Galapagos. In addition, Galapagos intends to seek shareholder approval to issue two warrants allowing Gilead to further increase its ownership of Galapagos to up to 29.9% of the company’s issued and outstanding shares. The agreement also includes a 10-year standstill restricting Gilead’s ability to seek to acquire Galapagos or increase its stake in Galapagos beyond 29.9% of the company’s issued and outstanding shares, subject to limited exceptions.

 

The transaction, which is expected to close late in the third quarter of 2019, is subject to certain closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and receipt of merger control approval from the Austrian Federal Competition Authority.

 

Barclays, Centerview Partners and Lazard are acting as financial advisors to Gilead. Moelis & Co. and Morgan Stanley are acting as financial advisors to Galapagos. Skadden, Arps, Slate, Meagher & Flom, Covington & Burling LLP and Eubelius are serving as legal counsel to Gilead and Baker McKenzie and Linklaters are serving as legal counsel to Galapagos.

 

Conference Call

 

At 3:00 p.m. Eastern Time today, the Gilead and Galapagos management teams will host a joint conference call and a simultaneous webcast to discuss the collaboration. To access the live call via the internet, please connect to the company’s website at http://investors.gilead.com/events or www.glpg.com 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast.

 

To access the call by telephone from the U.S./Canada, please call 1-877-359-9508 or 1-224-357-2393 from the U.S./Canada and use the conference ID 186 9522.

 

For international telephone access, please call Belgium: 080073264; France: 0805081488; Netherlands: 08000232838 and United Kingdom: 08000288438 and use the conference ID 186 9522.

 

3


 

A replay of the webcast will be archived on the companies’ websites for one year, and a phone replay will be available approximately two hours following the call through July 28, 2019. To access the phone replay, please call 1-855-859-2056 or 1-404-537-3406 and dial the conference ID 186 9522.

 

About Galapagos

 

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. The company’s pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. Galapagos’ ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

 

About Gilead Sciences

 

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.  The company strives to transform and simplify care for people with life-threatening illnesses around the world.  Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.  For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

 

Galapagos Forward-Looking Statement

 

This release may contain forward-looking statements with respect to Galapagos, including statements regarding Galapagos’ strategic ambitions, regarding the expected timing of closing of the transaction with Gilead, filings and approvals relating to the transaction, the amount and timing of potential future milestone, opt-in and/or royalty payments by Gilead, the mechanism of action and potential safety and efficacy of filgotinib, GLPG1690 and/or GLPG1972, the anticipated timing of clinical studies with filgotinib, GLPG1690 and/or GLPG1972, the progression and results of such studies, and statements regarding the regulatory pathway for filgotinib and the timing of regulatory filings.  Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods.  Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, uncertainty regarding the ability of the parties to complete the transaction considering the transaction is subject to closing conditions and any applicable antitrust clearance requirements, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of Galapagos’ drug candidates due to safety, efficacy or other reasons), Galapagos’ reliance on collaborations with third parties (including its collaboration partner Gilead), and estimating the commercial potential of filgotinib, GLPG1690 and/or GLPG1972. A further list and description of these risks, uncertainties and other risks can be found in Galapagos’ Securities and Exchange Commission (SEC) filings and reports, including in Galapagos’ most recent annual report on Form 20-F filed with the SEC and subsequent filings and reports filed by Galapagos with the SEC.  Given these uncertainties, the reader is

 

4


 

advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document.  Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

 

Gilead Forward-Looking Statement

 

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Galapagos and the collaboration and option agreement and restructuring of the filgotinib collaboration that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies and members of their senior management team. Forward-looking statements include, without limitation, the risk that Gilead may not realize any benefits from the global collaboration and option agreement; its potential effects on Gilead’s revenues and earnings; Gilead may fail to discover, develop and commercialize any of  Galapagos’ pipeline products under the agreement; the filing of the new drug applications for approval of filgotinib in the currently anticipated timeframe; approval of filgotinib by regulatory authorities, including any approvals, if granted, may have significant limitations on its use; the anticipated timing of clinical data of Galapagos’ pipeline products; the possibility of unfavorable results from these clinical trials; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction in a timely manner or at all; and the accuracy of any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the closing of the collaboration and option transaction; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration and option agreement; the effects of the transaction (or the announcement thereof) on relationships with employees, customers, other business partners or governmental entities; transaction costs; the risk Galapagos’ stockholders do not approve Gilead’s board nominees or issuance of the warrants, as the case may be. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

 

###

 

5


Categories

SEC Filings