UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE TO

Tender Offer Statement Under Section 14(d)(1) or 13(e)(1)

of the Securities Exchange Act of 1934

(Amendment No. 7)

 

 

 

SPARK THERAPEUTICS, INC.

(Name of Subject Company)

022019 MERGER SUBSIDIARY, INC.

(Offeror)

A Wholly Owned Subsidiary of

ROCHE HOLDINGS, INC.

(Parent of Offeror)

(Names of Filing Persons—Offeror)

Common Stock, Par Value $0.001 Per Share

(Title of Class of Securities)

 

 

84652J103

(Cusip Number of Class of Securities)

 

Dr. Sean A. Johnston

Roche Holdings, Inc.

1 DNA Way, MS #24,

South San Francisco, CA 94080

Telephone: (650) 225-1000

(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)

Copies to:

Marc O. Williams, Esq.

Brian Wolfe, Esq.

Davis Polk & Wardwell LLP

450 Lexington Avenue

New York, New York 10017

Telephone: (212) 450-4000

 

 

CALCULATION OF FILING FEE

 

Transaction Valuation*   Amount of Filing Fee**
$4,805,265,563.50   $582,398.19

*Estimated solely for purposes of calculating the filing fee pursuant to Rule 0-11(d) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The Transaction Value was calculated by adding (i) the product of (A) 38,053,350 outstanding shares (“Shares”) of common stock of Spark Therapeutics, Inc., of which 8,750 were restricted shares and (B) $114.50 (the “Offer Price”); (ii) the product of (A) 4,157,775 Shares subject to issuance pursuant to Spark Stock Options granted and outstanding under the Spark Equity Incentive Plans and (B) $71.74, which is the difference between the $114.50 per share tender offer price and $42.76, the average weighted exercise price of such options (all of which are “in-the-money”); (iii) the product of (A) outstanding restricted stock units in respect of 1,287,829 Shares subject to such restricted stock units (with any applicable performance conditions deemed to be achieved at maximum performance) and (B) the Offer

 

 

 

Price; and (iv) the product of (A) 21,151 Shares which are estimated to be subject to outstanding purchase rights under the 2015 Employee Stock Purchase Plan (assuming that the closing price per Share as reported on the NASDAQ Global Select Market on the last day of the offering period in effect under the 2015 Employee Stock Purchase Plan on May 31, 2019 was equal to the Offer Price) and (B) the Offer Price.

 

The foregoing figures have been provided by Spark Therapeutics, Inc. to the Offeror and Parent of Offeror and are as of February 28, 2019, the most recent practicable date.

 

**The amount of the filing fee was calculated in accordance with Rule 0-11 of the Securities Exchange Act, by multiplying the Transaction Valuation by 0.0001212.

 

þCheck box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing.

 

Amount Previously Paid: $582,398.19   Filing Party: Roche Holdings, Inc.
Form or Registration No.: Schedule TO   Date Filed: March 7, 2019

 

¨Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.

 

Check the appropriate boxes below to designate any transactions to which the statement relates:

 

third-party tender offer subject to Rule 14d-1.

 

issuer tender offer subject to Rule 13e-4.

 

going-private transaction subject to Rule 13e-3.

 

amendment to Schedule 13D under Rule 13d-2.

 

Check the following box if the filing is a final amendment reporting the results of the tender offer. ☐

 

 

 

 

This Amendment No. 7 to the Tender Offer Statement on Schedule TO amends and supplements the Schedule TO filed with the Securities and Exchange Commission on March 7, 2019 (as it may be amended and supplemented from time to time, the “Schedule TO”) and relates to the offer by 022019 Merger Subsidiary, Inc., a Delaware corporation and a wholly owned subsidiary of Roche Holdings, Inc., a Delaware corporation (“Parent”), to purchase all outstanding shares of common stock, par value $0.001 per share of Spark Therapeutics, Inc., a Delaware corporation (“Spark”), at $114.50 per Share, net to the seller in cash, without interest and less applicable withholding taxes, upon the terms and subject to the conditions set forth in the Offer to Purchase, dated March 7, 2019, and in the related Letter of Transmittal, copies of which are incorporated by reference to Exhibits (a)(1)(i) and (a)(1)(ii), respectively, of the Schedule TO (which, together with any amendments or supplements thereto, collectively constitute the “Offer”).

 

All information contained in the Offer to Purchase and the related Letter of Transmittal, including all schedules thereto, is hereby incorporated herein by reference in response to Items 1 through 9 and Item 11 in the Schedule TO. Capitalized terms used and not otherwise defined in this Amendment have the meanings given to such terms in the Offer to Purchase.

 

Items 1 through 9; and Item 11.

 

1.       The information set forth in Section 16—“Certain Legal Matters; Regulatory Approvals—Regulatory Matters” of the Offer to Purchase under the “U.S. Antitrust” subsection is hereby amended and restated in its entirety and replaced by the paragraphs set forth below.

 

Under the HSR Act and the rules that have been promulgated thereunder, certain acquisition transactions may not be consummated unless Premerger Notification and Report Forms have been filed with the Federal Trade Commission (the “FTC”) and the Antitrust Division of the United States Department of Justice (the “Antitrust

 

 

 

Division”) and certain waiting period requirements have been satisfied. The purchase of Shares pursuant to the Offer and the Merger is subject to such requirements.

 

Each of Parent and Spark filed a Premerger Notification and Report Form under the HSR Act with respect to the Offer and the Merger with the Antitrust Division and the FTC on March 1, 2019. On March 18, 2019, Parent withdrew the March 1, 2019 filing and refiled the Premerger Notification and Report Form with respect to the Offer and the Merger with the Antitrust Division and the FTC. Parent subsequently withdrew the March 18, 2019 filing effective on April 2, 2019 and Parent and Spark each refiled their respective Premerger Notification and Report Forms. Effective April 25, 2019, Parent withdrew the April 10, 2019 filing and Parent and Spark each refiled their respective Premerger Notification and Report Forms on May 23, 2019. On June 7, 2019, Parent received from the FTC a Request for Additional Information and Documentary Material (a “Second Request”) under the HSR Act with respect to the Offer. Spark has informed Parent that it also received a Second Request on June 7, 2019. As a result of the Second Requests, the waiting period under the HSR Act applicable to the purchase of the Shares pursuant to the Offer has been extended until 11:59 p.m., New York City time, on the date that is ten calendar days after substantial compliance by Parent with its Second Request, unless such waiting period is terminated earlier by the FTC. Thereafter, such waiting period can be extended only by court order or agreement of Parent, Purchaser, Spark and the FTC. See “—Section 15—Conditions to the Offer” for certain conditions to the Offer, including conditions with respect to certain governmental actions, and “—Section 13—The Transaction Documents—The Merger Agreement—Termination” for certain termination rights pursuant to the Merger Agreement with respect to certain governmental actions. It is also possible that Parent and Spark could enter into a timing agreement with the FTC that could affect the timing of the closing of the transactions contemplated by the Merger Agreement. Parent and Spark continue to work cooperatively and expeditiously with the FTC in connection with its review.

 

2.       The information set forth in Section 16—“Certain Legal Matters; Regulatory Approvals—Regulatory Matters” of the Offer to Purchase under the “Other Antitrust Approvals” subsection is hereby amended and restated in its entirety and replaced by the paragraphs set forth below.

 

Spark and its subsidiaries transact business in a number of additional countries outside of the United States. Under the antitrust or merger control statutes or regulations of certain of these foreign countries, certain acquisition transactions require the filing of information with, or the obtaining of the approval of, antitrust or competition authorities therein. We do not believe that the purchase of Shares by us in the Offer or the Merger is subject to such requirements.

 

The UK Competition and Markets Authority (the “CMA”) has opened an investigation in order to obtain further information in relation to Parent’s proposed acquisition of Spark.  The investigation will determine whether the CMA considers it has jurisdiction over the acquisition; and, if so, whether the CMA considers that the acquisition may be expected to result in a substantial lessening of competition in the UK such as to warrant a more detailed, Phase 2 review.  In the latter case, the CMA may accept remedies offered by the parties to avoid a Phase 2 review.  Pending the outcome of its investigation, the CMA has issued an Interim Enforcement Order that would become effective upon closing of the transaction and would require Parent to hold separate the Spark business.  The parties are working cooperatively with the CMA and will continue to do so. 

 

3.       The information set forth in Items 1 through 9 and Item 11 of the Schedule TO is hereby amended and supplemented by adding the following text thereto:

 

On June 10, 2019, in connection with the Second Requests (as defined above) that Parent and Spark received from the FTC on June 7, 2019, pursuant to the Merger Agreement, Parent extended the expiration of the Offer. The Offer was previously scheduled to expire at 5:00 p.m., New York City Time, on June 14, 2019. The expiration date of the Offer is extended to 5:00 p.m., New York City Time, on July 31, 2019, unless further extended. The Depositary has advised Parent that, as of 5:00 p.m., New York City time, on June 7, 2019, approximately 8,125,931 Shares (none of which were tendered by Notice of Guaranteed Delivery) had been validly tendered and received, and not validly withdrawn, pursuant to the Offer, representing approximately 21.1% of the outstanding Shares.

 

On June 10, 2019, Parent issued a media release relating to the Second Requests and announcing the extension of the Offer. The full text of the press release is attached as Exhibit (a)(5)(xxi) to the Schedule TO and is incorporated herein by reference.

 

 

 

4.       Amendments to the Offer to Purchase and the exhibits to the Schedule TO:

 

The information set forth in the Offer to Purchase and Items 1 through 9 and Item 11 of the Schedule TO, to the extent such Items incorporate by reference the information contained in the Offer to Purchase, is hereby amended and supplemented as follows:

 

All references to “5:00 p.m., New York City time, on June 14, 2019” set forth in the Offer to Purchase (Exhibit (a)(1)(i)), Letter of Transmittal (Exhibit (a)(1)(ii)), Notice of Guaranteed Delivery (Exhibit (a)(1)(iii)), Letter to Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees (Exhibit (a)(1)(iv)), and Letter to Clients for use by Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees (Exhibit (a)(1)(v)) are hereby amended and replaced with “5:00 p.m., New York City time, on July 31, 2019”.

 

Item 12. Exhibits.

 

Item 12 of the Schedule TO and the Exhibit Index is hereby amended and supplemented by adding the following Exhibits to the List of Exhibits:

 

   

Exhibit No.

Description

   
(a)(5)(xx)*

Second Request Q&A dated June 10, 2019.

 

(a)(5)(xxi)*

 

Media Release issued by Roche Holdings, Inc., dated June 10, 2019.

 

*Filed herewith

 

 

 

SIGNATURES

 

After due inquiry and to the best knowledge and belief of the undersigned, each of the undersigned certify that the information set forth in this statement is true, complete and correct.

 

Date: June 10, 2019

 

  022019 MERGER SUBSIDIARY, INC.
   
   
  By:   /s/ Bruce Resnick
      Name: Bruce Resnick
      Title: President

 

   
  ROCHE HOLDINGS, INC.
   
   
  By:   /s/ Bruce Resnick
      Name: Bruce Resnick
      Title: Vice President

 

 

 

EXHIBIT INDEX

 

Exhibit No. 

Description 

(a)(1)(i)

Offer to Purchase, dated as of March 7, 2019.

 

(a)(1)(ii)

Letter of Transmittal (including Guidelines for Certification of Taxpayer Identification Number on IRS Form W-9).

 

(a)(1)(iii)

Notice of Guaranteed Delivery.

 

(a)(1)(iv)

Letter to Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees.

 

(a)(1)(v)

Letter to Clients for use by Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees.

 

(a)(1)(vi)

Summary Advertisement as published in the Wall Street Journal on March 7, 2019.

 

(a)(5)(i)

Media Release issued by Spark Therapeutics, Inc. dated February 25, 2019 (incorporated by reference to Exhibit 99.1 of the Spark Therapeutics, Inc. Current Report on Form 8-K (File No. 001-36819) filed with the Commission on February 25, 2019).

 

(a)(5)(ii)

Email sent to Spark Therapeutics, Inc. employees from Jeffrey Marrazzo, CEO of Spark Therapeutics, Inc., dated February 25, 2019 (incorporated by reference to the Spark Therapeutics, Inc. Solicitation/Recommendation Statement on Form 14D-9 (File No. 005-88577) filed with the Commission on February 25, 2019).

 

(a)(5)(iii)

Spark Therapeutics, Inc. Current Report on Form 8-K dated February 25, 2019 (incorporated by reference to the Spark Therapeutics, Inc. Current Report on Form 8-K (File No. 001-36819) filed with the Commission on February 25, 2019).

 

(a)(5)(iv)

Social media post by Spark Therapeutics, Inc. on www.twitter.com (incorporated by reference to the Company’s Solicitation/Recommendation Statement on Schedule 14D-9 filed on February 25, 2019).

 

(a)(5)(v)

Social media post by Jeffrey D. Marrazzo, the Company’s Chief Executive Officer, on www.twitter.com (incorporated by reference to the Company’s Solicitation/Recommendation Statement on Schedule 14D-9 filed on February 25, 2019).

 

(a)(5)(vi)

Q&A provided to employees of Spark Therapeutics, Inc. on February 25, 2019 (incorporated by reference to the Company’s Solicitation/Recommendation Statement on Schedule 14D-9 filed on February 25, 2019).

 

(a)(5)(vii)

Media Release issued by Roche Holdings, Inc. dated February 25, 2019 (incorporated by reference to Exhibit 99.1 of the first Roche Holdings, Inc. Pre-Commencement Communication on Schedule TO filed with the Commission on February 25, 2019).

 

(a)(5)(viii)

Key Messages and Q&A dated February 25, 2019 (incorporated by reference to Exhibit 99.2 of the first Roche Holdings, Inc. Pre-Commencement Communication on Schedule TO filed with the Commission on February 25, 2019).

 

(a)(5)(ix)

Roche Press Release announcing the commencement of the Offer, dated as of March 7, 2019.

 

(a)(5)(x)

Complaint filed as of March 7, 2019 (Wang v. Spark Therapeutics, Inc., et al., Case No. 1:19-cv-00479).

 

(a)(5)(xi)

Complaint filed as of March 11, 2019 (Kent v. Spark Therapeutics, Inc., et al., Case No. 1:19-cv-00485).

 

(a)(5)(xii)

Complaint filed as of March 18, 2019 (Newman v. Spark Therapeutics, Inc., et al., Case No. 1:19-cv-00528).

 

 

 

 

(a)(5)(xiii)

Complaint filed as of March 20, 2019 (Gomez v. Spark Therapeutics, Inc., et al., Case No. 1:19-cv-02487).

 

(a)(5)(xiv)

Media Release issued by Roche Holdings, Inc., dated April 3, 2019.

 

(a)(5)(xv)

Withdrawal and Refiling Q&A dated April 3, 2019.

 

(a)(5)(xvi)

Media Release issued by Roche Holdings, Inc., dated April 26, 2019.

 

(a)(5)(xvii)

Complaint filed as of April 18, 2019 (Grant v. Bennett, et al., Case No. 1:19-cv-02615).

 

(a)(5)(xviii)

Withdrawal and Refiling Q&A dated April 26, 2019.

 

(a)(5)(xix)

Media Release issued by Roche Holdings, Inc., dated May 14, 2019.

 

(a)(5)(xx)*

Second Request Q&A dated June 10, 2019.

 

(a)(5)(xxi)*

 

Media Release issued by Roche Holdings, Inc., dated June 10, 2019.
(c)

Not applicable.

 

(d)(1)

Agreement and Plan of Merger, dated as of February 22, 2019, by and among Spark Therapeutics, Inc., Roche Holdings, Inc. and 022019 Merger Subsidiary, Inc. (incorporated by reference to Exhibit 2.1 of the Spark Therapeutics, Inc. Current Report on Form 8-K (File No. 001-36819) filed with the Commission on February 25, 2019).

 

(d)(2)

Confidentiality Agreement, dated as of October 9, 2018, between Roche Holdings, Inc. and Spark Therapeutics, Inc.

 

(e)

Not applicable.

 

(f)

Section 262 of the Delaware General Corporation Law (included as Schedule II to the Offer to Purchase previously filed as Exhibit (a)(1)(i)).

 

(g)

Not applicable.

 

(h)

Not applicable.

 

* Filed herewith

 

 

Exhibit (a)(5)(xx)

 

 

SPARK Q&A REGARDING FTC’S SECOND REQUEST

 

1. What is the purpose of the FTC (Federal Trade Commission) second request?

 

A second request provides the FTC additional time to complete its current review and allows the FTC to receive additional documents and data to assist in conducting the review.

The issuance of a second request extends the waiting period until 10 days after Roche has substantially complied with the second request, unless the waiting period is terminated earlier by the FTC or the parties have entered into a timing agreement with the FTC. Spark and Roche remain committed to the transaction and will continue to cooperate with the FTC staff in its review of the transaction.

2. How is a “second request” different from the “pull and refile’ mechanism you have used previously?

Compliance with a second request is a more formalized procedure pursuant to statutory rules, but in actual practice we are continuing the same course of working collaboratively with the FTC to provide documents and information responsive to FTC staff questions.

3. Is there a problem with the on-going FTC review?

As a matter of policy, we do not comment on ongoing FTC reviews.

4. What is the FTC’s role in general?

The FTC is a bipartisan federal agency with a dual mission to protect consumers and promote competition. The FTC typically monitors business practices and reviews potential mergers to ensure that the market works according to consumer preferences.
(source: www.ftc.gov)

5. Can you give more details about the FTC review?

No. As a matter of policy, we do not comment on ongoing FTC reviews. See this link for general information from the FTC on second requests: https://www.ftc.gov/tips-advice/competition-guidance/guide-antitrust-laws/mergers/premerger-notification-merger-review.

 

6. Are the FTC concerns mainly around haemophilia?

 

As a matter of policy, we do not comment on ongoing FTC reviews.

 

7. Why is the FTC review taking so long?

 

As a matter of policy, we do not comment on ongoing FTC reviews.

 

8. Is the transaction at risk?

 

Both Roche and Spark were aware that FTC review and clearance would be required for the transaction. This step in the process allows the FTC more time to complete its review and receive additional documents and data to assist in conducting its review.

As a result of receiving the second request, the conditions to the tender offer are not expected to be satisfied at the currently scheduled expiration of the tender offer. Therefore, Roche is extending the offer period, which was previously scheduled to expire on Friday, June 14, 2019, until Wednesday, July 31, 2019, in accordance with the merger agreement in order to provide additional time for the FTC to complete its review, unless it is extended further under the circumstances set forth in the merger agreement.

 

 

 

 

In a transaction of this type, a significant portion of shareholders customarily tender their shares during the last day of the tender offer period. Therefore, we do not view the level of tendered shares at this time as in any way indicative of shareholder support for the transaction.

 

9. You have already extended the offer three times. Why are you extending it again?

 

As a result of receiving the second request, the conditions to the tender offer are not expected to be satisfied at the currently scheduled expiration of the tender offer. Therefore, Roche is extending the offer period, which was previously scheduled to expire on Friday, June 14, 2019, until Wednesday, July 31, 2019, in accordance with the merger agreement in order to provide additional time for the FTC to complete its review, unless it is extended further under the circumstances set forth in the merger agreement.

10. Is this related to the recent lawsuits filed on behalf of Spark shareholders?

 

No. The FTC process is an independent legal process. As a matter of policy, we cannot comment on legal matters.

 

11. Does this change the previously stated estimate of Q2 deal closing?

 

As a second request provides the FTC with additional time to complete its current review, it is unlikely that the transaction will close during the first half of 2019. The parties expect the transaction to close in 2019.

 

12. What is the new expected closing date?

 

As a result of receiving the second request, the conditions to the tender offer are not expected to be satisfied at the currently scheduled expiration of the tender offer. Therefore, Roche is extending the offer period, which was previously scheduled to expire on Friday, June 14, 2019, until Wednesday, July 31, 2019, in accordance with the merger agreement in order to provide additional time for the FTC to complete its review, unless it is extended further under the circumstances set forth in the merger agreement. As a second request provides the FTC with additional time to complete its current review, it is unlikely that the transaction will close during the first half of 2019. The parties expect the transaction to close in 2019.

13. Until now you were very confident that you would be able to close the deal within the first half of 2019. While a Second Request seems to be part of the regulatory review process, you clearly were not expecting this. How is this possible? Has something unexpected occurred?

 

As a matter of policy, we do not comment on ongoing FTC reviews.

 

14. Are there concerns about shareholder support?

 

We believe our offer, which has been unanimously recommended by the board of Spark, to be full and fair. Shareholders need to tender more than 50 percent of the total number of shares of Spark common stock outstanding in order to satisfy the minimum condition to complete the tender offer.

 

In a transaction of this type, a significant portion of shareholders customarily tender their shares during the last day of the tender offer period. Therefore, we do not view the level of tendered shares at this time as in any way indicative of shareholder support for the transaction.

 

 

 

 

15. Why should Spark shareholders have confidence that this deal will eventually go through?

 

We believe our offer, which has been unanimously recommended by the board of Spark, to be full and fair. Spark and Roche will continue to cooperate with the FTC staff in its review of the transaction.

16. When is the end date in the merger agreement?

 

In general, the end date (the date by which the closing of the transaction must occur) is December 31, 2019, but if the conditions relating to antitrust laws have not been satisfied by that time then Roche and Spark each have the right to extend until January 31, 2020. Please see the offer to purchase for a more detailed description of the relevant provisions of the merger agreement.

17. Is it possible a third party could now acquire Spark?

 

We believe our offer, which has been unanimously recommended by the board of Spark, to be full and fair. We cannot speculate as to what third parties might do. As described in the offer to purchase, the merger agreement contains customary “deal protection” mechanisms, including a prohibition on Spark soliciting competing offers and a requirement that Spark pay Roche a “break-up fee” of US $144 million in certain circumstances (for example, if Spark terminates the merger agreement to accept a superior proposal).

 

18. [If required:] On April 3rd you communicated that approximately 29.4% of Spark's outstanding Shares have been validly tendered and received, on April 26th, you communicated that number was approximately 26.1%, and on May 13th, you communicated that number was approximately 21.0%. Now on June 7th, you have communicated a marginally higher percentage (21.1%). Is this an indication that shareholders are [less/more] supportive of the deal?

 

In a transaction of this type, a significant portion of shareholders customarily tender their shares during the last day of the tender offer period. A change in the number of tendered shares during the tender offer period is not unusual. Until the end of the offer period, shareholders have the right to tender their shares, withdraw and re-tender them. Therefore, we do not view the level of tendered shares at this time as in any way indicative of shareholder support for the transaction.

 

19.  What are the details related to the UK Competition and Markets Authority (CMA) investigation?  Could the UK authorities prevent the Spark acquisition from going through? What are the consequences of the Interim Enforcement Order?

 

The UK Competition and Markets Authority (the “CMA”) has opened an investigation in order to obtain further information in relation to Roche’s proposed acquisition of Spark. The investigation will determine whether the CMA considers it has jurisdiction over the acquisition; and, if so, whether the CMA considers that the acquisition may be expected to result in a substantial lessening of competition in the UK such as to warrant a more detailed, Phase 2 review. In the latter case, the CMA may accept remedies offered by the parties to avoid a Phase 2 review.  Pending the outcome of its investigation, the CMA has issued an Interim Enforcement Order (IEO) that would become effective upon closing of the transaction and would require Roche to hold separate the Spark business. The parties are working cooperatively with the CMA and will continue to do so.

 

It is common practice for the CMA to issue a post-closing IEO. The issuance of an IEO does not of itself mean that the CMA has substantive concerns about the acquisition nor that the CMA has the legal power to intervene to impose conditions to the acquisition proceeding.

 

 

 

 

20. What will Roche do if the acquisition doesn’t go through? Are you considering to partner with Spark? Or will you look for other companies with gene therapy expertise to acquire?

 

Roche remains focused on completing the transaction and continuing to cooperate with the FTC staff in its review of the transaction.

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

 

SOME OF THE STATEMENTS CONTAINED IN THIS DOCUMENT ARE FORWARD-LOOKING STATEMENTS, INCLUDING STATEMENTS REGARDING, AMONG OTHER THINGS, THE EXPECTED CONSUMMATION OF THE TRANSACTION, WHICH INVOLVES A NUMBER OF RISKS AND UNCERTAINTIES, INCLUDING THE SATISFACTION OF CLOSING CONDITIONS FOR THE TRANSACTION, INCLUDING REGULATORY APPROVAL, THE TENDER OF A MAJORITY OF THE OUTSTANDING SHARES OF COMMON STOCK OF SPARK THERAPEUTICS, THE POSSIBILITY THAT THE TRANSACTION WILL NOT BE COMPLETED, AND OTHER RISKS AND UNCERTAINTIES DISCUSSED IN SPARK THERAPEUTICS’ PUBLIC FILINGS WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION (THE “SEC”), INCLUDING THE “RISK FACTORS” SECTIONS OF SPARK THERAPEUTICS’ ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2018, AND IN ANY SUBSEQUENT PERIODIC REPORTS ON FORM 10-Q AND FORM 8-K, AS WELL AS THE TENDER OFFER DOCUMENTS FILED BY ROCHE AND ITS ACQUISITION SUBSIDIARY AND THE SOLICITATION/RECOMMENDATION FILED BY SPARK THERAPEUTICS. THESE STATEMENTS ARE BASED ON CURRENT EXPECTATIONS, ASSUMPTIONS, ESTIMATES AND PROJECTIONS, AND INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS THAT MAY CAUSE RESULTS, LEVELS OF ACTIVITY, PERFORMANCE OR ACHIEVEMENTS TO BE MATERIALLY DIFFERENT FROM ANY FUTURE STATEMENTS. THESE STATEMENTS ARE GENERALLY IDENTIFIED BY WORDS OR PHRASES SUCH AS “BELIEVE”, “ANTICIPATE”, “EXPECT”, “INTEND”, “PLAN”, “WILL”, “MAY”, “SHOULD”, “ESTIMATE”, “PREDICT”, “POTENTIAL”, “CONTINUE” OR THE NEGATIVE OF SUCH TERMS OR OTHER SIMILAR EXPRESSIONS. IF UNDERLYING ASSUMPTIONS PROVE INACCURATE OR UNKNOWN RISKS OR UNCERTAINTIES MATERIALIZE, ACTUAL RESULTS AND THE TIMING OF EVENTS MAY DIFFER MATERIALLY FROM THE RESULTS AND/OR TIMING DISCUSSED IN THE FORWARD-LOOKING STATEMENTS, AND YOU SHOULD NOT PLACE UNDUE RELIANCE ON THESE STATEMENTS. ROCHE AND SPARK THERAPEUTICS DISCLAIM ANY INTENT OR OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS AS A RESULT OF DEVELOPMENTS OCCURRING AFTER THE PERIOD COVERED BY THIS REPORT OR OTHERWISE.

 

ADDITIONAL INFORMATION AND WHERE TO FIND IT

 

THIS DOCUMENT IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFER TO PURCHASE OR A SOLICITATION OF AN OFFER TO SELL ANY SHARES OF THE COMMON STOCK OF SPARK THERAPEUTICS. THE TENDER OFFER IS ONLY BEING MADE PURSUANT TO AN OFFER TO PURCHASE AND RELATED MATERIALS. ROCHE AND ITS ACQUISITION SUBSIDIARY FILED A TENDER OFFER STATEMENT ON SCHEDULE TO WITH THE SEC ON MARCH 7, 2019, AND SPARK THERAPEUTICS FILED A SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WITH RESPECT TO THE OFFER WITH THE SEC ON MARCH 7, 2019, IN EACH CASE AS AMENDED FROM TIME TO TIME. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THESE MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS), AS THEY MAY BE AMENDED FROM TIME TO TIME, CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER SINCE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER. THE OFFER TO PURCHASE, SOLICITATION/RECOMMENDATION STATEMENT AND RELATED MATERIALS HAVE BEEN FILED WITH THE SEC, AND INVESTORS AND SECURITY HOLDERS MAY OBTAIN A FREE COPY OF THESE MATERIALS AND OTHER DOCUMENTS FILED BY ROCHE AND SPARK THERAPEUTICS WITH THE SEC AT THE WEBSITE MAINTAINED BY THE SEC AT WWW.SEC.GOV. INVESTORS AND SECURITY HOLDERS MAY ALSO OBTAIN FREE COPIES OF THE SOLICITATION/RECOMMENDATION STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC BY SPARK THERAPEUTICS AT WWW.SPARKTX.COM.

 

 

 

 

Exhibit (a)(5)(xxi)

 

 

Media Release

 

RoLo40c

 

Roche and Spark Therapeutics, Inc. receive Request for Additional Information from FTC under Hart-Scott-Rodino Act and announce extension of tender offer for shares of Spark Therapeutics, Inc.

 

Basel, 10 June 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that they have each received a request for additional information and documentary material (the “Second Request”) from the U.S. Federal Trade Commission (the “FTC”) in connection with the FTC’s review of Roche’s pending acquisition of Spark.

 

Issuance of the Second Request is part of the regulatory review process. The effect of the Second Request is to extend the waiting period until 10 days after Roche has substantially complied with the Second Request, unless the waiting period is terminated earlier by the FTC or the parties have entered into a timing agreement with the FTC. The parties remain committed to the transaction and are working cooperatively and expeditiously with the FTC in connection with its review.

 

As a result of the Second Request, pursuant to the Agreement and Plan of Merger, dated as of February 22, 2019, by and among Roche Holdings, Inc., 022019 Merger Subsidiary, Inc., and Spark (the “Merger Agreement”), Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock (the “Shares”) of Spark for USD 114.50 per Share, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 7, 2019 (as it may be amended and supplemented from time to time, the “Offer”). The Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on Friday, June 14, 2019, has been extended until 5:00 p.m., New York City time, on July 31, 2019, unless it is extended further under the circumstances set forth in the Merger Agreement. All terms and conditions of the Offer shall remain unchanged during the extended period.

 

Citibank, N.A., the depository for the Offer, has advised Roche that, as of 5:00 p.m., New York City time, on June 7, 2019, approximately 8,125,931 Shares of Spark (none of which were tendered by notice of guaranteed delivery) had been validly tendered and received, and not validly withdrawn, pursuant to the Offer,

 

    
F. Hoffmann-La Roche Ltd

4070 Basel

Switzerland

Group Communications

Roche Group Media Relations

Tel. +41 61 688 88 88

www.roche.com

 

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representing approximately 21.1% of Spark’s outstanding Shares. Stockholders who have already tendered their Shares of Spark do not have to re-tender their Shares or take any other action as a result of the extension of the expiration date of the Offer.

 

In addition, the UK Competition and Markets Authority (the “CMA”) has opened an investigation in order to obtain further information in relation to Roche’s proposed acquisition of Spark.  The investigation will determine whether the CMA considers it has jurisdiction over the acquisition; and, if so, whether the CMA considers that the acquisition may be expected to result in a substantial lessening of competition in the UK such as to warrant a more detailed, Phase 2 review.  In the latter case, the CMA may accept remedies offered by the parties to avoid a Phase 2 review.  Pending the outcome of its investigation, the CMA has issued an Interim Enforcement Order that would become effective upon closing of the transaction and would require Roche to hold separate the Spark business.  The parties are working cooperatively with the CMA and will continue to do so.

 

Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and received, and not validly withdrawn, a majority of the outstanding Spark Shares.

 

MacKenzie Partners, Inc. is acting as information agent for the Offer. Requests for documents and questions regarding the Offer may be directed to MacKenzie Partners, Inc. by telephone, toll-free at (800) 322-2885 (please call (212) 929-5500 (collect) if you are located outside the US or Canada) or via email at tenderoffer@mackenziepartners.com.

 

About Spark Therapeutics
Spark Therapeutics is a fully integrated, commercial company committed to discovering, developing and delivering gene therapies. The company challenges the inevitability of genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), Spark Therapeutics’ investigational therapies have the potential

 

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to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed Spark Therapeutics’ scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases.

Spark Therapeutics is headquartered in Philadelphia, Pennsylvania.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

 


Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

 

 

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All trademarks used or mentioned in this release are protected by law.

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

SOME OF THE STATEMENTS CONTAINED IN THIS ANNOUNCEMENT ARE FORWARD-LOOKING STATEMENTS, INCLUDING STATEMENTS REGARDING, AMONG OTHER THINGS, THE EXPECTED CONSUMMATION OF THE TRANSACTION, WHICH INVOLVES A NUMBER OF RISKS AND UNCERTAINTIES, INCLUDING THE SATISFACTION OF CLOSING CONDITIONS FOR THE TRANSACTION, INCLUDING REGULATORY APPROVAL, THE TENDER OF A MAJORITY OF THE OUTSTANDING SHARES OF COMMON STOCK OF SPARK THERAPEUTICS, THE POSSIBILITY THAT THE TRANSACTION WILL NOT BE COMPLETED, AND OTHER RISKS AND UNCERTAINTIES DISCUSSED IN SPARK THERAPEUTICS’ PUBLIC FILINGS WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION (THE “SEC”), INCLUDING THE “RISK FACTORS” SECTIONS OF SPARK THERAPEUTICS’ ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2018, AND IN ANY SUBSEQUENT PERIODIC REPORTS ON FORM 10-Q AND FORM 8-K, AS WELL AS THE TENDER OFFER DOCUMENTS FILED BY ROCHE AND ITS ACQUISITION SUBSIDIARY AND THE SOLICITATION/RECOMMENDATION FILED BY SPARK THERAPEUTICS. THESE STATEMENTS ARE BASED ON CURRENT EXPECTATIONS, ASSUMPTIONS, ESTIMATES AND PROJECTIONS, AND INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS THAT MAY CAUSE RESULTS, LEVELS OF ACTIVITY, PERFORMANCE OR ACHIEVEMENTS TO BE MATERIALLY DIFFERENT FROM ANY FUTURE STATEMENTS. THESE STATEMENTS ARE GENERALLY IDENTIFIED BY WORDS OR PHRASES SUCH AS “BELIEVE”, “ANTICIPATE”, “EXPECT”, “INTEND”, “PLAN”, “WILL”, “MAY”, “SHOULD”, “ESTIMATE”, “PREDICT”, “POTENTIAL”, “CONTINUE” OR THE NEGATIVE OF SUCH TERMS OR OTHER SIMILAR EXPRESSIONS. IF UNDERLYING ASSUMPTIONS PROVE INACCURATE OR UNKNOWN RISKS OR UNCERTAINTIES MATERIALIZE, ACTUAL RESULTS AND THE TIMING OF EVENTS MAY DIFFER MATERIALLY FROM THE RESULTS AND/OR TIMING DISCUSSED IN THE FORWARD-LOOKING STATEMENTS, AND YOU SHOULD NOT PLACE UNDUE RELIANCE ON THESE STATEMENTS. ROCHE AND SPARK THERAPEUTICS DISCLAIM ANY INTENT OR OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS AS A RESULT OF DEVELOPMENTS OCCURRING AFTER THE PERIOD COVERED BY THIS REPORT OR OTHERWISE.

ADDITIONAL INFORMATION AND WHERE TO FIND IT

 

THIS ANNOUNCEMENT IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFER TO PURCHASE OR A SOLICITATION OF AN OFFER TO SELL ANY SHARES OF THE COMMON STOCK OF SPARK THERAPEUTICS. THE TENDER OFFER IS ONLY BEING MADE PURSUANT TO AN OFFER TO PURCHASE AND RELATED MATERIALS. ROCHE AND ITS ACQUISITION SUBSIDIARY FILED A TENDER OFFER STATEMENT ON SCHEDULE TO WITH THE SEC ON MARCH 7, 2019, AND SPARK THERAPEUTICS FILED A SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WITH RESPECT TO THE OFFER WITH THE SEC ON MARCH 7, 2019, IN EACH CASE AS AMENDED FROM TIME TO TIME. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THESE MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS), AS THEY MAY BE AMENDED FROM TIME TO TIME, CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER SINCE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER. THE OFFER TO PURCHASE, SOLICITATION/RECOMMENDATION STATEMENT AND RELATED MATERIALS HAVE BEEN FILED WITH THE SEC, AND INVESTORS AND SECURITY HOLDERS MAY OBTAIN A FREE COPY OF THESE MATERIALS AND OTHER DOCUMENTS FILED BY ROCHE AND SPARK THERAPEUTICS WITH THE SEC AT THE WEBSITE MAINTAINED BY THE SEC AT WWW.SEC.GOV. INVESTORS AND SECURITY HOLDERS MAY ALSO OBTAIN FREE COPIES OF THE SOLICITATION/RECOMMENDATION STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC BY SPARK THERAPEUTICS AT WWW.SPARKTX.COM.

 

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Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

 

- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger


 




 

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